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2200MRI

Anesthesia Ventilator
MRI Compatible

User and Maintenance


Manual
073-0245-00/REV. C

2200MRI Ventilator User Manual 1


2 2200MRI Ventilator User Manual
2200MRI
Ventilator

User
Manual
MODIFICATIONS LABEL

REV A REV B REV C REV D REV E

PR023074 PR023688 PR023860


REV F REV G REV H REV I REV J

Spacelabs Healthcare Ltd.


1 Harforde Court • John Tate Road • Hertford •
SG13 7NW • United Kingdom
Tel: +44 (0)1992 507700
Fax: +44 (0)1992 501213
Part Number:
e-mail (enquiries): advsales@spacelabs.com 073-0245-00/Rev. C
December 2010
e-mail (technical): advsupport@spacelabs.com
www.spacelabshealthcare.com

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4 2200MRI Ventilator User Manual


IMPORTANT
The user must be familiar with the machine and its various functions
before using it on a patient.

Federal law restricts this device for sale by or on the order of a


physician.

Incorrect use of the equipment described herein may result in injury


to the patient. Read this manual before operating the machine. You
must be familiar with the machine and its functions before using it on
a patient.

Be sure to pay special attention to warnings, cautions and notes


within the manual. A full list of these can be found in Section 4 of this
manual.

Warning Notices

Warning notices denote a potential hazard to the health and safety


of users and/or patients. These notices clearly state the nature of the
respective hazard and the means by which it can be avoided.
Warning notices appear in full in the preliminary pages and are
repeated at their points of application in the manual.

Caution Notices

Cautionary notices denote a potential hazard to the physical integrity


of equipment/software but NOT a danger to personnel. These notices
clearly state the nature of the hazard and the means by which it can
be avoided.

Notes

Relevant or helpful information

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6 2200MRI Ventilator User Manual


Table of Contents

Contents Page

Chapter 1
Introduction 13
1.1 Introduction 15
1.2 Purpose 15
1.3 Explanation of Serial Numbering 15
1.4 Description 15
1.4.1 Front Panel Description 17
1.4.2 Underside Description 18
1.5 Major Features 20
1.6 Data Summary 20
1.7 Associated Equipment and Accessories 22

Chapter 2
Installation 23
2.1 Ventilator Set -Up Procedure 25
2.2 Unpacking 25
2.3 Preparation for Use 26
2.4 Changing Bellows Units 27
2.4.1 Installing the Pediatric Bellows 27
2.4.2 Installing the Adult Bellows 27
2.4.3 Adult Bellows Assembly Description 28

Chapter 3
Operation 31
3.1 Pneumatic System 33
3.1.1 Pneumatic Circuit Description 34
3.2 Ventilation Cycle Description Using Bellows 36

2200MRI Ventilator User Manual 7


3.3 Control Unit 37
3.4 Using the 2200MRI Anesthesia Ventilator in a Circle
Breathing System 38
3.5 In Use 39
3.6 Safety 40
3.6.1 Pneumatic Safety 40

Chapter 4
Preventative Inspection & Maintenance 41
4.1 Pre-Use Function Test 43
4.2 Clinical Operation 43
4.3 Incidental & User Maintenance 44
4.3.1 Service schedule 44
4.3.2 Cleaning of the ventilator control unit 45
4.3.3 Cleaning and sterilization of the bellows unit 45
4.4 Cleaning and Sterilization 45
4.4.1 Ventilator Surfaces 46
4.4.2 Pop-Off Valve Seat 47

Chapter 5
Troubleshooting 49
5.1 General Fault Diagnosis 51

Chapter 6
Notices 53

8 2200MRI Ventilator User Manual


List of Figures
Figure 1 - 2200MRI Anesthesia Ventilator 16
Figure 2 - Rear View & Underside View 19
Figure 3 - Adult and Pediatric Bellows 29
Figure 4 - Pneumatic Diagram 33
Figure 5 - Ventilation Cycle Using the Bellows 35
Figure 6 - Circle Breathing System 38
Figure 7 - Use with a Bain Circuit 38
Figure 8 - Expiratory Valve 47
Figure 9 - Removing the Pop-off Valve 48

2200MRI Ventilator User Manual 9


Copyright

© 2010 Spacelabs Healthcare Limited.

All rights reserved. The information contained in this publication may not be
used for any purpose other than that for which it was originally supplied.

This publication may not be reproduced in part or in whole without the written
consent of Spacelabs Healthcare Limited.

10 2200MRI Ventilator User Manual


2200MRI
Ventilator
How to Use This Manual
This manual is designed as a guide for learning to operate the 2200MRI
Ventilator, and also as a reference tool to use once you are familiar with the
system.

Keep this manual with the system to refer to and to answer any
questions that arise about system operation, maintenance or, if
necessary, repair.

All pictures shown in this manual are of the 2200MRI Ventilator.

