IFU Ed 2.0 - DFM100 - English-453564403811

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English

Instructions for Use

Eff i ci a DF M10 0
De fi b ri l l ato r /Mo n ito r

866199
Notice
About This Edition Medical Device Directive
Edition 2.0
Publication Number: 453564403811 0123
Publication Date: June 2021 The Efficia DFM100 complies with the requirements of the
Medical Device Directive 93/42/EEC and carries the mark
This information is subject to change without notice. accordingly.
The information in this document applies to the
Efficia DFM100 using software version 2.00. Manufacturer:
Philips shall not be liable for errors contained herein or for Philips Goldway (Shenzhen) Industrial Inc.
incidental or consequential damages in connection with the Registered/Production address:
furnishing, performance, or use of this material. No.2 Keji North 3rd Road, Nanshan District,
Shenzhen, P.R. China 518057
Copyright Tel: +86 755 26980999
Fax: +86 755 26980222
©2019 Koninklijke Philips N.V. All rights reserved.
Reproduction in whole or in part is prohibited without the prior Authorized EU-representative:
written consent of the copyright holder.
Shanghai International Holding Corp. GmbH (Europe)
Philips and the Philips shield are trademarks of Koninklijke Eiffestraße 80, 20537
Philips N.V. Hamburg, Germany
SMART Biphasic is a registered trademark of Philips. Tel: 0049-40-2513175
All other trademarks are the property of their respective owners. Fax: 0049-40-255726

i
Notice

Conventions Used in This Manual


This book contains the following conventions:

WARNING: Warning statements alert you to a potential serious outcome, adverse event or safety hazard. Failure
to observe a warning may result in death or serious injury to the user or patient.

CAUTION: Caution statements alert you to where special care is necessary for the safe and effective use of the
product. Failure to observe a caution may result in minor or moderate personal injury or damage to
the product or other property, loss of data, and possibly in a remote risk of more serious injury
and/or cause environmental pollution.

NOTE: Notes contain additional information on usage.

TIP: Tips provide hands-on insight into using this product.

 The “bull’s eye” icon indicates a process or a procedure (a set of steps to achieve a certain goal).
“Voice” represents voice prompt messages
 represents messages that appear on the display
 represents soft key labels that appear on the display above the button to which they
correspond
“See represents hypertext links; click on the blue link to go to that destination
“Introduction” (Computer screen viewing only)
on page 1”

ii
Table of Contents
Chapter 1 Introduction 1

Overview . . . . . . . . .. . . . . . . . . . . . . . . 1
Intended Use . . . . . . .. . . . . . . . . . . . . . . 2
Indications for Use and Contraindications . . . . . . . . . . . . . . . 2
Safety Considerations . . . . . . . . . . . . . . . . . . . . 5
Getting Started . . . . . . . . . . . . . . . . . . . . . . 5

Chapter 2 Device Basics 7

Introduction . . . . . . . . . . . . . . . . . . . . . . . 7
Basic Orientation . . . .
. . . . . . . . . . . . . . . . . . 8
Front of the Device . . .
. . . . . . . . . . . . . . . . . . 8
Right Side . . . . .
. . . . . . . . . . . . . . . . . . 9
Connecting the Therapy Cable . . . . . . . . . . . . . . . . . . 9
Left (Monitor) Side. . . . . . . . . . . . . . . . . . . . . 11
Top Panel . . . . . . . . . . . . . . . . . . . . . . . 14
Back Panel . . . . . . . . . . . . . . . . . . . . . . . 16
Installing Paper . . . . . . . . . . . . . . . . . . . . . . 19
Test Plug & Test Load . . . . . . . . . . . . . . . . . . . . 20
Additional Features . . . . . . . . . . . . . . . . . . . . . 21
EMS Environment . . . . . . . . . . . . . . . . . . . . . 23

Chapter 3 Operating the Device 25

Operating Modes . . . . . . . . . . . . . . . . . . . . . . 25
Controls . . . . . . . . . . . . . . . . . . . . . . . . 26
Therapy Knob and Controls . . . . . . . . . . . . . . . . . . 26
Smart Select Knob . . . . . . . . . . . . . . . . . . . . . 27
General Function Buttons . . . . . . . . . . . . . . . . . . . 27
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . 28
Ready For Use Indicator . . . . . . . . . . . . . . . . . . . . 28
Power . . . . . . . . . . . . . . . . . . . . . . . . . 29
Lithium Ion Battery . . . . . . . . . . . . . . . . . . . . 29
Power Indicators . . . . . . . . . . . . . . . . . . . . . 30
Turning the Efficia DFM100 On . . . . . . . . . . . . . . . . . 30
Turning the Efficia DFM100 Off . . . . . . . . . . . . . . . . . 30
Device Shutdown . . . . . . . . . . . . . . . . . . . . . 30
The Display . . . . . . . . . . . . . . . . . . . . . . . 31
Status Area . . . . . . . . . . . . . . . . . . . . . . . 31
Parameter Area . . . . . . . . . . . . . . . . . . . . . . 32
Message Area . . . . . . . . . . . . . . . . . . . . . . 33
Waveform and Display Soft Keys Area . . . . . . . . . . . . . . . . 33
Adjusting Volumes . . . . . . . . . . . . . . . . . . . . . 36
Alarms . . . . . . . . . . . . . . . . . . . . . . . . 37

iii
Table of Contents

Clinical Mode Alarm Notification . . . . . . . . . . . . . . . . . 38


Responding to Alarms . . . . . . . . . . . . . . . . . . . 41
Entering Patient Information . . . . . . . . . . . . . . . . . . 42
Continued Use . . . . . . . . . . . . . . . . . . . . . . 43
Mark Events . . . . . . . . . . . . . . . . . . . . . . 43
Passwords . . . . . . . . . . . . . . . . . . . . . . . 44
Service Mode Password . . . . . . . . . . . . . . . . . . . 44
Configuration Mode Password . . . . . . . . . . . . . . . . . 44
Data Management Mode Password . . . . . . . . . . . . . . . . 44
Safety Considerations . . . . . . . . . . . . . . . . . . . . 45

Chapter 4 ECG Monitoring 47

Overview . . . . . . . . . . . . . . . . . . . . . . . 47
Preparing to Monitor ECG . . . . . . . . . . . . . . . . . . . 48
Skin Preparation . . . . . . . . . . . . . . . . . . . . . 48
Monitoring ECG with Pads . . . . . . . . . . . . . . . . . . 48
Monitoring ECG with Electrodes . . . . . . . . . . . . . . . . . 48
Monitor View . . . . . . . . . . . . . . . . . . . . . . 52
Selecting the Waveform . . . . . . . . . . . . . . . . . . . 52
Displaying an Annotated ECG . . . . . . . . . . . . . . . . . 54
Arrhythmia Monitoring . . . . . . . . . . . . . . . . . . . 55
Aberrantly-Conducted Beats . . . . . . . . . . . . . . . . . . 55
Intermittent Bundle Branch Block . . . . . . . . . . . . . . . . 55
Arrhythmia Learning/Relearning . . . . . . . . . . . . . . . . . 55
Heart Rate and Arrhythmia Alarms . . . . . . . . . . . . . . . . 56
Setting Alarms . . . . . . . . . . . . . . . . . . . . . 59
Responding to Alarms . . . . . . . . . . . . . . . . . . . 60
HR/Arrhythmia Alarms in AED Mode . . . . . . . . . . . . . . . 60
Troubleshooting . . . . . . . . . . . . . . . . . . . . . 60

Chapter 5 AED Mode Option 61

Precautions for AED Therapy . . . . . . . . . . . . . . . . . . 62


AED View . . . . . . . . . . . . . . . . . . . . . . . 63
AED Soft Keys . . . . . . . . . . . . . . . . . . . . . 64
Using AED Mode to Defibrillate . . . . . . . . . . . . . . . . . 64
Preparation . . . . . . . . . . . . . . . . . . . . . . 64
Operation . . . . . . . . . . . . . . . . . . . . . . 65
Using AED Mode to Monitor . . . . . . . . . . . . . . . . . . 71
Configurable Resuscitation Protocols . . . . . . . . . . . . . . . . 72
AED Alarms . . . .
. . . . . . . . . . . . . . . . . . 72
Other Alarms in AED Mode . . . . . . . . . . . . . . . . . . 73
Troubleshooting . . . . . . . . . . . . . . . . . . . . . 73

iv
Table of Contents

Chapter 6 Manual Defibrillation 75

Overview . . . . . . . . . . . . . . . . . . . . . . . . 75
Precautions for Manual Defibrillation . . . . . . . . . . . . . . . . 76
Code View . . . . . . . . . . . . . . . . . . . . . . . 77
Preparing for Defibrillation . . . . . . . . . . . . . . . . . . . 78
Using Multifunction Electrode Pads . . . . . . . . . . . . . . . . . 78
Using External Paddles . . . . . . . . . . . . . . . . . . . . 78
Using Infant Paddles . . . . . . . . . . . . . . . . . . . . 79
Using Internal Paddles . . . . . . . . . . . . . . . . . . . . 79
Defibrillation . . . . . . . . . . . . . . . . . . . . . . . 79
Step 1 - Select Energy . . . . . . . . . . . . . . . . . . . . 79
Step 2 - Charge. . . . . . . . . . . . . . . . . . . . . . 80
Step 3 - Shock . . . . . . . . . . . . . . . . . . . . . . 80
Manual Defibrillation Alarms . . . . . . . . . . . . . . . . . . 81
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 82

Chapter 7 Synchronized Cardioversion 83

Overview . . . . . . . . . . . . . . . . . . . . . . . . 83
Precautions for Cardioversion . . . . . . . . . . . . . . . . . . 84
Preparing for Synchronized Cardioversion . . . . . . . . . . . . . . . 85
Code View and Cardioversion . . . . . . . . . . . . . . . . . . 86
Delivering a Synchronized Shock . . . . . . . . . . . . . . . . . . 86
With External Paddles . . . . . . . . . . . . . . . . . . . . 87
Delivering Additional Shocks . . . . . . . . . . . . . . . . . . 87
Turning Sync Off . . . . . . . . . . . . . . . . . . . . . 88
Cardioversion Alarms . . . . . . . . . . . . . . . . . . . . . 88
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 88

Chapter 8 Pacing 89

Overview . . . . . . . . . . . . . . . . . . . . . . . . 89
Pacing View . . . . . . . . . . . . . . . . . . . . . . . 89
Demand Mode Versus Fixed Mode . . . . . . . . . . . . . . . . . 90
Preparing for Pacing . . . . . . . . . . . . . . . . . . . . . 91
Demand Mode Pacing . . . . . . . . . . . . . . . . . . . . 92
Fixed Mode Pacing . . . . . . . . . . . . . . . . . . . . . 93
Defibrillating During Pacing . . . . . . . . . . . . . . . . . . . 94
Pacing Alarms . . . . . . . . . . . . . . . . . . . . . . . 94
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 95

v
Table of Contents

Chapter 9 Monitoring CO2 97

Overview . . . . . . . . . . . . . . . . . . . . . . . 97
Precautions for Measuring EtCO2 . . . . . . . . . . . . . . . . . 98
Preparing to Measure EtCO2 . . . . . . . . . . . . . . . . . . 99
Sensors . . . . . . . . . . . . . . . . . . . . . . . 99
Selecting the Accessories . . . . . . . . . . . . . . . . . . . 99
Monitoring EtCO2 . . . . . . . . . . . . . . . . . . . . . 100
EtCO2 and AwRR Alarms . . . . . . . . . . . . . . . . . . . 101
Changing the EtCO2 Alarm Limits . . . . . . . . . . . . . . . . 102
Enabling/Disabling the EtCO2 Alarms . . . . . . . . . . . . . . . 103
Changing the AwRR Alarm Limits . . . . . . . . . . . . . . . . 103
Changing the Apnea Time Alarm Limit . . . . . . . . . . . . . . . 103
Enabling/Disabling AwRR Alarms . . . . . . . . . . . . . . . . 103
Zeroing Sidestream and Mainstream Sensors . . . . . . . . . . . . . . 104
Zeroing Using the Soft Key . . . . . . . . . . . . . . . . . . 104
Zeroing Using the Smart Select knob . . . . . . . . . . . . . . . . 104
Disabling the EtCO2 Monitoring Function . . . . . . . . . . . . . . 105
Troubleshooting . . . . . . . . . . . . . . . . . . . . . 105

Chapter 10 Monitoring SpO2 107

Overview . . . . . . . . . . . . . . . . . . . . . . . 107
Understanding Pulse Oximetry . . . . . . . . . . . . . . . . . . 108
Selecting a Sensor . . . . . . . . . . . . . . . . . . . . 109
Applying the Sensor . . . . . . . . . . . . . . . . . . . . 109
Monitoring SpO2 . . . . . . . . . . . . . . . . . . . . . 110
SpO2 Alarms . . . .. . . . . . . . . . . . . . . . . . 111
SpO2 Desat Alarm . .. . . . . . . . . . . . . . . . . . 112
Changing SpO2 Alarm Limits . . . . . . . . . . . . . . . . . . 112
Enabling/Disabling SpO2 Alarms . . . . . . . . . . . . . . . . . 113
Pulse Rate Alarms . . . . . . . . . . . . . . . . . . . . . 113
Changing Pulse Rate Alarm Limits . . . . . . . . . . . . . . . . 113
Enabling/Disabling Pulse Rate Alarms . . . . . . . . . . . . . . . . 114
Disabling SpO2 Monitoring . . . . . . . . . . . . . . . . . . 114
Caring for Sensors . . . . . . . . . . . . . . . . . . . . . 114
Troubleshooting . . . . . . . . . . . . . . . . . . . . . 114

Chapter 11 Monitoring NBP 115

Overview . . . . . . . . . . . . . . . . . . . . . . . 115
Measuring NBP . . . . . . . . . . . . . . . . . . . . . . 116
NBP Alarms . . . . . . .. . . . . . . . . . . . . . . 118
Changing NBP Alarm and Source Limits . . . . . . . . . . . . . . . 119

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Table of Contents

Enabling/Disabling NBP Alarms . . . . . . . . . . . . . . . . . 120


Caring for Cuffs . . . . . . . . . . . . . . . . . . . . . . 120
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 120

Chapter 12 Trending 121

Overview . . . . . . . . . . . . . . . . . . . . . . . . 121
Viewing Trend Data . . . . . . . . . . . . . . . . . . . . 121
Printing the Trends Report . . . . . . . . . . . . . . . . . . . 123
Troubleshooting . . . . . . . . . . . . . . . . . . . . . 123

Chapter 13 Data Management 125

Overview . . . . . . . . . . . . . . . . . . . . . . . . 125
Event Summary . . . . . . . . . . . . . . . . . . . . . . 125
Data Management Mode . . . . . . . . . . . . . . . . . . . . 133
Internal Memory . . . . . . . . . . . . . . . . . . . . . 134
Accessing Data on the USB Drive . . . . . . . . . . . . . . . . . 136
Printing Data . . . . . . . .. . . . . . . . . . . . . . . 137
Printing During a Patient Event . . .. . . . . . . . . . . . . . . 137
Printing While in Data Management Mode . . . . . . . . . . . . . . . 138

Chapter 14 Configuration 139

Overview . . . . . .. . . . . . . . . . . . . . . . . . 139
Entering Configuration Mode . . . . . . . . . . . . . . . . . . 139
Accessing Configuration Mode . . . . . . . . . . . . . . . . . . 139
Setting Date and Time . . . . . . . . . . . . . . . . . . . . 140
Changing Settings . . . . . . . . . . . . . . . . . . . . . 140
Exporting Settings . . . . . . . . . . . . . . . . . . . . . 141
Importing Settings . . . . . . . . . . . . . . . . . . . . . 141
Printing Settings . . . . . . . . . . . . . . . . . . . . . 141
Restoring Default Settings . . . . . . . . . . . . . . . . . . . 142
Configurable Parameters . . . . . . . . . . . . . . . . . . . 142

Chapter 15 Operational and Shift Check 151

Shift Check . . . . . . . . . . . . . . . . . . . . . . . 151


Weekly Shock Test . . . . . . . . . . . . . . . . . . . . . 152
Operational Check . . . . . . . . . . . . . . . . . . . . . 153
Performing an Operational Check . . . . . . . . . . . . . . . . . 154
Printing Operational Check Results . . . . . . . . . . . . . . . . . 160
Operational Check Summaries . . . . . . . . . . . . . . . . . . 162
Auto Test Summaries . . . . . . . . . . . . . . . . . . . . 163

vii
Table of Contents

Chapter 16 Maintenance 165

Overview . . . . . . . . . . . . . . . . . . . . . . . 165
Automated Tests . . . . . . . . . . . . . . . . . . . . . 165
Auto Test Summaries . . . . . . . . . . . . . . . . . . . . 166
Battery Maintenance . . . . . . . . . . . . . . . . . . . . 168
Initializing Batteries . . . . . . . . . . . . . . . . . . . . 168
Charging Batteries . . . . . . . . . . . . . . . . . . . . 168
Storing Batteries . . . . . . . . . . . . . . . . . . . . . 169
Discarding Batteries . . . . . . . . . . . . . . . . . . . . 169
General Battery Safety . . . . . . . . . . . . . . . . . . . 169
Power-Related Alarms . . . . . . . . . . . . . . . . . . . 170
Cleaning Instructions . . . . . . . . . . . . . . . . . . . . 171
Defibrillator/Monitor, Paddles, Cables and Battery. . . . . . . . . . . . . 171
Printer Printhead . . . . . . . . . . . . . . . . . . . . . 171
Side Pouches . . . . . . . . . . . . . . . . . . . . . . 172
SpO2 Sensor and Cable . . . . . . . . . . . . . . . . . . . 172
CO2 Sensor and Cable . . . . . . . . . . . . . . . . . . . 172
NBP Cuff . . . . . . . . . . . . . . . . . . . . . . 172
Service Life . . . . . . . . . . . . . . . . . . . . . . . 172
Efficia DFM100 Disposal . . . . . . . . . . . . . . . . . . . 172

Chapter 17 Troubleshooting 173

Overview . . . . . . . . . . . . . . . . . . . . . . . 173
Resolving Issues . . . . . . . . . . . . . . . . . . . . . . 173
Responding to Test Results . . . . . . . . . . . . . . . . . . 173
Symptoms . . . . . . . . . . . . . . . . . . . . . . . 174
Servicing the DFM100 . . . . . . . . . . . . . . . . . . . . 187
Calling for Service . . . . . . . . . . . . . . . . . . . . 187

Chapter 18 Supplies and Accessories 189

Ordering Replacement Supplies and Accessories . . . . . . . . . . . . . 189

Chapter 19 Specifications 193

Specifications . . . .
. . . . . . . . . . . . . . . . . . 193
General . . . . .
. . . . . . . . . . . . . . . . . . 193
Defibrillator . . . .
. . . . . . . . . . . . . . . . . . 193
Manual Defibrillation Mode . . . . . . . . . . . . . . . . . . 195
AED Mode . . . . . . . . . . . . . . . . . . . . . . 196
ECG and Arrhythmia Monitoring . . . . . . . . . . . . . . . . 196
Display . . . . . . . . . . . . . . . . . . . . . . . 198
Battery . . . . . . . . . . . . . . . . . . . . . . . 198
Thermal Array Printer . . . . . . . . . . . . . . . . . . . 198

viii
Table of Contents

Noninvasive Pacing . . . . . . . . . . . . . . . . . . . . . 199


SpO2 Pulse Oximetry . . . . . . . . . . . . . . . . . . . . 199
EtCO2 . . . . . . . . . . . . . . . . . . . . . . . . 201
AwRR . . . . . . . . . . . . . . . . . . . . . . . . 201
NBP . . . . . . . . . . . . . . . . . . . . . . . . 201
Environmental . . . . . . . . . . . . . . . . . . . . . . 202
USB Device . . . . . . . . . . . . . . . . . . . . . . 204
Security and Privacy . . . . . . . . . . . . . . . . . . . . . 204
Internal Event Summary and Patient Data Storage . . . . . . . . . . . . . 204
Software Upgrades . . . . . . . . . . . . . . . . . . . . . 205
Symbol Definitions . . . . . . . . . . . . . . . . . . . . . 205
Abbreviation Definitions . . . . . . . . . . . . . . . . . . . . 206
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . 207
Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . 207
Appendix 1 - Efficia DFM100 Shift Checklist . . . . . . . . . . . . . . 217

ix
NOTES

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1

Introduction
Overview
The Efficia DFM100 is a lightweight, portable defibrillator/monitor with a large display. It provides
four clinical modes of operation: Monitor, Manual Defibrillation/Synchronized Cardioversion,
AED, and Pacing.
In Monitor mode, depending on the ECG cable used, you can view 3 different ECG waveforms at
one time on the display. Using a 3-lead ECG cable, you can view either Lead I, II or III. With a
5-Lead ECG cable, you can view leads from Leads I, II, III, aVR, aVL, aVF or V. Optional
monitoring of SpO2 (numeric and pleth wave), EtCO2 (numeric and Capnogram) and NBP are
available. Measurements and waves are presented on the display and alarms are available to alert you
to a change in the patient’s condition. You can also display the Vital Signs Trending report to view all
key monitoring parameters and their measurements at a glance.
Manual Defibrillation mode provides simple 1-2-3 defibrillation. You analyze the patient’s ECG and,
if appropriate: 1) select an energy setting; 2) charge; and 3) deliver the shock. Defibrillation is
performed using paddles (internal or external) or multifunction electrode pads. You can also
perform synchronized cardioversion in Manual Defibrillation mode.
In the optional AED mode, the Efficia DFM100 analyzes the patient’s ECG and determines
whether a shock is advised. Voice prompts guide you through the 2-step defibrillation process, while
easy-to-follow instruction and patient information (including Adult and Infant/Child patient
categories) appear on the display. Voice prompts are reinforced by messages on the display.
Optional Pacing mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered
through multifunction electrode pads in Demand or Fixed modes.
The Efficia DFM100 incorporates low energy SMART Biphasic waveform for defibrillation.
The device automatically stores critical event data such as Event Summaries and Vital Signs
Trending.
In clinical mode, the Efficia DFM100 continually records data about a patient in an Event Summary
record. The recorded data includes vital signs (such as SpO2, and heart rate), ECG wave data, and
therapy events (such as shock delivered). The Event Summary can be printed or exported after the
patient event is completed.
You can also transfer the data to a USB drive and download it to a compatible version of the Philips
data management solution – HeartStart Event Review Pro.
The Efficia DFM100 is powered by a rechargeable Lithium Ion battery. Available battery power is
determined by viewing the battery power indicators located on the front of the device, the icon on
the display, or by checking the gauge on the battery itself. Additionally, AC Power may be applied as
a secondary power source and for continual battery charging.
The Ready For Use (RFU) Indicator provides a constant status update, indicating the Efficia
DFM100 is ready for use, needs attention or is unable to deliver therapy. The device performs
automated tests on a regular basis and displays results on the RFU Indicator. In addition,
performing specified operational checks ensures the Efficia DFM100 is functioning properly.
The Efficia DFM100 is highly configurable to better meet the needs of diverse users, including the
EMS (Emergency Medical Services) environment. Be sure to familiarize yourself with your device’s
configuration before using the Efficia DFM100. See “Configuration” on page 139 for more details.

1
1: Introduction Overview

Intended Use
Use Environment
The DFM100 may be used by Advanced Life Support (ALS) personnel in the following use
environments:
• General hospital crash-cart use, in which the defibrillator/monitor is typically placed on a cart
that includes other life-saving supplies and medications that can be wheeled to the patient’s
bedside in a cardiac emergency. The defibrillator/monitor geared for crash cart applications
would commonly be used in general care areas and critical care units (CCUs), as well as in
specialized areas such as the operating room, emergency department, and cardiac
catheterization laboratory. AED capability may be advantageous for crash-cart and in-hospital
transport applications because it would expand the number of potential users for a resuscitation
attempt to include Basic Life Support (BLS) personnel, who may arrive at the bedside before
the ALS resuscitation team.
• In the prehospital environment, a defibrillator/monitor may be used by ALS responders who
would be called to the scene of a medical emergency through the emergency medical response
system. This application also encompasses some other out-of-hospital uses, such as critical care
patient transport in an ambulance to a higher acute care facility. In addition, some EMS
organizations may choose to train their BLS personnel on the use of defibrillators/monitors in
AED mode.

Intended Use of the Efficia DFM100


The Efficia DFM100 is intended for use in a hospital or EMS setting by users trained in the
operation of the device and qualified by training in BLS and ALS. The Efficia DFM100 is intended
for use for emergency resuscitation as follows:
• In AED mode, the Efficia DFM100 is intended to detect a shockable rhythm and deliver a
shock.
• In Manual mode, the Efficia DFM100 is intended to deliver synchronized and asychronized
defibrillation.
• In Pacing mode, the Efficia DFM100 is intended to deliver external cardiac pacing.
• In Monitor mode, the Efficia DFM100 is intended to measure heart rate and heart rhythm via
ECG, measure blood oxygen saturation via SpO2, measure exhaled CO2 via EtCO2, and
measure systolic, diastolic, and mean blood pressure via NBP.

Intended Use Population


The Efficia DFM100 is intended to be used with the following populations as defined by the
European Resuscitation Council (ERC) according to Maconochie, I.K., et al. (2015):
• A newborn is a child just after birth.
• A neonate is a child in the first 28 days of life.
• An infant is a child under 1 year.
• A child is between 1 year and puberty.
• From puberty, children are referred to as adolescents, and adult guidelines apply.
• Adult guidelines continue to be applied after adolescence.

Indications for Use and Contraindications


Advanced Cardiac Life Support (ACLS) often starts with analyzing the patient’s heart rhythms with
a manual ALS monitor/defibrillator, such as the Efficia DFM100. In contrast to an AED in BLS,
where the machine makes the determination as to when to defibrillate (shock) a patient, the user
makes those decisions based on the rhythms on the monitor and the patient's vital signs. The next

2
Overview 1: Introduction

steps in ACLS are to provide defibrillation, pacing, insertion of intravenous (IV) lines, and
placement of various airway devices, such as an endotracheal tube (an advanced airway used in
intubations). Commonly-used ACLS drugs, such as epinephrine and amiodarone, are then
administered between defibrillations in cardiac arrest. Users trained in the operation of the device
and qualified by training in basic life support, advanced life support, or defibrillation often use the
Efficia DFM100 in the following modes.

AED Mode
In AED mode, the Efficia DFM100 is a semi-automatic defibrillator that uses the patented SMART
Analysis AED algorithm. This software algorithm analyzes the patient’s electrocardiographic (ECG)
rhythm and indicates whether or not it detects a shockable rhythm. The Efficia DFM100 in AED
mode requires user interaction to defibrillate the patient.
• Indications for Use: AED mode is indicated only on patients in cardiopulmonary arrest. The
patient must be unconscious, pulseless, and not breathing before you can use the defibrillator to
analyze the patient’s ECG.
• Contraindications: The Efficia DFM100 is contraindicated for asynchronous defibrillation in
AED mode for patients who are conscious, have a pulse, and are breathing.

Manual Defibrillation
A direct current defibrillator applies a brief intense pulse of electricity to the cardiac muscle. The
Efficia DFM100 delivers this energy through disposable electrode pads, external paddles applied to
the patient’s chest, or internal paddles applied to the heart. Defibrillation is one aspect of the
medical care required to resuscitate a patient with a shockable ECG rhythm. Depending on the
situation, other supportive measures may include CPR, oxygen administration, and/or drug therapy.
Successful resuscitation is related to the length of time between the onset of a heart rhythm that
does not circulate the blood (ventricular fibrillation, pulseless ventricular tachycardia) and
defibrillation. The American Heart Association (AHA) and ERC identified the following links in the
chain of survival from cardiac arrest:
• Early access
• Early CPR
• Early defibrillation
• Early advanced life support
The physiological state of the patient may affect the likelihood of successful defibrillation. Thus,
failure to resuscitate a patient is not a reliable indicator of Efficia DFM100 performance. Patients
will often exhibit a muscular response during energy transfer. The absence of such a response is not
a reliable indicator of actual energy delivery or device performance.
Unsynchronized defibrillation involves the use of a high-energy shock (delivered as soon as the
Shock button is pushed) to treat conditions such as ventricular fibrillation and pulseless ventricular
tachycardia. Synchronized defibrillation, or cardioversion, involves the delivery of a low-energy
shock that is timed at a specific point on the QRS complex to avoid inducing ventricular fibrillation.
Cardioversion is used to treat cardiac arrhythmias such as atrial fibrillation, atrial flutter, or
supraventricular tachycardia when medications have failed to convert the rhythm or when the
patient is unstable and the rhythm must be terminated. The Efficia DFM100 in Manual mode
requires user interaction to assess the ECG and decide whether to defibrillate the patient.
• Indications for Use: Manual defibrillation in the unsynchronized mode is indicated for
terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and
symptomatic ventricular tachycardia. Delivery of defibrillation in the synchronized mode is
indicated for treating atrial fibrillation, atrial flutter, supraventricular tachycardia, and ventricular
tachycardia.

3
1: Introduction Overview

• Contraindications: The Efficia DFM100 is contraindicated for asynchronous defibrillation in


manual mode for patients who are conscious, have a pulse, and are breathing, or who do not
have a pulse but are in a non-shockable rhythm, such as asystole or pulseless electrical activity.
The Efficia DFM100 is also contraindicated for synchronous defibrillation in patients that are
pulseless and unresponsive with rhythms consistent with ventricular fibrillation, pulseless
ventricular tachycardia, asystole, or pulseless electrical activity.

Transcutaneous Pacing
Non-invasive pacing in the Efficia DFM100 delivers an electrical impulse to the heart, causing
cardiac depolarization and myocardial contraction. The energy is delivered through electrode pads
placed on the chest. The AHA and ERC recognize that successful pacing of a patient is related to
the length of time between the onset of a bradydysrhythmia and the initiation of pacing. The
physiological state of the patient may affect the likelihood of successful pacing or skeletal muscle
activity. The failure to successfully pace a patient is not a reliable indicator of pacemaker
performance. The patient’s muscular response to pacing is also not a reliable indicator of energy
delivered. The Efficia DFM100 in Pacing mode requires user interaction to set the mA and rate and
start pacing the patient.
• Indications for Use: Non-invasive transcutaneous pacing is indicated for hemodynamically
unstable bradycardia in patients with a pulse who are unresponsive to atropine.
• Contraindications: The Efficia DFM100 is contraindicated for prolonged bradyasystolic
cardiac arrest.

ECG Monitoring
The electrocardiogram (ECG) is a recording of the electrical activity of the heart. ECG monitoring
allows for the identification and interpretation of cardiac rhythms or dysrhythmias and the
calculation of heart rate. ECG on the Efficia DFM100 is obtained by placing electrodes or
pads/paddles on the patient and allowing the heart’s electrical activity to be monitored and recorded.
The Efficia DFM100 in Monitoring mode requires user interaction to assess the patient’s ECG.
• Indications for Use: The Efficia DFM100 is indicated for monitoring and recording 3-5 lead
ECG waveforms and heart rate in patients with and without cardiac dysfunction.
• Contraindications: There are no known contraindications for ECG monitoring.

Pulse Oximetry (SpO2) Monitoring


Pulse oximetry is a noninvasive method that checks the saturation of oxygen in the arterial blood.
The pulse oximetry functionality in the Efficia DFM100 uses an optical sensor that detects light
through the patient’s finger and then measures the received light with a detector. The received light
is translated into a saturation percentage and is displayed as an SpO2 reading. The Efficia DFM100
in Monitoring mode requires user interaction to assess the patient’s SpO2.
• Indications for Use: Pulse oximetry is indicated for any patient who is at risk of developing
hypoxemia.
• Contraindications: There are no known contraindications for SpO2 monitoring.

Non-Invasive Blood Pressure (NBP) Monitoring


The Efficia DFM100 measures the blood pressure of patients by automatically inflating an
occluding cuff and using oscillometer measurement techniques to determine systolic, diastolic, mean
arterial pressures, and pulse. You can manually initiate this measurement, or you can set it to recur at
a predetermined interval. The Efficia DFM100 in Monitoring mode requires user interaction to
assess the patient’s NBP.

4
Overview 1: Introduction

• Indications for Use: Non-invasive blood pressure is indicated for detection of trends in
hypertension and hypotension. These include patient conditions indicated by abnormalities in
physiological parameters such as shock, perfusion during dysrhythmias, responses to fluid
therapy, titration of vasoactive and cardiotonic medications, and post-defibrillation recovery.
• Contraindications: NBP is contraindicated for patients with an upper arm circumference of
less than 13 cm.

End-Tidal CO2 Monitoring


The EtCO2 functionality in the Efficia DFM100 is a capnometric device that uses non-dispersive
infrared spectroscopy to continuously measure the amount of carbon dioxide (CO2) during each
breath and report the amount present at the end of exhalation. The sample is obtained by the
sidestream method and can be used with intubated and non-intubated patients. Respiration rate is
also measured and displayed in breaths per minute. The Efficia DFM100 in Monitoring mode
requires user interaction to assess the patient’s EtCO2.
• Indications for Use: EtCO2 monitoring is indicated for the detection of trends in the level of
expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute
cardiopulmonary care (for example, to determine the adequacy of chest compressions during
CPR, or to detect endotracheal tube placement or misplacement).
• Contraindications: There are no known contraindications for EtCO2 monitoring.

Safety Considerations
General warnings and cautions that apply to the use of the Efficia DFM100 are provided in “Safety
Considerations” on page 45. Additional warnings and cautions specific to a particular feature are
provided in the appropriate sections of these instructions.

WARNINGS: The Efficia DFM100 is not intended to be deployed in settings or situations that promote use by
untrained personnel. Operation by untrained personnel can result in injury or death.
Electric shock hazards exist internally. Do not attempt to open the device. Refer servicing to
qualified personnel.
Use only supplies and accessories approved for use with your Efficia DFM100. Use of
non-approved supplies and accessories could affect performance and results.
Use the Efficia DFM100 on one patient at a time.
Use single-use supplies and accessories only once.

Getting Started
The Efficia DFM100 comes from the factory ready to use. However, before putting the device into
clinical use for the first time, it is recommended you:
• Read these Instructions for Use in their entirety.
• Fully charge the battery. See “Power” on page 29.
• Run an operational check. See “Operational Check” on page 153.
• Perform a shift check. See “Shift Check” on page 151.

5
NOTES

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_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
2

Device Basics
Introduction
Combining Philips’ experience in resuscitation with the current wants and needs of today’s medical
environment, the Efficia DFM100 was designed with the user in mind.
Philips pioneered 1-2-3 defibrillation for you to defibrillate a patient and save a life quickly and
easily. Efficia DFM100 controls, indicators, menus and icons were carefully designed and organized
to facilitate ease of use. Display information is designed to present key information for the current
task.
This chapter provides a basic orientation on the Efficia DFM100’s external features, including the
various color-coded cable ports, installing the battery and printer paper, and optional external
paddles.
See “Operating the Device” on page 25 for instructions on how to operate the device.
If your Efficia DFM100 includes additional features for the EMS environment, review the section
related to “Additional Features” on page 21 as well as the rest of the chapter.

NOTES: If your Efficia DFM100 does not have some of the optional functionality listed in this chapter,
disregard these controls and the related information described throughout this manual.
Pictures of the Efficia DFM100 display appearing throughout this manual are for illustration
purposes only. The content of these areas varies with the display view, the options on your device
and the function being performed.

7
2: Device Basics Basic Orientation

Basic Orientation
This section provides an overview of the Efficia DFM100, options and accessories.

Front of the Device


The front of the device contains operational controls and indicators as shown in Figure 1.

Figure 1 Efficia DFM100

External Power
Indicator

Battery
External Indicator
Paddles

Ready For
Patient Use (RFU)
Category Indicator
button
AED Monitor
Lead OFF Therapy port
Select
button
Display Pacer
Therapy knob
Sync button
Parameter Sync
ports
Soft Charge
Charge button
keys (4)
Shock Shock button
Alarms Mark Events Reports Print

Alarms Mark Event Reports Print Smart


button button button button Select knob

Additional controls and indicators are located on the external paddles (see “External Paddles” on
page 14) and the Lithium Ion battery (see “Battery Fuel Gauge” on page 17).

8
Basic Orientation 2: Device Basics

Right Side
The right side of the Efficia DFM100 is dedicated to administering therapy and printing. It contains
a therapy port for paddles (external or internal) or a therapy cable with multifunction electrode pads.
It also contains the printer.

Figure 2 Therapy Port and Printer

Therapy port

Printer

Connecting the Therapy Cable


If your device also has the Therapy Cable Collar, see “Therapy Cable Collar” on page 21.

 To connect the Therapy Cable:


1 Align the white pointer on the cable with the white arrow on the green Therapy port. See
Figure 3.
2 Insert the cable into the green Therapy port and push until you hear it click into place. Confirm
the connection by gently tugging on the cable to make sure it does not come loose.

Figure 3 Connecting the Therapy Cable

9
2: Device Basics Basic Orientation

 To detach the Therapy Cable:


1 Rotate the green knob in a clockwise direction as indicated by the unlock symbol next to
the Therapy port.
2 Pull the cable away from the device.

Multifunction Electrode Pads


You can use multifunction electrode pads to monitor and deliver therapy to patients with the Efficia
DFM100.
Figure 4 Multifunctional Pads

Anterior-Anterior Anterior-Posterior
Placement Placement

Connecting Multifunction Electrode Pads


 To connect multifunction electrode pads:
1 Check the expiration date on the pads package and inspect the package for any damage. Discard
expired or damaged pads.
2 Connect the Therapy cable to the Efficia DFM100 (see “Connecting the Therapy Cable” on
page 9).
3 Open the package and connect the pads connector to the end of the Therapy cable (see
Figure 5).

Figure 5 Connecting Multifunctional Pads

4 Apply the pads to the patient as directed on the pads packaging or according to your
organization’s protocol.

10
Basic Orientation 2: Device Basics

Left (Monitor) Side.


The left side of the Efficia DFM100 is dedicated to monitoring key vital signs (see Figure 6). It has
ports for ECG, SpO2, CO2 and NBP.

Figure 6 Monitoring Side

Gray CO2 port

Blue SpO2 port

Red NBP port

Pouch White ECG port


connectors

Connecting the ECG Cable


 To connect a 3- or 5-Lead cable:
1 Align the ECG cable with the white ECG port (see Figure 7). The white key marker on the
ECG cable faces the top of the device.
2 Push the ECG cable firmly into the ECG port.

Figure 7 Connecting the ECG Cable

11
2: Device Basics Basic Orientation

Connecting the CO2 Cable and Sample Line


 To connect the CO2 cable:
1 Hold the cable connector with the flat side facing the front of the Efficia DFM100, insert the
cable into the gray CO2 port (see Figure 8) and push completely in.
2 Attach the Sample line to the sensor (see Figure 8) and then to the patient. See “Monitoring
EtCO2” on page 100.

Figure 8 Connecting the CO2 Cable

Connecting a Sidestream Module

Connecting a Mainstream Module

12
Basic Orientation 2: Device Basics

Connecting the SpO2 Cable


 To connect the SpO2 cable:
1 Hold the cable connector with the flat side and blue marking facing the front of the Efficia
DFM100 (see Figure 9).
2 Insert the cable into the blue SpO2 port and push the blue portion of the connector into the
device until it is no longer visible.

Figure 9 Connecting the SpO2 Cable

Connecting the NBP Cable


 To connect the NBP cable:
1 Insert the NBP cable into the red NBP port (see Figure 10) and push completely in.
2 Attach the NBP cable to the NBP cuff.

Figure 10 Connecting the NBP Cable

13
2: Device Basics Basic Orientation

Top Panel
The top of the Efficia DFM100 has a handle for easy transport and, if optional external paddles are
present, they reside in the paddle tray on the top of the device (see Figure 11).

Figure 11 Top Panel

External
Paddles

Handle

External Paddles
The Efficia DFM100 has two options for external paddles - part numbers M3543A and
989803196431. While the paddle sets look slightly different, they function the same in a clinical
environment.
Each External Paddle set can be used on both adult/child (10kg) and infant (< 10kg) patients.
Each apex paddle has a yellow button to remotely charge the defibrillator. Both paddles in each set
have orange shock buttons that flash when the defibrillator is charged. Press both orange buttons
simultaneously to administer a shock. Each sternum paddle contains a Patient Contact indicator
(PCI) with PCI icons . Orange or red lights on the PCI indicate poor patient contact. Adjust
paddle pressure and placement to optimize patient contact. Green lights on the PCI indicate that
good contact is established.

Figure 12 External Paddle Features - M3543A


Flashing Shock buttons

Patient
Contact
indicator
Remote
Charge
button

Proper sternum Release buttons for Proper apex


paddle placement Infant Paddles paddle
icon placement icon

14
Basic Orientation 2: Device Basics

Figure 13 External Paddle Features - 989803196431


Release buttons for Infant Paddles

Patient
Contact
Indicator
Remote
Charge
button

Proper sternum
paddle placement Flashing Proper apex
icon Shock paddle
buttons placement icon

Accessing Infant Paddles


Accessing the Infant Paddles is the same on both the M3543A and 989803196431 external paddle
sets.
To access the infant paddles: Figure 14 Infant Paddles
1 Press down on the release
buttons located on the front of
the external paddles.
2 Slide the adult electrode clip
off and away from the paddle
exposing the infant-sized
surface underneath.
Infant Paddles

WARNING: Make sure the defibrillator is not charged before accessing the infant paddles.

15
2: Device Basics Basic Orientation

Back Panel
The back panel of the Efficia DFM100 has a compartment for the Lithium Ion battery. It also
contains the AC power connection, the ECG Out jack to connect to an external monitor, the USB
port and the LAN port. See Figure 15. For more information on ECG Out, see “ECG Out Cable”
on page 18.

Figure 15 Back Panel

Cable Strap/
Rear Pouch
connectors

Bedrail Hook
connection

AC Power
Cord Guard

Battery Latch
LAN Port

USB Port
ECG Out Port Equalization AC Connection Battery
Terminal* Compartment
* - When the Efficia DFM100 is used together with other devices, their equalization terminals can be connected together to
eliminate any potential electrical differences between the two.

WARNING: Do not connect a LAN cable to the Efficia DFM100 while in a clinical mode. Incorrect ECG
diagnosis may result due to excessive electrical background noise. The LAN port should only be used
by production line staff or for servicing the device. It is not for customer use.

Installing the Battery


 To install the Efficia DFM100 Lithium Ion battery (see Figure 16):
1 Align the battery in the battery compartment. Confirm the arrow on the Battery Tab is pointed
up.
2 Push the battery into the battery compartment until you hear the Battery Latch lock into place.

Figure 16 Installing the Battery

16
Basic Orientation 2: Device Basics

NOTE: You can also lift the latch while pushing the battery into the battery compartment. Once the battery
is in the compartment, let the battery latch down to secure the battery inside the compartment.

Removing the Battery


 To remove the Efficia DFM100 Lithium Ion battery:
1 Push the Battery Latch up in the direction of the arrow.
2 The battery will eject out of the compartment. If it does not, pull on the Battery Tab to
completely remove the battery.

Battery Fuel Gauge


To check the power remaining in your Lithium Ion battery when it is not installed in the Efficia
DFM100, press the Battery Power Gauge (see Figure 17) located on the end of the battery opposite
the battery tab. Each solid blue light indicates approximately 20 percent charge. A flashing blue light
farthest to the button indicates the battery is too weak and must be recharged before use.

Figure 17 Battery Gauge

Press here

To check the battery power remaining when the battery is inserted in the device, look at the battery
gauge on the display (see “Battery Charge Level” on page 32).

WARNING: Use only approved batteries to power the Efficia DFM100. Use of non-approved batteries could
affect performance and results.

AC Power Cord Guard


Your Efficia DFM100 is equipped with an AC power cord guard.

 To put the power cord guard in proper position:


1 Plug the AC power cord into the AC connection on the back of the device. Push it snugly into
place.
2 Lower the power cord guard into place, confirming it catches on the back of the AC power cord
(see Figure 18).
3 Confirm a snug fit by lightly tugging on the cord.

Figure 18 AC Power Cord Guard

17
2: Device Basics Basic Orientation

ECG Out Cable


Also referred to as a Sync Cable, the Philips ECG Out Cable is used to establish a connection
between the Efficia DFM100 and a bedside monitor to send ECG signals between the two devices.
The cable sends one analog ECG waveform from the sending device to the receiving device.

 To connect the ECG Out Cable:


1 Plug the phono plug into the ECG Out Port on the device you want to send the ECG from -
now known as the primary device.
2 Plug the Pin Connector into the white ECG In Port on the receiving device - now known as the
secondary device.
The ECG waveform from the primary device appears as Lead II on the secondary device’s display.
Figure 19 Connecting ECG Out Cable
Primary Device Secondary Device
ECG Out Port
ECG In Port

Phono Plug

Pin Connector

WARNINGS: If you use an external monitor as the ECG source during synchronized cardioversion, a biomedical
technician MUST verify that the combination of the external monitor and the Efficia DFM100 can
deliver a synchronized shock within 60 ms of the peak of the R-wave. Use a 1 mV QRS complex
with a QRS width of 40 ms. This performance cannot be guaranteed with all commercially available
monitors.
When pacing in Demand mode, the ECG cable must be directly connected from the patient to the
Efficia DFM100.

NOTES: Lead II is the only lead selection on the secondary device that accurately displays the waveform sent
from the primary device. The secondary device lead selection should remain on Lead II. To avoid
confusion, the primary device lead selection should also be set to Lead II, if clinically possible.
If you are using the ECG Out Cable to send an ECG signal from the Efficia DFM100 to a bedside
monitor, the ECG signal and alarms on the Efficia DFM100 should be considered primary. The
bedside monitor ECG is ancillary/secondary.
If the device is pacing or if it detects internal pacemaker pulses, the ECG Out waveform includes
pace pulse markers at the appropriate points.
Do not use a Philips SureSigns monitor connected to the Efficia DFM100. The devices are not
compatible.

18
Basic Orientation 2: Device Basics

Installing Paper
The Efficia DFM100 uses 50 mm paper for printing.

 To install printer paper:


1 Open the printer door by pulling up on the door latch. Allow the door to fall open (see
Figure 20).
2 If there is an empty or almost empty paper roll in the printer, pull up on the roll to remove it.
3 Examine the new roll of printer paper and remove any remaining adhesive residue from the
outer layer of paper.
4 Place the new roll of paper in the paper well, positioning the roll so that the end of the roll is on
the bottom as indicated by the symbol inside the printer.
5 Pull the end of the paper out past the roller.
6 Close the printer door.
7 Test the printer before putting the defibrillator back into service. See “Operational and Shift
Check” on page 151.

Figure 20 Installing Printer Paper

19
2: Device Basics Basic Orientation

Test Plug & Test Load


Your Efficia DFM100 comes with a defibrillator Test Plug to assist in performing a weekly shock
test. You can also use the M3725A or M1781A Test Load, ordered separately, to perform a weekly
shock test.
To use either the Test Plug or Test Load during a weekly shock test, insert the plug or load into the
Therapy cable (see Figure 21).
The Test Plug and Test Load behave differently during the weekly shock test. Similar successful
weekly shock test results appear differently on the device:
• The Test Plug creates an electrical “short” so the device does not deliver a shock into it. You hear
a “Shock Canceled” audio message, see a  alarm on the display and the printed strip
indicates .
• The Test Load applies an impedance at the end of the Therapy cable such that the device
delivers a shock. You hear a “Shock Delivered” audio message and the printed strip indicates 
.

For more on the weekly shock test, see “Weekly Shock Test” on page 152.

Figure 21 Connecting Defibrillator Test Plug/Load

Test Plug

Test Load

CAUTION: The defibrillator test plug is not for use with the HeartStart MRx or HeartStart XL.

NOTE: Using the tie provided, tie the test plug about 50 cm (18 inches) from the end of the therapy cable
tight enough to prevent the plug from sliding along the cable. The plug should be oriented such that
it can easily be inserted into the cable while you have the cable stowed.

20
Basic Orientation 2: Device Basics

Additional Features
The additional features of the Efficia DFM100 may include:
• Therapy Cable Collar
• Cable Straps
• Cradle
• Carry Bags

Therapy Cable Collar


When the Efficia DFM100 is used in transport or high-vibration environments, Philips strongly
suggests the device be fitted with the Therapy Cable Collar before being placed into service. The
collar adds an extra level of security to prevent excessive wear and vibration with the Therapy port.
For Efficia DFM100 EMS devices, the Therapy Cable Collar base comes installed from the factory.

 To connect the Therapy Cable and install the Collar Lid:


1 With the base already installed, plug the Therapy Cable into the green connector port.
2 Slide the feet of the Collar Lid into the grooves on the Collar base and push the top of the Lid
into place. See Figure 22.
3 Grab the Locking Key and push in while turning clockwise until the Key locks into place.
4 To remove the cover, lift up on the lid latch and turn counter clockwise. After the Key unlocks,
lift the lid out of place. You can also use a flat-head screwdriver to engage and disengage the
cover.

Figure 22 Locking the Collar Lid into Place

WARNINGS: If you use the Efficia DFM100 in a transport or high-vibration environment without the Therapy
Cable fully installed, your device is susceptible to premature Therapy port and cable wear and
potential failure which may result in a delay in therapy.
Do not leave the Therapy collar base installed without the lid in place. The exposed metal pole could
get caught on cables or users’ clothing and potentially cause injury.

Cable Straps
To aid with cable management, straps can be snapped on to the side of the Efficia DFM100 in the
predefined snap locations or they can be attached to the side carry bags.

21
2: Device Basics Basic Orientation

Cradle and Carry Bags


To install the Efficia DFM100 cradle and carry bags, all you need is a Phillips-head screwdriver.

