Anestar - User Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 99

Anestar™

Anesthesia Delivery System


Operating Instructions
Table of Contents

Introduction .........................................................................................................................................................v
Warnings and Precautions.............................................................................................................................vi
Symbols and Descriptions ......................................................................................................................... viii
Description and Utilization........................................................................................................................... 1 - 1
Product improvements.............................................................................................................................. 1 - 2
Responsibilities of operators............................................................................................................. 1 - 2
Functional Description.................................................................................................................................. 2 - 1
Anesthesia ventilator ................................................................................................................................ 2 - 1
Fresh gas decoupling......................................................................................................................... 2 - 2
Constant volume provided by controlled ventilation........................................................................ 2 - 2
Compliance compensation ................................................................................................................ 2 - 2
Bag-in-bottle system ......................................................................................................................... 2 - 2
Fresh gas dosing ...................................................................................................................................... 2 - 3
Vaporizer ................................................................................................................................................. 2 - 4
Vaporizer mounting device ............................................................................................................... 2 - 4
Patient Module ........................................................................................................................................ 2 - 5
Circuit absorber system..................................................................................................................... 2 - 5
CO2 absorber..................................................................................................................................... 2 - 5
Reservoir and manual ventilation bag............................................................................................... 2 - 5
Volume measurement ....................................................................................................................... 2 - 5
Oxygen measurement........................................................................................................................ 2 - 5
Patient Module heating ..................................................................................................................... 2 - 6
Touchscreen interface ............................................................................................................................. 2 - 7
Ventilation Mode Rotary Knob......................................................................................................... 2 - 7
Key descriptions................................................................................................................................ 2 - 7
Options ...................................................................................................................................... 2 - 7
Alarm Limits ............................................................................................................................. 2 - 8
View Settings ............................................................................................................................ 2 - 8
Tidal Vol./Flow (CMV mode) .................................................................................................. 2 - 8
Tidal Vol/Flow (PCV mode) .................................................................................................... 2 - 8
Resp. Rate ................................................................................................................................. 2 - 8
I:E .............................................................................................................................................. 2 - 8
PEEP ......................................................................................................................................... 2 - 8
Plateau pressure (CMV mode) .................................................................................................. 2 - 9
Enter .......................................................................................................................................... 2 - 9
Up / Down Arrow ..................................................................................................................... 2 - 9
Mute .......................................................................................................................................... 2 - 9
Vent Mode ................................................................................................................................ 2 - 9
Default Settings................................................................................................................................. 2 - 10
Operating Elements/Connections for Appliances....................................................................................... 3 - 1
Views of machine..................................................................................................................................... 3 - 2
Front of machine ............................................................................................................................... 3 - 2
Rear of machine ................................................................................................................................ 3 - 3
Left side of machine.......................................................................................................................... 3 - 4
Right side of machine ....................................................................................................................... 3 - 5
Ventilator unit .......................................................................................................................................... 3 - 6

Anestar™ Operating Instructions 0070-00-0516 i


Table of Contents

Ventilation Modes - selection switch................................................................................................ 3 - 6


Gas dosing arrangement ........................................................................................................................... 3 - 7
Vaporizer mounting manifold .................................................................................................................. 3 - 8
Patient Module (breathing circle system)................................................................................................. 3 - 9
Sample gas recirculation .......................................................................................................................... 3 - 10
Advisory and Alarm Messages ..................................................................................................................... 4 - 1
Corrective Action for Advisory and Warning Alarm Signals.................................................................. 4 - 1
Definition of Categories ........................................................................................................................... 4 - 15
Alarm functions test ................................................................................................................................ 4 - 16
Apnea Alarm ..................................................................................................................................... 4 - 16
Peak pressure is greater than Pmax................................................................................................... 4 - 16
FiO2 is greater than O2 minimum .................................................................................................... 4 - 16
Startup and Functional Tests ....................................................................................................................... 5 - 1
Installation................................................................................................................................................ 5 - 1
Initial Setup ............................................................................................................................................. 5 - 2
Checkout recommendations .................................................................................................................... 5 - 3
Pre-operation steps ................................................................................................................................... 5 - 3
Before every patient ................................................................................................................................. 5 - 3
Perform every 3 days (or when prompted by the Anestar) ..................................................................... 5 - 4
Perform after changing Pre-Packs or after changing the vaporizer. ........................................................ 5 - 4
Anestar startup ......................................................................................................................................... 5 - 5
System start ....................................................................................................................................... 5 - 5
Pressure test....................................................................................................................................... 5 - 6
Standby mode options window ............................................................................................................... 5 - 9
O2 sensor calibration ........................................................................................................................ 5 - 10
Leak test ............................................................................................................................................ 5 - 13
Pressure Test ..................................................................................................................................... 5 - 17
Operation of Individual Functions............................................................................................................... 6 - 1
Standby mode........................................................................................................................................... 6 - 1
Manual ventilation mode.......................................................................................................................... 6 - 2
Manual ventilation mode settings ..................................................................................................... 6 - 2
Alarm Limits setting (manual).......................................................................................................... 6 - 3
CMV ventilation mode ............................................................................................................................ 6 - 4
CMV ventilation mode settings ........................................................................................................ 6 - 4
PCV Ventilation mode ............................................................................................................................ 6 - 6
PCV ventilation mode settings.......................................................................................................... 6 - 6
Alarm limits setting (CMV / PCV) ................................................................................................... 6 - 9
Operators Maintenance ................................................................................................................................ 7 - 1
Dismantling and Reassembling ................................................................................................................ 7 - 1
Patient Module .................................................................................................................................. 7 - 1
CO2 absorber canister (see figure 7-1) ............................................................................................. 7 - 1
Bag-in-bottle system (see figure 7-1)................................................................................................ 7 - 2
Dismantling the Airway Pressure Limiting Valve (APL) ........................................................ 7 - 3
Replacing Air, Inspiration, Expiration, and APL Valve Components
and Bag Arm (see figure 7-2) ............................................................................................... 7 - 3

ii 0070-00-0516 Anestar™ Operating Instructions


Table of Contents

Replacing Diaphragm Valve Components (see figure 7-2) ...................................................... 7 - 4


Connection and disconnection of the vaporizers .............................................................................. 7 - 5
Cleaning and sterilization......................................................................................................................... 7 - 5
Cleaning the housing......................................................................................................................... 7 - 5
Patient Module .................................................................................................................................. 7 - 5
Sterilizing the Patient Module .................................................................................................. 7 - 5
Specifications.................................................................................................................................................. 8 - 1
Safety Designations ................................................................................................................................ 8 - 1
General .................................................................................................................................................... 8 - 2
Dimensions........................................................................................................................................ 8 - 2
Weight............................................................................................................................................... 8 - 2
Environmental .......................................................................................................................................... 8 - 2
Electrical .................................................................................................................................................. 8 - 3
Electrical Power Requirements ......................................................................................................... 8 - 3
Battery Power Requirements ............................................................................................................ 8 - 3
Auxiliary Outlets............................................................................................................................... 8 - 3
Pneumatic ................................................................................................................................................ 8 - 4
Central Gas Supply Requirements .................................................................................................... 8 - 4
Cylinder Gas Supply Requirements.................................................................................................. 8 - 4
Gas Management...................................................................................................................................... 8 - 4
Ratio System ..................................................................................................................................... 8 - 4
Patient Module / Circular System ........................................................................................................... 8 - 5
Ventilator ................................................................................................................................................. 8 - 6
Accuracy of the measurements ...................................................................................................... 8 - 7
Inputs / Outputs ....................................................................................................................................... 8 - 8
Electrical ........................................................................................................................................... 8 - 8
Input Power ............................................................................................................................... 8 - 8
Auxiliary Outlets ....................................................................................................................... 8 - 8
O2 Sensor .................................................................................................................................. 8 - 8
Pneumatic.......................................................................................................................................... 8 - 8
Pipeline connections ................................................................................................................. 8 - 8
Cylinder connection(s) .............................................................................................................. 8 - 8
Vaporizer connection(s) ............................................................................................................ 8 - 8
Patient Module connections ...................................................................................................... 8 - 8
Aux O2 connector ..................................................................................................................... 8 - 8
Recirculation gas collector ........................................................................................................ 8 - 9
Displays / Controls .................................................................................................................................. 8 - 10
Electronic .......................................................................................................................................... 8 - 10
Display ...................................................................................................................................... 8 - 10
Advisory and Alarm LEDs ....................................................................................................... 8 - 10
Mode Selector Switch ............................................................................................................... 8 - 10
Pneumatic.......................................................................................................................................... 8 - 11
Line Pressure Gauges ................................................................................................................ 8 - 11
Cylinder Pressure Gauges ......................................................................................................... 8 - 11
Flowmeter and Control Valve ................................................................................................... 8 - 11
O2 Flush .................................................................................................................................... 8 - 11
Changeover Switch ................................................................................................................... 8 - 11

Anestar™ Operating Instructions 0070-00-0516 iii


Table of Contents

Patient Module .......................................................................................................................... 8 - 11


Warranty ........................................................................................................................................................ 9 - 1
Datascope’s Responsibility ...................................................................................................................... 9 - 2
How to Get Help ...................................................................................................................................... 9 - 2
Checkout Recommendations ...................................................................................................................... 10 - 1
Checkout Steps....................................................................................................................................... 10 - 1

iv 0070-00-0516 Anestar™ Operating Instructions


Introduction

The Anestar Anesthesia Delivery System Operating Instructions are intended to provide
information for proper operation.

General knowledge of anesthesia and an understanding of the features and functions of the
Datascope Anestar Anesthesia Delivery System are prerequisites for its proper use.

Do not operate this machine before reading these instructions.

Information for servicing this instrument is contained in the Anestar Service Manual. For
additional information or assistance, please contact an authorized Datascope
representative in your area.

CAUTION: Federal Law restricts this device to sale by or on


the order of a physician or other practitioner
licensed by state law to use or order the use of
this device.

Anestar™ Operating Instructions 0070-00-0516 v


Introduction Warnings and Precautions

Warnings and Precautions


Please read and adhere to all warnings, precautions and notes listed here and in the
appropriate areas throughout this manual.

WARNINGS alert the user to potential serious outcomes (death, injury or serious adverse
events) to the patient or user.

PRECAUTIONS alert the reader to exercise special care necessary for the safe and
effective use of the device.

WARNING: In order to prevent an electric shock, the machine


(protection class I) may only be connected to a
correctly grounded mains connection (socket
outlet with grounding contact).

WARNING: Possible explosion hazard. Do not operate


machine near flammable anesthetic agents or
other flammable substances. Do not use
flammable anesthetic agents (i.e., ether or
cyclopropane.)

WARNING: The use of anti-static or electrically conductive


breathing tubes, when utilizing high frequency
electric surgery equipment, may cause burns and
is therefore not recommended in any application
of this machine.

WARNING: Possible fire hazard. Fuses (i.e., additional


sockets) must only be replaced by fuses of the
same type and with the same rating.

WARNING: Possible electric shock hazard. The machine may


only be opened by Datascope qualified or
Datascope authorized service personnel.

WARNING: Compressed gasses are considered Dangerous


Goods/Hazardous Materials per I.A.T.A. and D.O.T.
regulations. It is a violation of federal and
international law to offer any package or over
pack of dangerous goods for transportation
without the package being appropriately
identified, packed, marked, classified, labeled
and documented according to D.O.T. and I.A.T.A.
regulations. Please refer to the applicable I.A.T.A.
Dangerous Goods Regulations and /or the Code of
Federal Regulations 49 (Transportation, Parts
171-180) for further information.

CAUTION: Carry out the daily checks specified on the


checklist and do not operate the system in case
of a fault until the fault has been repaired.

vi 0070-00-0516 Anestar™ Operating Instructions


Warnings and Precautions Introduction

CAUTION: If possible, always connect the output of the


ventilation pressure valve (APL) to the anesthetic
gas removal line, usually installed in the
operating suite.

CAUTION: The patient should be visually monitored by


qualified personnel. In certain situations
circumstances may occur which may not
necessarily trigger an alarm.

CAUTION: Always set the alarm limits so that the alarm is


triggered before a hazardous situation occurs.
Incorrectly set alarm limits may result in
operating personnel not being aware of changes
in the patient’s condition.

CAUTION: This machine must only be operated by trained,


skilled medical staff.

CAUTION: Before starting the machine, the operating


personnel must be familiar with Operating
Instructions and must have been trained by a
Datascope representative.

CAUTION: If the machine does not function as described,


the machine must be examined and possibly
repaired by qualified service personnel, before
being returned to use.

CAUTION: Handle the machine with care to prevent damage


or functional faults.

CAUTION: Ensure that the gas supply of the machine always


complies with the technical specification.

CAUTION: Before clinical use, the machine must be


correctly calibrated and/or the respective
machine tests performed, as described in the
Operating Instructions.

CAUTION: If the machine should show faults during the


initial calibration or testing, the machine should
not be operated until the fault has been repaired
by a qualified service person.

CAUTION: After servicing, functional, sensor and system


tests must be carried out before clinical use.