Please read all warnings and notices in section 6 before using the
equipment

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12 2200MRI Ventilator User Manual


2200MRI
Ventilator

Chapter 1

Introduction

2200MRI Ventilator User Manual 13


Symbols and Abbreviations
Below are the symbols and abbreviations used on Spacelabs Healthcare
equipment labels and in this manual

bpm BPM Breaths per minute l/m lpm liters per minute

Gauge pressure expressed


cmH2O in centimetres of water
ml milliliters

Continuous positive airway


CPAP pressure
O2 Oxygen

Positive end expiratory


PEEP pressure
psi Pounds per square inch

A ratio of inspiratory to
I:E Ratio expiratory time
psig Pounds per square inch gauge

Caution consult
accompanying l Liters
documentation

IEC symbol denoting type IEC symbol for alternating


of equipment (B) current

Consult instructions for


Dangerous Voltage present
use.

Equipment serial number Power off

Manufacturer Power on

CE Mark. Confers
approval under the Caution: Denotes a potential
European Medical Device hazard and NOT a danger to
Directive and the notified personnel.
body number.
WARNING: There is danger of
Relevant or helpful
personal injury to the user or
information
patient.
Shows that turning the
control in the direction
of the thickening line, Year of manufacture
increases the parameter
setting.

14 2200MRI Ventilator User Manual


Introduction

1.1 Introduction
This manual contains installation and operating instructions for the 2200MRI
anesthesia ventilators. It also includes sections describing operation, cleaning
and sterilization methods, service instructions and troubleshooting procedures.

1.2 Purpose
The 2200MRI anesthesia ventilator is a pneumatically controlled oxygen
driven anesthesia ventilator designed for mechanical ventilation during
anesthesia. It can be used in closed circuit anesthesia to drive a bellows
assembly and to drive a Bain circuit directly.

1.3 Explanation of Serial Numbering


Each 2200MRI ventilator is marked with a unique Serial Number which also
indicates the Date of Manufacture which is indicated as follows:

XXXXX - XXX - The first three digits represent the Year of Manufacture
(i.e. 196=1996, 209=2009)
XXXXX - XXX - The 4th & 5th digits represent the Month of Manufacture
(i.e. 04=April, 06=June)
XXXXX - XXX - The final three digits are a sequential run of the number of
units built (i.e. 000 to 999)

1.4 Description
The 2200MRI anesthesia ventilator is a time cycled flow generator type
ventilator that is oxygen driven and can be provided with an ascending
bellows unit which is easily detachable for cleaning.

The 2200MRI anesthesia ventilator, when fitted with a bellows unit, is


designed for use with a circle-type absorber and is ideally suited to both
low-flow and high-flow applications.

The ventilator may also be used with or without the bellows to drive any semi
closed circuit such as a Bain-type coaxial circuit or a Jackson-Rees/Ayres
T-piece type pediatric circuit with no modification being necessary.

2200MRI Ventilator User Manual 15


Introduction

Key:
A - On/Off Switch
D B - Manometer
C - Adjustable pressure relief
knob
D - Inspiratory time control
knob
E - Expiratory time control
knob
E F - Flow control knob

Figure 1 - 2200MRI Anesthesia Ventilator

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Introduction

1.4.1 Front Panel Description


Refer to Figure 1 Spacelabs Healthcare 2200MRI Anesthesia Ventilator.

1. On/Off switch - rotates 90 degrees clockwise to turn the ventilator on


(A).
2. Manometer - calibrated between -20 to +100cmH2O, the gauge must
be connected to the inspiratory limb of the breathing circuit via the
connector on the underside (B).
3. Adjustable pressure relief valve which is calibrated at 0.5 litres per
second flow. Note - the pressure relief valve will relieve at a slightly
lower or higher level depending on the flow rate selected on the flow
control knob (C).

WARNING: The pressure relief valve is not intend for use as a pres-
sure limiter but as a pressure relief valve (safety valve).

4. Inspiratory time control knob - calibrated between 0.25 and 2.0


seconds (D).
Rotation of the knurled knob clockwise increases the inspiratory time.

5. Expiratory time control knob - calibrated between 0.5 and 5.0 seconds
(E).
Rotation of the knob in a clockwise direction increases the expiratory
time.

Breaths per minute are determined in the following way:


60
_______________________
BPM =
Inspiratory time + Expiratory time

The I:E ratio is determined in the following way:


Inspiratory time
1: = __________________
Expiratory time

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Introduction

6. Flow control knob - calibrated between 0.2 and 1.0 litres per second
(F).
Rotation of the grooved knob in an anti clockwise direction increases
the flow rate.
The tidal volume delivered to the patient is determined in the
following way:

Tidal volume = inspiratory time x flow rate


(litres) (seconds) (litres per second)

For further information on the bellows unit assembly, see paragraphs 2.4 to
2.4.3.

1.4.2 Underside Description


1. High pressure oxygen inlet connector - a 1.5 metre long high pressure
hose is supplied for connection to the DISS oxygen inlet connector.
2. Driving gas connector - a patient valve with a 22mm male taper and a
15mm female taper which connects to the patient circuit with a flexible
corrugated tube (see Figure 2 - Rear View and Underside View).
3. Pressure relief valve exhaust port - this exhaust port allows the drive
gas to exhaust to atmosphere when the set pressure at the adjustable
pressure relief valve has been reached.

WARNING: Do not attempt to block the exhaust port.

