CritiCool User Manual Rev H Nov 2014

CritiCool® Operating Manual

Important Notice 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. Patent Nos. US 6,500,200 B1 , US 5,508,831 B1, US 6,685,731 B1

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. 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 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 Wrap in each procedure while operating the system. Note that all Wraps 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.

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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.

Training MTRE or it's authorized distributor will provide training for the system user according to the intended use of the device or system. The training may be personal or by training the trainers. The scope of the training is part of the agreement between MTRE or it's authorized distributor and the end user. It is the responsible of the hospital management to ensure that only users trained to use the equipment efficiently and safely, operate the equipment.

Operator Profile Connections and device settings should, typically, be performed by a physician (doctor) expert in thermoregulation, with the help of a nurse. If the system is used in CCU, a Cardiologist should be involved. A Neonatologist and pediatric Neurologist should also be involved if the treatment is by Hypothermia in the NICU. Follow-up during the prolonged Hypothermia procedures of 1 to 4 days, should be performed by nurses trained to supervise thermoregulation, with a physician on call.

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TABLE OF CONTENTS Important Notice ... 1-2 Disclaimer ... 1-2 Use of Manual ... 1-3 Training ... 1-3 Operator Profile ... 1-3 Chapter 1: Safety Precautions Definitions... 1-1 Intended Use ... 1-1 Warnings ... 1-1 Precautions ... 1-2 EMC Safety ... 1-3 Improper Use ... 1-3 Labels ... 1-4 CritiCool Device Labels ... 1-4 Label Symbols ... 1-5 Chapter 2: System Description ... General Description ... 2-1 CritiCool System... 2-1 CritiCool Device... 2-1 External Features ... 2-2 Front View ... 2-2 Side View ... 2-3 Rear Panel... 2-4 Wrap ... 2-4 Accessories ... 2-8 System Specifications ... 2-11 Chapter 3: Installation Pre-installation Requirements ... 3-1 Space and Environmental Requirements ... 3-1 Electrical Requirements... 3-1 Unpacking and Inspection ... 3-1 Assembling the Handle... 3-2 Equipment List ... 3-2 Moving the Unit ... 3-3 Preparation:... 3-3 Locking and Unlocking the Trolley Wheels ... 3-3

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Storage Conditions and Transport ... 3-3 Storage ... 3-3 Chapter 4: Operating Instructions General ... 4-1 Application Specification ... 4-1 Indication for Use ... 4-1 Location ... 4-1 Patient Age and Weight ... 4-1 Procedures ... 4-2 Controls, Indicators and Connections ... 4-3 Main Power Switch ... 4-3 QCC-Quick Coupling Connector ... 4-3 Sensor Sockets ... 4-3 Getting Started ... 4-4 Preparing the System for Operation ... 4-4 Turning on the System ... 4-4 The Control Panel ... 4-8 Set-Point Set Up ... 4-9 Selecting Modes ... 4-10 Controlled Rewarming Setup ... 4-12 Step by Step Operation ... 4-13 Preparing the System for Operation ... 4-13 Cooling Mode ... 4-15 Normothermia Management ... 4-17 Manual Rewarming ... 4-18 Controlled Rewarming Mode ... 4-19 Replacing the Wrap... 4-21 STAND-BY Mode ... 4-22 CritiCool After Use Care ... 4-22 Empty Mode ... 4-23 Operation Panel Messages ... 4-24 Technical Messages ... 4-24 Clinical Messages ... 4-24 Safety Messages ... 4-24 Informative Messages ... 4-25 Cooling Therapy Messages ... 4-25 Auto Rewarming Therapy Messages ... 4-27 Chapter 5: Ordering Information Equipment and Accessories ... 5-1 Available Wraps ... 5-1 Chapter 6: Maintenance Introduction ... 6-1 Service Information ... 6-1 Routine Maintenance... 6-1

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Safety Measures Before Service ... 6-1 System Calibration ... 6-2 Alarm System Check ... 6-4 Sterilization of Reusable Sensors and Disposable Sensor Adapters... 6-5 Cleaning and Disinfecting Procedures for Reusable Sensors ... 6-5 Cleaning ... 6-5 Disinfecting ... 6-5 Filter Replacement ... 6-5 Chapter 7: Troubleshooting General ... 7-1 Trouble-shooting Guide ... 7-1 Chapter 8: CliniLogger Installation and Operating Instructions Overview and Installation ... 8-1 Introduction ... 8-1 Using the CliniLogger Application ... 8-1 The CliniLogger Software ... 8-1 Installing the Software ... 8-1 Using the CliniLogger Viewer Application ... 8-5 Downloading Data ... 8-5 Viewing Downloaded Data ... 8-6 CliniLogger Viewing Panel ... 8-8 Graphic Display Area ... 8-10 Function Selection Area ... 8-11 Converting to Excel ... 8-16 Ending a Viewing Session ... 8-17

