Smiths HOTLINE HL-90 User manual

Introduction /
Specifications

Sub-Assemblies

Technical Description

Disassembly Procedures

Maintenance, Testing
and Calibration

®

Troubleshooting

Spare Parts

Rounding Off

Appendix 1­Circuits

Appendix 2 ­PCB Layout

Blood and

Fluid Warmer

Appendix 3 ­Symbols Glossary

Appendix 4 ­Frequently Asked Questions
Information Bulletins

Welcome...

Who are we?

medical devices for treating critically ill patients. These devices may

be used in high-risk situations, and include ambulatory and hospital

PREFACE



Welcome...

... to one of

Smiths Medical’s

Technical Service Packs

Smiths Medical is a global manufacturer and supplier of

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

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

PREFACE



Welcome...

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.

HOTLINE® Blood and Fluid Warmer Technical Service Pack ii

PREFACE

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.



Welcome...

■ 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

Published by:

Smiths Medical ASD, Inc.

160 Weymouth St, Rockland, MA 02370, USA

■ For assistance or further information, contact Smiths Medical

USA/ Canada

■ Smiths Medical ASD, Inc.

■ USA/Canada 1-800-258-5361

PREFACE

ASD, Inc., Technical Service Department or your Smiths Medical
ASD, Inc., distributor at:

160 Weymouth Street, Rockland, MA 02370 USA

International [phone]



Welcome...

European Representative

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■ 7HO««««

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

PREFACE É Welcome...

■ 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
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.

to ensure that the correct version is used

■ 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

trademarks of the Smiths Medical family of companies. All other
trademarks are acknowledged as the property of their respective
owners.

■ The symbol

Trademarks Office and in certain other countries.

®

” “Smiths” “HOTLINE®” and “LEVEL 1®” are all

® indicates it is registered in the U.S. Patents and

© 2011 Smiths Medical family of companies.
All rights reserved.

HOTLINE® Blood and Fluid Warmer Technical Service Pack v

Revision History

PREFACE É Revision History

Issue

No:

000 New Revision - First Release All July 2006

001 Updated EU Rep address iv, v, vi, 6,

Reason for Change Pages

Affected

front and

back covers

Date

October 2011

HOTLINE® Blood and Fluid Warmer Technical Service Pack vi

Aims

PREFACE  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

Objectives

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.

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

PREFACE  Objectives

This manual will give you the necessary information to enable

The material covered by this manual is also offered as part of a

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

Contents

Section 1 - Introduction and Specifications

Superior Performance - - - - - - - - - - - - - - - - - 2
Ease of Use - - - - - - - - - - - - - - - - - - - - - - 2
Features - - - - - - - - - - - - - - - - - - - - - - - 3
Specifications - - - - - - - - - - - - - - - - - - - - - 4

Contra-Indications - - - - - - - - - - - - - - - - - - - 6

Section 2 - Sub-assemblies

CONTENTS

Environmental - - - - - - - - - - - - - - - - - - - 5
Miscellaneous - - - - - - - - - - - - - - - - - - - 5

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

HOTLINE® Blood and Fluid Warmer Technical Service Pack

ix

CONTENTS

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

HOTLINE® Blood and Fluid Warmer Technical Service Pack

x

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

CONTENTS

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

®

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 normo-

thermic 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 connec-

tion, thus eliminating “patient line cool-down.”

SECTION 1  HOTLINE® HL-90

Superior Performance

■ The HOTLINE® innovative tubing design eliminates “patient

line cool-down,” and delivers warm intravenous fluids to pa-

tients

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

HOTLINE® Blood and Fluid Warmer Technical Service Pack

2

Features

y

SECTION 1  HOTLINE® HL-90

■ 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 solu-

tion temperature

■ Green “Warming” operating LED

■ Red fault indicator LEDs identify 3 common fault conditions

■ Audible alarm indication

■ Alarm test facility

Fault Condition LEDs

Disposable Interlock

Temperature Displa

Operating LED

Recirculating Solution Level

Over Temperature

HOTLINE® Blood and Fluid Warmer Technical Service Pack

GM-0163-8102-GB-A

Figure 1 - 1: HOTLINE® Front Panel

3

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

SECTION 1  Specifications

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

HOTLINE® Blood and Fluid Warmer Technical Service Pack

4

Environmental

Temperature

Operating Range 10oC — 45oC,

Transport / Storage -20oC — 70oC

Water Resistance

Enclosure Protection IEC 60529, IP Code: IPX1

Miscellaneous

SECTION 1  Specifications

10 — 95% RH, (non-condensing)

5 — 95% RH, (non-condensing)

Standards Compliance

Fluid Warmers ASTM F2172-02

Product Safety EN60601-1, UL2601-1

EMC EN60601-1-2; FCC 47

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)

CFR part 15, Class B

Recirculating Solution 1.4 litres Capacity

HOTLINE® Blood and Fluid Warmer Technical Service Pack

5

Contra-indications

■ Not Suitable for use in the presence of flammable anaesthetic

mixtures with air or oxygen or with nitrous oxide.

SECTION 1  Contra-indications

■ HOTLINE

devices generating over 300 mmHg.

®

disposables are not suitable for use with pressure

HOTLINE® Blood and Fluid Warmer Technical Service Pack

6

Sub-Assemblies

Blood and

Fluid Warmer

®

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

SECTION 2  Sub-assemblies

These are detailed on the following pages.

HOTLINE® Blood and Fluid Warmer Technical Service Pack

8

Enclosure (1)

SECTION 2  Enclosure (1)

HOTLINE® Blood and Fluid Warmer Technical Service Pack

9

Enclosure (2)

SECTION 2  Enclosure (2)

Newer design Fillport Cover removes

need for chain or retaining screw

HOTLINE® Blood and Fluid Warmer Technical Service Pack

10

Enclosure (3)

SECTION 2  Enclosure (3)

HOTLINE® Blood and Fluid Warmer Technical Service Pack

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SECTION 2  Recirculating Solution Path

Recirculating Solution Path

HOTLINE® Blood and Fluid Warmer Technical Service Pack

12

Interlock Block

SECTION 2



Interlock Block

HOTLINE® Blood and Fluid Warmer Technical Service Pack

13

PCB Mounting

SECTION 2  PCB Mounting

HOTLINE® Blood and Fluid Warmer Technical Service Pack

14

Technical Description

Blood and

Fluid Warmer

®

SECTION 3  Technical Description

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

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.

- a co-axial arrangement of warm

Mechanical

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.

HOTLINE® Blood and Fluid Warmer Technical Service Pack

The rear left-hand side of the unit is a reservoir, holding 1.4

16

SECTION 3  Technical Description

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.

HOTLINE® Blood and Fluid Warmer Technical Service Pack

17