4. Manometer connection - this connects to the tube and the 22mm taper
male/female sensing tee which must be placed in the inspiratory limb
of the patient breathing circuit.

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Introduction

Rear View

B E
A

Key

A - High pressure oxygen


inlet connector
A C
B - Scavenging Port
E
C - Drive gas outlet
D - Pressure relief valve
exhaust port
E - Manometer connection

Underside View
Figure 2 - Rear View & Underside View

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Introduction

1.5 Major Features


The Spacelabs Healthcare 2200MRI anesthesia ventilator consists of two basic
modules: the control unit and the bellows assembly.
• Two sizes of bellows housing are available: adult and pediatric. Both
housings fit on the bellows base.
• Direct drive of Bain and other circuits without use of bellows.
• De-mountable, autoclavable expiratory valve.

1.6 Data Summary

Control/Parameter Range/Value
1
Input supply gas 2.5-7Bar 250-700kpa
13 Adult bellows size 1600ml
14 Pediatric bellows size 350ml
5 Inspiratory flow rate 0.2 to 1.0/sec ±10%
6 Inspiratory time 0.25 to 3 sec ± 0.05 or ± 10% whichever is
the greater
7 Expiratory time 0.5 to 6.0 sec ± 0.05 or ± 10% whichever is
the greater
8 Pressure relief control 20-80cmH2O
2 Gas supply oxygen
3 Gas supply hose 1.5 metres of white antistatic hose fitted with
a DISS fitting.
4 Hose end Oxygen probe to BS5682 mini schräder.
Patient airway pressure 63mm diameter aneroid pressure gauge with
gauge -20 to +100cmH2O.
15 Ventilator to bellows 22mm male taper/15mm female.
connection
16 Bellows to patient taper 22mm male taper to BS3049

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Introduction

Control/Parameter Range/Value

Bellows exhaust gas


17 taper 30mm male taper.
9 Frequency range 6.6 to 80 breaths per minute (derived
from inspiratory and expiratory times).
10 Tidal volume range 0.05 to 3 litres per breath (derived from
inspiratory time and inspiratory flow rate).

The maximum tidal volume that can be achieved is 1.6 litres due to
the capacity of the bellows.

Minute volume range derived from tidal volume and frequency.


12 I:E ratio variable between 6:1 and 1:25

Dimensions:
Height of complete 400mm
ventilator
Height of control unit 290mm (excluding expiratory valve).
Weight 6.0Kg
Width 100mm
Depth 220mm
Expiratory valve 110mm
Alarms none.

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Introduction

1.7 Associated Equipment and Accessories

Part No. Description


127MU000 User and Maintenance Manual
81031 Pediatric bellows assembly complete
81030 Adult bellows assembly complete
12500012 Bellow base assembly
83034 Adult bellows only
83035 Adult bellows cover only
83036 Pediatric bellows only
81037 Pediatric bellows cover only
81038 Pediatric bellows base adapter
ST2101 Corrugated tubing 42-in (22mm)
Sl1509 Clear tube—patient pressure (any length per metre)
10500003 Patient pressure adapter (T-piece)
81010 High Pressure Pipeline
Sl637 Filter - patient pressure internal or external line
Sl638 Luer female to male adapter
Sl639 Luer male to male adapter

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2200MRI
Ventilator

Chapter 2

Installation

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24 2200MRI Ventilator User Manual


Installation

2.1 Ventilator Set -Up Procedure


1. Mounting the ventilator - the ventilator can be mounted on the
anesthetic machine with a choice of mounting brackets.
2. High pressure hose assembly - attach the hose to the ventilator, care
must be taken to attain a leak free seal without over tightening the
fitting. Attach the other end of the hose assembly to the high pressure
oxygen supply.
3. Ventilator to bellows drive hose - attach the corrugated hose to both
the ventilator drive gas taper and the bellows drive gas taper.
4. Manometer tube - attach the tube to the manometer connection on
the underside, place the pressure sensing tee piece in the inspiratory
limb of the patient breathing circuit.
5. Patient breathing system drive hose - connect the 22mm male taper
to the breathing system taper.
6. Scavenging system - connect the exhaust port to a scavenging
system.

WARNING: The anesthetic gas scavenging system must not generate


more than 0.5cmH2O of negative or positive pressure.

WARNING: Failure to comply with this requirement will result in posi-


tive or negative pressure within the breathing circuit.

2.2 Unpacking
There is no transit packing used within the Spacelabs Healthcare 2200MRI
anesthesia ventilator. However, check that all pneumatic inlets and outlets are
completely free from any packing. In particular, check breathing tubes and
ports are totally free of any particles and are unobstructed.

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Installation

2.3 Preparation for Use


Locate the ventilator in a safe place, preferably permanently mounted on the
anesthesia machine to prevent accidental damage due to falling, or accidental
hose disconnection.

WARNING: The screws must not penetrate more than 7mm into the
ventilator or damage may be caused to internal components.

