6272204

Thermoregulation
Systems
S E R V I C E M A N U A L
Catalog No.FDT-200-000
Rev: C
R e v i s e d December 2 0 1 3
For CritiCool machines with

00
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices

as amended by 2007/47/EC.
Manufacturer’s Name :
MTRE Advanced Technologies 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
US Representative:
Mennen Medical Corp.
290 Andrews Road
Feasterville-Trevose, PA 19053-3480
Phone 215 259-1020
Fax 215 357-2010
C a t a l o g N o . FDT-200-000 Rev C
Revised December 2013
(For 100-OPT99)
Copyright © MTRE Advanced Technologies Ltd. 2013 All RIGHTS RESERVED
Registered trademarks are the intellectual property of their respective holders.

Thermoregulation® Service Manual
Copyright 2013 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. 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 Thermoregulation 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.
ii MTRE Advanced Technologies Ltd.

Use of Manual
The MTRE Thermoregulation system described in this manual has been designed to meet international
safety and performance standards. Only qualified personnel may service the system, and these field
engineers 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 service the system. It is important
that you read this manual and familiarize yourself thoroughly with its contents before you attempt to
service 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.
Field Repairs Statement

Repair of MTRE. Equipment in the field will be performed by service engineers, authorized by MTRE
Repair will be performed on a board level only.
The list of replaceable component and boards is available in the spare part list.(Appendix B)
System testing will be performed using the test form available in the Service manual.
Training and Qualification

MTREor it's authorized distributer will provide training for technicians and sales personal as per the
Intended use of the device or system.
The scope of the training is part of the agreement between MTRE or it's authorized distributer and/or the
end user.
Servicing of MTRE equipment is allowed only to persons that were trained and qualified to service the
equipment efficiently and safely.
Warning!!!
No modification of this equipment is allowed. Software update must be performed by service engineer
authorized by MTRE.
MTRE Advanced Technologies Ltd. iii

iv MTRE Advanced Technologies Ltd.

TABLE OF CONTENTS
Chapter 1:
About This Manual
Applicable Systems ................................................................................................................................ 1-1
Garments ............................................................................................................................................... 1-1
Essential Performance ............................................................................................................................ 1-1
Chapter 2:
Warnings and Precautions
Definitions ............................................................................................................................................. 2-1
Intended Use ......................................................................................................................................... 2-1
Warnings ............................................................................................................................................... 2-1
Precautions ............................................................................................................................................. 2-2
Labels ..................................................................................................................................................... 2-4
Thermoregulation Device Labels ........................................................................................................ 2-4
............................................................................................................................................................. 2-4
Chapter 3:
System Description
General Description ............................................................................................................................... 3-1
Thermoregulation Device .................................................................................................................... 3-1
External Features .................................................................................................................................... 3-2
Front View ........................................................................................................................................... 3-2
Side View ............................................................................................................................................ 3-3
Rear Panel ............................................................................................................................................ 3-4
Accessories ......................................................................................................................................... 3-4
Chapter 4:
Installation
Pre-installation Requirements ................................................................................................................ 4-1
Space and Environmental Requirements ............................................................................................. 4-1
Electrical Requirements ....................................................................................................................... 4-1
Unpacking and Inspection ................................................................................................................... 4-1
Assembling the Handle ........................................................................................................................ 4-1
Accessory Kits ..................................................................................................................................... 4-3
Moving the Unit ..................................................................................................................................... 4-5
Preparation .......................................................................................................................................... 4-5
Locking and Unlocking the Trolley Wheels ....................................................................................... 4-6
Storage Conditions and Transport .......................................................................................................... 4-6
Storage Environment ........................................................................................................................... 4-6
Chapter 5:
Panels and Covers
Introduction ........................................................................................................................................... 5-1
Removal of the Trolley ......................................................................................................................... 5-8
MTRE Advanced Technologies Ltd. iv

Chapter 6:
Electrical System
Introduction .......................................................................................................................................... 6-1
Release of PCB Spacer Supports ........................................................................................................... 6-2
Slide Lock Connector ............................................................................................................................ 6-2
Power Supply Assembly ........................................................................................................................ 6-2
Controller Board .................................................................................................................................... 6-4
Controller Board Fuses ....................................................................................................................... 6-7
Removal of Controller Board ............................................................................................................. 6-7
TEC Control (Thermo-Electric Components) Board ............................................................................ 6-8
Human Sensors (HS) Board ................................................................................................................ 6-12
MMI (Man-Machine Interface) ........................................................................................................... 6-15
FP Board .............................................................................................................................................. 6-16
HCU (Heating Cooling Unit) .............................................................................................................. 6-18
Z Heat Exchanger ............................................................................................................................. 6-19
Thermal Exchange Components (Peltier) ......................................................................................... 6-20
Heat Sink .......................................................................................................................................... 6-20
Fan .................................................................................................................................................... 6-20
Pump ................................................................................................................................................... 6-22
Solenoid Bypass Valve ........................................................................................................................ 6-22
Thermistors .......................................................................................................................................... 6-23
Water-out and Thermostat Thermistor Replacement ........................................................................ 6-23
Water-in Thermistor Replacement .................................................................................................... 6-24
Float .................................................................................................................................................... 6-25
Chapter 7:
Hydraulic System
Introduction .......................................................................................................................................... 7-1
Water Tank Assembly ........................................................................................................................... 7-3
Water Tank Top Cover Assembly ...................................................................................................... 7-4
Filter ..................................................................................................................................................... 7-5
............................................................................................................................................................... 7-5
Replacing the Filter ............................................................................................................................. 7-5
Removing the Filter ............................................................................................................................ 7-5
Installing the New Filter ..................................................................................................................... 7-6
Pump ..................................................................................................................................................... 7-7
Removing the Pump ............................................................................................................................ 7-7
Pump Block Diagram .......................................................................................................................... 7-9
Solenoid Bypass Valve .......................................................................................................................... 7-9
Water-In and Water-Out Connectors .................................................................................................. 7-10
Chapter 8:
Software
Overview ............................................................................................................................................... 8-1
Self-Test ............................................................................................................................................... 8-1
Safety Algorithm ................................................................................................................................... 8-1
Halt Conditions ..................................................................................................................................... 8-2
Technician Mode Error Messages ......................................................................................................... 8-3
Explanation of Error Messages ........................................................................................................... 8-3
v MTRE Advanced Technologies Ltd.

