CritiCool Pro User Manual Rev A Jan 2010

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name: Mennen Medical Ltd. 4 Hayarden Street, Yavne, 81228 P.O. Box 102, Rehovot, 76100, Israel Tel.: +972-8-9323333 Fax: +972-8-9328510 European Representative: Charter-Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel.: 01908 646070 Fax: 01908 646030 Publication No. DDT-136-007 Rev. A Revision: January 2010

Copyright 2010 by MTRE. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders.

CritiCool Pro™ Operating Manual

Important Notice This document is delivered subject to the following conditions and restrictions: All rights reserved. No part of this manual may be reproduced or copied in any form by any graphic, electronic or mechanical means - including photocopying, scanning, typing or information retrieval systems - without advanced written permission from MTRE Ltd.. U.S. Patent No. 6,500,200 BI

Trademarks CritiCool Pro is a trademark of MTRE Ltd. Other company and brand, product and service names are for identification purposes only and may be trademarks or registered trademarks of their respective holders. Data is subject to change without notice.

Responsibility of Manufacturer MTRE Ltd. considers itself responsible for the effects on safety, reliability, and performance of the equipment only if: Repairs are carried out by authorized MTRE personnel only. Electrical installation of the room in which the system is installed complies with all aspects of the relevant internationally-recognized electrical safety standards, as well as specific hospital requirements. The equipment is used in accordance with instructions for use. MTRE is not responsible for any consequential or incidental damages or expenses of any kind, impairment of or damage to other goods or to any third party resulting from loss of use of the system caused by or due to the following: a.Installed, operated, maintained contrary to MTRE's instructions, notes or warnings under this manual. b.Misuse, unauthorized use, negligence, accident, (including fire, water, explosion, smoke, vandalism, etc.) c.Ignoring any of the warnings, precautions and safety measures indicated in this manual. d.Replace, repair or alter not by MTRE's authorized personnel. e.Anyone other than MTRE's authorized and certified personnel removes, casing and/or attempts to make or makes any internal changes, removals, attachments or additions to the CritiCool Pro System or components thereof; 2

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f.The power supplied to the System or any part thereof differs from the rated value, or any external device attached by user creates conditions exceeding the tolerance of the System; or g.The use of accessories and other parts or equipment made by other manufacturers, whether or not warranted by such manufacturers, which have been attached or connected to the System after installation, unless such accessories and other parts have been supplied and attached or installed by the MTRE. h.Using the system in a contrary manner than indicated in this manual, or using the system for any purpose other than indicated in the manual. i.Failure to replace the Garment in each procedure while operating the system. Note that all Garments are one-use disposable materials and should not be reused. j.Force Majeure In no event shall MTRE be liable for loss of use, loss of profits, or other collateral, special or consequential damages.

Use of Manual The MTRE CritiCool Pro system described in this manual has been designed to meet international safety and performance standards. Only qualified personnel may operate the system, and these operators must first have a full understanding of the proper operation of the system. The purpose of this manual is to help qualified personnel understand and operate the system. It is important that you read this manual and familiarize yourself thoroughly with its contents before you attempt to operate the system. If you do not understand any part of this manual, or if anything is unclear or ambiguous in any way, please contact your MTRE representative for further clarification. The information provided in this manual is not intended to replace regular medical training procedures. This manual should always accompany the system. All qualified personnel operating the system should know the location of the manual. For additional copies of this manual, please contact your MTRE representative

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TABLE OF CONTENTS Chapter 1: Safety Precautions 1-1 Definitions... 1-1 Intended Use... 1-1 Warnings... 1-1 Precautions... 1-2 Improper Use... 1-3 Labels... 1-4 CritiCool Pro Device Labels... 1-4 Chapter 2: System Description... 2-1 General Description... 2-1 CritiCool Pro System... 2-1 CritiCool Pro Device... 2-2 External Features 2-2 Front View 2-2 Side View 2-3 Rear Panel... 2-4 Garment... 2-4 Accessories... 2-7 Chapter 3: Installation... 3-1 Pre-installation Requirements... 3-1 Space and Environmental Requirements... 3-1 Electrical Requirements... 3-1 Unpacking and Inspection... 3-1 Assembling the Handle... 3-1 Equipment List... 3-2 Moving the Unit... 3-3 Preparation:... 3-3 Locking and Unlocking the Trolley Wheels... 3-3 Storage Conditions and Transport... 3-3 Storage... 3-3

