CARE P&L

Product Support Launch Plan

Engström Carestation

Rev: 1.5
Date: October 2004
Doc: PSLP Engström Carestation Rev 1.5
Localized By: Marlin Rogers/Service Delivery Engineer

Product Support Launch Plan, Engström Carestation

Page 1
Table of Contents

1 Introduction

2 Product Information

2.1 Product Launch Schedule

2.2 Product Description
2.2.1 Product Features
2.3 Product Specifications
2.3.1 Technical Specifications
2.3.2 Safety Standards and Specifications
2.4 Warranty
2.4.1 Product Warranty
2.4.2 Spare Part Warranty
2.4.3 Sonar Reporting
2.5 Product Discontinuance

3 Service Support Policy

3.1 Technical Support

3.2 Technical Training
3.2.1 Technical Training Material
3.3 Installation and Configuration
3.4 Planned Maintenance
3.5 Field Repair Strategy
3.6 Factory Repair and Exchange Service
3.7 Traceability

4 Service Support Materials

4.1 Tools and Test Equipment

4.2 Documentation
4.3 Spare Parts
4.4 Exchange Parts

Product Support Launch Plan, Engström Carestation

Page 2
1 Introduction
This document contains the service support launch plans for the Datex-
Ohmeda Engström Carestation and is intended to be used as a tool by
Datex-Ohmeda Subsidiaries and Distributors as a guide in preparing local
product launch and service business plans.

The information contained within this plan is valid as of the date shown on
the front cover, but is subject to change without further notice.

2 Product Information
2.1 Product Launch Schedule
CARE Marketing, in conjunction with the channel organizations, will
determine the launch schedule for each country.

Activity Estimated Date Market

User Preference Trials May – Sep 2004 Austria, Netherlands,
UK, Australia

Product Launch Oct 2004 Europe / Australia

Pending 510K USA

2.2 Product Description

The Engström Carestation is a flexible, adaptable, and intuitive critical care
ventilator. A wide selection of performance options gives the user full control
of the system configuration.

2.2.1 Product Features

• The ventilator is designed to be used with infant through adult patients
with a body weight of 5 kg or greater. The Engström Carestation is
designed to maintain lung ventilation in the absence of spontaneous
breathing effort as well as in support of the patient’s existing spontaneous
breathing effort. The Engström Carestation is not designed for use during
the transport of patients.
• The ventilator consists of three main components: a display, a ventilator
unit, and an optional module bay. The display allows the user to interface
with the system and control settings. The ventilator unit controls electrical
power, nebulization, and pneumatic gas flow to and from the patient. The
module bay allows the integration of various patient-monitoring modules
with the ventilator.
• Optional accessories include an air compressor, airway modules, module
bay, humidifier and water trap mounting brackets, and auxiliary electrical
outlets.

Product Support Launch Plan, Engström Carestation

Page 3
2.3 Product Specifications
2.3.1 Technical Specifications
All specifications are approximate values and can change without notice.

Mechanical construction

EV with the cart EV without the cart

Height (display up) 144 cm Height (display up) 66 cm

Height (display down) 123 cm Height (display down) 46 cm

Width 53 cm Width 38 cm

Depth 78 cm Depth 36 cm

Weight 66 kg Weight 29 kg

Environmental specifications

Thermal Humidity Altitude

15 to 95% RH, -440 to 3565 m
Operating range 10 to 40 º C
non-condensing (800 to 500 mmHg)
15 to 95% RH, -440 to 5860 m
Storage range -20 to 50 º C
non-condensing (800 to 375 mmHg)

Pneumatic specifications

Supply gas Medical Air and Oxygen

Supply pressure 240 to 641 kPa / 35 to 94 psi

Supply gas flow - peak 160 l/min per gas supply

100 cmH2O
Maximum limited pressure
Range of inspiratory pressure 5 to 100 cmH2O ± 10%
Minimum limited pressure
-1.5 cmH2O
(subatmospheric)
Maximum working pressure range 12 to 100 cmH2O

Product Support Launch Plan, Engström Carestation

Page 4
 Electrical requirements

85 to 132 VAC, 47 / 63 Hz
Supply voltage (switchable)
187 to 264 VAC, 47 / 63 HZ

Electrical power consumption < 200 W

Internal batteries
The Engström Carestation is not designed for use during the transport of patients
between facilities. Two internal 12 VDC sealed lead-acid batteries supply battery
backup. Batteries are used as backup power in case of a power failure. The battery
is in a float charge state as long as the system is connected to a primary electrical
source.
• Capacity to operate for > 30 minutes minimum, 120 minutes typical, battery fully
charged
• Ampere-hour rating: 4 A-h
• Voltage requirement: 12 VDC
• Current requirement: 7.5 A
• Shelf life: 9 months following last charge.
• Recharge time: full discharge to full charge in 8 hours.
• Estimated life: four to six years; 250 100% discharge cycles.
• The System Status menu shows the status of the internal battery.