To prepare the ventilator for use, proceed as follows:


1. Connect the 40 to 101.5psi driving gas input port on the control unit to
a wall or cylinder outlet.
2. Connect the 22mm corrugated hose provided between the control unit
bellows driving gas port and the bellows base driving gas port.
3. Connect the bellows base exhaust port to a scavenging system using
a 30mm hose in conjunction with any required adapters. The pop-off
valve under the bellows is connected internally to the exhaust port,
where excess breathing gas is discharged.
4. Connect the pressure sensor port, on the underside, to the breathing
system. The recommended position is in the inspiratory limb of the
breathing circuit, as close as possible to the patient.
5. Ensure that the correct bellows type for the intended mode of use is
installed.
Before using the ventilator, check that all connections are correct, and verify
there are no leaks (See 4.1 Pre-Use Function Test).

Maximum tidal volume for the paediatric bellows is 300ml. The adult
bellows must be used to attain tidal volumes of greater than 300ml up
to a maximum of 1600ml.

WARNING: Applying negative or positive pressure to the exhaust


port results in positive pressure in the patient breathing system. The
scavenging system must not generate more than 0.5cmH2O positive
or negative pressure when connected to the ventilator.

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Installation

WARNING: Connecting a PEEP valve or any other restrictive device


to the exhaust port of the bellows assembly could generate increased
pressure in the bellows and could cause the bellows to become de-
tached.

WARNING: Any problem arising from an improperly functioning scav-


enging system is solely the user’s responsibility.

2.4 Changing Bellows Units


Refer to Figure 3 - Adult and Pediatric Bellows.

If the ventilator is used for pediatric patients at 300ml tidal volume or less, the
optional pediatric bellows should be used.

2.4.1 Installing the Pediatric Bellows


1. Remove the bellows housing by twisting it slightly counter-clockwise
until the bayonet tabs are free, then lift it from the base.
2. Remove the bellows by pulling gently off the base.
3. Press the pediatric bellows adapter into place.
4. Mount the pediatric bellows over the adapter.
5. Push the pediatric bellows housing down over the bellows, then twist it
slightly clockwise to engage the bayonet tabs.

2.4.2 Installing the Adult Bellows


1. Remove the bellows housing by twisting it slightly counter-clockwise
until the bayonet tabs are free, then lift it from the base.
2. Remove the pediatric bellows by pulling gently off the adapter.
3. Remove the pediatric adapter.
4. Mount the adult bellows.
5. Push the adult bellows housing down over the bellows, then twist it
slightly clockwise to engage the bayonet tabs.

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Installation

WARNING: If there is any malfunction, do not use the ventilator. Refer


to Trouble shooting for help. If the problem cannot be located, call an
authorized service engineer or return the ventilator to the supplier.

2.4.3 Adult Bellows Assembly Description


1. Bellows base assembly - the bellows base assembly is attached to the
top of the ventilator case and incorporates an O-ring for the bellows
housing to seal against and an O-ring to seal between the bellows
base and the exhaust gas diaphragm assembly.
2. Bellows unit assembly - the bellows canister is marked with a scale
which allows the tidal volume to the patient to be determined with bel-
lows movement.
3. An exhaust valve seat which allows the escape of excess exhaust gas
to the bellows exhaust port on the rear of the assembly at the end of
the expiratory phase is situated in the centre of the assembly.

WARNING: Care must be taken not to damage the exhaust valve seat.

4. Bellows base screws - thumb screws which hold the bellows base to
the top of the ventilator case (4 off).
5. Exhaust diaphragm assembly - this assembly contains a diaphragm
and a sealing disc which seals on the exhaust valve seat in the bellows
base during the expiratory phase.
6. Exhaust diaphragm assembly screws - thumb screws which hold the
diaphragm assembly onto the bellows base assembly (3 off).
7. Adult bellows - the bellows are attached to the bellows base assembly
by the lower convolution on the shoulder of the bellows base assembly.
8. Adult bellows housing - the adult bellows housing is located on the
bellows base assembly by the location ring on the bellows base as-
sembly it is then locked in position by twisting clockwise until the lugs
are located in the bellows base assembly.

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Installation

A - Bellows base
assembly
B - Bellows base
screws
C - Exhaust diaphragm
assembly
D - Exhaust diaphragm
assembly screws
E - Adult bellows
F - Adult bellows
housing
G - Pediatric bellows
H - Pediatric bellows
housing
J - Mounting bracket
Figure 3 - Adult and Pediatric Bellows

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30 2200MRI Ventilator User Manual


2200MRI
Ventilator

Chapter 3

Operation

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32 2200MRI Ventilator User Manual


Operation

3.1 Pneumatic System

J Exhaust
F

D R Inspiratory Logic
Timer Gate

O2
Supply
On/Off Spool Flow Control
Regulator Valve
Switch Valve
40
to 35psi
101.5psi
E
Expiratory
A G Timer
P Adjustable
Exhaust Pressure
Relief Valve

Patient Circuit Patient Patient


Manometer Circuit Valve

Key
H
A Drive gas input port 40 to 101.5psi
Exhaust
D Input pressure regulator (set to 34.5psi) to
E Flow control valves Scavenging
System
F Timer (inspiratory)
G Timer (expiratory)
H Patient valve
J Logic gate
P Pressure gauge
R On/Off switch
Figure 4 - Pneumatic Diagram

2200MRI Ventilator User Manual 33


Operation

3.1.1 Pneumatic Circuit Description


The pneumatic circuit consists of two pneumatic timers which control a spool
valve supplying high pressure oxygen to the flow control valve.