 To install the cradle and carry bags:


1 Open the cradle and set the Efficia DFM100 down snugly inside.
2 Taking one cradle edge at a time, lift the edge into place.
3 Using a Phillips-head screwdriver, screw two of the snaps provided into the predefined holes on
the cradle and into holes on the device. See Figure 23.
4 Use the other four snaps and repeat on the other side and back of the Efficia DFM100.
5 Stretch the long gray cradle strap across the top of the device and thread through the small metal
loop. Pull snug and secure in place with the hook and loop fasteners.
6 Take the carry bag with the plastic paper guide inside and align it with the printer on the side of
the device. Snap the bag into place, starting with the bottom first and then the top. Press the
hook and loop fasteners together. Tug lightly to confirm a solid connection.
7 Repeat Step 6 with the other side bag and the rear bag. See Figure 23.
8 Optional tray cover pouch: If you want to install the tray cover pouch, use the hook and loop
strip to fasten one edge of the bag through the metal loop on one side of the device. Stretch the
pouch across the paddle tray and fasten the other side. Tug lightly to confirm a solid connection.
9 Optional shoulder strap: Hook the strap into place, using the front metal loops on each side of
the cradle.
NOTES: When snapping the therapy/printer side bag in place, confirm that the printer paper path is clear so
the strip can come out of the printer freely.
For in-hospital use, the side carry bags can be installed without using the cradle.

Figure 23 Attaching the Cradle and Side Carry Bags

22
Basic Orientation 2: Device Basics

EMS Environment
Use in the EMS Environment
The Efficia DFM100 with the X01 option is designed for use in the Emergency Medical Services
(EMS) environment and is delivered with the carry case and with the Ambulance Docking Station.
The Ambulance Docking Station (part number 989803199241) must be installed by qualified
service personnel using special tools. Also, the Efficia DFM100 should be docked into the
Ambulance Docking Station by qualified service personnel using special tools. Prior to installation,
service personnel must install or confirm the presence of a mains isolation switch.
See the Efficia DFM100 Service Manual for instructions on how to install the Ambulance Docking
Station and the Efficia DFM100 into the Ambulance Docking Station.
With the Ambulance Docking Station and Efficia DFM100 installed in an ambulance, all
maintenance on the dock or the Efficia DFM100, including replacement of the power supply cord
and mains isolation switch, should only be performed by qualified service personnel, including the
use of tools to remove the Efficia DFM100 from the dock and the disconnection of the power
supply cord to safely isolate the device from all power sources.
See the Efficia DFM100 Service Manual for all installation, maintenance and service instructions.
While the DFM100 has been designed for use in the EMS environment, use in these conditions can
put stresses on the device and its accessories that could potentially affect essential performance. Users
in these environments should be aware of the following:
• Direct sunlight and other sources of excessive illumination can affect SpO2 readings. For more
information see “Understanding Pulse Oximetry” on page 108.
• The device has been built to withstand lint and dust. After an event where the DFM100 was
exposed to lint and dust, you should thoroughly clean it. See “Cleaning Instructions” on
page 171 for more information.
• Cellular telephones, 2-way radios and other radio frequency-emitting devices could cause
interference problems and potentially affect the behavior of the device. Users should abide by
the recommended separation distances found on page 216.
• Check all accessories frequently. Confirm that all sensors, electrodes, ports and the Therapy
cable are in working order. Replace all that are not in good working order.
• Make sure that the Therapy Cable Collar is installed on devices in high-vibration environments.
See “Therapy Cable Collar” on page 21.
• Devices in the EMS environment may require a power converter to convert vehicle DC power
to AC power for the Efficia DFM100.

23
NOTES

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
3

Operating the Device


Operating Modes
The Efficia DFM100 has four clinical modes and four non-clinical modes:
• Clinical modes are listed in Table 1. They are used by trained clinicians to monitor patients and
provide therapy. These modes do not require passwords.
• Non-clinical modes are listed in Table 2. User information is included in the Description
column.

Table 1 Clinical Modes

Mode Description For more information


Monitor This mode is used to monitor ECG, “ECG Monitoring” on page 47;
optional NBP, EtCO2, and SpO2 “Monitoring CO2” on page 97;
parameters and for viewing Vital Signs “Monitoring SpO2” on page 107;
Trends data. “Monitoring NBP” on page 115;
“Trending” on page 121.
AED This optional mode is used to analyze “AED Mode Option” on page 61.
ECG and if necessary, administer
semi-automated external defibrillation.
You can also monitor HR, EtCO2, and
SpO2.
Manual This mode is used to perform “Manual Defibrillation” on page 75.
Defibrillation asynchronous and synchronous
cardioversion (defibrillation).
Pacer This optional mode is used to perform “Pacing” on page 89.
demand or fixed pacing.

25
3: Operating the Device Controls

Table 2 Non-Clinical Modes

Mode Description For more information


Operational This mode is typically used by clinicians to perform “Operational and Shift
Check routine maintenance activities related to operational Check” on page 151.
and shift checks. This mode does not require a
password.
Data This mode is typically used by hospital administrators “Data Management” on
Management to review Event Summary information after clinical page 125.
use. This mode has an optional password.
Configuration This mode is used to display and change “Configuration” on
configuration options. Hospital administrators use page 139.
this mode to set up configuration options, which
requires a password. Clinicians, service personnel,
and hospital administrators may use this mode to
view, print, or export configuration information.
Service This mode is used by service personnel to service the The Efficia DFM100
device and install software upgrades. This mode Service Manual
requires a password.

Controls
Operating controls are organized by function with the defibrillation controls to the right of the
display, soft keys under the display, and general function buttons under the soft keys and to the left
of the display.

Therapy Knob and Controls


The Efficia DFM100 Therapy knob is customized for the options included in your device. If you
have the Pacing and/or the AED Option, those positions are included on the knob. The knob
enables AED mode, Pacing mode, Monitor mode or selects an energy for Manual Defibrillation
mode to deliver defibrillation or cardioversion.
Regardless of the options, the knob and controls function the same:
Turning the Efficia DFM100 on – Turn the Therapy knob to the right for Monitor mode, Manual
Defibrillation or Pacing; turn to the left for AED mode.
Charge button – Charges the defibrillator to the selected Manual Defibrillation energy setting. It is
used only in Manual Defibrillation mode. The defibrillator charges automatically in AED mode.
Shock button – Delivers a shock through multifunction electrode pads or switchless internal
paddles. In Manual Defibrillation mode, the shock is delivered at the selected energy. In AED mode,
if the patient category is Adult, you have the ability to preconfigure the energy delivered. The factory
default is 150J. If the patient category is Infant/Child, 50J is delivered. The button flashes when
charged.

NOTE: When you use external paddles or switched internal paddles (internal paddles that have Shock
buttons, as opposed to switchless internal paddles where you administer the shock by pressing the
Shock button on the device), the Shock button(s) on the paddles delivers the shock.

Sync button – Toggles between synchronized energy delivery used during cardioversion and
asynchronous energy delivery used during defibrillation. The Sync button lights blue when Sync is
active.

26
Controls 3: Operating the Device

Figure 24 Therapy Controls

AED Monitor
OFF

Therapy knob

Pacer

Sync button

Sync

Charge Charge button

Shock Shock button

Smart Select Knob


Use the Smart Select knob (see Figure 1 “Efficia DFM100” on page 8) to navigate through menus
and options and make selections. You can:
Press the knob - If there is no menu on the display, the  menu is displayed. If there is a menu
on the screen, then the highlighted entry is selected.
Twist the knob - Turn the Smart Select knob clockwise to scroll down a menu’s list or counter
clockwise to scroll up the list. The scroll skips over any unavailable entries in the menu. If you have
a numeric selection window open, turning the knob clockwise increases the numerical value; counter
clockwise decreases the value.

General Function Buttons


The General Function buttons control monitoring or non-critical resuscitation activity. See “Efficia
DFM100” on page 8 for the location of the buttons and below for their definitions.
Table 3 General Function Buttons

Name Button Description


Lead Select Changes the ECG lead in Wave Sector 1. Pressing this button cycles
through the available ECG waves, changing the displayed wave and
label. The list of available ECG waves is based on the connected
lead set and your device configuration, including pads, if the
corresponding cable is connected. See “Lead Selection” on page 50.
Patient Category Allows you to change the patient category from adult (25kg or 8
years old) to infant/child (<25kg or < 8 years old) and back again.
Alarms When pressed, the Alarms button pauses all audible physiological
and technical alarms for the configured time interval. At the end of
the pause interval, each alarm returns to its previous setting.
Pressing the Alarms button during the pause interval returns the
alarms to their previous setting. When in AED mode, pressing the
Alarms button activates alarms. See “Alarms” on page 37.

27
3: Operating the Device Ready For Use Indicator

Table 3 General Function Buttons (Continued)

Name Button Description


Mark Event The Mark Event button allows you to insert a time-stamped
annotation in the Event Summary report to note events as they
occur, including the administration of certain drugs. See “Mark
Events” on page 43.
Reports When pressed, the Reports button will bring up the  menu.
From the  menu, you can print an Event Summary or
Trends report. See “Printing Data” on page 137.
Print The Print button begins a continuous printout of the primary ECG
and other selected waveforms in real time or with a 10-second
delay, depending upon your configuration. Pressing the Print
button while printing is in progress stops the printing. See “Printing
Data” on page 137.

Soft Keys
The soft keys perform the function displayed directly above it on the display. The display and
function change for the various modes of operation. Functionality of the soft keys are described in
their appropriate chapters throughout these Instructions for Use.

Ready For Use Indicator


The Ready For Use (RFU) Indicator is located in the upper right section on the front of the device.
It indicates the status of the therapy delivery functions using the following conventions:
Table 4 Ready For Use Indicator and Status

Type Indicator Status Description


Blinking Hourglass Indicates the shock, pacing and ECG functions of the device
are ready for use. Sufficient battery power is available for
device operation.
Blinking red “X” with Indicates either:
periodic audio chirp • A low battery condition exists and the battery is not
charging.
• There is no battery installed and the device is running
on AC power only.
Blinking red “X” Indicates a low battery power condition but the battery is
without periodic currently charging. The device can be used but its
audio chirp battery-only operation time is limited.
Solid red “X” with Indicates that a critical failure has been detected that may
periodic audio chirp prevent the delivery of defibrillation therapy, pacing or ECG
acquisition.
Solid red “X” without Indicates no power available or the device cannot power on.
periodic audio chirp If, after power is returned, the indicator reverts to the
blinking black hourglass symbol, the device is ready for use.

28
Power 3: Operating the Device

Power
The Efficia DFM100 is powered by a Lithium Ion battery or AC power. The battery should always
be installed so the device is ready for use whether AC power is available at the point of care. A
 message is displayed when AC power is removed and a battery is installed. When
pacing, AC power should be connected if possible to prevent the battery from eventually becoming
depleted and interrupting the pacing operation.
The Efficia DFM100 can also be powered through a DC power converter which takes DC power
and converts it to AC to power the device. When using this converter, the device is fully operational.
Keep your battery charged at all times. For more information on your battery, see “The Display” on
page 31, and “Battery Maintenance” on page 168.

WARNING: To avoid the risk of electric shock, the Efficia DFM100 must be plugged into a hospital-grade outlet
with protective ground. To remove AC power, disconnect the power cord from the outlet.

NOTES: If AC power is used as the only power source during defibrillation (for instance, when no battery is
installed or when the battery is fully discharged), the Efficia DFM100 may take longer to charge to
the desired energy level, and, in the event of power loss longer than 30 seconds, all settings reset to
configured settings and a new event is created when power is returned. However, all saved data
remains intact (up to the device’s memory capacity) and can be found by retrieving the previous
event. Keep your battery installed and charged.
If you question the AC power cord’s functionality, disconnect it from the device and operate on
battery power. Replace the cord before reconnecting to AC power.

For information on power-related alarms, see “Power-Related Alarms” on page 170.

Lithium Ion Battery


The Efficia DFM100 uses a Lithium Ion battery for power.

Battery Capacity
A new fully-charged battery, at 20 °C (68 °F), provides power for at least:
• 100 full-energy charge/shock cycles.
or
• 2.5 hours of monitoring (ECG, EtCO2 and SpO2 continuously monitored and NBP
sampled every 15 minutes) followed by 20 full-energy charge/shock cycles.
or
• Two hours of pacing (180ppm at 140mA with 40msec pulse) and monitoring (ECG,
EtCO2 and SpO2 continuously monitored and NBP sampled every 15 minutes).

Low Battery Conditions


The Efficia DFM100 enters a low battery condition when:
• The battery charge is low but contains sufficient power to provide at least six full-energy
charge/shock cycles and at least 10 minutes of monitoring.
• The Efficia DFM100 cannot determine the battery’s charge level.
To optimize performance, a battery that is in the low battery condition (less than 40% remaining)
should be charged as soon as possible.

29
3: Operating the Device Power

NOTE: The longer the battery stays in the Low Battery condition without charging, the ability to deliver six
full-energy shocks and perform 10 minutes of monitoring diminishes.

Battery Charging
With AC power connected and the device turned off, the Efficia DFM100 recharges its battery to
80% capacity in less than 2 hours and to 100% capacity in less than 3 hours. Charge time can be
substantially longer if the device is turned on.

Battery Maintenance
For information on battery maintenance, see “Battery Maintenance” on page 168.

Power Indicators
The Power Indicators are located in the upper right corner of the Efficia DFM100’s front panel (see
Figure 25). The green AC Power Indicator is lit whenever AC power is connected to the Efficia
DFM100, even if the device is turned off.
The green Battery Charging Indicator flashes when the battery is charging. The indicator is solid
green when the battery is fully charged and AC power is present. The light is off if no battery is
installed, the battery is installed but not functioning properly or there is no AC power present.

Figure 25 Power Indicators

AC Power Battery Charge


Indicator Indicator

Turning the Efficia DFM100 On


To turn the Efficia DFM100 on, turn the Therapy knob to the desired mode of operation.

Turning the Efficia DFM100 Off


To turn the Efficia DFM100 off, turn the Therapy knob to the OFF position. If you turn the device
off while in a clinical mode, the Efficia DFM100 enters the Continued Use Period (see “Continued
Use” on page 43). The screen displays a 10-second countdown before turning off.

NOTE: You should leave the device plugged in to keep the battery charged and allow automated diagnostic
tests to run periodically.

Device Shutdown
When no AC power is connected and the battery charge level drops to a critically low level, the
Efficia DFM100 can no longer guarantee correct operation. The defibrillator generates an Imminent
Shutdown alarm. You have approximately one minute to connect the device to AC power before it
shuts down.
If power is returned within 30 seconds after a complete loss of power and the Therapy knob is not
in the OFF position, the Efficia DFM100 automatically turns back on, user settings are restored to
their values prior to the shutdown, the Efficia DFM100 continues to use the current Event
Summary and the duration of the shutdown is recorded in the Event Summary.

30
The Display 3: Operating the Device

WARNING: Pacing is not automatically restarted after the Efficia DFM100 recovers from a power loss. You must
restart pacing manually.

If the Efficia DFM100 restarts after 30 seconds and the Therapy knob is not in the OFF position,
all settings are returned to their configured values, a new Event Summary starts and you are notified
that the previous Event Summary was closed.
NOTE: Based on the software’s status when power was lost, alarm settings in effect at the time of power loss
may be restored in situations where power is returned up to 45 seconds after a power loss.

The Display
The Efficia DFM100’s display layout is easily configurable. There are four basic segments of the
display. See Figure 26.

Figure 26 General Display Layout



 
Status
area  
 
             


Parameter
     
     
area  
   


Message area



 
Waveform  
Display and

Soft Keys
area





Dotted box indicates location of menu when


displayed. See “Menus” on page 35.

Status Area
The Status Area contains device and patient information.

Figure 27 Status Area


Patient Category Paced Patient Event Timer Date and Battery
Weight Range Status Name/ID Time Status



 
 
 

Clinical Alarm Area Technical Alarm Area Multiple Technical


Alarms Indicator

31
3: Operating the Device The Display

Patient information includes:


• Name/ID – If entered, displays the patient’s name, patient’s ID or nothing depending on
the current configuration. See Table 36 “General Settings” on page 143.
• Date and Time – The current date and time.
• Paced Status – Internally paced or non-paced. The area remains blank if paced status has
not been selected. (This information is not displayed in Pacing and AED modes.)
• Event Timer – The elapsed time for the current event, displayed in hours:minutes:seconds.
• Patient Category and Weight Range – Adult (defined as  25kg) or Infant/Child (defined as
< 25kg). The background color changes with the selected patient category for Adult
(orange) and Infant/Child (blue).
Device information includes:
• Clinical Alarm Indicator - Indicates the state of global alarms. If alarms are on and audio is
not paused, the indicator is blank. If they are off, the indicator says  and uses the
Alarms Off icon .
• Technical Alarms - Technical alarms not related to the battery or pacing are displayed in the
Technical Alarms area. A triangle indicates there are multiple alarms present, alternating
on the display.
• Battery Status – If a battery is installed, the battery icon indicates the level of charge
remaining. See Figure 28.
Figure 28 Battery Charge Level

No Low     90%


Battery Battery remaining remaining remaining remaining
Condition*
* - See “Low Battery Conditions” on page 29.

Parameter Area
The Parameter Area displays the physiological parameters currently being monitored. See Figure 29.
Displayed values for each parameter include:
• Parameter Label
• Current value. Display:
• Number – a valid value was obtained
•  – an invalid value was obtained
•  with a number – the value obtained is questionable
• blank – the parameter is unavailable or off
• Currently configured upper and lower alarm limits with the units label
• Alarm Off icon (visible when the alarm is disabled and the global alarm state is not set to
off)

32
The Display 3: Operating the Device

Figure 29 Parameter Area


Heart Rate SpO2 Pulse Rate
Parameter Parameter Parameter
Label Units Label Label Units Label Label Units Label

     


Upper and Upper and Upper and

  
 Lower  Lower  Lower
 Alarm Limits  Alarm Limits  Alarm Limits
* Pulse Limits are
configured off by
default but when
HR Value SpO2 Value Pulse Value they are on, they
appear in this
location.

NBP EtCO2 AwRR

Parameter Time of Parameter Parameter


Label Frequency last NBP Units Label Label Units Label Label Units Label

Alarm
      
 Source

 


    


  

Upper and Upper and Upper and


Systolic/Diastolic Mean Lower Alarm EtCO2 Lower AwRR Lower
Values Value Limits Value Alarm Limits Value Alarm Limits

Message Area
The message area displays key messages during an event. The type of message shown varies
according to the current mode.

Figure 30 Message Area



Waveform and Display Soft Keys Area


The Efficia DFM100 is configured to populate each of its three wave sectors with a preconfigured
waveform when powered on in Monitor, Manual Defibrillation (two wave sectors only), Pacing
mode (two wave sectors only) and AED (one wave sector). A dashed line in an ECG wave sector
indicates that the waveform source is invalid. Wave sectors may contain a variety of information as
appropriate to the parameter, view and task currently being performed.
You can display one, two or three waveforms at one time on the display depending on which mode
the Efficia DFM100 is currently in and how you have your device configured. The area also displays
other key information including the number of shocks delivered and the selected energy.

Wave Sector 1
Wave Sector 1 contains only an ECG waveform. This waveform is used by the arrhythmia, heart rate
derivation and AED analysis algorithms. Available waveforms include: Paddles (unavailable in AED
mode), Pads, I, II, III, aVR, aVL, aVF and V.
Wave Sector 1 also contains the ECG Calibration Bar, the Auto-Gain Indicator, Rhythm Label,
ECG filter setting and R-Wave arrows. The Calibration Bar is used as a reference point to compare
the actual ECG wave displayed to the selected size. The Auto-Gain Indicator is displayed when

33
3: Operating the Device The Display

auto-scaling is active. R-Wave arrows appear when the device is in Sync mode, Monitor mode, or
Demand mode pacing.
Figure 31 Wave Sector 1 Markings
R-Wave Arrows
Lead
Label 

Calibration
Bar
Auto-Gain 
Indicator   Rhythm Label
ECG Filter
Setting

After the ECG analysis algorithm analyzes the waveform in Wave Sector 1, if the DFM100 is
configured to display the rhythm, the waveform is labeled (in all clinical modes except AED).
Possible labels include:
•  •  •  • 
•  •  •  • 
•  •  •  • 
•  • 

If the Rhythm Label is configured off, the device only displays Learning ECG and Learning Rhythm
labels. For more on configuring the label, see Table 37 “Heart Rate/ECG Settings” on page 144.
The ECG filter settings for the display are:
 - Monitor Bandwidth
 - EMS Monitor Bandwidth
 - ST Monitor Bandwidth
ECG filter settings can be changed in Configuration mode. See Table 37 “Heart Rate/ECG
Settings” on page 144.

NOTES: In synchronized cardioversion mode, the R-Wave arrows indicate which R-Waves a shock would be
triggered on if the shock button is pressed.
In Demand mode pacing, the time until the next delivered external pace pulse is from the previous
pace pulse or the R-Wave arrow, whichever is the most recent. R-Waves immediately after an
external pace pulse are not marked because they are likely caused by the pace pulse.
The displayed heart rate is determined by the arrhythmia analysis which is independent from
R-Wave arrows for synchronized cardioversion or for Demand mode pacing.

Wave Sectors 2 and 3


Wave Sectors 2 and 3 are automatically populated when the parameter source’s cable is connected to
the Efficia DFM100. If the parameter source is the configured choice of a particular wave sector, it
is displayed in that wave sector when available. Available waveforms include: Paddles, Pads, I, II, III,
aVR, aVL, aVF, V, Pleth, Capnogram, and a Cascade Wave from Wave Sector 1. If you select an
ECG wave for sectors 2 or 3, the ECG filter setting is also displayed (except in cascade and
annotated ECGs).
You can also select an annotated ECG for Wave Sector 2. See “Displaying an Annotated ECG” on
page 54.

34
The Display 3: Operating the Device

Changing Displayed Waveforms


Wave Sector 1 has a dedicated Lead Select button (see “General Function Buttons” on page 27)
to change the displayed lead/source. Waveforms displayed in the other sectors are changed for the
current event using the Smart Select knob. See “Menus” on page 35.

Soft Key Labels


The four soft key labels correspond to the soft key buttons located immediately below. See Figure 32.
These labels change, as appropriate, according to the current display view and function. Soft key
labels appearing as gray text indicate the soft key is inactive.

Figure 32 Waveform and Display Soft Keys Area





 
Waveforms 



Soft 
Keys

Menus
Menus with controls and options specific to each Efficia DFM100 function are easily accessible
using the Smart Select knob on the front panel. Menus are used to adjust volume, select waveforms,
select waves for printing, set alarms, enter patient information, generate reports and complete a
variety of other tasks.
To display a menu, press the Smart Select knob, and then turn the Smart Select knob to scroll
through the available choices. You can scroll in either direction continuously because the menu
options will restart as you reach the end of the list.
To make a selection, highlight the menu entry you want and press the Smart Select knob. Select Exit
to close the menu without making a selection. Arrows at each end of the menu indicate additional
list options are available in that direction on the menu. Turn the Smart Select knob to scroll up or
down to reveal the remaining options.
Depending upon your given situation, some options are unavailable for use. Menu choices are
grayed out when they are unavailable. They cannot be highlighted or selected. See Figure 33.

35
3: Operating the Device The Display

Figure 33 Sample Menu


Scroll Up Arrow

 Selected Item


 Disabled Item


Scroll Down Arrow

NOTE: Menus are removed from the display when the Charge button is pressed.

Adjusting Numeric Values


Using the Efficia DFM100 Smart Select knob, you can enter numeric values for several parameters,
including high and low alarm limits. See Figure 34. The value initially displayed is the default value.
Some values are adjustable in increments greater than 1. To exit, press the Smart Select knob.

Figure 34 Setting Numeric Values


Title




Increase Arrow
Decrease Arrow 

The Increase/Decrease arrow icons are


not shown if the displayed value is at the Current Value Unit of Measure
upper/lower limit of the range.

Adjusting Volumes
The volume levels for alarms, voice prompts, and the QRS Indicator are adjustable.

 To adjust the volume for the current event:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select the volume type (, , ) you wish to adjust and press the Smart Select knob.
NOTE: You can adjust one volume type without affecting the other volume types. For example, adjusting
the QRS volume does not affect the volumes for alarms and voice.

4 Select the new volume level and press the Smart Select knob.
The new volume level remains in place for the duration of the current event. Use Configuration
mode to adjust the default volume levels. See “Configurable Parameters” on page 142.

36
Alarms 3: Operating the Device

Alarms
The Efficia DFM100 uses various alarms to indicate changes in patient condition or device/cable
conditions that may require attention:
• Physiological alarms are detected in a clinical mode and result from a patient-related parameter
being monitored.  is an example of a physiological alarm. These alarms are not
detected in non-clinical modes.
• Technical alarms result from an equipment-related issue.
Alarm conditions are based on comparisons against preset limits and algorithm results. Alarms can
be configured as latching or non-latching for Pulse Rate, NBP, EtCO2 (excluding Apnea), and SpO2
(excluding Desat):
• Non-latching alarms are automatically removed when the alarm condition no longer exists.
• Latching alarms remain active even when the alarm condition no longer exists. Apnea and
Desat alarms are latching alarms and cannot be configured as non-latching.
For alarm priorities, see Table 5. For information on how to respond to alarms, see “Responding to
Alarms” on page 41.

WARNING: Setting the alarm volume below the ambient noise level can result in missed alarm conditions.

Table 5 Alarm Priority

Alarm Priority Condition


High Priority An immediate response is required. A

life-threatening alarm condition exists. The device
displays a red alarm message and emits a
high-priority alarm tone. High-priority alarms are
latching.
Medium Priority Prompt response is required. A non-life-threatening

alarm condition exists. The device displays a yellow
alarm message and emits a medium-priority alarm
tone. Medium-priority alarms are latching or
non-latching depending on your device’s
configuration, except two Pacer-related alarms that
are always latching. See Table 36 “General Settings”
on page 143.
Low Priority Awareness is required. A non-life-threatening alarm

condition exists. The device displays a cyan alarm
message and emits a low-priority alarm tone.
Low-priority alarms are non-latching.

NOTES: The presence of multiple alarm conditions at the same time is possible. To avoid confusion and help
prevent a less serious condition from hiding a more serious condition, the Efficia DFM100
prioritizes and categorizes alarms. The highest priority alarm condition is announced. If multiple
same-parameter, same-priority alarms occur, the alarms are displayed one at a time.
Physiological alarms are not detected or displayed in a non-clinical mode. Only technical alarms are
displayed in non-clinical modes.

37
3: Operating the Device Alarms

Clinical Mode Alarm Notification


When in a clinical mode, the Efficia DFM100 can be configured to react differently when an alarm
condition occurs. See Table 6.

Table 6 Alarm Notification Types

Type Alarm Location Alarm Status Comments


Alarms None None Both visual and audio All alarms are on.
On indications are on.
Alarm Upper left corner of Only visual indications This message appears
Audio  the display are on for the when you press the
Pause underneath the configured Audio Pause Alarms button and
(message includes duration of the pause)
Patient Category. timeframe. Audio the configured alarm
returns when the pause pause is set to
timeframe is complete. something other than
indefinite.
Alarm Upper left corner of This message appears
Audio  the display when you press the
Off underneath the Alarms button and
Patient Category. the configured alarm
Only visual indications pause is indefinite.
In the Menu area are on. When displayed, press
 above the Smart the Smart Select knob
Select knob. to turn Audio off.
Alarm In the Menu area Only visual indications When displayed, press
Audio  above the Smart are on for the the Smart Select knob
Pause Select knob. configured Audio Pause to pause Audio.
timeframe. Audio
returns when the pause
timeframe is complete.
Alarms  When in AED Both audio and visual Press the Alarms
Off mode, upper left alarm indications are button to activate
corner of the display off. alarms in AED mode.
underneath the
Patient Category.

All alarm conditions are cleared when you switch from a clinical mode to a non-clinical mode.
If you intentionally disconnect a sensor, an alarm sounds. Press the Smart Select knob to stop the
alarm. The Efficia DFM100 prompts you to confirm your selection. Press the Smart Select knob
again.

WARNINGS: Silencing either audio or audio and visual indications of active alarms can result in missed alarm
conditions and also inhibit indications of new alarm conditions.
Confirm that alarm limits are appropriate for the patient each time there is a new patient event.
Do not set alarm limits to such extreme values that render the alarm system useless.
A potential hazard exists if different alarm limits are used for the same or similar equipment in any
single area.

38
Alarms 3: Operating the Device

Alarm Notification Display Locations


Depending on the alarm type, the Efficia DFM100 displays notifications in various locations. See
Figure 35.

Figure 35 Alarm Notification Locations


Technical alarms Battery-related alarms
The device’s are displayed here. are displayed here.
general
alarm status



is displayed 
here.   

 

Alarms        


Multiple Alarm

     
related to       Indicator

parameter   
  
limits appear
above the
parameter. 

Messages in
the Message
Area help with
technical
alarms and
provide
clinical Smart Select
knob indicator



NOTE: Pacing alarms appear in the Pacing Bar. See “Pacing Alarms” on page 94.

Adjusting Alarm Limits


Alarm limits are preset on the Efficia DFM100 based on its configuration and the patient type.
When alarms are on, alarm limits are visible next to the parameter’s numeric value. At times, you
might want to adjust an alarm limit for the current event.

 To adjust an alarm limit:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select the desired parameter and press the Smart Select knob.
4 Select the parameter limit and press the Smart Select knob.
5 Turn the Smart Select knob to adjust the limits. Press the Smart Select knob to finish.

Alarm Management
The Efficia DFM100 allows you to adjust alarm notifications when first powering the device on. In
Configuration mode you can configure the alarms for HR/Arrhythmia, NBP, EtCO2, AwRR, and
SpO2 to be on or off when the device first powers on.
If the Efficia DFM100 is in Monitor mode and the device’s overall alarm audio sounds have been
turned off (alarm audio pause set to indefinite), the device can be configured to remind you with an
audio signal that these alarms are silent.
See Chapter 14 “Configuration” on page 139 and the individual parameter sections on alarms.

39
3: Operating the Device Alarms

Audio Tones and Alarm Indications


The Efficia DFM100 uses a mixture of audio tones and alarm indications to communicate device
and patient status. Table 7 describes the device’s audio tones and alarm indications.

Table 7 Tones and Alarms

Tone/Indication Description Tone level


Single beep and Alarm Message. Accompanies a new message on the display - 2000 Hz
Audio Reminder tone generally informational.
Continuous tone Charged. Generated when the selected defibrillation 2042 Hz
energy is reached and continues until the Shock button is
pressed or the device is disarmed.
Continuous tone - lower Charging. Generated when the Charge button is pressed 1333 Hz
pitch than charged tone and continues until the device is fully charged.
Periodic chirp Attention. Generated in instances such as low battery and 1000 Hz
device failure.
Tone synchronized with QRS. Single beeps aligned with the QRS. The volume of 667 Hz
each heart beat this tone can be set in Configuration. See “General
Settings” on page 143.
Continuous tone with Imminent shutdown. The device will shut down in one Alternating
alternating pitch minute. between
1000 and
2100 Hz
Philips tone lasting 0.5 960 Hz
second, repeated every
second
High priority alarm condition.
IEC high priority alarm Meets IEC
60601-1-8/
YY 0709
Philips tone lasting 1 480 Hz
second, repeated every 2
seconds
Medium priority alarm condition.
IEC medium priority Meets IEC
alarm 60601-1-8/
YY 0709
Philips tone lasting 0.25 480 Hz
second, repeated every 2
seconds
Low priority alarm condition
IEC low priority alarm Meets IEC
60601-1-8/
YY 0709

Configuring Alarms
The Efficia DFM100 allows you to adjust alarm notifications. In Configuration mode you can
configure alarms for HR/Arrhythmia, NBP, EtCO2, AwRR and SpO2 alarms to be on or off when
the device first powers on. See the individual parameter’s section of Chapter 14 “Configuration” on
page 139.

40
Alarms 3: Operating the Device

Responding to Alarms
Alarm limits are displayed with each parameter, if alarms for the parameter are on. When an alarm
condition occurs, there are several ways to respond. Initially:
1 Attend to the patient.
2 Identify the alarms indicated.
3 Silence (pause) the alarms. Press the Smart Select knob on the front panel of the Efficia
DFM100 to pause/silence the alarm, and then press the knob again to acknowledge the alarm.
The alarm is paused for the configured pause period while you attend to the patient. If the
alarming condition continues to exist, it re-alarms after the configured pause period ends.
Silencing a specific alarm does not prevent another alarm from sounding. If you silence the
second alarm, it resets the pause period for all active alarms.
If you press the Alarms button, you silence all parameter alarms for the configured pause
period. No new alarms sound.
4 Address the alarm condition:
• To acknowledge an individual alarm, use the alarm response menu. See Figure 36.
• If you are in Monitor mode, you can use  in the  to clear all latched
alarms that no longer have an associated condition. See Figure 33.

Figure 36 Sample Alarm Response Menu

 For latching alarms, 


clears the alarm when the alarm
 condition no longer exists.
Turns off the parameter’s
alarms and prevents future 
alarms from sounding.  Select this entry to change the
parameter’s alarm limits.

NOTE: Alarm history can be accessed in the patient’s Event Summary. This information is maintained after
powering the device down and in the unlikely event of a power loss. To access this information, see
“Event Summary” on page 125.

For more information on alarms and messages as they pertain to a particular functionality, see the
specific alarm section in the Efficia DFM100 Instructions for Use:
• Heart rate and arrhythmia alarms - see “Heart Rate and Arrhythmia Alarms” on page 56
• AED alarms - see “AED Alarms” on page 72
• Defibrillation alarms - see “Manual Defibrillation Alarms” on page 81
• Cardioversion alarms - see “Cardioversion Alarms” on page 88
• Pacing alarms - see “Pacing Alarms” on page 94
• SpO2 alarms - see “SpO2 Alarms” on page 111
• Pulse alarms - see “Pulse Rate Alarms” on page 113
• NBP alarms - see “NBP Alarms” on page 118
• EtCO2 and AwRR alarms - see “ETC02 and AwRR Alarms” on page 101
• Power alarms - see “Power-Related Alarms” on page 170

41
3: Operating the Device Entering Patient Information

Entering Patient Information


In Monitor, Manual Defibrillation, and Pacer modes, you can add, change, or delete patient
information using the menu. You cannot add, change, or delete patient information in
AED mode or non-clinical modes. If information was previously entered for the patient, those
values are listed as appropriate.
Patient information includes the patient name, ID, sex, and paced status. The  field defaults to
Male, and the  field defaults to No (not paced).
NOTES: Ensure the patient’s paced status is correct to optimize ECG analysis.
Paced status does not appear in AED or Pacer modes.

 To enter patient information on the device:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select the category you want, and press the Smart Select knob.
4 If you are entering the patient name, the field and menu appears (see Figure 37):
a Turn the Smart Select knob to highlight the character, and press the Smart Select knob to
select it.
b Use the Smart Select knob to finish entering the characters of the last name. Up to 18
characters are allowed.
c When you finish entering the last name, select . The last name is saved, and you are
prompted to enter the first name.
d Use Smart Select knob to enter the first name like you did for the last name (up to 18
characters), and select . The first name is saved, and you are prompted to enter the
patient ID.
5 If you are entering the patient ID, the  field and menu appears:
a Turn the Smart Select knob to highlight the character, and press the Smart Select knob to
select it.
b Use the Smart Select knob to finish entering the patient ID. Up to 16 characters are
allowed.
c When you finish entering the patient ID, select .
6 If you are entering the patient sex, use the Smart Select knob to highlight and select  or
.

7 If you are entering the patient’s paced status, use the Smart Select knob to highlight and select
 if the patient has an internal pacemaker.

Figure 37 Entering Patient Name









42
Continued Use 3: Operating the Device

Continued Use
Once in a clinical mode, the Continued Use feature is activated. This feature facilitates continued
treatment of the same patient by retaining the current settings and patient record when the Efficia
DFM100 is turned off for less than 10 seconds. This could occur when turning the knob from
Monitor mode to AED mode or when the Therapy knob is accidentally moved to the OFF position.
If you turn the Efficia DFM100 back on within 10 seconds, it retains the most recent:
• Alarm settings and conditions
• Wave sector settings
• Event timing
• Volume settings
• Vital Signs Trending data
• Pacing settings
• Synchronized Cardioversion settings
• SpO2 value
• EtCO2 value
• AwRR value
• NBP value and measurement frequency
• Event Summary

NOTES: The Sync feature remains active if the Efficia DFM100 is turned off for less than 10 seconds.
However, Sync is disabled when AED mode is activated and must be turned back on upon returning
to Manual Defibrillation mode.
Pacing stops if you leave Pacer mode. It must be restarted manually.
The Continued Use feature does not function if both battery and external AC power are removed
from the device, even briefly.

Mark Events
The Mark Events button allows you to annotate the Event Summary and ECG strip when
the button is pressed. If configured, pressing the Mark Event button prints a 10-second ECG strip
leading up to the event, the event itself, and the 5 seconds after the event.

 To mark an event:
1 Press the Mark Event button. The menu (see Figure 38) is displayed.
2 Turn the Smart Select knob to select the desired event.
3 Press the Smart Select knob to mark the event. If configured, an ECG strip is printed, including
the mark event symbol and the selected event label.
NOTE: If the Mark Event button is pressed and no event is selected from the  menu within 5 seconds,
the  menu is removed from the screen and a generic event is logged. If the Mark Event button
is pressed a second time within 5 seconds of the first event, a generic event is logged and the 
menu screen remains on the display for 5 seconds.

43
3: Operating the Device Passwords

Figure 38 Events Menu








Passwords
Your organization is responsible for managing password and data access according to your
organization’s policies and practices.
For the default passwords, see the Efficia DFM100 Password Letter. For the Service mode
password, see the Efficia DFM100 Service Manual. Philips recommends defining new passwords
when first setting up the device.

Service Mode Password


Service mode requires a password. For instructions on how to set up and change the Service mode
password, see the Efficia DFM100 Service Manual.

Configuration Mode Password


The Configuration mode password is changed in Service mode, and the Service mode password is
required to change the Configuration mode password. For instructions on how to change the
Configuration mode password, see the Efficia DFM100 Service Manual.

Data Management Mode Password


Data Management mode has an optional password. The device is initially set up to require a Data
Management mode password. You can change the requirement in the  view.
For instructions on how to change the Data Management Mode password, see “Changing the Data
Management Mode Password” on page 141. The Configuration mode password is required to
change the Data Management mode password.

44
Safety Considerations 3: Operating the Device

Safety Considerations
The following general warnings and cautions apply to the use of the Efficia DFM100. Additional
warnings and cautions specific to a particular feature are provided in the appropriate sections.

WARNINGS: The Efficia DFM100 is not intended to be deployed in settings or situations that promote use by
untrained personnel. Operation by untrained personnel can result in injury or death.
Use of the Efficia DFM100 is restricted to a single patient at a time.
Algorithms in the Efficia DFM100 use the currently set Paced Status during rhythm analysis.
Confirm that the patient’s paced status is correct.
When transporting a patient or carrying the Efficia DFM100, it is important to position it with the
display facing away from the body or other surfaces. If not, the Therapy and Smart Select knobs may
be bumped and inadvertently moved from their desired position.
Never operate the Efficia DFM100 in standing water. Do not immerse or pour fluids on any portion
of the Efficia DFM100. If the device does get wet, dry it with a towel.
Do not use the Efficia DFM100 in the presence of a flammable anesthetic mixture or oxygen
concentrations greater than 25% (or partial pressures greater than 27.5 kPa/206.27 mmHg). This
can cause an explosion hazard.
Avoid connecting the patient to several devices at once. Leakage current limits may be exceeded. Do
not use a second defibrillator on the patient while pacing with the Efficia DFM100.
Operating the Efficia DFM100 or its accessories in conditions outside the environmental
specifications can result in device or accessory malfunction. The Efficia DFM100 should be allowed
to stabilize within the operating temperature range for 30 minutes prior to operation.
The Efficia DFM100 should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Efficia DFM100 should be observed to verify normal operation in the
configured use.
Use only 3-wire AC power cords with 3-pronged grounded plugs.
Do not touch the communication ports and a patient simultaneously.

CAUTIONS: Be aware of patient cables, including ECG monitoring equipment when used with high frequency
surgical equipment.
Accessory equipment connected to the Efficia DFM100’s data interface must be certified according
to IEC Standard 60950/GB4943 for data-processing equipment or IEC Standard
60601-1/GB9706.1 for electromedical equipment. If in doubt, contact your local Customer Care
Center or representative.
This device is suitable for use in the presence of high-frequency surgical equipment. Following
electrosurgery interference, the equipment returns to the previous operating mode within 10
seconds without loss of stored data. Measurement accuracy may be temporarily decreased while
performing electrosurgery or defibrillation. This does not affect patient or equipment safety. See the
electrosurgery device’s Instructions for Use for information on reducing hazards of burns in the event
of a defect in its equipment.
Do not expose the Efficia DFM100 to x-ray or strong magnetic fields (MRI).

45
3: Operating the Device Safety Considerations

NOTES: This device and its accessories are not intended for home use.
If you use sterilizable paddles, confirm that they have not reached the end of their sterility before
using in an event. See the sterilizable paddles’ Instructions for Use.
Keep your Efficia DFM100 Lithium Ion battery charged and a spare battery nearby.
If a daylight saving time change occurs between the start and end of an event, the timestamps for
that event are not adjusted. The next event does use the adjusted time.
The Efficia DFM100 does not require the practice of any special ElectroStatic Discharge (ESD)
precautionary procedures.

46
4

ECG Monitoring
Overview
This chapter describes the Efficia DFM100’s basic ECG and arrhythmia monitoring functions. The
device uses Philips’ ST/AR Algorithm for ECG analysis.
You can use the Efficia DFM100 to monitor your patient’s ECG through:
• multifunction electrode pads.
• 3- or 5-lead ECG monitoring electrode sets.
• external paddles (for quick assessment only, not continuous monitoring).
If both pads and monitoring electrodes are connected, the Efficia DFM100 allows you to select a
lead to monitor from either source.
Configurable heart rate and arrhythmia alarms clearly communicate patient status, both audibly and
visually.
You can use the Efficia DFM100 to monitor both adult and infant/child ECGs. Use the Patient
Category button to switch categories.
When pressing the Patient Category button, all parameter alarm limits change to the new patient
category. These changes are retained when you switch modes.
• For patients that are 25 kg or 8 years old, use the Adult patient category.
• For patients <25 kg or < 8 years old, use the Infant/Child patient category.
ECG waveforms can be acquired through the Therapy port for pads/paddles or the ECG
Monitoring port for 3- or 5-lead sets. When you are using 3-lead ECG monitoring, only one ECG
lead vector is available. If you are using 5-lead ECG monitoring, up to three ECG lead vectors are
available at the same time for display.

WARNINGS: When monitoring neonatal ECGs, inaccurate measurements and alarms could result because of
differences in the characteristics of the adult ECG compared to the neonatal ECG.
When an external pacemaker is being used on a patient, arrhythmia monitoring is severely
compromised due to the high energy level in the pacer pulse. This may result in the arrhythmia
algorithm’s failure to detect pacemaker non-capture or asystole.
During complete heart block or pacemaker failure (to pace or capture) tall P-Waves (greater than
1/5 of the average R-Wave height) may be erroneously counted by the arrhythmia algorithm,
resulting in missed detection of cardiac arrest.
Algorithms in the Efficia DFM100 use the currently set internal Paced Status during rhythm
analysis. If the Paced Status is set to unknown, the algorithm uses Paced. In order to get a more
accurate rhythm analysis, confirm that the patient’s paced status is set correctly.

47
4: ECG Monitoring Preparing to Monitor ECG

Preparing to Monitor ECG


You can monitor ECG through multifunction electrode pads or ECG electrodes and do a quick
look with external paddles.
NOTE: If monitoring for an extended period of time, monitoring electrodes and multifunction electrode
pads may need to be changed periodically. Refer to the manufacturer’s documentation for how often
to replace the monitoring electrodes or pads.

Skin Preparation
Skin is a poor conductor of electricity so proper skin preparation is important to achieving good
electrode/pad-to-skin contact.

 To prepare the skin:


1 Identify the appropriate locations:
For pads – see the pads package.
For electrodes – see “Electrode Placement” on page 49.
2 If necessary, clip hair at the site or shave if needed.
3 Clean and abrade skin at the site.
4 Dry the site briskly to increase capillary blood flow in the tissues and to remove oil and skin
cells.

Monitoring ECG with Pads


 To monitor ECG through multifunction electrode pads:
1 If not preconnected, connect the Therapy cable to the Efficia DFM100 as described in
“Connecting the Therapy Cable” on page 9.
2 Connect the pads to the Therapy cable as described in “Connecting Multifunction Electrode
Pads” on page 10.
3 Prepare the skin. See “Skin Preparation” on page 48
4 Apply the pads to the patient as described on the pads package.

Monitoring ECG with Electrodes


 To monitor ECG through electrodes:
1 Prepare the skin. See “Skin Preparation” on page 48.
2 Attach the snaps or grabbers to the electrodes before placing them on the patient.
3 Apply electrodes by peeling them, one at a time, from the protective backing and sticking them
firmly to the patient’s skin. Press around the entire edge of each electrode to ensure they are
secure. Make sure the lead wires do not pull on the electrodes. See “Electrode Placement” for
proper electrode locations.
4 If not preconnected, connect the ECG cable as described in “Connecting the ECG Cable” on
page 11.

WARNING: Be sure the electrodes do not come in contact with other conductive material, especially when
connecting or disconnecting the electrodes to/from the patient.

48
Preparing to Monitor ECG 4: ECG Monitoring

NOTE: Use only approved lead-sets with the Efficia DFM100. Failure to do so may introduce noise and
result in intermittent  messages.

Electrode Placement
Figure 39 shows the typical electrode placement for a 3-lead ECG set.

Figure 39 3-Lead Placement

LA/L
RA/R I + (black/yellow)
(white/red)
– – placement: directly below
placement: – the clavicle and near the
left shoulder
directly below
the clavicle and III
near the right LL/F (red/green)
shoulder II placement: on the left
lower abdomen

+
+

Figure 40 shows the typical electrode placement for a 5-lead ECG set.

Figure 40 5-Lead Placement


RA/R (white/red) LA/L (black/yellow)
placement: directly I + placement: directly
below the clavicle and – – below the clavicle and
near the right shoulder – aVR
L

near the left shoulder


aV

V/C (brown/white)
placement: on the
chest; position depends III
on your required lead
II LL/F (red/green)
aVF

selection, see Figure 41


placement: on the
RL/N (green/black) left lower abdomen
placement: on the right
lower abdomen +
+
The single V/C lead may be placed in any of the precordial electrode positions as shown in Figure 41
(V1/C1 through V6/C6).

49
4: ECG Monitoring Preparing to Monitor ECG

Figure 41 V/C Electrode Placement


V/C 1 placement: fourth intercostal space at
right sternal margin
V/C 2 placement: fourth intercostal space at
left sternal margin
V/C 3 placement: midway between V/C 2
and V/C 4
1 2
3 V/C 4 placement: fifth intercostal space at
4 5 6 left midclavicular line
V/C 5 placement: same level as V/C 4 on
anterior axillary line
V/C 6 placement: same level as V/C 4 at left
mid axillary line

NOTES: No matter which V/C electrode placement you select, it appears as V on the Efficia DFM100.
If using a V electrode, it can act as a reference electrode if the RL electrode is unavailable.

For accurate V/C lead placement and measurement, it is important to locate the fourth intercostal
space.

 To locate the fourth intercostal space:


1 Locate the second intercostal space by first palpitating the Angle of Lewis (small bony
protuberance where the body of the sternum joins the manubrium). This rise in the sternum is
where the second rib is attached, and the space just below this is the second intercostal space.
2 Palpate and count down the chest until you locate the fourth intercostal space.

Lead Selection
It is important to select a suitable lead for monitoring so that a QRS complex can be accurately
detected.
For non-paced patients:
• QRS complex should be tall and narrow (recommended amplitude > 0.5 mV).
• R-Wave should be above or below the baseline but not biphasic.
• P-Wave should be smaller than 1/5 R-Wave height.
• T-Wave should be smaller than 1/3 R-Wave height.
NOTE: To prevent detection of P-Waves or baseline noises as QRS complexes, the minimum detection level
for QRS complexes is set at 0.15 mV, according to AAMI-EC 13/YY1079 specifications. If the
ECG signal is too weak, you may get false alarms for asystole.

For paced patients with internal/transvenous pacemakers:


• Confirm paced status is set correctly on the Efficia DFM100. See “Entering Patient
Information” on page 42.
• All four criteria for non-paced patients listed above.

50
Preparing to Monitor ECG 4: ECG Monitoring

• Large enough to be detected (half the height of the QRS complex), with no re-polarization
artifact. Some unipolar pacemakers display pace pulses with re-polarization tails which may be
counted as QRSs in the event of cardiac arrest or other arrhythmias. Choose a lead to minimize
the size of re-polarization tails.
NOTE: Adjusting the ECG wave size on the display does not affect the ECG signal which is used for
arrhythmia analysis.

Lead Choices
Available monitoring leads vary depending on what type of ECG cable is connected to the Efficia
DFM100 and its configuration. See Table 8.

Table 8 Lead Choices

If you are using These leads are available


a 3-Lead ECG set I, II, III
a 5-Lead ECG set I, II, III, aVR, aVL, aVF, V

To select leads to display on the Efficia DFM100, see “Selecting the Waveform” on page 52.

WARNING: Avoid touching monitoring electrodes and other measuring devices when they are applied to the
patient. Doing so can degrade safety and may affect results.

CAUTIONS: Beware of patient cables, including ECG monitoring equipment when used with high frequency
surgical equipment.
Line isolation monitor equipment may produce power line transients that may resemble actual
cardiac waveforms and thus inhibit heart rate alarms. Keep electrode wires and cables away from
power cords to minimize this problem.
Conductive parts of electrodes and associated connectors for applied parts, including the neutral
electrode, should not contact other conductive parts including earth.