Chapter 9:
Periodic Maintenance
Overview of the Periodic Maintenance Procedures ............................................................................... 9-1
Removing the Cover .............................................................................................................................. 9-2
Replacing the Water Filter ..................................................................................................................... 9-2
Activating the CritiCool Machine .......................................................................................................... 9-2
Human Sensors Verification .................................................................................................................. 9-2
Water Temperature Sensors Verification ............................................................................................... 9-4
Thermostat Verification ......................................................................................................................... 9-6
Pressure Verification ............................................................................................................................. 9-8
TEC Current Test ................................................................................................................................... 9-9
Check for Water Leakage ..................................................................................................................... 9-11
Self-test ............................................................................................................................................... 9-11
Replacing Controller Board Fuses ..................................................................................................... 9-11
Chapter 10:
Troubleshooting
Halt Messages ...................................................................................................................................... 10-1
Text Messages ...................................................................................................................................... 10-3
Chapter 11:
Special Equipment and Tools
Calibration Toolset: Verification and Calibration Units ...................................................................... 11-1
MTRE Temperature Calibration Unit P/N: 017-00184 ....................................................................... 11-2
MTRE Temperature Calibration Unit - Controls .............................................................................. 11-2
Analog Flow and Pressure Calibration Unit P/N 017-00190 ............................................................... 11-4
Digital Pressure Gauge P/N 017-00290 ............................................................................................ 11-4
TEC Current Verification Unit ............................................................................................................ 11-6
Calibration Cables ................................................................................................................................ 11-7
Core Calibration Cable ...................................................................................................................... 11-7
Surface Calibration Cable .................................................................................................................. 11-7
Standard Tools ..................................................................................................................................... 11-8
Calibration Test for the MTRE Temperature Calibration Unit ............................................................ 11-8
Thermostat Verification Tool ............................................................................................................... 11-9
PCB Extraction Tool ............................................................................................................................ 11-9
Chapter 12:
Specifications
Appendix A:
Technician Mode
Technician Mode ................................................................................................................................... A-1
Technician Mode Screen .................................................................................................................... A-1
Technician Mode Screen—Details ..................................................................................................... A-2
Entering Technician Mode ................................................................................................................... A-4
Appendix B:
Spare Parts List
Disclaimer ............................................................................................................................................. B-1
CritiCool™ – Cooling Control Unit ..................................................................................................... B-1
CritiCool™ – Spare Parts List ........................................................................................................... B-2
MTRE Advanced Technologies Ltd. vi

Allon 2001™ – Warming Control Unit, Version-05 .......................................................................... B-17

Allon 2001™ – Spare Parts List For, Version-05 ............................................................................ B-17
Upgrade Package for Allon 2001™ Warming Control Unit ........................................................... B-17
Appendix C:
Service Form
Appendix D:
Periodic Maintenance
For Stimlator: TP-400 FOGG .............................................................................................................. D-1
For Stimulator MTRE Temperature Calibration Unit .......................................................................... D-5
Appendix E:
Downloading Updated CritiCool Software
vii MTRE Advanced Technologies Ltd.

CHAPTER 1:
ABOUT THIS MANUAL
Applicable Systems
This Service Manual covers all Normothermia management and Cooling Therapy systems
produced by MTRE Advance Technology Ltd. To avoid confusion, all systems will be referred to
in this manual as the Thermoregulation System.
Information (component descriptions or procedures) specific to any particular system will be
noted within the manual in the relevant section.
Garments
The Thermoregulation System is designed to function with both the ThermoWrap and the
CureWrap systems. Both ThermoWrap and CureWrap will be referred to in this manual as the
Garment.
Information specific to any one of these Garments will be noted within the manual in the relevant
section.
Essential Performance
The following functions are considered by the manufacturer as essential:
• Water temperature control
• Unexpected core temperature alarm
WARNING!!!The system will HALT if any of these elements of the control mechanism fail.
MTRE Advanced Technologies Ltd. 1-1

About This Manual Thermoregulation® Service Manual

1-2
CHAPTER 2:
WARNINGS AND 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 Thermoregulation System is designed to regulate body temperature as determined by the
physician.
Warnings
1. 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. Mishandling of the temperature regulation equipment can be potentially harmful to the patient.
4. Do not plug wet PL plugs of the human sensors into the sensor sockets of the Thermoregulation
device.
5. The user should verify that no fluids are present at the skin/Garment interface during the
operation. 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.
6. In operations 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

Warnings and Precautions Thermoregulation® Service Manual
Thermoregulation system does not prevent this occurrence. It is therefore recommended to use
pressure sores protective means between the operating table and the Garment.
7. Before initiating maintenance procedures as described in Chapter 9, disconnect the power cable
from the power source.
8. The default setting is intended to maintain normothermia. However, the system provides the
physician with the option of selecting a body temperature in the range of 30°C to 40°C (86°F to
104°F).
9. Do not lift or move the patient by means of the Garment. This may cause tearing and water
leakage.
10. Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400
compatible sensors.
11. 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 Thermoregulation system is mandatory.
12. Repair, and servicing of the Thermoregulation System should be performed only by MTRE
Advanced Technologies LTD or authorized agents of MTRE Advanced Technologies LTD.
Precautions
Follow the warning notes listed in the various sections of this manual.
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 Thermoregulation System. All hospital personnel using the Thermoregulation
system must complete the Thermoregulation training program.
The repair, and servicing of the Thermoregulation 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
Thermoregulation device, disconnect the power cable from its power source, and correct the
problem before proceeding.
The desired set-point temperature should be fixed only as prescribed by and under the order of a
physician.
If the Thermoregulation 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 10: Troubleshooting).
Avoid folds in the Garment—these may obstruct water flow.

2-2
Do not block the Thermoregulation device ventilation grills. Air must be able to flow freely in and
out in order to the device cool.
Do not use de-ionized or distilled water. Use tap water only.
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.
WARNING!!!Improper use of the Thermoregulation systems, may lead to skin burns, electrical
hazards, and several changes in body temperature.
CAUTION! The technical principles, clinical applications, and risks associated with circula-
tory 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 Thermoregulation system is mandatory
WARNING!!!U.S. Federal law restricts this device to sale by or on the order of a physician.

Labels
Thermoregulation Device Labels
Figure 2-1: Label Placement for the CritiCool Thermoregulation Device

2-4
Figure 2-2: Label Placement for the Allon Thermoregulation Device

Table 2-1: Key for Label Symbols
Symbol Description
Location of core sensor socket
Location of surface sensor socket
AC Voltage
Fuse
The 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.
See User Manual
Type BT equipment
Date of manufacture
The CSA symbol indicates that the product has received the approval of
the
Canadian Standards Association.
xx-yyyy Machine Version - Machine serial number

Water-in connector indicator
Water-out connector indicator
No Pushing

2-6
Thermoregulation® Service Manual System Description
CHAPTER 3:
SYSTEM DESCRIPTION
General Description
MTRE's Thermoregulation 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 Mild Hypothermia to Normothermia.
The system is composed of two elements, the Thermoregulation device and the Garment. The
Thermoregulation 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. . The MTRE garment is proprietary to MTRE and this is the only garment authorized to be
used with the Thermoregulation Device.
Thermoregulation Device
The Thermoregulation device has a microprocessor that controls the water temperature to 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 Thermoregulation device is equipped with a handle for easy transport.
CAUTION!Never place the Thermoregulation device on its rear or side.