The oxygen inlet pressure is regulated down by a regulator which incorporates


a sintered metal filter.

As the ventilator enters the inspiratory phase the flow activates a diaphragm
valve and blocks the exhaust port.

At the expiratory phase the diaphragm deflates through a logic valve allowing
the drive gas or expired gas to exhaust to the scavenging port.

The patient valve which is attached to the underside incorporates the exhaust
diaphragm. An adjustable pressure relief valve, which relieves if the circuit
pressure reaches the preset level during the inspiratory phase, is upstream
of the patient valve. The relief valve consists of a spring loaded plunger which
seals on a seat with a silicone seal.

The relief pressure is adjusted by changing the spring loading via the knob on
the front panel.

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Operation

Key
A Drive gas port
B Pop-off valve
C Breathing system port
D Exhaust (to scavenging system)

Figure 5 - Ventilation Cycle Using the Bellows

2200MRI Ventilator User Manual 35


Operation

3.2 Ventilation Cycle Description Using Bellows

The following is a brief description of the functioning of the bellows assembly


(See Figure 5 Ventilation Cycle Using the Bellows).
1. The bellows prior to the start of the inspiratory phase is fully inflated
and retain this position due to the weight of the exhaust diaphragm
valve giving a slight back pressure within the bellows with the fresh
gas flow entering the breathing circuit.
2. At the start of the inspiratory phase drive gas from the ventilator enters
the inside of the bellows housing and forces the bellows down driving
the patient gas within the bellows into the breathing circuit. During
the inspiratory phase the ventilator patient valve exhaust diaphragm
inflates blocking the exhaust port and the bellows exhaust diaphragm
is held shut by the pressure of the drive gas flow from the ventilator.
3. At the start of the expiratory phase the flow of drive gas from the
ventilator ceases and the ventilator patient valve exhaust diaphragm
deflates allowing the drive gas within the bellows housing to exhaust
through the ventilator patient valve exhaust port as the bellows rise
as the exhaled gas enters the bellows. Excess exhaled gas exhausts
through the bellows exhaust port into the scavenging system.
Start of inspiration: Controlled drive gas enters the bellows assembly via the
driving gas input port A. This causes the pop-off valve B to close due to the
differential pressure created across the valve by the drive gas flow. As pressure
rises in the canister, the bellows are driven down and anaesthesia gases are
driven out of the breathing system port C to the breathing circuit.

End of inspiration: Controlled driving gas ceases to be applied to the bellows


assembly once the desired volume of gas has been delivered, and the pressure
exerted on the pop-off valve B equalizes with the patient pressure.

Start of expiration: The pneumatic module is now in expiratory mode. The


pop-off valve B remains closed as the pressure required to open it must be
positive on the patient side by approximately 2cmH2O. The bellows is forced
up by the returning anesthesia gases and the gas exhausts through the patient
valve.

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Operation

End of expiration: As the bellows reaches the top of the inside of the canister
the internal pressure in the bellows rises by approximately 2cmH2O and the
pop-off valve is forced open. Excess anesthesia gases are expelled through the
exhaust port D and into the external scavenging system.

WARNING: Avoid control combinations which may produce very


short inspiratory times (<150mS) as inconsistent breath delivery may
occur.

WARNING: Pressure limiting is a safety feature. It is not intended to


create micro-breaths or emulate other specialised high frequency/
low volume ventilation systems.

3.3 Control Unit


Please refer to Chapter 1 Installation for the location of front panel controls and
indicators.

2200MRI Ventilator User Manual 37


Operation

3.4 Using the 2200MRI Anesthesia Ventilator in a Circle


Breathing System

Figure 6 - Circle Breathing System

Figure 7 - Use with a Bain Circuit

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Operation

3.5 In Use
• Perform the pre-use checks (4.1 Pre-Use Function Test).
• Prior to patient use, check that all connections are correct and that
there are no leaks.

To start ventilating the patient, switch the breathing system from the breathing
bag to the ventilator, close the APL valve (if not already isolated) and turn the
ventilator on.

If PEEP is required, the PEEP valve must be located in the expiratory limb of
the breathing system, between the patient connection and the expiratory valve.
The only pressurized parts of the breathing system should be the patient and
the connecting hoses between the inspiratory and expiratory valves.

WARNING: Do not connect a PEEP valve to the exhaust port of the


bellows base. This will increase the pressure inside the bellows and
could detach it from its base, causing a serious malfunction.

The bellows can support no more than 10cmH2O pressure. Normally the internal
and external bellows pressures are about the same. During the expiratory
phase the pop-off valve under the bellows is released so that the inside of the
bellows is connected to ambient air pressure through the exhaust port.

WARNING: Do not allow the bellows internal pressure to rise above


10cmH2O. This could detach it from its base, causing a serious mal-
function.