CAUTION: Only bacterial filters with a low flow resistance


must be connected to the patient module and/or
the patient connection.

CAUTION: Failure to connect device to a grounded mains


outlet may elevate leakage current in excess of
permissible values when auxiliary AC outlets are
utilized.

Anestar™ Operating Instructions 0070-00-0516 vii


Introduction Warnings and Precautions

CAUTION: During transportation of the Patient Module, the


transportation protection should be applied to the
rear to protect the diaphragm valves.

CAUTION: After changing the pre-packs, carry out a fresh-


gas system leak test.

CAUTION: The spring in the top of the Airway Pressure


Limiting valve may not be stressed. After removal
from the bottom section, place the top section to
one side, taking care that the spring is not unduly
loaded.

CAUTION: Only vaporizers with Interlock-System may be


used with the Anestar unit.

CAUTION: After each exchange of a vaporizer, carry out a


fresh-gas system leak test.

CAUTION: Use cleaning agent sparingly. Excess fluid could


enter the machine, causing damage.

CAUTION: The patient dome of the bag-in-bottle system


cannot be autoclaved. It is not in contact with the
ventilation gas. If soiled, the patient dome should
be cleaned with water and liquid cleaning agent.
The unit can be disinfected with a standard
surface-disinfecting agent. Do not use alcohol.

CAUTION: Do not clean the machine while it is on and/or


plugged in.

Copyright © Datascope Corp., 2001. Printed in U.S.A. All rights reserved. Contents
of this publication may not be reproduced in any form without permission of
Datascope Corp.

viii 0070-00-0516 Anestar™ Operating Instructions


Introduction Symbols

Symbols and Descriptions


SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying


Type B Equipment
Documents / Refer to Manual

On/Off Switch Type BF Equipment

Alternating Current Data Output

Anestar™ Operating Instructions 0070-00-0516 ix


1.0 Description and Utilization

Introduction
The Anestar Anesthesia Delivery System represents a flexible anesthesia workplace for
implementing and monitoring inhalation anesthesia in the semi-closed system and the
closed circuit system for low-flow techniques with minimum gas and anaesthetic agent
utilization.

The standard model contains the following system components:

A. Electronic ventilator
The micro processor-controlled ventilator allows constant-volume ventilation for all
patient groups with a body weight of 4 kg and upwards. Due to the system compliance
compensation, even small tidal volumes can be precisely administered. The ventilation
type, CMV and PCV mode, as well as others various forms of artificial ventilation,
facilitate secure ventilation, even for complicated lung conditions. The clear design of the
user interface and the display allow the secure operation and quick detection of the
selected ventilation parameters.

B. Patient Module
The circular patient absorber system is integrated into an aluminum block. The block is
heated to prevent the formation of condensation. The block also contains an emergency air
valve, a fresh gas reservoir in the form of a hand-held anesthesia bag, and an expiratory
flow sensor. All sensors are automatically calibrated during the start-up of the machine
and continuously monitored during operation.

Anestar™ Operating Instructions 0070-00-0516 1-1


Product improvements Description and Utilization

C. Integrated fresh-gas dosing system, including


vaporizer unit
The flowmeter tube block contains all mandatory safety equipment as well as a pneumatic
control system or hypoxic guard to maintain a minimum oxygen concentration of 25% in
the fresh-gas flow (ratio system).

1.1 Product improvements


Datascope Corp. retains the right to carry out modifications or update the machine and/or
operating instructions without prior notification. These Operating Instructions explain all
features of the Anestar Anesthesia Delivery System and are correct at time of
manufacture. Instructions and models produced at a later stage, may contain
improvements or modifications that were not included in previous models.

1.1.1 Responsibilities of operators

The correct functioning of the Anestar Anesthesia Delivery System can only be
guaranteed if the machine is operated and serviced in accordance with the information
provided by the manufacturer. The non-compliance with this information voids all
guarantee claims against Datascope Corp.

NOTE: Before using the machine, please read the


Operating Instructions including the section
“Warnings and Precautions” on page vi, observing
all information contained in these Operating
Instructions that are highlighted with CAUTION or
WARNING. These operating instructions only
describe the operation of the machine.
Information about service and repair by
Datascope employees or authorized distributors
is contained in the Anestar™ Service Manual.

The machine must only be operated by qualified and trained Datascope personnel. All
operators must fully observe these Operating Instructions or relevant additional
documentation and information provided by the manufacturer. They must also comply
with the Warnings and Precautions detailed in this manual and must be trained by a
Datascope representative.

1-2 0070-00-0516 Anestar™ Operating Instructions


2.0 Functional Description

2.1 Anesthesia ventilator


Ventilators are described according to the principle of controlling the change over from
inspiration to expiration. The Anestar machine offers the following characteristics in the
controlled ventilation modes.

Time- The timely sequence of inspiration and expiration has been specified
controlled by the ventilation frequency settings. The ratio of the inspiration to the
expiration time of the individual ventilation cycle is determined by the
adjustable I:E ratio.
Pressure The tidal volume during a controlled ventilation is supplied during the
limitation entire period of the inspiratory flow and can be set as a ventilation
parameter. The inspiration phase can be terminated before the tidal
volume has been delivered if the measured airway pressure reaches
the set peak pressure alarm limit.
Constant The inspiratory flow to the patient required, according to the set
volume parameters of frequency, tidal volume, and ventilation time ratio, is
automatically calculated by the ventilator. This inspiratory flow is
generated via the drive gas for the patient module. In standard
anesthesia ventilators, deviations to the tidal volume actually supplied
to the patient can occur due to the respective fresh gas setting and
system compliance of the ventilation system. The ventilator of the
Anestar machine has in each setting a constant volume. The patient
module containing the bellows is decoupled from the fresh gas, and
the system compliance of the patient module is automatically taken
into consideration by the ventilator when generating the tidal volume.

Anestar™ Operating Instructions 0070-00-0516 2-1


Anesthesia ventilator Functional Description

2.1.1 Fresh gas decoupling

During the fresh gas decoupling in the controlled ventilation modes, the fresh gas flow is
directed into the manual ventilation bag. The manual ventilation bag serves as a fresh gas
reservoir. This principle offers the following advantages for controlled ventilation:
1. The tidal volume is completely independent from the set fresh gas flow. The ventila-
tion is therefore also referred to as constant volume ventilation.
2. The fresh gas flow can be maintained at a very low level, i.e. below
500 ml/min, depending on the patient. The manual ventilation bag serves as a reservoir
for the fresh gas administered during the inspiration. The entire fresh gas volume is
available during the next inspiration, i.e., not only the fresh gas stored in the reservoir
but also the fresh gas supplied during the expiration period.

2.1.2 Constant volume provided by controlled ventilation

During controlled ventilation, the set tidal volume is administered irrespective of the
pulmonary circumstances. The ventilator drive represents, in principle, a constant flow
generator. The inspiratory flow of the ventilation gas is automatically adapted to the
respective settings of the tidal volume, the ventilation frequency rate, and the ventilation
time ratio.

2.1.3 Compliance compensation

The administered tidal volume is corrected to the set value, set by the user, with the aid of
compliance compensation. The system compliance of each ventilation system, i.e., the
compliance of patient hoses and the breathing circuit, always leads to losses in the
administered tidal volume. The Anestar system’s automatic compensation of the system
compliance can correct this volume loss with the aid of a control loop. For this purpose,
several ventilation cycles are required with the drive gas flow being slightly increased
above the normal values, i.e., the values for achieving the set ventilation volume. The
correct tidal volume is administered to the patient, while the slightly higher volume is
absorbed by the system compliance due to the effective compliance compensation.

2.1.4 Bag-in-bottle system

The bag-in-bottle system is part of the breathing circuit system. The gas-conducting
sections are divided from the ventilator into a primary (ventilator) and a secondary circuit
(patient). The gas volume provided by the drive is not directly administered to the patient
but instead compresses a bellows inside a pressure dome. As a result, the ventilation gas
contained in the bellows is administered to the patient. An increased drive volume,
flowing into the pressure dome, also increases the tidal volume. Once the drive-gas flow
has finished, the pressure compensation between the primary and secondary circuit is
ended. A distinctive plateau in the ventilation pressure curve is produced if the system
does not switch over to the expiration directly after the end of the inspiratory gas flow. For
this purpose, the drive volume contained in the pressure dome is maintained at a steady
level for some time. The bellows is suitable for adults and pediatrics.

2-2 0070-00-0516 Anestar™ Operating Instructions


Functional Description Anesthesia ventilator

2.2 Fresh gas dosing


The setup of the gas quantities administered to the patient is carried out on a measuring
tube block. This block contains measuring tubes that are also referred to as flowmeters.
The flowmeters consist of a vertical glass tube containing a float. As a glass tube expands
towards the top, gas flow lifts the float to a respective height. The gas flow is adjusted via
valve spindles, located below the individual measuring tube.

The setting of the O2/AIR or O2/N2O is selected with the changeover switch which opens
the respective gas line to the measuring tube block.

The fresh gas cannot be set with a mixture of Air and N2O where the oxygen is below
21%. The decrease of the oxygen content to below 21% is prevented by a pneumatic
safety system. This Ratio system ensures the continuous existence of a minimum O2
content of 25% in the dosed gas mixed with N2O. In case of an increase of the N2O flow,
the required O2 flow is also automatically increased. The fresh gas, appropriately
proportioned, is fed over a vaporizer, where it is mixed with an anesthetic agent.

Anestar™ Operating Instructions 0070-00-0516 2-3


Anesthesia ventilator Functional Description

2.3 Vaporizer

2.3.1 Vaporizer mounting device

The machine contains a Selectatec® compatible vaporizer mounting device capable of


accommodating two vaporizers. The vaporizer contains two chambers, with the bottom
section containing the liquid anesthetic agent. Via a woven metal wick, the top section of
the chamber is enriched with saturated anesthetic agent vapor. The concentration of the
saturated vapor at ambient temperatures is considerably higher than that acceptable for
clinical purposes. The desired concentration is achieved by a suitable mixing ratio of the
gas and anesthetic agent with a gas flow that is passed around this chamber. This is
achieved with the aid of the setting wheel.

For this purpose, the ratio of the flows of the carrier gas is adjusted by a bypass channel
and the vaporizer channel in such a way, that the chosen concentration is achieved at the
vaporizer outlet. When the vaporizer is in the zero position, the bypass channel remains
open while the vaporizer channel remains completely closed off to the flow of gas.

Although the anesthetic agent vapor concentration of the vaporizer chamber is saturated,
the absolute anesthetic agent content depends on the temperature. Consequently, the
bypass channel contains a temperature compensation valve. In case of changes in the
vapor pressure caused by temperature fluctuations, the valve changes the set dilution ratio
in such a way that the anesthetic agent concentration delivered is not affected by the
temperature.

For further information see the instructions of the respective anesthetic agent vaporizer.

2-4 0070-00-0516 Anestar™ Operating Instructions


Functional Description Anesthesia ventilator

2.4 Patient Module

2.4.1 Circuit absorber system

The circuit absorber system consists of a ventilation system with CO2 absorber. This
system allows anesthesia to be carried out at very low fresh gas settings. The ventilation
gas contains various parts of re-breathing gas, i.e., expiratory gas scrubbed free of CO2.
This is achieved with a circuit ventilation system, facilitating a re-breathing of the
formerly expiratory CO2-containing gas. A circuit system with high re-breathing contents
causes a reduction of the consumption of anesthetic agents. This system offers improved
breathing gas conditioning. The Patient Module is designed as a circuit absorber system in
the form of a compact aluminum manifold. The hose connections normally required
between the ventilator and the circuit system are thus no longer needed.

2.4.2 CO2 absorber

The absorber removes CO2 from expired air. The absorption process is a chemical reaction
in which carbon dioxide is bound, most of the reaction water evaporates, and the resulting
calcium is removed. Consequently the spent soda lime is dry and hard. Soda lime must be
hermetically sealed and stored in a cool and dry place in order not to lose its absorbency.

2.4.3 Reservoir and manual ventilation bag

The reservoir and the manual ventilation bag provide an inspiratory interim store for fresh
gas. The reservoir pressure during machine and spontaneous breathing is limited to 1-2 cm
H2O. During manual breathing, the APL valve allows the manual adjustment of the
desired ventilation pressure.

2.4.4 Volume measurement

Volume measurement is carried out by using a flow meter, that operates according to the
hot-wire anemometer principle, to measure the flow in the expiration branch. The
ventilator processors integrate this measured value with the displayed tidal and ventilation
minute volume. The tidal volume shown in the display is a measured value. The tidal
volume displayed during controlled ventilation is measured by an internal flow sensor and
is not dependent on the expiratory volume measurement.

2.4.5 Oxygen measurement

The oxygen is measured by a galvanic cell attached to the inspiration valve dome. This O2
cell, also referred to as a fuel cell, offers a longer life compared to other oxygen cells and
is less sensitive to anesthetic gases.