NOTES: Signals from TENS or ESU units can cause artifact.


For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest may be reduced by
monitoring these patients with low heart rate limit at or slightly above the basic/demand pacemaker
rate. A low heart rate alarm alerts you when the patient begins pacing. Proper detection and
classification of the paced rhythm can then be determined.
When using the ECG Analog Output, detected internal pacemaker pulses are inserted into the
output as pulses of less than 3.5 ms in width when measured at 50% of the peak of the pulse. The
amplitude of the inserted pulse is >40% and <70% of the detected pacemaker pulse amplitude for
pulses widths of 0.5 ms to 2.0 ms.

51
4: ECG Monitoring Monitor View

Monitor View
You primarily monitor your patient’s ECG waveform in Monitor View by turning the Therapy knob
to Monitor.
In Monitor View, you can review three waves simultaneously while monitoring all current vital sign
parameters. See Figure 42.

Figure 42 Monitor View Layout


Status   
Area  

             
Parameter

      
Area      
 
   

Message
Area

Wave 
Sector 1

 
Wave
Sector 2


Wave
Sector 3

 


Selecting the Waveform


The Efficia DFM100 allows you to configure the lead displayed as the primary ECG lead in Wave
Sector 1 when the device is turned on. The factory default is Lead II. See “Waves Settings” on
page 147.
When you first turn the Efficia DFM100 on in Manual Defibrillation, Synchronized Cardioversion
or Monitor modes or switch into one of those modes, the default lead is displayed in Wave Sector 1.
If the default lead is not available or is of poor quality, the device automatically searches for the
ECG lead with the best quality and displays that new lead in Wave Sector 1. The device searches for
an active ECG source in the following order: default lead, II, Pads (or Paddles), I, III.
You can also change the waveform for each sector during a patient event. How to change a
waveform differs depending if you are in AED mode or not.

Non-AED Mode
The ECG wave for Wave Sector 1 is selected through the Lead Select button (see “General
Function Buttons” on page 27) or through the menu. The waves for Wave Sectors 2
and 3 are selected through the  menu only.

 To select a waveform using the Displayed Waves menu:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob (see
Figure 43).
3 Select the wave sector you want to modify and press the Smart Select knob.
4 Select the new wave type you want and press the Smart Select knob.

52
Monitor View 4: ECG Monitoring

5 If needed, select the appropriate ECG wave size and press the Smart Select knob.
NOTE: When you select the ECG wave size for a certain lead, all instances of that lead adjust to the selected
size. For example, if you have Lead II selected for both Wave Sectors 1 and 2, and you change the
size in Wave Sector 1, Wave Sector 2’s size changes automatically.

Figure 43 Wave Menus

  


  
  
  
  
 
 


NOTES: Selecting the  size, automatically adjusts the ECG size to the maximum size allowed without
clipping the wave sector.
Adjusting the ECG wave size on the display only affects the wave size on the display for viewing. It
does not affect the ECG signal used for arrhythmia analysis. Detected R-Waves for Synchronized
Cardioversion and Demand Pacing are also unaffected by the ECG wave size.

In AED Mode
The Pads ECG wave is automatically populated in Wave Sector 1 in AED mode. The waves
configured for use in AED mode are placed in Wave Sector 2 using the Smart Select knob.

 To select a waveform for Wave Sector 2 in AED mode:


1 Confirm your device is configured to monitor CO2 and/or SpO2 in AED mode.
2 From AED mode, press the Smart Select knob.
3 Turn the Smart Select knob to highlight Wave 2 and press the Smart Select knob.
4 Select the wave you want placed in Wave Sector 2 and press the Smart Select knob.

Figure 44 Wave 2 Menu in AED mode

 

 

 

 



53
4: ECG Monitoring Monitor View

Dashed Lines
A dashed line on your ECG display indicates that you have an invalid ECG signal in the wave sector.
You can either troubleshoot the currently selected lead to solve the problem (see Table 54 “ECG
Problems” on page 177) or select a different lead.

 To replace a dashed line with a different lead:


In Wave Sector 1 - use the Lead Select button to cycle through available leads and select an
appropriate lead.
OR
Use the displayed wave menu to select an appropriate lead.
NOTE: When using a 3-Lead cable, dashed lines will briefly occur with a change of the selected lead.

Displaying an Annotated ECG


You may choose to display an annotated ECG with arrhythmia beat labels in Wave Sector 2. The
same ECG source appearing in Wave Sector 1 is displayed in Wave Sector 2 with a six-second delay.
 appears near the waveform. White arrhythmia beat labels also appear. See Table 9 for beat
label classifications.

Table 9 Arrhythmia Beat Labels

Label Description Where Displayed


 Normal
 Ventricular Ectopic
 Paced Above QRS
 Learning Patient’s ECG
 Insufficient information to classify beats
 Pacer Spike Above waveform, where pacer spike was
detected (If the patient is both atrially and
ventricularly paced, the display shows two
marks above the waveform aligned with the
atrial and ventricular pacing.)
 Biventricular Pace Pulse Above waveform where the biventricular
pace pulse was detected
 Artifact (noisy episode) Above waveform where noise was detected
 Inoperative condition (for example, a lead Above waveform; at start of a technical
is off) alarm, every second of the alarm and at the
end
 Pause, Missed Beat, No QRS Above waveform where condition was
detected

 To display an annotated ECG:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.

54
Arrhythmia Monitoring 4: ECG Monitoring

Arrhythmia Monitoring
The Efficia DFM100 uses the ST/AR Algorithm. Arrhythmia analysis provides information on your
patient’s condition, including heart rate and arrhythmia alarms. The Efficia DFM100 uses the ECG
lead appearing in Wave Sector 1 for single-lead arrhythmia analysis.
During arrhythmia analysis, the monitoring function continuously:
• Optimizes ECG signal quality to facilitate arrhythmia analysis. The ECG signal is continuously
filtered to remove baseline wander, muscle artifact and signal irregularities. Also, if the patient’s
paced status is set to yes, pace pulses are filtered out to avoid processing them as QRS beats.
• Measures signal features such as R-Wave height, width and timing.
• Creates beat templates and classifies beats to aid in rhythm analysis and alarm detection.
• Examines the ECG signal for ventricular arrhythmias and asystole.
NOTE: Because the ST/AR Algorithm is the Efficia DFM100’s cardiotach source and is needed to generate
heart rate and heart rate alarms, the algorithm can never be disabled. However, if desired,
arrhythmia and heart rate alarms can be turned off. See “Setting Alarms” on page 59.

ST/AR cardiotach and alarms, when activated, also work in AED mode for ECG monitoring.

Aberrantly-Conducted Beats
As P-Waves are not analyzed, it is difficult and sometimes impossible for the algorithm to
distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the
aberrant beat resembles a ventricular beat, it is classified as a ventricular beat. You should always
select a lead where the aberrantly-conducted beats have an R-Wave that is as narrow as possible to
minimize incorrect classifications.

Intermittent Bundle Branch Block


Bundle branch and other fascicular blocks create a challenge for the arrhythmia algorithm. If the
QRS complex changes considerably from the learned normal due to bundle branch block, the
blocked beat may be incorrectly identified as ventricular, and may cause false PVC alarms. You
should always select a lead where bundle branch block beats have an R-Wave that is as narrow as
possible to minimize incorrect classifications.

Arrhythmia Learning/Relearning
When arrhythmia monitoring starts, a “learning” process is initiated. The goal is to learn the
patient’s normal complexes and/or paced complexes (if the patient with an internal/transvenous
pacemaker is in paced rhythm). The learning process involves the first 15 valid (non-noisy) beats
encountered during the learning phase.
The QRS selected to represent the “normal” complex includes the beat that is the most frequently
seen, narrowest, on-time beat. For this reason, learning should not be initiated when the patient’s
rhythm is primarily ventricular.
Arrhythmia learning/relearning automatically occurs when:
• The Therapy knob is turned to Monitor, Pacer, AED or a Manual Defibrillation setting.
• Any time there is a change in the lead selection for Wave Sector 1.
• After the correction of a leads or pads off condition that has been active longer than 60
seconds.
Initiate manual relearning if the beat detection is not occurring or if beat classification is incorrect
and results in a false alarm. Remember if the same signal condition which caused the algorithm to

55
4: ECG Monitoring Heart Rate and Arrhythmia Alarms

perform poorly still exists, relearning does not correct the problem. The problem can only be
corrected by improving the signal quality (e.g., selecting a different lead).

 To initiate relearning manually:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
 and  messages appear in the bottom portion of Wave Sector 1.

WARNINGS: If arrhythmia relearning takes place during a ventricular rhythm or during a period of poor ECG
signal quality, ectopic beats may be incorrectly learned as the normal QRS complex. This may result
in missed detection of subsequent events of V-tach and high PVC rates. For this reason you should:
• Take care to initiate arrhythmia relearning only when the ECG signal is noise-free.
• Be aware that arrhythmia relearning can happen automatically.
• Respond to any messages (e.g., if you are prompted to reconnect electrodes).
• Display an annotated wave to ensure the beat labels are correct.
Pacemaker Pulse Rejection: When arrhythmia monitoring paced patients who exhibit only intrinsic
rhythm, the monitor may erroneously count paced pulses as QRS complexes when the algorithm
first encounters them, resulting in missed detection of cardiac arrest. Be sure that the paced status is
set correctly on the device.
Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS
complex, and could result in incorrect HR and failure to detect cardiac arrest or some arrhythmias.
Keep pacemaker patients under close observation. See Chapter 19 “Specifications” on page 193 for
details on Pacemaker Pulse Rejection Capability.

NOTE: It is important to set the patient’s correct paced status in order to optimize ECG analysis.

Heart Rate and Arrhythmia Alarms


The Efficia DFM100 detects HR and arrhythmia alarm conditions by comparing ECG data to a set
of pre-defined criteria. An alarm can be triggered by a rate exceeding a threshold (e.g., HR >
configured limit), an abnormal rhythm (e.g., Ventricular Tachycardia) or an ectopic event (e.g., PVC
> configured limit).
HR/Arrhythmia alarms can be generated for the conditions shown in Tables 10 and 11. Once
generated, they appear as alarm messages in the HR alarm status area above the HR numeric. When
ECG alarms are off an  message appears above the HR numeric. There are both audio
and visual alerts. For more information on alarms, see “Alarms” on page 37.
NOTE: Alarm notification is configurable. See “Alarm Management” on page 39.

56
Heart Rate and Arrhythmia Alarms 4: ECG Monitoring

Table 10 HR/Arrhythmia Physiological Alarms

Alarm Message Condition Type of Alarm Indication


 No detectable beats for four
seconds in the absence of V-Fib.
 A fibrillatory wave detected for
four seconds.
 Consecutive PVCs and HR
exceed configured limits.
 Extreme Brady - 10 bpm below
HR low limit, capped at 30 bpm.
High Priority Red Alarm message
 Extreme Tachy - Adult: 20 bpm
Latching Alarm with alarm tone
above HR High limit, up to
180 bpm, 200 bpm for limits
between 180-200.
Extreme Tachy - Infant/Child:
20 bpm above HR High limit, up
to 220 bpm, 240 bpm for limits
between 220-240.
For higher rates, the limit is equal
to the HR High limit.
 No QRS following internal pacer
pulse. Medium Priority
 No QRS or pacer internal pulse Latching Alarm
detected.
 The number of detected PVCs in Yellow Alarm message
(detected rate > limit) a minute exceed the limit. with alarm tone
Medium Priority
 The HR exceeds the configured Latching
HR High limit. Configurable
Alarm
 The HR is below the configured
HR Low limit.

NOTE: The high HR alarm condition is not detected when the HR High limit is configured greater than the
maximum Extreme Tachy threshold. You get the Extreme Tachy alarm. The low HR alarm
condition is not detected when the HR Low limit is configured less than or equal to the minimum
Extreme Brady threshold.

57
4: ECG Monitoring Heart Rate and Arrhythmia Alarms

Table 11 HR/Arrhythmia Technical Alarms

Alarm Message Condition Type of Alarm Indication


 The multifunction electrode

pad/paddles or leads used as the
source for Wave Sector 1 during
 Synchronized Cardioversion may
be disconnected or not attached
securely.
ECG data in Wave Sector 1
cannot be analyzed – an
electrode used is
disconnected/not attached High Priority
 Red Alarm message
securely. Non-Latching
with alarm tone
Alarm
The analyzing algorithm cannot
analyze the ECG signal.
 A malfunction has occurred in
 the ECG hardware.
 A malfunction has occurred in
 the Pads ECG hardware.
 Therapy is disabled due to an
 equipment failure.

Figure 45 Basic Mode Arrhythmia Alarm Priority Chain

For Monitor, Manual Defibrillation, Synchronized Cardioversion and Pacing


Red Alarms (High Priority)






 

Yellow Arrhythmia Alarms (Medium Priority)

PVC Alarms Beat Detection Alarms Rate Alarms

 /
 

58
Heart Rate and Arrhythmia Alarms 4: ECG Monitoring

Figure 46 Cardiotach Mode Arrhythmia Alarm Priority Chain

For AED Mode Only


Red Alarms (High Priority)




 

Yellow Arrhythmia Alarms (Medium Priority)

/

Setting Alarms
Alarm settings for Heart Rate (HR), VTach and PVC Rate Limit for the current patient event can be
changed via the Smart Select knob during the event. Settings for other HR and arrhythmia alarms
may not be changed.

Changing Alarm Limits


 To change HR, VTach or PVC Rate Limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select the limit you want to adjust, and press the Smart Select knob.
5 Select the new value, and press the Smart Select knob.

Enabling/Disabling Alarms
 To enable/disable the HR and Arrhythmia alarms:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  (), and press the Smart Select knob.

59
4: ECG Monitoring Troubleshooting

Responding to Alarms
When an alarm occurs, the audio pause label appears above the Smart Select knob. Press the knob to
silence the alarm audio while you attend to the patient. The alarm sounds again if the condition
continues to exist beyond the configured alarm pause period or another alarm condition occurs.
After pausing the audio on the Efficia DFM100, attend to the patient and press the Smart Select
knob to acknowledge the alarm condition. If required, adjust the alarm limits using the Smart Select
knob.

Figure 47 Sample Alarm Response Menu


Certain lethal arrhythmias
 only have  as

a menu option.

HR/Arrhythmia Alarms in AED Mode


If alarms are turned on in AED mode, all Technical Alarms listed in Table 11 and the following
Physiological Alarms from Table 10 are generated when the condition exists:
•  •  • 
•  •  • 

For more information on AED mode, see “AED Mode Option” on page 61.
For more information on Alarms, see “Alarms” on page 37.

Troubleshooting
If your Efficia DFM100 does not operate as expected during ECG and Arrhythmia monitoring, see
“ECG Problems” on page 177.

60
5

AED Mode Option


Defibrillation therapy is the definitive method for termination of lethal arrhythmias. The Efficia
DFM100’s optional Semi-Automated External Defibrillation (AED) mode is designed to guide you
through standard treatment algorithms for cardiac arrest. If your device has this option, the Efficia
DFM100 provides therapy through the application of a brief biphasic pulse of current to the heart.
This energy is transferred through disposable multifunctional pads applied to the patient’s bare
chest.
This chapter describes how to use AED mode. It explains the voice and visual prompts that guide
you through the defibrillation process and describes how prompts vary depending upon the
condition of the patient and the configuration of your device. Configuration choices allow you to
customize AED mode to better meet the unique needs of your institution or resuscitation team.
The Efficia DFM100 uses Philips’ SMART Analysis algorithm as the basis for making a shock
decision in AED mode. The SMART Analysis algorithm was designed to make aggressive shock
decisions concerning ventricular fibrillation. Because ventricular tachycardia rhythms may have an
associated pulse, SMART Analysis is more conservative when making shock decisions with these
rhythms.
In AED mode you can also monitor the patient’s ECG, SpO2, pulse, EtCO2 and AwRR. Certain
ECG alarms can also be displayed in AED mode. Even though ECG alarms, which are obtained
through the ST/AR Algorithm, can be viewed in AED mode, the SMART Analysis algorithm is
used as the only basis for determining a shock. See “Other Alarms in AED Mode” on page 73.
AED mode can be used on both adult and infant/child patients. Use the Patient Category
button to switch categories.
When pressing the Patient Category button, all parameter alarm limits change to the new patient
category. These changes are retained when you switch modes.
• For patients that are 25 kg or 8 years old, use the Adult patient category.
• For patients <25 kg or < 8 years old, use the Infant/Child patient category.
For information on annotating, storing, exporting and printing event information acquired in AED
mode, see “Data Management” on page 125.
For guidance on setting AED configuration choices, see “AED Settings” on page 148.
Optional CO2, AwRR, SpO2 and Pulse monitoring are also available in AED mode. For more
information, see:
• “CO2 and AwRR” on page 73
• “SpO2 and Pulse” on page 73
• Chapter 9 “Monitoring CO2” on page 97
• Chapter 10 “Monitoring SpO2” on page 107

61
5: AED Mode Option Precautions for AED Therapy

Precautions for AED Therapy


WARNINGS: The AED algorithm is not designed to handle erratic spiking problems caused by a properly or
improperly functioning pacemaker. In patients with cardiac pacemakers, the Efficia DFM100 may
have reduced sensitivity and not detect all shockable rhythms.
Use only pads that are approved for use with the Efficia DFM100. Use of non-approved pads could
affect performance and results. See Table 61 “Approved Supplies and Accessories” on page 189 for a
list of supported pads.
For adults in AED mode, the multifunction electrode pads must be in the anterior-anterior position
shown on the packaging. For infant/child patients, the pads can be in the anterior-posterior position.
Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and
patient skin burns during defibrillation and may divert current away from the heart.
During defibrillation, air pockets between the skin and multifunction electrode pads may cause
patient skin burns. To help prevent air pockets, make sure the pads completely adhere to the skin.
Do not use dried out pads. Do not open pads package until just prior to use.
Never touch the patient or any equipment connected to the patient (including the bed or gurney)
during analysis and defibrillation.
Avoid contact between the patient and conductive fluids and/or metal objects such as the gurney.
Medical electrical equipment which does not incorporate defibrillator protection should be
disconnected before defibrillation.

NOTES: Successful resuscitation depends on many variables specific to the patient’s physiological state and
the circumstances surrounding the patient event. Failure to have a successful patient outcome is not
a reliable indicator of defibrillator/monitor performance. The presence or absence of muscular
response to the transfer of energy during electrical therapy is not a reliable indicator of energy
delivery or device performance.
Impedance is the resistance found between the defibrillator’s pads when applied to the patient’s
body the device must overcome to deliver an effective discharge of energy. The degree of impedance
differs from patient to patient and is affected by several factors including the presence of chest hair,
moisture, lotions, or powders on the skin. The low-energy SMART biphasic waveform is an
impedance-compensating waveform that is designed to be effective across a wide range of patients.
However, if you receive a  message on the display, check that the patient’s skin has
been washed and dried and that any chest hair has been clipped. If the message persists, change the
pads and/or Therapy cable.
The SMART Analysis algorithm detects internal pacemaker pulses that are 2.5 ms or less in duration
and removes these pulses so that they are not counted by the algorithm.
Perform all routine diagnostic tests to verify that voice prompts are operational during the
operational check and according to your organization’s protocol.

62
AED View 5: AED Mode Option

AED View
When the Therapy knob is moved to AED, AED View is displayed (see Figure 48). AED
mode-related information includes:
AED Message Area: Displays important messages for the user while in AED mode.
Shock Counter: Displays the number of shocks for the current event (including shocks delivered in
Manual Defibrillation mode).
Delivered Energy: Displays the energy amount that was delivered for the most recent shock.
Replaces the Shock Counter for 15 seconds after the shock is delivered.
Selected Energy: Displays the configured energy for the current patient category.
Wave Sector 2: Displays the Capnogram or the SpO2 waveform depending upon which
combinations of options you have configured (see Table 43 on page 148) or the AED Pause/CPR
Progress Bar.
Patient Contact Indicator: Graphical representation of the contact quality between the patient and
the multifunction electrode pads. Orange or red lights on the PCI indicate poor patient contact.
Adjust pads to optimize patient contact. Multiple green lights on the PCI indicate good contact is
established. The PCI is displayed when pads are attached and the device is charging or is charged. It
is not displayed when using paddles. When using paddles, use the PCI on the paddles as a patient
contact indicator.
AED Pause/CPR Progress Bar: When in use, replaces the wave in Wave Sector 2 and tracks the
progress of the analysis pause and CPR periods.
Patient Category: Displays the current patient category. The patient category triggers specific
alarm limits and AED energy settings for defibrillation. The background color changes with the
selected patient category for Adult (orange) and Infant/Child (blue).

Figure 48 AED View Layout


Patient  
Category  

         

    
    
    
AED
Message
Area 


Enlarged
Wave
Sector 1
waveform

    

Energy
Wave   Setting
Sector 2

    Length of


  Pause
Patient Period
Contact Shock Counter/Delivered Energy Current
Indicator Duration

NOTE: Only the ECG acquired through multifunction electrode pads is displayed in AED mode.

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5: AED Mode Option Using AED Mode to Defibrillate

AED Soft Keys


AED mode has multiple soft keys available for use (see Figure 48):
• CPR - Pressing the soft key initiates the configured pause period to perform CPR.
• Resume Analyzing - Pressing the soft key initiates the AED analysis
algorithm to resume or restart analysis.
• Zero CO2 - Available if you have the CO2 option installed and AED CO2 monitoring
enabled. Pressing the soft key zeros the sensor.
• Background Analysis - This key is available if your device is configured for No Shock
Advised (NSA) Monitoring and you have activated NSA Pause. Press it to begin NSA
monitoring.
Pressing the Smart Select knob brings up the main menu for AED mode. See Figure 49.

Figure 49 AED Main Menu

Select  to adjust the volume of AED


mode voice prompts.
Select  to adjust the volume of AED
mode alarms.

 Select  to modify the ECG wave size.
 See Figure 43 on page 53.
 Select  to select which wave is to appear in
 Wave Sector 2.
 Select  to modify alarm limits.

Select or  to turn the parameter off

in AED mode.

Select  to exit the menu.

NOTE: SpO2 Off and EtCO2 Off will not display as menu options if they are not configured to be available
in AED mode.

For more information on menus, see “Menus” on page 35.


NOTE: In loud environments, use the display prompts in addition to the voice prompts.

Using AED Mode to Defibrillate


Preparation
 To prepare for defibrillation in AED mode:
1 Confirm the patient is:
• Unresponsive
• Not breathing
• Pulseless
2 Expose patient’s bare chest. Wipe moisture from the patient’s chest and, if necessary, clip or
shave excessive chest hair.

64
Using AED Mode to Defibrillate 5: AED Mode Option

3 Check the expiration date on the pads package and inspect the package for any damage.
4 Connect the Therapy cable to the Efficia DFM100 (see “Connecting the Therapy Cable” on
page 9).
5 If the pads are not expired and package is undamaged, open the package and connect the pads
connector to the end of the Therapy cable (see “Connecting Multifunction Electrode Pads” on
page 10).
6 Apply the pads to the patient as directed on the pads packaging or according to your
organization’s protocol.

CAUTION: Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads.
Discard the pads if they become damaged.

Operation
 To operate the Efficia DFM100 in AED mode:
1 Turn the Therapy knob to AED. The Efficia DFM100 announces and displays the current
patient category.
If not correct, use the Patient Category button to select the appropriate patient category.
• For patients that are 25 kg or 8 years old, use Adult patient category.
• For patients <25 kg or < 8 years old, use Infant/Child patient category.
2 Follow the voice and screen prompts.
3 Press the orange Shock button if prompted.
See the following sections for more information.
NOTE: While operating in AED mode, the capabilities of the device are limited to those essential to the
performance of semi-automated external defibrillation. Only the ECG acquired through pads is
displayed. If you have the CO2 and/or SpO2 option, based on your configuration, the numeric and
related waveform is also displayed in AED mode. Previously set alarms and scheduled NBP
measurements are indefinitely paused and entry of patient information (with the exception of
patient category) is disabled. Additionally, the Sync, Lead Select and Alarm Pause buttons are
inactive.

Step 1 - Turn the Therapy Knob to AED


When the Efficia DFM100 is turned to AED, it announces and displays the patient category.
Confirm you have the correct category active for the patient. If not, use the Patient Category button
to select the correct category.
The device also checks to see if the Therapy cable and multifunction electrode pads are properly
connected. If the:
• Therapy cable is not properly attached, you are prompted to “Plug in Connector” with a
 prompt and graphic illustration on the screen.

• Multifunction electrode pads are not connected to the Therapy cable, pads are not applied
to the patient or pads are not making proper contact with the patient’s skin, you are
prompted to “Insert connector firmly. Apply pads.”
Follow the audio and visual prompts to correct the issues. When properly connected, AED mode
automatically begins shock analysis. If the patient category is changed when shock analysis is in
progress, you do not need to abort the analysis in progress and restart a new one. The algorithm is
not sensitive to patient category.

65
5: AED Mode Option Using AED Mode to Defibrillate

Step 2 - Follow Screen and Voice Prompts


Once an ECG is detected through the multifunction electrode pads, the Efficia DFM100 warns you
not to touch the patient and automatically analyzes the patient’s heart rhythm.
NOTE: The AED algorithm only looks at the ECG for analysis. It does not use any other data, even if the
option is active in AED mode.

WARNING: Handling or transporting the patient during ECG rhythm analysis can cause an incorrect or delayed
diagnosis. Under these circumstances, if the Efficia DFM100 issues a “Shock Advised” command,
keep the patient as still as possible for at least 10 seconds so the device can reconfirm the rhythm
analysis before pressing the orange Shock button to deliver a shock.

The AED mode algorithm can return one of the following results:
• Shock Advised - If a shockable rhythm is detected, the Efficia DFM100 automatically charges
to the preconfigured Joule setting (default is 150J) if the Adult patient category is selected (see
“AED Settings” on page 148) or 50 J if in the Infant/Child category. Charging is accompanied
by voice and screen prompts. When the device is fully charged, a steady high-pitched tone
sounds, and the orange Shock button flashes.
Heart rhythm analysis continues while the Efficia DFM100 charges. If a rhythm change is
detected before the shock is delivered, and a shock is no longer appropriate, the defibrillator
disarms itself.
NOTE: When fully charged, you can disarm the device at any time by turning the Therapy knob off the
AED position. Resume AED monitoring by turning the Therapy knob back to AED.

• No Shock Advised (NSA) - If a shockable rhythm is not detected, the Efficia DFM100 tells
you “No shock advised.” Follow your institution's protocol for a No Shock Advised alert. The
device’s next steps are determined by the No Shock Advised Action configuration choice. If the
configuration is set to:
- Monitor - The Efficia DFM100 monitors the ECG and automatically resumes analysis if
a potentially shockable rhythm is detected. You are periodically prompted to press 
and to begin CPR if CPR is indicated. The frequency of these prompts is defined in the
Monitor Prompt Interval configuration choice. You may press  to suspend monitoring
and administer CPR. The pause period is defined by the CPR Timer configuration choice.
See “AED Settings” on page 148.
- Pause Time - Analysis is suspended for the specific period which is defined by the NSA
Action configuration choice. You may attend to the patient and administer CPR if
indicated. The Pause Status Bar is displayed (see “AED View Layout” on page 63). At the
end of the pause period, the Efficia DFM100 resumes analyzing.
• ECG cannot be analyzed - If artifact interferes with analysis, the device alerts you and
attempts to continue analyzing. If artifact persists and the device announces that the ECG can’t
be analyzed, it enters a pause period.
While paused, analysis is suspended. Check that the pads are making proper contact with the
patient’s skin and minimize movement. Analysis resumes automatically in 30 seconds or when
you press the  soft key. You should always use the analyze function to
determine if a rhythm is shockable.
For more information on AED messages, see “AED Mode User Messages” on page 67.

Step 3 - Press Shock Button if Prompted


Once charging is complete, the Efficia DFM100 prompts you with “Deliver shock now.” Make sure
no one is touching the patient or anything connected to the patient. Call out clearly and loudly “Stay
Clear!’ Then press the flashing orange Shock button to deliver a shock to the patient.

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Using AED Mode to Defibrillate 5: AED Mode Option

WARNINGS: The Shock button must be pressed to deliver a shock. The Efficia DFM100 does not automatically
deliver a shock.
Defibrillation current can cause operator or bystander injury. Do not touch the patient or equipment
connected to the patient during defibrillation.

Delivery of the shock is confirmed by an  visual message and the


shock counter is updated to reflect the number of shocks given. The defibrillator then announces
“Begin CPR” and enters the configured CPR Timer period. Prompts may be brief or detailed as
defined by the Voice Prompt configuration choice. Analysis begins again at the end of the pause
period or when you press the  soft key. If you switch to Manual Defibrillation
during the CPR Pause period, the device continues the CPR period. If you switch to Monitor or
Pacer modes, the CPR Pause period exits.

NOTES: Once prompted to administer the shock, if you do not do so within the configured Auto Disarm
time interval, the Efficia DFM100 disarms itself and enters a pause period for CPR. The device
resumes analyzing at the end of the pause period or when you press the  soft key.
Rhythm monitoring is intended to provide a backup or secondary measure of potentially shockable
rhythms in various environments but is not a substitute for being attentive to the patient’s state.

AED Mode User Messages


AED mode guides you through the defibrillation process. Depending upon the given situation,
voice prompts and display messages are presented to assist you in using the mode. See Tables 12-19.

Table 12 AED Mode Connect Pads Messages


These messages may appear when the Therapy cable is not connected properly to the Efficia DFM100.
Audio Message Display Text Condition User Action
“Plug in Connector.”  The Therapy cable is not Securely connect the Therapy
connected to the Efficia cable to the device.
DFM100.
None  A paddles cable is attached to the Disconnect the paddles cable
Efficia DFM100. and attach the pads Therapy
cable.

Table 13 AED Mode Messages


These messages may appear during normal AED mode operation.
Audio Message Display Text Condition User Action
“Adult mode.”  The current AED mode
None
 patient category is Adult.

“Infant/Child mode.”  The current AED mode



patient category is None
Infant/Child.
“Low battery.” Charge the battery or
See battery icon in upper right The Efficia DFM100
replace it with a
of the display. battery charge level is low.
charged battery.

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5: AED Mode Option Using AED Mode to Defibrillate

Table 14 AED Mode Analysis Related Messages


These messages may appear during AED analysis.
Audio Message Display Text Condition User Action
“Stay clear of patient. Analyzing.  Do not touch the
ECG analysis is underway.
Stay clear.” patient.
“No shock advised.”  ECG analysis has Attend to the patient.
 determined the rhythm is Begin CPR if
not shockable. indicated.
“Shock advised.” Once the device is
ECG analysis has
 charged, press the
“Shock advised, Stay clear.” determined the rhythm is
 flashing orange Shock
shockable.
button.
“Analyzing Interrupted. Stay  ECG analysis was Stop patient
clear of patient. Stop all  interrupted because of a bad movement and
motion.” ECG signal. reanalyze.
“Cannot analyze.”  Check pads
ECG analysis cannot
connection. Attend to
determine if the rhythm is
patient, begin CPR if
shockable or not.
indicated.

Table 15 AED Mode Pads Off Messages


These messages may appear when the multifunction electrode pads are not secured to the patient.
Audio Message
L = long prompts S = short prompts
Display Text Condition User Action
Not noted = Both

L - “Insert connector firmly.


Apply pads to patient’s bare
chest.” With Adult patient category
S - “Insert connector firmly. selected, there is no
Apply pads.” connection between the
“Apply Pads” is repeated four pads and the Therapy cable.
Securely connect the
times or until the connection Therapy cable and the
is made. pads connector. See
“Insert connector firmly. Look  With Infant/Child patient “Connecting
carefully at the screen for category selected, there is Multifunction
Infant/Child pad placement.” no connection between the Electrode Pads” on
pads and the Therapy cable. page 10.
“Apply pads as shown on With Infant/Child patient
screen. Apply first pad to child’s category selected, if pads
chest. Apply second pad to remain disconnected, more
child’s back. Apply pads as audio prompts follow.
shown on screen.”

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Using AED Mode to Defibrillate 5: AED Mode Option

Table 15 AED Mode Pads Off Messages (Continued)


These messages may appear when the multifunction electrode pads are not secured to the patient.
Audio Message
L = long prompts S = short prompts
Display Text Condition User Action
Not noted = Both

“Press pads firmly to patient’s Securely connect the


bare skin. Pads must not be Therapy cable and the
touching clothing or each other. pads connector. See
If needed, remove hair from “Connecting
patient’s chest.” Multifunction
 Electrode Pads” on
“Be sure pads connector is
The Therapy cable is page 10.
completely inserted.”
connected. A pads off Confirm there is a
condition still exists. good pads contact
with the skin.
“Poor pads contact, Replace 
Replace the pads.
pads.”

“Begin CPR.”  Begin CPR, if


 indicated.

Table 16 AED Mode Marginal Impedance Messages


These messages may appear when the Efficia DFM100 detects a higher pad impedance than expected in the average
patient. The cause could be excessive hair on the chest, expired or dried out pads, or poor pad placement/contact on
the patient.
Audio Message Display Text Condition User Action
“Press pads firmly to patient’s
bare skin.”
Recheck pads.
“Press pads firmly to patient’s Confirm they are
bare skin. Pads must not be 
securely connected to
touching clothing or each other. the patient.
If needed remove hair from
patient’s chest.” When the device is not
charged, charging or
“Poor pads contact, Replace  delivering a shock or in a Recheck pads.
pads.” pause period, pads Confirm they are
impedance condition is securely connected to
marginal. the patient. If they are,
remove them and
replace with new pads.
“Begin CPR.” None or  Good pads contact
 cannot be established.
If CPR is indicated,
begin CPR.

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5: AED Mode Option Using AED Mode to Defibrillate

Table 17 AED Mode Low Impedance Messages


These messages may appear when the Efficia DFM100 detects a lower pad impedance than expected in the average
patient. The cause could be that the pads are touching or there is too much moisture on the patient.
Audio Message Display Text Condition User Action
“Poor pads contact. Apply pads  Confirm there is good
as shown on screen.” pads contact with the
skin.
“Poor pads contact, Replace  Recheck pads.
pads.” Confirm they are
When the device is not in a securely connected to
pause period, the pads are the patient. If they are,
detecting a low impedance. remove them and
replace with new pads.
“Begin CPR.” None or  Good pads contact
 cannot be established.
If CPR is indicated,
begin CPR.

Table 18 AED Mode Shock Related Messages


These messages may appear when a shock is advised or immediately after a shock is delivered in AED mode.
Audio Message Display Text Condition User Action
“Deliver shock now.”  The defibrillator is charged
Press the flashing
“Press the flashing orange  and waiting for you to press
orange Shock button.
button now.” the Shock button.

“Shock cancelled.” After charging, the device


detected a non-shockable
“Shock cancelled, No shock Attend to the patient.
rhythm and automatically
advised.”
disarmed.
“Shock cancelled. Pads must not 
A shock was aborted due to Confirm pad
be touching clothing or each placement is correct
low impedance.
other.” and pressed firmly
“Shock cancelled. Press pads A shock was aborted due to against the chest then
firmly to patient’s bare skin.” high impedance. try shocking again.

“Shock button not pressed.”  A shock was aborted Re-analyze and press
because the shock button the Shock button
was not pressed. when told to do so.
“Shock delivered.” None A shock has been delivered
Attend to the patient.
to the patient.

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Using AED Mode to Monitor 5: AED Mode Option

Table 18 AED Mode Shock Related Messages (Continued)


These messages may appear when a shock is advised or immediately after a shock is delivered in AED mode.
Audio Message Display Text Condition User Action
“Press pads firmly to patient’s None Shock delivered abnormal Confirm pad
bare skin.” energy due to marginal placement is correct
impedance. and pressed firmly
against the chest.
 The final shock in a series
None Attend to the patient.
 has been delivered.
 A shock in a
None  yet-to-be-completed series Stay clear of patient.
has been delivered.

Table 19 AED Mode Forced Pause Related Messages


These messages may appear during a forced pause time period when analysis is not taking place and you can attend
to the patient.
Audio Message Display Text Condition User Action
A shock series has ended
and the device has entered a
pause period for CPR.
 A no-shock decision has
been made and the device
“Begin CPR.” has entered a pause period
for CPR.
A no-shock decision has Attend to the patient.
been made and during Begin CPR if
 indicated.
monitoring, artifact has
been detected.
“Attend to patient.”  You have paused the device.
“No shock advised.”  A no-shock decision has
 been made and the device
“Begin CPR, Check patient.”  has entered a pause period
 for CPR.

“Stop CPR.” None The CPR pause period has Attend to patient.
ended. Resume analysis if
indicated.

Using AED Mode to Monitor


You can use AED mode to monitor your patient’s ECG, SpO2, pulse, EtCO2 and AwRR. Related
alarms can also be activated for the parameters.

 To monitor ECG in AED mode and activate alarms:


1 Turn the Therapy knob to AED. The Efficia DFM100 announces the patient category currently
set.
If not correct, use the Patient Category button to select the appropriate patient category.

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5: AED Mode Option Configurable Resuscitation Protocols

• For patients that are 25 kg or 8 years old, use the Adult patient category.
• For patients <25 kg or < 8 years old, use the Infant/Child patient category.
2 After performing an initial ECG rhythm analysis, if the rhythm is not shockable, the Efficia
DFM100 begins to monitor the patient.
3 To activate ECG alarms in AED mode, press the Alarms button on the front of the
Efficia DFM100.

 To monitor optional SpO2 and pulse in AED mode and activate alarms:
1 Once in AED mode, attach an SpO2 sensor to the device and patient (see “Applying the Sensor”
on page 109).
2 If you have the device configured to monitor SpO2 in AED mode, SpO2 monitoring begins
once a pulsatile reading is obtained. For more information on SpO2, see Chapter 10
“Monitoring SpO2” on page 107.
3 To activate SpO2 and Pulse alarms in AED mode, press the Alarms button on the front of the
Efficia DFM100.

 To monitor optional EtCO2 and AwRR in AED mode and activate alarms:
1 Once in AED mode, attach an CO2 sensor to the device and the patient (see “Connecting the
CO2 Cable and Sample Line” on page 12).
2 If you have the device configured to monitor CO2 in AED mode, CO2 monitoring begins once
a reading is obtained. For more information on CO2, see Chapter 9 “Monitoring CO2” on
page 97.
3 To activate CO2 and AwRR alarms in AED mode, press the Alarms button on the front of the
Efficia DFM100.

Configurable Resuscitation Protocols


In AED mode, you have the flexibility to configure the Efficia DFM100 to match your institution’s
resuscitation protocols. You can:
• Customize the device for the number of shocks (1-4) in a series.
• Select the energy setting within a given shock series (Adult patient category only).
• Set the CPR Pause interval from 1-3 minutes.
• Select the level of detail you want while in AED mode.
• Select what the device does after a No Shock Advised decision.
For more information, see Tables 43 and 44 in the Configuration chapter.

AED Alarms
The SMART Analysis algorithm generates AED Defibrillation alarms for the conditions shown in
Table 20. There are both audio and visual alerts, when turned on.
When monitoring a patient, the ST/AR ECG Monitoring Algorithm generates ECG alarms in AED
mode, if turned on. See “Other Alarms in AED Mode” on page 73.
For more information on alarms, see “Alarms” on page 37.

72
Troubleshooting 5: AED Mode Option

Table 20 AED Defibrillation Alarms

Alarm Message Condition Type of Alarm Indication


 With pads in use, the connection High Priority
between the device and patient Non-Latching
has been lost. Alarm
 A shock has been automatically
aborted.
 Abnormal shock dose delivered
 due to marginal patient Red Alarm message
impedance. with alarm tone
High Priority
 The device detected a change in Latching Alarm
 paddles or pads type or the
therapy cable identification is
invalid.
 Therapy is disabled due to an
 equipment failure.

Other Alarms in AED Mode


ECG
If ECG alarms are turned on in AED mode, all Technical Alarms listed in “HR/Arrhythmia
Technical Alarms” on page 58 and the following Physiological Alarms from “HR/Arrhythmia
Physiological Alarms” on page 57 are generated when the condition exists:
•  •  • 
•  •  • 

Once generated, all alarms appear as messages in the HR alarm status area above the HR numeric.
There are both audio and visual alerts. For more information on ECG alarms, see “Arrhythmia
Monitoring” on page 55.

SpO2 and Pulse


If SpO2 and Pulse alarms are turned on, the alarm messages appear in the SpO2 or Pulse status area
above their respective numeric. For more information, see “SpO2 Alarms” on page 111 and “Pulse
Rate Alarms” on page 113.

CO2 and AwRR


If EtCO2 or AwRR alarms are turned on, the alarm messages appear in their respective status areas
above the numeric. For more information, see “ETC02 and AwRR Alarms” on page 101.

Troubleshooting
If your Efficia DFM100 does not operate as expected during AED mode, see “Defibrillation and
Pacing Problems” on page 179.
If there is a delay in delivering therapy, start CPR if indicated.

73
NOTES

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_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
6

Manual Defibrillation
This chapter explains how to prepare for and perform defibrillation or asynchronous cardioversion
on the Efficia DFM100 using multifunction electrode pads, external paddles and internal paddles.
See Chapter 7 “Synchronized Cardioversion” on page 83 for information on synchronized
cardioversion.

Overview
Defibrillation therapy is the definitive method for termination of lethal arrhythmias.The Efficia
DFM100 provides this therapy through the application of a biphasic pulse of current to the heart.
This electrical energy is transferred through attached paddles or disposable multifunction electrode
pads applied to the patient’s bare chest. Internal paddles for open-chest intrathoracic defibrillation
can also be used.
In Manual Defibrillation mode, the entire defibrillation process is under your control. You must
assess the ECG, decide if defibrillation or cardioversion is indicated, select the appropriate energy,
charge the Efficia DFM100 and deliver the shock. Text messages on the display provide relevant
information throughout the process. Be attentive to these messages.
The ECG strip and Event Summary are easily annotated with information using the Mark Event
button. See “Mark Events” on page 43.
Monitoring alarms are available in Manual Defibrillation mode but they are turned off by default.
To activate alarms, press the Alarm button . Alarms are reactivated once the Therapy knob
is moved to Monitor, an energy setting or Pacer or the Sync button is pressed.
Manual Defibrillation mode can be used on both adult and infant/child patients. Use the Patient
Category button to switch categories.

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6: Manual Defibrillation Precautions for Manual Defibrillation

Precautions for Manual Defibrillation


WARNINGS: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely
eliminate any chance of recovery. Asystole should not be routinely shocked. Begin CPR.
Remain attentive to the patient during the delivery of therapy. Delay in delivering a shock may result
in a rhythm that was identified as shockable converting spontaneously to non-shockable and could
result in inappropriate shock delivery.
Keep hands and feet clear of the paddle electrode edges. Use your thumbs to depress the shock
buttons on the paddle handles.
Use only pads that are approved for use with the Efficia DFM100. Use of non-approved pads could
affect performance and results. See “Approved Supplies and Accessories” on page 189 for a list of
supported pads.
Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and
patient skin burns during defibrillation and may divert current away from the heart.
When monitoring neonatal ECGs, inaccurate measurements and alarms could result because of
differences in the characteristics of the adult ECG compared to the neonatal ECG.
During defibrillation, air pockets between the skin and multifunction electrode pads may cause
patient skin burns. To help prevent air pockets, make sure the pads completely adhere to the skin.
Do not use dried out pads. Do not open pads package until just prior to use.
Never touch the patient or any equipment connected to the patient (including the bed or gurney)
during defibrillation.
Avoid contact between the patient and conductive fluids and/or metal objects such as the gurney.
Medical electrical equipment which does not incorporate defibrillator protection should be
disconnected during defibrillation.

CAUTION: Do not discharge the defibrillator with the paddles shorted together.

NOTES: Successful resuscitation depends on many variables specific to the patient’s physiological state and
the circumstances surrounding the patient event. Failure to have a successful patient outcome is not
a reliable indicator of defibrillator/monitor performance. The presence or absence of muscular
response to the transfer of energy during electrical therapy is not a reliable indicator of energy
delivery or device performance.
Defibrillation is always performed through paddles or pads. However, during defibrillation you may
choose to monitor the ECG using an alternate ECG source (3- or 5-Lead monitoring electrodes). If
an alternate ECG source is connected, any available lead may be displayed.
Do not use medical gels or pastes of poor electrical conductivity.
Use only approved lead sets and monitoring electrodes with the Efficia DFM100. Failure to do so
may introduce noise and result in intermittent  messages.

76
Code View 6: Manual Defibrillation

Code View
In Manual Defibrillation mode, when an energy is selected, Code View is displayed. Code View is
optimized to clearly communicate data associated with a resuscitation event (see Figure 50).
Code-related information in Code View includes:
Enlarged Wave Sector 1: The waveform in Wave Sector 1 is larger for easier viewing.
Shock Counter: Displays the number of shocks for the current event (including shocks delivered in
AED mode).
Selected Energy: Displays the currently selected energy.
Delivered Energy: Displays the energy amount that was delivered for the most recent shock.
Replaces the Shock Counter for 15 seconds after the shock is delivered.
Wave Sector 2: Displays the currently configured waveform. If Cascade is selected, depending on
the ECG size, parts of the wave may be clipped due to the smaller sector size.
Patient Contact Indicator: Graphical representation of the contact quality between the patient and
the multifunction electrode pads. Orange or red lights on the PCI indicate poor patient contact.
Adjust pads to optimize patient contact. Multiple green lights on the PCI indicate good contact is
established. The PCI is displayed when pads are attached and the device is charging or is charged. It
is not displayed when using paddles. Use the PCI on the paddles as a patient contact indicator.
CPR Progress Bar: When in use, replaces the Patient Contact Indicator and tracks the progress of
the analysis pause and CPR periods.
Patient Category: Displays the current patient category. The patient category triggers specific
alarm limits and AED energy settings for defibrillation. The background color changes with the
selected patient category for Adult (orange) and Infant/Child (blue).

Figure 50 Code View Layout


Patient
  
 
Category

             

      
     
 
   




Enlarged
Wave
Sector 1
waveform

    



   



   
Patient Contact Indicator or
CPR Progress Bar
Shock Counter/Delivered Energy Selected
Energy

77
6: Manual Defibrillation Preparing for Defibrillation

Preparing for Defibrillation


 To prepare for defibrillation:
1 Prepare the patient’s skin to improve skin contact. See “Skin Preparation” on page 48.
2 Connect the appropriate therapy cable. See “Connecting the Therapy Cable” on page 9.
3 Apply paddles or pads as described in the following sections.

Using Multifunction Electrode Pads


 To set up for defibrillation using multifunction electrode pads:
1 Check the expiration date on the pads package and inspect the package for any damage.
2 If not preconnected, connect the Therapy cable to the Efficia DFM100 (see “Connecting the
Therapy Cable” on page 9).
3 If the pads are not expired and package is undamaged, open the package and connect the pads
connector to the end of the Therapy cable (see “Connecting Multifunction Electrode Pads” on
page 10).
4 Apply the pads to the patient as directed on the pads packaging or according to your
institution’s protocol.
5 Follow the defibrillation steps in “Defibrillation” on page 79.

Using External Paddles


 To set up for defibrillation using external paddles:
1 After connecting the paddles cable to the Efficia DFM100, remove the paddle set from the
paddle tray by pulling the paddles straight up and out of the paddle tray. Confirm you are using
the correct size paddles for the patient and verify there is no debris or residue (including dried
electrode gel) on the surface of the paddles. Clean if necessary.
2 Apply conductive matter as per your organization’s protocol.

CAUTION: Do not distribute conductive matter by rubbing the paddle electrode surfaces together. Surfaces
could get scratched or damaged if you do.

3 Apply the paddles to the patient’s bare chest using the anterior-anterior placement (or in
accordance with your organization’s protocol).
4 Use the Patient Contact Indicator (PCI) lights on the sternum paddle handle to adjust paddle
pressure and placement to optimize patient contact. Once proper contact is made, the PCI
turns green. See “External Paddles” on page 14.
NOTE: Reasonable effort should be made to obtain at least one green PCI light. Due to size of the patient
or other physical factors, this might not be possible for some patients. Orange lights may be the best
that can be achieved.

5 Follow the defibrillation steps in “Defibrillation” on page 79.

78
Defibrillation 6: Manual Defibrillation

Quick Look
You can use external paddles for a “Quick Look” to assess the patient’s ECG rhythm and then, if
necessary, deliver therapy. Use this process only when multifunction pads and monitoring electrodes
are not immediately available.

 To view a patient’s ECG using external paddles:


1 Make sure the device is turned on to Monitor.
2 Apply external paddles to the patient’s chest, minimizing any unnecessary movement.
3 After the Efficia DFM100 detects the ECG, view the waveform on the display.
NOTE: Viewing the patient’s ECG through paddles is not recommended for long-term monitoring.

Using Infant Paddles


The Efficia DFM100 external paddle set comes with infant paddles included. The American Heart
Association recommends using the smaller paddles on children weighing less than 10 kg. Larger
paddles may be used as long as contact between the paddles is avoided.

 To set up for defibrillation using infant paddles:


1 Expose the infant paddle surfaces. See “Accessing Infant Paddles” on page 15.
2 Store the adult paddle surfaces in the paddle tray pockets.
3 Follow the steps for using external paddles. See “Using External Paddles” on page 78.
4 Follow the defibrillation steps in “Defibrillation” on page 79.

Using Internal Paddles


 To set up for defibrillating using internal paddles:
1 Select the appropriate paddle electrode size.
2 If using switchless internal paddles, connect the paddles to the M4740A Paddle Adapter Cable.
3 Connect the paddles cable (or the paddle adapter cable) to the Efficia DFM100. See
“Connecting the Therapy Cable” on page 9.
4 Follow the defibrillation steps in “Defibrillation” on page 79.
NOTE: The Efficia DFM100 has a built-in limit of 50 J when you are using internal paddles.