The pop-off valve has approximately a 2cmH2O opening pressure to keep


the bellows from collapsing. The outside of the bellows inside the housing is
connected to ambient air pressure through the discharge valve in the control
unit. Therefore the only pressure gradient across the bellows is the opening
pressure of the pop-off valve.

WARNING: Do not use oxygen flush during inspiration.

2200MRI Ventilator User Manual 39


Operation

3.6 Safety
3.6.1 Pneumatic Safety
The maximum gas supply pressure is 7bar (101.5psi).

40 2200MRI Ventilator User Manual


2200MRI
Ventilator

Chapter 4
Preventative Inspection
& Maintenance

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42 2200MRI Ventilator User Manual


Preventative Inspection & Maintenance

4.1 Pre-Use Function Test


1. Ensure that the ventilator is correctly connected - refer to the ventilator
set up procedure.
2. Set the adjustable pressure relief valve to the required setting.
3. Set the desired inspiratory time.
4. Set the desired expiratory time.
5. Set the desired flow rate.
6. Attach a 2 litre breathing bag to the patient connection as a test lung.
7. Fill the bellows by using the anesthetic machine oxygen flush.
8. Turn the ventilator on and ensure that the ventilator delivers the correct
tidal volume - this can be checked by the scale on the bellows housing.
9. Remove the breathing bag occlude the end of the patient connector.
10. Refill the bellows with the oxygen flush.
11. Turn the ventilator back on and check that the patient circuit relieves
at the set level.

WARNING: The pressure relief valve is not intended for use as a pres-
sure limiter but as a pressure relief valve.

WARNING: The pressure at which the circuit relieves is effected by


the flow rate set at the ventilator.

4.2 Clinical Operation


1. Prior to use with a patient check that all connections are correct and
that there are no leaks.
2. Perform the pre-use function test (see 4.1 Pre-Use Function Test).
3. Set the desired ventilator parameters.

WARNING: The actual ventilation of the patient may vary from the set
ventilator parameters due to compliance and circuit leaks.

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Preventative Inspection & Maintenance

WARNING: The patient ventilation must be monitored independently


from the ventilator.

WARNING: It is the responsibility of the user to monitor patient ven-


tilation.

WARNING: The use of this ventilator is not recommended without the


use of a breathing circuit disconnection alarm.

4.3 Incidental & User Maintenance


4.3.1 Service Schedule
The ventilator must be serviced by a factory trained engineer to the following
schedule:
a) 3 monthly inspection and function check.
b) 12 monthly bellows replacement.
c) 12 monthly replacement of patient valve exhaust diaphragm.
d) 5 yearly major service.

Service requirements are available to factory trained personnel.


There are no user serviceable parts within the control unit.

Further details are available from:


Global Technical Support Dept.
Spacelabs Healthcare Limited
1 Harforde Court • John Tate Road • Hertford •
SG13 7NW United Kingdom

Tel: +44 (0)1992 507700 Fax: +44 (0)1992 501213

Always provide the following information with any communication:


a) Type of product and part number.
b) Product name.
c) Serial number.
d) Date of purchase.
e) Details of suspected fault.

44 2200MRI Ventilator User Manual


Preventative Inspection & Maintenance

4.3.2 Cleaning of the ventilator control unit


The ventilator control unit must only be cleaned with a damp cloth and if
necessary with warm mild detergent to remove persistent grime.

WARNING: Do not allow the cleaning liquid to enter the control unit.

WARNING: Do not use harsh or abrasive cleaning agents on any


parts of the ventilator.

4.3.3 Cleaning and sterilization of the bellows unit


To disassemble the bellows assembly for cleaning and sterilization.
1. Twist the bellows housing counter-clockwise until the location lugs
clear the bellows base, then lift it off by pushing gently at the front.
2. Pull the bellows gently off the bellows base.
3. Unscrew the exhaust diaphragm from the bellows base.

WARNING: Do not lose the O-ring which seals between the bellows
base and the expiratory diaphragm.

WARNING: Do not damage the exhaust seat or the seat on the


exhaust diaphragm.

4.4 Cleaning and Sterilization

Item Sterilization Method


Bellows housing Gas, liquid or low temperature autoclave
Bellows Gas, liquid or low temperature autoclave
Exhaust diaphragm Gas, liquid or low temperature autoclave
assembly
Bellows base assembly Gas, liquid or low temperature autoclave

2200MRI Ventilator User Manual 45


Preventative Inspection & Maintenance

The complete bellows assembly is suitable for autoclave sterilization to 134ºC.


Each time the bellows assemblies are opened for cleaning, all visible parts
should be inspected carefully and damaged components replaced. The bellows
material deteriorates with age and use, and should be examined and replaced,
if necessary, every twelve months.

4.4.1 Ventilator Surfaces


Clean the outside surfaces of the ventilator with a damp cloth. If necessary,
a warm, mild detergent solution can also be used. Ensure all residues are
removed after cleaning.

Never use abrasive cleaning agents as the surfaces are not scratch-resistant.

WARNING: Ensure no water enters the control unit, as serious dam-


age may result.

WARNING: Follow the sterilization agent manufacturer’s instructions.

