Professional Documents
Culture Documents
Anesthesia Ventilator
MRI Compatible
User
Manual
MODIFICATIONS LABEL
Warning Notices
Caution Notices
Notes
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
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
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.
Keep this manual with the system to refer to and to answer any
questions that arise about system operation, maintenance or, if
necessary, repair.
Please read all warnings and notices in section 6 before using the
equipment
Chapter 1
Introduction
bpm BPM Breaths per minute l/m lpm liters per minute
A ratio of inspiratory to
I:E Ratio expiratory time
psig Pounds per square inch gauge
Caution consult
accompanying l Liters
documentation
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.
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.
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 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.
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
WARNING: The pressure relief valve is not intend for use as a pres-
sure limiter but as a pressure relief valve (safety valve).
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.
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:
For further information on the bellows unit assembly, see paragraphs 2.4 to
2.4.3.
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.
Rear View
B E
A
Key
Underside View
Figure 2 - Rear View & Underside View
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
Control/Parameter Range/Value
The maximum tidal volume that can be achieved is 1.6 litres due to
the capacity of the bellows.
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.
Chapter 2
Installation
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.
WARNING: The screws must not penetrate more than 7mm into the
ventilator or damage may be caused to internal components.
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.
If the ventilator is used for pediatric patients at 300ml tidal volume or less, the
optional pediatric bellows should be used.
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.
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
Chapter 3
Operation
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
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
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.
Key
A Drive gas port
B Pop-off valve
C Breathing system port
D Exhaust (to scavenging system)
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.
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.
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.
3.6 Safety
3.6.1 Pneumatic Safety
The maximum gas supply pressure is 7bar (101.5psi).
Chapter 4
Preventative Inspection
& Maintenance
WARNING: The pressure relief valve is not intended for use as a pres-
sure limiter but as a pressure relief valve.
WARNING: The actual ventilation of the patient may vary from the set
ventilator parameters due to compliance and circuit leaks.
WARNING: Do not allow the cleaning liquid to enter the control unit.
WARNING: Do not lose the O-ring which seals between the bellows
base and the expiratory diaphragm.
Never use abrasive cleaning agents as the surfaces are not scratch-resistant.
A
B
Key C
D
A - Diaphragm
B - Valve top
C - To Circuit
D - Scavenging port
Figure 8 - Expiratory Valve
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.
Key
C A - Bellows Cover
B - Bellows
C - Pop-off valve
D - Valve seat
D E - Bellows base
F - Mounting bracket
E
Chapter 5
Troubleshooting
When the ventilator is turned it does The oxygen high pressure hose is not
not cycle. connected.
The oxygen supply is not turned on.
Chapter 6
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.
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.
If the ventilator is suspected of being worn, defective or otherwise unfit for use,
it should under no circumstances be used.
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.
Contact Information
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.
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.