Level 1 Models H-1000, H-1025, H-1100 and H-1200 Technical Service Pack Rev 000 Dec 2007

Technical Service Pack

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Introduction / Specifications Sub-Assemblies Technical Description Disassembly Procedures Maintenance, Testing and Calibration Troubleshooting Spare Parts Rounding Off Appendix 1Circuits and PCB Layout Appendix 2 Symbols Glossary Appendix 3 Quick Reference Guide Cards Appendix 4 Information Bulletins

P R E F A C E

Fast Flow Blood and Fluid Warmers

Technical Service Pack

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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

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W e l c o m e . . .

P R E F A C 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. 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(h) (Normothermia). If these factors persist for a prolonged period of time (b,d), 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.

(References are cited on page xii)

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What hypothermia does to the patient ■

Cardiovascular instability (a, e, g, h) ■

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Increased coagulopathy (f, h, j) ■

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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 (a, h) ■

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

Altered action and reduced clearance of anesthetics (h) ■

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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 (c, h, j) ■

Thermal discomfort, shivering, and fatigue can occur when core temperature decreases by 1°C .

The Level 1 ® Fast Flow Blood and Fluid Warmers The Level 1® H-1200 Fast Flow Blood and Fluid Warmer provides a

rapid flow of warmed fluids, such as crystalloid or blood product, including red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. A Blood and Fluid Warmer provides a flow of warmed fluid to re-warm patients during surgery by trained medical personnel. I.V. fluid and/or blood products are warmed through the use of a sealed heat exchanger through which heated recirculating solution flows. (References are cited on page xii)

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Pressure Infusion Chambers can be used to apply pressure to the bagged infusate and thereby deliver the fluids at a faster flow rate. An Air Detector/Clamp monitors for the presence of air in the disposable Gas Vent/Filter Assembly, and automatically clamps off the patient line and sounds an alarm if a bubble of air is detected. This manual is appropriate for the servicing and testing of the H-1200 Fast Flow Blood and Fluid Warmer. There are a number of earlier models (such as H-1000), and some still-current models (for example, H-1100), that share technology with the H-1200; this manual will also help in dealing with those and their variants. Pre-tower style models (e.g., H-250, H-500) are not covered. The models covered, and a comparison of features is shown below.

Application Model

Features

Infusion/ NormoPressure Powered Fluid Fluid thermic Cham- Elevating ReplaceWarming Irrigation bers I.V. Pole ment

Air Detect/ Clamp

H-1000 / System 1000

✔

✖

✔

✖

H-1025

✔

✖

✔

✖

H-1100

✖

✔

✖

✔

✖

H-1200

✔

✖

✔

✖

✔

Note that the Pressure Chambers (Part number H-2) and the Air Detector / Clamp (part number H-31B) may be retrofitted to an existing H-1000 or H-1025 to bring it up to the latest specification.

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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

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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

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Tel +61 (0) 7 3340 1300 Fax +61 (0) 7 3340 1399

World WideWeb: ■

www.smiths-medical.com

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W e l c o m e . . .

P R E F A C E

■

Read the entire Operators Manual for each device before operating any of the Level 1® Fast Flow Blood and Fluid warmers. Failure to follow the instructions and important information contained in these manuals can lead to death or serious injury.

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The issue date of this Technical Service Pack is included for your information. If one year or more has elapsed between the issue date of this manual and servicing of the device, the user should contact Smiths Medical to inquire if a more current version of this manual is available.

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Level 1 and the Smiths Medical design mark are trademarks of the Smiths Medical family of companies. The symbol indicates that the trademark is registered in the U.S. Patents and Trademarks Office and certain other countries. All other names and marks are trademarks, tradenames, or service marks of their respective owners.

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H i s t o r y

Revision History

Issue No:

Reason for Change

Pages Affected

Date

000

New Revision - First Release

All

September 2007

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Aims To provide technical engineering support staff with the practical and theoretical knowledge necessary to ...

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... diagnose,

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maintain,

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repair,

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and update ...

... Smiths Medical products to meet the needs of your healthcare establishment’s equipment management protocols.

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O b j e c t i v e s

Objectives This manual provides the necessary information to enable a qualified Biomedical Engineer or Technician with appropriate experience to successfully repair or replace components, and recalibrate the Level 1® Fast Flow Blood and Fluid Warmers, either routinely or following repair work. The material covered by this manual is also offered as part of a training course that can be held at Smiths Medical, or at your own establishment. Successful training course attendees are eligible for certification by Smiths Medical. We strongly recommend course attendance for the highest standards of maintenance for your Level 1® Fast Flow Blood and Fluid Warmers. Please contact your local Smiths Medical distributor for more details. On completion, delegates will have knowledge of the following:

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General functionality and device application.

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Principles of operation of electronic and mechanical systems.

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Access to, and use of, the menu systems as appropriate.

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Appropriate methods of testing and the equipment required.

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Essential safety features and verification of performance.

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Routine maintenance requirements.

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Analysis of faults, fault codes and download software as appropriate.

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References

Reference (a)

Source Arndt K. Inadvertent hypothermia in the OR.

AORN J. 1999;70:204-214 (b)

Frank SM, Nguyen JM, Garcia CM, Barnes RA. Temperature monitoring practices during regional anaesthesia.

Anesth Analg. 1999;88:373-377 (c)

GuiffreM, Finnie J, Lynam DA, Smith D. Rewarming postoperative patients: lights, blankets, or forced warm air.