WARNING: PATIENT VALVE ONLY

WARNING: Gas sterilization should be followed by quarantine in a


well -ventilated area to allow dissipation of residual absorbed gas.

WARNING: The expiratory valve must be disassembled prior to


autoclaving to prevent the occurrence of clamping stresses.

46 2200MRI Ventilator User Manual


Preventative Inspection & Maintenance

A
B
Key C
D
A - Diaphragm
B - Valve top
C - To Circuit
D - Scavenging port
Figure 8 - Expiratory Valve

4.4.2 Pop-Off Valve Seat


1. Remove the bellows housing and bellows (See 2.4 Changing Bellows
Units).
2. Loosen the three black thumbscrews to remove the pop-off valve.
3. Clean the valve seat carefully.

WARNING: Take care not to damage the precision-moulded surface


of the valve seat. Never use a hard object or abrasive detergent. Use
only a soft cloth. If the valve seat is damaged, the pop-off valve will
leak and may cause serious malfunction.

4. After cleaning, check that the O-ring located in the bellows base which
seals against the pop-off valve is in place, as the ventilator cannot
function correctly without it.

2200MRI Ventilator User Manual 47


A

Key
C A - Bellows Cover
B - Bellows
C - Pop-off valve
D - Valve seat
D E - Bellows base
F - Mounting bracket
E

Figure 9 - Removing the Pop-off Valve

48 2200MRI Ventilator User Manual


2200MRI
Ventilator

Chapter 5

Troubleshooting

2200MRI Ventilator User Manual 49


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50 2200MRI Ventilator User Manual


Troubleshooting

5.1 General Fault Diagnosis

Fault Condition Possible Cause

Bellows cannot be filled, or it Breathing system hose disconnected


collapses. or leaking.
Broken bellows base.
Defective or detached bellows.
Damaged pop-off valve.
Missing or defective O-rings.

Bellows progressively deflates Breathing system leak.


despite normal fresh gas flow. Open or defective pop-off valve.
Damaged pop-off valve seat.
Damaged bellows base O-ring.
Damaged bellows base.

Tidal Volume not delivered. Pressure limit set too low.


Obstruction in breathing system or
bellows drive gas.

Unwanted PEEP and overfull Defective or poorly regulated


bellows. scavenging system.
Partially obstructed exhaust.

When the ventilator is turned it does The oxygen high pressure hose is not
not cycle. connected.
The oxygen supply is not turned on.

2200MRI Ventilator User Manual 51


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52 2200MRI Ventilator User Manual


2200MRI
Ventilator

Chapter 6

Notices

2200MRI Ventilator User Manual 53


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54 2200MRI Ventilator User Manual


Notices

Product Improvement
Spacelabs Healthcare Limited has a policy of continued product improvement
and therefore reserves the right to make changes which may affect the
information contained in the manual without giving prior notice.

Amentments:

Details: Unlike the current production Adult Bellows cover, the pediatric
bellows cover cannot be autoclaved.

Action: Theoretically, the bellows cover should never need to be disinfected.


However, if required, it is possible to disinfect the pediatric bellows
cover using non-alcohol surgical wipes.

It is also possible to Gas sterilize (Ethylene Oxide, 54°C) and cold sterilize
(Cidex, Sporicidin, sonacide) the pediatric bellows.

Alcohol or chlorine based cleaning agents must not be used to disinfect the
pediactric bellows cover.

Responsibilities of the Manufacturer


The manufacturer accepts responsibility for the effects on safety, reliability
and performance of the equipment only if assembly operations, extensions,
adjustments, modifications and repairs are carried out by persons with written
authorisation from the manufacturer, and the equipment is used in accordance
with the instructions for use and the electrical installation of the relevant room
complies with the ‘Regulations for the Electrical Equipment of Buildings’.

Responsibilities of the User


The Spacelabs Healthcare 2200MRI anesthesia ventilator conforms with
the specifications and operating procedures described in this manual and
on any accompanying notices and labels only if it has been installed, used
and maintained in accordance with the instructions. The safe function of the
ventilator can only be guaranteed if it is regularly checked and serviced at or in
excess of the standards specified in this manual.

2200MRI Ventilator User Manual 55


Notices

If the ventilator is suspected of being worn, defective or otherwise unfit for use,
it should under no circumstances be used.

Broken, worn, missing or contaminated components must be replaced


immediately; contact the Spacelabs Healthcare distributor from whom the
ventilator was obtained for further service advice.

Note to Service Personnel


The contents of this manual is not binding. If any significant difference is found
between the product and this manual please contact Spacelabs Healthcare
Limited for further information at the following address.

Service Policy
Spacelabs Healthcare Limited recommends that the equipment should be
checked at regular intervals by Qualified Service Personnel.

There are no serviceable parts within the unit. In the case of a failed unit it is to
be returned to Spacelabs Healthcare for exchange or repair and re-calibration.

In communication with Spacelabs Healthcare Limited, quote the model and


serial number of the equipment, with the approximate date of purchase. If the
unit is being returned for repair, indicate the nature of the fault or the work you
require to be carried out.

