2200MRI Anesthesia Ventilator User and Maintenance Manual Rev F

2

2200MRI Ventilator User Manual

2200MRI Ventilator User Manual

Spacelabs Healthcare Ltd. Unit B, Foxholes Centre • John Tate Road • Hertford • SG13 7DT • United Kingdom Tel: +44 (0)1992 507700 Fax: +44 (0)1992 501213 e-mail (enquiries): [email protected] e-mail (technical): [email protected] www.spacelabshealthcare.com

2200MRI Ventilator User Manual

Part Number: 073-0245-00/Rev. F August 2016

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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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2200MRI Ventilator User Manual

Table of Contents

Contents

Page

Chapter 1 Introduction 1.1 1.2 1.3 1.4

Introduction Purpose Explanation of Serial Numbering Description

13 15 15 15 15

1.4.1 Front Panel Description

17

1.4.2 Underside Description

18

1.5 1.6 1.7

Major Features Data Summary Associated Equipment and Accessories

20 20 22

Chapter 2 Installation 2.1 2.2 2.3 2.4

Ventilator Set -Up Procedure Unpacking Preparation for Use Changing Bellows Units

23 25 25 26 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 3.1

31 Pneumatic System

3.1.1 Pneumatic Circuit Description

3.2

Ventilation Cycle Description Using Bellows

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36

7

3.3 3.4 3.5 3.6

Control Unit Using the 2200MRI Anesthesia Ventilator in a Circle Breathing System In Use Safety

3.6.1 Pneumatic Safety

37 38 39 40 40

Chapter 4 Preventative Inspection & Maintenance 4.1 4.2 4.3

Pre-Use Function Test Clinical Operation Incidental & User Maintenance

41 43 43 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 5.1

General Fault Diagnosis

49 51

Chapter 6 Notices

8

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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

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Copyright © 2016 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.

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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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2200MRI Ventilator User Manual

2200MRI Ventilator Chapter 1

Introduction

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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

cmH2O

Gauge pressure expressed in centimetres of water

ml

milliliters

CPAP

Continuous positive airway pressure

O2

Oxygen

PEEP

Positive end expiratory pressure

psi

Pounds per square inch

I:E Ratio

A ratio of inspiratory to expiratory time

psig

Caution consult accompanying documentation

l

Pounds per square inch gauge

Liters

IEC symbol denoting type of equipment (B)

IEC symbol for alternating current

Consult instructions for use.

Dangerous Voltage present

Equipment serial number

Power off

Manufacturer

Power on

Year of manufacture

Caution: Denotes a potential hazard and NOT a danger to personnel.

Relevant or helpful information

WARNING: There is danger of personal injury to the user or patient.

Shows that turning the control in the direction of the thickening line, increases the parameter setting.

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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.

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Introduction C A

B

D

E

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

F

Figure 1 - 2200MRI Anesthesia Ventilator 16

2200MRI Ventilator User Manual

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 pressure 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: BPM =

60 _______________________ 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 = (litres)

inspiratory time (seconds)

x

flow rate (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

D

Rear View

B

E A Key

A

A - High pressure oxygen inlet connector

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 2200MRI Ventilator User Manual

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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 connection

16

Bellows to patient taper 22mm male taper to BS3049

20

22mm male taper/15mm female.

2200MRI Ventilator User Manual

Introduction Control/Parameter

Range/Value

17

Bellows exhaust gas 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.

12

Minute volume range

derived from tidal volume and frequency.

I:E ratio

variable between 6:1 and 1:25

Dimensions: Height of complete ventilator

400mm

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 User Manual

2200MRI Ventilator Chapter 2

Installation

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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 positive 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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2200MRI Ventilator User Manual

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 detached. WARNING: Any problem arising from an improperly functioning scavenging 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 bellows 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 assembly it is then locked in position by twisting clockwise until the lugs are located in the bellows base assembly.

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2200MRI Ventilator User Manual

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 2200MRI Ventilator User Manual

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2200MRI Ventilator User Manual

2200MRI Ventilator Chapter 3

Operation

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2200MRI Ventilator User Manual

Operation 3.1

Pneumatic System J

F

R

D O2 Supply

On/Off Switch

Regulator 40 to 101.5psi

Inspiratory Timer

Spool Valve

Logic Gate

Flow Control Valve

35psi A

G

Expiratory Timer

P

E Adjustable Pressure Relief Valve

Exhaust

Patient Circuit Manometer Key A D E F G H J P R

Exhaust

Patient Valve

Patient Circuit H

Drive gas input port 40 to 101.5psi Input pressure regulator (set to 34.5psi) Flow control valves Timer (inspiratory) Timer (expiratory) Patient valve Logic gate Pressure gauge On/Off switch

Exhaust to Scavenging System

Figure 4 - Pneumatic Diagram

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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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2200MRI Ventilator User Manual

Operation

Key A B C D

Drive gas port Pop-off valve Breathing system port Exhaust (to scavenging system)

Figure 5 - Ventilation Cycle Using the Bellows

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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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2200MRI Ventilator User Manual

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.

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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 38

2200MRI Ventilator User Manual

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 malfunction.

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.

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Operation 3.6

Safety

3.6.1

Pneumatic Safety

The maximum gas supply pressure is 7bar (101.5psi).

40

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2200MRI Ventilator Chapter 4

Preventative Inspection & Maintenance

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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 pressure 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 ventilation. 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) b) c) d)

3 monthly inspection and function check. 12 monthly bellows replacement. 12 monthly replacement of patient valve exhaust diaphragm. 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 Unit B, Foxholes Centre • John Tate Road • Hertford • SG13 7DT 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 assembly

Gas, liquid or low temperature autoclave

Bellows base assembly

Gas, liquid or low temperature autoclave

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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 damage 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.

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Preventative Inspection & Maintenance

B

Key

A C D

A B C D

-

Diaphragm Valve top To Circuit 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.

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A

B

Key

C

A - Bellows Cover B - Bellows C - Pop-off valve D - Valve seat

D

E - Bellows base F - Mounting bracket

E F

Figure 9 - Removing the Pop-off Valve

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2200MRI Ventilator Chapter 5

Troubleshooting

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