System Description Thermoregulation® Service Manual
External Features
Front View
Figure 3-1: Front View

3-2
Side View
Figure 3-2: Side View

Rear Panel
Figure 3-3: Rear View

Accessories
To operate the Thermoregulation system, the following accessories are needed:
1. Human Temperature Sensors

• Reusable Sensors
There are three color-coded sensors: Core (gray), Surface (green), and Infant Core (gray). Both
core and surface sensors must be plugged into the device. The core sensor must be inserted into
the patient's body and the surface sensor must be attached to the patient's skin for the device to
function properly.
• Disposable Sensors
Disposable sensors are attached to two color-coded adapters: gray (Core) and green (Surface). The
core sensor must be inserted into the patient's body and the surface sensor must be attached to the
patient's skin for the device to function properly.
Sensors and adapters are guaranteed for one year.

3-4
WARNING!!!Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI
series 400 compatible sensors.
Use reusable surface sensors or disposable surface sensor adaptors supplied by
MTRE only.
• Reusable Core Sensor (Part No. 014-00020):

The core sensor (gray) measures core body temperature when inserted into the patient’s body. The
PL plug of the sensor cable is plugged into the gray core sensor socket at the front of the
Thermoregulation device.
The other end is inserted into the patient and measures core body temperature.
• Disposable Core Sensor Adapter (Part No. 014-00028):
The disposable sensor is attached to the core sensor adapter (gray). The PL plug of the adapter is
plugged into the gray core sensor socket at the front of the Thermoregulation Device. The sensor
is inserted into the patient and measures core body temperature.
• Reusable Infant Core Sensor (Part No. 014-00005):
The infant core sensor (gray) measures infant core body temperature when inserted into the
patient’s body. The PL plug of the sensor cable is plugged into the gray core sensor socket at the
front of the Thermoregulation device. The other end is inserted into the patient and measures core
body temperature.
• Reusable Surface Sensor (Part No. 014-00021):
The surface sensor (green) measures body surface temperature when attached to the patient's skin.
The PL plug of the sensor cable is plugged into the green surface sensor socket at the front of the
Thermoregulation device. The other end is attached with adhesives to the patient’s skin.
• Disposable Surface Sensor Adapter (Part No. 014-00129):
The disposable sensor is attached to the surface sensor adapter (green). The
PL plug of the adapter is plugged into the green surface sensor socket at the front of the
Thermoregulation device. The sensor is attached with adhesives to the patient’s skin and
measures surface body temperature.
Table 3-1: Sensors and Data Provider Input Specification
Model No. Name Description Accuracy Resolution Type
014-00020 Core Inner body ± 0.3°C ± 0.1°C Medical Grade

temp. Thermistor
014-00021 Surface Skin temp ± 0.3°C ± 0.1°C Medical Grade

Thermistor
014-00005 Core Infant Infant Inner ± 0.3°C ± 0.1°C Medical Grade

body temp. Thermistor

2. Detachable Electric Power Cable and Plug

• Power cord (European Standard) (Part No. 014-00017)
• Power Cord (USA Standard-Hospital Grade) (Part No. 014-00016)
3. .Connecting Tubes for CureWrap (Part No. 200-00147)

Two flexible 2.5 m long, color-coded connecting tubes, connect a CureWrap with the
Thermoregulation device to enable the flow of water between them.
The tubes are supplied as a paired unit with two male Quick Coupling Connectors at the
Thermoregulation device end and with three female Quick Coupling Connectors at the CureWrap
end.
4. Connecting Tubes for ThermoWrap or CureWrap Garments (Part No. 200-00109)

Two flexible 2.5m long connecting tubes connect the Garment with the Thermoregulation device
to enable the flow of water between them. The tubes are supplied as a paired unit with two male
Quick Coupling Connectors at the Thermoregulation device end and with two female Quick
Coupling Connectors at the Garments end.
5. Male Connector for Draining Water Tank (Part No. 002-00069)

Refer to Section "Draining the Water Tank" in Chapter 9.
6. Spare Water Filter (Part No. 200-00130)

For annual filter replacement - packed in the accessory box
7. Handle
• Allon Model (Part No. 007-00333)
• CritiCool Model (Part No. 007-00365)

3-6
CHAPTER 4:
INSTALLATION
Pre-installation Requirements
Space and Environmental Requirements
The Thermoregulation device is supplied on a trolley as a mobile unit for user convenience.
Locate the Thermoregulation device not less than 5 cm (2") from other objects to avoid impairing
its ventilation.
The following dimensions should be considered when placing the Thermoregulation device:
260 mm W x 625 mm D x 940 mm H / (10.23"W x 24.6"D x 37"H)
Electrical Requirements
230/120 VAC 500W
CAUTION! Verify that the voltage switch is set for the local voltage.
Unpacking and Inspection

The Thermoregulation device has undergone full quality assurance testing before shipment and
should be operational upon delivery.
The device should be unpacked, installed and tested only by MTRE’s authorized personnel. No
attempt should be made by the purchaser to unpack or assemble the device alone.
Note: Report any container damage prior to opening the container, or any unit
damage prior to unpacking, installation, or testing to your MTRE
distributor.
Assembling the Handle

 To assemble the handle:
1. Release the four thumb captive screws from the handle.