J Post Anesth Nurs 1991:6:387-393 (d)

McNeil B. Addressing the problems of inadvertent hypothermia in surgical patients. Part 2: Self Learning Package

Br J Theatre Nurs. 1998;8:25,27-33. (e)

Morrison RC. Hypothermia in the elderly.

Int Anesthesiol Clin. 1988;26:124-133. (f)

Ouellette RG. Comparison of four intraoperative warming devices.

J Am Assoc Nurse Anesth 1993;61:394-396 (g)

Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming.

Anesthesiology. 1995;82:674-681 (h)

Sessler DI. Mild perioperative hypothermia.

New Engl J Med. 1997;335:1730-1737. (j)

Sobota C, Stewart TP, Payne MM, Mathieu A. Managing perioperative temperature.

New World Health

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S E C T I O N

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I n t r o d u c t i o n

Introduction The Level 1® Fast Flow Blood and Fluid Warmers are designed for use with Level 1® “D” series disposables, to warm blood and IV fluids and deliver them at high flow rates and normothermic temperatures.

H-1000/ System 1000 Developed from the earlier units H-250 and H-500, the H-1000 was the base model in the current “tower” style. A warmed solution is circulated around the unit, passing upwards through a heat exchanger that transfers the heat to the infusate. The temperature of the recirculating solution is closely monitored by no less than four thermistors and two mechanical thermostat devices. The infusate passes through the heat exchanger in the opposite direction to the recirculating solution, giving better temperature control. The heat exchanger also features an aluminium core for maximum efficiency. Alarms, both audible and visual, give warning of error conditions, such as excessively high temperatures, low fluid levels, or incorrectly fitted disposables.

Figure 1 - 1: An H-1025, showing pressure chambers.

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I n t r o d u c t i o n

S E C T I O N

H-1025 The H-1025 Fast Flow Blood and Fluid Warmer, fitted with pressure chambers, handles the toughest and most unpredictable trauma cases in the operating room and emergency department. Warm fluids can be delivered as fast as 1,100 ml/minute. The pressure chambers accommodate all standard blood and solution bags, applying and maintaining constant 300 mmHg pressure, forcing the infusate through at a greater rate than is achievable by gravity alone.

H-1100 The H-1100, although positioned for a rather different medical function, is essentially the same as a H-1000 base unit, with the additional novel feature of an electrically powered self-elevating IV pole able to lift up to 12 litres of fluid. Widely used for irrigation during urology procedures, this variation allows greater bag height to be achieved, while still making the task of bag changing easier for nurses. Greater bag height means that the available gravity pressure to drive the irrigating fluid towards the patient is increased, resulting in higher maximum flow rates without reliance on pressure chambers which limit bag size.

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I n t r o d u c t i o n

H-1200 The new H-1200 Fast Flow Blood and Fluid Warmer builds on the benefits of the existing Level 1 Fluid Warmer legacy, and incorporates the features of integrated air detection and automatic clamping capability. An ultrasonic signal continually passes through the fluid filled gas vent/filter assembly. If a bolus of air displaces the fluid in the gas vent/filter assembly, the ultrasonic signal is broken and the clamp closes, stopping the air before it enters the patient line. Simultaneously, audible and visual Figure 1 - 2: The Air Detector/Automatic alarms are activated, notifying the user that Clamp, which is a standard the fluid flow has stopped. Clearing the bolus fitting for H-1200, can be retrofitted to earlier of air and restoring the fluid flow are quickly models. The model shown accomplished without disconnecting from the here is a H-31B, developed from the earlier SA-1000 patient. and H-30 models. (see section 8 for details)

Superior Performance A series of truly universal machines that handle your toughest and most unpredictable cases, delivering warm fluids as fast as 60,000 ml/hr or as slow as 75 ml/hr. All models feature an aluminium heat exchanger which transfers heat 1000 times faster than plastic and counter-current recirculating solution to provide safe, effective and stable heating.

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I n t r o d u c t i o n

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Features ■

Integrated, highly effective design gives unparalleled ease of use.

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Pressure Chambers:

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Accommodate all standard blood and solution bags.

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Constant 300 mmHg pressure is applied and maintained.

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On/Off toggle switch automatically pressurizes chamber.

Heat Exchanger: ■

Aluminum heat exchanger transfers heat 1000 times faster than plastic at high flows.

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Counter current 42°C recirculating solution for effective and stable heat.

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Digital display of Recirculating Solution temperature.

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Electronic circuitry continuously monitors Recirculating Solution temperature.

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Green “Warming” operating LED.

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Coloured fault indicator LEDs identify common fault conditions.

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Audible alarm indication.

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Alarm test facility.

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S p e c i f i c a t i o n s :

H - 1 0 2 5

Specifications: H-1025 Weights and Dimensions

H-1025

Height

170.8 cm

67¼ inches

Depth

50.8cm

20 inches

Width

50.8cm

20 inches

Weight (dry)

30.0 kg

66 lbs

Performance

H-1025

Min Flow Rate*

75 ml/hr*

Max Flow Rate*

66 l/hr*

Temperature Set Point

41.7 oC +/- 0.3 oC

Over Temperature Set Point

43.9 oC +/- 0.1 oC

Warming from Room Temp. (21°C) to 41°C

3 to 7 min

Compressor Source Pressure

300 mmHg

Reservoir Capacity

1.4 litres 0.37 US gallons 0.31 UK gallons

* Depends on disposable administration set used, whether pressurised or not, cannula/catheter size used and fluid type. WARNING:

Anaesthetics: Not Suitable for use in the presence of flammable anaesthetic mixtures with air or oxygen or with nitrous oxide.

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