CritiCool User's Manual Rev 04

Copyright © 2008 by MTRE 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.

U.S. Patent No. 6,500,200 BI Disclaimer 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. b. c. d. e.

Installed, operated, maintained contrary to MTRE’s instructions, notes or warnings under this manual. Misuse, unauthorized use, negligence, accident, (including fire, water, explosion, smoke, vandalism, etc.) Ignoring any of the warnings, precautions and safety measures indicated in this manual. Replace, repair or alter not by MTRE’s authorized personnel. 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 System or components thereof;

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 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.

European Authorized Representative: United Kingdom: Charter Kontron Ltd. Unit 18 Avant Business Center 21 Denbigh Road Milton Keynes MK1 1DT, UK Phone: +44 1908 646070 Fax: +44 1908 646030

TABLE OF CONTENTS CHAPTER 1 ... 1-1 Safety Precautions ... 1-1 1.1. Definitions ... 1-1 1.2. Intended Use ... 1-1 1.3. Warnings... 1-1 1.4. Precautions... 1-3 1.4.1. Improper Use ... 1-4 1.5. Labels... 1-5 1.5.1. CritiCool Device Labels... 1-5 CHAPTER 2 ... 2-1 System Description ... 2-1 2.1. General Description ... 2-1 2.2. CritiCool System... 2-2 2.2.1. CritiCool Device ... 2-2 2.3. External Features ... 2-3 2.3.1. Front View ... 2-3 2.3.2. Side View... 2-4 2.3.3. Rear Panel ... 2-5 2.3.4. Garment... 2-6 2.3.5. Accessories ... 2-10 CHAPTER 3 ... 3-1 Installation ... 3-1 3.1. Pre-installation Requirements ... 3-1 3.1.1. Space and Environmental Requirements ... 3-1 3.1.2. Electrical Requirements ... 3-1 3.1.3. Unpacking and Inspection... 3-2 3.1.4. Assembling the Handle ... 3-2 3.1.5. Equipment List... 3-3 3.2. Moving the Unit... 3-4 3.2.1. Preparation: ... 3-4 3.2.2. Locking and Unlocking the Trolley Wheels ... 3-4 3.3. Storage Conditions and Transport ... 3-4 3.3.1. Storage ... 3-4

i

TABLE OF CONTENTS CHAPTER 4... 4-1 Operating Instructions ... 4-1 4.1. General ... 4-1 4.2. Controls, Indicators and Connections ... 4-1 4.2.1. Main Power Switch ... 4-1 4.2.2. QCC-Quick Coupling Connector ... 4-2 4.2.3. Sensor Sockets ... 4-2 4.3. Preparing the System for Operation ... 4-2 4.4. Procedures for Turning on the System... 4-3 4.5. Self-Test ... 4-3 4.6. Cooling Therapy Treatment Mode... 4-4 4.6.1. Cooling Therapy Control Panel... 4-5 4.6.2. Getting Started ... 4-6 4.6.3. Operation Mode ... 4-7 4.6.4. Changing the Set Point Temperature ... 4-8 4.6.5. Selecting Modes ... 4-9 4.6.6. Operation Mode ... 4-9 4.6.7. Temp Graph Mode ... 4-10 4.6.8. Stand-by Mode ... 4-11 4.6.9. Preference Mode ... 4-12 4.6.10. Inserting and Attaching Human Sensors ... 4-13 4.6.11. Insert Core Sensor into Patient... 4-13 4.6.12. Attaching Surface Sensor ... 4-13 4.6.13. Fastening Garment to Patient ... 4-13 4.6.14. Replacing the Garment... 4-14 4.7. Normothermia Management Treatment Mode... 4-15 4.7.1. Preparing the System for Operation ... 4-15 4.7.2. Procedures for Turning on the System ... 4-16 4.7.3. Self-Test ... 4-17 4.7.4. Self-Test Messages... 4-17 4.7.5. Selecting Mode... 4-18 4.7.6. Selecting Treatment Mode ... 4-18 4.7.7. Normothermia Management Control Panel ... 4-20 4.7.8. Operation Mode Screen... 4-21 4.7.9. Changing the Set Point Temperature ... 4-22 4.7.10. Exceeding the Normothermia Range ... 4-23 4.7.11. Selecting Modes ... 4-24 4.7.12. Operation Mode ... 4-24 4.7.13. Temp Graph Mode ... 4-25 4.7.14. Stand-by Mode ... 4-26 4.7.15. Preference Mode ... 4-27 4.7.16. Selecting Cooling Therapy... 4-28 4.7.17. Inserting and Attaching Human Sensors ... 4-28 4.7.18. Insert Core Sensor into Patient... 4-28 ii

