2200MRI Anesthesia Ventilator User and Maintenance Manual Rev E Aug 2013

2

2200MRI Ventilator User Manual

2200MRI Ventilator User Manual

Spacelabs Healthcare Ltd. 1 Harforde Court • John Tate Road • Hertford • SG13 7NW • 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. E August 2013

3

This page is intentionally left blank

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

2200MRI Ventilator User Manual

5

This page is intentionally left blank.

6

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

1.4.1 Front Panel Description 1.4.2 Underside Description

1.5 1.6 1.7

Major Features Data Summary Associated Equipment and Accessories

13 15 15 15 15 17 18

20 20 22

Chapter 2 Installation 2.1 2.2 2.3 2.4

23

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

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

33

3.1.1 Pneumatic Circuit Description

34

3.2

Ventilation Cycle Description Using Bellows

2200MRI Ventilator User Manual

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

53

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 © 2013 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

2200MRI Ventilator User Manual

11

This page is intentionally left blank

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

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

Pounds per square inch gauge

Caution consult accompanying documentation

14

l/m lpm

l

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

CE Mark. Confers approval under the European Medical Device Directive and the notified body number.

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.

Year of manufacture

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 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

2200MRI Ventilator User Manual

17

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.

18

2200MRI Ventilator User Manual

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

19

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