Anestar™ Operating Instructions 0070-00-0516 2-5


Anesthesia ventilator Functional Description

2.4.6 Patient Module heating

The heating of the Patient Module prevents the formation of condensation within the
Patient Module and on the valve caps of the inspiration and expiration valves. The heating
positively contributes to ventilation gas conditioning. The Heating Mat functions as a
sealing mat and is installed between the top and bottom section of the Patient Module. An
electronic control integrated in the ventilator keeps the temperature of the Patient Module
constant at 36°C. An over-temperature protection circuit protects the Patient Module
against overheating.

2-6 0070-00-0516 Anestar™ Operating Instructions


Functional Description Anesthesia ventilator

2.5 Touchscreen interface


The Anestar interface uses a touchscreen with hot keys. With the exception of the N 2O/Air
selector switch, all data input is entered via the touchscreen. The touchscreen reacts to
pressure. To change a value, select the value you want to change. The screen value will
then highlight. While the selection is still highlighted, use the up and down arrows to
increase or decrease the value. While the selection is still highlighted, confirm the change
by selecting the ENTER key. Use View Settings at any time to see your settings.

2.5.1 Ventilation Mode Rotary Knob

The ventilation mode rotary knob allows the operator to switch between manual and
automatic ventilation modes for both adults and children. CMV and PCV modes are
available via the VENT MODE touch-key. The system is protected by automatically
identifying possible miscues in knob rotation.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE

ALARM
LIMITS

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 2-1 Touchscreen display

2.5.2 Key descriptions

2.5.2.1 Options

The Options utilities are only available when the ventilation mode rotary knob is in the
Standby position. The utilities available via this screen are: Pressure Test, O2 Calibration,
Leak Test, Running Hours, Patient Module temperature, Patient Module ejection control
and LCD display contrast adjustment.

Anestar™ Operating Instructions 0070-00-0516 2-7


Anesthesia ventilator Functional Description

2.5.2.2 Alarm Limits

The Alarm Limits screen is available in the Manual, CVM and PCV, Adult or Child
ventilation modes. Selecting the ALARM LIMITS key activates and deactivates the
Alarm screen.

2.5.2.3 View Settings

Selecting VIEW SETTINGS allows the operator to view the ventilator settings. These
values are shared with the measured parameters of the ventilator.

The measured values are viewed as normal graphics. The ventilator settings are viewed in
reverse graphics.

2.5.2.4 Tidal Vol./Flow (CMV mode)

Selecting TIDAL VOL. allows the operator to set the ventilator tidal volume. Please read
the UP / DOWN ARROW and ENTER sections for additional information.

2.5.2.5 Tidal Vol/Flow (PCV mode)

Selecting FLOW allows the operator to control the inspiratory flow rate in liters per
minute. The operator adjusted value appears in reverse graphics. When the value displays
in normal graphics the patient's tidal volume is displayed in milliliters. Please read the UP
/ DOWN ARROW and ENTER sections for additional information.

2.5.2.6 Resp. Rate

Selecting RESP. RATE allows the operator to set the ventilator respiration rate in breaths
per minute. Please read the UP / DOWN ARROW and ENTER sections for additional
information.

2.5.2.7 I:E

Selecting I:E allows the operator to control the ventilator's timing for the ratio of
inspiratory time to expiratory time. The displayed value is always the operator's setting
and is not available during manual ventilation. Please read the UP / DOWN ARROW and
ENTER sections for additional information.

2.5.2.8 PEEP

Selecting PEEP allows the operator to set the end-expiratory pressure in the patient lung
during CMV and PCV modes. Please read the UP / DOWN ARROW and ENTER
sections for additional information.

2-8 0070-00-0516 Anestar™ Operating Instructions


Functional Description Anesthesia ventilator

NOTE: PEEP should never be controlled with the APL


valve while in the automatic ventilation modes.
The APL valve should always be set to the CMV/
SP position while in the CVM or PCV modes. Use
the APL valve to control pop-off pressure while
ventilating in Manual mode.

2.5.2.9 Plateau pressure (CMV mode)

Selecting PLATEAU PRESSURE allows the operator to prolong the inspiratory phase of
respiration 20% or 30% longer. It may also be set to OFF, which does not prolong
inspiration. Please read the UP / DOWN ARROW and ENTER sections for additional
information.

2.5.2.10 Enter

Selecting ENTER allows the operator to begin automatic tests, lock in operator selected
ventilator settings and alarm limit set points. This key is often used after the ventilator
control value and the UP/DOWN ARROWS have been utilized to set a new value.

2.5.2.11 Up / Down Arrow

Selecting the UP ARROW changes the operator selected setting to the next higher
incremental value. Selecting the DOWN ARROW changes the operator selected setting
to the next lower incremental value.

2.5.2.12 Mute

Selecting MUTE allows the operator to discontinue the audible alarm for two minutes.
Mute can be canceled by selecting the key again during the two-minute period while the
violation is still occurring. While MUTE is active, an icon is displayed. Certain critical
messages will not allow the muting of the audio alarm.

2.5.2.13 Vent Mode

Selecting VENT MODE allows the operator to toggle back and forth between CMV and
PCV modes. For safety, the operator must select VENT MODE twice to change between
settings. Operator settings are saved and will resume when switching out of and returning
to, a ventilation mode. Default settings will resume after power cycling the Anestar.

Anestar™ Operating Instructions 0070-00-0516 2-9


Anesthesia ventilator Functional Description

2.5.3 Default Settings

The CMV and PCV modes and the Patient Alarm set points default to the following
settings when powering on the Anestar:

VENTILATOR DEFAULTS ADULT CHILD


Tidal Volume (CMV): 500 200
Resp Rate: 10 20
I:E (Ratio): 1:2 1:2
PEEP: 0 0
Plateau Pressure: OFF OFF
(Inspiratory) Flow (PCV): 10 20
Plateau (Target) Pressure 20 20
(PCV):
Vent Mode (initial): CMV CMV

ALARM DEFAULTS ADULT CHILD


Apnea Delay: (only available in 30 30
Manual / Ventilation mode)
O2 (low): 18 18
O2 (high): 99 99
Vtmin (Tidal Volume): 350 100
P (high) (CMV): 60 50
P (low) (CMV): 12 14
P (low) PCV: 12 10
M.Vol (Minute Volume): 2.0 1.0
Vol (Audio Volume): 8 of 10 8 of 10

If the operator should change any setting, that new setting will resume when switching
back from another ventilation mode or from Standby. All settings resume their default
values when the Anestar is powered on.

2 - 10 0070-00-0516 Anestar™ Operating Instructions


3.0 Operating Elements/
Connections for Appliances

Introduction
This chapter describes the various controls components and displays that make up the
Anestar Anesthesia Delivery System. The Anestar system's integrated breathing system
contains the absorber, ventilator bellows, and a heated aluminum manifold. The manifold,
or Patient Module, coupled with a ventilator, includes automatic compliance
compensation, pressure-controlled ventilation, and a touchscreen interface. Volume
control and pressure control ventilation modes allow precise ventilation for a wide variety
of patients, including patients with pulmonary complications.

A more detailed description of these functions may be found in the Functional Description
of Chapter 2.

Anestar™ Operating Instructions 0070-00-0516 3-1


Views of machine Operating Elements/Connections for Appliances

3.1 Views of machine

3.1.1 Front of machine

FIGURE 3-1 Anestar, front view

1. Vaporizer mount Selectatec® compatible vaporizer mount for


connection of two vaporizers.
2. Flowmeter block Five-tube flowmeter block with integrated Ratio-
system, O2-Bypass and N20/AIR changeover switch.
3. Ventilator unit Microprocessor controlled ventilator with EL or
LCD-display.
4. Patient Module Absorber circuit system with integrated bag-in-bottle
system, active and passive valves, such as the APL-
valve.

3-2 0070-00-0516 Anestar™ Operating Instructions


Operating Elements/Connections for Appliances Views of machine

3.1.2 Rear of machine

3
5

FIGURE 3-2 Anestar, rear view

1. Mains cable Voltage supply cable for connecting the machine to


an AC outlet with grounding contact.
2. AC Outlets Additional devices up to a maximum power
consumption of 2.5 amp per device can be connected
to four outlets.
3. Circuit breakers One 5A circuit breaker for the ventilator unit, one 5-
amp circuit breaker for the battery, one 10-amp
circuit breaker for the AC outlets.
4. Cylinder yokes Pin-index cylinder yokes, for N2O, O2 and AIR.
5. Fan A fan provides ventilation of the housing, and
cooling of the integral components.
6. Pipeline supply Diameter-index connections for O2, AIR and N2O
from central gas supply. Three pipeline pressure
gauges indicate supply pressure.

Anestar™ Operating Instructions 0070-00-0516 3-3


Views of machine Operating Elements/Connections for Appliances

3.1.3 Left side of machine

1
2

FIGURE 3-3 Anestar, left view

1. Rail for mounting arm Use only approved mounting arms and weight
restrictions.
2. Oxygen-sensor with Galvanic O2 cell and interface cable for oxygen
cable monitoring.
3. Patient Module Patient Module may be removed for maintenance or
when transporting the Anestar.

3-4 0070-00-0516 Anestar™ Operating Instructions


Operating Elements/Connections for Appliances Views of machine

3.1.4 Right side of machine

FIGURE 3-4 Anestar, right view

1. Mains switch The machine is switched on/off with this switch

Anestar™ Operating Instructions 0070-00-0516 3-5


Ventilator unit Operating Elements/Connections for Appliances

3.2 Ventilator unit

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2 O 1 / min Vol.%

OPTIONS MUTE
24 9 2.2 21 CMV
40

20

ALARM
LIMITS
0
-5
0 2 4 6 8 10 12 14 16

VIEW 220 10 1: 2 2 ENTER


SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

Manual Vent. Child Alarm


(40-400 ml)
Advisory
Standby Adult
(300-1400 ml)

FIGURE 3-5 Ventilator display and selector switch

1. Ventilator display The ventilator uses either a LCD or EL display. These


displays are high contrast, clearly visible from side
view angles, and provide all measured values and
settings of the ventilator.

3.2.1 Ventilation Modes - selection switch

This switch is for selecting a ventilation mode. It has four positions:


1. Standby Position for starting and performing pressure and
system tests, or during manual or spontaneous
ventilation.
2. Manual/Vent In this position, the ventilator is switched to the manual
or spontaneous ventilation mode.
3. Child In this position, the ventilator is switched to the CMV
or PCV mode for the controlled ventilation of children.
4. Adult In this position, the ventilator is switched to the CMV
or PCV mode for the controlled ventilation of adults.

3-6 0070-00-0516 Anestar™ Operating Instructions


Operating Elements/Connections for Appliances Gas dosing arrangement

3.3 Gas dosing arrangement

9
6
10
7
8

FIGURE 3-6 Gas dosing arrangement

1. Flowmeter tube, N2O Low measuring range for settings between


0 to 1000 ml/min
2. Flowmeter tube, N2O High measuring range for settings between
1.5 to 10 l/min
3. Flowmeter tube, AIR Measuring range of 0 to 12 l/min
4. Flowmeter tube, O2 Low measuring range for settings between
0 to 1000 ml/min
5. Flowmeter tube, O2 High measuring range for settings between
1.5 to 10 l/min
6. Valve spindle for O2 Gas dosing
7. Valve spindle for AIR Gas dosing
8. Valve spindle for N2O Gas dosing
9. N2O/AIR changeover This switch allows the pre-selection of N2O or AIR,
switch which can then be dosed with the respective valve
spindles. The previously set volume flow is retained
after switching back to the same gas type.
10. O2 flush The O2 flush is an O2 bypass that supplies a high O2
flow (approximately 50 l/min) directly into the Patient
Module. Upon releasing the bypass key, the key returns
to its original position and the O2 bypass is
automatically stopped.

Anestar™ Operating Instructions 0070-00-0516 3-7


Vaporizer mounting manifold Operating Elements/Connections for Appliances

3.4 Vaporizer mounting manifold

1
2

FIGURE 3-7 Vaporizer mounting manifold

1. Valve cartridge of Vaporizer index and outlet parts.


vaporizer mount
2. Locking device Vaporizer locking mechanism to secure against
accidental disconnection.
3. Mounting bar Bar holds two vaporizers. Interlock provides for use of
one vaporizer to deliver one agent at a time.

3-8 0070-00-0516 Anestar™ Operating Instructions


Operating Elements/Connections for Appliances Patient Module (breathing circle system)

3.5 Patient Module (breathing circle system)


13

3 4
5
9

1 14

8
2 12
7 15
6
10 11

FIGURE 3-8 Patient Module (circle system)

1. Emergency air valve Device prevents negative end expiratory pressure (NEEP).
2. Inspiration valve Valve allows flow of inspiratory gas to the patient.
3. Oxygen sensor Galvanic fuel cell
4. Airway pressure limiting Rotary regulator for setting the pressure control during
(APL valve) manual ventilation. Set to CMV/SP during automatic
ventilation.
5. Expiration valve Allows flow of expiratory gas flow from the patient to the
rebreathing system.
6. Expiratory Limb Exhaled breathing circuit connection
7. Waste Gas outlet The anesthetics gas scavenging system is connected to this
(not shown) point.
8. Inspiratory Limb and Device indicates patient airway pressure.
PAW gauge
9. Bag arm Reservoir/manual ventilation bag
10. Bellows, including Durable silicone bellows
bellows dome
11. CO2 absorber canister Two Pre-Paks can be used.
12. Emergency air valve Air enters to fill bellows if fresh gas is interrupted.
inlet
13. O2 cell external cable Connection to O2 cell
14. Manual Pop Off Emergency pressure release. Push to release airway
pressure to atmosphere.
15. Y-Piece Seal Provides a parking position for the breathing circuit
y-piece. Used to seal the y-piece during the pressure test.