Installation Thermoregulation® Service Manual
2. Slide the two ends of the handle into the holes in the top cover (pay attention to the
direction of the curve in the handle) until the handle is inserted all the way in (see Figure
4-1).
3. Press in and screw the four thumb captive screws by hand (do not use force when
screwing) to secure the handle and the top cover.
Figure 4-1: Handle Assembly

4-2
Accessory Kits
Note: Refer to User's Manual for the equipment list specific to the
Thermoregulation model.
The Thermoregulation system includes one of the following accessories kits:
Allon 2001™ Accessory Kits

Table 4-1: Acc. Kit for Adult with Reusable Temperature Sensors - 200-00400
QTY Description Part Number
1 Connector 1/4' with hose barb 002-00069
1 Adult Eso / Rectal Core Sensor 014-00020
1 SURF Sensor, YSI B-C, GREEN 014-00021
1 Accessories Box 015-00035
1 ThermoWrap Connecting Tube 200-00109
1 Filter Assembly 200-00130
1 Quick Reference Guide, English 014-00058
1 Label Set, Multilanguage 200-00091
Table 4-2: Acc. Kit for Adult with Interface Cables Only for Disposable Sensors - 200-00410
1 Interface Cable for Disp. Core Sensor 014-00028
1 Interface Cable for Disp. SURF Sensor 014-00029
1 Filter Assy 200-00130

Table 4-3: Acc. Kit for Infant with Reusable Temperature Sensors - 200-00420
1 Infant Eso / Rectal Core Sensor 014-00005
CritiCool™ Accessory Kits
Table 4-4: Acc. Kit for Adult with Reusable Temperature Sensors -200-00300
QTY Description Part Number:
1 Adult Eso / Rectal Core Sensor 014-00020
1 CureWrap Connecting Tubes 200-00147

4-4
1 CureWrap Connecting Tubes 200-00147
Table 4-6: Acc. Kit for Infant with Interface Cables Only for Disposable Sensors - 200-00330
Moving the Unit

Preparation
Prior to moving the unit:
1. Ensure that the Thermoregulation device is off by pressing the ON / OFF switch.
2. Ensure that all electrical connections are disconnected.

Locking and Unlocking the Trolley Wheels

The Thermoregulation device trolley has four wheels. The front wheels are fitted with a brake.
The brake lever is located over the wheel. To lock, firmly depress the lever. To release, lift the
lever. When the unit is stationary, the brakes must be in the locked position. Release the brakes
only when transporting the unit.
Storage Conditions and Transport

Storage Environment
Store the Thermoregulation device in a clean and dry area with:
• An ambient temperature of -40°C to +70°C (-40°F to +158°F)
• A relative humidity range of 10% to 100%, including condensation
• An atmospheric pressure range of 500 hPa to 1060 hPa
Note: Disconnect connecting tubes and sensors when the device not in use.
Drain the water and keep the water tank top open.

4-6
CHAPTER 5:
PANELS AND COVERS
Introduction
This chapter contains a description of:
• Which element of the Thermoregulation device can be accessed by each cover
• The instructions for removal and re-assembly of each cover
Figure 5-1: Covers Assembly

Panels and Covers Thermoregulation® Service Manual
Table 5-1: Thermoregulation Device Elements and Removal Instructions
Item Number
Element Removal and re-assembly
in Figure 5-1:
MMI Cover 1 The MMI cover provides access to the human sensors board. It
is attached with two M4x8 socket-head Allen screws and three
hexagon nuts screwed to the Human Sensor temperature
sockets.
The MMI is connected to:
• The main controller with a ribbon cable
• A drainage tube by means of a gutter that drains any
fluids spilled on the MMI. The fluid flows down
through the drainage tube and exits at the bottom of
the unit.
 To remove the MMI:

1. Unscrew the two Allen head screws located behind the
moving panel.
2. Open the three nuts screwed on the human sensor
jacks.
3. Disconnect the connector of the ribbon cable from
the controller board (J4) and slide the ribbon cable
through the chassis.
 To re-assemble the cover:

1. Connect the connector of the ribbon cable to the
controller board (J4) and slide the ribbon cable through
the chassis.
2. Close the three hexagonal nuts, and tighten with a
torque of 80–90 Ncm.
3. Screw the two Allen head screws located behind
the moving panel
Caution: Do not stretch the ribbon cable when removing
the MMI cover.

5-2
Item Number
in Figure 5-1:
Left Side Cover 2 The left side cover provides access to the following
components:
• HCU (Heating Cooling Unit) No. 1
• Water-in temperature sensor
• The right side cover provides access to the following
components:
• HCU (Heating Cooling Unit) No. 2
Right Side • Water-out temperature and thermostat sensors
3
Cover • Solenoid by-pass valve
 To remove the Side Covers (see Figure 5-1)

1. Unscrew the three M4x8 Philips-head screws on the
top lip and the two screws in the back of the cover.
2. Slightly release the cover from the back and rotate
the front end of the cover so that it clears the
Quick Coupling Connector.
3. Release the two 2mm Allen screws at the bottom
side of the cover.
Figure 5-2: Side Cover Removal

Item Number
in Figure 5-1:
 To re-assemble the side covers:

1. Position the slot in the front to fit around the Quick
Coupling Connectors.
2. Align the back end.
3. Tighten all screws.
Rear Cover 4 The rear cover provides access to the following:
• FP circuit board
• Pressure tubes
• Pressurestat tube
• Pump
The top of the cover is inserted into a slot in the frame of
the unit and the bottom is attached with two Thumb
Captive screws.
 To remove of the Rear Cover

1. Unscrew the two thumb-captive screws at the bottom
of the cover.
2. Pull the bottom part of the cover towards you and
then down to release the lip from the chassis.
 To re-assemble the rear cover:

1. Insert the lip at the top of the cover into the unit.
2. Tighten the two screws at the bottom of the cover.

5-4
Item Number
in Figure 5-1:
Bottom 5 The bottom cover provides access to the water-in and

Front Cover water-out tubes leading from the bottom of the water tank.
To remove the water tank, it is necessary to remove the
bottom front cover.
 To remove the Bottom Front Cover:

1. Remove the handle.
2. Remove the top cover.
3. Remove the right and left side covers (see page 5-
2) to expose the two M4x8 Philips-head screws
that secure the bottom front cover.
4. Unscrew the two M4x8 Philips-head screws, one
on each side of the cover.
5. Carefully place the Thermoregulation device on
its side.
6. Unscrew the 2mm Allen screw (located at the
bottom front edge of the trolley.

1. Return the cover and tighten the 2mm Allen screw and
the two Philips-head screws.
2. Re-assemble the right and left side covers.

Item Number
in Figure 5-1:
Top Cover 6 The top cover provides access to the following elements:
• Main controller
• Power supply unit
• TEC controller
• Water-in, water-out, thermostat temperature sensor
connectors
The top cover is attached by means of four thumb captive
screws and one
M4x8 Philips-head screw in the back of the unit. To
remove the top cover, the handle must also be removed.
 To remove the top cover:

1. Unscrew the four screws by hand.
2. Pull out the handle.
3. Slide the cover out from the back of the unit.

1. Slide the back cover, and replace the handle.
2. Press in and screw the four thumb captive screws
by hand (do not use force when screwing) to
secure the handle and the top cover.

