Technical Service Pack
131 Pages
Preview
Page 1
Intentionally Blank
Introduction / Specifications
Sub-Assemblies
Technical Description
Disassembly Procedures
Maintenance, Testing and Calibration
Troubleshooting
Spare Parts
Rounding Off
Appendix 1Circuits
®
Blood and Fluid Warmer
Appendix 2 PCB Layout
Appendix 3 Symbols Glossary Appendix 4 Frequently Asked Questions Information Bulletins
P R E F A C E
W e l c o m e . . .
Welcome... ... to one of
Smiths Medical’s Technical Service Packs Who are we? Smiths Medical is a global manufacturer and supplier of medical devices for treating critically ill patients. These devices may be used in high-risk situations, and include ambulatory and hospital infusion pumps, neo-natal and paediatric monitors, blood and fluid warmers, and convective warming systems for patients.
Figure P - 1: A selection of Smiths Products - old and new
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
i
P R E F A C E
W e l c o m e . . .
Smiths Medical has a long history, bringing many well known brands to the market, such as Portex ®, Level 1 ®, BCI®, Graseby ®, Wallace®, Bivona ®, Pneupac ®, Deltec ®, DHD® and Medex® . It is part of the Smiths Group, a British engineering consortium founded in 1851. Now all of these formerly independent business units have been merged into one Global company - Smiths Medical. Smiths Medical is a world leader in the design, manufacture and distribution of medical devices.
What about Level 1®? The Level 1® range of products is synonymous with a high quality, cost effective range of temperature management products. The range includes blood and fluid warming products for both gravity flow and fast flow intravenous or irrigation applications, and convective (hot air) warming systems. These products help to prevent hypothermia and maintain normothermia in patients undergoing surgery in the operating theatre, recovery ward and in the casualty departments in emergency situations.
Why is Temperature Management important? Patients undergoing surgical procedures are exposed to a variety of influences that have a effect on their ability to maintain their normal body temperature (Normothermia). If these factors persist for a prolonged period of time, the patient will become hypothermic, i.e., their body temperature drops below 36°C. Even mild hypothermia (34°-36°C) puts patients at risk. Trauma cases and extensive procedures present well-known temperature management challenges. But so can routine operations. Clinical evidence shows that warming is important in any case lasting more than an hour and/or using more than one litre of fluid.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
ii
P R E F A C E
W e l c o m e . . .
What hypothermia does to the patient ■
Cardiovascular instability ■
■
Increased coagulopathy ■
■
Hypothermia decreases a patient’s metabolism, resulting in a need for higher amounts of anesthetics. It also contributes to delayed emergence from anesthesia and longer recovery room stays.
Increased risk of wound infection ■
■
Coagulopathy may result in increased bleeding, possibly necessitating blood transfusions.
Altered action and reduced clearance of anesthetics ■
■
Vasoconstriction, decreased cardiac output, and changes in electrical conduction can contribute to an increased incidence of cardiac ischemia, arrhythmias, and arrest.
Wound infection and delayed wound healing result in longer hospital stays. Wound infection can prolong hospitalization.
Postoperative discomfort ■
Thermal discomfort, shivering, and fatigue can occur when core temperature decreases by 1°C .
The HOTLINE® Blood and Fluid Warmer The HOTLINE® Blood and Fluid Warmer uses a special disposable that totally encloses the patient’s end of the IV administration set in a bath of warmed recirculating fluid. This means that the IV fluid is introduced at or above core body temperature, rather than in the chilled state that it may have been stored at. This simple solution eliminates the chill being passed to the patient, and assists the patient’s own efforts at maintaining normothermia.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
iii
P R E F A C E
W e l c o m e . . .
Published by: Smiths Medical ASD, Inc. 160 Weymouth St, Rockland, MA 02370, USA ■
For assistance or further information, contact Smiths Medical ASD, Inc., Technical Service Department or your Smiths Medical ASD, Inc., distributor at:
USA/ Canada ■
Smiths Medical ASD, Inc. 160 Weymouth Street, Rockland, MA 02370 USA
■
USA/Canada 1-800-258-5361 International +1-781-878-8011
European Representative ■
Smiths Medical International Ltd Colonial Way, Watford, Herts, WD24 4LG, UK Registered in England Number: 362847
■
Tel +44 (0) 1923 246434 Fax +44 (0) 1923 231595
Australian Representative ■
Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Brisbane Technology Park Eight Mile Plains, QLD 4113, Australia
■
Tel +61 (0) 7 3340 1300 Fax +61 (0) 7 3340 1399
World WideWeb: ■
www.smiths-medical.com
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
iv
P R E F A C E
W e l c o m e . . .
