Blease
Blease Anesthesia Devices and Accessories
BleaseGenius MRI Anaesthesia Machine User Manual Rev C Dec 2010
User Manual
106 Pages
Preview
Page 1
BleaseGenius MRI Anesthesia Machine MRI Compatible
User Manual BleaseGenius MRI User Manual
073-0241-00/REV. C 1
2
BleaseGenius MRI User Manual
BleaseGenius MRI Anesthesia System
User Manual MODIFICATIONS LABEL REV A
REV B
REV C
PR023073
PR023688
PR023860
REV F
REV G
REV H
REV D
REV E
REV I
REV J
Spacelabs Healthcare Ltd. (Anesthesia Delivery & Ventilation Division) 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.spacelabs.com
BleaseGenius MRI User Manual
Part Number: 073-0241-00/Rev. C December 2010
3
This page is intentionally left blank
4
BleaseGenius MRI User Manual
IMPORTANT The user must be familiar with the machine and its various functions before using it on a patient.
U.S. 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 This symbol indicates information that is relevant or helpful to the user.
BleaseGenius MRI User Manual
5
This page is intentionally left blank
6
BleaseGenius MRI User Manual
Table of Contents
Contents
Page
Chapter 1 Introduction Symbols and Abbreviations Used 1.1
Introduction
15 16 17
Chapter 2 Description 2.1 2.2 2.3 2.4 2.5
General The Frame Pneumatic Assembly Flowblock Assembly Detachables
19 23 23 23 24 24
Chapter 3 Specification 3.1
Physical
3.1.1 Machine Weight and Dimensions 3.1.2 Maximum Loading (wall bracket)
3.2
Pneumatics
3.2.1 Gas-Specific Color Specifications 3.2.2 Miscellaneous 3.2.3 Common Gas Outlet
3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7
3.4
25 26 26 26
26 26 26 26
Technical/Performance Specifications
27
Controls Monitoring Alarms/Indicators Oxygen Monitor Technical Specifications Regulator Safety Valve Settings Supplies Environmental
27 27 27 28 28 28 29
Ancillaries and Optional Features
29
3.4.1 Standard Features 3.4.2 Optional Fittings
BleaseGenius MRI User Manual
29 30
7
Chapter 4 Installation 4.1 4.2 4.3
33
Unpacking and Installing the Cylinders Pipeline Connections Connecting the Oxygen Transducer
4.3.1 Guidelines for Handling
4.4 4.5 4.5.
4.6 4.7 4.8 4.9
35 37 38 39
Fitting a Selectatec Vaporizer Fitting an Absorber
39 42
Making The Breathing System Connections
42
Fitting the Bellows Fitting Suction Units Fitting Ancillary Equipment Post-Installation Check
42 42 43 44
Chapter 5 Operation 5.1 5.2 5.3 5.4 5.5
45 General Oxygen System and Oxygen Failure Warning Device Nitrous Oxide System Medical Air System Oxygen Monitor System
5.5.1 Principles of Operation 5.5.2 Components Description 5.5.3 Calibrating the O2 Monitor 5.5.4 To Calibrate the O2 Monitor. 5.5.5 Automatic Calibration to Room Air 5.5.6 Factors Influencing Calibration 5.5.7 Alarm Setting Procedure 5.5.8 Basic Operation 5.5.9 Alarm Conditions 5.5.10 Problem Solving
5.6 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5
8
47 50 51 52 53 53 57 60 61 62 62 64 65 65 66
Fitting a New Oxygen Sensor Controls
66 67
On/Off Switch Flow Controls Oxygen Flush Hypoxic Guard Vaporizers
67 67 68 68 69
BleaseGenius MRI User Manual
Chapter 6 User Maintenance 6.1 6.2 6.3 6.4
User Checking Policy Pre-Use Check (Perform on a daily basis) Full System Check Cleaning
71 73 73 73 73
Chapter 7 Pre-Use Check 7.1 7.2 7.3 7.4 7.5 7.6
Cylinder and Pipeline Supplies Flowblock Assemblies Oxygen Failure Warning System Check Oxygen Monitor Check Leak Test -Vaporizers General
75 77 77 78 78 79 79
Chapter 8 Full System Check 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8
Leak Test On/Off Switch and Warning System Checks Mechanical Hypoxic Guard Test Oxygen Flush Tap Test Auxiliary Outlet Test Vaporizer Test Integrated Oxygen Monitor Tests General Test
81 83 84 85 85 85 86 86 86
Chapter 9 Notices & Important Information 9.1 9.2 9.3 9.4
Product Improvement Responsibilities of the User Responsibilities of the Manufacturer Disclaimer
BleaseGenius MRI User Manual
87 89 89 89 90 9
9.5 9.6
Technology Disclaimer / Tamper Proof Seal Note to Service Personnel
9.6.1 Contact Details
9.7 9.8 9.9 9.10 9.11
91
CE Marking Trademarks and Acknowledgements Warnings Electrostatic Sensitive Devices (ESD) Warnings and Cautions Cautions
9.11.1 Anesthetic Machines
9.12 9.13 9.14
90 90 91 92 93 94 95 95
Oxygen Monitor Ventilator Vaporizer
96 97 98
Appendix A Optional Ventilator Mounting Bracket
10
101
BleaseGenius MRI User Manual
List of Figures Figure 1 - BleaseGenius MRI
20
Figure 2 - Battery Pack
21
Figure 3 - Parameter Diagram
22
Figure 4 - Installing the Cylinders
36
Figure 5 - Oxygen Probe
38
Figure 6 - CAS Absorber
41
Figure 7 - BleaseGenius MRI Components
46
Figure 8 - BleaseGenius MRI Pneumatic Circuit
49
Figure 9 - Blease Oxygen Monitor
56
Figure A1 - Optional Ventilator Mounting Bracket
103
BleaseGenius MRI User Manual
11
Copyright © 2010 Spacelabs Healthcare Ltd. 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 Ltd.