Appendix A: MTRE Ltd. Customer Service Representative Appendix B: RF Separation

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LIST OF FIGURES Figure 1-1: Label Placement for the CritiCool 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: Measurements... 2-6 Figure 2-5: Disposable Sensor connection... 2-9 Figure 3-1: Handle Assembly... 3-2 Figure 4-1: Select Mode... 4-5 Figure 4-2: Thermoregulation Control Panel... 4-6 Figure 4-3: Neonatal Cooling control panel... 4-8 Figure 4-4: Set-Point Setting Panel... 4-9 Figure 4-5: Mode Selecting panel... 4-11 Figure 4-6: Target Temperature Setting Panel... 4-12 Figure 4-7: Alarm Message "Fix Sensor if out of Place... 4-16 Figure 4-8: Thermoregulation is Continuing Message... 4-17 Figure 4-9: Out of Normothermia Message... 4-18 Figure 4-10: Controlled Rewarming... 4-19 Figure 4-11: Switching to Rewarming Message... 4-20 Figure 4-12: Controlled Rewarming... 4-20 Figure 4-13: “Temperature Regulation Paused” Message... 4-21 Figure 4-14: Stand-By mode... 4-22 Figure 4-15: Empty Mode... 4-23 Figure 4-16: Low Core temperature... 4-25 Figure 4-17: “Thermoregulation is continuing” Message... 4-27 Figure 4-18: “Temp Regulation Paused “ Message... 4-27 Figure 4-19: “Low Core Temperature Thermoregulation is continuing” Message... 4-28 Figure 6-1: Selecting System Calibration... 6-3 Figure 6-2: System Calibration in Progress... 6-3 Figure 6-3: System Calibration Completed... 6-4 Figure 6-4: Filter Orientation... 6-6 Figure 7-1: ThermoWrap Connecting Tubes and Special Male Connector... 7-3 Figure 7-2: CureWrap Connecting Tubes and Special Male Connector... 7-3 Figure 8-1: CliniLogger Application Window... 8-6 Figure 8-2: CliniLogger viewing panel... 8-9 Figure 8-3: Graphic Display Area... 8-10 Figure 8-4: Function Selection Area... 8-11 Figure 8-5: Section of Excel Table... 8-16

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LIST OF TABLES Table 1-1: Key to Label Symbols ... 1-5 Table 2-1: Cure Wrap ... 2-7 Table 2-2: Disposable Sensors ... 2-9 Table 2-3: Sensor and Data Provider Input Specifications ... 2-10 Table 5-1: Wrap Information ... 5-1 Table 5-2: Accessory Part Numbers ... 5-2 Table 6-1: Inspection and Maintenance Schedule ... 6-7 Table 7-1: CritiCool System Malfunction (No Message) Troubleshooting Guide ... 7-2 Table 7-2: Water tank overfilling ... 7-3 Table 7-3: CritiCool System Messages Troubleshooting Guide ... 7-4 Table 8-1: Zoom Tool Buttons ... 8-12 Table 8-2: Mode Codes ... 8-14 Table B-1: Separation Distances in meters ...B-1

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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 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.

2.

The patient should be constantly attended by a physician.

3.

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

4.

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

5.

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

6.

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 from happening. In order to prevent pressure sores, hospital routine care should be taken during long themoregulation procedures.

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Safety Precautions

7.

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

8.

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

9.

Use only reusable core sensors or disposable sensor adapters supplied by MTRE.

10. 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. 11. The repair, calibration, and servicing of the CritiCool system should be performed only by MTRE Ltd. or authorized agents trained by MTRE Ltd. 12. Prevent any thermal isolation, such as a pillow or other items, between the CureWrap and the patient's body.

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1.

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

2.

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

3.

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

4.

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

5.

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

6.

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).

7.

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).

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8.

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

9.

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.

10. Do not use de-ionized or distilled water. Use tap water only. 11. When X-ray imaging is performed on a patient wearing a Wrap, shadows from the Wrap may appear on the X-ray film. 12. Avoid inserting any sharp object between the patient and the Wrap.

EMC Safety For safe use of the CritiCool it is required to keep the CritiCool at safe distance from devices emitting radio frequency energy. Refer to Appendix B for recommended separation distances between the CritiCool and RF source. CAUTION!

Power interrupts affect the functionality of the system, depending on the mode of operation - Interrupts longer than 10 seconds return the machine to the Startup Screen. A beep is heard when the power is returned to indicate that the machine has returned to the StartUp screen. - Interrupts shorter than 10 seconds return the machine to the mode that was operating before the interruption, but a warning will appear.

IMPORTANT! Make sure to read the messages in order to ensure correct reactivation of the machine.

Improper Use Improper use of the CritiCool 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 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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Labels CritiCool Device Labels

Figure 1-1: Label Placement for the CritiCool Device

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Label Symbols 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.

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

Table 1-1: Key to Label Symbols

Symbol

Description Date of manufacture

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

xx - yyyy

Machine Version - Machine serial number Do not push

Refer to Instruction manual / booklet

Restricts the sale and use of this instrument to qualified medical personnel only.

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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 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 a member of MTRE’s product family of body temperature regulating systems: Allon 2001, CritiCool including ThermoWraps, CureWraps and accessories. The system is composed of two elements, the CritiCool device, and the CureWrap. 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 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 area of the body, thus allowing optimization of energy transfer. The MTRE garment is proprietary to MTRE and this is the only garment authorized to be used with the Thermoregulation Device.

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

CritiCool device Wrap Accessories

CritiCool Device The CritiCool device has a microprocessor that controls the water temperature flowing into the Wrap worn by the patient. The decision as to the correct water

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temperature is based on the desired set point temperature and the actual measured patient temperature (core and surface). Water pressure in the Wrap is regulated by timed pauses of the flow during clinical operation. The CritiCool device is equipped with a handle for easy transport.

External Features Front View

Figure 2-1: Front View

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Side View

Figure 2-2: Side View

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