Smiths HOTLINE HL-90 User manual

®

Blood and

Fluid Warmer

Introduction /

Specifications

Sub-Assemblies

Technical Description

Disassembly Procedures

Maintenance, Testing

and Calibration

Troubleshooting

Spare Parts

Rounding Off

Appendix 1-

Circuits

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

HOTLINE® 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.

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P R E F A C E

W e l c o m e . . .

What hypothermia does to the patient

■Cardiovascular instability

■Vasoconstriction, decreased cardiac output, and changes in electrical conduction can contribute to an increased incidence of cardiac ischemia, arrhythmias, and arrest.

■Increased coagulopathy

■Coagulopathy may result in increased bleeding, possibly necessitating blood transfusions.

■Altered action and reduced clearance of anesthetics

■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

■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.

HOTLINE® 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 [phone]

European Representative

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Australian Representative

■Smiths Medical Australasia Pty. Ltd.

61 Brandl Street, Brisbane Technology Park Eight Mile Plains, QLD 4113, Australia

■Tel [phone] Fax [phone]

World WideWeb:

■www.smiths-medical.com

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	iv

P R E F A C E

É

W e l c o m e . . .

■All possible care has been taken in the preparation and production of this publication, but Smiths Me dical 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 t hat 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.

©2011 Smiths Medical family of companies.

All rights reserved.

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	v

P R E F A C E

É

R e v i s i o n

H i s t o r y

Revision History

	Issue	Reason for Change	Pages	Date
	No:		Affected
000		New Revision - First Release	All	July 2006
001		Updated EU Rep address	iv, v, vi, 6,	October 2011
			front and
			back covers

HOTLINE® 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.

HOTLINE® 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.

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	viii

C O N T E N T S

Contents

Section 1 - Introduction and Specifications

Superior Performance						-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2
Ease of Use	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2
Features -	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	3
Specifications		-	-	-	-	- - - - - - - - - - - - - - - - -																	4
Environmental - - - - - - - - - - - - - - - - - - -																							5
Miscellaneous				-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	5
Contra-Indications				-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	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

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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

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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

HOTLINE® 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

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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

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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

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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 — 45oC,
	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	ASTM F2172-02
Product Safety	EN60601-1, UL2601-1
EMC	EN60601-1-2; FCC 47
	CFR part 15, Class B

Performance

Recirculating Solution temperature display will reach 37oC 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 (42 inch)
Recirculating Solution	1.4 litres Capacity

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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.

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Sub-Assemblies

®

Blood and

Fluid Warmer

S E C T I O N 2

S u b - a s s e m b l i e s

Sub-assemblies

The principal sub-assemblies to be found in the HOTLINE®

HL-90 are:

■The enclosure and chassis parts

■The recirculating solution path components

■The PCB and its mountings

These are detailed on the following pages.

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S E C T I O N 2

E n c l o s u r e ( 1 )

Enclosure (1)

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	9

S E C T I O N 2

E n c l o s u r e ( 2 )

Enclosure (2)

Newer design Fillport Cover removes need for chain or retaining screw

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	10

S E C T I O N 2

E n c l o s u r e ( 3 )

Enclosure (3)

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S E C T I O N

2

R e c i r c u l a t i n g

S o l u t i o n

P a t h

Recirculating Solution Path

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	12

S E C T I O N

2

I n t e r l o c k

B l o c k

Interlock Block

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	13

S E C T I O N 2

P C B M o u n t i n g

PCB Mounting

HOTLINE® Blood and Fluid Warmer		Technical Service Pack	14

Technical Description

®

Blood and

Fluid Warmer

S E C T I O N 3

T e c h n i c a l D e s c r i p t i o n

Technical Description

General

The HOTLINE® employs a safe recirculating solution heating system, inherently free of hotspots, to actively warm the HOTLINE® Blood and Fluid Warming Set - a co-axial arrangement of warm fluid-filled jacket and sterile IV line. The primary temperature control circuit limits the recirculating solution to 42oC maximum. In the unlikely event of a malfunction of this circuit, a second watchdog circuit will visually and audibly alarm and stop pumping the recirculating solution if the temperature reaches 43oC.

The heater current is supplied via a thermal cutout, so in the case of a circulation failure, the heater will be protected against burn-out; the same cutout will act in the event of catastrophic breakdown of components in the HOTLINE® circuitry that prevents the alarm state from disengaging the heater.

These three levels of safety ensure that the IV Fluid in the HOTLINE® Fluid Warming Set is never exposed to any damaging or dangerous temperature while the unit is operating.

Mechanical

The rear left-hand side of the unit is a reservoir, holding 1.4 litres of either distilled water or a disinfectant solution. This fluid will henceforth be referred to as recirculating solution. Do not confuse recirculating solution with the IV Fluid being dispensed to the patient.

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S E C T I O N 3

T e c h n i c a l D e s c r i p t i o n

Controls and Indicators

Shows the current temperature of the circulating warmed recirculating solution.

This steady GREEN indicator illuminates when power is ON and the Warming Set is correctly installed. The recirculating solution is being warmed and circulated.

This flashing RED indicator with audible alarm shows that warming and circulating has been stopped because the Warming Set is not fitted properly. Reattach the Warming Set and continue.

This flashing RED indicator with audible alarm shows that warming and circulating has stopped because there is not enough recirculating solution in the unit to operate the float switch. Refill, and continue.

This flashing RED indicator with alarm shows that warming and circulating has been stopped because the recirculating solution reached a temperature above the set point. The unit must be removed from service, and repairs effected before returning to service.

SIDE PANEL BUTTON

Simulates triggering of the Over Temperature watchdog alarm for testing.

SIDE PANEL BUTTON

General Alarm Test

Simulates triggering of all alarms for testing.

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