TABLE OF CONTENTS 4.7.19. Attaching Surface Sensor... 4-28 4.7.20. Fastening the Garment ... 4-29 4.8. Procedures for Turning Off the System ... 4-29 CHAPTER 5 ... 5-1 Ordering Information ... 5-1 5.1. Equipment and Accessories - Ordering Information ... 5-1 5.2. Equipment and Accessories - Inventory ... 5-1 5.2.1. Available Garments... 5-1 CHAPTER 6 ... 6-1 Maintenance... 6-1 6.1. Introduction... 6-1 6.2. Service Information ... 6-1 6.3. Routine Maintenance ... 6-1 6.4. System Calibration... 6-2 6.5. Sterilization of Reusable Sensors and Disposable Sensor Adapters... 6-4 6.6. Cleaning and Disinfecting Procedures for Reusable Sensors ... 6-5 6.6.1. Cleaning ... 6-5 6.6.2. Disinfecting... 6-5 6.7. Filter Replacement ... 6-5 CHAPTER 7 ... 7-1 Troubleshooting... 7-1 7.1. General... 7-1 7.2. Trouble-shooting Guide ... 7-1 CHAPTER 8 ... 8-1 Specifications ... 8-1 8.1. Physical... 8-1 8.2. Control System ... 8-1 8.3. Auxiliary Systems... 8-2 8.4. Warranty ... 8-2 8.5. Operation ... 8-2 8.6. Storage and Transport without Water ... 8-2 8.7. Electricity... 8-2 8.8. Safety ... 8-3 8.9. Accessories ... 8-4 Appendix A ... A-1 MTRE Customer Service Representative ... A-1 iii

LIST OF FIGURES Figure 1-1 Label Placement for the CritiCool Device ... 1-5 Figure 2-1 Front View ... 2-3 Figure 2-2 Side View ... 2-4 Figure 2-3 Rear View ... 2-5 Figure 3-1 Handle Assembly ... 3-2 Figure 4-1 Self Test Screen ... 4-3 Figure 4-2 Control Panel ... 4-5 Figure 4-3 Operation Mode Screen... 4-7 Figure 4-4 Mode Selection Screen... 4-9 Figure 4-5 Temp Graph Mode ... 4-10 Figure 4-6 Stand-by Mode Screen... 4-11 Figure 4-7 Preference Mode Screen... 4-12 Figure 4-8 Self Test Screen ... 4-17 Figure 4-9 Mode Selection Screen... 4-18 Figure 4-10 Treatment Mode Selection Screen... 4-18 Figure 4-11 Normothermia Management Control Panel... 4-20 Figure 4-12 Normothermia Management Operation Mode Screen... 4-21 Figure 4-13 Out of Normothermia Message... 4-23 Figure 4-14 Mode Selection Screen... 4-24 Figure 4-15 Temp Graph Mode ... 4-25 Figure 4-16 Stand-by Mode Screen... 4-26 Figure 4-17 Preference Mode Screen... 4-27 Figure 6-1 Selecting System Calibration ... 6-2 Figure 6-2 Performing System Calibration... 6-3 Figure 6-3 System Calibration Completed... 6-4 Figure 6-4 Filter Orientation... 6-6 Figure 6-5 Filter Assembly ... 6-6 Figure 7-1 ThermoWrap Connecting Tubes and Special Male Connector... 7-3 Figure 7-2 CureWrap Connecting Tubes and Special Male Connector... 7-4 v

LIST OF TABLES Table 1-1 Key to Label Symbols... 1-6 Table 2-1 CureWrap ... 2-8 Table 2-2 Pediatric ThermoWraps ... 2-9 Table 2-3 Infant ThermoWraps ... 2-9 Table 2-4 Sensor and Data Provider Input Specifications... 2-11 Table 4-1 Key to Control Panel Symbols ... 4-5 Table 4-2 Key to Control Panel Symbols ... 4-20 Table 5-1 CureWrap ... 5-1 Table 5-2 Pediatric ThermoWraps ... 5-2 Table 5-3 Infant ThermoWraps ... 5-2 Table 5-4 Accessories Inventory... 5-3 Table 6-1 Inspection and Maintenance Schedule ... 6-7 Table 7-1 CritiCool System Undisplayed Malfunction Troubleshooting Guide... 7-2 Table 7-2 CritiCool System Message Troubleshooting Guide... 7-5

vii

viii

CHAPTER 1 Safety Precautions

1.1. 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

1.2. Intended Use

The CritiCool is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital intensive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

1.3. Warnings

1.

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 system is mandatory.

2.

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

3.

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).

4.

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.

5.

