Model 2200 Anaesthesia Ventilator User Manual Issue 1 Aug 1998

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Read this Manual before operating the ventilator.

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Contents

Table of Contents Product Improvement ... ... ... 5 Responsibilities of the Manufacturer ... ... ... 5 Responsibilities of the User ... ... ... 5 Note to Service P ersonnel ... ... ... 5 Service Policy ... ... ... ... 6 Copyright ... ... ... ... 7 Warnings ... ... ... ... 11 Symbols & Abbreviations ... ... ... 13 1. Introduction ... ... ... 15 1.1 Purpose ... ... ... .15 1.2 Description ... ... ... 15 1.2.1 Front Panel Description ... ... 18 1.3 Major Features ... ... ... 20 1.4 Data Summary ... ... ... 20 1.5 Associated Equipment & Accessories ... ... 22 2. Installation ... ... ... 23 2.1 Ventilator Set -up Procedure ... ... 23 2.2 Unpacking ... ... ... 23 2.3 Preparation for Use ... ... ... 24 2.4 Changing bellows Units ... ... ... 25 2.4.1 Installing the Paedi atric Bellows ... ... 25 2.4.2 Installing the Adult Bellows ... ... 25 2.4.3 Adult Bellows Assembly Description ... ..26 3. Operation ... ... ... 29 3.1 Pneumatic System ... ... ... 29 3.1.1 Pneumatic Circuit Description ... ... 30 3.2 Ventilati on Cycle Description Using Bellows ... ... 32 3.3 Control Unit ... ... ... 33 3.4 Using the 2200 Ventilator in a Circle Breathing Sy stem ... 34 3.5 In Use ... ... ... ... 35 3.6 Safety ... ... ... ... 36 3.6.1 Pneumatic Safety ... ... ... 36 4. Preventative Inspection & Mai ntenance ... ... 37 4.1 Pre -Use Function Test ... ... ... 37 4.2 Clinical Operation ... ... ... 38 4.3 Incidental & User Maintenance ... ... 38 4.3.1 Service Schedule ... ... ... 38 4.3.2 Cleaning of the Ventilator Control Unit ... 39

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Contents

4.3.3 Cleaning and Sterilisation of the Bellows Unit ... 39 4.4 Cleaning and Sterilisation ... ... .. 40 4.4.1 Ventilator Surfaces ... ... . 40 4.4.2 Pop -off Valve Seat ... ... . 42 5. Troubleshooting ... ... ... 45

List of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9

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B lease 2200 Anaesthesia Ventilator ... ... 16 Rear View and Underside View ... ... 19 Adult & Paediatric Bellows ... ... 27 Pneumatic Diagram ... ... ... 29 Ventilation Cycle using the Bellows ... ... 31 Circle Breathing System ... ... 34 Use with a Bain Circuit ... ... .. 34 Expiratory Valve ... ... ... 41 Removing Pop -off Valve Seat ... ... 43

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Notices

Product Improvement Blease Medical Equipment 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.

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 Blease 2200 anaesthesia 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. 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 Blease distributor from whom the ventilator was obtained for further service advice.

Note to Service Personnel The contents of this manual are not binding. If any significant difference is found between the product and this manual please contact Blease Medical Equipment Limited for further information at the following address.

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Notices

Service Policy Blease Medical Equipment 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 Blease for exchange or repair and re-calibration. In communication with Blease Medical Equipment 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: Blease Medical Equipment Limited Beech House • Chiltern Court • Asheridge Road • Chesham • Buckinghamshire HP5 2PX • England Tel: +44 (01) 494 784422 Fax: +44 (01) 494 791497

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Notices

Copyright © 1998 Blease Medical Equipment 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 Blease Medical Equipment Limited.

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Notices

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

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Notices

The following statements are made to comply with the requirements of IEC 601-1. 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 101.5 psi (7 bar). 2. This equipment must not be used with flammable anaesthetic agents. Only anaesthetic agents which comply with the requirements on nonflammable anaesthetic agents in the IEC standard, Particular requirements for the safety of anaesthetic machines, are suitable for use with this equipment. 3. As this machine is not suitable for use with flammable anaesthetic agents such as ether and cyclopropane the use of antistatic breathing 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).

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Notices

The Blease 2200 anaesthesia ventilator is intended for use by a qualified practitioner under the direction of a qualified anaesthesiologist. Personnel operating the ventilator must become thoroughly familiar with the instruction manual prior to using the 2200 anaesthesia 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 convenient operation. The following WARNINGS must be read and understood before using the Blease 2200 anaesthesia ventilator. WARNINGS:

10

•

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 extreme care to prevent such an occurrence.

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Warnings

WARNINGS:

•

This ventilator is designed to be driven by oxygen. Using any other gas will cause inaccurate operation.

•

FIRE HAZARD - Never use oil or grease on any anaesthesia or oxygen equipment. In general, oils and greases oxidise readily and will burn v iolently 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 obstruc tion 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 t he patient breathing system. The scavenging system must therefore not generate more than 5cm H 2O positive or negative pressure when connected to the ventilator. The use of an AGSS to BS6834 1987 is recommended.