2.3.2 Safety Standards and Specifications

• Reference Section 11 of the Engström Carestation User Reference

Manual. P/N 1505-1000-000

2.4 Warranty
2.4.1 Product Warranty
The warranty period for the Datex-Ohmeda Engström Carestation is 12
months from the date of original delivery to Buyer or to Buyer’s order, but in
no event for a period of more than two years from the date of original
delivery by Datex-Ohmeda to a Datex-Ohmeda Autherized Dealer.
(Reference warranty statement in the User Reference Manual)

Disposable accessories and supplies are intended for single use, therefore
the warranty is limited to ninety (90) days from the date of shipment or when
used, whichever comes first.

2.4.2 Spare Part Warranty

Delivered spare parts have 3 months warranty from the date of original
shipment from the manufacturing site.

Product Support Launch Plan, Engström Carestation

Page 5
 2.4.3 Sonar Reporting
Issues or problems encountered during installation or during the warranty
period should be reported through Sonar. As always, please follow the US
escalation pathway – MS00055. Keep in mind any Out of Box Failures should
be reported through Sonar via MW 19070.

Please follow the guidelines in the SOP MW01041 Product Compliant Decision
Process and the guidelines in the SOP # MW19301 section 3.6.2, for returning
parts.

2.5 Product Discontinuance

Best effort will be made to provide factory support for delivered units for a
minimum of 7 years after announced sales discontinuance.

3 Service Support Policy

3.1 Technical Support
Technical support for the Engström Carestation will be provided by trained
personnel through the existing service channels currently utilized for support
of other CARE P&L systems as follows:

• It is the responsibility of the US Technical Support to provide first level

technical support to the end user customer.
• If required, second level technical support will be escalated by the US
Technical Support though the Madison Technical Support.

Technical Support HelpDesk Contact information:

Telephone Support (Monday – Friday):
7:00AM to 6:00PM CST

Phone number: (800) 345-2700

Product Support Launch Plan, Engström Carestation

Page 6
 3.2 Technical Training

Technical training for the Engström Carestation will be provided by the US

Technical Training Department under the following guidelines:

• The Technical Training Team will determine the best method and media
to use to deliver training to local country service organizations based on
the individual requirements of each territory.
• The development of the technical training materials required for class
presentations will be managed by the Technical Training Team.

Note: The US Technical training Department should be contacted for

additional details regarding class schedules and availability.

3.2.1 Technical Training Material

The following material will be provided to each student attending technical

training for the Engström Carestation.
• Technical Reference Manual (TRM)
• User Reference Manual (URM)
• Training PowerPoint Presentations
• Windows based EV Service Application: P/N 1505-8001-000

3.3 Installations and Configuration

The Datex-Ohmeda Service Representative should perform the following
system setup, calibration, and preoperative tests during the installation of
the Engström Carestation:

Unpack and setup the Engström Carestation per Section 3 “Setup and
Connections” of the User’s Reference Manual.

Turn system on per Section 4, Page 4-2 of the User’s Reference Manual.

Access the Installation and Service menus per Section 4.1 of the
Technical Reference Manual.

Access the Service menu per Section 4.4 of the Technical Reference
Manual and perform:
Configuration: Set language, altitude and units.

Product Support Launch Plan, Engström Carestation

Page 7
 (Note: Copy Configuration Menu can be used to save a configuration to a
PCMCIA card and then copy the configuration to additional machines)
Service Log: Review and reset error and alarm log entries.

Access the Install/Service menu per Section 4.2 of the Technical

Reference Manual and set the following as required:
Colors – Set Colors
Units – Set Units
Show Alarm Limits – Yes/No
Time and Date – Set clock and calendar
Defaults – Set or change defaults
Calibration – Calibrate airway gas and test backlights

Perform the Pre-use Checkout per Section 4, Page 4-2 of the User’s
Reference Manual.

3.4 Planned Maintenance

The recommended service level PM interval for the Engström Carestation
is every 12 months. Reference Section 6 of the Technical Reference
Manual for PM requirements.

3.4.1 PM Parts

Part Number Description Replacement

Frequency
1505-3027-000 Vent Engine Fan Filter As Required
897010 Display Unit Fan Filter As Required
1504-3708-000 Gas Inlet Filters As Required
1009-5682-000 Battery, Sealed Lead 48 Months *
(2 required) Acid 12V

*Battery replacement may be extended to a maximum of 72 months (6years)

by performing the battery capacity test in Section 6.2 of the Technical
Reference Manual during the 48-month inspection.