Defibrillation
After performing the necessary preparation, defibrillation with Efficia DFM100 is a simple 1-2-3
process.
1 Select an energy.
2 Charge the device.
3 Administer the shock.
See the following sections for more information.

Step 1 - Select Energy


Rotate the Therapy knob to the desired energy level. The current energy selection is displayed on
the device in the Select Energy section. The recommended energy dose for adult patients is 150 J.
Follow your institution’s guidelines for Infant/Child patients.

79
6: Manual Defibrillation Defibrillation

Energy choices range from 1 to 200J with 150J highlighted as the recommended level for
defibrillating adult patients. Selecting the 1-10 energy setting brings up the  menu. See
Figure 51. Use the Smart Select knob to increase or decrease the desired setting. The Efficia
DFM100 automatically knows your energy setting.

 To re-adjust a low energy setting:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Turn the Smart Select knob to increase or decrease the energy level and press the Smart Select
knob.
Figure 51 Select Energy



6 

WARNINGS: For manual defibrillation of infant/child patients follow your institution's policy (guidelines are 2 to
4 J/kg first shock and 4 J/kg per subsequent shocks).
The Efficia DFM100 has a built-in limitation of 50 Joules when you are using internal paddles.
Do not leave patients unattended when the Efficia DFM100 is in Manual Defibrillation mode with
pads applied to the patient.

Step 2 - Charge
Press the Charge button on the front panel. See “Therapy Knob and Controls” on page 26. If using
external paddles, the Charge button on the side of the apex paddle may be used instead. As the
defibrillator charges, the energy selection shown on the display changes to show the current charge
state. A continuous low-pitch charging tone sounds until the desired energy level is reached, at
which point a continuous high-pitch charged tone sounds.
You may increase or decrease the selected energy at any time during or after charging. Move the
Therapy knob to the desired energy level. The Efficia DFM100 charges to the selected energy level
automatically.
If you need to disarm the defibrillator, press the  soft key. Also, the defibrillator
disarms automatically when the Shock button has not been pressed within the time period specified
in the Time to Auto Disarm configuration setting.
NOTE: Do not change the energy level while pressing the Shock button.

Step 3 - Shock
Confirm that a shock is still indicated and the defibrillator is charged to the selected energy level.
Make sure no one is touching the patient or anything connected to the patient. Call out loudly and
clearly, “Stay Clear!”
If using:
• Pads or switchless internal paddles - Press the flashing Shock button on the
front of the Efficia DFM100 to deliver a shock.

80
Manual Defibrillation Alarms 6: Manual Defibrillation

• External paddles - Simultaneously press the flashing Shock buttons located on the
paddles to deliver a shock.
• Switched internal paddles - Press the orange Shock button located on the paddle to
deliver a shock.
If the shock is the last in a configured shock series, “Begin CPR” is announced and displayed on the
screen.

WARNINGS: Defibrillation current can cause operator or bystander injury. Do not touch the patient, or
equipment connected to the patient, during defibrillation.
Alarm audio is turned off when an energy setting is selected for defibrillation, and the 
 message is displayed. Audio remains off until turned back on by pressing the Alarm button, Sync
mode is turned on or the Therapy knob is turned to Monitor or Pacer.

Manual Defibrillation Alarms


Defibrillation alarms can be generated for the conditions shown in Table 21. There are both audio
and visual alerts when activated by the Alarms button. When you switch patient categories, all
parameter alarm limits change to the new patient category. These changes are retained when you
switch modes.
• For patients that are 25 kg or 8 years old, use the Adult patient category.
• For patients <25 kg or < 8 years old, use the Infant/Child patient category.
For more information on alarms, see “Alarms” on page 37.

Table 21 Defibrillation Alarms

Alarm Message Condition Type of Alarm Indication


 With pads in use, the connection High Priority
between the device and patient Non-Latching
has been lost. Alarm
 A shock has been automatically
aborted.
 Abnormal shock dose delivered
 due to marginal patient Red Alarm message
impedance. with alarm tone
High Priority
 The device detected a change in Latching Alarm
 paddles or pads type or the
therapy cable identification is
invalid.
 Therapy is disabled due to an
 equipment failure.
 A power overload has been Medium Priority Yellow Alarm
 detected in the paddles. Latching message with alarm
Configurable tone
Alarm

81
6: Manual Defibrillation Troubleshooting

Troubleshooting
If your Efficia DFM100 does not operate as expected during Manual Defibrillation, see
“Defibrillation and Pacing Problems” on page 179.
If there is a delay in delivering therapy, start CPR if indicated.

82
7

Synchronized Cardioversion
This chapter explains how to prepare for and perform synchronous cardioversion on the Efficia
DFM100.
See Chapter 6 “Manual Defibrillation” on page 75 for information on asynchronized cardioversion.

Overview
The Efficia DFM100 provides synchronized cardioversion therapy by delivering a biphasic pulse of
current to the heart immediately following an R-Wave detected in the ECG waveform. The
waveform utilized in the Efficia DFM100 has undergone clinical testing demonstrating its
effectiveness for cardioversion of atrial fibrillation.
You can perform synchronized cardioversion with:
• Multifunction electrode pads or external paddles and 3 or 5-Lead set monitoring electrodes
directly connected to the Efficia DFM100.
• Only the multifunction electrode pads directly connected to the Efficia DFM100.
• Multifunction electrode pads directly connected to the Efficia DFM100 and an ECG signal
coming from a Philips bedside monitor into the Efficia DFM100.

NOTE: The best quality source for cardioversion is a 3 or 5-Lead set connected to the Efficia DFM100.

No matter what your monitoring source is, cardioversion is still delivered through pads or paddles.

83
7: Synchronized Cardioversion Precautions for Cardioversion

Precautions for Cardioversion


WARNINGS: Cardioversion should only be delivered by trained healthcare professionals.
When performing synchronized cardioversion through external paddles, you should not use paddles
as your monitoring lead in Wave Sector 1. Artifact introduced by paddle movement may resemble an
R-Wave arrow and trigger a defibrillation shock. Use external paddles as a monitoring lead for
Synchronized Cardioversion only if no other lead source is available and you are in an emergency
situation.
Incorrect timing of Synchronized Cardioversion could occur if the patient has an internal pacemaker
with pacemaker tails large enough to be detected as an R-Wave.
Use only pads that are approved for use with the Efficia DFM100. Use of non-approved pads could
affect performance and results. See Table 61 “Approved Supplies and Accessories” on page 189 for a
list of supported pads.
Remain attentive to the patient during the delivery of therapy.
Keep hands and feet clear of the paddle electrode edges. Use your thumbs to depress the shock
buttons on the paddle handles.
Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and
patient skin burns during defibrillation and may divert current away from the heart.
During defibrillation, air pockets between the skin and multifunction electrode pads may cause
patient skin burns. To help prevent air pockets, make sure the pads completely adhere to the skin.
Do not use dried out pads. Do not open pads package until just prior to use.
Never touch the patient or any equipment connected to the patient (including the bed or gurney)
during defibrillation.
Avoid contact between the patient and conductive fluids and/or metal objects such as the gurney.
Medical electrical equipment which does not incorporate defibrillator protection should be
disconnected during defibrillation.

NOTES: Successful cardioversion depends on many variables specific to the patient’s physiological state and
the circumstances surrounding the patient event. Failure to have a successful patient outcome is not
a reliable indicator of defibrillator/monitor performance. The presence or absence of muscular
response to the transfer of energy during electrical therapy is not a reliable indicator of energy
delivery or device performance.
Synchronized Cardioversion should be turned off unless you specifically intend to perform
synchronized cardioversion. Sync mode can prevent the delivery of defibrillation in situations
involving cardiac arrest.
If you enter Pacing mode, Sync settings are turned off.
Use only approved lead sets with the Efficia DFM100. Failure to do so may introduce noise and
result in intermittent  messages.

84
Preparing for Synchronized Cardioversion 7: Synchronized Cardioversion

Preparing for Synchronized Cardioversion


 To prepare for synchronized cardioversion:
1 Perform tasks as described in “Preparing for Defibrillation” on page 78.
2 If monitoring through a 3- or 5-Lead ECG cable, plug the ECG cable into the ECG port on the
Efficia DFM100 and apply monitoring electrodes to the patient (see “Lead Selection” on
page 50).
3 Use the Lead Select button to select the waveform you want in Wave Sector 1. The
selected ECG source should have a clear signal and a large QRS complex. Use external paddles
as the monitoring lead only if no other lead source is available. See “With External Paddles” on
page 87.

NOTES: When a patient is already connected to Philips bedside monitoring equipment, an external ECG Out
(Sync) cable can plug into the bedside’s ECG Output jack and into the Efficia DFM100’s ECG port.
This connects the ECG signal from the monitor into the Efficia DFM100 where it is displayed and
synchronization occurs.
The signal from the bedside monitor is displayed as Lead II on the Efficia DFM100 even though it
may not necessarily be Lead II coming from the bedside monitor.
Do not use a Philips SureSigns monitor connected to the Efficia DFM100. The devices are not
compatible.

WARNING: If you use an external monitor as the ECG source, a biomedical technician MUST verify that the
combination of the external monitor and Efficia DFM100 can deliver a synchronized shock within
60ms of the peak of the R-Wave. Use a 1 mV QRS complex with a QRS width of 40 ms. This
performance cannot be guaranteed with all commercially available monitors.

85
7: Synchronized Cardioversion Code View and Cardioversion

Code View and Cardioversion


When Synchronized Cardioversion is active, Code View adds R-Wave arrows and a Sync notification
to the display. The Sync button is also backlit. See Figure 52.

Figure 52 Code View With Sync Layout






             

      
     
  AED
   







    
Pacer


   


  

Delivering a Synchronized Shock


 To perform synchronized cardioversion:
1 Turn the Therapy knob to the desired energy setting
2 Press the Sync button (see Figure 1 on page 8).
3 Confirm that the Sync button lights up, the Sync indicator is present and R-Wave arrows appear
only with each R-Wave.
R-Wave arrows do not always appear at the peak of the R-Wave but always appear on the
R-Wave. Use the Lead Select button to change leads if the R-Wave arrows do not appear
correctly.
4 Press the yellow Charge button on the Efficia DFM100, or if using paddles, the yellow charge
button located on the apex paddle.
You may increase or decrease the selected energy at any time during charging or after
charging. Move the Therapy knob to the desired energy level. The Efficia DFM100 charges
to the selected energy level automatically. Wait until the charge reaches the selected energy
level before proceeding.
If you need to disarm the defibrillator, press the  soft key. Also the
defibrillator disarms automatically when the Shock button has not been pressed within the
time period specified in the Time to Auto Disarm configuration setting.
5 When the defibrillator has reached its charge level, make sure no one is touching the patient or
anything connected to the patient. Call out clearly and loudly “Stay Clear”.

86
Delivering a Synchronized Shock 7: Synchronized Cardioversion

6 Check your ECG and then re-confirm your energy dose and waveform. Press and hold the
Shock button on the Efficia DFM100 or, if using external paddles, press and hold the orange
buttons on both paddles. It is important to continue to hold the Shock button (or the paddle
buttons) until the shock is delivered. The defibrillator shocks with the next detected R-Wave.
Once the shock is delivered, release the shock button. The Shock counter increases by one.

WARNINGS: Defibrillation current can cause operator or bystander injury. Do not touch the patient, or
equipment connected to the patient, during defibrillation.
Do not change the energy level while holding the Shock button down.

NOTES: If an ECG or pads technical alarm occurs while performing synchronized cardioversion, the Efficia
DFM100 does not charge, and if charged, disarms automatically.
If the Efficia DFM100 does not detect an ECG lead when you press Charge, a 
message is displayed. Fix the lead problem before pressing Charge again.

With External Paddles


Carefully review the waveform immediately prior to administering synchronized cardioversion and
confirm that you have a non-paddles wave label.

WARNING: When performing synchronized cardioversion through external paddles, you should not use paddles
as your monitoring lead in Wave Sector 1. Artifact introduced by paddle movement may resemble an
R-Wave arrow and trigger a defibrillation shock. Use external paddles as a monitoring lead for
Synchronized Cardioversion only if no other lead source is available and you are in an emergency
situation.

 To perform synchronized cardioversion using external paddles:


1 Prepare your patient for synchronized cardioversion as stated above.
2 Place paddles on the patient’s chest prior to charging the defibrillator.
3 Look at the wave label appearing in Wave Sector 1.
If the label is Paddles:
• Change the monitoring lead in Wave Sector 1 by pressing the Lead Select button multiple
times to cycle through available leads. Select the waveform you wish to use.
• Confirm a non-paddles monitoring leads appears in Wave Sector 1. Check for R-Wave
arrows.
• Proceed with the normal protocol for synchronized cardioversion.
If the label is not Paddles:
• Proceed with the normal protocol for synchronized cardioversion.

Delivering Additional Shocks


There are times when additional synchronized shocks are clinically indicated.

 To deliver additional synchronized shocks:


1 Confirm the Sync function is still enabled, the Sync button is lit, the Sync indicator is present
and the R-Wave arrows are still visible.
2 Repeat steps 3-5 under “Delivering a Synchronized Shock” on page 86.

87
7: Synchronized Cardioversion Cardioversion Alarms

NOTE: The Efficia DFM100’s Sync function can be configured to either be enabled or disabled after each
synchronized shock is delivered.

Turning Sync Off


To turn the Sync function off, press the Sync button again. The button light turns off and Sync
indications are removed from the display.

Cardioversion Alarms
Alarms can be generated for the conditions shown in Table 22. There are both audio and visual
alerts. When you switch patient categories, all parameter alarm limits change to the new patient
category. These changes are retained when you switch modes.
• For patients that are 25kg or 8 years old, use Adult patient category.
• For patients <25kg or < 8 years old, use Infant/Child patient category.
For more information on alarms, see “Alarms” on page 37.

Table 22 Defibrillation Alarms

Alarm Message Condition Type of Alarm Indication


 With pads in use, the connection High Priority
between the device and patient has Non-Latching
been lost. Alarm
 A shock has been automatically
aborted.
Red Alarm
 Abnormal shock dose delivered due
message with
 to marginal patient impedance.
High Priority alarm tone
 The device detected a change in Latching Alarm
 paddles or pads type or the therapy
cable identification is invalid.
 Therapy is disabled due to an
 equipment failure.

Troubleshooting
If your Efficia DFM100 does not operate as expected during Cardioversion, see “Defibrillation and
Pacing Problems” on page 179.

88
8

Pacing
This chapter explains the noninvasive transcutaneous pacing option available with the Efficia
DFM100 and describes how to perform pacing.

Overview
Noninvasive transcutaneous pacing therapy is used to deliver monophasic pace pulses to the heart.
Pace pulses are delivered through multifunction electrode pads that are applied to the patient’s bare
chest. Pacing with paddles is not supported.
While in Pacing mode, the ECG strip and Event Summary are easily annotated using the Mark
Event button. See “Mark Events” on page 43.
Pacing mode can be used on both adult and infant/child patients. Use the Patient Category
button to switch categories.

WARNING: Pacing therapy should only be delivered by trained healthcare professionals.

CAUTION: Pacing must be turned off before defibrillating with a second defibrillator. Failure to do so could
damage the Efficia DFM100.

NOTES: Use only approved lead sets when pacing with the Efficia DFM100. Failure to do so may introduce
noise and result in intermittent  messages.
For treatment of patients with implantable devices, such as permanent pacemakers or
cardioverter-defibrillators, consult a physician and the instructions for use provided by the device’s
manufacturer.
Waveforms, ECG monitoring, measurements and most alarms remain active and retain their settings
when you transition from Monitor or Manual Defibrillation mode to Pacing mode. However, the
waveform displayed in Wave Sector 3 is replaced by the Pacing Status Bar.

Pacing View
Pacing View appears when the Therapy knob is turned to the Pacer position. Pacing View includes a
status block which appears in Wave Sector 3 of the display (see Figure 53). The patient's internal
paced status is not displayed. Pacing-related information in Pacing View includes:
• Pacing Markers: Markers, indicating a pace pulse was delivered, appear in Wave Sector 1 (and
in Wave Sector 2, if the wave is cascading) each time a pacer pulse is delivered.
• R-Wave Arrows: R-Wave arrows appear in Wave Sector 1 (and in Wave Sector 2, if the wave is
cascading) when in Demand mode pacing. R-Wave arrows do not appear on paced beats.
• Pacing Status: Indicates the current pacing status.
• When pacing is active,  is displayed when the device is on AC power.
• If the device is running on battery,  is displayed.
• If pacing is not active,  is displayed.

89
8: Pacing Demand Mode Versus Fixed Mode

• Pacing Alarm: If there is a pacing-related alarm during pacing, the current pacing status is
replaced with an alarm message. See “Pacing Alarms” on page 94.
• Pacing mode: Indicates if the device is in Demand or Fixed mode pacing.
• Pacing Rate: Indicates the current pacing rate, including unit of measure.
• Pacing Output: Indicates the current output, including unit of measure.
• Alarms: Are on automatically.

Figure 53 Pacing View Layout




 
             

      
     
 
   


Pacing 
R-Wave
Markers Arrows




Pacing Bar:
Mode,

Status,
Alarms     

   



   

Pacing Pacing
Rate Value Output Value

Pacing Control soft key: Press  Pacer Settings soft key: Press  to
to pause pacing; press  to start or bring up the menu for adjusting Pacer Rate and
resume pacing Output.

WARNING: If pacing is interrupted for any reason, you must press the  soft key to resume pacing.

Demand Mode Versus Fixed Mode


The Efficia DFM100 can deliver paced pulses in Demand mode or Fixed mode.
• In Demand mode, the pacer only delivers synchronous paced pulses when the patient’s heart
rate is lower than the selected pacing rate.
• In Fixed mode, the pacer delivers asynchronous paced pulses at the selected rate.

WARNING: Use Demand mode pacing whenever possible. Use Fixed mode pacing when artifact or other ECG
noise makes R-Wave detection unreliable, when monitoring electrodes are not available or at your
clinical discretion.

The Efficia DFM100 requires a 3- or 5-Lead ECG cable and monitoring electrodes as the source of
the ECG during Demand mode pacing. Pace pulses are delivered through multifunction electrode
pads. However, during Demand mode pacing, the pads cannot be used to monitor ECG and deliver
paced pulses simultaneously.

90
Preparing for Pacing 8: Pacing

NOTES: The ECG derived from pads does not need to be displayed in a wave sector in order to deliver
pacing therapy.
When using the Efficia DFM100 for pacing in the operating room in the presence of cautery tools,
use Fixed mode only.
When using Demand mode, pads are not an available choice for display in Wave Sector 1, through
either the Lead Select button or the  menu.

Preparing for Pacing


 To prepare for pacing:
1 If not already connected, connect the Therapy cable to the Efficia DFM100. See “Connecting
the Therapy Cable” on page 9.
2 Prepare the patient’s skin to achieve good contact. See “Skin Preparation” on page 48.
3 Connect the multifunction electrode pads. See “Connecting Multifunction Electrode Pads” on
page 10.
4 If pacing in Demand mode, apply monitoring electrodes (see “Electrode Placement” on
page 49) and connect the ECG cable to the Efficia DFM100 (see “Connecting the ECG Cable”
on page 11).

WARNING: Do not reverse pad position on the patient. Reversing the pads’ positions increases the pacing
threshold which means more current is needed to capture the heart, resulting in greater patient
discomfort.

NOTES: Pacing Therapy should be administered while connected to AC power with a battery installed for
backup so that pacing will not be interrupted in the event of either an AC power failure or the
battery losing its charge.
If you enter Pacing mode, Sync settings are turned off.
If Paddles is selected for display in Wave Sector 2 and the device enters Pacer mode, the Wave Sector
2 waveform automatically switches to None.
If Paddles is selected for display in Wave Sector 1 and the device enters Pacer mode, the Wave Sector
1 waveform switches to Lead II.
If Pads is selected for the display in Wave Sector 2 and the device enters Demand mode pacing, the
Wave Sector 2 waveform automatically switches to None.
If monitoring for an extended period of time, monitoring electrodes and multifunction electrode
pads may need to be changed periodically. Refer to the manufacturer’s documentation for
replacement frequency.
Signals from TENS or ESU units can cause interference with the ECG which may impact pacing.

Pace Pulse Duration


You can configure the duration of the paced pulse in Configuration mode to either 20 or 40 msec.
Confirm with your organization which setting best meets your clinical needs. If you select 20 msec,
you can select a current setting between 10-200 mA. If you select 40 msec, you can select a current
setting between 10-140 mA. See “Pacer Settings” on page 149.

91
8: Pacing Demand Mode Pacing

Demand Mode Pacing


 To pace in Demand mode:
1 Turn the Therapy knob to the Pacer position.
The message  appears in the Pacing Bar, indicating that the pacing function is
enabled but pace pulses are not being delivered. Pacing is enabled in Demand mode with the
configured lead in Wave Sector 1 used for R-Wave detection.
2 Press the Lead Select button to select the best lead with an easily detectable R-Wave.
3 Verify white R-Wave arrows appear above or on the ECG waveform. A single arrow should be
associated with each R-Wave. If the R-Wave arrows do not appear, are incorrectly labeling beats,
or do not coincide with the R-Wave, select another lead.
4 Select the Pacer Rate by pressing the  soft key and then selecting  from
the menu. Use the Smart Select knob to adjust the rate, then press the Smart Select knob to
confirm the value and close the Pacer Rate window. Repeat and select  to adjust the
Pacer Output.
5 Press .  appears in the Pacing Bar.
6 Verify white pacing markers or white R-Wave arrows appear on the ECG waveform.
7 Press the  soft key, and then select . Use the Smart Select knob to
increase the output until cardiac capture occurs. Capture is indicated by the appearance of a
QRS complex after each pacing marker. Decrease the output to the lowest level that still
maintains capture, and then press the Smart Select knob to confirm the value and close the
Pacer Output window.
8 Assess the patient for a peripheral pulse.

 To stop pacing:
• Press the  soft key. A message asks you to confirm your action. Using the Smart
Select knob, select  to pause pacing; select  to continue pacing. Once paused, press the
flashing  soft key to resume pacing.
OR
• Move the Therapy knob away from the Pacer position.

WARNINGS: Use care when handling the multifunction electrode pads on the patient to avoid shock hazard
during pacing.
Use multifunction electrode pads prior to their expiration date. Discard pads after use. Do not reuse
pads. Do not use for more than 8 hours of continuous pacing.
If pacing is interrupted for any reason, you must press the  soft key to resume pacing.
When pacing in Demand mode, the ECG cable from the patient must be directly connected to the
Efficia DFM100.
If you are using the pacing function with battery and the Low Battery alarm sounds, connect the
device to external power to avoid interrupted pacing therapy.

NOTES: Pacing does not start if there is a problem with the multifunction electrode pads connection or
patient contact. Pace pulses are not delivered if there is a problem with the ECG monitoring
electrode connections. If either situation occurs, a system message is displayed.
The  soft key is grayed out for Demand mode pacing until a leads-on condition is
detected for the ECG lead used for R-Wave detection and the pads-on condition is detected. In
Fixed mode, the soft key is grayed out until pads are detected.

92
Fixed Mode Pacing 8: Pacing

Fixed Mode Pacing


 To pace in Fixed mode:
1 Turn the Therapy knob to the Pacer position.
The message  appears in the Pacing Bar, indicating that the pacing function is
enabled but pace pulses are not being delivered. Demand pacing is the default pacer mode.
2 Change to Fixed mode pacing, as shown in Figure 54.
a Press the Smart Select knob.
b Turn the Smart Select knob to highlight  and press the Smart Select knob.
c Select  and press the Smart Select knob.
Figure 54 Fixed Pacer Mode
 
 
 




3 Press the Lead Select button to select the desired lead for viewing.
4 Select the Pacer Rate by pressing the  soft key and then selecting  from
the menu. Use the Smart Select knob to adjust the rate, and then press the Smart Select knob to
confirm the value and close the Pacer Rate window. Repeat and select  to adjust the
Pacer Output.
5 Press the  soft key.  appears in the Pacing Bar.
6 If you have an ECG waveform, verify white pacing markers appear.
7 Verify the presence of a peripheral pulse and increase the output if required.
8 Press the  soft key and then select . Use the Smart Select knob to
increase the output until cardiac capture occurs. Capture is indicated by the appearance of a
QRS complex after each pacing marker. Decrease the output to the lowest level that still
maintains capture, and then press the Smart Select knob to confirm the value and close the
Pacer Output window.
9 Assess the patient for a peripheral pulse.

 To stop pacing:
• Press the  soft key. A prompt message asks you to confirm your action. Using the
Smart Select knob, select  to pause pacing; select  to continue pacing. Once paused, press
the flashing  soft key to resume pacing.
OR
• Move the Therapy knob away from the Pacer position.

WARNINGS: Use care when handling the multifunction electrode pads on the patient to avoid shock hazard
during pacing.
Use multifunction electrode pads prior to their expiration date. Discard pads after use. Do not reuse
pads. Do not use for more than 8 hours of continuous pacing.
If pacing is interrupted for any reason you must press the  soft key to resume pacing.
If you are using the pacing function with battery and the Low Battery alarm sounds, connect the
device to external power to avoid interrupted pacing therapy.

93
8: Pacing Defibrillating During Pacing

Defibrillating During Pacing


If you need to defibrillate the patient during pacing, refer to the procedure for defibrillation in
Manual Defibrillation mode (see Chapter 6 “Manual Defibrillation” on page 75) or AED mode
(Chapter 5 “AED Mode Option” on page 61). Once the Therapy knob is moved from the Pacer
position to a Manual Defibrillation mode energy setting or AED, pacing is stopped.
To resume pacing after defibrillation, repeat the pacing procedure as described in “Demand Mode
Pacing” on page 92 or “Fixed Mode Pacing” on page 93. When pacing is resumed, pacing settings
selected prior to defibrillation (mode, rate and output) are retained. Be sure to confirm cardiac
capture has been retained.

CAUTION: Pacing must be turned off before defibrillating with a second defibrillator. Failure to do so could
damage the Efficia DFM100.

Pacing Alarms
Pacing alarms can be generated for the conditions shown in Table 23. Once generated, they appear
as alarm messages in the Pacer Bar. There are both audio and visual alerts. When you switch patient
categories, all parameter alarm limits change to the new patient category. These changes are retained
when you switch modes.
• For patients that are 25 kg or 8 years old, use the Adult patient category.
• For patients <25 kg or < 8 years old, use the Infant/Child patient category.
For more information on alarms, see “Alarms” on page 37.

Table 23 Pacing Alarms

Alarm Message Condition Type of Alarm Indication


 Pacing has stopped. There has been a

power failure during pacing.
 Pacing has stopped. A pads off

condition has been detected during
pacing.
 Pacing has stopped. The Efficia

DFM100 has detected an error which
prevents delivery of pacing therapy.
 Pacing has stopped. The Therapy
 High Priority Red Alarm
cable is disconnected from the
device. Non-Latching message with
Alarm alarm tone
 Therapy is disabled due to an

equipment failure.
 Pacing has stopped. The primary

ECG lead has become invalid in
Demand mode pacing.
 The actual delivered pace pulse
current is less than the selected
output.
 The battery’s charge level is low.

94
Troubleshooting 8: Pacing

NOTE: Once the reason for the Pacing Stopped alarm has been resolved, that part of the alarm message is
removed from the display. The audio alarm continues. Press the  soft key to resume
pacing, remove the remainder of the alarm text from the display and silence the audio alarm.

WARNING: Observe the patient closely while pacing. Heart rate displays and alarms function during pacing but
can be unreliable. Do not rely on the indicated heart rate or heart rate alarms as a measure of the
patient’s perfusion status.

Troubleshooting
If your Efficia DFM100 does not operate as expected during pacing, see “Defibrillation and Pacing
Problems” on page 179.

95
NOTES

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
9

Monitoring CO2
This chapter describes how to monitor carbon dioxide (CO2) and measure end-tidal carbon dioxide
(EtCO2) and Airway Respiration Rate (AwRR) with the Efficia DFM100. You can use one of two
sensor types:
• Philips Mainstream
• Philips Sidestream

Overview
The carbon dioxide monitoring function of the Efficia DFM100 measures the partial pressure of
carbon dioxide in a sample of the patient’s exhaled breath. The Efficia DFM100 may be used to
monitor carbon dioxide in both intubated and non-intubated patients.
The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide
concentration with the ambient pressure. From the partial pressure measurement, the end-tidal
carbon dioxide (EtCO2) is derived.
EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient’s
respiratory status. The EtCO2 measurement uses a technique based on the absorption of infrared
radiation by some gases. It indicates the change in:
• The elimination of CO2.
• The delivery of O2 to the lungs.
The CO2 monitoring function of the Efficia DFM100 provides an EtCO2 value, a CO2 waveform
(Capnogram), and an airway respiration rate (AwRR). The AwRR relies on CO2 functionality to
identify valid breaths for numeric display and alarm conditions such as Apnea.
CO2 monitoring is available in AED, Monitor, Pacer and Manual Defib modes and on both adult
and infant/child patients. Use the Patient Category button to switch categories.
When pressing the Patient Category button, all parameter alarm limits change to the new patient
category. These changes are retained when you switch modes.
• For patients that are 25 kg or 8 years old, use Adult patient category
• For patients <25 kg or < 8 years old, use Infant/Child patient category
The neonatal patient category is not supported.

97
9: Monitoring CO2 Precautions for Measuring EtCO2

Precautions for Measuring EtCO2


WARNINGS: The EtCO2 readings do not always correlate closely with blood gas values, especially in patients with
pulmonary disease, a pulmonary embolism or inappropriate ventilation.
EtCO2 and AwRR measurements may be inaccurate when the CO2 sensor needs to be zeroed, has
not been set to the correct barometric pressure or has not had sufficient time to warm up. Sensor
application errors and environmental conditions may also affect measurements.
Check for physical occlusions such as a kink in the sample line or the patient lying on the sample line
before measuring EtCO2.
Danger - explosion hazard - do not use in the presence of flammable anesthetics mixture with air or
with oxygen or nitrous oxide. Sampling line may ignite in the presence of oxygen when directly
exposed to laser, ESU devices or high heat. When performing head and neck procedures involving
laser, electrosurgical devices or high heat, use caution to prevent flammability of the sampling line or
the surrounding environment.
CO2 measurements may be inaccurate when measured in the presence of aerosolized
pharmaceuticals or anesthetic gases.
The Sidestream CO2 sensor port should vent into open air. Do not block the exhaust port on your
Sidestream sensor. If the port is blocked, there could be a significant delay in measurement readings
with no indication of a problem.
When using a nasal sample line, if one or both nostrils are partially or completely blocked, or the
patient is breathing through the mouth, the displayed EtCO2 values may be significantly low.
When measuring EtCO2 on patients who are receiving or have recently received anesthetics,
connect exhaust tubing from the CO2 Outlet port to a scavenging system or to the anesthesia
machine/ventilator to prevent exposing medical staff to anesthetics. Use an exhaust tube attached to
the CO2 outlet port to remove the sample gas to a scavenging system.
To avoid risk of patient cross-infection, do not connect the exhaust to the patient airway.
Use only accessories listed in the supplies chapter to ensure correct functioning of the CO2
measurement.
Carefully route the sampling line to reduce the possibility of patient entanglement or strangulation.
Reflux of gastric contents, mucus, pulmonary edema fluid or endotracheal epinephrine introduced
into the detector can increase airway resistance and affect ventilation. Discard accessory if this
occurs.
The presence of carbonated beverage or antacids in the stomach may cause incorrect readings and
unreliable capnography in identifying esophageal intubation.

CAUTIONS: If the Sidestream sensor is used in close proximity to the ECG monitoring electrodes, you may see
noise on the ECG waveform. If this occurs, move the sensor away from the monitoring electrodes.
The Efficia DFM100 is not equipped with automatic barometric pressure compensation. The device
needs to be set to the local atmospheric pressure before being used to monitor EtCO2. An incorrect
pressure setting results in an incorrect reading. See your Efficia DFM100 Service Manual for more
information on setting the atmospheric pressure.

98
Preparing to Measure EtCO2 9: Monitoring CO2

Preparing to Measure EtCO2


Sensors
There are two sensors that can be used with the Efficia DFM100 to measure EtCO2:
• Mainstream
• Sidestream

Figure 55 EtCO2Sensors

Sidestream Mainstream

NOTE: See your individual sensor’s Instructions for Use for further warnings, cautions and other instructions.

Selecting the Accessories


There are some factors to consider when selecting accessories for your particular sensor:
• the type of patient, adult or pediatric (Neonate is not supported.)
• airway status of the patient, ventilated or not ventilated.
• if a ventilated patient, whether humidified or non-humidified ventilation is used.
Do not re-use, clean, or sterilize single-use CO2 accessories as they are intended for single-patient,
one-time use. Clean reusable accessories according to the manufacturer’s recommendations.
See Chapter 18 “Supplies and Accessories” on page 189 for a listing of approved CO2 accessories.

WARNING: Use only accessories listed in the supplies chapter to ensure correct functioning of the CO2
measurement.

99
9: Monitoring CO2 Monitoring EtCO2

Monitoring EtCO2
 To monitor EtCO2:
1 Connect the sensor to the Efficia DFM100 and the sampling line to the sensor (see
“Connecting the CO2 Cable and Sample Line” on page 12).
2 Apply the sampling line to the patient.
3 If the Efficia DFM100 is not turned on, turn the Therapy knob to Monitor.
• EtCO2 needs to be configured to appear in AED mode.
4 Check that the patient category is appropriate for the patient. If necessary change the Patient
Category to select the appropriate category. See “General Function Buttons” on page 27.
The EtCO2 measurement automatically turns on when you connect a sensor to the CO2 port. The
Capnogram is displayed in the configured Wave Sector if available. The measurement values for
EtCO2 and AwRR are displayed.
Question marks:
- If there is a  in the parameter block and a dashed line in place of the Capnogram on the
display, the waveform source is invalid. Check patient, confirm airway status and examine the
cable and sensor for a good connection. Also check the sampling line to make sure it is
connected to the sensor and not kinked or pinched.
- If there is a  before the measurement and a Capnogram on the display, the sensor is warming
up. As soon as the sensor is warmed up, the  is removed from the display.
Figure 56 EtCO2 and AwRR

             

      
     
 
   


   

 
 
 

Alarm Limits - If alarms are turned on, the alarm limits are displayed. If
alarm limits are turned off, the alarms off symbol is displayed.

WARNING: Leakages in the breathing system or sampling system may cause the displayed EtCO2 values to be
significantly too low. Always connect all components securely and check for leaks according to
standard clinical procedures. Displacement of the nasal or combined nasal oral cannulas can cause
lower than actual EtCO2 readings. Even with combined nasal oral cannulas, the EtCO2 readings
may be slightly lower than actual in patients breathing through the mouth only.

NOTE: Mainstream and Sidestream sensors detect breaths down to 5 mmHg. For values below 5 mmHg,
you see a  in place of the EtCO2 measurement in the parameter bar.

100
EtCO2 and AwRR Alarms 9: Monitoring CO2

EtCO2 and AwRR Alarms


Alarms behave the same regardless of which sensor is attached to the Efficia DFM100. Alarms
sound if measurements fall outside the configured limits for high or low EtCO2, high or low Airway
Respiration Rate (AwRR) and Apnea time.
EtCO2 alarms can be generated for the conditions shown in Table 24 and Table 25. Once generated,
they appear as alarm messages in the EtCO2 alarm status area above the numerics. There are both
audio and visual alerts. For more information on alarms, see “Alarms” on page 37.

NOTE: Alarm notification is configurable. See “Alarm Management” on page 39.

Table 24 EtCO2 Physiological Alarms

Alarm Message Condition Type of Alarm Indication


 No detectable breaths for the High Priority, Red alarm message with audio
configured number of Latching Alarm tone
seconds.
 The EtCO2 value exceeds the
high alarm limit.
 The EtCO2 value has fallen Medium
below the low alarm limit. Priority,
Yellow alarm message with
Latching
 The AwRR value exceeds the audio tone
Configurable
high alarm limit. Alarm
 The AwRR value has fallen
below the low alarm limit.

Table 25 EtCO2 Technical Alarms

Alarm Message Condition Type of Alarm Indication


 CO2 sensor has reached its
end of service life.
 CO2 sensor is reporting an
 over temperature condition. High Priority
Red alarm message
Non-Latching
 CO2 sensor requires service. with audio tone.
Alarm
 CO2 sensor is connected but
 the Efficia DFM100 cannot
communicate with it.

101
9: Monitoring CO2 EtCO2 and AwRR Alarms

Table 25 EtCO2 Technical Alarms (Continued)

Alarm Message Condition Type of Alarm Indication


 CO2 sensor needs to be
zeroed.
 CO2 sensor has not warmed
 up to operating temperature
range.
 The sampling line is kinked or
blocked.
For Sidestream only.

 The airway adapter is blocked.


 Low Priority
For Mainstream only. Cyan alarm message
Non-Latching
 A non-critical failure has been Alarm with audio tone.
detected.
 CO2 is out of range.
A Zero Required prompt appears after one
minute.

 Sampling line is disconnected.


 CO2 sensor is unplugged.


 CO2 sensor has a power


problem.

NOTE: EtCO2 and AwRR alarms are on (except AED mode) unless you turn them off or alarms for the
entire device are off. Once disabled, alarms remain off until they are turned back on.

WARNING: Turning off alarms prevents all alarms associated with EtCO2 or AwRR measurements from
annunciating. If an alarm condition occurs, NO alarm indication will be given.

Changing the EtCO2 Alarm Limits


 To change the EtCO2 alarm limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight the  menu and press the Smart
Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
6 Set the new low limit value and press the Smart Select knob.

102
EtCO2 and AwRR Alarms 9: Monitoring CO2

Enabling/Disabling the EtCO2 Alarms


 To enable or disable the EtCO2 alarms:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight the  menu and press the Smart
Select knob.
3 Select  and press the Smart Select knob.
4 Select  () and press the Smart Select knob.

Changing the AwRR Alarm Limits


 To change the AwRR alarm limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight the  menu and press the Smart
Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
6 Set the new low limit value and press the Smart Select knob.

Changing the Apnea Time Alarm Limit


 To change the apnea time alarm limit:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight the  menu and press the Smart
Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
6 Set the new low limit value and press the Smart Select knob.

Enabling/Disabling AwRR Alarms


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight the  menu and press the Smart
Select knob.
3 Select  and press the Smart Select knob.
4 Select  () and press the Smart Select knob.

WARNING: The safety and effectiveness of the respiration measurement method in the detection of apnea,
particularly the apnea of infancy, has not been established.

103
9: Monitoring CO2 Zeroing Sidestream and Mainstream Sensors

Zeroing Sidestream and Mainstream Sensors


To avoid inaccurate readings, Sidestream and Mainstream sensors need to be reset and require a
valid zero be performed when:
• attaching a new sample line
• there has been a significant change in environmental conditions
• when the accuracy of the reading is questionable
• requested by the Efficia DFM100

NOTES: Do not zero Sidestream and Mainstream CO2 sensors without a sampling line installed.
Wait 20 seconds after removing the sampling line from the patient’s airway before zeroing the CO2
sensor, so any lingering CO2 in the line can dissipate.
Keep the sampling line away from all sources of CO2, including exhaled breaths (yours and the
patient’s) and ventilator exhaust.
During zeroing, EtCO2 data is invalid. A  is displayed in the parameter block and a dashed line
appears in the wave sector.

Zeroing Using the Soft Key


 To zero the CO2 sensor using the soft key:
1 Confirm the Efficia DFM100 is in a clinical mode.
2 Press the  soft key.
3 The  message appears on the display. The message disappears when zeroing
is finished.

Zeroing Using the Smart Select knob


 To zero the CO2 sensor using the Smart Select knob:
1 Confirm the Efficia DFM100 is in a clinical mode.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  menu and press the Smart Select
knob.
4 Select  and press the Smart Select knob.
5 Select  and press the Smart Select knob.
6 The  message appears on the display. The message disappears when zeroing
is finished.
See Table 26 for messages which might appear during zeroing.

104
Disabling the EtCO2 Monitoring Function 9: Monitoring CO2

Table 26 Zeroing Messages

Message Situation Possible Solution


 The CO2 sensor is being zeroed. No action required.
 There is CO2 in the sample line.
 If patient is not breathing into
The CO2 sensor is still attached to the tube, zero again.
 a patient.
 The CO2 sensor is warming up. Allow the sensor to finish
warming up and re-try zeroing

NOTES: The soft key is grayed out when the device is in the process of zeroing the sensor.
The soft key does not appear while the Trends table is displayed.

Disabling the EtCO2 Monitoring Function


To disable the EtCO2 monitoring function, disconnect the sensor’s cable from the Efficia DFM100.
The message  appears. Select  and press the Smart Select
knob.
Should the sensor and cable be disconnected accidentally, the message 
appears to notify you of the disconnection. Select  and press the Smart Select knob.
Secure the connection. The CO2 monitoring function is enabled again.

Troubleshooting
If your Efficia DFM100 does not operate as expected during CO2 Monitoring, see Table 57 “EtCO2
Problems” on page 183.

105
NOTES

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
10

Monitoring SpO2
Pulse Oximetry (SpO2) is one of the tools available to assist in assessing a patient’s cardiac and
respiratory systems. This chapter explains how Pulse Oximetry works and how to use the Efficia
DFM100 to monitor SpO2.

Overview
Pulse oximetry is a non-invasive method of continuously measuring functional oxygen saturation
(SpO2) in arterial blood. SpO2 readings indicate the percentage of hemoglobin molecules in arterial
blood which are saturated with oxygen.
You can monitor SpO2 in all Efficia DFM100 clinical modes and on both adult and infant/child
patients. Use the Patient Category button to switch categories.
When pressing the Patient Category button, all parameter alarm limits change to the new patient
category. These changes are retained when you switch modes.
• For patients that are 25 kg or 8 years old, use Adult patient category
• For patients <25 kg or < 8 years old, use Infant/Child patient category
The neonatal patient category is not supported.

WARNINGS: Do not leave an SpO2 sensor on a patient undergoing an MRI.


For patients with an intra-aortic balloon pump, access peripheral pulses according to your
institution’s protocol.
Do not rely solely on SpO2 readings; assess the patient at all times. Inaccurate measurements may be
caused by:
• Incorrect sensor application or use
• Significant levels of intravascular dyshemoglobins such as carboxyhemoglobin or
methemoglobin in patient
• Patients with other disorders of hemoglobin
• Patients with restricted blood flow to the extremities (such as those in severe shock or
hypothermia)
• Injected dyes such as methylene blue
• Exposure to excessive illumination such as surgical lamps (especially those with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps or direct sunlight

107
10: Monitoring SpO2 Understanding Pulse Oximetry

Understanding Pulse Oximetry


A pulse oximetry sensor sends light through patient tissue to a receiver on the other side of the
sensor. Light-emitting diodes transmit red and infrared light through the peripheral areas of the
body such as a finger. See Figure 57.

Figure 57 Pulse Oximetry Sensor

Light
Emitting
Diodes

Photodetector

A photodetector positioned opposite the light emitting diodes compares the light absorption before
and after pulsation. The amount of light getting through reflects the blood flow in the arterioles.
This measurement of light absorption during pulsation is translated into an oxygen saturation
percentage. The SpO2 value and wave are displayed.

WARNING: SpO2 readings may be inaccurate in patients that:


• Are hypothermic
• Are receiving a photosensitive drug
• Are receiving vasoconstrictor medications
• Have poor circulation

NOTE: For accurate SpO2 measurements, the following conditions must apply:
• The patient must have perfusion in that extremity.
• The light emitter and photodetector must be directly opposite each other.
• All of the light from the emitter must pass through the patient’s tissue.
• The sensor site should be free of vibration and excessive motion.
• The sensor cable and connector should be positioned away from power cables to avoid
electrical interference.

108
Understanding Pulse Oximetry 10: Monitoring SpO2

Selecting a Sensor
The most important factor when selecting a sensor is the position of the light emitting diodes in
relation to the photodetector. When the sensor is applied, the diodes and the photodetector must be
opposite each other. Sensors are designed for patients with a specific weight range and for specific
sites. Be sure to:
• Select a sensor appropriate for the patient’s weight.
• Select a sensor site with adequate perfusion.
• Avoid application to sites with edematous tissue.
SpO2 sensors are either reusable or disposable. Reusable sensors can be reused on different patients
after they have been cleaned and disinfected (see the manufacturer’s instructions supplied with the
sensor). Disposable sensors should only be used once and then discarded. They may be relocated to
another appropriate site on the same patient but not reused on different patients.
See Table 61 “Approved Supplies and Accessories” on page 189 for a list of SpO2 sensors and
accessories that can be used with the Efficia DFM100.

CAUTIONS: Do not use more than one extension cable (M1941A).


Do not use the ear transducer on patients with small ear lobes as incorrect measurements may result.

Applying the Sensor


Follow the manufacturer’s directions for applying and using the sensor, making sure to observe any
warnings or cautions. For best results:
• Make sure the sensor is dry.
• If the patient is moving, secure the sensor cable loosely to the patient.
• Make sure the sensor is not too tight. Too much pressure can cause venous pulsation or can
impede blood flow, resulting in low readings.
• Keep power cables away from the sensor cable and connection.
• Avoid placing the sensor in an environment with bright lights. If necessary, cover the sensor
with opaque material.
• Avoid placing the sensor on an extremity with an arterial catheter, blood pressure cuff or
intravenous infusion line.

WARNINGS: Failure to apply the sensor properly may reduce the accuracy of the SpO2 measurement.
Inspect the sensor application site at least every two hours for changes in skin quality, correct optical
alignment and proper sensor application. If skin quality is compromised, change the sensor site.
Change the application site at least every four hours. More frequent checking may be required due to
an individual patient’s condition.
Do not use a damaged sensor or one with exposed electrical circuits.

109
10: Monitoring SpO2 Monitoring SpO2

Monitoring SpO2
 To monitor SpO2:
1 Connect the appropriate sensor cable to the Efficia DFM100 (see “Connecting the SpO2 Cable”
on page 13).
2 Apply the sensor to the patient.
3 If the Efficia DFM100 is not turned on, turn the Therapy knob to a clinical mode.
• SpO2 needs to be configured to appear in AED mode and does not display unless it is
pulsatile.
4 Check that the patient category is appropriate for the patient. If necessary, change the Patient
Category to select the appropriate category. See “General Function Buttons” on page 27.
Once the sensor cable is connected and the device is turned on, an SpO2 measurement begins. A 
is displayed for the SpO2 value in the Parameter Area while the oxygen saturation is initially
measured and value calculated. In a few seconds a value replaces the . See Figure 58.

Figure 58 SpO2 Value

             

      
     
 
   


 
Alarm Limits - If SpO2 alarms are
turned on, the alarm limits are


 displayed. If alarm limits are turned off,
the alarms off symbol is displayed.

Pulse Rate
The patient’s pulse rate, as derived from pulse oximetry, is displayed in the Parameter Area. See
Figure 59.

Figure 59 Pulse Rate Value

             

      
     
 
   


Alarm Limits - If pulse rate alarms are


  turned on, the alarm limits are



displayed. If alarm limits are turned off,

the alarms off symbol is displayed.
Pulse alarms are off by default.

110
SpO2 Alarms 10: Monitoring SpO2

Pleth Wave
When the sensor is connected to the Efficia DFM100, the pleth wave is displayed in the configured
Wave Sector. Grid lines are displayed to indicate signal quality. When the signal quality is good, the
pleth wave is auto-scaled to the grid lines. When the signal is poor, the size of the wave is
proportionally decreased and appears not to reach the grid lines.

Figure 60 Pleth Waves


Good Pleth Signal Quality



Poor Pleth Signal Quality



SpO2 Alarms
Alarms activate if measurements fall outside the configured limits for high or low SpO2, or if the
measurement falls below the configured SpO2 Desat Limit.
SpO2 alarms can be generated for the conditions shown in Tables 27 and 28. Once generated, they
appear as alarm messages in the SpO2 alarm status area above the SpO2 numeric. There are both
audio and visual alarms. For more information on alarms, see“Alarms” on page 37.
NOTE: Alarm notification is configurable. See “Alarm Management” on page 39.

Table 27 SpO2 Physiological Alarms

Alarm Message Condition Type of Alarm Indication


 The SpO2 value has fallen below High Priority Red alarm message
the Desat low limit. Latching Alarm with audio tone
 The SpO2 value exceeds the high Medium Priority
alarm limit. Latching Yellow alarm message
 The SpO2 value has dropped Configurable with audio tone
below the low alarm limit. Alarm

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10: Monitoring SpO2 SpO2 Alarms

Table 28 SpO2 Technical Alarms

Alarm Message Condition Type of Alarm Indication


 The device is unable to detect a
 Pleth waveform due to a SpO2
sensor malfunction.
 The SpO2 sensor is
disconnected.
 A noisy SpO2 sensor signal has
been detected.
 Light interference has been
detected at the SpO2 sensor.
 A non-pulsatile SpO2 signal has
been detected. Low Priority
Cyan alarm message
Non-Latching
 A problem with the SpO2 with audio tone
Alarm
 module has been detected.
 An erratic measurement has been
detected.
 The SpO2 measurement has not
 been updated within the last 30
seconds.
 The device has detected low
perfusion.
 A non-critical failure has been
detected.

NOTES: SpO2 alarms are on in all clinical modes (except AED and Manual) unless you specifically turn them
off or alarms for the entire device are off. Once disabled, alarms remain off until they are turned
back on.
While an NBP measurement is in progress, SpO2 alarms are suppressed.