•

Any problem arising from an improperly func tioning scavenging system is solely the user’s responsibility.

•

The bellows can support only approximately 10cm H differential positive pressure, above which it may be dislodged from the mounting ring, resulting in a dangerous malfunction of the ventilator.

•

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 bellow s and cause it to detach from the base, causing a serious malfunction.

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WARNINGS:

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•

OPENING OF THE UNIT BY UNAUTHORISED PERSONNEL AUTOMATICALLY VOIDS ALL WARRANTIES AND SPECIFICATIONS. THE PREVENTION OF TAMPERING IS SOLELY THE USER’S RESPONSIBILITY; THE MANUFACTURER ASSUMES NO LIABILITY FOR ANY MANLFUNCTION 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.

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Symbols & Abbreviations

Symbols and Abbreviations Used on Blease Equipment and in this Manual bpm BPM

Breaths per minute

cmH 2O

Gauge pressure expressed in centimetres of water

CPA P

Continuous positive airway pressure

PEEP

Positive end expiratory pressure

I:E Ratio

A ratio of inspiratory to expiratory time IEC symbol to consult the instructions for use

IEC symbol denoting type of equipment (B)

WA RNING: There is danger of personal injury to the user or patient Further relevant or helpful information

Shows that by turning the control in the direction of the thickening line, an increase in that parameter is produced

Power off

Power on

Dangerous voltage

l/ m

lpm

Litres per minute

ml

Millilitres

O2

Oxygen

psi

Pounds per square inch

psig

Pounds per square inch gauge

l

Litres IEC symbol for alternating current Confers approval under the European Medical Device Directive

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1. Introduction

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

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

1.2 Description The Blease 2200 anaesthesia 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 Blease 2200 anaesthesia 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 s emi closed circuit such as a Bain-type coaxial circuit or a Jackson-Rees/ Ayres T-piece type paediatric circuit with no modification being necessary.

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1. Introduction

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C

PRESSURERELIEF

40

20

OFF

60

cmHO

ON

A

80

2

30

40

50

20

60

10

cmH2O

70

0

80

-10

B

90

-20

+

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

100

0.25

-

Key to Figure 1

D 2.0 1.5 1.0

INSPIRATORY (SECONDS)

0.5

0.7 5

E 5.0 4.0

3.0

EXPIRATORY (SECONDS)

0.

2.0 1.5

1.0

75

2.0

F

0.3

1.0

0.4

0.

0.6

8

Figure 1 16

FLOWRATE (l/SEC)

Blease 2200

Blease 2200 Anaesthesia Ventilator User Manual

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1.2.1

1. Introduction

Front Panel Description Refer to Figure 1 Blease 2200 Anaesthesia Ventilator. 1.

On/Off switch - rotates 90 degrees clockwise to turn the ventilator on (A).

2.

Manometer - calibrated between -20 to +100 cm of water, 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 a s 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.

Breathes per minute is determined in the following way: BPM = 60 _______________________ Inspiratory time + Expiratory time

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The I:E ratio is determined in the following way: Inspiratory time I:E Ratio = ____________________________ 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: Tidal volume = inspiratory time (litres) (seconds)

x

flow rate (litres per second)

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

1.2.2

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 22 mm male taper and a 15 mm 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.

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

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D PRESSURE RELIEF VALVE EXHAUST DO NOT BLOCK

Blease BEECH HOUSE CHILTERN COURT ASHERIDGE ROAD CHESHAM BUCKS. HP5 2PX ENGLAND TEL. (01494) 784422 TELEX 83119 BLEASE G FAX. (01494) 791497

REAR VIEW Key to Figure 2

ANAESTHESIA VENTILATOR

A High pressure oxygen inlet connector

SERIAL NUMBER

B Scavenging Port C Drive gas outlet D Pressure relief valve exhaust port E

Manometer connection

A

E

B

C

A

E

VIEW OF UNDERSIDE

Figure 2

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Rear View and Underside View

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1.3 Major Features The Blease 2200 anaesthesia ventilator consists of two basic modules: the control unit and the bellows assembly. •

Two sizes of bellows housing are available: adult and paediatric. Both housings fit on the bellows base.

•

Direct drive of Bain and other circuits without use of bellows.

•

De-mountable, autoclavable expiratory valve.

1.4 Data Summary

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Control/Parameter

Range/Value

Input supply gas

40 to 101.5 psig at 120 lpm

Adult bellows size

1600 ml

Paediatric bellows size

350 ml

Flow rate

0.2 to 1.0/sec ± 10%

Inspiratory time

0.2 to 2.0 sec ± 0.05 or ± 10% whichever is the greater

Expiratory time

0.5 to 5.0 sec

Pressure limit control:

adult and paediatric ventilation during anaesthesia.

Gas supply

oxygen

Gas supply hose

1.5 metres of white antistatic hose fitted with a DISS fitting.

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