12
BleaseGenius MRI User Manual
Important
BleaseGenius MRI Anesthesia System
Important Read this Manual before operating the Equipment. Read the Vaporizer manual before operating the machine. Read the Ventilator manual before operating the machine. The user must be familiar with the machine and its various functions before using it on a patient.
BleaseGenius MRI User Manual
13
This page is intentionally left blank
14
BleaseGenius MRI User Manual
Chapter 1
BleaseGenius MRI Anesthesia System
Chapter 1
Introduction
BleaseGenius MRI User Manual
15
Chapter 1
Symbols and Abbreviations Used Caution - Consult accompanying documentation
Year of manufacture
IEC symbol denoting type B applied part
Manufacturer
WARNING: There is danger of personal injury the user or patient
CE Mark. Confers approval under the European Medical Device Directive and the Notified Body Number
Further relevant or helpful information
Equipment serial number
Caution: Denotes a potential hazard and NOT a danger to personnel
Consult operating instructions
Power Off
Oxygen Flush
Power On
Bag
l/m l/pm Liters per minute ml
Milliliters Liters
l
O2
Oxygen This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment
16
Cylinder Pipeline
psi psig
Pounds per square inch Pounds per square inch gauge ESD - Electrostatic Discharge
Safe for use in a magnetic resonance (MR) environment
BleaseGenius MRI User Manual
Chapter 1 1.1
Introduction
This manual describes the BleaseGenius MRI anesthetic machine and the instructions required to install, set up, operate and maintain this machine. If an integrated oxygen monitor is installed, refer to the Oxygen Monitor section in this manual. For information on vaporizer operation, refer to the vaporizer operating manual. This manual, the vaporizer manual and the machine’s associated documentation should be studied thoroughly before any attempt is made to set up, use or operate the machine. Requests for advice, assistance or servicing facilities should be addressed to Spacelabs Healthcare or an authorized Spacelabs Healthcare agent. Any adaptations, modifications or procedures not recommended by Spacelabs Healthcare or their agents may affect any warranty relating to the machine. No matter which part of the manual you are using, you should always be familiar with the Warnings and Cautions sections at the beginning of the manual. Before using this system, familiarize yourself with the BleaseGenius MRI Anesthesia System by reading through this entire manual. Also read the manuals for any optional monitors and accessories installed in the system. Pay special attention to the Warnings and Cautions that appear throughout this manual and any that are summarized in the Warnings and Cautions at the beginning of this manual. Read the User Responsibility statement. It describes your responsibilities to maintain the system. Read the Warranty. It describes Spacelabs Healthcare’s responsibility in case of a functional defect. Keep this manual with the system to refer to and to answer any questions that arise about the system’s operation, maintenance or, if necessary, repair.
BleaseGenius MRI User Manual
17
This page is intentionally left blank
18
BleaseGenius MRI User Manual
Chapter 2
BleaseGenius MRI Anesthesia System
Chapter 2
Description
BleaseGenius MRI User Manual
19
Chapter 2 B T H
S L
M G N K A D J
P A B D F G H J
W
Frame Pneumatic unit Hypoxic guard Cylinder/pipeline gauges Flowblock assemblies Oxygen flush Cylinder Reg Box
F K L M N P T W
Flow control knobs Backbar Vaporizer Common gas outlet Main On/Off switch Oxygen monitor N2O/Air selector switch
Figure 1 - BleaseGenius MRI 20
BleaseGenius MRI User Manual