Anestar™ Operating Instructions 0070-00-0516 3-9


Sample gas recirculation Operating Elements/Connections for Appliances

3.6 Sample gas recirculation

FIGURE 3-9 Anestar, left view

1. Sample gas The exhaust from an external side-stream gas monitor


recirculation port may be connected to the Sample Gas Recirculation port
on the left side of the machine. The patient sample gas
is returned to the reservoir bag.

Always use a hydrophobic filter at the inlet of the


recirculation port when connecting to the exhaust port
of a gas monitor.

3 - 10 0070-00-0516 Anestar™ Operating Instructions


4.0 Advisory and Alarm Messages

Introduction
The Anestar Anesthesia Delivery System displays alarm messages on the ventilator
display during operation. The alarm message is displayed until the fault condition that
triggered the alarm is resolved. The selection of the alarm silence key does not influence
the alarm shown on the display.

Advisory messages are displayed on the screen. Alarm messages are displayed on the
screen and are accompanied by audio and/or visual indication.

4.1 Corrective Action for Advisory and Warning


Alarm Signals
Alarm situations that may arise during operation and their corrective actions are explained
in the table that appears on the following pages.

Anestar™ Operating Instructions 0070-00-0516 4-1


4-2

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
0070-00-0516

Pressure Test The Startup Pressure Test System is ready for use
Passed. Press has Passed successfully. X
Enter to continue
Pressure Test The Startup Pressure Test Ventilator may be used safely with
Passed. Leak rate has Passed. The leak rate is adequate fresh gas flows. If
is between 300-600 between 300-600ml/min. necessary use the Pressure Test in
X
ml/min. Press OPTIONS to retest after tightening
Enter to continue the breathing circuit and valve
rings.
Pressure Test The leakage of the circle Ventilator may be used safely with
Passed. Leak rate system and the patient hoses adequate fresh gas flows. If
AnestarTM Operating Instructions

is higher than 600 is higher than 600 ml/min at necessary use the Pressure Test in

Advisory and Alarm Messages


X
ml/min. Please 40 cm H2O. Standby / OPTIONS to retest after
check for leaks tightening the breathing circuit and
valve rings.
ATTENTION! Use The Pressure Test has not Perform the Pressure Test in
Manual/Spont. been carried out or has failed. Standby / OPTIONS. If problems
Mode only Automatic mechanical persist call for service. X
ventilation is not available
until Pressure test is passed.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
System resistance Resistance of patient hoses Replace bacteria filter and
too high or bacteria filter is too high. breathing circuit. Use the Pressure
0070-00-0516

Test in Standby / OPTIONS to X


retest. If problems persist call for
service.

Corrective Action for Advisory and Warning Alarm Signals


Compliance out of The compliance of the Replace bacteria filter and
range connected patient hoses lies breathing circuit. Use the Pressure
outside the range of 3.0 to 9.9 Test in Standby / OPTIONS to X
ml/cm H2O. retest. If problems persist call for
service.
Pressure Test The leak rate of the Ventilator may be used safely with
Passed. Leak rate inspiratory limb and the adequate fresh gas flows. If
is --- ml/min patient hoses is displayed in necessary retest after tightening
Compliance is -.- ml/min. at 40 cm H2O. the breathing circuit and valve X
ml/cm H20. Please rings.
check breathing
circuit
4-3
4-4

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
Leak Test Passed The leak rate of the circle Ventilator may be used safely with
Leak rate is --- ml/ system and the patient hoses adequate fresh gas flows. If
0070-00-0516

min. Please check is displayed in ml/min. at necessary, retest after checking


breathing circuit 40 cm H2O. the breathing circuit, tighten valve X
and vaporizers. rings, o-rings, seals on vaporizer
mounts, bellows and absorber
domes.
Leak Test Passed. The leak rate of the circle Ventilator may be used safely with
Leakage rate is system and the patient hoses adequate fresh gas flows. Retest
higher than 1000 is higher than 1000 ml/min at after checking the breathing circuit,
ml/min. Please 40 cm H2O. tighten valve rings, o-rings, seals
X
check for leaks. on vaporizer mounts, bellows and
Change breathing absorber domes.
AnestarTM Operating Instructions

circuit and check

Advisory and Alarm Messages


CO2 absorber
O2 Calibration O2 calibration has passed. System is ready for measuring
X
successful circuit FiO2.
O2 Cell is out of O2 cell is either in a Expose cell to 21% oxygen, with its
range Press Enter concentration of O2 that is cable plugged in, or replace
to Start lower than 21%, is the cell. X
disconnected from the cable
or is faulty.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
O2 concentration O2 cell is either in a Expose cell to 21% oxygen or
too high. Expose concentration of oxygen that replace the cell.
0070-00-0516

Sensor to room air. is higher than 21% or cell is X


Press Enter to faulty.
start.

Corrective Action for Advisory and Warning Alarm Signals


APNEA No breathing by the patient is Check connections and patient
detected in manual mode breathing. Initial Apnea indication
when measuring the (beeps) is adjustable to 15, 30, or X X X
expiratory volume. 45 seconds. A steady tone
indicates Apnea after 2 minutes.
Breathing Circuit No adequate pressure Attach breathing circuit.
Disconnect increase is detected during X X X
ventilation.
Peak pressure The peak pressure Ppeak Check that Tidal Volume setting is
greater than alarm exceeds the set Pmax appropriate. Lungs deflate when
X X X
limit pressure limit. Pmax is reached. Check Pmin.
Alarm setting.
Peak pressure The peak pressure Ppeak is Check that Tidal Volume or Plateau
below alarm limit lower than the set Pmin Pressure setting is appropriate. X X X
pressure limit.
4-5
4-6

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
FiO2 lower than O2 The measured FiO2 value is Check that supplied FiO2 is
min less than the set minimum appropriate. Check O2 Alarm
X X X
0070-00-0516

oxygen concentration FiO2 setting.


min.
FiO2 greater than The measured FiO2 exceeds Check that supplied FiO2 is
O2 max the set FiO2 max. oxygen appropriate. Check O2 Alarm X X X
concentration limit. setting.
Tidal Volume lower The measured tidal volume Vt Check that Tidal Volume setting is
than Vtmin value is less than the set Vt appropriate. Check Tvmin Alarm X X X
min. limit. setting.
Check Vent. Mode The Selector Switch is in an Reposition the vent mode selector
Switch Position invalid position longer than 3 switch to a valid position. Reselect X X X
AnestarTM Operating Instructions

seconds. ventilation mode. Restart ventilator.

Advisory and Alarm Messages


Minute volume The ventilation minute volume Check that Minute Volume setting
lower than M.Vol M vol. is lower than the set M is appropriate. Check M.Vol. Alarm X X X
vol. min. limit. setting.
PEEP greater than The measured PEEP Check that APL valve setting is
Pmin exceeds the set Pmin appropriate. Check Pmin. Alarm X X X
pressure limit. setting.
PEEP greater than The PEEP is greater than the Check that PEEP setting is
X X X
PEEP-Setting PEEP setting. appropriate.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
Ppeak lower than The inspiration time and/or Check that I:E ratio and breathing
plateau setting the flow is too low for the frequency setting are appropriate.
X X X
0070-00-0516

selected plateau pressure to


be attained
Check APL-Valve is Message to remind operators Set the airway pressure limiting

Corrective Action for Advisory and Warning Alarm Signals


in CMV Position to set the ventilation pressure valve (APL) to the CMV/SP
valve (APL) to the CMV/SP position after activating either X X
position after activating the mechanical ventilation mode.
CMV mode.
Ambient Air Intake; The emergency air valve in Check if the fresh gas flow is
Check Fresh-Gas the patient section has sufficient. Check for Leaks. Check
opened; check the fresh-gas if patient is breathing Spon- X X X X
setting and increase the fresh taneously. If problems persist call
gas flow, if necessary. for service.
Continuous A continuous ventilation Check that APL valve is set to the
X X X
Pressure pressure is detected. CMV/SP position.
4-7
4-8

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
Check Settings The set parameters, for CMV Check Tidal Volume setting is
mode ventilation, are for an appropriate.
0070-00-0516

inspiratory flow that cannot be


achieved by the machine. The X X
max. limit is a minute volume
of < 20 l/min, or an inspiratory
flow < 75 l/min.
PCV Setting not The combination of Change the PCV settings
valid inspiratory flow, frequency
X X X
and I:E ratio cannot be
realized by the ventilator.
Expiratory time too The set expiration time does Check that I:E ratio and breathing
short not allow the below to refill frequency setting are appropriate. X X X
AnestarTM Operating Instructions

Advisory and Alarm Messages


completely
Drive gas OK; Drive gas now available after Select ventilation mode. Restart
Restart Ventilation the ventilator had stopped, the ventilation.
X X
because of a loss of drive
gas.
System The system detects a Vent the system by pressing the
pressurized continuous pressure. red pop-off button on the Patient X
Module. Monitor system pressure.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
System is not The circle system is vented Check the O2 cell is present, APL
sealed during the pressure or leak valve is set to max (leak test) and
X
0070-00-0516

test. breathing circuit is connected


properly.
No drive gas, The compressed gas (air or Check air or O2 pressure supply.

Corrective Action for Advisory and Warning Alarm Signals


please check O2) supply with which the
X X
drive gas of the ventilator is
generated, has failed.
ATTENTION! The Selector Switch is in an Reposition the vent mode selector
Ventilator has invalid position longer that 12 switch to a valid position. Reselect
stopped. Check seconds. ventilation mode. Restart ventilator. X X
position of mode
selector switch.
AC Power lost, The mains voltage supply has Check AC linecord is plugged into
using Battery failed, the machine is being AC outlet. If problems persist call X X
powered by the battery. for service.
AC Power lost, Less than 30 minutes of Plug in AC Linecord.
using Battery battery power available. X X
30 min. remaining
4-9
4 - 10

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
AC Power lost, Less than 25 minutes of Plug in AC Linecord.
using Battery battery power available X X
0070-00-0516

25 min. remaining
AC Power lost, Less than 20 minutes of Plug in AC Linecord.
using Battery battery power available X X
20 min. remaining
AC Power lost, Less than 15 minutes of Plug in AC Linecord.
using Battery battery power available X X
15 min. remaining
AC Power lost, Less than 10 minutes of Plug in AC Linecord.
using Battery battery power available X X
10 min. remaining
AnestarTM Operating Instructions

AC Power lost, Less than 5 minutes of battery Mechanical ventilation will

Advisory and Alarm Messages


using Battery power available discontinue in approximately 5
5 min. remaining minutes. Display and numeric
values will continue until battery X X
power is exhausted. Patient can be
manually ventilated as long as
there is compressed gas available.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
AC Power lost, The power supplied by the Check AC linecord is plugged into
using Battery battery is too low for AC outlet. If problems persist call
0070-00-0516

Battery running automatic mechanical for service. X X


low ventilation. The display will
fade within minutes.

Corrective Action for Advisory and Warning Alarm Signals


Data not saved Data for parameter or alarm Retry function. If problems persist
limit settings was not saved call for service. X
correctly.
Data exchange The data exchange between Retry function. Reboot machine. If
failed the ventilator modules and problems persist call for service. X
on-screen display is faulty.
Failure of Pressure The system has detected a Retry function. Reboot machine. If
Transducer fault on one or both pressure problems persist call for service. X
sensors.
Patient Module is The patient module is not Gently push module into docking
unlocked correctly seated in the station. System should draw the X
machine. module into the docking station.
Hotwire During the test, the hotwire Retry function. Reboot machine. If
Measurement sensor did not pass its test. problems persist call for service. X
invalid Sensor may be faulty.
4 - 11
4 - 12

Corrective Action for Advisory and Warning Alarm Signals


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
System vented or The system did not detect Check O2 (drive gas) pressure
X
drive gas missing drive gas pressure. supply.
0070-00-0516

Microcontroller The automatic test routine Call Service.


system faulty has detected a processor X X X
control fault.
Watchdog Error The watchdog control system Call Service.
X X
has detected a failure.
Expired Valve The ventilation pressure does Remove the Patient Module from
locked not decrease during the Docking Station. Check X X
expiration. Expiratory valve actuation.
Solenoid Valve(s) One or more solenoid valves Remove the Patient Module from
faulty actuating the bellows valve the Docking Station. Check the
AnestarTM Operating Instructions

have failed. Bellows valve actuation. Perform

Advisory and Alarm Messages


X X
the Pressure Test in Standby /
OPTIONS. If problems persist call
for service.
Check Diaphragm The system has detected a Remove the Patient Module from
Valves pressure increase. The the Docking Station and check the
diaphragm valves may be Decoupling and Expiratory valves X
leaking drive gas into the for intact membranes. Replace as
circle system. required or call Service.
AnestarTM Operating Instructions

Advisory and Alarm Messages


AUDIO VISUAL CATEGORY

STEADY TONE. NOT MUTABLE

STEADY AUDIO TONE

OSCILLATING AUDIO TONE

TWO BURSTS/15 SEC. STEADY @ 2 MIN.