5-6
Item Number
in Figure 5-1:
Handle 7 The handle allows easy transport of the Thermoregulation

device. It must be removed to enable removal of the top cover.
 To remove of the Handle:

1. Release the four thumb captive screws by hand.
2. Pull up the handle.
 To re-assemble the handle:

1. Slide the two ends of the handle into the holes in the
top cover (pay attention to the direction of the curve in
the handle) until the handle is inserted all the way in.
2. Press in and screw the four thumb captive screws
by hand (do not use force when screwing) to
secure the handle and the top cover.
Figure 5-3: Cover Assembly

Removal of the Trolley

 To remove the trolley:
1. Empty the water tank.
2. Place the Thermoregulation device on its side.
3. Unscrew the six Phillips-head screws and washers that secure the trolley to the main
chassis.
To re-assemble the trolley, follow the above procedure in reverse order. Make sure that you
tighten the screws with the washers.
Note: Assemble the trolley with the braked wheels in front.
Figure 5-4: Trolley Assembly
Table 5-2: Trolly Parts
Item No. Qty. Part No. Description

1 6 009-00034 Screw M6x12 Pan Philips s.s
2 6 010-00025 Spring Washer M5 s.s
3 1 200-00067 Allon Trolley
200-00141 CritiCool Trolley

5-8
CHAPTER 6:
ELECTRICAL SYSTEM
This section outlines the electric and electronic systems that control the functioning of the
Thermoregulation system.
WARNING!!!Detach the power cable before you do any maintenance or replacement proce-
dures. Failure to do so could result in severe personal injury.
CAUTION! Before performing any procedure in this chapter, use an ESD

(Electrical-Static Discharge) wrist-strap to connect yourself to the
chassis of the device.
Failure to do so can cause irreparable damage to the electrical
components.
Introduction
This chapter describes the electrical system of the Thermoregulation device.
The electrical system consists of the following elements:
• Power Supply Assembly on paragraph 6-4
• Controller Board on paragraph 6-5
• TEC Control (Thermo-Electric Components) Board on paragraph 6-6
• Human Sensors Board on paragraph 6-7
• MMI (Man-Machine Interface) on paragraph 6-8
• FP Board on paragraph 6-9
• HCU (Heating Cooling Unit) on paragraph 6-10
• Pump on paragraph 6-11
• Solenoid Bypass Valve on paragraph 6-12
• Thermistors on paragraph 6-13
• Float on paragraph 6-14

Electrical System Thermoregulation® Service Manual
Release of PCB Spacer Supports

PCB spacer support release is accomplished by means of the PCB Extraction tool (see Chapter 11 "Special
Equipment and Tools").
The extraction tool enables the release of the PCB spacer supports by insertion:
• To the hole at the end of the extraction tool where there is enough clearance (see Figure 6-
1).
• To the hole on the side of the tool where there is not enough clearance (see Figure 6-2).
Inserting the spacer support into the extraction tool collapses the pinch head so that the PCB can be
released (see Figure 6-1 and Figure 6-2).
Figure 6-1: Using the Extraction Tool Figure 6-2: Using the Extraction Tool
from the End from the Side
Slide Lock Connector

Connectors on the PCB are equipped with a slide lock assembly. The slide lock assembly consists of a
sliding bracket fitted on the PCB connector and corresponding lock posts that fit into the mounting holes of
the mating connector.
After attaching the flat cable connector to the PCB, slide the bracket to lock the connectors together. To
release the connectors, slide the bracket in the opposite direction.
Power Supply Assembly

The Power Supply Assembly consists of the following:
• External electrical connection by means of a hospital-grade power cable, switchable 230/
120 VAC with two 6.3 amp fuses

6-2
• On/Off switch
• Medical isolation transformer 230/120V 500W
• Two current harnesses to the TEC Control board
• One current harness to the controller board
• Current ground harness
 To remove the Power Supply Assembly:

1. Remove the handle and the top cover (see Chapter 5 "Panels and Covers").
2. Remove the two Philips-head screws from the ON/OFF switch panel in the rear of the
3. Remove the controller board (see "Removal of the Controller Board ", paragraph 6.5.2)
4. Remove the four Philips-head screws and washers.
5. Release all cables leading from the controller board and both halves of the TEC Control
board.
Note: To re-assemble the Power Supply Assembly, follow the above procedure in
reverse order.

Figure 6-3: Power Supply Assembly
Table 6-1: Power Supply Parts
1 1 200-00059 Power Supply Assembly
Controller Board
The controller board monitors all system functions, performs all the internal algorithms, and converts
analog signal received from the sensors to digital input.
The controller board contains the following components:
• controller 87C552
• RAM /ROM
• Flesh Memory
• Address and data components
• Voltage regulators
• Very Fast-Acting type fuses
• Rectifiers
• LEDs
• RS-232 Communication Port
• Audible alarm
The controller board receives input from the:
• Human Sensors
• Water Temperature sensors
• FP board
• Power Supply Assembly
• Water level sensor
• MMI
It controls output to the:

6-4
• TECs
• MMI—the display
• Solenoid bypass valve
• Pump
• Fans
The controller board incorporates the power distribution circuit. Power from the transformer is
rectified and supplied to the:
• Controller board
• MMI
• FP Board
• Human Sensors Board
The TEC control has its own power-rectifying circuit.
The following table lists all main power distribution components on the controller board.
Table 6-2: Controller Board—Power ON LEDs on the Controller
LED LED Indication Remarks

Identifier
LED 6 Vent 1 Vent voltage
LED 3 Vent 2 Vent voltage
LED 30 Com cable Indicates RS 232 cable connector
LED 26 Com 5v
LED 9 VCC
LED 29 LCD -12V
LED 4 X3 Over pressure pump
LED 27 X1 Communication
LED 28 X2 Communication
LED 5 AUX Not in use
LED 15 - 12V Voltage indication
LED 13 + 12V Voltage indication
LED 10 Pump Pump voltage

Table 6-2: Controller Board—Power ON LEDs on the Controller
LED 7 Sol 2 Solenoid voltage
D2 Fan Voltage type D2

(Allon & CritiCool)
Table 6-3: Controller Board—Connectors
Identifier Type Description
J4 DB37 socket MMI connector
J6, J8 DB15 socket TEC board control (right and left)
J9 DB15 socket FP board connector
J10 DB15 socket Human Sensors board connector
P1 DB9 socket RS-232 connector
J1 Header Left side FAN and pump
J3 Header Right side FAN, solenoid, and water level

float position
J2 Header Power Supply Assembly connector

6-6
Controller Board Fuses

Controller board fuses of the Thermoregulation device are soldered to the board.
In case a fuse blows, MTRE allows the service engineer the option of soldering a replacement fuse instead
of replacing the controller board. Fuses are purchased directly from the manufacturer (Littelfuse, Inc.)
according to the catalog number listed in Table 6-3..
See Chapter 9 "Periodic Maintenance" for fuse replacement procedure.
Figure 6-4: Controller Board Component Placement—Print Side
Removal of Controller Board

 To remove the Controller Board:
(see Figure 6-5)
2. Detach all the ribbon cables from the underside of the controller board by pressing the
slide lock brackets.