Contact Information

Spacelabs Healthcare Limited


1 Harforde Court
John Tate Road
Hertford
SG13 7NW
United Kingdom

Tel: +44 (0) 1992 507700


Fax: +44 (0) 1992 501213

56 2200MRI Ventilator User Manual


Notices

The following statements are made to comply with the requirements of


IEC 60601-1.

1. This equipment must only be connected to gas pipeline supply lines


that are fitted with pressure relief valves that limit the supply pressure
to less than 101.5psi (7bar).
2. This equipment must not be used with flammable anesthetic agents.
Only anesthetic agents which comply with the requirements on
nonflammable anesthetic agents in the IEC standard, Particular
requirements for the safety of anesthetic machines, are suitable for
use with this equipment.
3. As this machine is not suitable for use with flammable anesthetic
agents, such as ether and cyclopropane, the use of antistatic breath-
ing tubes and face masks is not necessary. The use of antistatic 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.
4. Performance of this equipment may be affected at temperatures
below 10ºC (50ºF) and above 40ºC (104ºF).

2200MRI Ventilator User Manual 57


Notices

The Spacelabs Healthcare 2200MRI anesthesia ventilator is intended for use


by a qualified practitioner under the direction of a qualified anesthesiologist.

Personnel operating the ventilator must become thoroughly familiar with


the instruction manual prior to using the Spacelabs Healthcare 2200MRI
anesthesia ventilator with patients.

Statements in this manual preceded by the following symbols are of special


significance:

WARNING: Means there is a possibility of personal injury to yourself


or others, or of damage to the instrument or other property.

Indicates points of particular interest for more efficient and conven-


ient operation

The following WARNINGS must be read and understood before using the
Spacelabs Healthcare 2200MRI anesthesia ventilator.

WARNINGS:
• Throughout this manual warnings and cautions relating to various
aspects of use of this ventilator are given.
• It is the responsibility of the user to read this manual and fully
understand the functions of this ventilator prior to use.
• When the ventilator is connected to a patient, it is recommended
that a qualified practitioner be in attendance at all times to react to
an alarm or other indication of a problem.
• It is recommended that the patient oxygen concentration be
monitored continuously at or near the PROXIMAL AIRWAY with an
oxygen monitor that incorporates high/low alarms.
• Patient circuit disconnection is a hazard to the patient. Take ex-
treme care to prevent such an occurrence.
• This ventilator is designed to be driven by oxygen. Using any other
gas will cause inaccurate operation.

58 2200MRI Ventilator User Manual


Notices

WARNINGS:
• FIRE HAZARD - Never use oil or grease on any anesthesia or oxy-
gen equipment. In general, oils and greases oxidise readily and will
burn violently in the presence of oxygen.
• Before using the ventilator, check that all connections are correct
and that there are no leaks.
• The driving gas is discharged through the port on the back of the
ventilator. This opening must be completely free of any obstruction
and should have nothing connected to it. The discharged driving
gas is oxygen and does not contaminate the environment
• Applying negative or positive pressure to the exhaust port of the
bellows assembly marked EXHAUST results in positive pressure in
the patient breathing system. The scavenging system must there-
fore not generate more than 5cmH2O positive or negative pressure
when connected to the ventilator. The use of an AGSS to EN 740 is
recommended.
• Any problem arising from an improperly functioning scavenging
system is solely the user’s responsibility.
• The bellows can support only approximately 10cmH2O differential
positive pressure, above which it may be dislodged from the
mounting ring, resulting in a dangerous malfunction of the ventila-
tor.
• Connecting a PEEP valve or any other restrictive device to the
EXHAUST port of the bellows assembly could generate increased
pressure in the bellows and cause the malfunction described
above. Do not connect a PEEP valve to the EXHAUST port of the
bellows base. This will increase the pressure inside the bellows
and cause it to detach from the base, causing a serious malfunc-
tion.
• OPENING OF THE UNIT BY UNAUTHORIZED PERSONNEL AUTO-
MATICALLY VOIDS ALL WARRANTIES AND SPECIFICATIONS. THE
PREVENTION OF TAMPERING IS SOLELY THE USER’S RESPON-
SIBILITY; THE MANUFACTURER ASSUMES NO LIABILITY FOR
ANY MALFUNCTION OF FAILURE OF THE VENTILATOR IF THE
CONTROL UNIT IS OPENED.
• The actual ventilation of the patient may be different from the
ventilator parameters due to compliance and leaks, and therefore
must be monitored independently of the ventilator. It is the user’s
responsibility to monitor patient ventilation.

2200MRI Ventilator User Manual 59


Notes

60 2200MRI Ventilator User Manual


2200MRI Ventilator User Manual 61
www.spacelabshealthcare.com

Spacelabs Healthcare Inc. Spacelabs Healthcare Ltd.


5150 220th Ave SE 1 Harforde Court
Issaquah WA 98029 John Tate Road
USA Hertford.
SG13 7NW United Kingdom

Tel: 425-657-7200 Tel: +44 (0)1992 507700


Fax: 425-657-7212 Fax: +44 (0)1992 501213
North America: 800-522-7025

e-mail (enquiries): advsales@spacelabs.com e-mail (technical): advsupport@spacelabs.com

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