ONE BURST/2 SEC.

STEADY YELLOW LED ADVISORY

FLASHING YELLOW LED ADVISORY

STEADY RED LED ALARM

FLASHING RED LED ALARM

MONITORING INFORMATION

SET-UP INFORMATION

MACHINE INFORMATION

MACHINE ERROR

MACHINE FAULT
SCREEN MESSAGE CAUSE CORRECTIVE ACTION
Proportional Valve The proportional valve for Perform the Pressure Test in
faulty generating the ventilation Standby / OPTIONS. If problems
X X
0070-00-0516

volume does not function persist call for service.


correctly.
Pressure Sensor The system has detected a Perform the Pressure Test in

Corrective Action for Advisory and Warning Alarm Signals


faulty fault on one or both pressure Standby / OPTIONS. If problems X X
sensors. persist call for service.
External Flow The external flow sensor for Perform the Pressure Test in
Sensor faulty measuring the expiratory Standby / OPTIONS. If problems
X X
volume in the patient section persist call for service.
is faulty.
Internal Flow The internal flow sensor, Perform the Pressure Test in
Sensor faulty measuring the generated Standby / OPTIONS. If problems
X X
ventilation volume, does not persist call for service.
functioning correctly.
Temperature The temperature sensor of Perform the Pressure Test in
Sensor faulty the patient module has failed. Standby / OPTIONS. If problems X X
persist call for service.
Heating System The control of the patient Call Service.
faulty module heating, or the X X
4 - 13

heating mat, is faulty.


Corrective Action for Advisory and Warning Alarm Signals Advisory and Alarm Messages
MACHINE FAULT
X

X
CATEGORY

MACHINE ERROR
MACHINE INFORMATION
SET-UP INFORMATION
MONITORING INFORMATION
FLASHING RED LED ALARM
VISUAL

STEADY RED LED ALARM


FLASHING YELLOW LED ADVISORY
STEADY YELLOW LED ADVISORY
ONE BURST/2 SEC.
TWO BURSTS/15 SEC. STEADY @ 2 MIN.
AUDIO

OSCILLATING AUDIO TONE


X

STEADY AUDIO TONE


STEADY TONE. NOT MUTABLE
CORRECTIVE ACTION
Call Service.

Call Service.

Call Service.
housing and cools the integral

Startup test for Internal circuit

The ventilator has a technical


The fan that ventilates the

fault that stops controlled


modules has stopped.

EEPROM has failed.

ventilation.
CAUSE
SCREEN MESSAGE

EEPROM Data not

System Failure
Please call for
Fan faulty

Service
saved!
4 - 14 0070-00-0516 AnestarTM Operating Instructions
Advisory and Alarm Messages Definition of Categories

4.2 Definition of Categories

CATEGORY DEFINITION ACTION


Monitoring A monitored patient parameter Check ventilator settings and
Information or a machine effecting the alarm limits.
patient needs attention.
Set-Up Information A machine related interface Check the connection of an
needs attention. accessory or patient interface
device.
Machine Information Machine-related status is Information only. Action is not
identified for the operator's required.
information.
Machine Error A recoverable machine error Re-setting the function may
has occurred. correct the error. If rebooting
doesn't correct the error, call
Service.
Machine Fault A non-recoverable fault has Rebooting the Anestar
occurred. unlikely to correct the
machine fault. Call Service.

Anestar™ Operating Instructions 0070-00-0516 4 - 15


Definition of Categories Advisory and Alarm Messages

4.3 Alarm functions test


The apnea, peak pressure and low O 2 alarms are safety features. Each should be utilized to
match the needs of the individual patient and procedure. To verify these alarm functions,
they should be checked periodically. Below are proven methods for testing presented for
the convenience of the operator.

4.3.1 Apnea Alarm


1. Switch the selector switch to Manual/spontaneous position and do not ventilate for
30 seconds.
2. Verify that a double-beep is heard after either 15, 30, 45, or 60 seconds from the onset
of Apnea. (Double-beeps occur at 15-second intervals thereafter.)
3. Verify that a steady audio tone sounds continuously, two minutes after the onset
of Apnea.

4.3.2 Peak pressure is greater than Pmax


1. Switch the selector switch to CMV position.
2. Using a test lung, select the Ventilation parameters and alarm settings in such a manner
that the airway pressure will exceed the set pressure limit. (Make sure the inspiration
phase is cut off and check that the alarm message “P greater than P max” appears on the
screen after three ventilation cycles.)

4.3.3 FiO2 is greater than O2 minimum


1. Place the O2 cell in ambient air and set O2 min to a value above 25% and
start ventilation.
2. Block the O2 mount port to close the pneumatic system. Check that the alarm
“FiO2 lower than O2 min” appears on the screen after three ventilation cycles.

4 - 16 0070-00-0516 Anestar™ Operating Instructions


5.0 Startup and Functional Tests

Introduction
The following sections outline the procedures one follows when installing, configuring,
checking out, and pre-operation testing the Anestar anesthesia machine. A description of
startup procedures and other periodically performed tests and calibration steps are also
described.

5.1 Installation
After uncrating the machine, the following must be performed prior to preparing the
machine for initial setup:
1. Connect the following accessories, if available:
• Auxiliary O2 flowmeter
• Waste gas scavenger assembly
• Patient suction regulator
• Side mount rail (optional)
• Large equipment shelf (optional)

Anestar™ Operating Instructions 0070-00-0516 5-1


Installation Startup and Functional Tests

5.2 Initial Setup


The following steps must be carried out upon initial assembly or in any instance which
requires disassembly of any gas machine part(s):
1. Install the machine so that the operating controls, ventilator display and the flowmeter
tubes are within easy reach.
2. Once the machine has been installed in the correct location, activate the brakes on the
casters.
3. Connect the gas supply by plugging the hose connectors into the gas supply sockets.
Verify that the pressure of the gas supply is within the specifications of the machine.
4. Plug the mains cable into a grounded socket and switch on the power supply using the
mains switch (located on the right side of machine). Wait until the ventilator display
provides information about the pressure test.
5. If the Patient Module has not yet been connected to the machine:
a. Remove the transportation cover, if attached.
b. Slide the Patient Module into position. After sliding in the Patient Module nearly
up to the stop, the automatic motor-driven connection engages.
c. Push the Patient Module slightly farther into the seat until the screw spindle con-
nects securely into the docking station. Once the Patient Module is fully con-
nected to the machine, the motorized movement stops automatically.
6. Install the Patient Module bellows and bellows dome.
7. Install the CO2 absorber canister.
8. Connect a set of hoses for the anesthesia gas scavenging to the outlet of the airway
pressure-limiting valve (APL-valve).
9. Connect the hose from the gas scavenger to the operating room’s EVAC connector.
10. Connect the manual ventilation bag to the bag arm on the Patient Module. Connect a
patient breathing circuit to the inspiratory and expiratory connections.

5-2 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Pre-operation steps

5.3 Checkout recommendations


See “Checkout Recommendations” on page 10-1.

5.4 Pre-operation steps


The following steps must be carried out each day prior to using the gas machine in clinical
practice. Perform these steps in accordance with the steps detailed in Chapter 10. See
“Checkout Recommendations” on page 10-1.
1. Install and lock the vaporizers to the gas machine.
2. Turn on the gas machine mains switch to activate electronics and gas supply.
3. Supply a source of compressed oxygen and ventilator drive gas (air or oxygen). Drive
gas is factory configured.
4. Ensure that a suitable independent device for manual ventilation (e.g., ambulatory
bag) is available at or near the machine.

5.5 Before every patient


The following steps should be carried out prior to each new patient being attached to the
device or when a different operator uses the gas machine. Perform these steps in
accordance with the steps detailed in Chapter 10. See “Checkout Recommendations” on
page 10-1.
• Check that the O2 emergency tank is full.
• If the ventilator operates on compressed air, check that the emergency air tank is
full. Ventilator drive gas is factory configured.

Anestar™ Operating Instructions 0070-00-0516 5-3


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

5.6 Perform every 3 days (or when prompted by


the Anestar)
O2 calibration should be carried out when prompted and when changing the O2 cells.

5.7 Perform after changing Pre-Packs or after changing


the vaporizer.
• Leak Test

5-4 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

5.8 Anestar startup


The following activities are performed automatically when the gas machine is powered on
(Mains switch):

5.8.1 System start

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE

Anestar
ALARM Selected mode must be Standby
LIMITS

Please wait

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-1 First display message during system start

Anestar™ Operating Instructions 0070-00-0516 5-5


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

5.8.2 Pressure test

After the automatic system start has been completed, the following display for
implementing the pressure test appears.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Pressure Test
1. Stop any fresh gas delivery
2. Connect breathing circuit
ALARM to the Patient Module
LIMITS
3. Seal the Y-piece
4. Press Enter to start
the Test

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-2 Display before pressure test

Follow the instructions on the ventilator display. Select the ENTER key to activate the
test.

The system now checks and calibrates all sensors. The sensors that are checked include
the expiratory flow sensor, the pressure sensors, and the internal sensors of the ventilator
drive. Active components such as pneumatics control valves, are also checked during the
pressure test.

The Patient Module, patient connection hoses, the Y-piece, etc., are also tested for leaks.
Furthermore, the system compliance and the effect the patient connection hoses
contributes to compliance is also detected during the sensor test.

5-6 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

During the pressure test a display message confirms that the test is running.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Pressure Test

Pressure Test in progress


ALARM
LIMITS

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-3 Display during the pressure test

Anestar™ Operating Instructions 0070-00-0516 5-7


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

After a successful pressure test the text message Pressure Test Passed appears.
Information about leakage rate may appear.

PEAK MEAN MINUTE VENT


Fi O 2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Pressure Test
Pressure Test Passed
Leak rate is between
ALARM 300-600 ml/min
LIMITS

Please Enter to continue

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-4 Display after the pressure test

During the pressure test, a compliance measurement is also carried out. Along with
measuring system compliance, this test also checks for leaks in the Patient Module, patient
connecting hoses, Y-piece, etc. This test should be repeated if the patient connection hoses
are exchanged for hoses that may have a relevant difference in tube compliance.

5-8 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

5.9 Standby mode options window


The Options window, active only in the standby mode, is opened by selecting the
OPTIONS key on the display panel. The following window is displayed:

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Running Hours
Test
ALARM
LIMITS 0 P. Module
Leak Test
unlock
Temp. [ºC]
Cal. 02 35.2 Contrast

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP PRESSURE
FLOW RATE

FIGURE 5-5 Standby mode options display

In this screen the running hours of the machine and the temperature of the Patient Module
are displayed. The Pressure Test, Leak Test and O2 calibration routines may also be
accessed in this screen. Select the OPTIONS key again, and the window will close.

Selecting the PATIENT MODULE UNLOCK key causes the motorized Patient Module
to unlock and extend outward for removal.

Manually positioning the Patient Module inward causes the Patient Module to engage the
locking mechanism and it returns to the locked position automatically.

Contrast adjustment is available for the LCD display only.

Anestar™ Operating Instructions 0070-00-0516 5-9


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

5.9.1 O2 sensor calibration

To carry out the O2 calibration, select the onscreen key labeled CAL. O2 on the display
while viewing the Options screen.

When starting the O2 sensor calibration, the following display appears.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
1. Expose O2 sensor
Test
ALARM to room air
LIMITS
Leak Test
2. Press Enter to start
calibration
Cal. 02

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-6 First display message of O2 sensor calibration

Pull the O2 sensor out of the inspiration valve cap. to ensure proper calibration, place the
sensor into ambient air while still plugged to the O2 sensor cable.

NOTE: Be sure that the O 2 sensor is exposed to room air


before starting the calibration.

5 - 10 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

During the calibration of the O2 sensor, a window providing information about the
progress of the calibration process appears.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Test O2 cell calibration
ALARM in progress
LIMITS
Leak Test

Cal. 02

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-7 Second display message of O2 sensor calibration

Anestar™ Operating Instructions 0070-00-0516 5 - 11


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

The result of the O2 sensor calibration is then displayed as follows:

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Test O2-calibration
ALARM successful
LIMITS
Leak Test

Cal. 02

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-8 Third display message of O2 sensor calibration

Re-insert the O2 sensor back into the inspiration valve cap. This completes the calibration
of the O2 sensor.