3. With the extraction tool, release all seven PCB spacer supports.
4. To remove the controller board, slide it out from the side.
Note: To re-assemble the controller board, follow the above procedure in reverse
order.
Figure 6-5: Controller Board Assembly
Table 6-4: Controller Board Parts
1 1 300-00114/300-00118 Controller 2 Assembly
2 7 004-00029 PCB Spacer Support SCC-15
TEC Control (Thermo-Electric Components) Board

The TEC Control board is located under the MMI. It has two identical halves that operate independently.
Both halves of the TEC Control board receive power supply directly from the transformer, rectify it, and
distribute power to the TECs via digitally-controlled current switches. The internal system algorithm on the
controller board calculates the human and temperature sensors' values, and determines the quantity of TEC
pairs actuated by the TEC control boards.
Digital signals from the main control board are processed by the local MSP controller on the TEC control
board. The MSP controller controls pairs of P and N MOSFET transistors that drive the TEC units. Each

6-8
pair of transistors can, depending on the command, drive the TEC unit in forward or reverse current to heat
or cool the water.
MSP controller also measure the output voltage of each power bridg and provide status indication by
dedicated color (Reg/Green or orange)
Table 6-5: TEC Control Board—Fuse List
Identifier Value Size Type Voltage to:
F3 25A 6.3mmx32mm Slow Blow D8
F4 25A 6.3mmx32mm Slow Blow D9
F1L 25A 6.3mmx32mm Slow Blow D6L
F2L 25A 6.3mmx32mm Slow Blow D5L
Table 6-6: TEC Control Board—Connectors
J3 Header 16 Control signals from controller board
J4L Header 16 Control signals from controller board
J1 Header 8 Power to TECs
J2L Header 8 Power to TECs
J6 Header 4 AC power from transformer
J5L Header 4 AC power from transformer
J19 Molex 9 pin Controller JTAG Right Side
J20 Molex 9 pin Controller JTAG Left Side
Table 6-7: TEC Control Board—Led undicators
Identifier Meaning Note
CR5 Right Side TEC NUM 1 Cooling = Green, Heating = Red

Table 6-7: TEC Control Board—Led undicators
CR9 Left Side TEC NUM 1 Cooling = Green, Heating = Red
CR3 Left Side Bridge1 Voltage Indication Green/Orange = OK OFF = Fault
CR4 Left Side Bridge2 Voltage Indication Green/Orange = OK OFF = Fault
CR1 Right Side Bridge1 Voltage Indication Green/Orange = OK OFF = Fault
CR2 Right Side Bridge2 Voltage Indication Green/Orange = OK OFF = Fault
Figure 6-6: TEC Control Board - Component Placement

6-10
J6
JL5
J2L J1
J4L J3
Figure 6-7: TEC Control Board—Component Placement
 To remove the TEC Control Board:

(See Figure 6-8)
2. Detach the three cables (voltage in, voltage out, control) from each side of the TEC
control board.
3. With the extraction tool, release all four PCB spacer supports.
4. Slide out the TEC control board from the side.
Note: To re-assemble the TEC control board, follow the above directions in
reverse order.

Figure 6-8: TEC Controller Assembly
Table 6-8: TEC Controller Components

1 1 300-00117 TEC Controller Assembly
2 4 004-00030 PCB Spacer Support ECC-5
Human Sensors (HS) Board

The Human Sensors board receives input from the:
• Human temperature sensors
• Water-in and water-out temperature sensors
• Thermostat sensor
The Human Sensors board relays voltage back to the controller board. The controller board converts the
analog signal from analog to digital and makes the temperature adjustments according to the system
calibration.
All Human Sensor inputs are from thermistor temperature sensors.

6-12
Table 6-9: Human Sensor Board—Input Signal
Sensor Input Type Measurement
Core Thermistor Continuous
Surface Thermistor Continuous
Water-in Thermistor Continuous
Water-out Thermistor Continuous
Thermostat Thermistor ON/OFF*
Note: The Thermostat input signal passes through a comparator on the Human
Sensor board; the comparator output (Logic 0 or 1) activates the
“ATTENTION HALT - PLEASE RESTART (3)” warning.
Table 6-10: Human Sensor Board—Connectors
J10 DB15 Power supply from controller board, output

signals to controller board
J1 0.25” stereo socket CORE input signal
J5 0.25” stereo socket SURFACE input signal
J4 Header 2 Water-out temperature input signal
J6 Header 2 Water-in temperature input signal
J7 Header 2 Thermostat input signal

Figure 6-9: Human Sensors Board—Component Placement
 To remove the Human Sensors Board:

(see Figure 6-10)
2. Remove the MMI Cover (see Chapter 5 "Panels and Covers").
3. Remove the two Philips-head screws and washers that connect the Human Sensors board
to the bracket.
4. Detach the ribbon cable to the controller board by pressing the slide lock bracket.
5. Detach the Water-in, Water-out, and thermostat connectors.
Note: To re-assemble the Human Sensors board, follow the above directions in reverse
order. Tighten the three hexagonal nuts to a torque of 80–90 Ncm with a 5/8"
socket wrench

6-14
Figure 6-10: Human Sensors Board Assembly
Table 6-11: Humar Sensor Board Parts
1 1 300-00016 Human Sensor Board
2 3 Nut Sensor Socket
MMI (Man-Machine Interface)

The MMI receives:
• Input from the user via the soft touch buttons.
• Output from the controller board and displays it on the interface screen.
The data is relayed via a ribbon cable to the controller board. The connector of the ribbon cable is inside
the MMI and cannot be disconnected without the removal of the back cover.
For removal of the MMI see Chapter 5 "Panels and Covers".
Table 6-12: MMI Parts

1 1 200-00062 Top Panel Assembly (display and cover)

FP Board
The FP board reads the measurement of pressure coming from the pump. It receives power from the
controller board power supply, rectifies it and activates the piezoelectric transducers.
Table 6-13: FP Board Connector
J1 Header 16 Power input from controller board, output signals

to controller board
Figure 6-11: FP Board Component Placement

6-16
J1
Pressurstat Sensor (Indicated Pressurstat Sensor (Indicated

in the Technician Mode in the Technician Mode
screen as Press 1) screen as Press 1)
Figure 6-12: FP Board
 To remove the FP board:

(See Figure 6-13)
1. Remove the rear cover (see Chapter 5 "Panels and Covers").
2. Detach the ribbon cable by pressing the slide lock bracket.
3. With the extraction tool, release all four PCB spacer supports — two on each side of the
board.
4. Detach the two tubes connected to the piezoelectric transducers by pressing the release
ring of each fitting and pulling out the tubes.
Note: To re-assemble the FP board, follow the above directions in reverse order.
Note: Label the tubes before you remove the FP board.