SpO2 Desat Alarm


The SpO2 Desat alarm provides an additional limit setting below the low limit setting to notify you
of potentially life-threatening decreases in oxygen saturation. This additional limit is preset through
Configuration mode.
NOTE: If the SpO2 Low Limit alarm value is set below the configured SpO2 Desat Limit, the Desat Limit is
automatically adjusted to the SpO2 Low Limit value. Should the SpO2 reading fall below this value,
the SpO2 Desat Limit Alarm is announced.

Changing SpO2 Alarm Limits


 To change the SpO2 high and low alarm limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.

112
Pulse Rate Alarms 10: Monitoring SpO2

3 Select  and press the Smart Select knob.


4 Select  and press the Smart Select knob.
5 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
6 Select the new low limit and press the Smart Select knob.

Enabling/Disabling SpO2 Alarms


 To enable/disable SpO2 alarms:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  () and press the Smart Select knob.

WARNING: Turning alarms off prevents all alarms associated with the SpO2 measurement from being
annunciated. If an alarm condition occurs, no alarm indication is announced.

Pulse Rate Alarms


You can turn on/off Pulse Rate alarms in all clinical modes where SpO2 is available. The configured
alarm limits may be changed during use. Alarms are annunciated if measurements fall outside the
configured limits for high or low pulse rate.
Pulse Rate alarms can be generated for the conditions shown in Table 29. Once generated, they
appear as alarm messages in the Pulse status area right above the Pulse numeric. There are both audio
and visual alerts. For more information on alarms, see “Alarms” on page 37.

Table 29 Pulse Rate Alarms

Alarm Message Condition Type of Alarm Indication


 Pulse value is greater than the Medium
Pulse high alarm limit. Priority
Yellow alarm message
Latching
 Pulse value is less than the Pulse with audio tone
Configurable
low alarm limit.
Alarm

NOTE: Pulse alarms are off by default except when the Efficia DFM100 enters Pacing mode.

Changing Pulse Rate Alarm Limits


 To change the Pulse high and low alarm limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
6 Select the new low limit and press the Smart Select knob.

113
10: Monitoring SpO2 Disabling SpO2 Monitoring

Enabling/Disabling Pulse Rate Alarms


 To enable/disable Pulse alarms:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  () and press the Smart Select knob.

Disabling SpO2 Monitoring


 To disable SpO2 monitoring:
1 Disconnect the sensor cable from the SpO2 port. The message 
appears.
2 Select  and press the Smart Select knob.
NOTE: If the sensor cable is disconnected accidentally, the message 
appears. Select  and press the Smart Select knob. Secure the sensor connection to begin SpO2
monitoring again.

Caring for Sensors


Refer to the manufacturer’s instructions for care and cleaning of your sensors. To get the best results
from your reusable sensors, always handle the sensors and cable with care and protect them from
sharp objects. The sensor houses a sensitive electronic device that can be damaged. Harsh treatment
of the sensor reduces their useful life.

Troubleshooting
If your Efficia DFM100 does not operate as expected during SpO2 Monitoring, see Table 56 “SpO2
Problems” on page 182.

114
11

Monitoring NBP
This chapter explains how to monitor blood pressure (NBP) using the Efficia DFM100.

Overview
The Efficia DFM100 measures blood pressure for both adult and infant/child patients using the
oscillometric method. Systolic, diastolic and mean measurements are provided. Alarms are
available to alert you to changes in the patient’s condition.
NBP measurements can be taken in Monitor, Manual Defibrillation (including Synchronized
Cardioversion), and Pacing modes. NBP is not available in AED mode. NBP measurements can
be taken automatically on a pre-set schedule or manually on demand.
Use the Patient Category button to switch between patient categories.
When pressing the Patient Category button, all parameter alarm limits and initial inflation
pressures change to the new patient category. These changes are retained when you switch
modes.
• For patients that are 25 kg or 8 years old, use Adult patient category.
• For patients <25 kg or < 8 years old, use Infant/Child patient category.
The neonatal patient category is not supported.
While an NBP measurement is in progress, the current cuff pressure is displayed in the
Parameter area. Once the measurement is complete, the values for systolic, diastolic and mean
pressure are displayed along with the measurement schedule (manual or automatic intervals) and
a time stamp (see Figure 61.)

Figure 61 NBP Values


             

      
     
 
   


    Alarm Limits - If NBP alarms are


  


turned on, the alarm limits are
displayed. If alarm limits are turned
off, the alarms off symbol is
displayed.

WARNING: Do not perform NBP monitoring on patients whose upper arm circumference is less than 13cm.
Doing so may result in inaccurate measurements.

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11: Monitoring NBP Measuring NBP

Measuring NBP
The first time an NBP measurement is taken, the cuff’s initial inflation pressure is 160
mmHg/21.3 kPa for adults and 120 mmHg/16 kPa for infant/child. The device aborts a
measurement, deflates the cuff and generates an alarm before the inflation pressure exceeds 290
mmHg/38.6 kPa.
NOTE: For pediatric and adult patient populations, blood pressure measurements made with the Philips
Goldway NBP Module are equivalent to those obtained by trained observers using the
cuff/stethoscope auscultatory method within limits prescribed by ANSI/AAMI SP10: 1992 &
2002/YY 0670-2008 (mean error difference of ±5 mmHg or less, standard deviation of 8 mmHg
or less).

 To measure NBP:
1 Select the appropriately sized cuff for the patient. The cuff width should be either 40% of the
limb circumference or 2/3 of the upper arm length. The inflatable part of the cuff should be
long enough to encircle 50-80% of the limb.
NOTE: Selecting the right cuff size for the patient is important. The wrong cuff size may give false and
misleading results. If you do not have the correct cuff size, use a larger one to minimize error.

2 Attach the cuff to the NBP tubing, making sure that air can pass through the tubing and the
tubing is not squeezed or kinked. See Figure 62.

Figure 62 Connecting the NBP Cuff/Tubing

NOTE: Securely attach the cuff and tubing to prevent accidental disconnections.

3 Insert the NBP tubing into the NBP port as described in “Connecting the NBP Cable” on
page 13.
4 Apply the blood pressure cuff to the patient’s arm or leg as follows:
a Ensure that the cuff is completely deflated.
b Wrap the cuff around the arm, making sure that the artery marker is aligned over the
brachial artery. Ensure that:
• The cuff is not placed on the same extremity as an SpO2 sensor.
• The cuff is not wrapped too tightly around the limb. Excessive tightness may cause
discoloration and eventual ischemia of the extremities.
• The NBP tubing from the defibrillator to the cuff is not compressed, crimped or
damaged.
• The edge of the cuff falls within the range identified by the <----> markings. If it
does not, use a cuff that fits better.
5 Place the limb used for taking the measurement at the same level as the patient’s heart.

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Measuring NBP 11: Monitoring NBP

6 Press the  soft key. As the cuff begins to inflate and then deflate, the pressure is
displayed.
7 When the measurement is complete, the NBP values are displayed.
To stop an NBP measurement in progress, press the  soft key.

Assessment of Hypertension
 To make a measurement for use in the assessment of hypertension:
1 Ensure the patient is comfortably seated with their legs uncrossed and feet flat on the floor.
Their back and arm should be supported.
2 Ask the patient to relax as much as possible and not talk during the measurement.
3 Confirm, the middle of the cuff is at the level of the right atrium of the heart.
4 If possible, wait five minutes before making the first measurement.

WARNINGS: Do not perform noninvasive blood pressure measurements on patients with sickle-cell disease or
any condition where skin damage has occurred or is expected.
Do not use in a hyperbaric chamber.
Care should be taken when using an oscillometric NBP device on patients with decreased
consciousness, neuropathy, irregular cardiac rhythm, labile high blood pressure, increased arm
activity, or arterial insufficiency especially if the unit is utilized for a prolonged period. A
safeguard of the NBP system is that the device incorporates a softkey that can be pressed to
deflate the cuff if the cuff is causing patient pain. Pay particular attention to unconscious patients
since they cannot alert you if the pain is present.
Use clinical judgement to decide whether or not to perform automatic blood pressure
measurements on patients with severe blood clotting disorders because of the risk of hematoma
in the limb wearing the cuff.
Do not apply the cuff to a limb that has an intravenous infusion or arterial catheter in place. This
could cause tissue damage around the catheter when the infusion is slowed or blocked during
cuff inflation.
Use only approved cuffs and tubing in order to prevent inaccurate data, injury or damage. All
specified cuffs are protected against the effects of the discharge of a defibrillator.
Prolonged series of NBP measurements in automatic mode may be associated with purpura,
ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the
extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is
observed, stop the blood pressure measurements immediately.
Blood pressure readings may be affected by the position of the patient, their physiologic
condition, the presence of arrhythmia and other factors.
Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow
interference and potentially resulting in injury to the patient.
Do not apply the cuff over a wound as this can cause further injury.
Avoid applying the cuff on the same side as a mastectomy as the pressure increases the risk of
lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether
the benefit of the measurement outweighs the risk.
To obtain accurate blood pressure readings, the cuff must be the correct size and also be correctly
fitted to the patient. Incorrect size or incorrect fitting may result in incorrect readings.
NBP measurements may be impacted if there is excessive motion or vibration, such as when the
patient is being transported in a moving vehicle.

117
11: Monitoring NBP NBP Alarms

CAUTIONS: Do not compress or restrict pressure tubes during an NBP measurement.


If a spill occurs and liquid appears inside the tubing, contact your service personnel.

NOTE: When utilizing NBP, use your clinical judgment on appropriate application for patient's clinical
status.

NBP Schedule
NBP measurements can be taken on a manual or predetermined automatic basis, depending on
how the device is configured and the patient’s needs:
Manual - There is no schedule for additional measurements. One measurement is taken each
time you press the  soft key. Take additional measurements by pressing the 
soft key.
Automatic - A measurement is attempted at configured intervals - every 1, 2.5, 5, 10, 15, 30, 60
or 120 minutes. In order for a measurement to successfully begin, any previous measurement has
to have ended, the cuff must be deflated and 30 seconds of rest time elapsed.
NOTE: All criteria must be met in order for an automatic NBP to be taken. For example, if you have the
automatic measurement setting set to every 1 minute, the device attempts to take an NBP every
60 seconds. However, for the measurement to successfully begin, the previous measurement
must have ended, cuff must be deflated and 30 seconds must have elapsed after cuff deflation. If
these criteria are not met, the device waits the 60 seconds to attempt another measurement.

Additional manual measurements can be taken without affecting the automatic measurement
schedule by pressing the  soft key.
The configured NBP measurements schedule may be changed during an event.

 To change the NBP schedule and/or the interval of automatic measurements for the current
patient:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select
knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Select the desired interval and press the Smart Select knob.

NOTES: Interval choices are listed in the format “qx” indicating measurements are taken every “x” minutes
from the time you first press the [Start NBP soft key.
When cuff measurements are set to be taken at an automatic interval, there is a forced 30-second
minimum period in between measurements, even if a measurement is due to be taken. The Efficia
DFM100 display shows the last NBP (if obtained in the last 60 minutes), time obtained and
frequency.
If no subsequent measurements are taken, NBP values are removed from the display after 60
minutes but can still be obtained through Vital Sign Trending and the Event Summary.

NBP Alarms
Alarms are annunciated when a measurement for the configured source (systolic, diastolic or mean)
falls outside the configured high or low limits. Both the source of the alarm and the limits may be
changed during an ongoing patient event.

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NBP Alarms 11: Monitoring NBP

NBP alarms can be generated for the conditions shown in Tables 30 and 31. Once generated, they
appear as alarm messages in the NBP alarm status area above the NBP numeric. There are both
audio and visual alerts. For more information on alarms, see “Alarms” on page 37.
NOTE: Alarm notification is configurable. See “Alarm Management” on page 39.

Table 30 NBP Physiological Alarms

Alarm Message Condition Type of Alarm Indication


 The NBP systolic value exceeds
the high alarm limit.
 The NBP diastolic value
exceeds the high alarm limit.
 The NBP mean value exceeds
the high alarm limit. Medium
Priority
 The NBP systolic value has Yellow alarm message
Latching
fallen below the low alarm with audio tone
Configurable
limit. Alarm
 The NBP diastolic value has
fallen below the low alarm
limit.
 The NBP mean value has fallen
below the low alarm limit.

Table 31 NBP Technical Alarms

Alarm Message Condition Type of Alarm Indication


 The cuff pressure exceeded 300
 mmHg/40 kPa.
 The cuff has failed to deflate.

Low Priority
 The device is unable to Cyan alarm message
Non-Latching
 complete a measurement. with audio tone
Alarm
 A problem with the NBP
 module has been detected.
 A non-critical failure has been
detected.

Changing NBP Alarm and Source Limits


 To change the NBP alarm source and/or limits:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  and press the Smart Select knob.

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11: Monitoring NBP Caring for Cuffs

5 Select the desired source for the alarm (,  or ) and press the Smart Select
knob.
6 Turn the Smart Select knob to select the new high limit value then press the Smart Select knob.
7 Select the new low limit and press the Smart Select knob.

Enabling/Disabling NBP Alarms


 To enable/disable NBP alarms:
1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob.
4 Select  () and press the Smart Select knob.

WARNING: Turning alarms off prevents all alarms associated with the NBP measurement from being
annunciated. If an alarm condition occurs, no alarm indication is announced.

NOTES: NBP alarms are on unless you specifically turn them off or alarms for the entire device are off. Once
disabled, alarms remain off until they are turned back on. The Efficia DFM100 allows you to adjust
alarm notifications.
Taking a manual NBP measurement also acknowledges any latched NBP alarm from the previous
measurement.

Caring for Cuffs


Refer to the manufacturer’s instructions for care and cleaning of your NBP cuffs. To get the best
results from your cuffs, handle them with care and protect them from sharp objects.

Troubleshooting
If your Efficia DFM100 does not operate as expected during NBP Monitoring, see Table 58 “NBP
Problems” on page 185.

120
12

Trending
This chapter describes how to review patient data using Efficia DFM100 Trending.

Overview
In Monitor mode your Efficia DFM100 provides the ability to view and print numeric vital signs
trending data for the current incident. Trending data are automatically acquired if parameters are on.
When viewing trending data, the Trends report is displayed in the Efficia DFM100’s lower two wave
sectors and takes over the soft key functions. Trend data can be displayed at selected intervals for up
to 8 hours of monitoring. You can set your trend interval to 1, 5, 10, 15, 30 or 60 minutes.
Trending data displayed for parameters continuously measured (heart rate, SpO2, EtCO2 and pulse)
are the average of multiple measurements over the trend time period. Trending data for NBP appear
with the timestamp of the measurement.

Viewing Trend Data


 To view trending data:
1 Confirm your Efficia DFM100 is in Monitor mode.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the knob in. The Trends report takes
over the bottom two wave sectors. See Figure 63.
To close the Trends report, press the  soft key.

Figure 63 Trends Report





          

          

          

          

          

          

  


 

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12: Trending Overview

About the Data Displayed


• When trending is initially displayed, the most recent trending data appear in the far right
column.
• The display automatically updates as new data become available, with the newest data appearing
in the far right column of the display and older data moving over to the left. If the display is full,
the oldest displayed data is removed.
• If you scroll horizontally to view older data, the Efficia DFM100 updates the newest data when
you scroll back.
• If a parameter data point has invalid information, a  is displayed. Questionable data are
indicated by a question mark just before the numeric value. Unavailable data are indicated by a
blank space.
• If a parameter has not been measured during the display period, it is not listed in the far left
column.
• The Heart Rate parameter is always the top entry in the Trends report. If your device has the
SpO2 Option and values for SpO2 and Pulse are available, they are listed second and third in the
Trends report. If your device has the EtCO2 option and values are available, the EtCO2 and
AwRR values are listed next. If your device has the NBP option and values for NBP are
available, they are listed after AwRR in the Trends report.
• For continuous trend data (HR, EtCO2, SpO2, pulse) the displayed number is the average of the
valid values during the time period.
• NBP measurements are displayed with a timestamp.
• The units of measure for trend data are not displayed in the Trends table and report.
Setting Trend Intervals
Trending data can be shown at selected intervals for up to the last 8 hours of monitoring. You can
adjust the display’s time interval for the current incident to 1, 5, 10, 15, 30 or 60 minutes. The default
is 5 minutes.

 To adjust the Trend Interval:


1 Confirm there is a Trends report on the Efficia DFM100 screen.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the knob.
4 Select the interval you want and press the knob.

Navigating Around the Trends Report


Use the horizontal scroll soft keys to scroll left and right (backward and forward in time) in the
Trends report. The soft key is inactive (grayed out) if there is no more data to be viewed in that
direction.
If there are more lines of data than can be shown on the screen, turn the Smart Select knob to scroll
up and down the display.

NOTE: Make sure there are no active menus before using the Smart Select knob to scroll up and down the
Trends report. If you do have an active menu, exit the menu before trying to scroll up or down in
the Trends report.

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Overview 12: Trending

Printing the Trends Report


You can print a Trends report with or without a Trends report on the Efficia DFM100’s display.

 To print a Trends report from Monitor mode:


1 Press the Report button .
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select the appropriate interval and press the knob.
A report for the entire event period is printed. See Figure 64.

Figure 64 Sample Trends Printed Report

Trends Header Page: Trends Data Page:


           

            

            

            

            

            

      

       

       

     

Trends reports can also be printed from Data Management mode. See “Data Management” on
page 125.

NOTE: Do not enter Data Management mode while monitoring a patient.

Troubleshooting
If your Efficia DFM100 does not operate as expected during trending, see “Troubleshooting” on
page 173.

123
NOTES

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
13

Data Management
This chapter describes the data management features of the Efficia DFM100, including Data
Management mode, Event Summary, and printing functionality.

Overview
The Efficia DFM100 automatically generates an Event Summary for each patient event. Each Event
Summary is assigned a unique event identification number, is date/time stamped and stored in the
device’s internal memory. Data related to the current event is available for viewing, reporting, and
printing. Vital sign parameters are part of the Event Summary but are also available in the Trends
report.
The current Event Summary or Trends report may be printed by pressing the Reports button on the
front of the Efficia DFM100.
When the internal memory is full, each additional summary causes one or more of the oldest event
summaries to be overwritten.
Event Summaries stored in internal memory can be:
• Printed.
• Copied to a USB flash drive in Data Management mode for transfer to a data management
application.

Event Summary
A new Event Summary is initiated the first time one of the following occurs after the device is
powered on:
• The arrival of a valid ECG signal either through electrodes or pads/paddles.
• The arrival of valid SpO2 data.
• The arrival of valid CO2 data
• The arrival of valid NBP data.
• The Charge button is pressed.
• The Mark Event button is pressed.
An Event Summary ends when the device is turned off or enters a non-clinical mode.
NOTE: There is an 8-hour data limit per incident for an Event Summary. When the 8-hour limit is reached,
the Efficia DFM100 stops recording and a message is displayed on the Efficia DFM100. The
number of Event Summaries that can be stored is related to the duration of each individual Event
Summary. For example, the Efficia DFM100 can store approximately 50 Event Summaries of
approximately 30 minutes in length or 5 Event Summaries of approximately 8 hours in length.

Event Summary Data Collected


Patient data collected, if available, includes:
• Two ECG waveforms with beat labels

125
13: Data Management Event Summary

• One pleth waveform


• One CO2 waveform
• Patient event information including:
• Patient name, sex, category, ID
• Parameter information/Trends data
• Physiological alarms and alarm limits
• Defibrillation and pacing events
• Mark events
• Technical/device event information including:
• Power on/off
• Technical alarms
• Initial mode and mode changes
• Initial battery status and subsequent changes
• Print Strip
• Research data, including waves (AED mode only) and shock/no-shock decisions
You can configure the Efficia DFM100 to save short or long Event Summaries. Short Event
Summaries include all the above information except waveforms. Long Event Summaries contain
everything.

Printing an Event Summary


You can print an Event Summary report (see Figure 65) during a patient event or from Data
Management mode after the event has concluded. See “Printing While in Data Management Mode”
on page 138.

Figure 65 Sample Printed Event Summary Report


Event ID: 12232000K 05:33:53 Device On

SMITH, FRED 05:33:53 Monitor Mode

Patient ID: CGP03061998 05:34:10 Pads On Alarm Identification:


Patient Sex: M
High priority physiological
First Event: 25 2014 05:33:53 alarms are preceded by .
Last Event: 25 2014 05:34:10 Medium priority physiological
Elapsed Time: 00:00:13
alarms are preceded by .
High priority technical alarms
Total Shocks: 0
are preceded by . Medium
Total Pacer Time: 0
priority alarms are preceded
 866199; S/N: (CN325678) by . Low priority alarms are
SW Rev: 1.0 not preceded by any marks.

Two waves can be included when printing an Event Summary:


- First printed wave is always the primary ECG
- Second printed wave is:
• A Capnogram if you are measuring EtCO2

126
Event Summary 13: Data Management

• A Pleth wave if you are measuring SpO2 and not EtCO2


• A second ECG if you are not measuring either EtCO2 or SpO2 and there is a valid second ECG
wave available
• Empty if there is no valid EtCO2, SpO2 or a second ECG wave available.

Events Stored in an Event Summary


Events and wave segments can be stored in an Event Summary. Table 32 lists events and related
information stored in an Event Summary. Not all events listed are possible, based on your device’s
configuration. Text in parenthesis are replaced by an appropriate value.
To have waves stored in the Event Summary you must have the Efficia DFM100 configured for
long Event Summaries. See Table 47 on page 149. Segments include a header, waveform and events.

NOTES: If an Event Summary stops printing because the paper runs out, the report resumes printing if a
new roll of paper is installed within 3.5 minutes.
If a Daylight Savings Time change occurs during an event, the timestamps for that event are not
adjusted. The next Event Summary uses the adjusted time.
Values listed on a printed Event Summary also include the parameter’s unit of measurement.

Table 32 Event Information

Logged Event Frequency


Power-related events
 Logged when device first turns on.
 Logged when device is turned on after being turned off for less than 10 seconds.
 Logged when the Therapy knob is turned to the Off position.
 Logged when a critical device failure has been reported.
 Logged when any out-of-range voltages are detected.


 Logged when the device determines that one or more subsystems is not functioning
 properly.
 Logged when the device cannot determine when the last Autotest was run.
 Logged when power was not available (for a week or longer) to run a scheduled
Autotest.
 Logged during RFU testing if the battery can’t sufficiently charge the device.
Mode and Energy Positions





Logged at the start of an event and when mode or selected energy changes.




(value) 
 Logged when exiting a clinical mode.

127
13: Data Management Event Summary

Table 32 Event Information (Continued)

Logged Event Frequency


Patient Info
 or  Logged when patient category is set or changed.
, ,  Logged when internal paced status is set or changed.


Battery Status
 Logged when battery is low.
 Logged when you are pacing and the battery is low.
 Logged when imminent shutdown warning is issued.
 Logged when shutdown warning is issued.
 Logged when the battery charge level is good.
 Logged when the battery is not present.
 Logged when communication with the battery has failed.
 Logged when the battery has reached its end of life.
 Logged when an incompatible battery is connected.
Pads/Paddles/Leads
 Logged when pads are applied to the patient.
 Logged after a  event if the multifunction electrode pads are removed from
the patient or the Therapy cable is disconnected.
 Logged when a pad impedance is low.
 Logged when pad impedance is minimal.
 Logged when external paddles make contact with the patient.
 Logged after  if paddles lose contact with the patient.
 Logged when internal paddles make contact with the patient.
 Logged after  if paddles lose contact with the patient.
 Logged when monitoring electrodes for primary ECG are attached to the patient.
 Logged after  if a monitoring electrode for the primary wave loses contact
with the patient.
Vitals
 (value),  (value),  Values logged when measurement is taken - a minimum of every 5 minutes.
(value),  (value), 
(value),  (value)

128
Event Summary 13: Data Management

Table 32 Event Information (Continued)

Logged Event Frequency


HR/ECG





Logged when a high priority latching physiological alarm is generated.
 (value, limit

 (value,
limit)
 Logged when a medium priority latching physiological alarm is generated and Pacer
 mode is selected.



 (value, limit) Logged when a medium priority non-latching physiological alarm is generated.
 (value, limit)
 Logged when there is ECG data that cannot be analyzed.
 Logged when there has been an ECG equipment malfunction.
 Logged when there has been a ECG pads (or paddles) equipment malfunction.


/ Logged when ECG alarms are turned off or on and any subsequent change.
 (low) (high) Logged when HR alarms are turned on and when there is a change in alarm limits.
 (with Logged when VTACH alarms are turned on and when there is a change in alarm
limits) limits.
 (limit) Logged when PVC rate alarms are turned on and when there is a change in alarm
limits.
 Logged when the Efficia DFM100 is evaluating the ECG signal.
 Logged when the Efficia DFM100 is evaluating the ECG rhythm.
 Initial ECG bandwidth for display, printing and storage are logged.
 (with settings)
 Logged when the device detects a therapy equipment failure.
SpO2
/ Logged when SpO2 monitoring is connected and any subsequent
disconnect/connect.
 (value, limit) Logged when the patient’s SpO2 value is higher than the configured limit.
 (value, limit) Logged when the patient’s SpO2 value is lower than the configured limit.
 (value, limit) Logged when the patient’s Desat value is lower than the configured limit.
 Logged when the device is on and unable to acquire a Pleth waveform.
 Logged when SpO2 monitoring is on and the sensor is disconnected.
 Logged when SpO2 is on and a noisy signal is detected.
 Logged when SpO2 is on and light interference is detected at the SpO2 sensor.

129
13: Data Management Event Summary

Table 32 Event Information (Continued)

Logged Event Frequency


 Logged when SpO2 is on and a non-pulsatile SpO2 sensor signal is detected.
 Logged when SpO2 is on and an SpO2 equipment malfunction is detected.
 Logged when SpO2 is on and an erratic measurement condition occurs.
 Logged when SpO2 is on and the SpO2 measurement update period exceeds
30 seconds.
 Logged when SpO2 is on and low perfusion occurs.
 Logged when a non-critical SpO2 error is detected.
/ Logged when SpO2 alarms are turned on or off and any subsequent change.


 (low) (high)  Logged when SpO2 alarms are turned on and when there is a change in alarm limits.
(limit)
Pulse
 (value, limit) Logged when the patient’s pulse is higher than the configured limit.
 (value)  (limit) Logged when the patient’s pulse is lower than the configured limit.
/ Logged when pulse alarms are turned on or off and any subsequent change.


 (low limit) (high Logged when pulse alarms are turned on and when there is a change in alarm limits.
limit)
EtCO2
/ Logged when EtCO2 monitoring is connected and any subsequent
disconnect/connect.
 (value, limit) Logged when the patient’s EtCO2 value is higher than the configured limit.
 (value, limit) Logged when the patient’s EtCO2 value is lower than the configured limit.
(type) Logged when a CO2 sensor is connected to the Efficia DFM100.
 Logged when the CO2 sensor has not warmed up to operating temperature range.
 Logged when the CO2 sensor is unplugged or the filter line is disconnected.
 Logged when the CO2 sensor is unplugged.
/ Logged when CO2 alarms are turned on or off and any subsequent change.


 (low value) (high Logged when CO2 alarms are turned on and when there is a change in alarm limits.
value)
 If using the Mainstream or Sidestream sensor, logged when the sensor is zeroing.
 If using the Mainstream or Sidestream sensor, logged when the sensor needs to be
zeroed.
 If using the Mainstream or Sidestream sensor, logged when the sensor zeroing is
complete.
(reason) If using the Mainstream or Sidestream sensor, logged when the sensor zeroing
failed.
 Logged when the CO2 sensor has reached its end of life.

130
Event Summary 13: Data Management

Table 32 Event Information (Continued)

Logged Event Frequency


 Logged when the CO2 sensor needs servicing.
 Logged when the CO2 sensor detects a kinked or blocked filter line.
 Logged when the CO2 sensor detects the airway adapter is blocked.
 Logged when the CO2 sensor detects that it is over temperature.
 Logged when the CO2 sensor detects its result is out of range.
 Logged when a non-critical EtCO2 error is detected.
 Logged when the Efficia DFM100 cannot communicate with the CO2 sensor.
AwRR
/ Logged when AwRR alarms are turned on or off and any subsequent change.


 (low value) (high Logged when AwRR alarms are turned on and when there is a change in alarm
value) limits.
 (value, limit) Logged when the patient’s AwRR value is higher than the configured limit.
 (value, limit) Logged when the patient’s AwRR value is lower than the configured limit.
 (value) Logged when the Apnea alarm is displayed.
 (time) Logged when there is a change to the Apnea alarm Limit setting.
NBP
 Logged when a manual NBP measurement is requested.
 (frequency value) Logged when an automatic NBP measurement is requested (including frequency
value).
 Logged when an automatic NBP measurement is changed to manual (including
frequency value).
 (frequency) Logged when the NBP frequency is changed.
/ Logged when NBP alarms are turned on or off and any subsequent change.
 (low value, Logged when the Systolic NBP alarm limit is changed.
high value)
 (low value, Logged when the Diastolic NBP alarm limit is changed.
high value)
 (low value, Logged when the Mean NBP alarm limit is changed.
high value)
(value, limit) Logged when the patient’s Systolic NBP is higher than the configured limit.
 (value, limit) Logged when the patient’s Systolic NBP is lower than the configured limit.
(value, limit) Logged when the patient’s Diastolic NBP is higher than the configured limit.
 (value, limit) Logged when the patient’s Diastolic NBP is lower than the configured limit.
(value, limit) Logged when the patient’s Mean NBP is higher than the configured limit.
 (value, limit) Logged when the patient’s Mean NBP is lower than the configured limit.
 Logged when the NBP cuff fails to deflate after 3 minutes.
 Logged when the NBP cuff pressure reaches 300 mmHg/40 kPa.

131
13: Data Management Event Summary

Table 32 Event Information (Continued)

Logged Event Frequency


 Logged when an NBP measurement fails to complete.
 Logged when the device detects a non-critical NBP failure.
 Logged when the NBP module detects a malfunction.
Defibrillation
 (value)  Logged when charging is initiated.
 Logged when the device is disarmed manually.
 (reason) Logged when the device disarms automatically. Reasons include:
:Logged when the automatic disarm is caused by a bad connection between
the device and the patient.
: Logged when the device is unable to reach the
selected energy during charging.
: Logged when the device reaches its configured auto-disarm period.
: Logged when, in AED mode, the algorithm determines the
rhythm is not shockable.
: Logged when the device is turned off while charged.
: Logged inSynchronized Cardioversion mode when a leads off condition is
detected in the synchronizing lead.
: Logged when, with the therapy cable connected, the
device detects a change in the paddles or pads type or if the therapy cable type
identification is not valid.
(number) (energy)  Logged when a shock is delivered.
(impedance) (peak current) 
 (impedance) Logged when a shock is initiated but aborted before a full shock dose is delivered.
/ Logged when Sync is turned on or off and any subsequent change.
 Logged when a shock is initiated and completed but the full dose is not delivered.
 Logged when a a critical failure has occurred, preventing therapy delivery.
AED Mode
 Logged when the algorithm begins analysis.
 Logged when artifact has been detected.
 Logged when the algorithm detects a shockable rhythm.
 Logged when the algorithm detects a non-shockable rhythm.
 Logged when the algorithm is unable to make a shock/no-shock decision.
 Logged when the device enters or exits a forced pause.
 Logged when the device enters or exits a NSA pause.
 Logged when the device enters or exits NSA monitoring.
 Logged when the device enters or exits CPR pause.
Pacing

132
Data Management Mode 13: Data Management

Table 32 Event Information (Continued)

Logged Event Frequency


/ Logged when pacing starts and when the mode is changed.


 (value) Logged when the Pacer Rate is changed.


 (value) Logged when the Pacer Output is changed.
 Logged when pacing is paused.
 (rate) (current) Logged when pacing starts.
(width)
 Logged when power is restored if pacing is interrupted or stopped due to a power
 loss and the Therapy knob remains in the Pacer position.
(value) < Logged when the Pacer Output is less than the selected setting by 20 percent or
(value) 10mA (whichever is greater).
Pacing stopped with reason Logged when the device stops pacing. Reasons include:
: Logged when a pads-off condition is detected.
: Logged when a device error that prevents delivery of
pacing therapy is detected.
: Logged when the Therapy cable is disconnected from
the device.
: Logged when there is a leads-off condition with the
primary ECG lead for pacing.
Mark Event
 Logged when the Mark Event button is pressed.
(Configured Event Text) Logged when you select an entry from the  menu.
Printing
 Logged when you hit the Print button on the front of the device.
 Logged when there is a printer failure during an operational check.
Alarms
/ Logged when alarms are enabled/disabled.
 Logged when alarm audio is paused.
 Logged when alarm audio is turned off.
 Logged when an active alarm’s audio is paused.
 Logged when an active alarm’s audio is turned off.

Data Management Mode


Data Management mode is a non-clinical mode used to manage event data records. You can print or
export an individual Event Summary or export all Event Summaries. You can also configure the
Efficia DFM100 to remove patient information from Event Summaries before exporting them. And
you can also manage Event Summary data on the external USB drive.
NOTE: Do not enter Data Management mode while monitoring a patient.

133
13: Data Management Data Management Mode

 To enter Data Management mode:


1 Turn the Therapy knob to either Monitor, Pacer or Manual Defib.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Confirm your selection. Use the Smart Select knob to select  and press the Smart Select
knob. If you select , you are returned to the mode you started from.

Internal Memory
When first entering Data Management mode, the Internal Memory screen is displayed. See
Figure 66.

Figure 66 Data Management Internal Memory




ID Date and Time Elapsed Paced Event ID Shocks

N 2011-02-03 09:59 0:44:08 10:37 345432567 4

Y 2011-02-04 11:11 0:20:09 12:09 345634261 2

N 2011-02-05 07:59 0:26:54 0:00 345634274 3

Scroll
Bar

Event Storage Used/Free: 8MB/195MB Number of Events Stored: 3



 

The following information is listed on the display:


• ID – Indicates if the event data record contains any patient information which could
uniquely identify the individual.  indicates there is;  indicates there isn’t.
• Date and Time – Date and time the event began.
• Elapsed – Duration of the event.
• Paced – Total paced time for the event.
• Event ID – The unique ID for the event.
• Shocks – Total number of shocks delivered during the event.
• Event Storage Used/ Free – The amount of space used/available in internal memory.
• Number of Events Stored – The number of events that are currently stored in internal
memory.

Internal Memory Menu


From the internal memory menu you can print, export, and remove all patient identification data.
You can also view data on your USB drive.

134
Data Management Mode 13: Data Management

 To use the Internal Memory menu:


1 Confirm you are in Data Management mode.
2 Press the Smart Select knob.
3 Using the Smart Select knob, select your desired operation. See Figure 67.

Figure 67 Data Management - Internal Memory Menu


Select  to print the currently selected Event Summary.
Select  to export the currently selected Event

Summary to the USB drive.

Select  to export all Event Summaries currently in
 Internal Memory to the USB drive.

Select  to de-identify all Event

Summaries in Internal Memory. See “Removing All Patient

Information” on page 135.

Select  to view all Event Summaries on an
external USB drive. See “Accessing Data on the USB Drive”
on page 136.
Select  to exit the menu.

4 Press the Smart Select knob to perform the task. If your organization enabled the Data
Management mode password, you are prompted to enter the password before performing
certain tasks, such as printing and exporting.

NOTES: Select  from the  menu to cancel an export once it begins. The option
appears in the menu after you have begun to print/export. To cancel printing, press the Print
button.
If you change from Data Management mode to a clinical mode while data is exporting, the device
alerts you that data export is in process and asks you whether you want to  Select 
to stop data export and continue to the new mode. Select  to continue exporting data.
If you turn the device off while exporting data, the export is stopped, and the exported data might
be incomplete.

Removing All Patient Information


Patient information includes the patient name, medical record number, dates related to the
individual, and other information that could uniquely identify an individual.
In Data Management mode, you have two methods to remove patient information from Event
Summaries:
• When exporting Event Summaries, you may receive the message 
before the data is exported. If this function is enabled, select  to export the data without the
patient information or  to export the data with the patient information.
• In the internal memory menu (Figure 67), selecting  displays the message
 Select  to remove the patient information
from all the stored Event Summaries or  to keep the patient information.

CAUTION: All Efficia DFM100 users are responsible for protecting the use, disclosure, and exchange of
electronic Protected Health Information (ePHI).

135
13: Data Management Data Management Mode

Accessing Data on the USB Drive


When you select the  option from the internal memory menu, the Efficia DFM100
first checks that there is a compatible USB drive inserted into the USB port on the back of the device
(see Figure 15 on page 16). If a compatible USB drive is not found, the Internal Memory screen
remains on the display. If a compatible drive is found, then the USB Drive screen is displayed.
NOTE: The USB Drive screen’s layout is similar to the Internal Memory screen (see Figure 66) except
Internal Memory is replaced with USB Drive in the screen’s title.

Using the Efficia DFM100, you are only able to save Event Summaries to and delete from the USB
drive. Additional USB drive operations can be performed with a USB-compatible computer.

Saving Data to the USB Drive


You can save data to a USB drive from Data Management mode, Configuration mode, and after an
operational check.

 To save data to a USB Drive:


1 Confirm you have a USB drive inserted into the USB port.
2 Press the Smart Select knob and select  from the menu. The Efficia DFM100 copies your
data to the USB drive.

CAUTION: Use only the USB driver recommended by the manufacturer. Using other brands of USB drivers
may cause damage or be incompatible with the Efficia DFM100.

NOTE: If data exporting is in progress and you change from a non-clinical mode to a clinical mode or vice
versa, the Efficia DFM100 asks you if you want to continue exporting. Select  to stop;  to
continue with the export.

Deleting Event Summaries from the USB Drive


 To delete Event Summaries from the USB drive:
1 Confirm you are in Data Management mode.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the Smart Select knob.
4 Once in the USB Drive screen, press the Smart Select knob.
5 The USB Drive menu appears. See Figure 68.
6 Turn the Smart Select knob to select .
7 Press the Smart Select knob to erase all event summaries from the USB drive.
8 The device prompts you to confirm your selection. Select  to erase all data on the drive.
Select  to leave all data on the drive.

Figure 68 USB Drive Menu

Select  to erase all data on the USB



drive.

Select  to view all Event

Summaries in the device’s internal memory.

Select  to exit the menu.

136
Printing Data 13: Data Management

Printing Data
The Efficia DFM100 can print multiple pieces of information in both clinical and non-clinical
modes. The device can be configured to print automatically when certain events occur or you can
initiate a print request at any time during an event.

Printing During a Patient Event


The Efficia DFM100 allows you to print various data reports in a clinical mode during a patient
event.
NOTE: If you attempt to change from a clinical mode to a non-clinical mode while printing, the device asks
if you want to stop printing. Select  to stop printing and change to the non-clinical mode. Select
 to continue printing and stay in the clinical mode.

 To print a strip during an event:


1 Press the Print button .
The printed strip (see Figure 69) contains the header information, configured waveforms, wave
markings (R-Wave Arrows, Pacing Markers) and events, including event markers. See Table 33.

Figure 69 Sample Printed Strip











Table 33 Event Markers

Event Symbol
Mark Event
Physiological Alarm
Shock Delivered

The Efficia DFM100 can also be configured to print a strip when an alarm, charge, shock, or mark
event occurs. See Table 47 “Printing Settings” on page 149.

 To print an Event Summary for the current event:


1 Press the Report button .
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.

137
13: Data Management Printing Data

Printing While in Data Management Mode


If your organization requires a Data Management mode password, you will be prompted to enter the
password before printing begins.

 To print an Event Summary contained in Internal Memory:


1 Use the Smart Select knob to select the Event Summary you wish to print.
2 Press the Smart Select knob and select .
OR
Press the Report button , select  from the list, and press the Smart Select
knob to print.

 To print a Trends report related to an Event Summary contained in Internal Memory:


1 Select the Event Summary that contains the Trends report you wish to print.
2 Press the Report button , select  from the list, and press the Smart Select knob.
3 Use the Smart Select knob to select the Trend Interval you want. Press the Smart Select knob to
begin printing.

NOTES: For steps to install printer paper, see “Installing Printer Paper” on page 19.
If you manually started printing a strip and the Efficia DFM100 automatically tries to initiate a strip,
the automated print strip is ignored.
If the Efficia DFM100 automatically initiates a print strip and then automatically initiates another
print strip, the first strip is extended to include data through the end time of the second strip.
If you request to print a data report while the printer is printing another report, the Efficia DFM100
prompts you with questions. Your answers determine which report takes precedence for printing.

138
14

Configuration
This chapter describes the configurable parameters of the Efficia DFM100 and procedures for
modifying configuration.

Overview
Configuration settings allow you to customize the Efficia DFM100 to meet your needs.
Configuration is viewed and changed through the Configuration menu. The Configuration mode
password is required to change your device’s configuration.
NOTE: As you make configuration choices, consider all the clinical environments the Efficia DFM100
may be used in. Choices for one department might not be suitable for another department.

Entering Configuration Mode


In Configuration mode, you can view, change, print, save, or export configuration settings. For
settings that change your device configuration, you are prompted to enter the Configuration
mode password. If you change configuration settings, press the  soft key to save
them.

WARNING: Do not perform configuration activities while the Efficia DFM100 is connected to a patient.

Accessing Configuration Mode


 To access Configuration mode:
1 Turn the Therapy knob to Monitor, Manual Defibrillation or Pacer.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 To confirm your selection, select  and press the Smart Select knob. If you select , you
are returned to the mode you started from.
Once in Configuration mode, press the  soft key to return to clinical operation.

139
14: Configuration Overview

Setting Date and Time


 To change the date and time in Configuration mode:
1 In Configuration mode, press the Smart Select knob.
2 Select  and press the Smart Select knob. The Configuration Date/Time screen appears.
See Figure 70.

Figure 70 Configuration Date/Time Screen

Date/Time Format Standard


Year 2013
Month March
Day 6
Hour 1
Minute 09
am/pm pm

3 Use the Smart Select knob to select the entry you want to change, and press the Smart Select
knob.
4 Use the Smart Select knob to adjust the value. Press the Smart Select knob to accept your change
and make it effective.
5 Select another value for modification, or press the  soft key to return to the Main
Configuration screen.
NOTE: To adjust the format of the date and time, you need to enter the Configuration mode password.
See “Changing Settings” on page 140.

Changing Settings
 To change default settings in Configuration mode:
1 Press the Smart Select knob, select the menu item, and then press the Smart Select knob.
2 Select the submenu item you want, and press the Smart Select knob.
3 Select a new value, and press the Smart Select knob to confirm the new value.
4 If necessary, use the   or   soft key to advance to other
configuration menus and repeat steps 1 – 3 to make more changes.
5 When your changes are complete, press the   soft key to return to the
Configuration Main screen.
6 Press the   soft key to save the new configuration.
7 Follow the prompt to enter the Configuration mode password:
a Use the Smart Select knob to select the first character, and press the Smart Select
knob. Continue using the Smart Select knob to enter the rest of the password.
b When finished, select  and press the Smart Select knob.
8 Press the   soft key to return to normal operating mode. If you made changes
and press   before saving your changes, the    
 dialog appears.
• If you want to save the changes, select  press the Smart Select knob, and return to
Step 6 to save the configuration.
• If you do not want to save the configuration, select  and press the Smart Select
knob to exit Configuration mode.

140
Overview 14: Configuration

Changing the Data Management Mode Password


You can change the Data Management mode password from the 
screen. The Data Management mode password must be at least eight characters.

 To change the Data Management mode password:


1 In the  field, enter a new password.
2 In the  field, re-enter the new password.
3 In the  field, enter the Configuration mode password.
4 Press the  soft key to save the password.
Table 34 Configuration - Change DataMgmnt Password

Parameter Description Setting Choices


 8-14 characters At least eight characters,
blank
 8-14 characters At least eight characters,
blank
 8-14 character password for At least eight characters,
Configuration mode, required to blank
change the Data Management mode
password

Exporting Settings
 To export configuration settings to a USB drive:
1 Confirm you have a USB drive inserted into the USB port and you are in Configuration
mode.
2 Press the  soft key.
3 The Efficia DFM100 copies your current configuration to the USB drive.
NOTE: If you already have a configuration stored on the USB drive, exporting another to the USB drive
overwrites the one already on the drive.

Importing Settings
 To import configuration settings from a USB drive:
1 Once in Configuration mode, insert the USB drive with the saved settings into the USB port.
2 Press the  soft key and enter the Configuration mode password.
3 Press the  soft key. The Efficia DFM100 copies the current configuration from the
USB drive.
4 Make any device-specific configuration changes.
5 Press the  soft key.
Printing Settings
 To print the configuration settings:
1 In Configuration mode, press the Smart Select knob.
2 Using the Smart Select knob, select .
3 Press the Smart Select knob to print the report. See Figure 71.

141
14: Configuration Overview

NOTE: To stop printing, press the Print button.

Figure 71 Sample Configuration Report

Configuration Report

Options Date/Time Format Settings General Settings

23Dec2014 11:06 Date Format: (xx) Patient Category: (xx)

 866199 Time Format: (xx) Voice Volume: (xx)

S/N: CN32600030 Auto Correct For Daylight QRS Volume: (xx)


Savings Time(DST): (xx)

SW Rev: 1.0 DST Start: (xx) Units Display: (xx)

DST End: (xx) Export Without Patient Info: (xx)

DST Offset: (xx) Patient Information To Display: (xx)

Following the General Settings listing, the Configuration report continues to list the configured
device settings in the order they are listed in Configuration mode. See “Configurable Parameters”
on page 142.

NOTE: Configuration settings in parenthesis with “xx” in Figure 71 are replaced by the
current settings when an actual Configuration report is printed. For example,
Time Format: (xx) is replaced with the currently configured time format.

Restoring Default Settings


 To return all configuration settings to those originally set during manufacturing:
1 Press the  soft key.
2 Enter the Configuration mode password.
3 Press the  soft key.
4 Once you are prompted to save changes, select  and press the Smart Select knob.

Configurable Parameters
The following tables list configurable parameters for the Efficia DFM100. Default settings are in
bold type. Values are adjusted in increments of 1 unless otherwise stated. Use the User Setting
column to record your choice.

Table 35 Date/Time Format Settings

Parameter Description Setting Choices User Setting


 Defines the time format. , 

 Defines the date format. , 

(D = Day, M=Month, Y=Year)


 Defines whether your device , 
 auto corrects for Daylight
 Savings Time.

142
Overview 14: Configuration

Table 35 Date/Time Format Settings

Parameter Description Setting Choices User Setting


 Defines the hour and minute ±2 hours, + 1 hour
time shift during DST. adjusted in 30 minutes increments
 Defines the month DST DST Start Settings DST End Settings
begins/ends.
Any of the 12 Any of the 12 months, 
months, 
 Defines the week DST , , , , , , ,
begins/ends. ,  

 Defines the day DST , , , , ,
begins/ends. , , , , ,
, , 


 Defines the hour DST 00-23 (if 24-hour format); 01-12 (if 12-hour
begins/end. format), 2
 Defines the minute DST 00-59, 00
begins/end.
 Shown is the 12-hour format , 
is chosen.

NOTE: Daylight Saving Time changes occur when the next event is started. The time does not change
in the middle of an event that crosses over the DST change.

Table 36 General Settings

Parameter Description Setting Choices User Setting


 Selects the default patient category. , 

 Defines either traditional Philips or IEC , 


standard alarm tones.
 Defines the interval of time during which , , , , 
 alarms are paused after the Alarm button is , 
pressed.
 Defines alarm volume level. , , , ,


 Defines the minimum audible alarm level , , , ,
 available within use. 

 Defines voice prompt levels. , , , ,




 Defines the volume level of audible beeps with ,, , ,
each QRS complex detected. , 

 Defines if parameter values are displayed with , 


or without the corresponding measurement
units.

143
14: Configuration Overview

Table 36 General Settings (Continued)

Parameter Description Setting Choices User Setting


 Defines if when exporting clinical data a , 
 prompt is displayed asking if you want to
de-identify the data.
 Defines what type of patient information is , , 
 displayed.


 Defines if all physiological alarms are latched , 


 when first displayed.


 Defines if the device automatically reminds you , 


 every 3 minutes when alarms are suspended
indefinitely.
 Defines whether the Data Management mode , 

password is required.



NOTE: The list of available alarm volumes is limited so that no choice less that the current setting for
Minimum Alarm Volume is presented. If the Minimum Alarm Volume is changed and the
current alarm volume is quieter than the new Minimum Alarm Volume, the current alarm volume
is changed to match the setting for the Minimum Alarm Volume.

Table 37 Heart Rate/ECG Settings

Parameter Description Setting Choices User Setting


 Selects the HR/ECG color. , , , , ,
, 

 Determines whether ECG size is automatically , 


adjusted to the maximum wave size without
clipping the wave sector. If auto-gain is off, the
gain is set to x1 (10mm/mV).

NOTE: Adjusting the ECG wave size on the display does not affect the ECG signal which is used for
arrhythmia analysis.

 Selects the setting used to filter out AC line , 
noise from ECG data. Adjust setting to the
power frequency of your country.
 Selects the display filter frequency for 3/5-Lead (Monitor)
 ECG cable. (ST Monitor)
(EMS)
 Selects the display filter frequency for the , 
 attached therapy cable or 3/5-Lead ECG cable. 

 Selects the electrode label format. AAMI: RA, , 
 LA, LL, RL, V; IEC: R, L, F, N, C.