5 - 12 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

5.9.2 Leak test

To carry out a leak test for the entire fresh gas system, select the LEAK TEST key on the
display while in the Options screen.

PEAK MEAN MINUTE VENT


Fi O 2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure 1. Stop any fresh gas delivery


Test 2. Connect Y-piece to
ALARM
LIMITS
the bag arm
Leak Test 3. Set APL valve to the
MAX position
Cal. 02 4. Press Enter to start the
Leak Test
VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-9 Display prior to the fresh gas system leak test

Follow the instructions on the ventilator display.

Apart from the Patient Module, patient connection hoses, Y-piece, etc., the leak test of the
fresh gas system also checks the flowmeter tube block, the vaporizer mount and
vaporizers, absorber canister, manual ventilation hose, and Airway Pressure Limited valve
(APL) for any leaks.

Anestar™ Operating Instructions 0070-00-0516 5 - 13


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

During the fresh gas system leak test, a message confirming that the test is being carried
out is displayed.

PEAK MEAN MINUTE VENT


Fi O 2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Test
ALARM Leak Test in progress
LIMITS
Leak Test

Cal. 02

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-10 Display during the fresh gas system leak test

5 - 14 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

After a successful fresh gas system leak test, a window, indicating the exact volume leak,
is displayed.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Test
Leak Test Passed
ALARM Leak Rate is
LIMITS 350 ml/min
Leak Test
Please check breathing
circuit and vaporizers.
Cal. 02

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-11 Display after the fresh gas system leak test

Anestar™ Operating Instructions 0070-00-0516 5 - 15


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

Return the Patient Module hoses to their normal condition and reconnect the reservoir/
manual ventilation bag. Return the airway pressure valve to the CMV position.

To exit the leak test window, select the ENTER key.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure
Running Hours
Test
ALARM
LIMITS 8 P. Module
Leak Test
unlock
Temp. [ ºC]
Cal. 02 23.7
VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-12 Display after selecting the OPTIONS key

5 - 16 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

5.9.3 Pressure Test

To initiate a pressure test without powering off the machine, select pressure test from the
options screen. See “Pressure test” on page 5-6.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure 1. Stop any fresh gas


Test delivery
ALARM 2. Connect breathing
LIMITS
Leak Test circuit to the
Patient Module
3. Seal the Y-piece
Cal. 02 4. Press Enter to start
the test
VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-13 Pressure Test screen from Options Menu

Anestar™ Operating Instructions 0070-00-0516 5 - 17


Perform after changing Pre-Packs or after changing the vaporizer. Startup and Functional Tests

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Pressure Test

Pressure Test in progress


ALARM
LIMITS

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-14 Pressure Test progress from Options Menu

5 - 18 0070-00-0516 Anestar™ Operating Instructions


Startup and Functional Tests Perform after changing Pre-Packs or after changing the vaporizer.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Configuration

Pressure Pressure Test Passed


Test Leak rate is
ALARM
LIMITS
350 ml/min
Leak Test Compliance is
3.9 ml/cm H20
Cal. 02 Please check
breathing circuit
VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 5-15 Pressure Test completion from Options Menu

Anestar™ Operating Instructions 0070-00-0516 5 - 19


6.0 Operation of Individual
Functions

6.1 Standby mode


This is the startup operating mode position prior to switching on a ventilation or in
between ventilation operations. The system returns to this mode after the pressure test has
been carried out. The display shows the following window:

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE
Standby

ALARM
LIMITS

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-1 Standby mode display

All patient alarms are disabled in Standby mode.

Anestar™ Operating Instructions 0070-00-0516 6-1


Manual ventilation mode Operation of Individual Functions

6.2 Manual ventilation mode


The Anestar offers a manual ventilation mode of operation which provides pressure,
volume parameters, respiration rate and O2 concentration values. It also offers a real-time
airway pressure waveform. Alarm limits specific to manual and spontaneous respiration
are available via the Alarm Limits screen.

6.2.1 Manual ventilation mode settings


1. Set the ventilator mode selector knob to Manual when manually ventilating or sponta-
neously breathing patients.
2. During manual ventilation or spontaneous breathing a real-time airway pressure
waveform will be displayed at full scale.
3. Adjust the APL valve to limit the patient’s airway pressure.
4. Observe the ventilation parameters measured by the system: Peak Pressure, Mean
Pressure FiO2 concentration, Tidal Volume, Respiration Rate and PEEP (Peak End
Expiratory Pressure).
5. I:E Ratio and Plateau Pressure are not displayed as they are available only during
controlled ventilation.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS
5 --- 3.4 19 MAN
MUTE

60

40

20
ALARM
LIMITS
0
-5
0 2 4 6 8 10 12 14 16

VIEW 1450 20 1 ENTER


SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-2 Manual ventilation mode display

6-2 0070-00-0516 Anestar™ Operating Instructions


Operation of Individual Functions Manual ventilation mode

6.2.2 Alarm Limits setting (manual)

The alarm limits screen, pictured below, is available during manual ventilation mode by
selecting the ALARM LIMITS key on the operating panel.
1. To set an alarm limit, select the touchscreen’s bar graph number. Adjust the value with
the Up/Down arrows. Select ENTER to confirm the selection.
2. Select ALARM LIMITS again to return to the ventilation screen. The valves that are
displayed in the alarm screen are actual real-time patient values.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS MUTE

ALARM
LIMITS

VIEW
ENTER
SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-3 Alarm Limits screen (manual ventilation mode)

The individual alarms mean:


O2 min Limit for main FiO2 valve in Volume %
O2 max Limit for max FiO2 valve in Volume %
Apnea delay Delay time (in seconds) between the onset of Apnea and the
occurrence of the first set of double-beeps.

Anestar™ Operating Instructions 0070-00-0516 6-3


Manual ventilation mode Operation of Individual Functions

6.3 CMV ventilation mode


The Anestar Anesthesia Delivery System offers two patient size-specific modes for
controlled ventilation, adult and pediatric. Each mode is accessible via the Ventilator
mode Selector Switch. The differences between the two modes are the default ventilation
parameters and alarm limit settings. These are specific to the patient group.

Select the ventilation mode based on the ventilation requirements of the patient. Tube and
filter systems should also be fitted to the patient.

6.3.1 CMV ventilation mode settings


1. Set the rotary switch to Child for the controlled ventilation of pediatrics or to Adult
for the controlled ventilation of adults.
2. Use the ventilator display to select the ventilation mode CMV by selecting the VENT
MODE key. Select the START CMV ADULT key (center screen) to begin
ventilation.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS CMV MUTE

ALARM
LIMITS
START CMV ADULT

VIEW
SETTINGS 500 10 1: 2 0 OFF ENTER

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-4 Start window for the CMV ventilation mode

After starting the CMV mode, a reminder will be displayed on the screen to set the APL
valve to the CMV position. The APL valve is in the CMV position when the CMV/SP
label is positioned directly above the vertical line on the side of the APL valve. This is the
fully open position.

During the CMV ventilation mode, the display shows the measured pressures, volumes,
respiration rate, oxygen concentration, I:E ratio and PEEP.

Any alarm messages are displayed below the real-time waveform.

6-4 0070-00-0516 Anestar™ Operating Instructions


Operation of Individual Functions Manual ventilation mode

Selecting VIEW SETTINGS will show the ventilator settings in reverse graphics at the
bottom of the display.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS 35 10 2.2 43 CMV MUTE

40

20
ALARM
LIMITS
0
-5
0 2 4 6 8 10 12 14 16

VIEW
SETTINGS
290 10 1: 2 0 ENTER

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-5 CMV ventilation mode settings

In the measured value fields, the following is displayed


PEAK Airway pressure value in RESP Ventilation frequency in
PRESSURE cm H2O RATE breaths/min
MEAN Average pressure in I:E Inspiratory to expiratory
PRESSURE cm H2O ratio
MINUTE Minute volume in l/min PEEP Positive end expiratory
VOLUME pressure in cm H2O
FiO2 Inspiratory O2 PLATEAU Plateau pressure in
concentration in PRESSURE cm H2O
Volume %
TIDAL VOL. Volume in ml FLOW Not active in CMV Mode
(see Tidal Volume)

Anestar™ Operating Instructions 0070-00-0516 6-5


Manual ventilation mode Operation of Individual Functions

6.4 PCV Ventilation mode


For pressure-controlled ventilation, the Anestar Anesthesia Delivery System offers the
ventilation modes PCV child and PCV adult.

With Pressure Controlled Ventilation, an adjustable maximum inspiratory (plateau)


pressure will be maintained. The change to expiration is time regulated. The Tidal Volume
is a result of the inspiratory time, pre-set plateau pressure, flow and pulmonary resistance.
The advantage is the avoidance of pressure peaks that may injure delicate, or otherwise
compromised, lungs.

6.4.1 PCV ventilation mode settings


1. Set the ventilation mode rotary switch to Child for the controlled ventilation of chil-
dren or to Adult for the controlled ventilation of adults.
2. Use the ventilator display to select the ventilation mode PCV by touching the VENT
MODE key. Select the START PCV ADULT key (center screen) to begin
ventilation.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS PCV MUTE

ALARM
LIMITS
START PCV ADULT

VIEW
SETTINGS 10 10 2: 1 0 20 ENTER

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-6 Start window for the PCV ventilation mode

After starting the PCV mode, a reminder will be displayed on the screen to set the APL
valve to the PCV position. The APL valve is in the PCV position when the PCV/SP label
is positioned directly above the vertical line on the side of the APL valve. This is the fully
open position.

6-6 0070-00-0516 Anestar™ Operating Instructions


Operation of Individual Functions Manual ventilation mode

During the PCV ventilation mode, the display shows the measured pressures, volumes,
ventilation rate, I:E ratio, PEEP and operator-set plateau pressure.

In the PCV mode, the duel function TIDAL VOL./FLOW key allows for adjustment of
the flow during the inspiration phase of respiration.

In the PCV mode, the PLATEAU PRESSURE key allows for the adjustment of the target
PEAK PRESSURE, which will plateau during the inspiration phase of respiration.

Any alarm messages are displayed below the real-time waveform.

Selecting VIEW SETTINGS will show the parameter alarm settings by displaying them
in the bottom of the display.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS
30 22 5.0 50 PCV
MUTE

40

20

ALARM
LIMITS
0
-5
0 2 4 6 8 10 12 14 16

VIEW 800 10 2: 1 0 30 ENTER


SETTINGS

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-7 PCV ventilation mode display.

In the measured value fields, the following is displayed:


PEAK Airway pressure value RESP. Ventilation rate/min
PRESSURE in cm H2O RATE
MEAN Average pressure I:E Inspiratory to expiratory
PRESSURE in cm H2O ratio
MINUTE Minute volume in l/min PEEP Positive end expiratory
VOLUME pressure in cm H2O

Anestar™ Operating Instructions 0070-00-0516 6-7


Manual ventilation mode Operation of Individual Functions

FiO2 Inspiratory O2 PLATEAU Target pressure is


concentration in PRESSURE adjustable. Measured
Volume % value in cm H20
TIDAL VOL. Tidal volume in l/min FLOW Inspiratory flow rate is
Available as a displayed adjustable
measurement value.
Tidal Volume is not
adjustable in the PCV
mode.

6-8 0070-00-0516 Anestar™ Operating Instructions


Operation of Individual Functions Manual ventilation mode

6.4.2 Alarm limits setting (CMV / PCV)

The alarm limits screens, pictured below, is available during either ventilation mode by
selecting the ALARM LIMITS key on the operating panel.
1. To set an alarm limit, select the touchscreen bar graph’s number. Adjust the value with
the UP/DOWN ARROWS. Select ENTER to confirm the selection.
2. Select ALARM LIMITS again to return to the ventilator screen. The valves that are
displayed during the alarm screen are actual real-time patient valves.

PEAK MEAN MINUTE VENT


Fi O2 MODE
PRESSURE PRESSURE VOLUME
cm H 2O cm H 2O 1 / min Vol.%

OPTIONS
22 16 1.6 19 PCV MUTE

Vtmin P M.Vol O2 Vol.


ALARM
LIMITS

VIEW
SETTINGS 160 10 2: 1 0 19 ENTER

TIDAL VOL. RESP. PLATEAU


I:E PEEP
FLOW RATE PRESSURE

FIGURE 6-8 Alarm Settings PCV ventilation mode

The individual alarms mean:

T. Vol. min Limit for min. tidal M. Vol. min Limit for min. minute
volume in ml volume

P max Maximum pressure limit P min Minimum pressure limit


(high pressure limit) in (lowest pressure limit)
cm H2O in cm H2O

O2 max Limit for max. FiO2 value O2 min Limit for min. FiO2 value
in % in %

Audio Range of audio volume


Volume during alarm conditions

Anestar™ Operating Instructions 0070-00-0516 6-9


7.0 Operators Maintenance

7.1 Dismantling and Reassembling

7.1.1 Patient Module

To remove the Patient Module, first the CO2 absorber and then the bag-in-bottle system
are removed. The Patient Module can be pulled out of its seat after releasing it from the
machine.