Figure 6-13: FP Board Assembly(
Table 6-14: FP Board Parts

1 1 300-00015 FP Board
2 4 004-00031 PCB Spacer Support LCC-10
HCU (Heating Cooling Unit)

The HCU is the element that exchanges energy with the water as it flows through the system. It is
comprised of the following components:
• Z heat exchanger—used for dispersing energy (heat) from the Thermal Exchange
Components to the water
• Thermal Exchange Components (Peltier)
• Heat sink—used for dispersing energy (heat or cold) from the Thermal exchange elements
• Fan

6-18
Note: The HCU is an integrated unit. If any of the components listed above is
faulty, replacement of the entire HCU is necessary.
Figure 6-14: 6-14 HCU Assembly
Item Qty. Part No. Description

No.
1 1 200-00054 HCU Assembly
Z Heat Exchanger
There are four Z heat exchangers on each side of the Thermoregulation device. Water flows from the
water tank, through the filter, through the pump, and through each set of the Z heat exchangers. The water
is either heated or cooled in the Z heat exchanger by the thermal exchange units according to the demands
of the system.
Figure 6-15 displays the water flow represented by the geometric cross hatch.

Figure 6-15: Z Heat Exchanger—Cross-section
Thermal Exchange Components (Peltier)

The TEC components are solid-state modules (no moving parts) that convert electrical energy into a
temperature gradient, known as the "Peltier effect". They are composed of two similar alloys that have
different free electron densities at the same temperature.
One is composed of material having a deficiency of electrons while the other has an excess of electrons. As
current flows up and down through the module it attempts to establish a new equilibrium within the
materials. The analog signal treats the first material as a hot junction needing to be cooled and the second
material as a cold junction needing to be heated. Since the material is actually at the same temperature, the
result is that the hot side becomes hotter while the cold side becomes colder. The direction of the analog
signal determines if a particular side will cool down or heat up. In short, reversing the polarity will switch
the hot and cold sides.
Heat Sink
The purpose of the heat sinks is to dissipate the heat or cold created by the thermal exchange elements as
quickly as possible. The capability of the TEC to either heat or cool depends on the level of temperature on
the side of the heat sink. If it is very cold on that side, its ability to heat is diminished. The faster the heat or
cold are dissipated, the faster the Thermoregulation device reaches the required water temperature.
Fan
The fans remove the heated or cooled air dissipated through the heat sinks. The air is drawn in from the
bottom grille and expelled through the grilles in the top cover and in the rear of the Thermoregulation
device. The fans receive power directly from the controller board.
 To remove the HCU:

(See Figure 6-16).

6-20
Note: Before you start, place a cloth on a flat surface. Turn the Thermoregulation device
on its side on the cloth to prevent damage.
2. Open the appropriate side cover.
3. Release the electric connector by unscrewing the two flat screws on top of the connector.
Firmly grasp the electric connector and pull up to release.
4. Release the Water-in tube and the Water-out tube from the HCU by pressing the release
ring of each fitting and pulling out the tubes.
5. Remove four nuts (with a 7mm socket) and washers—two on each side of the HCU.
6. Unscrew two Philips screws on the bottom sides of the HCU. Access the screws through
holes in the frames of the Thermoregulation device.
7. Grasp the two sides of the HCU and carefully slide it out of the Thermoregulation device.
8. Place the HCU on a flat surface.
CAUTION: The heavy heat sinks can deform the unit if it is not placed on a flat surface.
Note: To re-assemble the HCU follow the above procedure in a reverse order.
Note that there are oblong holes in the bracket of the HCU. Before
completely tightening the nuts, lift the HCU.
Figure 6-16: HCU Removal

Table 6-15: HCU Parts
1 1 200-00054 HCU Assembly
4 4 011-00001 Nuylock Nut M4 s.s Blue
5 4 010-00008 Flat Washer M4 s.s
Pump
The pump circulates water through the system at rates of 0.8-1.2 liters per minute. The pump is a positive
displacement type; it builds up unlimited pressure at the pump output. This pressure is limited in two
stages:
• Pres 1 - at 0.9bar
• Pres 2 - at 1.8 bar (safety)
The controller board controls the pump power supply by digital control (ON/OFF). There is a "Fast
Acting" fuse and a LED for the pump. The pump works on 12V (Machine Version 04, 05) and 10V
(Machine Version 03). The pump operates at 1.8 bar for two minutes before being stopped at system halt.
For removal of the pump, see Chapter 7 "Hydraulic System".
Solenoid Bypass Valve

The solenoid bypass valve directs the flow of water to the Garment or back to the water tank. It is activated
by the control signal from the controller board.
 To remove the Solenoid Valve:

(see Figure 6-17)
2. Open the right side cover.
3. Disconnect the 8 mm flow tube to the water-out assembly by pressing the release ring on
the fitting.
4. Disconnect the 8mm flow tube to the water tank.

6-22
5. Disconnect the 8mm tube to the HCU.

6. Disconnect the electrical control connection from the lower part of the solenoid with a
bulldog Philips screwdriver.
7. Unscrew the two Philips screws that secure the Solenoid Valve Bracket from the front of
the Thermoregulation device.
Figure 6-17: Solenoid Valve Removal
Table 6-16: Solenoid Parts
1 1 200-00078 Solenoid Valve Assembly
2 2 009-00024 Ejot Screws 35x12
Thermistors
The thermistor used for water-out and thermostat is a double thermistor unit assembly containing two
thermistors in one jacket. In case of damage in one of the thermistors, replace the complete component.
The thermistor used for Water-in is a single thermistor unit assembly
Water-out and Thermostat Thermistor Replacement

 To remove the Water-out and Thermostat Thermistor
1. Drain the water tank (see Chapter 7 "Hydraulic System").