■
All possible care has been taken in the preparation and production of this publication, but Smiths Medical accepts no liability for any inaccuracies that may be found.
■
This publication may be subject to revision and it is the user’s responsibility to ensure that the correct version is used appropriate to the intended use.
■
Users of the equipment must ensure that they have read and understood the contents of the complete manual including the warnings and cautions and have been trained in the correct use of the product.
■
This publication has been compiled and approved by Smiths Medical for use with their respective products.
■
It may be supplied in a format that permits users to access the text and illustrations for their own use (e.g., training and educational purposes). Smiths Medical cannot be held responsible for the accuracy of, nor any resulting incident arising from, information that has been extracted from this publication and compiled into the user’s documentation.
■
Other than as herein noted, no part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Smiths Medical.
■
“Graseby ® ” “Smiths” “HOTLINE® ” and “LEVEL 1® ” are all trademarks of the Smiths Medical family of companies. All other trademarks are acknowledged as the property of their respective owners.
■
The symbol indicates it is registered in the U.S. Patents and Trademarks Office and in certain other countries.
®
© 2006 Smiths Medical family of companies. All rights reserved.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
v
P R E F A C E
R e v i s i o n
H i s t o r y
Revision History
Issue No:
Reason for Change
Pages Affected
Date
000
New Revision - First Release
All
July 2006
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
vi
P R E F A C E
A i m s
Aims To provide technical engineering support staff with the practical and theoretical knowledge necessary to ...
■
... diagnose,
■
maintain,
■
repair,
■
and update ...
... Smiths Medical products as appropriate to meet the needs of your healthcare establishment’s equipment management protocols.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
vii
P R E F A C E
O b j e c t i v e s
Objectives This manual will give you the necessary information to enable a qualified Biomedical Engineer or Technician with appropriate experience to successfully tackle any repair or component replacement required, and recalibrate the unit either routinely or post-repair work. The material covered by this manual is also offered as part of a training course that can be held either at Smiths Medical’s premises, or at your own establishment if that would be more convenient. Successful training course attendees may be certified by Smiths Medical, an option not open to non-attendees. Please contact your local Smiths Medical distributor for more details. We strongly recommend course attendance wherever possible, to ensure the highest standards of maintenance for your HOTLINE® units. On completion of the program, delegates will have knowledge of the following:
■
General functionality and device application.
■
Principles of operation of electronic and mechanical systems.
■
Access to, and use of, the menu systems as appropriate.
■
Appropriate methods of testing and the equipment required.
■
Essential safety features and verification of performance.
■
Routine maintenance requirements.