144
Overview 14: Configuration

Table 37 Heart Rate/ECG Settings (Continued)

Parameter Description Setting Choices User Setting


 Selects if HR/Arrhythmia alarms are on or off , 
 at start up.
 Determines if the rhythm status is seen on the , 
 display with the primary ECG wave in all
clinical modes (except AED).
 Selects the default High Alarm Limit for the Adult: 35-300, 120 bpm
 HR derived from the ECG and the pulse Infant/Child: 35-300, 160 bpm
derived from SpO2. adjusted in increments of 5
 Selects the default Low Alarm Limit for the HR Adult: 30-295, 50 bpm
 derived from the ECG and the pulse derived Infant/Child: 30-295, 80 bpm
from SpO2. adjusted in increments of 5
 Selects the VTach heart rate limit. Adult: 95-150, 100 bpm
Infant/Child: 95-150, 120 bpm
adjusted in increments of 5
 Selects the VTach run limit. Adult: 3-20, 5
Infant/Child: 3-20, 5
 Selects the PVC limit. Adult: 1-99, 10
Infant/Child: 1-99, 5

Table 38 NBP Settings

Parameter Description Setting Choices User Setting


 Selects the NBP color. , , , , ,
, 

 Selects the measurements units. , 

 Selects if NBP alarms are on or off at start up. , 

 Selects the frequency for NBP measurement: , q1, q2.5, q5, q10,
manual or automatic on a selected schedule. q15, q30, q60, q120
 Selects the alarm source. , , 


 Selects the high limit alarm value when systolic Adult: 35-255, 160 (mmHg);
 is the selected alarm source. 4.5-34, 21 (kPa)
Infant/Child: 35-135, 120
(mmHg); 4.5-18, 16 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa
 Selects the low limit alarm value when systolic Adult: 30-250, 90 (mmHg);
 is the selected alarm source. 4-33.5, 12 (kPa)
Infant/Child: 30-130, 70
(mmHg); 4-17.5, 9 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa

145
14: Configuration Overview

Table 38 NBP Settings (Continued)

Parameter Description Setting Choices User Setting


 Selects the high limit alarm value when Adult: 15-220, 90 (mmHg);
 diastolic is the selected alarm source. 2-29.5, 12 (kPa)
Infant/Child: 15-110, 70
(mmHg); 2-15, 9 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa
 Selects the low limit alarm value when diastolic Adult: 10-215, 50 (mmHg);
 is the selected alarm source. 1.5-29, 7 (kPa)
Infant/Child: 10-105, 40
(mmHg); 1.5-14.5, 5 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa
 Selects the high limit alarm value when mean is Adult: 25-235, 110 (mmHg);
the selected alarm source. 3.5-31.5, 15 (kPa)
Infant/Child: 25-125, 90
(mmHg); 3.5-16.5, 12 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa
 Selects the low limit alarm value when mean is Adult: 20-230, 60 (mmHg);
the selected alarm source. 3-31, 8 (kPa)
Infant/Child: 20-120, 50
(mmHg); 3-16, 7 (kPa)
adjusted in increments of 5
mmHg/0.5 kPa

Table 39 SpO2 Settings

Parameter Description Setting Choices User Setting


 Selects if SpO2 alarms are on or off at start up. , 

 Selects the SpO2 color. , , , , ,
, 

 Selects the high alarm limit value. Adult: 51-100, 100%
Infant/Child: 51-100, 100%
 Selects the low alarm limit value. Adult: 50-99, 90%
Infant/Child: 50-99, 90%
 Selects the extreme low limit alarm value. Adult: 50-SpO2 Low Limit,
80%
Infant/Child: 30-SpO2 Low
Limit 80%

146
Overview 14: Configuration

Table 40 EtCO2 Settings

Parameter Description Setting Choices User Setting


 Selects the EtCO2 color. , , , , ,
, 

 Selects the measurements units. , 

 Selects if EtCO2 alarms are on or off at start up. , 

 Selects if AwRR alarms are on or off at start up. , 

 Selects the high alarm limit value. Adult: 20-145, 50 (mmHg);
2.7-19.3, 6.7 (kPa)
Infant/Child: 20-145, 50
(mmHg); 2.7-19.3, 6.7 (kPa)
adjusted in increments of 1
mmHg, 0.1 kPa
 Selects the low alarm limit value. Adult: 10-140, 30 (mmHg);
1.3-18.7, 4.0 (kPa)
Infant/Child: 10-140, 30
(mmHg); 1.3-18.7, 4.0 (kPa)
adjusted in increments of 1
mmHg, 0.1 kPa
 Selects the high alarm limit value. Adult: 10-100, 30 rpm
Infant/Child: 10-100, 60 rpm
adjusted in increments of 1
 Selects the low alarm limit value. Adult: 0-99, 8 rpm
Infant/Child: 0-99, 12 rpm
adjusted in increments of 1
 Selects the length of time without respiration Adult: 10-40, 20 sec
required to trigger an apnea alarm. Infant/Child: 10-40, 20 sec
adjusted in increments of 5

Table 41 Waves Settings

Parameter Description Setting Choices User Setting


 Selects the waveform displayed in Wave Sector , , , , , , , 
1.

NOTE: The default for Wave Sector 1 cannot be set to paddles.

 Selects the waveform displayed in Wave Sector , , , , , ,
2. , , , 
, , , 

 Selects the waveform displayed in Wave Sector , , , , , ,
3. , , , , .
Default: CO2 if you have the
EtCO2 option; Pleth if you
have the SpO2 option but not
the EtCO2 option; None if
you do not have either option.

147
14: Configuration Overview

Table 42 Defib Sync Settings

Parameter Description Setting Choices User Setting


 Defines the device’s low-energy setting. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 J


 Defines if the device remains in Sync mode , 


 after a delivered shock.


 Defines the amount of time the device remains 30, 60, 90 
 charged if a shock has not been delivered.
Applies to Manual Defibrillation and Sync
modes only.
 Defines the number of shocks in a shock series. 1, 2, 3, 4
 Defines the time interval used to determine if a , , 
 shock should be counted as part of a shock
series.

Table 43 AED Settings

Parameter Description Setting Choices User Setting


 Defines the level of detail in AED mode voice , 
prompts.
 Defines what the device does after a No Shock , 
Advised decision. (NSA Monitor allows you to
initiate background shock advisory
analysis; NSA CPR prompts you to
initiate a CPR Pause period, if
needed.)

 Defines the interval for patient care prompts in 1, 2, 3,  (no prompts
 NSA Monitor following a No Shock Advised at all) min
decision.
 Defines whether SpO2 monitoring is available , 
in AED mode.
 Defines whether EtCO2 monitoring is available , 
 in AED mode.
 Defines the energy dose for the first shock in a All energy settings 150J up
 series in AED mode. to 200J, 150
 Defines the energy dose for the second shock in All energy settings  the first
 a series in AED mode. configured shock in the series
up to 200J, 150
 Defines the energy dose for the third and All energy settings  the
 subsequent shocks in a series in AED mode. second configured shock in
the series up to 200J, 150
 Defines whether the alarm state is off in AED , 
mode.

148
Overview 14: Configuration

Table 44 CPR Settings

Parameter Description Setting Choices User Setting


 Defines the length of the CPR administration 1, 1.5, 2, 2.5, 3 min
interval.

Table 45 Pacer Settings

Parameter Description Setting Choices User Setting


 Defines the delivery rate of paced pulses. 30-180, 70 pulses per minute
 Adjusted in increments of 10
 Defines the paced pulse duration. 20, 40 msec


 Defines the pacer output default setting at If Paced Pulse duration is
 which paced pulses are delivered. 20 msec: 10-200, 30 mA
If Paced Pulse duration is
40 msec: 10-140, 30 mA

Table 46 Mark Events Settings

Parameter Description Setting Choices User Setting


 Defines the first mark event menu choice. 

 Defines the second mark event menu choice. 

 Defines the third mark event menu choice. 

 Defines the fourth mark event menu choice. 

 Defines the fifth mark event menu choice. 

 Defines the sixth mark event menu choice. 

 Defines the seventh mark event menu choice. 

 Defines the eighth mark event menu choice. 

NOTE: There is a 20 character limit when defining Mark Events. See “Mark Events” on page 43.

Table 47 Printing Settings

Parameter Description Setting Choices User Setting


 Defines the type of alarms that automatically 
print a strip.
 Defines if a continuous strip is printed when the 
device is charged.
 Defines if a continuous strip is printed when a 
shock is delivered or when a shock is attempted
but not delivered.

149
14: Configuration Overview

Table 47 Printing Settings (Continued)

Parameter Description Setting Choices User Setting


 Defines if a continuous strip is printed when the 
Mark Event button is pressed.
 Defines whether printed strips include an 
additional 10 seconds of information which
occurred prior to initiating the print.
 Defines the information contained in an Event 
 Summary. Short includes a log of events and
vitals; Long adds waveforms.
 Defines if an OpCheck report is automatically 
 printed upon the completion of an operational
check.
 Provides a numerical value indicating the 1-53, 53
 number of weekly tests in the auto text
 summary.

150
15

Operational and Shift Check


The Efficia DFM100 performs several automated tests to make sure it is ready for use (see
“Automated Tests” on page 165). Two important checks you perform to supplement the automated
tests are operational checks and shift checks. This chapter details both of these important tasks.

Shift Check
In order to ensure defibrillators are ready when needed, the American Heart Association (AHA)
recommends that users complete a checklist, often referred to as a shift check, at the beginning
of each change in personnel. These checks are performed in addition to the periodic checks
performed by your facility’s biomedical or clinical engineering team. The activities on this
checklist include verifying that the appropriate supplies and accessories are present, the device is
plugged in and has sufficient battery power, and the device is ready for use. Philips supports the
AHA checklist recommendations and has provided a shift checklist document with the device
and published a copy in this book. (See “Appendix 1 - Efficia DFM100 Shift Checklist” on
page 217.)
As part of the shift check, you must verify the device’s ability to deliver defibrillation therapy
once a week by performing a shock test. You can complete this important requirement by
performing one of the following:
• Weekly shock test (see “Weekly Shock Test” on page 152)
• Operational check (see “Operational Check” on page 153)

WARNING: When performing an operational check or weekly shock test, confirm the Efficia DFM100 is not
connected to a patient.

151
15: Operational and Shift Check Shift Check

Weekly Shock Test


A weekly shock test is performed using either a test plug, test load, or paddles. The weekly shock
test process and results differ depending which way you choose to perform the test. See the table
below.

 To perform a weekly shock test:


If you are using If you are using If you are using paddles:
pads with a test pads with a test
load: plug:

1 Turn the device on by turning the Therapy knob to 150 J.


2 Connect the Therapy cable Connect the Therapy cable to Make sure the paddles and the paddle tray are
to the defibrillator and test the defibrillator and test plug thoroughly clean and there is no debris or
load to the end of the to the end of the Therapy residue (including all conductive material) on
Therapy cable. cable. the electrode surfaces of the paddles and tray.
Secure paddles in tray and confirm Patient
Contact Indicator (PCI) LEDs are not lit. If
the LEDs are lit, adjust paddles in tray. If the
LEDs continue to light, clean both the adult
and infant paddle electrode surfaces.
3 Press the Charge button on the front panel. Confirm you Press the Charge button on the paddles sitting
hear the charging tone. If it becomes necessary to disarm in the tray. Confirm you hear the charging
the defibrillator, press . tone. If it becomes necessary to disarm the
defibrillator, press .
4 A strip prints, if configured to do so. If the strip does not A strip prints, if configured to do so. If the
print immediately, press the Print button. strip does not print immediately, press the
Print button.
5 Press the Shock button on the Efficia DFM100. Simultaneously press the Shock buttons
located on the paddles.
6 Confirm the printed strip Confirm that you hear a “Shock Cancelled” audio message, see a 
indicates  and the alarm on the display and the printed strip indicates . If not, confirm
energy delivered is150 J, you did the test properly before taking the device out of use and calling for
±15 J (135 J to 165 J). If service.
not, confirm you did the test
properly before taking the NOTE: It is normal behavior that a shock is not delivered in this instance.
device out of use and calling
for service.
7 Detach test load/plug from the Therapy cable so your Test complete.
device is ready for use when needed. Do not leave the test
load/plug attached to the Therapy cable. Test complete.

NOTES: For more information on the differences between a test load and test plug, see “Test Plug & Test
Load” on page 20.
If you perform a weekly shock test with internal paddles and corresponding test equipment, the
Efficia DFM100 must be set to 50 J. Refer to the test equipment manufacturer’s instructions for
information on interpreting results of the test.
If you use external paddles and have the Pacing option, you should confirm pads functionality by
performing an operational check.

152
Operational Check 15: Operational and Shift Check

Operational Check
Operational checks supplement automated tests by verifying therapy cables, the ECG cable,
paddles, audio, charge and shock buttons, and the ability to deliver defibrillation and pacing
therapy. Operational checks also check the printer and SpO2, NBP, and EtCO2 modules.
Operational checks should be performed weekly to supplement the hourly, daily and weekly tests
the Efficia DFM100 performs automatically.
From the  menu, you can also print automated test and operational check results.

WARNING: When performing an operational check or weekly shock test, confirm the Efficia DFM100 is not
connected to a patient.

NOTES: Do not run an operational check with internal paddles attached. Perform a weekly shock test to
test internal paddles.
To confirm the ECG cable used during an event is functioning properly, use that same cable
during an operational check.

 To access the Operational Check menu:


1 Turn the Therapy knob to Monitor.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the Smart Select knob.
4 Select  and press the Smart Select knob. See Figure 72 for 
menu options.

Figure 72 Operational Check Menu

 Select  to run an operational check.


 Select  to review a summary of
 operational checks (see “Operational Check
 Summaries” on page 162).

Select  to review a summary of
Auto Tests (see “Auto Test Summaries” on
page 163).
Select  to exit the menu.

5 Confirm your exit from a clinical mode. Select Yes and press the Smart Select knob.
The following tests are performed during an operational check (see “Operational Check Tests and
Results” on page 157):
• General System • Sync button • SpO2 • Pads/Paddles ECG
• Therapy Knob • Therapy • EtCO2 • Printer
• Charge button • Leads ECG • NBP • Battery
• Leads ECG rerun (if necessary) • Shock button • Audio

153
15: Operational and Shift Check Operational Check

Performing an Operational Check


Prior to performing an operational check:
If you use external paddles: Make sure the paddles are connected to the device, paddles and the
paddle tray are thoroughly clean and there is no debris or residue (including all conductive
material) on the electrode surfaces of the paddles and tray. Secure the paddles in the tray and
confirm the Patient Contact Indicator (PCI) LEDs are not lit. If the LEDs are lit, adjust the
paddles in the tray. If the LEDs remain lit, clean both the adult and infant/child paddle electrode
surfaces.
If you use multifunction electrode pads: Make sure the pads therapy cable is plugged into the
defibrillator test plug or test load.

 To begin an operational check:


1 Confirm your device has a charged battery and an ECG cable connected (but not connected
to a patient or lead sets).
2 Turn the Therapy knob to Monitor.
3 Press the Smart Select knob.
4 Turn the Smart Select knob to highlight  and press the Smart Select knob.
5 Select  and press the Smart Select knob.
6 Select  and press the Smart Select knob. The message 
appears.


7 Select  if you wish to continue with an operational check. Select  to return to Monitor
mode. Press the Smart Select knob to confirm your choice.
8 If you selected , the Efficia DFM100 displays the  screen and starts the
operational check automatically.
NOTE: If the Efficia DFM100 is not set up correctly, the display prompts you to make the required
changes for a successful operational check (see Figure 73). The Therapy knob must be set to 170 J to
begin the operational check. Once the check begins, set the knob back to 150 J when prompted to
do so. The operational check runs automatically. If you choose to proceed without setting up
properly, the operational check may fail.

Figure 73 Operational Check Setup Screen




 

 

 

Prompts for 


a successful

operational
check 



Proceed As Is?
 OK


154
Operational Check 15: Operational and Shift Check

9 During the operational check, when a response is required, use the Smart Select knob to
select your answer and then confirm your choice. As each test runs, the name of the test
appears highlighted on the display with the message . See Figure 74.

Figure 74 Operational Check In Process Screen





 866199

 USLLA01235

 23Jan2011 04:32PM Pass

 
 
 
 
 
 
 
 









NOTE: Once you have pressed the Sync button, you can leave the Efficia DFM100 unattended as the
operational check completes its process. If you cancel the operational check before it completes
all tasks, there is no record of the check in the Operational Check Summary.

After the automated part of the operational check concludes, an operational check report is
printed (see “Printing Operational Check Results” on page 160).
NOTE: It is important to complete all instructions listed on the Setup screen in order to successfully
complete an operational check. Approximately 10 seconds after entering an operational check, a
 prompt appears in the lower right corner of the display. This prompt allows you to
continue with the operational check if the device is not responding to actions you have taken
during Setup. Selecting  while there are still required items listed in the setup
instructions causes operational check failures.

155
15: Operational and Shift Check Operational Check

Operational Check Results


Each test that makes up the operational check either passes or fails (see Figure 74 for an example)
Once the operational check is completed, a summary note appears in the middle of the display.
To remove the message from the screen press the  soft key. To bring the messages
back, hit the  soft key.
If you fail an operational check for a therapy-related problem (for example a failed Therapy
knob or button), therapy is disabled. You receive messages on the display and the RFU Indicator
is a solid Red X. After exiting operational check, the Efficia DFM100 restarts with therapy
disabled.
NOTE: When exiting operational check, if the failure is related to the Therapy knob, you restart and
remain in Monitor mode regardless of the knob’s position on the dial. If the device does not turn
off with the knob in the OFF position, take it out of use and call for service.

The failure may have been caused by an improperly performed operational check. To clear the
failed operational check, successfully perform a proper operational check. If the device
continues to fail the operational check and you have confirmed you are performing the
operational check properly, take the device out of use and call for service.

Leads ECG Test Rerun


If the Leads ECG test fails, upon the completion of the operational check, the Efficia DFM100
prompts you with the message 
 As soon as you remove the ECG cable, the device reruns an operational check to
check if the problem is in the device itself. If you do not wish to rerun an operational check,
press the Smart Select knob to proceed without rerunning the test.

Re-Running Operational Check


Once an operational check is completed, you can re-run an operational check by pressing the
 soft key.

156
Operational Check 15: Operational and Shift Check

Table 48 Operational Check Tests and Results

Device
Test User Actions Results What to do for test failure
Prompts
General System None None Pass - All tested systems are Take the device out of use and
- tests internal functioning properly. call for service.
clock battery, Fail - One or more of the
power supply tested systems is not
and internal functioning properly.
memory
Therapy Knob - None Confirm the Pass - The Therapy knob is Confirm that the Therapy
tests if the Therapy knob is set to 170 J and functioning knob is set to 170 J and repeat
Therapy knob is at 170 J. properly. the operational check. If the
set to 170J and Fail - The Therapy knob is test continues to fail, take the
functioning not set to 170 J. device out of use and call for
properly service.
Fail - The Therapy knob is
not functioning properly.
NOTE: When the Therapy knob fails, you restart and remain in Monitor mode
regardless of the knob’s position on the dial.

Charge button - Depending on the cable Pass - Charge button Repeat the test and make sure
tests the Charge connected: passed. you press the Charge button. If
button’s Fail - Charge button is not the operational check
Therapy cable:
functionality functioning. continues to fail, take the
You are Move Therapy device out of use and call for
prompted to knob to 150. Fail - You used the Smart service.
 Select knob to charge.
Confirm test

load/defibrillato

r test plug is

attached and

press the Charge

button.
External Paddles:
You are Move Therapy
prompted to knob to 150.

Confirm the

paddles are

seated in their

pockets and

press the Charge

button.
If the device does not detect a
pressed Charge button within
10 seconds, you are prompted
to use the Smart Select knob to
charge.

157
15: Operational and Shift Check Operational Check

Table 48 Operational Check Tests and Results (Continued)

Device
Test User Actions Results What to do for test failure
Prompts
Shock button - Once Press the Shock Pass - Shock button passed. Repeat the operational check
tests the Shock charged, the button on the Fail - Shock button is not and make sure you press the
button’s device device or functioning. Shock button before the
functionality prompts you paddles. defibrillator disarms. If the
to  Fail - You used the Smart operational check continues to
 or Select knob to shock. fail, take the device out of use
 Fail - Device disarmed and call for service.
 automatically.


If the device does not detect a


pressed Shock button within
10 seconds, you are prompted
to use the Smart Select knob to
shock.
NOTE: The device auto disarms
when reaching the time specified in
Configuration. A 
message is displayed.

Audio - tests the The device Using the Smart Pass - You responded that Repeat the operational check.
speaker system announces: Select knob, you heard the audio test If it continues to fail, take the
“Shock select  or . prompt. device out of use and call for
Delivered” or Press the Smart Fail - You did not respond service.
“No Shock Select knob. or responded that you did
Delivered”
not hear the audio test
prompt.
Sync button - The device Press and Pass - Sync button passed. Repeat the operational check
tests the Sync prompts you release the Sync Fail - Sync button is not and make sure you press the
button’s to  button functioning. Sync button. If it continues to
functionality  fail, take the device out of use
 and call for service.
If the device does not detect a
pressed Sync button within
10 seconds, you are prompted
to use the Smart Select knob to
proceed.
Therapy None None Pass - Therapy Delivery test Repeat the operational check
Delivery - tests passed with the specified using a different cable.
defibrillation cable type connected. Passing a second time
and pacing Fail - Therapy Delivery test indicates the previous cable is
circuitry and failed with the specified defective and should be
delivers a shock cable type connected. removed from service. If it
continues to fail, take the
device out of use and call for
service.

158
Operational Check 15: Operational and Shift Check

Table 48 Operational Check Tests and Results (Continued)

Device
Test User Actions Results What to do for test failure
Prompts
Leads ECG - None None Pass - Tested system is Rerun the Leads ECG test
tests leads ECG functioning properly. when prompted at the end of
acquisition and Fail - Tested system is not the operational check. If it
the ECG cable functioning properly. continues to fail, take the
device out of use and call for
service.
Pads/Paddles None None Pass/cable type - ECG If the operational check fails
ECG - Checks acquisition and the cable are with a cable connected,
ECG acquisition both functioning. replace the cable and run the
with Pass/No Cable - ECG test again. If it continues to
pads/paddles acquisition is functioning; fail take the device out of use
cable not tested. and call for service.

Fail/Cable type - ECG


acquisition and/or the cable
specified are not
functioning.
Battery - tests None None None - there is no battery in
battery capacity the slot.
Pass - Battery is functioning
properly and charged.
Pass/Low Battery. Charge battery.
SpO2 - tests None None Pass - SpO2 passed test. Call for service to repair the
internal SpO2 Fail - SpO2 failed test. SpO2 module. If SpO2
functionality monitoring is essential to
(cable is not patient care, take the device
tested) out of use.
NBP- tests None None Pass - NBP passed test. Call for service to repair the
internal NBP Fail - NBP failed test. NBP module. If NBP
functionality monitoring is essential to
patient care, take the device
out of use.
EtCO2 - tests the None None Pass - EtCO2 passed test. If a failure is detected replace
external sensor Fail - EtCO2 failed test. the sensor and call for service.
and the device’s Replace CO2 sensor if it has
ability to Replace Sensor. reached its end of life. If no
measure EtCO2 No Sensor Detected. sensor is detected and you did
plug a sensor in, confirm
sensor is properly plugged in
and rerun the operational
check.
Printer - runs a None None Pass - Printer passed its Call for service.
printer self test self-test.
Fail - Printer failed its
self-test.

159
15: Operational and Shift Check Operational Check

Printing Operational Check Results


If configured to do so (see “Printing Settings” on page 149), the operational check report (see
“Sample Operational Check Report” on page 161) automatically prints out after an operational
check is completed. To manually print, press the Smart Select knob and select .
The first part of the printed operational check report lists test results. The second part lists checks
performed by the user.

User Checks
Once the operational check report prints, perform the following manual checks to complete the
operational check.
• Defibrillator Inspection – Make sure the Efficia DFM100 is clean (including the surfaces of
the paddles and paddle trays), clear of objects and has no visible signs of damage.
• ECG Cables/Connectors/Paddles/Pads/Monitoring Electrodes – Make sure there are no
visible cracks, broken wires or other visible signs of damage. Make sure all the connections
are secure. Check expiration date and quantity of pads and monitoring electrodes.
• Charged Battery – Make sure a charged battery is installed in the Efficia DFM100. Another
charged battery should be available or charging. Confirm the battery has no visible signs of
damage.
• AC Power Cord – Check the AC power source by connecting the AC power cord to the
Efficia DFM100 and plug it into a power outlet. Then verify that the external power
indicator on the front panel is lit.
• Printer Paper – Make sure the printer has sufficient paper and is printing properly.
• SpO2 Sensor – Inspect the sensor and cable for visible signs of damage.
• EtCO2 Sensor – Inspect the sensor and cable for visible signs of damage.
• EtCO2 Sampling Line – Inspect the tubing for blockages and visible signs of damage.
• NBP Cuffs and Tubing – Inspect the pressure cuffs and tubing for visible signs of damage.
• USB Connector – Inspect the port for visible signs of debris or damage.

NOTES: Upon completing the operational check and returning to a clinical mode, all settings are reset to
the device’s configured values.
If your institution’s protocol requires periodic alarm verification and you wish to perform an
alarm verification test (in a non-clinical environment), outside of operational check testing, you
can connect the Efficia DFM100 to a simulator, then manually change the alarm limits to a
setting which should cause the device to alarm. Look at the display and listen for the alarm. Be
sure to reset the alarm limits to the appropriate settings before returning the device to a clinical
environment.

160
Operational Check 15: Operational and Shift Check

Figure 75 Sample Operational Check Report

Operational Check Report Current Test Results:

General System Test: Pass Pads/Paddles ECG Test: Pass

 Therapy Knob: Pass Battery Test: Pass

S/N: USLLA01235 Charge Button: Pass SpO2 Test: Pass

SW Rev: 1.0 Shock Button: Pass EtCO2 Test: Pass

Current Operational Check: Audio Test: Pass NBP Test: Pass

25 2014 08: 55 Pass Sync Button: Pass Printer Test: Pass

Therapy Delivery Test: Pass

Last Operational Check:: Leads ECG Test: Pass

23 2014 06: 55 Pass

 

 

 













 



161
15: Operational and Shift Check Operational Check

Operational Check Summaries


Selecting  from the  menu (see Figure 72) displays a summary of
the last 60 operational checks stored in the Efficia DFM100 (see Figure 76). Press the Smart Select
knob (see Figure 77) to print or export the summary.

Figure 76 Operational Check Summary Screen




# Date and Time Result # Date and Time Result


1 16 2013 12:37 Pass
2 17 2013 01:11 Pass
3 18 2013 11:11 Fail/DX
4 18 2013 11:17 Pass
5 20 2013 01:11 Pass
6 25 2013 03:11 Fail/D
7 25 2013 03:18 Pass

 

Figure 77 Operational Check Summary Menu

 Select  to print the Operational Check Summary.


Select  to export the Operational Check
Summary to the USB drive (see “Saving Data to the

USB Drive” on page 136).

Select  to exit the menu.

162
Operational Check 15: Operational and Shift Check

Auto Test Summaries


Selecting  from the menu (see Figure 72) displays a summary of
automated test results currently stored in the Efficia DFM100.

Figure 78 Auto Test Summary Menu


Select  to print the Auto Test Summary.

Select  to export the Auto Test
 Summary to the USB drive. (See “Saving Data to the
 USB Drive” on page 136.)

Select  to export all Auto Test details to the

USB drive (see “Saving Data to the USB Drive” on
page 136).
Select  to exit the menu.

For more information, see “Automated Tests” on page 165.


NOTE: If you try to print a summary or report while the printer is printing another report or summary,
the Efficia DFM100 asks you if you want to stop the current printing and begin the second one.
Use the Smart Select knob to select your answer and then press the Smart Select knob.

163
NOTES

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
16

Maintenance
This chapter describes how to care for your Efficia DFM100 and its accessories.

Overview
Proper maintenance of the Efficia DFM100 is a simple, yet important factor in dependability.
Attending to routine maintenance is vital to keeping the Efficia DFM100 ready to respond in an
emergency.
Routine maintenance involves:
• Providing power so automated tests can run (see “Automated Tests” on page 165).
• Observing the Ready For Use (RFU) Indicator to confirm the device’s readiness (see “Ready For
Use Indicator” on page 28).
• Performing operational checks and shift checks (see “Operational and Shift Check” on
page 151).
• Caring for batteries (see “Battery Maintenance” on page 168).
• Cleaning the device and accessories (see “Cleaning Instructions” on page 171).
• Checking expiration dates on supplies and accessories, and ordering replacements (see
Chapter 18 “Supplies and Accessories” on page 189).

WARNINGS: Efficia DFM100 service should only be performed by qualified service personnel, in accordance
with the Efficia DFM100 Service Manual.
Electric shock hazards exist internally. Do not open device.

Automated Tests
The Efficia DFM100 performs many maintenance activities including three tests that run
automatically at regularly scheduled intervals when power is supplied and the device is off. The
tests assess operational performance and alert you if a problem exists.
Results of tests associated with critical device functionality are reported through the RFU
Indicator and the Automated Test Summary report. Results are also reported through statements
on the Efficia DFM100’s display when the device is turned on. Table 49 provides a brief explanation
of the tests and lists each test’s frequency.

165
16: Maintenance Automated Tests

Table 49 Automated Tests

Test Frequency Description


Hourly Every hour Tests power supply, charge level of the battery, internal
communication across all critical modules and
components and also the device’s internal temperature.
Daily Daily after midnight Tests all hourly components as well as defibrillation,
according to the ECG, pacing, SpO2, NBP and the printer.
device’s internal clock
Weekly Weekly, after Tests all daily components as well as various electrical
midnight Sunday circuit tests and administers a 150 J shock internally to
morning according to test the defibrillation circuitry.
the device’s internal
clock

NOTE: If the DFM100 is turned on in the middle of an automated test, the test stops and the device starts
in normal operating mode.

Auto Test Summaries


You can review, print and export all Auto Test Summaries the Efficia DFM100 performs.

 To view a summary of automated tests:


1 Turn the Therapy knob to Monitor.
2 Press the Smart Select knob.
3 Turn the Smart Select knob to highlight  and press the Smart Select knob.
4 Select  and press the Smart Select knob.
5 Select  and press the Smart Select knob. The message 
appears.


6 Select  if you wish to continue. Select  to return to Monitor mode. Press the Smart
Select knob to confirm your choice.
7 If you selected , the Efficia DFM100 displays the  screen (see
Figure 79).

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Automated Tests 16: Maintenance

Figure 79 Automated Test Summary Screen




Date and Time Period Result Date and Time Period Result
16 2013 12:11 Hourly Pass
16 2013 01:11 Daily Pass
15 2013 01:11 Daily Pass
14 2013 01:11 Daily Pass
13 2013 01:11 Daily Pass
12 2013 01:11 Daily Pass
11 2013 01:11 Daily Pass
10 2013 12:11 Weekly Pass

 

Auto Test Summary Results


The Automated Test Summary lists results for the hourly, daily and weekly tests that have been
performed. (See Table 50.) The AutoTest Summary lists the result of the most recent hourly test, the
six most recent daily tests and the configured amount (1-53) of weekly tests. The table below
describes each result and the corresponding RFU Indicator display. For more on the RFU
Indicator see “Ready For Use Indicator” on page 28.

Table 50 Auto Test Summary Results

Result RFU Indicator Definition Required Action


 Hourglass All tests passed. None.
 Solid red X, chirp Service required. A Turn the Therapy knob to Monitor. A
critical device failure message indicating the problem is
has been detected. displayed. Refer to Chapter 17
“Troubleshooting” on page 173 for
further action.
 Blinking red X Service is not Charge the battery as soon as possible
required but the or replace it with a charged battery. You
battery is low or can charge the battery in the Efficia
malfunctioning. DFM100 by connecting the device to
AC power.
 Solid red X, chirp An ECG cable failure Replace the ECG cable and rerun the
has been detected. operational check.
 Hourglass A non-critical failure Turn the Therapy knob to Monitor. A
has been detected. message indicating the problem is
displayed. Refer to Chapter 17
“Troubleshooting” on page 173 for
further action.

Printing/Exporting Auto Test Summaries


You can print or export the Auto Test Summaries from . See “Auto Test Summaries”
on page 163.

167
16: Maintenance Battery Maintenance

Battery Maintenance
Battery maintenance is essential to ensure that the battery’s charge state is accurately reported,
there is sufficient charge and capacity to operate your Efficia DFM100, and battery life is
optimized. Remove faulty batteries from service immediately. Battery maintenance begins when
you first receive your device and continues throughout the life of the battery. To optimize
performance, a battery that is in the low battery condition (less than 40%) should be charged as
soon as possible. Table 51 lists battery maintenance activities and when they should be performed.

Table 51 Battery Maintenance Activities

Activity When to perform


Visual inspection As part of a standard operational check.
Charge the battery Upon receipt; after use; if the  message is displayed.
Store the battery When not in use for an extended period of time, store the battery at a
20-40% charge.
Discard the battery When there are visual signs of damage or you receive a message to
replace the battery.

When properly cared for and used in its intended environment, the Efficia DFM100 Lithium Ion
battery has an approximate useful service life of 3 years in low use environments (5-10 hours per
week) and 1.5 years in high use environments (25-30 hours per week). Use outside intended
conditions could reduce battery life. To optimize performance, charge a low battery as soon as
possible.
NOTE: The Efficia DFM100 rechargeable Lithium Ion battery automatically calibrates itself.

Initializing Batteries
When opening a new battery for the first time, it needs to first be charged before the fuel gauge
lights activate.

Charging Batteries
The Efficia DFM100 Lithium Ion battery needs to be charged in the Efficia DFM100. Insert the
battery to be charged in the battery compartment and then plug the device into an AC power
outlet.
With AC power connected and the device turned off, the Efficia DFM100 recharges its battery to
80% capacity in less than 2 hours and to 100% capacity in less than 3 hours. Charge time can be
substantially longer if the device is on.
Once AC power is supplied, the Battery Charging Indicator flashes green to indicate the battery
is charging and the battery is 90 percent charged. The indicator turns solid green when the
battery charge is > 90 percent of capacity and AC power is present. If no battery is installed or
the installed battery is not functioning properly, the light remains off. Charging the battery at
temperatures above 40°C (104°F) may reduce battery life.

Charge Status
You can check the current charge status of a Efficia DFM100 Lithium Ion battery by:
• Pushing the fuel gauge button on the battery to illuminate the fuel gauge (see “Battery Fuel
Gauge” on page 17).

168
Battery Maintenance 16: Maintenance

• Turning the Therapy knob to any position and observing the battery power indicators displayed
in the Status Area (see “Status Area” on page 31).

Storing Batteries
Batteries should be rotated regularly to ensure even usage. When storing batteries, make sure the
battery terminals do not contact metallic objects.
• Store the battery from 15°C to 35°C (59°F to 95°F) and from 25% to 75% relative humidity.
• For optimal battery life, the recommended charge level range of a stored battery is 20% to 40%.
Check the charge level of the stored battery every two months, and recharge the battery if it is below
20%.
• For battery storage up to six months, the battery should be removed from the device and charged to
approximately 60%. Check the battery at least every six months, and recharge the battery to 60% as
needed.
• Charge the stored battery to full capacity before use.

CAUTION: Storing batteries in the Efficia DFM100, if the device is out of service for an extended period of
time, drains the battery.

Discarding Batteries
Batteries should be discarded if there are visual signs of damage. They should be discarded in an
environmentally safe manner.

WARNINGS: Properly dispose of or recycle batteries according to local regulations. Do not puncture, disassemble
or incinerate batteries.
Be careful not to short the battery terminals because this could result in a fire hazard.

General Battery Safety


The following general warnings and cautions apply to the Efficia DFM100 battery. Additional
warnings and cautions specific to a particular battery feature are provided in the appropriate sections.

WARNINGS: Built-in safety circuits cannot protect against handling abuse. Adhere to all warnings and cautions in
handling and using Lithium Ion batteries.
Keep batteries away from flame and other heat sources. Do not incinerate.
Do not short circuit or reverse polarity of the battery. Avoid placing batteries around metal objects
that may short circuit the battery. Do not directly connect the negative and positive terminals.
Avoid getting batteries wet or using batteries in high humidity environments.
Do not puncture, crush, dent, drop, physically shock or allow any deformation of the batteries.
Do not disassemble or open batteries. Do not attempt to alter or bypass the safety circuit.
Use only in the Efficia DFM100 and charge only in the specified battery charger. Do not charge near
a heater or in hot sunlight.
Do not connect the battery to any plug socket or to any other equipment.

169
16: Maintenance Battery Maintenance

CAUTIONS: Use caution when handling, using and testing batteries. Do not touch a leaking battery. Do not
short circuit, crush, drop, mutilate, puncture, apply reverse polarity, expose to high temperatures or
disassemble. Misuse or abuse could cause physical injury.
Do not drop or subject to strong physical shock.
Do not store your device for prolonged periods with the battery in.
Do not expose batteries to temperatures below -20°C (-4 °F) or greater than 50 °C (122 °F). Excess
temperatures may result in battery damage.
Wash skin with large amounts of water in the event of electrolyte leakage to prevent skin irritation
and inflammation.

Power-Related Alarms
Power-related alarms are generated for the conditions shown in Table 52. Once generated, they
appear as alarm messages on the Efficia DFM100 display. There are both audio and visual alerts. For
more information on alarms, see “Alarms” on page 37.

Table 52 Power-Related Alarms

Alarm Message Condition Type of Alarm Indication and


Location
 Battery power is low. High Priority if Red alarm message
pacing otherwise, if pacing, cyan if not
low priority with audio tone in
non-latching alarm Battery Status area.
 Battery power is critically High Priority if Red alarm message
low. The device will shut pacing otherwise, if pacing, yellow if
down in 1 minute. medium priority not with audio tone
non-latching alarm in Technical Alarm
area.
 Battery power is critically
low. The device is shutting Red alarm message
down now. High Priority with audio tone in
Non-Latching Technical Alarm
 A low voltage has been area.
 detected.
 Communications between Medium Priority Yellow alarm
 the device and the battery Non-Latching message with audio
have failed. tone in Battery
Status area.
 The battery has reached its Low Priority Cyan alarm message
end of life. Non-Latching with audio tone in
Technical Alarm
area.
 Logged when an High Priority Red alarm message
incompatible battery is Non-Latching with audio tone in
connected. Technical Alarm
area.

170
Cleaning Instructions 16: Maintenance

Cleaning Instructions
Listed below are the recommended cleaning instructions for the Efficia DFM100 and its associated
accessories.

CAUTIONS: The Efficia DFM100, along with its accessories and supplies, may not be autoclaved, steam
sterilized, ultrasonically cleaned or immersed unless otherwise indicated in the Instructions for Use
that accompany the accessory or supply.
Do not use abrasive cleaners or strong solvents such as acetone or acetone-based compounds.
Do not clean electrical contacts or connectors with bleach.
A soft cloth is recommended for cleaning the display window to prevent scratching.
Quaternary ammonium compounds such as Steris Coverage Plus NPD are not recommended for
routine cleaning.
Disinfect the Efficia DFM100 as determined by your institution’s policy to avoid damage to the
device.

Defibrillator/Monitor, Paddles, Cables and Battery


You can clean the exterior of the Efficia DFM100, external paddles, therapy cables, ECG cables and
battery by hand wiping with a clean cloth. Remove all soil (tissue, fluid, etc.) and wipe thoroughly
with a water-dampened cloth before applying one of the following cleaning products:
• Isopropyl alcohol (70% solution in water)
• Mild detergent and water
• Chlorine bleach (containing 6% sodium hypochlorite), 3% solution in water
• Cleaning solutions/wipes with milder Isopropyl alcohol and chlorine bleach concentrations

CAUTIONS: When cleaning, do not immerse. Wring any excess moisture from the cloth before cleaning and be
sure to avoid pouring fluids on the device. Do not allow fluids to penetrate the exterior surfaces of
the device.
No parts of the device (except sterilizable internal paddles) may be ultrasonically cleaned, immersed,
autoclaved or ETO sterilized.
The ECG cables may not be ultrasonically cleaned, immersed, autoclaved or steam sterilized.

NOTE: For information about cleaning and sterilizing internal sterilizable paddles, see the Sterilizable
Defibrillator Paddles Instructions For Use.

Printer Printhead
If the printout has light or varying print density, clean the printhead to remove any buildup of paper
residue.

 To clean the printhead:


1 Open the printer door.
2 Move the paper out of the way.
3 Clean the printhead surface (top, front of the compartment) with a cotton swap dipped in
isopropyl alcohol.
4 Replace roll of paper and close door.

171
16: Maintenance Service Life

Side Pouches
After removing from the device, the side pouches may be cleaned by hand with mild soap and water
and air dried. Do not wash or dry by machine.

SpO2 Sensor and Cable


Follow the manufacturer’s instructions to clean the SpO2 sensor and cable.

CO2 Sensor and Cable


Follow the manufacturer’s instructions to clean the CO2 sensor and cable.

NBP Cuff
Follow the manufacturer’s instructions to clean the cuff.

Service Life
Life expectancies for the Efficia DFM100 therapy cable and external paddles are related to the
environment they are used in, their frequency of use and how they are cared for. Their service life is
up to three years. To maintain reliable performance and reduce the possibility of failure during
patient use, replace them every three years from the time they were initially placed into service or if
they fail inspection. Extra care must be taken when using the Efficia DFM100 in transport and
Emergency Medical Service (EMS) environments that place additional stress on the cable
connection and increase the chance for wear, impacting its useful life.

Efficia DFM100 Disposal


Prior to disposal, clear all patient data in Service mode. For more information, refer to the Efficia
DFM100 Service Manual.
After clearing all patient data, remove the battery, and then dispose of the device and accessories in
accordance with your country’s regulations for equipment containing electronic parts.

WARNINGS: Disposing of the device with the battery inserted presents a potential shock hazard.
To avoid contaminating or infecting personnel, the environment, or other equipment, make sure
you disinfect and decontaminate the device and any appropriate accessories prior to disposal.

172
17

Troubleshooting
Overview
If the Efficia DFM100 detects an error or potential problem during use, it displays a textual
message to guide you. These messages are often accompanied by a voice prompt or audible
beeping tone. This chapter describes these statements that you see, along with other symptoms,
and provides suggestions for what to do and resources for you to contact for further information.

Resolving Issues
If you are unable to resolve a problem using the suggestions in this chapter, run an operational
check to determine if there is a malfunction requiring service. If a malfunction is identified, call
for service and:
• If the malfunction is related to ECG monitoring, defibrillation or pacing, take the Efficia
DFM100 out of service.
• If the malfunction is related to SpO2, EtCO2 or NBP, take the device out of service if the
function is essential to patient care in your institution.

Responding to Test Results


Results of automated tests associated with critical functionality are reported through the Ready
For Use Indicator and the Automated Test Summary report (see “Automated Tests” on page 165).
To respond to errors reported through operational check, see “Operational Check Tests and Results”
on page 157).
For further technical and repair information, refer to the Efficia DFM100 Service Manual.

WARNING: Product servicing and repair should only be performed by qualified service personnel.

Device Info Report


While troubleshooting, it is often beneficial to know what versions of software and hardware
your Efficia DFM100 contains. The Device Info report provides that information.

 To print a Device Info report:


1 Press the Smart Select knob.
2 Turn the Smart Select knob to highlight  and press the Smart Select knob.
3 Select  and press the Smart Select knob to print the report.
The Device Info report contains information on:
• Serial Number • Installed Options
• Software Revision • External Modules
• Main Processor PCA • Therapy Board
• Processor Module • Printer

173
17: Troubleshooting Symptoms

If there is a device failure and the Efficia DFM100 cannot determine a version number, a  is
displayed in its place.
If your Efficia DFM100 does not have an option installed or, in the case of the CO2 sensor, the
module is not connected to the device, no information is printed.

NOTE: When first turning the Efficia DFM100 on or plugging the CO2 sensor in, it needs to warm up for
10 seconds before information is ready for the Device Info report.

Symptoms
The following tables list symptoms, statements and messages that you may encounter while
using the Efficia DFM100. The tables also provide possible causes and potential solutions.
Symptoms are categorized by functionality.
When troubleshooting issues related to connecting the patient to the Efficia DFM100, it is
recommended that one single person follow the connection path from the patient to the device to
assure a proper end-to-end connection.

Table 53 General Problems

Symptom Possible Cause Potential Solution


The Efficia DFM100 does There is no power. Check the battery pack. Insert a fully charged battery.
not turn on. Connect the device to AC power.
Short battery life (battery Battery may be nearing its Replace the battery.
appears to lose its charge end of life.
quickly).
When turning the device Therapy mode is not Begin CPR if needed. Run an operational check. If it
on, it displays a  available because of a fails or the problem continues, take the device out of
 device failure. use and call for service.
 message. If you
turned the device to AED
or Manual Defibrillation
mode, 
is added to the message.
The ,  or Use the  menu to adjust the volume of the
volume is configured to a prompt.
Audio is too low or absent.  or  setting.

There is a problem with the Run an operational check to confirm the speaker is
device’s speaker. operating.
 A total power failure or Reset alarms, waveforms, volumes and other settings
 message on display. critical software failure has previously defined for the current patient.
occurred.
 An error has occurred Reset your Configuration settings to your customized
 which corrupted your settings.
 message on configuration file.
display.

174
Symptoms 17: Troubleshooting

Table 53 General Problems (Continued)

Symptom Possible Cause Potential Solution


 A critical device failure has
 been detected at startup or
message on display. during RFU testing.
 Clinical modes are Run an operational check. If it fails or the problem
 message on display. disabled. occurs repeatedly, take the device out of use and call
for service.
 A device failure has been
 message on display. detected at startup or during
RFU testing. The device is
unable to deliver therapy.
 A non-critical device failure Review error and alarm messages on screen. Call for
 has been detected at startup service.
message on display. or during RFU testing.
 There is a problem with the When prompted, pick the correct cable type from the
message on display. Therapy cable and/or the menu and press the Smart Select knob. (If you select
device’s Therapy port. the wrong cable type in error, unplug and re-plug in
the cable.)
Replace the Therapy cable.
If problems persist, take the device out of use and call
for service.
 message on The battery has reached its Replace the battery.
display. end of life.
 message on The battery may not have
display. enough remaining charge to
provide six 200J shocks and
Connect to AC power.
10 minutes of monitoring.
Insert a fully-charged battery.
 Very low battery and the
message on display. device is not connected to
AC power.
 message Battery charge is depleted Connect to AC power to restart the device.
on display. and the device is not
connected to AC power.
 The Efficia DFM100 is not Connect to AC power.
 technical alarm. able to communicate with Insert a fully-charged battery.
the battery.
If problems persist, call for service. If battery power
is essential to patient care, take the device out of use.
The power gauge on the Battery was shutdown to Insert the battery in a Efficia DFM100 for about 1
side of the battery does not prolong its life during minute to awaken it.
work when you first shipping.
receive the battery.
One or more controls do There is a faulty control or Remove the device from use and call for service.
not respond as expected connection problem.
(e.g. Lead Select button
does not function, soft keys
do not work).

175
17: Troubleshooting Symptoms

Table 53 General Problems (Continued)

Symptom Possible Cause Potential Solution


Trending data is not You might not be in Make sure your device is in Monitor mode before
appearing on the display. Monitor mode. attempting to display trending information.
You receive a  You have reached the eight To continue event recording, you need to start a new
technical hour duration limit for the event by powering the device off for 10 seconds and
alarm. current event. then turning it back on. Do not perform this function
if patient safety is an issue.
You receive a  Recording of events and waves has stopped. Restart
technical alarm. device when it is appropriate to do so. If the alarm
A non-critical device failure continues, call for service.
has occurred.
You receive a  Restart device when it is appropriate to do so. If the
technical alarm. alarm continues, call for service.
You receive a  The device’s internal Turn the device off and allow to cool. If the problem
 technical alarm. temperature is above 65°C persists, remove the device from use and call for
(149°F) service.
You receive a  The previous shutdown was
 caused by an internal device
technical alarm. error. Run an operational check to diagnose the problem. If
the problem persists, remove the device from use and
You receive a  A power supply failure has call for service.
 occurred but no critical
technical alarm. functions are affected.
One of the Ready For Use
Run an operational check to diagnose the problem. If
tests failed to run to
the problem persists, remove the device from use and
completion at its scheduled
You receive an  call for service.
interval.
 technical alarm.
The device has been Run an operational check to diagnose the problem. If
without power for more the problem persists, remove the device from use and
than one week. call for service.
You receive a  The installed battery is Insert a fully charged battery.
technical alarm. unable to charge the device Run an operational check to diagnose the problem. If
for defibrillation. the problem persists, remove the device from use and
call for service.
You receive a  A non-critical software Restart device when it is appropriate to do so. If the
 technical alarm. error has occurred. alarm continues, call for service.
Your device’s display The Therapy knob has Run a proper operational check to diagnose the
remains in Monitor mode failed an operational check. problem. If the problem persists, remove the device
even when you switch to a from use and call for service.
different mode. Therapy is
disabled.
 A device failure has been If the device is not required for use on a patient, take
 message on detected at startup or during it out of use and call for service.
display. RFU testing. The device
can still monitor and deliver
therapy in an emergency.

176
Symptoms 17: Troubleshooting

Table 53 General Problems (Continued)

Symptom Possible Cause Potential Solution


 Autotest has not been run in Run an operational check.
 message on the over a week, possibly
display. because the device was
without power.
 The device cannot Run an operational check.
message on the display. determine if all subsystems
are operational.
You are using a test plug or This is normal behavior. A shock is not delivered
paddles during the weekly during a weekly shock test using a test plug or
Device does not administer shock test. paddles.
a shock during the weekly
shock test. You are using a test load Confirm you did the test properly before taking the
during the weekly shock device out of use and calling for service.
test.
 alarm An incompatible battery is Connect compatible battery.
connected.