The patient should be constantly attended by a physician.

1-1

CritiCoolTM

Safety Precautions 6.

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

7.

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.

8.

For long procedures, special care should be taken to ensure that body fluids such as sweat or urine are not present between the garment and the patient's skin.

9.

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 system does not prevent this occurrence.

10. It is very important to use clinically proven measures to prevent pressure sores during cooling or warming treatment. Special care has to be taken during the prolonged cooling therapy. 11. Do not lift or move the patient by means of the Garment. This may cause tearing and water leakage.

1-2

CritiCoolTM

1.4. Precautions

Safety Precautions •

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

•

It is recommended to plug the system to a UPS power supply.

•

Please note: the system has a safety power fail of 10 seconds. In case of a power fail longer then 10 seconds, the system will switch to default mode (cooling therapy).

•

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 system. All hospital personnel using the CritiCool system must complete the CritiCool training program.

•

The repair, calibration, and servicing of the CritiCool 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.

•

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

•

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

•

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

•

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

•

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

•

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

•

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

1-3

CritiCoolTM

Safety Precautions

1.4.1. Improper Use

WARNING

! CAUTION

1-4

•

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

•

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

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

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 system is mandatory.

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

CritiCoolTM

Safety Precautions

1.5. Labels 1.5.1. CritiCool Device Labels

CritiCool

MTRE Advanced Technologies Ltd.

4 Ha-Yarden st., Yavne 81228, PO Box 102

Rehovot Israel

www.mtre.com

P/N 100-00004

Serial No. XX-XXXX 230V/115V 50/60Hz 500W 2x6.3A T 250V R

C

US

Mfg 2007

0473

Complies With 21CFR 870.5900

Figure 1-1 Label Placement for the CritiCool Device

1-5

CritiCoolTM

Safety Precautions Table 1-1 Key to Label Symbols Symbol

Description Location of core sensor socket

Location of surface sensor socket

~

AC Voltage

Fuse

0473

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

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

Date of manufacture

M fg 2007

R

C

US

xx - yyyy 1-6

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

Machine Version - Machine serial number

CHAPTER 2 System Description

2.1. 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 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 is member of MTRE’s product family of body temperature control systems: Allon 2001 and CritiCool including ThermoWraps, CureWraps, and accessories. The system is composed of two elements, the CritiCool device, and the Garment. The CritiCool 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 on-board 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 Garment. The Garment 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.

2-1

CritiCoolTM

System Description

2.2. CritiCool System

2.2.1. CritiCool Device

The CritiCool system consists of the following elements: •

CritiCool device

•

Garment

•

Accessories

The CritiCool device has a microprocessor that controls the water temperature flowing into the Garment worn by the patient. The decision as to the correct water temperature is based on the desired set point temperature and the actual measured patient temperature (core and surface). Water pressure in the Garment is regulated by timed pauses of the flow during clinical operation. The CritiCool device is equipped with a handle for easy transport.

2-2

CritiCoolTM

System Description

2.3. External Features 2.3.1. Front View

Handle

Adjustable Control Panel Surface Sensor Socket

Core Sensor Socket

Water-in Quick Coupling Connector

Water-out Quick Coupling Connector

Water Tank Cap

Water Level Indicator

Figure 2-1 Front View

2-3

CritiCoolTM

System Description

2.3.2. Side View

Top Cover with Air Grille

Accessories Bracket

Lower Side Cover

Air Inlet Grille

Figure 2-2 Side View

2-4

CritiCoolTM

System Description

2.3.3. Rear Panel

Thumb Screws (4) Three-prong Connector

Air Outlet Grille 6mm Threaded Hole for Equipotentiality Location

RS-232 Comm Connector

Power Switch

Rear Cover

Thumb Screws (2)

Figure 2-3 Rear View

2-5

CritiCoolTM

System Description

2.3.4. Garment 1. General The Garment is a one-piece garment with a one-inflow and a one or two-return water connection. It is designed to facilitate the wrapping of individual parts of the body (chest, arms thighs, etc) to maximize surface coverage. 2. Description and Use •

The Garment is: ‰

Disposable

‰

Biocompatible

‰

Latex free

‰

Antistatic

‰

Inflatable

Adjustable Each section of the Garment is separately wrapped around the appropriate area of the patient (e.g. chest, arms and thighs) to ensure maximum body surface coverage. ‰

•

2-6

•

The water’s exit and entrance points are short sections of tubing integrated with a Quick Coupling Connector (QCC) and welded to convenient locations on the edges of the Garment.

•

The Garment design allows the physician user to cover a maximum surface area as needed.

•

The Garment is secured to the patient via hook and loop strips or pressure sensitive adhesive strips.