CAUTION: During transportation of the Patient Module, the


transportation protection should be applied to the
rear to protect the diaphragm valves.

7.1.2 CO2 absorber canister (see figure 7-1)

To release the absorber canister from the Patient Module (1), turn the unit
counterclockwise to unscrew the unit. The pre-packs can now be changed.

CAUTION: After changing the pre-packs, carry out a fresh-


gas system leak test.

Anestar™ Operating Instructions 0070-00-0516 7-1


Dismantling and Reassembling Operators Maintenance

7.1.3 Bag-in-bottle system (see figure 7-1)

Unscrew the patient dome from the bayonet fitting (2) by turning it counterclockwise. The
dome can be pulled out from below.

Now the bellows can be pulled off the connection cone.

FIGURE 7-1 Bag-in-bottle System

7-2 0070-00-0516 Anestar™ Operating Instructions


Operators Maintenance Dismantling and Reassembling

7.1.3.1 Dismantling the Airway Pressure Limiting Valve (APL)


• To dismantle the Airway Pressure Limiting valve, unscrew the union nut. The top
section can now be removed.
• The membrane can be removed from the bottom section and replaced, if necessary.
• The membrane is placed back into the bottom section with the metal piece
facing upwards.
• Replace the top portion of the Airway Pressure Limiting valve and secure with
union nut.

CAUTION: The spring in the top of the Airway Pressure


Limiting valve may not be stressed. After removal
from the bottom section, place the top section to
one side, taking care that the spring is not unduly
loaded.

7.1.3.2 Replacing Air, Inspiration, Expiration, and APL Valve Components


and Bag Arm (see figure 7-2)
1. To dismantle the valves, the coupling ring (1) must be unscrewed from the valve body.
2. The valve cover (2, 2a) can now be removed.
3. The o-ring (3) and metal baskets (5) in the Inspiration and Expiration valves can now
be removed.
4. The valve disk (6) can now be removed.
5. The membrane of the Air valve (4) can be removed from the valve body after
removing the coupling ring (1) and the valve cover (2).
6. The APL valve membrane (7) can be removed after unthreading the APL valve
locking ring (8).
7. The bag arm can be removed by unthreading its coupling ring (9). The arm (10) can
then be removed by pulling it up.

Anestar™ Operating Instructions 0070-00-0516 7-3


Dismantling and Reassembling Operators Maintenance

7.1.3.3 Replacing Diaphragm Valve Components (see figure 7-2)


1. To disassemble the diaphragm valves (11) at the rear of the Patient Module, unthread
the coupling nut (12).
2. With the nut removed, remove the coupling ring (13).
3. With the ring removed, pull out the valve seat (14) This valve seat is pressurized
during valve activation.
4. With the coupling removed, the valve membrane (15) is exposed. Note the orientation
of this membrane and reinstalled in the valve seat the same way.
5. Assemble in reverse order.

10
1

2 9
1
3
2a 1
8
5
2
3
6 7 4
5
6

15 15
11
11
14
14

13
13

12
12

FIGURE 7-2 Patient Module, Exploded View

7-4 0070-00-0516 Anestar™ Operating Instructions


Operators Maintenance Cleaning and sterilization

7.1.4 Connection and disconnection of the vaporizers


• To connect the vaporizers, place them carefully on the vaporizer mounting device.
• Lock the vaporizer with the locking lever and check for proper seating.

CAUTION: Only vaporizers with Interlock-System may be


used with the Anestar unit.

CAUTION: After each exchange of a vaporizer, carry out a


fresh-gas system leak test.

7.2 Cleaning and sterilization


CAUTION: Do not clean the machine while it is on and/or
plugged in.

7.2.1 Cleaning the housing

The machine housing can easily be cleaned with a cloth slightly moistened with a liquid
cleaning agent. To avoid abrasion, the cloth must be soft and moist. If additional cleaning
is required, use a surface disinfecting agent.

CAUTION: Use cleaning agent sparingly. Excess fluid could


enter the machine, causing damage.

7.2.2 Patient Module

7.2.2.1 Sterilizing the Patient Module

The Patient Module can be autoclaved at a temperature of up to 134 °C. Before sterilizing,
the bag-in-bottle system and the absorber must be removed.

The transportation protection should be installed at the rear of the Patient Module after
removal from the machine.

CAUTION: The patient dome of the bag-in-bottle system


cannot be autoclaved. It is not in contact with the
ventilation gas. If soiled, the patient dome should
be cleaned with water and liquid cleaning agent.
The unit can be disinfected with a standard
surface-disinfecting agent. Do not use alcohol.

The absorber canister can be autoclaved up to 134 °C. In order to enhance the life of
sealing materials, a temperature of 121 °C is preferred.

The upper part of the airway pressure valve (APL) should be dismantled before
autoclaving. Autoclave the APL upper part and the membrane as separated parts.

Anestar™ Operating Instructions 0070-00-0516 7-5


8.0 Specifications

8.1 Safety Designations


Safety designations per IEC 601-1 Standard:

Type of protection against


electric shock: Class 1 and Internal Electric Power Source.
Where the integrity of the external protective
earth conductor arrangement is in doubt,
equipment shall be operated from its internal
electric power source.

Degree of protection against


electric shock: Console, Type B, Accessories - Type BF

Supply Connection: AC Operation:


120VAC (nominal)
60Hz; 5A

Internal Battery Operation:


12VDC Internal Battery

Mode of Operation: Continuous

Protection Against Hazards


of Explosion: Not protected. (Ordinary)

Protection Against Ingress of


Liquids: Not protected. (Ordinary)

Degree of Electrical Connection


Between Equipment and Patient: Equipment designed for non-electrical connection
to the patient.

Degree of Mobility: Mobile.

Anestar™ Operating Instructions 0070-00-0516 8-1


General Specifications

8.2 General

8.2.1 Dimensions

Height 1530 mm

Width 710 mm

Depth 790 mm

8.2.2 Weight

120 kg (without vaporizers or gas cylinders)

8.3 Environmental
Operating temperature +10 to +35 °C

Storage temperature -5 to +50 °C

Humidity (operating & storage) 10-95%RH, non-condensing

8-2 0070-00-0516 Anestar™ Operating Instructions


Specifications Environmental

8.4 Electrical

8.4.1 Electrical Power Requirements

Mains power supply 120 VAC +/- 10% / 60 Hz

Current input 12A (5A for Anestar, 7A for auxiliary outlets)

Power consumption (Anestar) approx. 210VA

Anestar fuse 5A resetable (externally accessible)

8.4.2 Battery Power Requirements

Battery 12V/ 6.5Ah lead acid

Battery run time Approx. 30 minutes

Battery charge time 7 hours max, if apparatus is activated

Battery fuse 5A resetable (externally accessible)

8.4.3 Auxiliary Outlets

Auxiliary outlets Four 120 volt, hospital grade

Auxiliary outlets fuse 10A resetable (externally accessible)

Anestar™ Operating Instructions 0070-00-0516 8-3


Gas Management Specifications

8.5 Pneumatic

8.5.1 Central Gas Supply Requirements

O2 350 kPa +/- 150 kPa

N2O 350 kPa +/- 150 kPa

Air 350 kPa +/- 150 kPa

8.5.2 Cylinder Gas Supply Requirements

O2 E Cylinder / pin indexed per CGA V-1

N2O E Cylinder / pin indexed per CGA V-1

Air E Cylinder / pin indexed per CGA V-1

8.6 Gas Management

8.6.1 Ratio System

Integrated with automatic N2O cutoff when O2 fails (minimum of 25% Vol% O2 in
fresh gas.)

8-4 0070-00-0516 Anestar™ Operating Instructions


Specifications Gas Management

8.7 Patient Module / Circular System


Internal volume approx. 2.51

Absorber capacity 2 Pre-paks

Absorber system Pre-pak canisters

Condensation block heated Patient Module


(36 +/- 2 °C)

Processing can be autoclaved at 134 °C

System compliance approx. 4.5 ml/Pa x 100 with standard hoses is


automatically compensated

Fresh gas coupling automatic during inspiration, allowing constant


volume ventilation

Anestar™ Operating Instructions 0070-00-0516 8-5


Gas Management Specifications

8.8 Ventilator
Ventilator control time control, pressure limited, constant volume

Ventilation types: Manual ventilation, spontaneous ventilation,


CMV Child, CMV Adult, PCV Child, PCV Adult

Tidal volume: 20 - 1400 ml (+/- 10%),


Child: 20 - 400 ml,
Adult: 300 - 1400 ml

Ventilation frequency: 4 - 60 bpm


Child: 10 - 60 bpm
Adult: 4 - 30 bpm

Resp. minute volume: max. 20 l/min

I: E ratio: 1:1; 1:1.5; 1:2, 1:3;

Inverse I:E Ratio 2:1 and 3:1

Plateau (end insp.) 20% or 30% of insp. period

PEEP 0 - 20 +/- 2 Pa x 100

Max. insp. pressure: 80 Pa x 100

Manual pressure control 4 - 60 Pa x 100

Sensor test Automatic

Leak tests Circular system, automatic after confirmation fresh


gas system, automatic after confirmation

Oxygen monitor Type: Galvanic Fuel cell


FiO2 display 0- 100 vol% O2,
resolution 1%

Pressure monitor Real-time graphics (waveform)


Numerical pressure values for PEEP,
Pmean, Ppeak

Pressure range –10 to 100cm H20

Accuracy ±3% cm H2O

Resolution 1 cm H2O

8-6 0070-00-0516 Anestar™ Operating Instructions


Specifications Gas Management

Ventilator monitor Real-time graphics (waveform)


Numerical values for Tidal
volumes, breathing frequency,
minute volumes

Tidal Volume Range:20 to 9999 ml

Minute Volume Range:1 to 999.9 liters

Rate: 0 to 99 bpm

Accuracy: ±10%

Resolution Tidal Volume:10 ml

Resolution Minute Volume: 0.1 liters

8.8.1 Accuracy of the measurements

Pressure ±5% of the measured value, at least 1 Pa x 100*

O2 ±3% of the measured value, at least 1%

Volume Adult mode: ±10% of the measured value*


Child mode: ±10% of the measured value at
least 10 ml*

Flow tubes ±3% of the scale value*

Rate ±1 bpm*

* ATPD

Anestar™ Operating Instructions 0070-00-0516 8-7


Gas Management Specifications

8.9 Inputs / Outputs

8.9.1 Electrical

8.9.1.1 Input Power

Input power is provided via a captive line cord with 120 volt, hospital grade plug.

8.9.1.2 Auxiliary Outlets

Four 120-volt, hospital grade outlets.

8.9.1.3 O2 Sensor

Four-pin connector for O2 cell cable.

8.9.2 Pneumatic

8.9.2.1 Pipeline connections

O2, DISS threaded body as per CGA V-5

N2O, DISS threaded body as per CGA V-5

Air, DISS threaded body as per CGA V-5

8.9.2.2 Cylinder connection(s)

Up to three E-cylinder gas tank yokes.The yokes are pin indexed (PISS) by gas type (O2,
N2O, Air), per CGA V-1.

8.9.2.3 Vaporizer connection(s)

Two vaporizers (max) using the Selectatec mounting system.

8.9.2.4 Patient Module connections

Four pneumatic connectors are provided on the patient module. One connection each for
the inspiration and expiratory hoses of the pneumatic circuit. A connection for the
breathing bag and a port for the O2 fuel cell.

8.9.2.5 Aux O2 connector

DISS threaded connector on the left side of unit for connection of an auxiliary O2 supply
flowmeter.

8-8 0070-00-0516 Anestar™ Operating Instructions


Specifications Gas Management

8.9.2.6 Recirculation gas collector

Female Leur fitting with captive dead-end plug.

Anestar™ Operating Instructions 0070-00-0516 8-9


Gas Management Specifications

8.10 Displays / Controls

8.10.1 Electronic

8.10.1.1 Display

Color LCD or EL with integrated touchscreen

The touchscreen contains the following permanent keys:


1. OPTIONS
2. ALARM LIMITS
3. VIEW SETTINGS
4. TIDAL VOL./FLOW
5. RESP. RATE
6. I:E
7. PEEP
8. PLATEAU PRESSURE
9. ENTER
10. DOWN ARROW symbol
11. UP ARROW symbol
12. MUTE
13. VENT MODE

8.10.1.2 Advisory and Alarm LEDs

Red LED for Alarm

Yellow LED for Advisory.

8.10.1.3 Mode Selector Switch

A four-position rotary switch for selecting the mode of operation.


1. Standby – for running daily initial checkout or leaving the Anestar powered up
between cases.
2. Manual Vent. – manual or spontaneous ventilation mode
3. Child (20-400ml) – for CMV (Constant Volume) or PCV (Pressure Controlled)
ventilation*
4. Adult (300-1400ml) – for CMV (Constant Volume) or PCV (Pressure Controlled)
ventilation*

*CMV is the default ventilation mode

8 - 10 0070-00-0516 Anestar™ Operating Instructions


Specifications Gas Management

8.10.2 Pneumatic

8.10.2.1 Line Pressure Gauges

Three line pressure gauges monitor the pipeline pressure supply of O2, N2O and Air.