Table 54 ECG Problems

Symptom Possible Cause Potential Solution


The QRS volume is Configure the QRS beeper volume.
configured to  or the
setting is too low.
QRS beeper inaudible or The QRS volume was Adjust the volume through the  menu.
beeps do not occur with turned off or set too low
each QRS complex. through the menu.
The amplitude of the QRS Select a different lead.
complex is too small to
detect.
The monitoring electrodes Check that the monitoring electrodes are properly
are not making proper applied. If necessary, prepare the patient’s skin and
contact with the patient. apply new electrodes.
The monitoring electrodes Check the date code on the electrodes. Do not open
Poor ECG signal quality are out of date or dried out. the electrode package until immediately prior to use.
(noisy trace, wandering
Radio frequency Relocate or turn off equipment that may be causing
baselines, etc.) from signal
interference (RFI) is RFI. Try repositioning the cables/leads.
acquired through
causing artifact.
monitoring electrodes.
The ECG cable may be Run an operational check with the ECG cable and
faulty. check Leads ECG results.
If the test fails, replace the ECG leadset and trunk
cable.

177
17: Troubleshooting Symptoms

Table 54 ECG Problems (Continued)

Symptom Possible Cause Potential Solution


The pads are not making Ensure proper skin preparation and correct
proper contact with the application. If necessary, apply new pads. Paddles are
patient. only for a quick look, not long term monitoring.
The pads are outdated or Check the date code on the pads. Do not open the
Poor ECG signal quality dried out. pads package until immediately prior to use.
(noisy trace, wandering
Radio Frequency Relocate or turn off equipment that may be causing
baselines, etc.) from signal
Interference (RFI) is RFI. Try repositioning the Therapy cable.
acquired through pads.
causing artifact.
The Therapy cable may be Run an operational check with the Therapy cable and
faulty. check pads ECG results.
If the test fails, replace the Therapy cable.
When monitoring with ECG data is not being Confirm that the desired lead is selected.
pads, there is a dashed line acquired. Check the pads, paddles or ECG cable connection.
on the display instead of an
ECG. Check that the pads, paddles, or monitoring
electrodes are properly applied.

NOTE: Viewing a patient’s ECG through paddles is not recommended for long-term monitoring. See
“Quick Look” on page 79.

Device is in AED mode. The Lead Select button is disabled in AED mode. To
select a lead, exit AED mode and enter Monitor or
Manual Defibrillation mode.
Pads/paddles cannot be Exit pacing or choose Fixed mode pacing.
The Lead Select button used for the primary ECG
does not respond as in Demand mode pacing.
expected.
If a 3-Lead cable is in use or Confirm all leads are connected.
some wires in a 5-Lead
cable are disconnected,
augmented and V-leads
may not be selectable.
Solid flat line - no Short in the patient cable or Run an operational check with the ECG cable. If the
waveform, no leads,  leads. test fails, run it without the ECG cable. If the test
 alarm passes, replace the cable. If not, remove the device
from use and call for service.
or  The multifunction electrode Check that the pads/paddles are properly applied. If
technical alarm pads or paddles may be necessary, replace the pads.
disconnected or not Change the ECG in Wave Sector 1 to a lead derived
attached securely. from monitoring electrodes.
 technical ECG data cannot be Check ECG signal quality. If necessary, improve lead
alarm. analyzed. An electrode may position or reduce patient movement.
be disconnected or the
analyzing algorithm cannot
analyze the ECG signal.

178
Symptoms 17: Troubleshooting

Table 54 ECG Problems (Continued)

Symptom Possible Cause Potential Solution


 A device hardware failure Disconnect the ECG cable and perform an operational
technical alarm. was detected. check. If the Leads ECG test fails, remove the device
from use and call for service. If the Leads ECG test
passes, replace the ECG cable and perform another
operational check.
 A device hardware failure Perform an operational check. If the Pads/Paddles
 technical alarm. was detected. ECG test fails with Therapy cable, disconnect the
Therapy cable from the device when prompted in
order for the Pads/Paddles ECG Test to run without
the cable connected. If the Pads/Paddles ECG Test
passes without the cable connected, replace the
Therapy cable. If the test fails, remove the device
from use and call for service.
 A device failure has been Run an operational check. If it fails or the problem
 technical alarm. detected. The device is occurs repeatedly, take the device out of use and call
unable to deliver therapy. for service.
 The waveform in Wave Check that the monitoring electrodes/pads are
 message Sector 1 is no longer valid properly applied.
on display. and another ECG source is Use the Lead Select button to select another lead to
available. monitor.
Lead wire off message on The specified monitoring Check that the monitoring electrodes are properly
the display. electrode is off or not applied. If necessary, prepare the patient’s skin and
making proper contact with apply new electrodes.
the patient.
 message Two or more limb lead Check that the limb lead electrodes are properly
on the display. electrodes are off or not applied.
making proper contact with This message does not display when V and RL are off
the patient. because the device assumes a 3-Lead cable is
attached.

Table 55 Defibrillation and Pacing Problems

Symptom Possible Cause Potential Solution


A test load or defibrillator Remove the test load or defibrillator test plug and
 test plug is attached to the attach multifunction electrode pads.
 message on end of the Therapy Cable.
display. Pads impedance is less than Check pads connection with the patient.
10 ohms.
Therapy cable is not Make sure the Therapy cable is connected and the
attached. Pads/paddles pads/paddles are making proper contact with the
 message is connection compromised. patient.
displayed. The Shock button was not No action required. If desired, charge the device and
pressed within the press the Shock button.
configured time period.

179
17: Troubleshooting Symptoms

Table 55 Defibrillation and Pacing Problems (Continued)

Symptom Possible Cause Potential Solution


 Check paddles connection with the patient. Remove
message is displayed. paste, moisture, or any other conductive material
A shock has been aborted between the paddles and patient.
due to high impedance.
 message is Check pads connection with the patient.
displayed.
 The pads or paddles Confirm all cables are properly connected.
message is displayed. Therapy cable is not
connected to the device.
 The pads cable is not Confirm all cables are properly connected and pads
message is displayed. connected to the Therapy are correctly placed on the patient.
cable or pads are not
properly applied to the
patient.
 An energy greater than 50J Re-set energy setting to 50J or less.
message is displayed. was selected with internal
paddles connected.
 message is A shock has been aborted Replace the pads and check connection with patient.
displayed. due to high impedance -
second notice.
 Confirm proper skin prep and reapply pads.
message on display.
 A shock has been aborted Confirm that paddles are not touching each other
 message on due to low impedance. when placed on the patient’s chest. Remove paste,
display. moisture, or any other conductive material between
the pads and patient.
 message Check pads connection with the patient.
on display. A shock was delivered but
there was marginal
 impedance. Check paddles connection with the patient.
 message on display.
 The device has detected a Run an operational check to see if the message clears.
message on display. power overload with the If it doesn’t, run an operational check with a different
connected paddles. set of paddles. If the message still doesn’t clear, take
the device out of use and call for service.
 The device can’t detect the Select the proper Therapy cable from the list
message on display. type of Therapy cable presented.
attached.
 A device failure has Run an operational check to diagnose the problem. If
 message occurred. the device is in use at the time of the message, begin
is displayed. CPR if indicated.
 Appears after power is Pacing does not restart automatically. If indicated,
 technical alarm. restored to indicate there resume pacing.
was a loss of power during
pacing.

180
Symptoms 17: Troubleshooting

Table 55 Defibrillation and Pacing Problems (Continued)

Symptom Possible Cause Potential Solution


 Proper pads contact has Check pads connection with patient. Confirm proper
technical alarm. been lost with the patient. skin prep.
Replace pads if necessary.
Resume pacing.
 The Efficia DFM100 has Replace the defibrillator. Remove the device from use
technical alarm. detected an error which and call for service.
prevents pacing therapy
delivery.
 technical High impedance is causing Check that pads are applied properly.
alarm. less current to be delivered
to the patient than specified
in the output current setting.
 The Therapy cable is Check all Therapy cable connections.
 technical alarm. disconnected from the Replace pads if necessary.
device.
Resume pacing.
 The primary ECG lead has Check that the monitoring electrodes are applied
technical alarm. become invalid. properly to the patient. Check cable connections.
Resume pacing.
 prompt but Poor skin contact, pads are Make sure the pads are applied properly.
you see a physiological not properly connected to Replace pads if necessary.
response from the patient the patient. Minimal patient
and the Shock Counter movement is possible in
remains unchanged. this situation as the
defibrillator may deliver a
small amount of energy.
 A device failure which Re-attempt therapy. If it fails again, the device
technical alarm prevented therapy from reboots. Re-try. If it fails for a third time, the message
being delivered has  appears. In an
occurred. emergency situation, use another device. Run
operational check to clear the error.
 A therapy malfunction has Re-attempt therapy.
technical alarm occurred.

NOTE: Once the reason for the Pacing Stopped alarm has been resolved, that part of the alarm message
is removed from the display. You must press the  soft key to resume pacing and
remove the remainder of the alarm from the display

181
17: Troubleshooting Symptoms

Table 56 SpO2 Problems

Symptom Possible Cause Potential Solution


The sensor is not properly Check the sensor connection and cable.
connected or the sensor Try another sensor.
cable is damaged.
The SpO2 waveform is not Use the  menu to select a wave sector
configured to be displayed to display the SpO2 waveform.
The SpO2 waveform is not
and there is not an unused
displayed.
wave sector.
You are in AED mode and Configure AED mode to use SpO2.
SpO2 waveform is not
configured to be displayed
or SpO2 is non-pulsatile.
 technical The patient’s pulse is absent Check perfusion at the measurement site.
alarm. or too weak to be detected Check that the sensor is applied properly.
or the sensor has come off.
Make sure the sensor site has a pulse.
Relocate the sensor to another site with improved
circulation.
If the message occurs during an NBP measurement on
the same limb, wait until the NBP measurement is
finished.
Try another sensor.
technical alarm. SpO2 measurements are Check that the sensor is applied properly.
The SpO2 numeric value is erratic. Make sure the sensor site has a pulse.
replaced with a . Relocate the sensor to another site with improved
circulation.
Try another sensor.
 technical Excessive patient Minimize patient movement.
alarm. movement or electrical Make sure the sensor cable is not positioned too close
interference. to power cables.
 technical Ambient light is too high. Cover the sensor with an opaque material to minimize
alarm. ambient light.
Make sure the sensor cable is not positioned too close
to power cables.
Make sure that the sensor cable is not damaged.
The sensor is not
connected.
 technical Check the SpO2 connection.
There is too much
alarm. Try another sensor.
interference.
The sensor is damaged.
 The SpO2 sensor or cable is Try another sensor.
technical alarm. faulty. If the problem persists, call for service of the SpO2
module. If SpO2 monitoring is essential to patient
care, take the device out of use.

182
Symptoms 17: Troubleshooting

Table 56 SpO2 Problems (Continued)

Symptom Possible Cause Potential Solution


 Faulty SpO2 hardware. Call for service of the SpO2 module. If SpO2
technical alarm. monitoring is essential to patient care, take the device
out of use.
 An NBP measurement or an Wait until the NBP measurement is complete.
technical alarm. excessively noisy signal is Try another sensor site.
The SpO2 numeric value is delaying display/update of
replaced with a . the SpO2 measurement for Move sensor to a different limb than the NBP cuff.
more than 30 seconds.
 technical The SpO2 signal is too low Check that the sensor is applied properly.
alarm. to give an accurate reading. Make sure the sensor site has a pulse.
The SpO2 numeric value is Relocate the sensor to another site with improved
replaced with a . circulation.
Try another sensor.
 technical alarm. A non-critical device failure Restart device when it is appropriate to do so. If the
has occurred. alarm continues, call for service of the SpO2 module.
If SpO2 monitoring is essential to patient care, take
the device out of use.

Table 57 EtCO2 Problems

Symptom Possible Cause Potential Solution


The sensor is warming up. No action required. As soon as the sensor has warmed
up and there is a detectable breath, the question mark
The numeric value is is removed from the display.
replaced with a . See the remainder of this Check the associated technical alarms and address the
table for other possible problem.
causes.
You have a Capnogram but The sensor is warming up. No action required. As soon as the sensor has warmed
the numeric has a question up, the question mark is removed from the display.
mark in front of it.
The Capnogram does not The Capnogram is not Use the  menu to select a wave sector
appear on the display. configured to be displayed. to display the Capnogram.
The Capnogram has a The sampling line is not Check all connections.
dashed line. properly connected Check sampling line for knots, kinks or pinches.
 See Table 26 “Zeroing Messages” on page 105 for possible causes and solutions.
 or 
 prompts.
 technical The CO2 sensor has Replace your sensor with a newer one.
alarm. reached its end of life.

183
17: Troubleshooting Symptoms

Table 57 EtCO2 Problems (Continued)

Symptom Possible Cause Potential Solution


 The CO2 sensor is over Move any adjacent devices that may be heating the
technical alarm. heated. CO2 sensor and remove anything covering the CO2
sensor so that it is directly exposed to ambient air at a
temperature below 40° C.
Unplug the sensor and wait for it to cool down. If you
still get an over temp alarm, replace the sensor.
 The CO2 sensor is Replace the sensor
malfunctioning.
 The CO2 sensor is Unplug the CO2 sensor and wait 10 seconds. If the
connected but cannot communication failure alarm remains, the Efficia
communicate with the DFM100 requires servicing. If the alarm changes,
Efficia DFM100. plug the sensor in firmly. If the Communication
Failure returns, replace the CO2 sensor.
 technical Your sensor needs to be Disconnect sampling line from the patient and zero
alarm. zeroed. the sensor. See “Zeroing Sidestream and Mainstream
Sensors” on page 104.
 Your sensor has not reach No action required. The technical alarm is removed
technical alarm. its proper operating when the sensor reaches its operating temperature.
temperature.
 technical The CO2 value is out of the Zero the sensor. If the error remains and you suspect a
alarm. measurement range. false high value, replace the CO2 sensor.
 technical For Sidestream sensors - Check the sampling line for kinks or blockages and
alarm. your sampling line is remove if found.
kinked or blocked. Replace sampling line.
 For Mainstream sensors - Clean airway adapter if mucus or moisture is seen.
technical alarm. your airway adapter is Mount sensor correctly on the adapter. Zero the
blocked or not mounted sensor.
properly.
 The CO2 sampling line is Confirm the sampling line is firmly connected to the
technical alarm. disconnected. CO2 sensor.
 The CO2 sensor is Confirm that the CO2 sensor is solidly connected to
technical alarm. unplugged. the Efficia DFM100. If the sensor is solidly connected
to the Efficia DFM100 and the technical alarm
remains on the display, try to re-zero the sensor to
clear the alarm.
 technical alarm. A non-critical error was Restart device when it is appropriate to do so. If the
detected. alarm continues, replace the CO2 sensor.

184
Symptoms 17: Troubleshooting

Table 58 NBP Problems

Symptom Possible Cause Potential Solution


NBP is not configured for Check/modify the configuration as needed.
automatic measurements.
Automatic measurements Use the Measurements/Alarms menu to define an
Measurement cycle does
are not scheduled for the automatic schedule of measurements for the current
not automatically start.
current patient. patient.
The  soft key has Press the  soft key.
not been pressed.
Defective cuff. Replace the cuff.
The pump operates but the
cuff does not inflate or fails Poor connection between Check connections and replace tubing if needed.
to inflate fully. the cuff and the Efficia
DFM100.
NBP measurements appear The cuff size is too Use the correct cuff size and take another
high/low. small/large for the patient. measurement.
 The cuff has not fully Remove the cuff from the patient.
technical alarm. deflated after 3 minutes. Release pressure in the cuff (disconnect cuff from
The NBP numeric value is tubing).
replaced with a . Replace the cuff. If the problem persists, call for
service.
 The NBP cuff pressure has The cuff should deflate automatically. If not, remove
technical alarm. exceeded the overpressure cuff from patient and deflate. Turn device off to reset
The NBP numeric value is safety limit of 300 the alarm and restart NBP.
replaced with a . mmHg/40 kPa.

 A measurement value could Check cuff size and placement.


technical alarm. not be obtained.
The NBP numeric value is
replaced with a .
 Faulty NBP hardware.
technical alarm. Call for service. If NBP monitoring is essential to
 technical alarm. A non-critical device failure patient care, take the device out of use.
has occurred.

Table 59 Printing Problems

Symptom Possible Cause Potential Solution


Paper will not move. Paper improperly loaded, Reload paper or clear jam. If paper is wet, replace
jammed, or wet. with a fresh, dry roll.
Door improperly latched. Check door latch.
Paper moves and then
stops. Paper improperly loaded or Reload paper or clear jam.
jammed.

185
17: Troubleshooting Symptoms

Table 59 Printing Problems (Continued)

Symptom Possible Cause Potential Solution


Paper roll improperly Check that the paper is installed correctly.
installed.
Incorrect paper type. Use only recommended paper type.
Paper moves but printing is
faint or absent. Printhead temperature Wait until the printer cools down to restart printing. If
approaching maximum there is a lot of black printed on the paper, check ECG
recommended operating for excessive noise.
temperature.
Paper moves but print
quality is poor or some dots
are missing. Dirty printhead. Clean the printhead.
White line running along
paper.
Loud buzzing or grinding Print door improperly Check door latch.
noise. latched.
 technical The printer has run out of Reload with new fresh, dry roll of paper.
alarm. paper.
 technical The printer door is not fully Open the printer door and reclose such that it snaps
alarm. closed. into place.
 The required font is If printing is essential to patient care, take the device
technical alarm. unavailable for the out of use and call for service.
currently installed
language.
 technical The printer is faulty or there Turn the Efficia DFM100 off for 15 seconds and then
alarm. is a problem turn it back on. If the problem persists, call for
communicating with the service. If printing is essential to patient care, take the
printer. device out of use.
 technical alarm. A non-critical device failure Restart device. If the error continues and printing is
has occurred. essential to patient care, take the device out of use and
call for service.

Table 60 USB Problems

Symptom Possible Cause Potential Solution


 A non-compatible USB Use only a compatible USB device to store data from
message on display. device has been inserted in the Efficia DFM100. See “USB Device” on page 204.
the USB port.
You cannot save data to the The USB flash drive is full. Delete or remove files from the flash drive to free up
USB flash drive. space or use a different flash drive.
You cannot import a The flash drive does not Save a new configuration file to the flash drive and
configuration file from the contain a configuration file. re-try.
USB flash drive.
 The USB flash drive was Re-insert the USB flash drive and retry.
message on display. removed during data
transfer.

186
Servicing the DFM100 17: Troubleshooting

Table 60 USB Problems (Continued)

Symptom Possible Cause Potential Solution


 The configuration file has Save a new configuration file to the flash drive and
 message on display. become corrupted. retry.
 A USB power overload has Turn the device off for 15 seconds. Replace the USB
technical alarm. been detected at the USB device. If the problem also occurs with a second USB
port. device, call for service.
 The configuration file being The configuration item in question is ignored. If this
technical alarm. imported contains an item item is critical to your device, re-export a new
that is not compatible with configuration file from a device with a similar
the device’s current software revision and retry.
software version.

Servicing the DFM100


For product support, contact your local Philips Customer Care Solutions Center or local Philips
representative.

Calling for Service


To download the latest documentation, go to:
https://incenter.medical.philips.com
For product support, contact your local Philips representative.
Before calling for service, prepare the following information:
• Serial number of the Efficia DFM100
• Problem description
• Information from operation check logs, error logs, and other applicable information

187
NOTES

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_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

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_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _

_ _ _ _ _ _ _ _ _ _ _ _
18

Supplies and Accessories


This chapter provides information on the various supplies and accessories for the Efficia
DFM100. Use of supplies or accessories other than those recommended by Philips may
compromise product performance.

Ordering Replacement Supplies and Accessories


If you have any questions or would like to order accessories and supplies:
• Visit the website:
http://www.philips.co.in/healthcare/product/HCNOCTN294/efficia-dfm100.
• Contact your local Philips sales office or your authorized Philips dealer or distributor.
Not all accessories and supplies are available in all countries. The list of accessories is subject to
change without notice.

WARNINGS: Use only multifunction electrode pads, battery and accessories listed in this Instructions for Use.
Substitutions may cause the Efficia DFM100 to function improperly and cause patient injury.
For example, some electrodes may be subject to large offset potentials due to polarization.
Use single-use supplies and accessories only once.
Use multifunction electrode pads prior to their expiration date. Discard pads after use. Do not
reuse pads. Do not use for more than 8 hours of continuous pacing.

Approved Supplies and Accessories


Table 61 Approved Supplies and Accessories

Part Number Description


ECG Monitoring Electrodes
M2202A Radio Translucent Foam Monitoring Electrodes
3-Lead ECG Cable Set
M1669A 3-Lead Trunk Cable, AAMI/IEC
M1671A 3-Lead Set, ICU Grabber, AAMI
M1672A 3-Lead Set, ICU Grabber, IEC
M1673A 3-Lead Set, ICU Snap, AAMI
M1678A 3-Lead Set, OR Grabber, IEC
M1674A 3-Lead Set, ICU, Snap, IEC
989803160641 Efficia 3/5 ECG Trunk Cable, AAMI/IEC
989803160651 Efficia 3-Lead Grabber, AAMI
989803160661 Efficia 3-Lead Grabber, IEC

189
18: Supplies and Accessories Ordering Replacement Supplies and Accessories

Table 61 Approved Supplies and Accessories (Continued)

Part Number Description


989803170171 OR 3-Lead ECG Trunk Cable, AAMI/IEC
5-Lead ECG Cable Set
M1644A 5-Lead Set, ICU Snap, Limb, AAMI
M1645A 5-Lead Set, ICU Snap, IEC
M1668A 5-Lead ECG Trunk Cable, AAMI/IEC
M1968A 5-Lead Set, ICU Grabber, Limb, AAMI
M1971A 5-Lead Set, ICU Grabber, IEC
M1974A 5-Lead Set, OR Grabber, IEC
989803160691 Efficia 5-Lead Grabber Limb, AAMI
989803160701 Efficia 5-Lead Grabber Limb, IEC
989803170181 OR 5-Lead ECG Trunk Cable, AAMI/IEC
989803176161 5-Lead Snap Limb, Shielded, AAMI
989803176181 5-Lead Snap Limb, Shielded, IEC
Internal Paddles
M4741A 7.5 cm Switched Internal Paddles
M4742A 6.0 cm Switched Internal Paddles
M4743A 4.5 cm Switched Internal Paddles
M1741A 7.5 cm Switchless Internal Paddles
M1742A 6.0 cm Switchless Internal Paddles
M1743A 4.5 cm Switchless Internal Paddles
M4740A Internal Paddles Adapter Cable
External Paddles
M3543A External Paddles with PCI (Water Resistant)
M4759A Paddle electrode replacement for M3543A paddles
989803196431 Efficia External Paddles
989803197591 Paddle electrode replacement for 989803196431 paddles
Hands-free Pads Therapy Cables
M3507A Hands-free Cable Barrel Connector
M3508A HeartStart Hands-Free Cable Connector
989803197111 Pads Adapter Cable
Multi-function Defibrillator Pads - Plug Connector
M3713A Adult/Child Plus Multifunction Electrode Pads
M3716A Adult/Child Radiolucent Multifunction Electrode Pads
M3717A Infant Plus Multifunction Electrode Pads
M3718A Adult/Child Radiotransparent Multifunction Electrode Pads

190
Ordering Replacement Supplies and Accessories 18: Supplies and Accessories

Table 61 Approved Supplies and Accessories (Continued)

Part Number Description


M3719A Infant Radiotransparent Multifunction Electrode Pads
989803158211 HS FR/FR2 Defib Pads (1 set)
989803158221 HS FR/FR2 Defib Pads (5 sets)
989803139261 SMART Pads II (1 set)
989803149981 SMART Pads III (1 set)
989803149991 SMART Pads III (5 sets)
EtCO2 Mainstream Sensor
M2501A Mainstream CO2 Sensor
EtCO2 Mainstream Adapters
M2513A Reusable Adult/Pediatric Airway Adapter, ET tube size > 4.0 mm
M2533A Single-Patient Use Adult Airway Adapter, ET tube size > 4.0 mm
EtCO2 Sidestream Sensor
M2741A Sidestream CO2 Sensor
EtCO2 Sidestream Sampling Lines (10 per box)
M2744A CO2 Nasal Cannula - Adult
M2745A CO2 Nasal Cannula - Pediatric
M2750A CO2/O2 Nasal Cannula - Adult
M2751A CO2/O2 Nasal Cannula - Pediatric
M2756A CO2 Oral-Nasal Cannula - Adult
M2757A CO2 Oral-Nasal Cannula - Pediatric
M2760A CO2/O2 Oral-Nasal Cannula - Adult
M2761A CO2/O2 Oral-Nasal Cannula - Pediatric
M2768A Airway Adapter Set - Pediatric/Adult
M2776A Straight Sample Line
989803144471 CO2/O2 Nasal Cannula - Infant
989803144531 Airway Adapter Set - Pediatric/Infant
SpO2 Sensors and Cables
M1191B Adult Reusable SpO2 Sensor, 2 m
M1191BL Adult Reusable SpO2 Sensor, 3 m
M1192A Reusable Pediatric/Small Adult Finger SpO2 Sensor, 1.5 m
M1196A Adult Reusable SpO2 Clip Sensor, 3 m
M1941A SpO2 Extension Cable, 2 m
Non-Invasive Blood Pressure Cuffs and Tubing
989803177511 Reusable Blood Pressure Cuff - Pediatric (GCF1202)
989803177521 Reusable Blood Pressure Cuff - Adult (GCF1203)

191
18: Supplies and Accessories Ordering Replacement Supplies and Accessories

Table 61 Approved Supplies and Accessories (Continued)

Part Number Description


989803177531 Reusable Blood Pressure Cuff - Adult Large (GCF1204)
989803177471 Reusable Blood Pressure Interconnect Tubing (3 m)
Data Management
989803171261 USB Data Drive
989803202611 USB Data Drive
Cable Management
989803190331 DFM100 Hospital Accessory Storage System
989803190341 DFM100 Prehospital Accessory Storage System
989803190351 Cable Management Straps
989803197571 Carry Case Shoulder Strap
989803197581 DFM100 Tray Cover Pouch
989803197671 DFM100 Tray Cover Pouch/Bag Shoulder Strap
Paper
989803190381 50 mm Chemical Thermal Paper, No Gridlines (12 rolls)
Power
989803190371 Rechargeable Lion Battery Pack
Mounting Solution
989803190361 Bedrail Mount
989803199601 DFM100 Docking station bundle - EXCLUDES Australia
989803199661 DFM100 Docking station bundle - AUSTRALIA ONLY
989803199241 Docking station for DFM100 assembly
989803199251 3-terminal power cord for DFM100 docking station - EXCLUDES Australia
989803199611 3-terminal power cord for DFM100 docking station - AUSTRALIA ONLY
Therapy Cable Collar
989803194281 Therapy Cable Collar
Test Loads and Shorting Plug
M1781A Test Load, 50 Ohms, barrel style
M3725A Test Load, 50 Ohms, plug style
989803171271 Test Plug - Shorted

192
19

Specifications
This chapter includes:
• Efficia DFM100 specifications.
• Symbol and abbreviation definitions. See Tables 64 and 65.
• Electromagnetic Compatibility, see “Electromagnetic Compatibility” on page 207.

Specifications
General
Approximate Dimensions: 23.5 cm (H) x 29 cm (W) x 20.5 cm (D); 9.25 in (H) x 11.4 in (W) x
8 in (D)
Approximate Weight (without battery): 5.66 kg; 12.5 lbs
Standard Operator Position: Within one meter (3 feet) of the device.
Power: Rechargeable Lithium Ion battery; AC power using a protectively grounded outlet.
Alarm Tone and Voice Message Volume Range: Maximum - 85 dB(A), Minimum - 45 dB(A).
Alarm Tone Volumes:
Imminent Shutdown - Continuous tone alternating between 1000 and 2100 Hz.
High Priority - Tone of 960 Hz lasting 0.5 sec repeated every second.
Medium Priority - Tone of 480 Hz lasting 1 sec repeated every two seconds.
Low Priority - Tone of 480 Hz lasting 0.25 sec repeated every two seconds.
Visual Alarm Characteristics:
High Priority - Flashing at 2 Hz with 50% duty cycle (a .25-sec flash twice every second).
Medium Priority - Flashing at 0.5 Hz with 50% duty cycle (a 1-sec flash every other
second).
Low Priority - Constant on.

Defibrillator
Waveform: Biphasic Truncated Exponential. Waveform parameters adjusted as a function of
patient impedance.
Shock Delivery: Via multifunction electrode pads or paddles.
Shock Series: Configurable energy escalation in a series.
Leads Off Sensing and PCI Sensing for Pads/Paddles: Apply 500nA rms (571Hz); 200uA
rms (32KHz)

193
19: Specifications Specifications

Table 62 Delivered Energy Accuracy

Nominal Delivered Energy vs. Load Impedance


Selected Load Impedance (ohms) ±2%
Energy
25 50 75 100 125 150 175
1J 1.2 1.3 1.3 1.2 1.1 1.0 0.9
2J 1.7 2.0 2.1 2.0 1.9 1.7 1.6
3J 2.6 3.0 3.1 3.2 3.2 3.1 2.9
4J 3.5 4.0 4.2 4.3 4.4 4.5 4.3
5J 4.3 5.0 5.2 5.4 5.5 5.6 5.4
6J 5.2 6.0 6.3 6.5 6.6 6.7 6.5
7J 6.1 7.0 7.3 7.6 7.8 7.8 7.6
8J 6.9 8.0 8.4 8.6 8.9 8.9 8.7
9J 7.8 9.0 9.4 9.7 10 10 9.8
10 J 8.7 10 10 11 11 11 11
15 J 13 15 16 16 17 17 16
20 J 17 20 21 22 22 22 22
30 J 26 30 31 32 33 33 33
50 J 43 50 52 54 55 56 54
70 J 61 70 73 76 78 78 76
100 J 87 100 105 108 111 111 108
120 J 104 120 126 130 133 134 130
150 J 130 150 157 162 166 167 163
170 J 147 170 178 184 188 189 184
200 J 173 200 209 216 222 223 217

The delivered energy accuracy is ±10% or ±1J whichever is greater for all energy settings.
Charge times:
Less than 5 seconds to the recommended adult energy level (150 Joules) with a new fully
charged battery installed.
Less than 6 seconds to the selected energy level (up to 200 Joules) with a new fully charged
battery installed, even after the delivery of 15 discharges at maximum energy.
Less than 15 seconds to the selected energy level while connected to AC power only, even when
operating on 90% of the rated mains voltage.
The device powers on in manual defibrillation mode ready to deliver shock in less than:
• 23 seconds with AC power only and at 90% of rated mains voltage.
• 15 seconds with a new, fully charged battery even after 15 discharges of maximum
energy.

194
Specifications 19: Specifications

Time from the initiation of analysis in AED mode until ready to deliver shock is less than:
• 20 seconds with AC power only and at 90% of rated mains voltage.
• 20 seconds with a new, fully charged battery even after 15 discharges of maximum
energy.
The device powers on in AED mode ready to deliver shock in less than:
• 32 seconds with AC power only and at 90% of rated mains voltage.
• 24 seconds with a new, fully charged battery even after 15 discharges of maximum
energy.
Patient Impedance Range: Minimum: 25 ohm (external defibrillation); 15 ohm (internal
defibrillation); Maximum: 250 ohm. Actual functional range may exceed these values.

Figure 80 Smart Biphasic Waveform

Philips Smart Biphasic Waveform at 200 J into 25-175 Ohms


2500

2000

1500

1000
Voltage (V)

500

-500

-1000

-1500
0 5 10 15 20

Time (ms)

Manual Defibrillation Mode


Manual Output Energy (Selected): 1-10, 15, 20, 30, 50, 70, 100, 120, 150, 170, 200 Joules;
maximum energy limited to 50 J with internal paddles.
Controls: On/Off Therapy knob, Charge, Shock, Sync, ECG Lead Select, Patient Selection, Print,
Mark Events, Reports, Alarms, Smart Select knob.
Energy Selection: Front panel Therapy knob.
Charge Control: Front panel button; button on external paddles.
Shock Control: Front panel button; buttons on external or switched internal paddles.
Synchronized Control: Front panel Sync button.
Synchronized Shock Timing: Maximum time from R-Wave detected to shock delivered is 25ms, as
measured with oscilloscope from peak of input QRS wave to leading edge of defibrillation discharge
into a 50-ohm test load.
Indicators: Text prompts, audio alerts, QRS beeper, battery status, Ready For Use (RFU), External
Power, Sync mode.
Armed Indicators: Charging/charged tones, flashing shock button on front of panel and on external
paddles, energy level indicated on the display.

195
19: Specifications Specifications

AED Mode
AED Energy Profile: 150 Joules (factory default) for Adult /50 J for Infant/Child nominal into a
50-ohm test load.
AED Controls: On/Off, shock.
Text and Voice Prompts: Extensive text/audible messages guide the user through a user-configured
protocol.
Indicators: Monitor display messages and prompts, voice prompts, battery status, RFU, external
power.
Armed Indicators: Charging/charged tones, flashing shock button, energy level indicated on the
display.
ECG analysis: Evaluates patient ECG and signal quality to determine if a shock is appropriate and
evaluates connection impedance for proper defibrillation pad contact.
Shockable Rhythms: SMART Analysis is designed to shock ventricular fibrillation, ventricular
flutter and polymorphic ventricular tachycardia. It is designed to avoid delivering a shock for
rhythms that are commonly accompanied by a pulse or rhythms that would not benefit from an
electrical shock.
Shock Advisory Algorithm Sensitivity: Meets AAMI DF39 requirements and AHA
recommendations; Adult: Ventricular Fibrillation - 90% with lower confidence limit (LCL) of 87%,
Polymorphic Ventricular Tachycardia and Ventricular Flutter - 75% with LCL of 67%;
Infant/Child: Ventricular Fibrillation - 90% with LCL of 87%.
Shock Advisory Algorithm Specificity: Meets AAMI DF39 requirements and AHA
recommendations; Normal Sinus Rhythm - 99% with LCL of 97%; Asystole - 95% with LCL of
92%; Other non-shockable Rhythms - 95% with LCL of 88%.

ECG and Arrhythmia Monitoring


Inputs: Up to 3 ECG waves may be viewed on the display and up to 2 waves printed simultaneously.
Lead I, II or III is obtained through the 3-wire ECG cable and separate monitoring electrodes. With
a 5-Lead ECG cable, leads aVR, aVL, aVF and V can also be obtained. Pads ECG is obtained
through two multifunction electrode pads.
Lead Fault: Messages and dashed lines appear on the display if an electrode or lead becomes
disconnected.
Pad Fault: Dashed line appears on the display if a pad becomes disconnected.
Heart Rate Display: Digital readout on the display from 16 to 300 bpm (Adult Patient Category) or
16 to 350 bpm (Infant/Child), with an accuracy of ±10% or ±5 bpm whichever is greater.
Heart Rate/Arrhythmia Alarms: HR high/low, Asystole, VFIB/V-TACH, VTACH, Extreme Tachy,
Extreme Brady, PVC rate, Pacer Not Capture, Pacer Not Pacing.
Common Mode Rejection: 105 dB for Leads ECG, 96 dB for pads ECG.
ECG Size: 1/4x, 1/2x, 1x, 2x, 4x, auto gain (1x gain is 10mm/mV on the printed strip).
ECG waveforms: Displayed at a fixed timebase of 25 mm/sec (printer) ±5%, 25 mm/sec (display)
±10%.
ECG Leads Off Sensing: 3- and 5-Lead wires apply a <35nA DC current patient electrodes,
<1.0uA other electrodes.

196
Specifications 19: Specifications

Maximum T-Wave amplitude: Device rejects up to 80% of R-Wave amplitude for synchronized
cardioversion; up to 55% of R-Wave amplitude for demand pacing; up to 34% of R-Wave
amplitude for arrhythmia analysis. Maximum T-wave amplitude when a QRS test signal is 1 mV
amplitude and 100 ms duration, with a heart rate of 80 1/min used: 18 mm.
Frequency Response:
• ECG AC Line Filter: 50 Hz or 60 Hz.
• ECG for Display: 0.15-40 Hz, 0.05-40 Hz (IEC 60601-2-27:2011 201.12.1.101.8 a, b),
2.0-20.0 Hz
• ECG for Printer: 0.05-150 Hz - Diagnostic, 0.05-40 Hz - ST Monitor (IEC 60601-2-27:2011
201.12.1.101.8 a, b), 0.15-40 Hz - Monitor, 2.0-20.0 Hz – EMS
Heart rate accuracy and response to irregular rhythm: Meets AAMI standard for ventricular
bigeminy (HR=80 bpm); slow alternating ventricular bigeminy (HR=60 bpm); rapid alternating
ventricular bigeminy (HR=120 bpm); bidirectional systoles (HR=90 bpm) as measured after a
20-sec stabilization time.
Heart rate averaging: For heart rates 50 bpm, heart rate is determined by averaging the 12 most
recent R-R intervals. Beats N, P, and V are included. When heart rate drops below 50 bpm, the four
most recent R-R intervals are used in the average. Note: For ventricular tachycardia alarms, which
have a user-definable PVC run length limit, the heart rate is based on the user-selected PVC length
up to 9 PVCs maximum. Heart rate display update time is 1 second maximum.
Pace Pulse Detection Sensitivity: 1 mV for a width of 100 µs; 200 µV for a 500-µs width and
200 µV for widths of 500 µs to 2 ms.
ECG Analog Output Bandwidth: 0.5 to 70 Hz
ECG Analog Output Gain: 1v output per 1 mV input ±10%
ECG Analog Output Delay: Propagation delay time is <25 ms from ECG input to ECG analog
output.
Pacemaker Pulse Rejection Capability: Amplitude from ± 2 mV to ± 700 mV, width from 0.1 ms
to 2.0 ms as per IEC 60601-2-27:2011 201.12.1.101.13/YY 1079 4.1.4.1, except the full overshoot
range of IEC 60601-2-27 methods A and B.
Pacer Pulse Detector rejection of Fast ECG Signals: Slew Rate of 1.1 V/s.
Heart Rate Response Time: 7 sec for a High Heart Rate alarm when the rate changes from 80 to
120 bpm, with the alarm limit set at 100 bpm; 6 sec for a Low Heart Rate alarm when the rate
changes from 80 to 40 bpm, with the alarm limit set at 60 bpm.
Time to Alarm for Tachycardia: 4 sec for 206 bpm (1 mV, halved amplitude and double amplitude)
and 195 bpm (2 mV, halved amplitude and double amplitude) as measured following a normal 80
bpm rate with upper alarm limit set at 100 and lower alarm limit set at 60 bpm.
Patient Isolation (Defibrillation Proof ):
• Lead ECG: Type CF
• SpO2: Type CF
• CO2: Type BF
• NBP: Type CF
• Pads/Paddles: Type BF
• Internal Paddles: Type CF

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19: Specifications Specifications

Other consideration: The Efficia DFM100 is suitable for use in the presence of electrosurgery. Burn
hazard protection is provided via a 1K current-limiting resistor contained in each ECG lead wire.
Proper lead placement (see “Electrode Placement” on page 49) is important to reduce burn hazards
in the event of a defect in the electrosurgical equipment. Do not entangle the ECG cables with the
electrosurgical equipment wires; do not place the ECG cabling near the electrosurgical equipment's
grounding plate.

Display
Size: Approximately 7 in (17.8 cm) diagonal viewing area.
Type: Color TFT LCD.
Resolution: 800 x 480 pixels (VGA) with 32 brightness levels per color.
Sweep Speed: 25 mm/s ± 10% nominal (stationary trace; sweeping erase bar) for ECG and SpO2;
capnogram wave is 6.25 mm/s ± 10%.
Wave Viewing Time: 6.5 sec ± 10%.

Battery
Type: Rechargeable, Lithium Ion; See battery label for capacity information.
Approximate Dimensions: 28.5 mm (H) x 80 mm (W) x 145.7 mm (L); 1.1 in (H) x 3.1 in (W) x
5.7 in (L)
Approximate Weight: Approximately 0.44 kg (1 lb)
Capacity: With a new fully charged battery, at 20 °C (68 °F), one of the following:
• 100 full-energy charge/shock cycles.
• 2.5 hours of monitoring (ECG, EtCO2 and SpO2 continuously monitored and NBP sampled
every 15 minutes) followed by 20 full-energy charge/shock cycles.
• Two hours of pacing (180ppm at 140mA with 40msec pulse) and monitoring (ECG, EtCO2
and SpO2 continuously monitored and NBP sampled every 15 minutes).
Charge Time with Device Turned Off and AC Power Connected: With temperature at 25°C (77°
F), less than 3 hours to 100% capacity; less than 2 hours to 80% capacity.
Battery Indicators: Battery gauge on battery, capacity indicator on display, power indicators on front
of device; flashing RFU indicator, audio beep and  messages on the display for low battery
condition. When a low battery message first appears, there is still enough energy for at least
10 minutes of monitoring and 6 maximum energy discharges.

Thermal Array Printer


Continuous ECG Strip: The Print key starts and stops the strip. The printer can be configured to be
run real time or with a 10-second delay. The strip prints the primary ECG lead and a second wave
with event annotations and measurements.
Auto Printing: The printer can be configured to automatically print on Mark Events, Charge, Shock
and Alarm.
Reports: The following can be printed:
• Event Summary (Long or Short)
• Vital Signs Trends
• Operational Check
• Configuration

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Specifications 19: Specifications

• Status Log
• Device Information
Speed: 25 mm/s with an accuracy of ±5%
Amplitude Accuracy: 5% for offset voltages of ± 300 mV at 5Hz
Paper Size: 50 mm (W) x 20 m (L)

Noninvasive Pacing
Waveform: Monophasic
Current Pulse Amplitude: 10 mA to 200 mA if the pulse width is set to 20 ms (5 mA increments);
accuracy ±10% or ±5 mA whichever is greater. For a 40 ms setting, the maximum pacing current is
140 mA.
Pulse Duration: 20 or 40 msec with ±10% accuracy
Rate: 30 ppm to 180 ppm (10 ppm increments); accuracy ±1.5%
Mode: Demand or Fixed
Refractory Period: 340 msec (30 to 80ppm); 240 msec (90 to 180 ppm) ±10%
Universal-function electrodes (Pads): After 60 minutes of pacing with approved defibrillators, the
Multifunction Electrodes (Pads) exhibit a post-defibrillation DC Offset of less than ± 800 mV at  4
seconds post-shock.

SpO2 Pulse Oximetry


SpO2 Measurement Range: 0-100%
SpO2 Resolution: 1%
SpO2 Update Period: 1-2 sec typical; maximum of 30 sec
Table 63 Sensor Accuracy*

Sensor Accuracy Sensor Accuracy


M1191B ±2% M1192A ±2%
M1191BL ±2% M1196A ±3%
* - Specified accuracy is the root-mean-square (RMS) difference between
the measured values and reference values.

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19: Specifications Specifications

NOTES: Accuracy outside the range specified for each sensor is not indicated. The sensors in Table 63 were
validated for use with the Efficia DFM100 using the Philips picoSAT II SpO2 module with Fourier
Artifact Suppression Technology (FAST).
While the SpO2 module is able to report values below 70% and alarm limits can be set below 70%,
the accuracy of measurements less than 70% has not been validated.
SpO2 accuracy was validated in human studies against arterial blood sample references measured
with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation
levels between 70-100% SaO2 were studied. The population characteristics for those studies were
approximately 50% male and 50% female, ranging in age from 19-39 with skin tone from light to
dark.
Pulse oximetry equipment measurements are statistically distributed, therefore only two-thirds of
pulse oximeter equipment measurements can be expected to fall within ±Arms of the value measured
by a CO-oximeter.
Functional test equipment designed for SpO2 testing cannot be used to assess the accuracy of the
SpO2 readings.
See the sensor’s instructions for use for the maximum temperature possible at the sensor-skin
interface and other information such as intended patient population, sensor application sites and use
criteria.
The Efficia DFM100 is calibrated to display functional oxygen saturation.

Ambient Light Sensitivity: Interference from fluorescent light is <2% SpO2 under the following
conditions: 0.3 and 1% perfusion, 50 nA/mA transmission, 10 to 1000 lx light intensity, 50/60Hz
power line frequency ±0.5 Hz line frequency.
SpO2 Alarm Range:
• Low Limit: 50-99% (Adult and Infant/Child)
• High Limit: 51-100% (Adult and Infant/Child)
SpO2 and Pulse High/Low Alarm Signal Generation Delay: 10 seconds
SpO2 Response Time (90 to 80%): average 18.9 seconds, standard deviation 0.88 seconds
SpO2 and Pulse Averaging Time: 10 sec
Emitted Light Energy: 15 mW
Wavelength Range: 500-1000 nm (Information about wavelength range can be useful to users,
especially those performing photodynamic therapy.)
Desat Alarm Signal Generation Delay: 20 sec
Pulse Rate Measurement Range: 30-300 bpm
Pulse Rate Resolution: 1 bpm
Pulse Rate Accuracy: ±2% or 1 bpm whichever is greater
Pulse Response Time (90 to 120 bpm): average 18.0 seconds, standard deviation 0.86 seconds
Pulse Alarm Range:
• Low Limit: 30-295 (Adult and Infant/Child)
• High Limit: 35-300 (Adult and Infant/Child)

200
Specifications 19: Specifications

EtCO2
Weight: Mainstream: 78 g (2.75 oz.); Sidestream: 272 g (9.6 oz.)
Dimensions: Mainstream: 43 mm (W) x 33 mm (H) x 23 mm (L); 1.69 in (W) x 1.29 (H) x .90 in
(L); Sidestream: 66 mm (W) x 38 mm (H) x 89 mm (L); 2.6 in (W) x 1.5 in (H) x 3.5 in (L)
Range: 0-150 mmHg
Resolution: 1 mmHg (0.1 kPa)
Accuracy: 0 - 40 mmHg ± 2 mmHg; 41 - 70 mmHg ± 5% of reading; 71 - 100 mmHg ± 8% of
reading; 101 - 150 mmHg ± 10% of reading. Gas at 25C.
Drift of Measurement Accuracy: Over any 24 hour period, the specified measurement accuracy is
maintained.
Warm-up time: 2 minutes at 25°C.
System Response Time: Sidestream: 3.5 seconds typical.
Alarm Delay Time: (after alarm condition has been met) Mainstream - less than 5 sec; Sidestream -
less than 8 sec; Measurement Method: Peak EtCO2 value within a 10 sec window.
Sample Flow Rate: Sidestream - 50 ml/min ±10 ml
Alarm Range:
• Low Limit: 10-140 mmHg (Adult, Infant/Child)
• High Limit: 20-145 mmHg (Adult, Infant/Child)

AwRR
Range: 0-150 rpm
Resolution: 1 rpm
Accuracy: ±1 rpm
Alarm Range:
• Low Limit: 0-99 rpm (Adult, Infant/Child)
• High Limit: 10-100 rpm (Adult, Infant/Child)
Alarm Delay Time: (after alarm condition has been met) Mainstream - less than 5 sec; Sidestream -
less than 8 sec; Measurement Method: AwRR - based on the last 8 detected breaths; Apnea -
Following the configured Apnea delay time.

NBP
Pressure Range:
mmHg kPa
Measurement
Adult Infant/Child Adult Infant/Child
Systolic 30-255 30-135 4-34 4-18
Diastolic 10-220 10-110 1.3-29.3 1.3-14.7
Mean 20-235 20-125 2.7-31.3 2.7-16.7

Initial Pressure: 160 mmHg/21.3 kPa (Adult); 120 mmHg/16 kPa (Infant/Child)
Maximum Pressure: 300 mmHg/40 kPa

201
19: Specifications Specifications

Overpressure Safety Limit: 290 mmHg/38.6 kPa


Cuff Inflation Time: 75 sec maximum
Pressure Transducer Accuracy: ±3 mmHg over the range 0-300 mmHg/0-40 kPa
Alarm Range:
mmHg kPa
Measurement
Adult Infant/Child Adult Infant/Child
Systolic high limit 35-255, 160 35-135, 120 4.5-34, 21 4.5-18, 16
Systolic low limit 30-250, 90 30-130, 70 4-33.5, 12 4-17.5, 9
Diastolic high limit 15-220, 90 15-110, 70 2-29.5, 12 2-15, 9
Diastolic low limit 10-215, 50 10-105, 40 1.5-29, 7 1.5-14.5, 5
Mean high limit 25-235, 110 25-125, 90 3.5-31.5,15 3.5-16.5, 12
Mean low limit 20-230, 60 20-120, 50 3-31, 8 3-16, 7

Auto Mode Repetition Time: 1, 2.5, 5, 10, 15, 30, 60 or 120 min
Maximum Measurement Time: 120 sec
Interconnect Tube Length:
989803177471 Connect tubing 3.0 m (9.24 ft.)

Environmental
Temperature: Operating temperature for the device: 0 °C to 45°C (32°F to 113°F); Operating
temperature range for EtCO2: 0°C to 40°C (32°F to 104°F); Storage/transport temperature range
for the device without battery: -20°C to 70°C (-4°F to 158°F).
Settling Time to 20°C: Time required for device to warm from -20°C before use is 80 minutes; time
required for device to cool from 70°C before use is 80 minutes.
Humidity: 15% to 95% relative humidity
• EtCO2 measurements meet all specifications during and after exposure to humidity conditions
from 10-90%
• Printer paper may jam if the paper is wet.
• Thermal printer may be damaged if wet paper is allowed to dry while in contact with printer
elements.
Atmospheric Pressure Range/Operation and Storage: 1060 mbar to 572 mbar (-1253 to
14,986 ft.; -382 to 4,568 m).
Shock:
Operating: Half-sine waveform, duration 11 ms, acceleration 15.3 G, 3 shocks per face.
Non-operating: Trapezoidal waveform, acceleration 30G, velocity change 7.42 m/s ±10% 1 shock
per face.