■
Analysis of faults, fault codes and download software as appropriate.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
viii
C O N T E N T S
Contents Section 1 - Introduction and Specifications Superior Performance - - - - - - - - - - - - - - - - Ease of Use - - - - - - - - - - - - - - - - - - - - - Features - - - - - - - - - - - - - - - - - - - - - - Specifications - - - - - - - - - - - - - - - - - - - - Environmental - - - - - - - - - - - - - - - - - - Miscellaneous - - - - - - - - - - - - - - - - - - Contra-Indications - - - - - - - - - - - - - - - - - - -
2 2 3 4 5 5 6
Section 2 - Sub-assemblies Enclosure - - - - - - - - - - - - - - - - - - - - - - 9-11 Recirculating Solution Path - - - - - - - - - - - - - - - 12 Interlock Block - - - - - - - - - - - - - - - - - - - - 13 PCB Mounting - - - - - - - - - - - - - - - - - - - - 14
Section 3 - Technical Description General - - - - - - - - - - - - - - - - - - - - - - - - 16 Mechanical - - - - - - - - - - - - - - - - - - - - - - 16 Controls and Indicators - - - - - - - - - - - - - - - - 17 Side Panel - - - - - - - - - - - - - - - - - - - - - 17 Electrical - - - - - - - - - - - - - - - - - - - - - - - 19 Power Circuits - - - - - - - - - - - - - - - - - - 19 Control Circuit - - - - - - - - - - - - - - - - - - 20 Digital Display - - - - - - - - - - - - - - - - - - - 22 Thermistor Loss - - - - - - - - - - - - - - - - - 23 Over Temperature Alarm - - - - - - - - - - - - - - 25 Flasher - - - - - - - - - - - - - - - - - - - - - 27 Interlock Alarm - - - - - - - - - - - - - - - - - - 29 Recirculating Solution Level Alarm - - - - - - - - - 30
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
ix
C O N T E N T S
Section 4 - Disassembly Procedure Tools you will need - - - - - - - - - - - - - - - - - - - 33 Disassembly - - - - - - - - - - - - - - - - - - - - - 34 Step 1: Open the case - - - - - - - - - - - - - - - - 34 Step 2: Remove the PCB - - - - - - - - - - - - - - 36 Step 3: Release the Earth Stud - - - - - - - - - - - 40 Step 4: The Recirculating Solution Return Pipe - - - - 41 Step 5: Removing the Chassis - - - - - - - - - - - - 42 Reassembly - - - - - - - - - - - - - - - - - - - - - - 44
Section 5 - Maintenance, Testing and Calibration Before each use - - - - - - - - - - - - - - - - - - - - 46 Lubrication of O-Ring Seals - - - - - - - - - - - - - 46 After each use - - - - - - - - - - - - - - - - - - - - - 46 Routine Maintenance Tasks - - - - - - - - - - - - - - - 47 Every 30 days - - - - - - - - - - - - - - - - - - - - - 48 Every 12 months - - - - - - - - - - - - - - - - - - - - 49 Maintenance Solutions - - - - - - - - - - - - - - - - - 54 Changing the Recirculating Solution - - - - - - - - - - - 54 Sterile Distilled Water - - - - - - - - - - - - - - - 54 Isopropyl Alcohol Solution - - - - - - - - - - - - - - 56 Hydrogen Peroxide Solution - - - - - - - - - - - - - 57 Routine Maintenance Checklists - - - - - - - - - - - - - 60 Full Service Test Procedure - - - - - - - - - - - - - - - 64 Things you will need - - - - - - - - - - - - - - - - 64 HL-90 Service Test Specification - - - - - - - - - - - 65
Section 6 - Troubleshooting Troubleshooting Hints - - - - - - - - - - - - - - - - - 71 Over Temperature Alarm always ON - - - - - - - - 71 Over Temperature Alarm not working - - - - - - - - 72 Fluid Warming Set Interlock Alarm always ON - - - - 72 Fluid Warming Set Interlock Alarm not working - - - 72 Low Recirculating Solution Level Alarm always ON - - 73 Low Recirculating Solution Level Alarm not working - 73 Non-Alarm related Faults - - - - - - - - - - - - - 74
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
x
C O N T E N T S
Section 7 - Spare Parts Enclosure Parts for two-part case - - - - - - - - - - - 76 Enclosure Parts for single-part case - - - - - - - - - - 77 Float Switch and related parts - - - - - - - - - - - - - - 77 Parts in the Recirculating Solution Path - - - - - - - - - 78 P.C.B and mounting accessories - - - - - - - - - - - - - 79 Water pump and related parts - - - - - - - - - - - - - - 79 Interlock Block and related parts - - - - - - - - - - - - 80 External Parts, Rear of case - - - - - - - - - - - - - - - 81 Poleclamp parts - - - - - - - - - - - - - - - - - - - - 82
Section 8 - Rounding Off Updates - - - - - - - - - - - - - - - - - - - - - - - - 84 Modifications - - - - - - - - - - - - - - - - - - - - - 84 GRI Pump - - - - - - - - - - - - - - - - - - - - - - - 86 Float Switch Sealing Washer - - - - - - - - - - - - - - - 87
Appendix 1- Circuits Appendix 2 - PCB Layout PCB layout - - - - - - - - - - - - - - - - - - - - A2 - 2 Component Listing - - - - - - - - - - - - - - - - - A2 - 3
Appendix 3 - Symbols Glossary Appendix 4 - Customer Information Bulletins HOTLINE® Frequently Asked Questions - - - - - - - A4 - 2 General Advisement - - - - - - - - - - - - - - - - A4 - 6 HOTLINE® - Specific Announcements - - - - - - - - A4 - 7
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
xi
Introduction / Specifications
®
Blood and Fluid Warmer
S E C T I O N
1
H O T L I N E ®
H L - 9 0
HOTLINE ® HL-90 Blood and Fluid Warmer The HOTLINE® HL-90 Blood and Fluid Warmer is designed for use with the HOTLINE ® Warming Set to warm blood and IV fluids, and deliver them to the patient’s intravenous access site at normothermic temperatures under gravity flow conditions. By jacketing the sterile patient IV line with a layer of precisely controlled warmed recirculating solution, HOTLINE® provides active warming of the patient line all the way down to the patient connection, thus eliminating “patient line cool-down.”