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Chapter 4: Operating Instructions... 4-1 General... 4-1 Controls, Indicators and Connections... 4-1 Main Power Switch... 4-1 QCC-Quick Coupling Connector... 4-1 Sensor Sockets... 4-2 Preparing the System for Operation... 4-2 Turning on the System... 4-2 System Setup... 4-2 Turning on the System... 4-4 Self-Test... 4-5 Cooling Therapy Control Panel... 4-5 Selecting Modes... 4-6 Set-Point Setting... 4-7 Target Temperature Setting... 4-9 Re-Warm Setup... 4-10 Getting Started... 4-11 Inserting and Attaching Human Sensors... 4-11 Attaching Surface Sensor... 4-11 Fastening Garment to Patient... 4-12 Replacing the Garment... 4-12 Cooling Mode... 4-12 Warming Mode... 4-13 Normothermia Management... 4-14 Re-Warming Mode... 4-14 STAND-BY Mode... 4-16 Empty Mode... 4-16 Turning Off the System... 4-17 Chapter 5: Ordering Information... 5-1 Equipment and Accessories - Ordering Information... 5-1 Equipment and Accessories - Inventory... 5-1 Available Garments... 5-1 Chapter 6: Maintenance... 6-1 Introduction... 6-1 Service Information... 6-1 Routine Maintenance... 6-1 Sterilization of Reusable Sensors and Disposable Sensor Adapters... 6-1 Cleaning and Disinfecting Procedures for Reusable Sensors... 6-2 Cleaning... 6-2 Disinfecting... 6-2 Filter Replacement... 6-2

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Chapter 7: Troubleshooting 7-1 General... 7-1 Trouble-shooting Guide... 7-1 Chapter 8: Specifications... 8-1 Physical... 8-1 Control System... 8-1 Auxiliary Systems... 8-1 Warranty... 8-2 Operation... 8-2 Storage and Transport without Water... 8-2 Electricity... 8-2 Safety... 8-2 Accessories... 8-3 Chapter 9: MTRE Customer Service Representative... A-1

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LIST OF FIGURES Figure 1-1 Label Placement for the CritiCool Pro Device ... 1-4 Figure 2-1: Front View ... 2-2 Figure 2-2: Side View ... 2-3 Figure 2-3: Rear View ... 2-4 Figure 2-4: Measurments ... 2-6 Figure 3-1: Handle Assembly ... 3-2 Figure 4-1 CritiCool Setup in VitaLogik ... 4-3 Figure 4-2 Full Screen monitor display ... 4-4 Figure 4-3 : Thermoregulation Control Panel ... 4-5 Figure 4-4 CritiCool Pro Mode selection panel ... 4-7 Figure 4-5 Set-Point Setting Panel ... 4-8 Figure 4-6 Target Temperature Setting Panel ... 4-9 Figure 4-7 Re-warm Mode ... 4-10 Figure 4-8 Re-Warm Setup Panel ... 4-10 Figure 4-9 Alarm Message "Core too low" ... 4-13 Figure 6-1: Filter Orientation... 6-3 Figure 6-2 Filter Assembly ... 6-3 Figure 7-1: ThermoWrap Connecting Tubes and Special Male Connector ... 7-3 Figure 7-2: CureWrap Connecting Tubes and Special Male Connector ... 7-4

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LIST OF TABLES Table 5-1 CureWrap Sizes ... 5-1 Table 5-2 Accessories Inventory ... 5-2 Table 6-1 Inspection and Maintenance Schedule ... 6-4 Table 7-1 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide ... 7-2 Table 7-2 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide (cont.) ... 7-3 Table 7-3 CritiCool Pro System Message Troubleshooting Guide ... 7-4 Table 7-4 CritiCool Pro System Message Troubleshooting Guide (cont.) ... 7-5 Table 7-5 CritiCool Pro System Message Troubleshooting Guide (cont.) ... 7-6 Table 7-6 CritiCool Pro System Message Troubleshooting Guide (cont.) ... 7-7

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CHAPTER 1: SAFETY PRECAUTIONS Definitions WARNING-indicates a condition that may endanger the patient or the system operator CAUTION-indicates a condition that may damage the equipment NOTE-indicates ways in which the system’s operation can be made more efficient.

Intended Use The CritiCool Pro system is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Warnings

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The physician must be notified if the patient's temperature does not respond properly, does not reach the prescribed temperature, or if there is any change in the prescribed temperature range. Failure to inform the physician may result in injury to the patient.

•

The patient should be constantly attended by a physician.

•

The misuse of the temperature regulation equipment can be potentially harmful to the patient.

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Do not plug wet PL plugs of the human sensors into the sensor sockets of the CritiCool Pro device.

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The user should verify that no fluids are present at the skin/Garment interface during the treatment. Failure to do so can cause lesions on the patient's skin. Following the procedure, a pattern resembling the Garment may appear for a short period of time on the patient's skin.

•

In procedures that usually extend over two hours, pressure sores may appear or develop when soft tissue is compressed between a bony prominence and external surface. The use of the CritiCool Pro system does not prevent this occurrence.