The range of each gauge is 0 to 100 psi.

8.10.2.2 Cylinder Pressure Gauges

Cylinder pressure gauges are provided to monitor the cylinder tank pressure for O2, N2O
and Air. The range of each gauge is 0 to 3000 psi.

8.10.2.3 Flowmeter and Control Valve

Three control knobs, one each for O2, N2O and Air, are used to set the fresh gas dosing
flow. Flow set by the control knobs is monitored by five flowmeter tubes. Two each for
O2 and N2O and one for Air. The scale of the flowmeters is,

O2 High Range 1.5 to 10 l/min

O2 Low Range 0 to 1000 ml/min

N2O High Range 1.5 to 10 l/min

N2O Low Range 0 to 1000 ml/min

Air 0 to 12 l/min

8.10.2.4 O2 Flush

A push button O2 flush valve supplies high O2 flow directly to the fresh gas outlet when
depressed. The button returns to its original closed position when released.

8.10.2.5 Changeover Switch

This two-position switch allows the either N2O or Air to be dosed into the fresh gas
supply.

8.10.2.6 Patient Module

The patient module contains two controls:


1. APL Valve
2. Emergency Room Air Valve

Anestar™ Operating Instructions 0070-00-0516 8 - 11


9.0 Warranty

Datascope Corp. warrants that the Anestar ™ Anesthesia Delivery Machine, its non-
consumable plumbing, electric and electronic components, will be free of defects in
materials and workmanship for the period of one year from the date of shipment.
Accessories are warranted for 90 days from the date of shipment.

Datascope Corp. warrants that consumable, one-time-use, and disposable items will be
free of defects in material and workmanship for their first use, or one year from date of
their purchase, whichever comes first. These items include consumable, one-time-use or
disposable devices such as batteries, rebuild kits and their components, filters and screens,
or any other device specified as consumable, disposable or “one-time” or “limited-time”
use.

Datascope Corp. shall not be liable for any incidental, special, or consequential loss
damage, or expense directly or indirectly arising from the use of its products. Liability
under this warranty and the buyers exclusive remedy under this warranty is limited to
servicing or replacing at Datascope Corp’s option, at the factory or at an authorized
Datascope Distributor, any product which shall under normal use and service appear to the
Company to have been defective in material or workmanship.

No agent, employee, or representative of Datascope Corp. has any authority to bind


Datascope Corp. to any affirmation, representation, or warranty concerning its products,
and any affirmation, representation or warranty made by an agent, employee or
representative shall not be enforceable by law.

This warranty is expressly in lieu of any other express or implied warranties, including
any implied warranty of merchantability or fitness, and of any other obligation on the part
of the seller.

Damage to any product or parts through misuse, neglect, accident, or by affixing any non-
standard accessory attachments or by any customer modification voids this warranty.
Datascope Corp. makes no warranty whatever in regard to trade accessories, such being
subject to the warranty of their respective manufacturers.

Anestar™ Operating Instructions 0070-00-0516 9-1


Datascope’s Responsibility Warranty

A condition of this warranty is that this equipment or any accessory which is claimed to be
defective be returned when authorized by Datascope, freight prepaid to Datascope Corp.,
to an Authorized Datascope Distributor or Authorized Datascope Service Facility.
Datascope Corp. shall not have any responsibility in the event of loss or damage in transit.

Certain calibration may be performed without the need to disassemble the instrument. It is
the responsibility of the purchaser to perform calibration as necessary, in accordance with
the instructions provided in the manual.

9.1 Datascope’s Responsibility


Datascope is responsible for the effects on safety, reliability and performance of the
equipment only if:
A. Assembly operations, extensions, readjustments, modifications or repairs are carried
out by persons authorized by Datascope; and
B. The electrical installation of the relevant room complies with the appropriate require-
ments; and
C. The equipment is used in accordance with the instructions for use.

9.2 How to Get Help


Datascope maintains a network of service representatives and factory-trained distributors.
Prior to requesting service, perform a complete operational check of the instrument to
verify proper control settings. If operational problems continue to exist, contact a
Datascope authorized distributor for assistance in determining the nearest field service
location.

Please include the instrument model number, the serial number, and a description of the
problem with all requests for service.

Any questions regarding the warranty should be directed to Datascope’s authorized


distributor in your region or to:

Service Manager
Datascope Corp.
800 Mac Arthur Blvd.
Mahwah, NJ 07430
(800) 288-2121

9-2 0070-00-0516 Anestar™ Operating Instructions


10.0 Checkout Recommendations

Introduction
Users should refer to the Operating Instructions for special procedures or precautions. If
an anesthetist uses the same machine in successive cases, the steps need not be repeated or
may be abbreviated after the initial checkout.

10.1 Checkout Steps


This checkout should be conducted before administering anesthesia. This is a guideline
which users are encouraged to modify to variations in local clinical practice. Such local
modifications should have appropriate peer review.
1. Inspect Anestar for:
• Identification number
• Valid inspection sticker
• Undamaged flowmeters, vaporizers, gauges, supply hoses
• Complete, undamaged breathing system with adequate CO2 absorbent (two (2)
PRE-PAKs)
• Correct mounting of cylinders in yokes
• Presence of cylinder wrench
2. Set the Ventilator Mode Selector switch to the Standby position.
• Turn ON (set to 1 position) Mains switch. Located on the right side of Anestar.
This will also turn on the Anestar’s integral O2 monitor and ventilator.
3. Turn ON the patient monitors to allow time for their warm-up. (ECG, Blood Pressure,
SpO2, Gas Monitoring, etc.)
4. Connect waste gas scavenging system:
• Adjust vacuum as required.

Anestar™ Operating Instructions 0070-00-0516 10 - 1


Checkout Steps Checkout Recommendations

5. Check that:
• Flow-control valves are off
• Vaporizers are off
• Vaporizers are filled (not overfilled)
• Filler caps are sealed tightly
6. Check oxygen (O2) cylinder supplies:
a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pres-
sure gauges to zero with O2 flush valve.
b. Open O2 cylinder; check pressure; close cylinder and observe gauge for evidence
of high-pressure leak.
c. With the O2 flush valve, flush to empty piping.
d. Replace any cylinder showing less than about 1000 psig.
e. Open the cylinder.
7. Check nitrous oxide (N2O) and other gas cylinder supplies:
• Use same procedure as described in 6a and b above, but open and close flow-
control valve to empty piping.

NOTE: N2O pressure below 745 psig indicates that the


cylinder is less than ¼ full.
8. Test flowmeters:
a. Check that float is at bottom of tube with flow-control valves closed.
b. Adjust flow of all gases through their full range and check for erratic movements
of floats.
9. Test Hypoxic-Guard System:
• Attempt to create hypoxic O2/ N2O mixture by slowly opening the N2O flow
control valve.
• Note that the O2 flow is 250 ml prior to the flow of N2O.
• Continue to increase the N2O flow and observe O2 and N2O rise in proportion to
maintain a minimum concentration of 25% O2 in fresh gas.
10. Test O2 pressure failure system:
a. Set O2 and N2O gas flows to mid-range.
b. Close O2 cylinder and flush to release O2 pressure.
c. Verify that all flows fall to zero.
d. Verify the “No drive gas, please check” indicator on the display screen and
auditory whistle sound.
e. Open O2 cylinder. Verify the “No drive gas, please check” indicator disappears.
f. Close all other cylinders and bleed piping pressures.
g. Close O2 cylinder and bleed piping pressure. Verify the “No drive gas, please
check” indicator reappears.
h. Shut off all flow-control valves.

10 - 2 0070-00-0516 Anestar™ Operating Instructions


Checkout Recommendations Checkout Steps

11. Test Central Pipeline Gas Supplies:


a. Inspect supply hoses (should not be cracked or worn).
b. Connect supply hoses, verifying correct color coding.
c. Set the Gas Selector Switch to N2O.
d. Adjust both O2 and N2O flows to at least mid-range.
e. Verify that the O2 and N2O supply pressures hold (45–55 psig).
f. Shut off flow-control valves.
g. Set the Gas Selector Switch to AIR.
h. Adjust the AIR flow to at least mid-range.
i. Verify that the AIR supply pressure hold (45–55 psig).
j. Shut off flow-control valves.
12. Accessories Connection:
• Connect the breathing circuit to the corresponding ports on the Patient Module.
• Connect the manual ventilation bag to the Bag Arm.
13. Check Unidirectional Valves:
a. Inhale and exhale through a surgical mask into the breathing system.
b. Verify unidirectional flow in each limb.
c. Reconnect tubing firmly.
14. Test for Leaks in Machine and Breathing System:
a. Ensure the Ventilator Mode Selector switch is in the Standby position.
b. Perform the PRESSURE TEST.
c. Follow screen directions. Select ENTER to start the test.
d. Verify PRESSURE TEST PASSES message appears on the screen.
15. Exhaust Valve and Scavenger System:
a. Test scavenging system according to manufacturer’s recommendations.
16. Test Ventilator:
a. Ensure the APL valve is set to the CMV position.
b. Set the Ventilator Mode Selector switch to the Adult position.
c. Attach a test lung to the Y-piece of the breathing circuit.
d. Select the O2 Flush button to fill the system with O2.
e. Select the screen area indicating START CMV ADULT.
f. Observe pressure waveform on screen and (test) lung movement.

NOTE: Expansion and contraction of the manual


ventilation bag is synchronized with the breathing
frequency.

Anestar™ Operating Instructions 0070-00-0516 10 - 3


Checkout Steps Checkout Recommendations

17. Test Low O2 Alarm.


a. Continue (step 16) in the Ventilation Mode Adult position.
b. Select the ALARM LIMITS key.
c. Activate the O 2 Low Alarm by setting an alarm limit that is higher than the current
O2 reading.
d. Verify:
• Corresponding screen message appears
• Flashing red LED indicator illuminates
• Alarm tone sounds
18. Test High Pressure Alarm Limit.
a. Continue in the Ventilation Mode Adult position.
b. Select the ALARM LIMITS key.
c. Activate the Pmax Alarm by setting an alarm limit that is below the current peak
pressure reading.
d. Verify:
• Corresponding screen message appears after several breaths
• Flashing red LED indicator illuminates
• Alarm tone sounds
• Expiration begins when the pressure limit is reached
19. Check for appropriate level of patient suction.
20. Check, connect and calibrate other electronic monitors.
21. Turn on and set other appropriate alarms for equipment to be used.
22. Perform O2 calibration.
a. Ensure the Ventilator Mode Selector switch is in the Standby position.
b. Remove (unthread) the O2 sensor from the elbow adapter, venting it to room air
for approximately 30 seconds.
c. Select the screen area indicating CAL O2.
d. Follow screen directions. Select OK when complete.

NOTE: The following step should be performed weekly or


whenever a new vaporizer is installed.
23. Test for leaks in the machine and vaporizers by accessing the Leak Test via the
Options menu.

NOTE: A vaporizer leak can only be detected if the


vaporizer is turned on during this test.
a. Ensure the Ventilator Mode Selector knob is set to the Standby position.
b. Select OPTIONS. Select the LEAK TEST key.
c. Follow the screen directions. Select ENTER to start the test.
d. Verify Leak Test Passes message appears on the screen.
e. Troubleshoot to resolve any leak higher than 300 ml/min.

10 - 4 0070-00-0516 Anestar™ Operating Instructions


Datascope Corp., US, Canada & Latin America | Patient Monitoring | Worldwide Headquarters |
800 MacArthur Blvd. | Mahwah, NJ 07430 USA | Dom. Customer Service: 1.800.288.2121 |
Dom. Fax: 1.800.926.4275 | Intl. Customer Service: 201.995.8237 |
E-Mail Address: [email protected]

Datascope Europe, Middle East & Africa Office | Drs. van Royenstraat | P.O. Box 26 | 3870 CA Hoevelaken |
The Netherlands | Tel: +31.33.2544911 | Fax: +31.33.2537621

Datascope Asia-Pacific Office | Billion Trade Center 1801 | 31 Hung To Road | Kwun Tong, Kowloon |
Hong Kong | Tel: 852.2793.5596 | Fax: 852.2344.8824

Datascope Middle East Office | 37 Ahmed El-Sawy Street | Area No.6, Nasr City Cairo | Egypt |
Tel: +20.2.274.8330 | Fax: +20.2.274.7471

Datascope GmbH | Fabrikstrasse 35 | 64625 Bensheim | Germany | Tel: 06251.17050 |Fax: 06251.67877

Datascope Medical Co., Ltd. | Lakeview Court | Ermine Business Park | Huntingdon |Cambs | England |
PE29 6XR | Tel: 01480.423600 | Fax: 01480.423638

Datascope SARL | Z.I.mAthelia 1 | 13705 La Ciotat | Cedex France | Tel: 004.42.08.77.50 |


Fax: 04.42.08.57.081

Printed in U.S.A. 0070-00-0516 Rev B December 10, 2001

You might also like