3.4.2 Estimated PM Times

12 Month PM 2.0 hours

48 Month PM 3.0 hours *

Product Support Launch Plan, Engström Carestation

Page 8
3.5 Field Repair
The Engström Carestation will typically be repaired at the customer’s site
utilizing a sub-assembly or component level parts replacement strategy. The
system has been designed to allow easy access to all electrical and
pneumatic components and sub-assemblies. Troubleshooting, repair and
part replacement procedures are covered in the Technical Reference
Manual. Once a defective part has been identified and a replacement part
obtained, the time required to replace it should typically be less than twenty
minutes.

Note: Datex-Ohmeda does not support repair or replacement of individual

components beyond the level specified in the Technical Reference Manual.

3.5.1 Checks Required After Field Repair

Perform the Checkout Procedure per Section 3 in the Technical Reference
Manual after any repair or service.

3.6 Factory Repair and Exchange Service

Does not apply. The CARE P&L does not offer a factory repair service for
the Engström Carestation.

3.7 Traceability
Datex-Ohmeda shall maintain serial and/or lot number and date of shipment records
for each Product so that, if necessary for corrective action purposes, the Product can
be identified and traced. In addition, each Party shall maintain the same or similar
records with respect to its components that are incorporated within the Product so
that, if necessary for corrective action purposes, the manufacturing and delivery lot
for such products can be identified and traced.

Product Support Launch Plan, Engström Carestation

Page 9
4. Service Support Materials
4.1 Tools and Test Equipment
4.1.1 Test Equipment

Description Minimum Stock Number

Specification
Leakage Current Test Approved test Dale 600
Device (reference TRM device (e.g. UL,
Section 3.5) CSA, or AAMI)
Low Pressure Test Device 0-150cmH20, ±2% Meriam Smart
(digital manometer or test of reading Manometer
gauge)

4.1.2 Special Tools

Description Stock Number

Manual shut off valve, O2 1505-8578-000
Manual shut off valve, Air 1505-8579-000
Cable, Display Unit (to be used when 1505-5600-000
removing engine from main enclosure)
Handle f/OF302-1.5SDA complete 5370055
(Service Handles for Jun-Air
Compressor)
Tool, Nebulizer connector removal 1505-8506-000

4.1.3 Software Tools

Description Stock Number

Windows based EV Service Application 1505-8001-000
RS-422 to USB Adapter w/PC cable 1505-8586-000
System Software / Service Diagnostic &
Troubleshooting Software (compact
flash) 1505-8000-000

Cable, USB Converter to Engström

1505-8587-000
Ventilator
PCMCIA Adapter for Compact Flash 1009-5874-000

4.1.4 Leak Test Devices

Description Stock Number

* EV Leak Test Device Kit 1505-8590-000
* Includes the following parts:
SYRINGE, 60ML LUER-LOK 1505-3061-000
Product Support Launch Plan, Engström Carestation

Page 10
 Description Stock Number
Clamp, tubing 7000-0000-097
Tee, 1/8 inch barb 7000-0000-186
Negative low pressure leak test device 0309-1319-800
Tee, sensing
0212-0763-100
22 mm to 15 mm
Connector, Endo tube 0219-5060-530
Plug, 4 mm 1006-3530-000
Plug, stopper (2 ea) 2900-0001-000
Silicone tubing 3/16 inch ID
1006-3666-000
(length = 24 inches)
Tubing, clear 1/8 inch ID
0994-6370-010
(length = 2 inches)

4.2 Documentation
User and Technical Reference Manuals for the Engström Carestation is
available through the normal Datex-Ohmeda distribution channels.

Technical Reference Manuals:

Part Number Description Scheduled Availability
1505-1018-000 Engström Carestation, English * October 2004
6189655 EVair03 Air Compressor Available

* Preliminary version available to support technical training classes

User Reference Manuals:

Part Number Description Scheduled Availability
1505-1000-000 Engström Carestation, English Available
1505-1012-000 Engström Carestation, Spanish Available

For the latest revision please refer to the GEMS-IT Instrumentarium US

Service Support Community on SupportCentral.

Product Support Launch Plan, Engström Carestation

Page 11
4.3 Spare Parts
The Engström Carestation Technical Reference Manual identifies all sub-
assemblies and components that are available as repair or maintenance
parts.