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Safety Precautions

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Before initiating maintenance procedures as described in Chapter 6, disconnect the power cord from the power source.

•

The default setting is intended to induce hypothermia. The system provides the physician with the option of selecting a body temperature in the range of 30°C to 40°C (86°F-104°F).

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Do not lift or move the patient by means of the Garment. This may cause tearing and water leakage.

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Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors.

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The technical principles, clinical applications, and risks associated with circulatory support must be thoroughly understood before using this product. Read the entire manual before attempting to activate the system. Completion of the training program prior to using the CritiCool Pro system is mandatory.

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The repair, calibration, and servicing of the CritiCool Pro system should be performed only by MTRE Advanced Technologies LTD or authorized agents trained by MTRE Advanced Technologies LTD.

Precautions

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Follow the warning notes listed in the various sections of this manual.

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Only trained personnel, familiar with all system operating procedures and certified only by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd, are allowed to use the CritiCool Pro system. All hospital personnel using the CritiCool Pro system must complete the CritiCool Pro training program.

•

The repair and servicing of the CritiCool Pro device should be performed only by qualified medical equipment service technicians certified by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd.

•

If moisture or leaks are discovered in the connecting hose and/or Garment, turn off the CritiCool Pro device, disconnect the power cable from its power source, and correct the problem before proceeding.

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The desired set-point temperature should be fixed only as prescribed by and under the order of a physician.

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If the device sounds an alarm and/or presents a display other than the standard MTRE display, the operator should proceed according to the display message

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and/or the troubleshooting instructions (see Chapter 7 Troubleshooting). •

Avoid folds in the Garment-these may obstruct water flow.

•

Do not block the CritiCool Pro device ventilation grilles. Air must be able to flow freely in and out in order to keep the device cool.

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Do not use de-ionized or distilled water. Use tap water only.

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When X-ray imaging is performed on a patient wearing a Garment, shadows from the Garment may appear on the X-ray film.

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Avoid inserting any sharp object between the patient and the Garment.

Improper Use Improper use of the CritiCool Pro system can lead to skin lesions, electrical hazards, and severe changes in body temperature.

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WARNING!!!

The technical principles, clinical applications, and risks associated with circulatory support must be thoroughly understood before using this product. Read the entire manual before attempting to activate the system. Completion of the training program prior to using the CritiCool Pro system is mandatory.

CAUTION!

U.S. Federal law restricts this device to sale by or on the order of a physician.

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Safety Precautions

Labels CritiCool Pro Device Labels

Figure 1-1 Label Placement for the CritiCool Pro Device

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Table 1-1 Key to Label Symbols

Symbol

Description Location of core sensor socket

Location of surface sensor socket

AC Voltage

Fuse

CE mark of conformity indicates that the product has received the European approval for MDD 93/42/EEC. 0473

Equipment not suitable in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Refer to user manual

Type BF equipment

Recycle

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Safety Precautions

Date of manufacture M fg 2 0 0 7

R

C

US

xx - yyyy

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CSA symbol indicates that the product has received the approval of the Canadian Standards Association.

Machine Version - Machine serial number

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CHAPTER 2: SYSTEM DESCRIPTION General Description A growing number of cases require a solution for controlling patient temperature in various hospital settings. Inducing hypothermia or simply controlling fever is beneficial and sometimes vital. The CritiCool Pro™ systems combines the thermal regulation capabilities of it's predecessor the CritiCool® with the well known VitaLogik patient monitoring. It provides integrated data storage of the thermal regulation and the clinical condition of the patient under going treatment. The patient monitoring waveforms and numeric vital sign can be viewed on Mennen Medical Central Nurse Station the Ensemble and the Enguard if the CritiCool Pro™ is connected to the MennenNet. The CritiCool Pro system induces, maintains, and reverses hypothermia in an effective and precise manner. The desired temperature is preset by the physician with a possible range of target temperature from Hypothermia to Normothermia. CritiCool Pro is member of MTRE’s product family of body temperature control systems: Allon 2001, CritiCool and CritiCool Pro including ThermoWraps CureWraps and accessories. The system is composed of two elements, the CritiCool Pro device, and the CureWrap garment. The CritiCool Pro device functions as a control unit and a cooling/heating pump, which circulates water. The control unit constantly monitors the Patients' core temperature through specific sensors, and using its onboard body temperature control algorithm, delivers the optimum water temperature to reach the desired set point temperature. The cooling/heating pump brings the water to the required temperature and the pump circulates it through the specially designed CureWrap. The CureWrap is a flexible 3D single piece design, through which the water circulates. It is designed to be in close contact with a large contact area of the body, thus allowing optimization of energy transfer.

CritiCool Pro System The CritiCool Pro system consists of the following elements: •

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