202
Specifications 19: Specifications

Vibration:
Non-Operating
Operating Random Non-Operating Random
Swept Sine

Frequency Slope PSD Frequency Slope PSD Frequency Amplitude


(Hz) (dB/octave) (m/s2)2/Hz (Hz) (dB/octave) (g2/Hz) (Hz)

10-100 — 1.0 10-20 — 0.05 10-57 ± .15 mm


100-200 -3.0 — 20-150 -3.0 — 57-150 2g
200-2000 — 0.5 150 — 0.0065 Test duration: 4 sweeps
per axis x 3 axes; Each
Test duration: 10 min/axis x 3 axes; Total RMS acceleration: 1.6 g; sweep: 10-150-10 Hz
30 minutes total. Test duration: 30 minutes x 3 axes cycle at a sweep rate of 1
oct/min

Bump: Half-sine, 15g peak, 6ms, 1000 hits (vertical with the device in its normal mounting
position)
Free Fall: IEC 68-2-32 Free Fall. Once on each face, total 6 faces (excluding bedrail hook).
• 40 cm (16 in.) without cradle and side carry bags
• 75 cm (29.5 in.) with cradle and side carry bags
Water/Solids Ingress Resistance: Meets Ingress Protection level IP54 - protected against dust
limited ingress (no harmful deposits) and against water sprayed from all directions (limited ingress
permitted).
EMC: Complies with the requirements of standard IEC 60601-1-2:2014/EN 60601-1-2: 2015 and
IEC 60601-1-2: 2007/EN60601-1-2:2007.
Transient Operating Conditions: The DFM100 meets all specifications for 20 minutes during
transient operating conditions of a temperature range of -20°C to 50°C and a relative humidity
range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than
50 hPa.
Safety: Meets EN 60601-2-4:2011/GB9706.8-2009, EN 60601-1/A1:2013/GB9706.1-2007.
Other considerations:
• The Efficia DFM100 is not suitable for use in the presence of concentrated oxygen or a
flammable anesthetic mixture with air, oxygen or nitrous oxide.
• Hazards arising from software errors are minimized by the product’s compliance with the
software requirements contained in IEC 62304.
Mode of Operation: Continuous
AC Line Powered: 100-240 VAC, 50 or 60 Hz, 1 - 0.46 A, Class I Equipment
Battery Powered: Minimum 14.4 V, Rechargeable Lithium Ion
Hazardous Waste:
Pb Hg Cd Cr6+ PBB PBDE
O O O O O O
• = One or more of the device’s raw materials has this harmful substance and
concentration over the standard concentration limit.
O = The raw material concentrations are within allowed limits.

203
19: Specifications Security and Privacy

The EU REACH Regulation 1907/2006 requires Philips to provide chemical content information
for Substances of Very High Concern (SVHC) if they are present in the relevant article above a
concentration of 0.1% weight by weight.
For information on substances contained in Philips products, see www.philips.com/REACH.

WARNING: The base material of this product can expose you to chemicals such as arsenic, which is known to the
State of California to cause cancer. For more information, see www.P65Warnings.ca.gov.

USB Device
Correct Drive: You can use the Philips USB Drive that came with your device, or you can order a
new one using the part number listed under “Supplies and Accessories” on page 189.

Security and Privacy


To protect the device from unauthorized access and operation, Philips recommends that the owning
organization maintains the physical security of the device at all times, including environmental
considerations.
The DFM100 includes the following role-based security controls:
• Clinical modes (Monitor, AED, Manual Defibrillation, Synchronized Cardioversion, and Pacer)
do not require a password because clinicians need to provide immediate patient care in
emergency situations.
• Data Management mode has an optional password. The device is initially set up to require a
Data Management mode password. You can change the requirement in the 
menu of Configuration mode.

• Configuration mode can be accessed without a password to view the configuration settings or
change the date and time. To change configuration settings other than the date and time, the
Configuration mode password is required.
• Service mode has the highest level of security and requires the Service mode password. In Service
mode, you can perform various tasks, such as changing the Service and Configuration mode
passwords and viewing the Access Log and Error Log files. For more information on Service
mode functions, see the Efficia DFM100 Service Manual.

Internal Event Summary and Patient Data Storage


The Efficia DFM100 can store up to 8 hours of 2 continuous ECG waves, 1 pleth wave, 1
capnogram wave, research waves (AED mode only) events, and trend data per Event Summary. The
device has a maximum capacity of approximately 50 events of approximately 30 minutes in length.
The most recent patient information entered during the live event is retained as appropriate. All
Event Summary records stored in the device are AES-256 encrypted.
Event Summaries are automatically deleted after 30 days. If the Event Summary storage is full, the
oldest event summary records are deleted as new Event Summary records are stored.
In Data Management mode, you can export Event Summary records to an approved USB drive. The
Event Summary records are AES-256 encrypted when exported, and you can remove patient data
before exporting the records. Only the compatible Philips data management application can read the
Event Summary data from the USB drive.
Philips recommends that you frequently export Event Summary records to a USB drive to back up
the data. The USB drive should be securely stored to prevent data loss, unauthorized access, and
damage to the USB drive.

204
Symbol Definitions 19: Specifications

Software Upgrades
The Philips Service organization distributes encrypted software upgrades that may include feature
upgrades and security patches. Philips recommends keeping your devices current with the most
recent software release.
All software upgrades are performed in Service mode. For more information, see the Efficia
DFM100 Service Manual.

Symbol Definitions
Table 64 lists the meaning of symbols appearing on the Efficia DFM100, the Lithium Ion battery,
and the shipping carton.
Table 64 Symbol Definition

Symbol Definition Symbol Definition


Meets IEC type CF Meets IEC type BF leakage
leakage current current requirements and is
requirements and is defibrillator protected.
defibrillator protected. (Patient Applied Part is
(Patient Applied part is isolated and defib-proof
isolated and defib-proof suitable for direct patient
suitable for direct patient contact except the heart or
contact including the heart major arteries.
or major arteries.)
Caution - See operating Manufacture Date
instructions in Instructions
For Use.
USB Port Manufacturer

Output AC current

RF Transmission Symbol NBP port

Recyclable Serial Number




Options installed Reference order number

Consult Instructions for Consult Instructions for Use


Use

Do not get wet Atmospheric pressure range

Relative humidity range Temperature range

RoHS exempt. Fragile


Environmentally friendly
for a use period of 50 years.

205
19: Specifications Abbreviation Definitions

Table 64 Symbol Definition (Continued)

Symbol Definition Symbol Definition

 This end up Equalization Terminal

Device complies with the Warning: dangerous voltage


requirements of the Medical
0123 Device Directive 93/42/EEC

DC current Rechargeable battery

Dispose of in accordance Consult Service Manual.


to your country’s
requirements.
A high level of risk exists.

NOTE: For definitions of symbols which appear on the Efficia DFM100’s front panel see “Basic
Orientation” on page 8 and “General Function Buttons” on page 27. For definitions of symbols
which appear on the external paddles see “External Paddles” on page 14.

Abbreviation Definitions
Table 65 lists various abbreviations used with the Efficia DFM100 and in these Instructions for Use.
Table 65 Abbreviations

Abbreviation Definition Abbreviation Definition


% percent µs microseconds
°C degrees Celsius µV microVolt
°F degrees Fahrenheit mA milliAmpere
AC alternating current mV milliVolt
bpm beats per minute min minutes
cm centimeter mmHg millimeters of mercury
dB Decibel ms millisecond
dB(A) A-weighted decibels mW milliwatt
Hz hertz nM nanometer
in inches NSA No Shock Advised
J Joules PSD Power Spectral Density
kg kilograms RFU Ready For Use
kPa kilo Pascal rpm respirations per minute
Lbs Pounds sec seconds
m meter V Volt

206
Electromagnetic Compatibility 19: Specifications

Electromagnetic Compatibility
When using the Efficia DFM100, electromagnetic compatibility with surrounding devices should be
assessed.
A medical device can either generate or receive electromagnetic disturbances. Testing for
electromagnetic compatibility EMC with the appropriate accessories has been performed according
to national and international standard for EMC for medical devices.
The EMC standards describe tests for both emitted and received disturbances. Emission tests deal
with electromagnetic disturbances generated by the device being tested.

WARNINGS: Electromagnetic interference coming from other devices may degrade or obstruct the performance of
the Efficia DFM100. The interference may come from signals radiated through the air or it may also
come from signals conducted through wired connections such as power cord, patient connections or
device to device connections such as ECG analog output. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the Efficia DFM100.
When connected to a patient, symptoms of interference may include degraded performance of ECG
signals from pads/paddles or ECG leadsets, unexpected technical alarms, or critical failure status on
the RFU Indicator. Electromagnetic compatibility testing should include both radiated and
conducted immunity. Testing in the presence of potentially interfering surrounding devices should
assess typical Efficia DFM100 usage scenarios including powering on, monitoring and delivering
therapy.
Fixed, portable, and mobile radio frequency communications equipment could affect the
performance of medical equipment. See Table 74 for the minimum recommended separation
distance between RF communications equipment and the Efficia DFM100.

Reducing Electromagnetic Interference


The Efficia DFM100 and associated accessories may be susceptible to interference from other RF
energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF
interference are medical devices, cellular products, information technology equipment and
radio/television transmission. Should interference be encountered, as demonstrated by error
conditions, artifact on the ECG or dramatic variations in parameter measurement values, attempt to
locate the source. Assess:
Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
• Does the interference occur only when in close proximity to certain medical devices?
• Does the interference occur only when certain medical devices are turned on?
• Does the interference occur only when certain medical devices are connected to the same patient
as the Efficia DFM100?
• Do parameter measurement values change dramatically when the AC line cord is unplugged?
Once the source is located, attempt to attenuate the EMC coupling path by distancing the
monitor/defibrillator from the source as much as possible or by changing the location or routing of
wired connections. If assistance is needed, call your local service representative.

Essential Performance Determinations


The essential performance of the Efficia DFM100 defibrillator/monitor is derived from the
product’s Safety Risk Assessment and includes:
• The ability to deliver defibrillation therapy (manual, AED and synchronized cardioversion).
• The ability to deliver pacing therapy (fixed and demand).

207
19: Specifications Electromagnetic Compatibility

• The ability to monitor the patient parameters (ECG monitoring, pulse oximetry, end-tidal
CO2, non-invasive blood pressure).
• The ability to detect and generate physiological alarms.
All other functions are considered non-essential performance but were monitored for EMC.

Restrictions for Use


Artifact on the ECG and parameter waveforms caused by electromagnetic disturbances should be
evaluated by a physician or physician-authorized personnel to determine if it will negatively impact
patient diagnosis or treatment.

Emissions and Immunity


The Efficia DFM100 is designed and tested to comply with the radiated and conducted emissions
requirements of international and national standards. The device is intended for use in the
electromagnetic environments specified in the following tables. Given the electromagnetic emissions
and immunity characteristics of the device, the customer or user should assure that the device is used
within the specified environments. The EMC standards state that manufacturers of patient-coupled
equipment must specify immunity and minimum separation distances between portable and mobile
communications equipment. Refer to the tables below.
See Table 66 through Table 73 for detailed information regarding declaration and guidance.

WARNING: The use of accessories, transducers and cables other than those specified might result in increased
emissions or decreased immunity of the Efficia DFM100.

The list of cables, transducers, and other accessories with which Philips claims compliance with the
emissions and immunity requirements listed in “Supplies and Accessories” on page 189.
Immunity is defined in the standard as the ability of a system to perform without degradation in the
presence of an electromagnetic disturbance. Degradation in ECG quality is a qualitative assessment
which could be subjective. See Table 73 for this detailed immunity information. See Table 74 for
recommended minimum separation distances between portable and mobile communications
equipment and the Efficia DFM100.
Caution should be taken in comparing immunity levels of different devices. The criteria used for
degradation is not specified by the standard and might vary with the manufacturer.
Table 66 EMC Emissions

Emissions Test Compliance Electromagnetic Environment - Guidance


RF emissions Group 1, Class B Emergency medical services environment
CISPR 11 Professional healthcare facility environment
Harmonic emissions Class A Emergency medical services environment
IEC 61000-3-2 Professional healthcare facility environment
Voltage Complies Emergency medical services environment
fluctuations/flicker Professional healthcare facility environment
emissions
IEC 61000-3-3

208
Electromagnetic Compatibility 19: Specifications

Table 67 Enclosure Ports

Immunity Test Immunity Test Compliance Level Electromagnetic


Level Environment - Guidance
Electrostatic ±8 kV contact ±8 kV contact Emergency medical services
discharge (ESD) ±2, ±4, ±8, ±15 kV ±2, ±4, ±8, ±15 kV air environment
IEC 61000-4-2 air Professional healthcare
facility environment
Radiated RF 10 V/m 10 V/m Emergency medical services
Electromagnetic 80 MHz - 2.7 GHz 80 MHz - 2.7 GHz environment
Field Professional healthcare
IEC 61000-4-3 facility environment
Radiated RF 20 V/m (only 20 V/m (only Emergency medical services
Electromagnetic defibrillation) defibrillation) environment
Field 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz Professional healthcare
IEC 60601-2-4 facility environment
(see Para.
202.6.2.3)

Proximity fields See Table 68 See Table 68 Emergency medical services


from RF environment
wireless Professional healthcare
communications facility environment
equipment
IEC 61000-4-3
Power frequency 30 A/m 30 A/m Emergency medical services
magnetic field 50 Hz or 60 Hz 50 Hz or 60 Hz environment
IEC 61000-4-8 Professional healthcare
facility environment

Table 68 Proximity Fields from RF Wireless Communications Equipment

Test Band a) Service a) Modulation Modulation Distance Immunity


Frequency (MHz) b) b) (m) Test Level
(MHz) (W) (V/m)
385 380-390 TETRA 400 Pulse 1.8 0.3 27
modulation
18 Hz
450 430-470 GMRS 460, FM 2 0.3 28
FRS 460 ± 5 kHz
deviation
1 kHz sine
710 704-787 LTE Band 13, Pulse 0.2 0.3 9
745 17 modulation

780 217 Hz

209
19: Specifications Electromagnetic Compatibility

Table 68 Proximity Fields from RF Wireless Communications Equipment

Test Band a) Service a) Modulation Modulation Distance Immunity


Frequency (MHz) b) b) (m) Test Level
(MHz) (W) (V/m)
810 800-960 GSM Pulse 2 0.3 28
870 800/900, modulation
TETRA 800, 18 Hz
930 iDEN 820,
CDMA 850,
LTE Band 5
1720 1700-1990 GSM 1800; Pulse 2 0.3 28
1845 CDMA 1900; modulation
GSM 1900; 217 Hz
1970 DECT; LTE
Band 1, 3, 4,
25; UMTS
2450 2400-2570 Bluetooth, Pulse 2 0.3 28
WLAN, modulation
802.11 b/g/n, 217 Hz
RFID 2450,
LTE Band 7
5240 5100-5800 WLAN Pulse 0.2 0.3 9
5500 802.11 a/n modulation

5785 217 Hz

WARNING: The use of portable and mobile radio communications equipment can affect the operation of this
device. Keep all portable and mobile radio communications equipment at a minimum distance of
30 cm (12 inches) from any part of the Efficia DFM100.

Table 69 Input AC Power Ports

Immunity Test Immunity Test Compliance Level Electromagnetic


Level Environment - Guidance
Electrical fast ±2 kV ±2 kV Emergency medical services
transient/burst environment
IEC 61000-4-4 Professional healthcare
facility environment
Surge ±0.5 kV, ±1 kV ±0.5 kV, ±1 kV Emergency medical services
Line to line environment

IEC 61000-4-5 Professional healthcare


facility environment
Surge ±0.5 kV, ±1 kV, ±0.5 kV, ±1 kV, Emergency medical services
Line to ground ±2 kV ±2 kV environment

IEC 61000-4-5 Professional healthcare


facility environment

210
Electromagnetic Compatibility 19: Specifications

Table 69 Input AC Power Ports (Continued)

Immunity Test Immunity Test Compliance Level Electromagnetic


Level Environment - Guidance
Conducted 3V 3V Emergency medical services
disturbances induced 0.15 MHz - 0.15 MHz - environment
by RF fields 80 MHz 80 MHz Professional healthcare
IEC 61000-4-6 6 V in ISM and 6 V in ISM and facility environment
amateur radio amateur radio
bands between bands between
0.15 MHz and 0.15 MHz and
80 MHz 80 MHz
Voltage dips, short 0% UT; 0.5 cycle 0% UT; 0.5 cycle Emergency medical services
interruptions, and At 0°, 45°, 90°, At 0°, 45°, 90°, environment
voltage variations on 135°, 180°, 225°, 135°, 180°, 225°, Professional healthcare
power supply input 270°, and 315° 270°, and 315° facility environment
lines
0% UT; 1 cycle 0% UT; 1 cycle
IEC 61000-4-11 and 70% UT; and 70% UT;
25/30 cycles 25/30 cycles
Single phase: at 0° Single phase: at 0°
Voltage interruptions 0% UT; 250/300 0% UT; 250/300 Emergency medical services
IEC 61000-4-11 cycle cycle environment
Professional healthcare
facility environment

Table 70 Signal Input/Output Ports

Immunity Test Immunity Test Compliance Level Electromagnetic


Level Environment - Guidance
Electrostatic discharge ±8 kV contact ±8 kV contact Emergency medical
(ESD) ±2, ±4, ±8, ±15 kV ±2, ±4, ±8, ±15 kV services environment
IEC 61000-4-2 air air Professional healthcare
facility environment
Electrical fast ±1 kV ±1 kV Emergency medical
transient/burst services environment
IEC 61000-4-4 Professional healthcare
facility environment
Conducted disturbances 3V 3V Emergency medical
induced by RF fields 0.15 MHz - 0.15 MHz - services environment
IEC 61000-4-6 80 MHz 80 MHz Professional healthcare
6 V in ISM and 6 V in ISM and facility environment
amateur radio amateur radio
bands between bands between
0.15 MHz and 0.15 MHz and
80 MHz 80 MHz

211
19: Specifications Electromagnetic Compatibility

Table 71 Patient Coupling Ports

Immunity Test Immunity Test Compliance Level Electromagnetic


Level Environment - Guidance
Electrostatic discharge ±8 kV contact ±8 kV contact Emergency medical
(ESD) ±2, ±4, ±8, ±15 kV ±2, ±4, ±8, ±15 kV services environment
IEC 61000-4-2 air air Professional healthcare
facility environment
Conducted disturbances 3V 3V Emergency medical
induced by RF fields 0.15 MHz - 0.15 MHz - services environment
IEC 61000-4-6 80 MHz 80 MHz Professional healthcare
6 V in ISM and 6 V in ISM and facility environment
amateur radio amateur radio
bands between bands between
0.15 MHz and 0.15 MHz and
80 MHz 80 MHz

The EMC standards state that manufacturers of medical equipment must specify the maximum
lengths of any associated cables that are likely to affect the compliance of the device with emission
and immunity tests. The following table lists the maximum lengths of these cables.
Table 72 Applicable Cables with Maximum Lengths

Part Number Maximum Cable Description


Length
3-Lead ECG Cable Set
M1669A 2.7 m 3-Lead Trunk Cable, AAMI/IEC
M1674A 1.0 m 3-Lead ICU Snap, IEC
M1678A 1.0 m 3-Leadset OR Grabber, IEC
M1672A 1.0 m 3-Leadset ICU Grabber, IEC
M1673A 1.0 m 3-Leadset ICU Snap, AAMI
M1671A 1.0 m 3-Leadset ICU Grabber, AAMI
989803160641 2.7 m Efficia 3/5 ECG Trunk Cable, AAMI/IEC
989803160651 1.0 m Efficia 3-Lead Grabber, AAMI
989803160661 1.0 m Efficia 3-Lead Grabber, IEC
989803170171 2.7 m OR 3-Lead ECG Trunk Cable, AAMI/IEC
5-lead ECG Cable Set
M1645A 1.6 m 5-Lead ICU Snap, IEC
M1668A 2.7 m 5-Lead ECG Trunk Cable, AAMI/IEC
M1971A 1.6 m 5-Leadset, ICU Grabber, IEC
M1974A 1.6 m 5-Leadset, OR Grabber, IEC
M1644A 1.6 m 5-Leadset, ICU Snap Limb, AAMI
M1968A 1.6 m 5-Leadset, ICU Grabber Limb, AAMI
989803160691 1.6 m Efficia 5-Lead Grabber Limb, AAMI

212
Electromagnetic Compatibility 19: Specifications

Table 72 Applicable Cables with Maximum Lengths (Continued)

Part Number Maximum Cable Description


Length
989803160701 1.6 m Efficia 5-Lead Grabber Limb, IEC
989803170181 2.7 m OR 5-Lead ECG Trunk Cable, AAMI/IEC
989803176161 1.6 m 5-Lead Snap Limb, Shielded, AAMI
989803176181 1.6 m 5-Lead Snap Limb, Shielded, IEC
Internal Paddles
M4741A 3.9 m 7.5 cm Switched Internal Paddles
M4742A 3.9 m 6.0 cm Switched Internal Paddles
M4743A 3.9 m 4.5 cm Switched Internal Paddles
M1741A 3.9 m 7.5 cm Internal Paddles
M1742A 3.9 m 6.0 cm Internal Paddles
M1743A 3.9 m 4.5 cm Internal Paddles
M4740A 0.3 m Internal Paddles Adapter Cable
External Paddles
M3543A 4.8 m External Paddles - Water Resistant
989803196431 4.8 m Efficia External Paddles with PCI - Water Resistant
Hands-free Pads Therapy Cables
M3508A 2.2 m HeartStart Hands-free Cable
989803197111 2.1 m DFM100 Pads Cable
Multifunction Defibrillator Pads - Plug Connector
M3713A 1.2 m HeartStart Pads Adult/Child (>10 kg) Plus (10 sets)
M3716A 1.2 m HeartStart Pads Adult/child Radiolucent Multifunction
Electrode Pads (10 sets)
M3717A 0.6 m HeartStart Pads Infant (<10 kg) Plus (10 sets)
M3718A 1.2 m HeartStart Pads Adult/child Radiotransparent
Multifunction Pads (10 sets)
M3719A 0.6 m HeartStart Pads Infant (<10 kg) Radiotransparent
Multifunction Pads (10 sets)
989803158211 1.2 m HS FR/FR2 Defib Pads (1 set)
989803158221 1.2 m HS FR/FR2 Defib Pads (5 sets)
989803139261 1.2 m SMART Pads II (1 set)
989803149981 1.2 m SMART Pads III (1 set)
989803149991 1.2 m SMART Pads III (5 sets)
EtCO2 Mainstream Sensor
M2501A 2.9 m Mainstream CO2 Sensor
EtCO2 Sidestream Sensor
M2741A 1.0 m Sidestream CO2 Sensor

213
19: Specifications Electromagnetic Compatibility

Table 72 Applicable Cables with Maximum Lengths (Continued)

Part Number Maximum Cable Description


Length
SpO2 Sensors and Cables
M1191B 2.0 m Adult Reusable SpO2 Sensor, 2 m
M1191BL 3.0 m Adult Reusable SpO2 Sensor, 3 m
M1192A 1.5 m Reusable Pediatric/Small Adult Finger SpO2 Sensor,
1.5 m
M1196A 3.0 m Adult Reusable SpO2 Clip Sensor, 3 m
M1941A 2.0 m SpO2 Extension Cable, 2 m

214
Electromagnetic Compatibility 19: Specifications

Table 73 Electromagnetic Immunity - Life Supporting Systems

Immunity Test Level Compliance Level Electromagnetic Environment - Guidance


Test
Portable and mobile RF communications equipment
should be used no closer to any part of the Efficia
DFM100 including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
3 Vrms
Conducted
150 kHz to 80 MHz 3 Vrms
RF Recommended Separation Distance:
outside ISM bandsa
IEC
61000-4-6/ 10 Vrms
10 Vrms
GB/T17626.6 150 kHz to 80 MHz
in ISM bands
Radiated RF 3 V/m 3 V/m* Recommended Separation Distances
80 MHz to 2.5 GHz
IEC 10 V/m, 20 V/m** 80 - 800 MHz:
61000-4-3/ 10 V/m 80 MHz to 2.5 GHz
GB/T17626.3 80 MHz to 2.5 GHz
800 MHz - 2.5 GHz
20 V/m (only SpO2,
CO2, defibrillation)
80 MHz to 2.5 GHz where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter’s
specified output power and d is the recommended
separation distance in meters (m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,c should be
less than the compliance level in each frequency range.d
Interference might occur in the vicinity of equipment
marked with the following symbol:

* Applies to functions that are not considered life-supporting.


** No inadvertent energy delivery (per IEC 60601-2-4/GB9706.8, ISO 80601-2-61/YY0784)
At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines might not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and people.
a
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz and 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b The compliance levels in the ISM frequency bands
between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this
reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency
ranges. c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Efficia DFM100 is used exceeds the applicable RF compliance level above, the Efficia
DFM100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Efficia DFM100. d Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3 V/m.

215
19: Specifications Electromagnetic Compatibility

Recommended Separation Distances


The Efficia DFM100 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Efficia DFM100 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Efficia DFM100 as recommended below,
according to the maximum output power of the communications equipment.
Table 74 Recommended Separation Distances

Separation Distances According to Frequency of Transmitter (m)


Rated Maximum 150 kHZ to 800 MHz 800 MHz to 2.5 GHz
Output Power of
Transmitter (W)
0.01 0.1 m 0.2 m
0.1 0.4 m 0.7 m
1 1.2 m 2.3 m
10 4m 7m
100 12 m 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter’s manufacturer.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines might not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

216
Appendix 1 - Efficia DFM100 Shift Checklist
Inspect your Efficia DFM100, accessories, and supplies at the change of every shift, per AHA
guidelines. Place a check mark in the box as you check each item in the list below or place a dash
(-) or N/A if not applicable. Then, initial the list to indicate the check was performed for that
shift.
Device Name or Serial Number:______________Unit or Department:________
Date:
Shift: 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
RFU Indicator -
Hourglass
If blinking red X - Plug
into AC power or insert
charged battery
If solid red X - Insert
charged battery or plug
into AC power. If
condition persists, call for
service
Case - clean, free from
spills and objects
Cables/connectors -
present and inspected
Paddles/Therapy cable -
present, inspected and
paddles release from tray
Multifunction pads -
present, sufficient supply;
check expiration date
Monitoring Electrodes -
present, sufficient supply;
check expiration date
Charged Batteries - one
in device, spares. Check
battery gauge
AC Power Cord -
plugged in, green light on
Printer Paper - present,
sufficient supply
USB Drive - present
SpO2 Sensors - present,
sufficient supply*
NBP cuffs/tubing -
present, sufficient supply*
CO2 sensor - present,
clean and free from spills*
CO2 Sample line -
present, sufficient supply*
Initials
* - if option is installed

217
Appendix 1 - Efficia DFM100 Shift Checklist

Shift Checklist (Page 2) Efficia DFM100 Weekly Shock Test


Do one of the following checks at least once a week to verify the ability to deliver defibrillation
therapy:
 Operational check (See the Efficia DFM100 Instructions for Use for details.)
 Deliver a 150 J shock into a test plug/load (if using multifunction electrode pads) or the
paddle tray (if using paddles).
 Weekly shock test is not applicable for this shift check.
Check off which option you selected and sign/date below.
Signature: Date:

NOTE: Test reusable sterilizable paddles (internal or external) prior to each use. See the Sterilizable
Defibrillator Paddles Instructions for Use.

 To perform the weekly shock test:


If you are using If you are using If you are using paddles:
pads with a test pads with a test
load: plug:

1 Turn the device on by turning the Therapy knob to 150 J.


2 Connect the Therapy cable to Connect the Therapy cable to Make sure the paddles and the paddle tray are
the defibrillator and test load the defibrillator and test plug thoroughly clean and there is no debris or
to the end of the Therapy to the end of the Therapy residue (including all conductive material) on
cable. cable. the electrode surfaces of the paddles and tray.
Secure paddles in tray and confirm Patient
Contact Indicator (PCI) LEDs are not lit. If the
LEDs are lit, adjust paddles in tray. If the LEDs
continue to light, clean both the adult and infant
paddle electrode surfaces.
3 Press the Charge button on the front panel. Confirm you hear Press the Charge button on the paddles sitting in
the charging tone. If it becomes necessary to disarm the the tray. Confirm you hear the charging tone.
defibrillator, press . If it becomes necessary to disarm the
defibrillator, press .
4 A strip prints, if configured to do so. If the strip does not print A strip prints, if configured to do so. If the strip
immediately, press the Print button. does not print immediately, press the Print
button.
5 Press the Shock button on the Efficia DFM100. Simultaneously press the Shock buttons located
on the paddles.
6 Confirm the printed strip Confirm that you hear a “Shock Cancelled” audio message, see a 
indicates  and the alarm on the display and the printed strip indicates . If not, confirm
energy delivered is150 J, you did the test properly before taking the device out of use and calling for
±15 J (135 J to 165 J). If not, service.
confirm you did the test
properly before taking the NOTE: It is normal behavior that a shock is not delivered in this instance.
device out of use and calling
for service.
7 Detach test load/plug from the Therapy cable so your device is Test complete.
ready for use when needed. Do not leave the test load/plug
attached to the Therapy cable. Test complete.

218
Index
A Alarms 174 Algorithm
adjusting numeric values 36 SMART Analysis 61
Aberrantly-conducted beats 55 adjusting volume 36 ST/AR 47, 55, 72
alarm area 31 American Heart Association 151
AC Line Filter 144
asystole 57
AC power cord guard 17 audio tones 40 Analysis messages 68
Access Log File 204 AwRR 100 Annotated ECG 54
Accessing USB drive 136 button 27 Apnea
cannot analyze ECG 58 changing limits 103
Adjusting numeric values 36 changing AwRR limits 103
Applying an SpO2 sensor 109
AED 64 changing EtCO2 limits 102
adjusting volume 36 changing pulse limits 113 Arrhythmia monitoring 47, 55
administer a shock 66 changing SpO2 limits 112 Asystole 57
adult patients 72 configuration options 143 Audio
AED Mode 25, 61 continuous tone 40 Operational Check results 158
AED View 63 ECG 56 tones 40
alarms 72 ECG alarm chain 58, 59
Alarms button 27 ECG in AED Mode 60, 73 Auto Gain 144
analysis messages 68 enabling AwRR 103 Auto Test
CPR 64 enabling EtCO2 103 hourglass 167
defibrillating 64 enabling NBP 120 print options 150
ECG alarms in AED Mode 60 enabling pulse 114 results 167
ECG cannot be analyzed 66 enabling SpO2 113 RFU 165
ECG monitoring 71 EtCO2 101 summaries 163
energy dose settings 148 EtCO2 limits 100 summary 153, 166
events stored in Event Summary 132 event markers 137 Auto-Gain 33
forced pause messages 71 Event Summary 41, 126
handling patient during ECG extreme brady 57 Automatic NBP measurements 118
analysis 66 extreme tachy 57 AwRR 101
impedance 62 general warnings 38 alarm limits 100
infant/child 72 high priority 37 alarms 101
low impedance messages 70 in AED Mode 72 changing alarm limits 103
marginal impedance messages 69 indications 38 enabling alarms 103
menus 64 location 31, 39
message area 33 low priority 37
mode messages 67 manual defibrillation 81
monitoring parameters 71 medium priority 37
monitoring pulse 71 multiple alerts indicator 31
multifunction electrode pads 63 multiple conditions 37
no shock advised 66 NBP 118
pads connect messages 67 NBP limits 115, 119
pads off messages 68 notification 38
Patient Category button 27, 65 pacing 94
pause time 66 parameter area 32
pause/progress bar 63 pausing 41
precautions 62 periodic chirp 40
prompts 66 periodic verification 160
resume analyzing 64 physiological 37
shock advised 66 power-related 170
shock analysis 61 print options 149
shock button 26 pulse 113
shock counter 63 pulse limits 110
shock related messages 70 reset 41
skin prep 48 resetting 41
specifications 196 responding 41
SpO2 71 setting ECG limits 59
successful resuscitation 62 silencing 41
user messages 67 single beep 40
AED Mode 1 specifications 193
waves 53 SpO2 111
SpO2 limits 110
stored in Event Summary 133
synchronized cardioversion 88
technical 37
location 31
types 37

219
Index B

B Battery 16, 172 Configuration 26, 139


activities 168 exporting 141
Basic orientation alarms 170 importing 141
AC power cord guard 17 capacity 29 modifying settings 140
adjusting numeric values 36 charge levels 32 options 142
adjusting volume 36 charge status 168 print 141
AED View 63 charging 168 restoring defaults 142
audio tones 40 cleaning 171 saving changes 139
Auto-Gain indicator 33 discarding 169 setting date and time 140
automatic NBP measurements 118 events stored in Event Summary 128 Connect Therapy cable message in AED
battery fuel gauge 17 location 31 Mode 67
beat labels 54 low battery condition 29
maintenance 168 Connecting
cable straps 21 NBP cuff 116
calibration bar 33 Operational Check results 159
carry bags 22 power 29 Continued use 43
changing configuration settings 140 safety 169 Controls 26
changing waveforms 35 specifications 198
conventions, this book ii
cleaning 171 status 31
code view layout 77 storing 169 CPR
connecting CO2 cable 12 troubleshooting 174 in AED Mode 64
connecting ECG cable 11 user checks 160 Cuff deflation 116
connecting NBP 13 Bedside monitor Cuff pressure 115
connecting SpO2 cable 13 and synchronized cardioversion 85
controls 26 Blinking hourglass 28 D
device back 16
device front 8 Blinking red X 28
Dashed line 178
Device Info report 173 Bundle branch block 55
device shutdown 30 Data 44
display 31 C Data management 133
entering patient ID 42 available space 134
entering patient info 42 Cable management cleaning printhead 171
entering patient sex 42 cleaning side pouches 172 Data Management Mode 26
getting started 5 user checks 160 entering 134
hourglass 167 event markers 137
Cable straps 21
infant paddles 15 Event Summary, initiating 125
Lead Select button 27 Calibration bar 33 events stored in event summary 127
making a selection 35 Calling for service 187 exporting configuration 141
manual NBP measurements 118 Cannot analyze ECG 58, 178 importing configuration 141
Mark Events 43 internal memory
menus 35 Carry bags 22 data captured 134
monitoring side 11 Changing configuration settings 140 deleting data 136
Operational Check 153 Changing leads with Lead Select button 27 menus 134
pacing view 90 viewing USB drive 135
Changing NBP schedule 118 Mark Events 43
printer 9
printing a strip 137 Changing waveforms 35 patient name 31
pulse rate 110 Charge print 138
red X 167 button 26 Print button 28
restoring default settings 142 Event Summary 125 printing configuration 141
Rhythm label 33 Operational Check results 157 removing patient data 135
R-Wave arrows 33 cancelled 179 Reports button 28
selecting an SpO2 sensor 109 print options 149 Date and time
setting date and time 140 synchronized cardioversion 86 Daylight Savings Time 143
Shift Check 151 the battery 168 location 31
Smart Select Knob 27 Cleaning 171 Default configuration 142
soft keys 28 cables 171
symbols 205 Defib Disarmed 158
disinfecting 171
therapy cable 9 NBP cuff 120, 172 Defibrillating in AED Mode 64
therapy cable collar 21 printer 171 Defibrillation
therapy knob 26 side pouches 172 during pacing 94
therapy port 9 SpO2 sensors 114, 172 therapy 75
top panel 14
turning device on 30 CO2 Deleting data, from internal memory 136
turning the device off 30 see EtCO2 97 Demand Mode pacing 90, 92
CO2 Cable 12 Desat alarm 112
Color Desat limit 111
ECG options 144
NBP options 145 device
SpO2 options 146 directive i
manufacturer i

220
E Index

Device basics 7 E Entering patient information 42


Device Info report 173 Entering patient sex 42
Diastolic NBP 119 ECG Environmental specifications 202
aberrantly-conducted beats 55
directive, device i alarm chain 58, 59 EtCO2 97
Discarding the Battery 169 alarms 56 alarm 101
Alarms button 27 alarm limits 100
Disinfecting 171 changing alarm limits 102
alarms in AED Mode 60
Display 198 annotated ECG 54 changing apnea alarms 103
alarm locations 39 arrhythmia beat labels 54 disabling 105
alarm state 31 asystole alarm 57 enabling alarms 103
annotated ECG 54 Auto-Gain indicator 33 Event Summary 125
battery status 31 bandwidth 144 events in Event Summary 130
dashed lines 54 bundle branch block 55 Mainstream 97
date and time 31 Calibration bar 33 monitoring 97, 100
ECG bandwidth 144 cannot analyze 58 picking an accessory 99
general layout 31 changing waveforms 35 precautions 98
paced status 31 dashed line 54, 178 preparing 99
patient category 31 ectopic event 56 question marks 100
status area 31 electrode placement 49 Sidestream 97
trending 121 Event Summary 125 zeroing messages 105
Wave Sector 2 34 events stored in Event Summary 129 zeroing sensor 104
Wave Sector 3 34 extreme brady 57 Smart Select knob 104
Disposing the unit 172 extreme tachy 57 soft key 104
lead choices 51 Event markers 137
Lead Select button 27 Event Summary
lead selection 50 alarm identification 126
lead size, arrhythmia analysis 53 alarms 41, 126
leads rerun in Operational Check 156 charge button 125
learning 55 data collected 125
manual relearning 55 data limit 125
Mark Event button 28 device shutdown 31
Mark Events 43 ECG 125
monitor view 52 EtCO2 125
monitoring with electrodes 48 events stored 127
monitoring with pads 48 exporting de-identified data 135
normal complex 55 initiating 125
paced status 31 Mark Events 43, 125
parameter limits 145 memory full 125
Patient Category button 27 NBP 118, 125
preparing to monitor 48 pacing 89, 126
Print button 28 patient name 31
quick look 79 Print button 28
Rhythm label 33 print options 150
R-Wave arrow 33 printing a saved event 138
selecting a waveform 52 printing current event 137
setting alarm limits 59 reports 126
skin prep 48 security 204
specifications 196 SpO2 125
v-fib/v-tach 57 stored events 127
Wave Sector 1 33, 52
Wave Sector 2 34 Exiting Configuration Mode 139
Wave Sector 3 34 Exporting
waveforms 47 configuration settings 141
ECG cable 11 data 136
ECG out cable 18 External Paddles
manual defibrillation 78
Ectopic Event 56
External paddles
Electrode labels 144 cleaning 171
Electrode placement 49 Operational Check results 159
Electrodes, monitoring 48 quick look 79
shock 81
Electromagnetic Compatibility 207 synchronized cardioversion 87
Electromagnetic Interference troubleshooting 178, 180
reducing 207 external paddles 14
Emissions and Immunity 208 Extreme brady 57
Energy doses in AED Mode 148 Extreme tachy 57
Entering patient ID 42

221
Index F

F Low impedance messages 70 Markers, in Pacer Mode 89


Mean NBP 119
Factory default settings 142 M Measuring NBP 116
Fixed Mode pacing 93 Menus 35
demand vs. fixed 90 Mainstream 12
grayed out options 35
Flat line 178 Mainstream EtCO2 97
Message area 33
Forced pause messages 71 Maintenance 165
Auto Test Modifying configuration settings 140
Fourth intercostal space, locating 50 hourglass 167 Monitor
Frequency of NBP 145 results 167 SpO2 110
summary 153, 166 Monitor Mode 1, 25
G battery safety 169 Alarms button 27
battery storage 169 Mark Event button 28
Getting started 5 calling for service 187
caring for NBP cuffs 120 Monitor View 52
dashed lines 54
H cleaning SpO2 sensors 114
discarding battery 169 Monitoring ECG
Heart rate leads rerun 156 with electrodes 48
accuracy 197 Operational Check 153 with pads 48
events stored in Event Summary 128 power alarms 170 MRI 107
RFU 165
Hourglass 167 Multifunction electrode pads 10
Shift Check 151
user checks 160 Operational Check results 159
I preconnected 65
Making a selection 35 troubleshooting 178, 180
Imminent shutdown tone 40 Manual Defibrillation 1
Impedance 62 Manual defibrillation 75 N
Importing configuration settings 141 1-10 energy settings 80
adjusting volume 36 NBP 115
Indications for Use 2 alarms 81 adjusting numeric values 36
Infant paddles Alarms button 27 AED 115
using 79 charge 80 alarm limits 115, 119
infant paddles 15 charge button 26 alarms 118
code view 77 Alarms button 27
Initial NBP cuff pressure 116 automatic measurements 118
defibrillating asystole 76
Initiating an Event Summary 125 energy selected 77 changing automatic schedule 118
Insert connector, apply pads message in events stored in Event Summary 132 cleaning cuff 120, 172
AED Mode 68 external paddles 78 connecting the cuff 116
infant paddles 79 cuff deflation 116
Installed options 173 cuff pressure 115
internal paddles 79
Intended Use 2 Manual Defib Mode 25 diastolic 119
Internal memory Mark Event button 28 enabling alarms 120
data captured 134 message area 33 Event Summary 118, 125
menus 134 NBP 115 events stored in Event Summary 128,
removing patient data 135 paced status 31 131
viewing USB drive 135 Patient Category button 27 manual measurements 118
precautions 76 mean 119
Internal paddles
preparation 78 measuring 116
Joule limit 80
quick look 79 message area 33
shock 80
shock 80 Operational Check results 159
using 79
shock button 26 parameter area 32
introduction 1, 25, 83, 89, 97, 115, 121, shock counter 77 precautions 117
125, 139, 151, 165, 173, 189, 193 qx in menu 118
shock series 148
skin prep 48 specifications 201
L specifications 195 start 117
therapy knob 26 systolic 119
Lead choices 51 three steps 79 time intervals 118
Lead Select with pads 78 user checks 160
button 27, 52, 92 Manual NBP measurements 118 NBP cable 13
troubleshooting 178 No capture 57
synchronized cardioversion 85 manufacturer i
wave sector 1 33 Marginal impedance messages 69 No Power 174
Lead selection 50 Mark Event 43 No shock advised in AED Mode 66
Leads button 28 No shock delivered 62
events stored in Event Summary 128 event markers 137
pacing 89 Event Summary 125 O
events stored in Event Summary 133
Learning ECG 55 pacing 89 Online viewing only ii
Low battery condition 29 print options 150
Operating modes 25, 26

222
P Index

Operational Check 26, 153 Pacing 57, 89, 92 Pause time in AED Mode 66
battery 159 adjusting numeric values 36 Pausing alarms 41
entering 153 alarms 94
external paddles 159 Alarms button 27 PCI Indicators 14, 63, 77
leads rerun 156 changing modes 93 Physiological alarms 37
NBP 159 charge button 26 Pleth wave 111
pads 159 defibrillation 94
Poor pads contact in AED Mode 69
performing 154 Demand Mode 92, 178
print options 150 device shutdown 31 Power 29
printer 159 Event Summary 126 alarms 170
printing a report 160 events stored in Event Summary 132 battery charge levels 32
reports 161 Lead Select button 92 battery safety 169
results 156 lead sets 89 battery status 31, 168
setup screen 155 Mark Event button 28 battery storage 169
SpO2 159 markers 89 battery, Operational Check results 159
summaries 162 mode indication 90 charging the battery 168
summary 153 NBP 115 device shutdown 30
tests performed 153 not pacing 57 discarding the battery 169
user checks 160 output 90 Event Summary events 127
pace pulse duration 91 imminent shutdown tone 40
Options, configuration 142
Pacer Mode 25 indicators 30
Ordering supplies 189 pacing status 89 specifications 193
pacing status bar 89 user checks 160
P Patient Category button 27 Preconnected pads 65
preparation 91 Preparing for manual defibrillation 78
Pace pulse duration 91 pulses delivered 90
Paced Status, location 31 rate 90, 92 Press pads firmly message in AED
R-Wave arrows 89, 92 Mode 69
Pacer Not Capture 57
shock button 26 Print 137
Pacer Not Pace 57 skin prep 48 Auto Test results 163
Pacer Output 149 specifications 199 button 28
Pacer Rate 92, 149 status bar 89 cleaning printhead 171
stopped 181 configuration settings 141
stopping 92 current Event Summary 137
TENS unit affects 91 during an event 137
therapy knob 26 ECG bandwidth 144
troubleshooting 180 event markers 137
view layout 90 events stored in Event Summary 133
with a second defibrillator 94 Operational Check 159, 160
with ECG Out Cable 18 printer specifications 198
Pacing Mode 1 saved event summary 138
Trends report 123
Paddles user checks 160
events stored in Event Summary 128
Printer 19
Pads
events stored in Event Summary 128 Printing
manual defibrillation 78 a strip 137
monitoring 48 configuration settings 141
Parameter area 32 Privacy 204
Passwords 204 Pulse
Configuration mode 44, 204 adjusting numeric values 36
Data Management mode 44, 141, 204 alarm limits 110
Service mode 44, 204 alarms 113
changing alarm limits 113
Patient category enabling alarms 114
adult 61, 72 events stored in Event Summary 128,
button 27, 61, 65 130
configuration options 143 parameter area 32
infant/child 61, 72 rate 110
location on display 31
NBP 116
weight range on display 31
Q
Patient information QRS 174, 177
clearing 172 adjusting volume 36
encryption 204 configuration options 143
entering 42
Quick look 79
Event Summary 125
removing 135
Status Area 31
storage 204

223
Index R

R Shock SpO2 107


administering in AED Mode 66 accurate measurements 108
Radio frequency (RF) interference i advised in AED Mode 66 adjusting numeric values 36
button 26 AED configuration 148
Reapply pads to dry chest message in AED
Operational Check results 158 alarm limits 110
Mode 70
counter 77 alarms 111
Red X counter, AED 63 Alarms button 27
Auto Test results 167 energy dose in AED 148 and MRI 107
blinking 28 event markers 137 caring for sensors 114
solid 28 print options 149 changing alarm limits 112
Relearning ECG 55 rhythms 196 cleaning sensors 172
Removing patient data 135 series 148 desat alarm 112
synchronized cardioversion 86, 87 desat limit 111
Reports timeout 148 edematous tissue 109
button 28 enabling alarms 113
device info 173 Shutdown countdown 30
Event Summary 125
Event Summary 126 Sidestream 12 events in Event Summary 128, 129
events stored in Event Summary 127 Sidestream EtCO2 97 how it works 108
Operational Check 161 message area 33
Silencing alarms 41
printed strip 137 monitoring 110
printing configuration settings 141 Skin preparation 48
Operational Check results 159
printing Operational Check SMART Analysis Algorithm 61 parameter area 32
results 160 Smart Select Knob 27 perfusion 109
trending 123 pleth wave 111
Soft keys 28, 35, 64
Responding to alarms 41 AED Mode 64 precautions 107
Results from Operational Check 156 pulse rate 110
Software sensor 108, 109
Resume analyzing, in AED Mode 64 revision 173 specifications 199
RFU 1, 28, 165 upgrades 205 user checks 160
Rhythm label 33 Software revision 173 values 110
R-Wave Solid red X 28 SpO2 cable 13
aberrantly conducted beats 55 Specifications ST/AR Algorithm 47, 55
arrows 33 AED 196 Starting an NBP measurement 117
pacing 89 alarms 193
synchronized cardioversion 83, 86 battery 198 Storing the battery 169
defibrillator 193 Supplies, ordering 189
S display 198 Symbols 205
ECG 196
Synchronized Cardioversion
Safety environmental 202
with ECG Out Cable 18
accessory precautions 189 general 193
AED precautions 62 manual defibrillation 195 Synchronized cardioversion 86
alarm warnings 38 NBP 201 additional shocks 87
battery precautions 169 pacing 199 adjusting volume 36
general considerations 45 printer 198 alarms 88
manual defibrillation precautions 76 SpO2 199 Alarms button 27
NBP precautions 117 synchronized cardioversion 195 and a bedside monitor 85
pacing with a second defibrillator 94 USB 204 button 26
SpO2 precautions 107 Operational Check results 158
synchronized cardioversion charge 86
precautions 84 charge button 26
code view 86
Safety considerations 5
events stored in Event Summary 132
Saving configuration changes 139 lead select 85
Screen prompts, AED 66 Mark Event button 28
Security 204 message area 33
NBP 115
Select energy 79 non-paddles lead 87
Select energy menu 80 paced status 31
Selecting an SpO2 sensor 109 Patient Category button 27
precautions 84
Separation distances 216 preparation 85
Serial number 173 R-Wave 83
Service Mode 26 R-Wave arrows 86
shock 87
Setting date and time 140
shock button 26
Shift Check 151 shock delivery 86
Shift Checklist 217 skin prep 48
specifications 195
with external paddles 87

224
T Index

Systolic NBP 119 Volume 177


configuration options 143
T V-Tach 57
Technical alarms 37 W
TENS unit, pacing 91
Test load 20 Wave Menus 53
Test plug 20 Wave Sector 1 33
lead behavior 52
Therapy cable pacing 91
installing lid 21 Rhythm label options 34
therapy cable Wave Sector 2 34, 54
connecting 9
Wave Sector 3 34
Therapy knob 26
select energy 79 Waveforms 47
Time intervals for NBP measurements 118 Weekly Shock Test 20, 152, 218
Trending
adjusting report 122
Z
display 121
Zeroing EtCO2 104
Print button 28
messages 105
print from internal memory 138
Smart Select knob 104
printing reports 123
soft key 104
Trends report 125
Troubleshooting 173
AED Mode user messages 67
blinking red X 28
calling for service 187
clinical alarm area 31
Device Info report 173
external paddles 178, 180
flat line 178
Lead Select button 178
message area 33
multiple alerts indicator 31
no shock delivered 62
pacing 180
pads 178, 180
solid red X 28
symptoms 174
technical alarms location 31
Turning the device off 30
Turning the device on 30

U
USB
accessing the drive 136
exporting Auto Test results 163
exporting configuration settings 141
security 204
specifications 204
user checks 160
viewing the drive 135
USB port 16
User checks during Operational Check 160
User messages in AED Mode 67

V
V-Fib 57
Viewing USB drive 135
viewing, online ii
Voice prompts
adjusting volume 36
AED 66

225
NOTES

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453564403811
On the web Edition 2.0
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By e-mail *453564403811*
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