Superior Performance ■
The HOTLINE® innovative tubing design eliminates “patient line cool-down,” and delivers warm intravenous fluids to patients
Ease of Use ■
Simple, 1-step plug-in disposable for fast setup and start
■
A 2.4 m (8 foot) patient line allows convenient positioning of unit
■
Requires 60 - 70% less priming volume (20 ml)
■
Compatible with standard IV sets, infusion pumps and in-line hand pumps
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
2
S E C T I O N
1
H O T L I N E ®
H L - 9 0
Features ■
Integrated, highly effective design gives unparalleled ease of use
■
Can be set up and operated in seconds
■
Warmed Intravenous Fluid delivery at up to 4750 ml/hr
■
Digital display of recirculating solution temperature
■
Electronic circuitry continuously monitors recirculating solution temperature
■
Green “Warming” operating LED
■
Red fault indicator LEDs identify 3 common fault conditions
■
Audible alarm indication
■
Alarm test facility
Temperature Display
Operating LED Fault Condition LEDs Disposable Interlock Recirculating Solution Level Over Temperature GM-0163-8102-GB-A
Figure 1 - 1: HOTLINE ® Front Panel
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
3
S E C T I O N
1
S p e c i f i c a t i o n s
Specifications Dimensions
inch
cm
Height
9.5
24.1
Length
8.3
21.0
Width
7.0
17.8
Weights
lbs
kg
Weight (dry)
7.6
3.5
Weight (full)
11.0
5.0
Weight (as Shipped)
7.95
3.6
Electrical
HL-90 US
HL-90 UK
Supply Voltage
115 V AC
230 V AC
Supply Current
3.0 A
1.5 A
Supply Frequency
50-60 Hz
50-60 Hz
Classification
Class 1
Class 1
Safety Rating
Type BF applied part
Type BF applied part
Power Cord
0.75mm x 3.6 m
0.75mm x 3.6 m
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
4
S E C T I O N
1
S p e c i f i c a t i o n s
Environmental Temperature Operating Range
10oC - 45 oC, 10 - 95% RH, (non-condensing)
Transport / Storage
-20oC - 70oC 5 - 95% RH, (non-condensing)
Water Resistance Enclosure Protection
IEC 60529, IP Code: IPX1
Miscellaneous Standards Compliance Fluid Warmers Product Safety EMC
ASTM F2172-02 EN60601-1, UL2601-1 EN60601-1-2; FCC 47 CFR part 15, Class B
Performance Recirculating Solution temperature display will reach 37 oC from ambient in about 4 minutes. Operating Temp. Set Point 41.5oC ± 0.5oC Over Temp. Set Point 42.6oC ± 0.5oC Max Height on IV pole
107 cm
Recirculating Solution
1.4 litres Capacity
HOT LINE ® Blood and Fluid Warmer
(42 inch)
Technical Service Pack
5
S E C T I O N
1
C o n t r a - i n d i c a t i o n s
Contra-indications ■
Not Suitable for use in the presence of flammable anaesthetic mixtures with air or oxygen or with nitrous oxide.
■
HOTLINE® disposables are not suitable for use with pressure devices generating over 300 mmHg.
HOT LINE ® Blood and Fluid Warmer
Technical Service Pack
6
Sub-Assemblies
®
Blood and Fluid Warmer