Tools & Spare Parts

Minimum Stocking
Recommendations
Stock Number Part Description X = Part
Also Used
on Avance
Service Tools Required per Rep
1505-8578-000 Manual shut-off valve — O2
1505-8579-000 Manual shut-off valve — AIR
1505-8590-000 EV Leak Test Devices Kit
755581 Airway Module Calibration Gas
755583 Airway Module Calibration Gas X
755534 Calibration Gas Regulator X
1505-8586-000 RS-422 to USB Adapter w/PC cable
1505-8587-000 Cable, USB Converter to Engström Ventilator
1505-8001-000 Windows Based EV Service Application
1505-8000-000 System Software / Service Diagnostic &
Troubleshooting Software (compact flash)
1009-5874-000 PCMCIA Adapter for Compact Flash X
1505-8506-000 Tool, Nebulizer connector removal
1505-5600-000 Cable, Display Unit (to be used when
removing engine from main enclosure)
5370055 Handle f/OF302-1.5SDA complete
(Service Handles for Jun-Air Compressor)

Lubricants and Adhesives

1001-3854-000 Lubricant, Krytox GPL 205, 2 oz
0220-5017-300 Thread Lock, Loctite No 24221 (medium
strength), 10 ml
0220-5021-300 Thread Lock, Loctite No 271 (high strength),
10 cc

Display Module
1009-8243-000 Backlight Kit X
1009-8289-000 CPU Board, Display unit (with PCMCIA
Frame)

Product Support Launch Plan, Engström Carestation

Page 12
 1503-3012-000 Encoder Assembly X
898794 Knob, Com Wheel X
1009-5505-000 Membrane Switches, Right Side X
1009-5507-000 Membrane Switches, Lower X
1009-5506-000 Membrane Switches, left
Language Specific (see TRM) Keypad Set
1009-5938-000 Display, LCD 12-inch Color (includes
backlights)
897010 Filter, Fan X
1009-5679-000 Door, PCMCIA X

Main Enclosure (external)

1505-3027-000 FILTER Fan 80 MM
1503-3073-000 Fuse, 2A 250V 5X20 mm Delayed Time
1605-3043-000 Switch, On/Standby DPST
1505-5600-000 Cable, Display Unit
1505-3411-000 Cover Display Arm
1505-3416-000 Cover Display Unit Pivot Mount

Main Enclosure (internal)

1505-5000-000 Power Supply Module
1505-5502-000 Power Management Board (PMB)
1505-5501-000 Vent Monitor Board (VMB)
1505-5500-000 Vent Control Board (VCB)
1009-5682-000 Battery (Internal) X

Vent Engine
1505-3256-000 Regulator w/screws
1505-3218-000 Restrictor, Pneumatic
1505-3220-000 Gasket, Pneumatic restrictor
1505-3208-000 Transducer Flow 0-160 LPM
1505-3209-000 Valve Flow Control 160 LPM
1505-3215-000 Transducer O2 Conc
1006-3616-000 O-ring, EPR, 2-016
1505-3262-000 Gasket Inspiratory Manifold
1503-3204-000 Valve Seat Free Breathing
0211-1454-100 Valve Flapper (Free Breathing)
1503-3208-000 O-ring, EPR, 2-126
1505-5706-000 Harness (vent engine to VCB/VMB)
1505-3267-000 Valve Umbrella Check

Product Support Launch Plan, Engström Carestation

Page 13
 1505-8502-000 Manifold Inspiratory Valve Assy
1505-8503-000 Pressure Sensor Assembly
1505-3059-000 O-Ring, VITON, BS 4518 0717-16

Outlet manifold
1505-3227-000 Actuator Voice Coil
1505-8568-000 Exhalation Valve Housing Assy
1505-3224-000 Diaphragm
1505-3225-000 Seal Rolling Shaft
1505-3236-000 Pull Exh Housing Latch
1505-3251-000 PCA Ultrasonic Neb Control
1505-5508-000 PCA Exh Flow Interface Brd
1505-5507-000 PCA Exh Flow Snsr Brd

Inlet manifold
1006-3430-000 Check Valve
1504-3708-000 Filter Disc, Wire Mech 2 Micron
1504-3612-000 O-ring, EPR 2-122 70 duro
1011-3413-000 Transducer, Pressure 827 kPa

Exhalation valve assembly

1505-8568-000 Exhalation valve assembly
(without flow transducer)
1505-3224-000 Diaphragm
1505-3223-000 Seal
1505-3257-000 Seal
1505-3039-000 Retaining ring
1505-3231-000 Flow transducer
(Includes check valve and screen)
1505-3244-000 Water Trap
1505-3009-000 O-Ring

AC Power Cords
1505-3041-000 Retainer, Outlet Power Cord Jumper
1505-3033-000 Retainer, Inlet Power Cord
0140-6219-130 Screw, M3X8 PAN HD Sems

Cart
21947-029 Caster Swivel 5” without Lock
21947-028 Caster Swivel 5” with Lock

Product Support Launch Plan, Engström Carestation

Page 14
 Module Rack
1505-5601-000 Cable, Patient Module Rack

Air Compressor
6985795 Air inlet filter
5471001 Filter kit f/OF302-1.5SDA
1006-3614-000 O-Ring –019 70 EPDM

4.4 Exchange Parts

No exchange parts have been identified for this product

Product Support Launch Plan, Engström Carestation

Page 15