3. Open the right side cover.
4. Disconnect the water-out and thermostat two pin Molex connectors from the Human
Sensors board (see Figure 6-18).
Figure 6-18: Socket Location
5. Follow the cable to the other end and remove the thermistor by pressing the release ring
from the water connector.
 To re-assemble the new water-out and thermostat thermistor:

1. Perform the same procedure in reverse order.
2. Fill the water tank and check for water leakage.
3. Replace the right side cover.
Water-in Thermistor Replacement

 To remove the Water- in Thermistor:
1. Drain the water tank (see Chapter 7: Hydraulic System).
2. Remove the handle and the top cover (see Chapter 5: Panels and Covers).
3. Open the left side cover.
4. Disconnect the Water-in pin Molex connectors from the Human Sensors board (see
Figure 6-18).
5. Follow the cable to the other end and remove the thermistor by pressing the release ring
from the water connector.
 To re-assemble the new thermistor:

1. Perform the same procedure in reverse order.
2. Fill the water tank and check for water leakage.

6-24
3. Replace the left side cover.
Float
The float contains a bottom switch that monitors the presence of water in the tank. The non-activation of
the switches sends a signal to the controller board. The system notifies the user with the following
message:
Allon:
1. During selftest: “ADD WATER”
2. In other cases: “ATTENTION NO WATER – PLEASE ADD WATER”
CritiCool:
1. During selftest :”TANK IS EMPTY”
2. In other cases: “ADD WATER”
Figure 6-19: Floats—Electrical Connections


6-26
CHAPTER 7:
HYDRAULIC SYSTEM
WARNING!!!The repair, calibration, and servicing of the Thermoregulation System should be

performed only by MTRE Advanced Technology Ltd or authorized agents of MTRE
Advanced Technology Ltd.
WARNING!!!Detach the power cable before you do any maintenance or replacement proce-
dures. Failure to do so could result in severe personal injury.
Introduction
This chapter describes the hydraulic system of the Thermoregulation device. The hydraulic
system circulates water from the water tank through a filter, pump, heating/cooling elements,
solenoid bypass valve, Garment, and back to the water tank.
Water flows through the internal connecting tubes in 2 circular loops:
• Through the Garment
• Through a solenoid valve to by-pass the Garment directly into the water tank
The hydraulic system consists of the following elements:
• Water Tank Assembly
• Filter
• Pump
• Solenoid Bypass Valve
• Water-In and Water-Out Connectors

Hydraulic System Thermoregulation® Service Manual
Figure 7-1: Hydraulic Block Diagram
Table 7-1: Hydraulic Block Diagram Elements
1 2 002-00147 QCC Brass, fem, 1/4BSPT, Viton
2 2 002-00148 Quick fitting 8mm BSPT fem str
3 2 002-00019 Quick Connector T 8mm/6mm
4 4 002-00158 Connector Plug-in 8mm elbow 8mm
5 1 002-00176 Connector T to 8mm Tube
6 1 200-00128 S. S. Thermistor Housing
7 1 200-00104 Water Tank Main Assy
8 1 002-00027 Quick Connector Elbow 8mm Tube
9 1 200-00130 Qosina Filter Assy
10 1 200-00115 RD5 Pump Assy
11 1 200-00069 Buffer Tube Assy

7-2
Table 7-1: Hydraulic Block Diagram Elements
12 1 200-00054 HCU Right
13 1 200-00054 HCU Left
14 2 002-00007 Quick Connector Straight 6mm
15 1 002-00178 Fitting Quick Reducer 10-8
16 1 002-00179 Quick Connector T 10-8
17 1 200-00131 Double Sensor Thermistor
18 1 003-00001 Solenoid Valve 3/2 Orif 3.5mm
19 1 003-00012 Solenoid Plug
20 1 300-00015 FP Assy
Water Tank Assembly

The water tank assembly consists of the following parts:
• Water tank—made of ABS. It contains up to 6.2 liters of water.
• Water tank top cover assembly—made of ABS. The water tank holds the float water level
sensors, tube connectors, and float electrical connector.
• Cap—made of molded plastic
• Lower water connectors—Water-in And water-out
• Bracket
• Water level indicator
Before removing the water tank you need to drain it.
 To drain the water tank – Allon 2001

1. Connect one male connector of the connecting tubes to the water outlet under the Core socket.
2. Turn the Thermoregulation device ON.
3. Switch to Operation mode.
4. Connect the special male connector Model No. 002-00069 to the female connector of the
tube that is connected under the Core socket (see Figure 7-2).
5. Allow the excess water to drain into a receptacle, pail or sink.
6. When the water finishes draining, turn the Thermoregulation device OFF.

 To drain the water tank – CritiCool

2. Select Empty Mode.
3. Connect one male connector of the connecting tubes to the water outlet under the Core
socket.
4. Connect the special male connector Model No. 002-00069 to the female connector of the
tube that is connected under the Core socket (see Figure 7-2).
5. Allow the excess water to drain into a receptacle, pail or sink.
6. When the water finishes draining, turn the Thermoregulation device OFF.
Figure 7-2: Connecting Tubes and Special Male Connector
 To remove the Water Tank

1. Drain the water tank (see procedure above).
2. Remove the two side covers, and the lower front cover (see Chapter 5 "Panels and
Covers").
3. Disconnect the two bottom tubes: Water-out on the right side, and Water-in on the left
side.
4. Open two self-locking 7 mm nuts and washers—one on each side of the tank.
5. Partially slide the water tank out and, from the top of the tank, disconnect the float
electrical connector and the water bypass tube coming from the solenoid.
6. Slide out the water tank.
Note: To re-assemble the new water tank, follow the same procedure in reverse order.
Water Tank Top Cover Assembly

The water tank top cover assembly performs the following functions:
• Seals the top of the water tank to prevent leakage
• Secures the float rod and contains the float electrical connector
• Allows the flow of water to the tank by means of the by-pass connector

7-4
Filter
Figure 7-3: Filter Orientation Figure 7-4: Filter Assembly
Replacing the Filter

Filter replacement must be performed every twelve months and is performed by the hospital
personnel.
Note: An additional filter is supplied in the accessory box.
Removing the Filter

 To remove the filter:
1. Drain the water tank (see To drain the water tank – Allon 2001or To drain the water tank –
CritiCool page 7-3).
2. Remove the rear cover:
a. Unscrew the thumb captive screws at the bottom of the cover.
b. Pull the bottom part of the cover towards you and then down to release the lip from the
chassis.
3. Unscrew the filter clamp screw and remove the filter clamp (see Figure 7-3, 7-4 on page 7-7).
4. Release both the Water-in and Water-out tubes from the filter assembly by pressing the
release ring of each end of the filter and pulling the tubes from the filter.
5. Dispose of the old filter.

Installing the New Filter

 To install the new filter assembly:
CAUTION : The filter is marked with an arrow indicating the direction of water flow (see Figure
7-3 and Figure 7-4.
You must assemble the filter in the manner indicated.
1. Connect the tubes to the new filter assembly. Insert both tubes with suitable force to ensure that
they are secure.
2. Position the filter clamp in the chassis and tighten the filter clamp screw by hand (see Figure 7-
5).
3. Close the rear cover and tighten the thumb captive screws by hand.
Figure 7-5: Filter Assembly Overview
Table 7-2: Filter Parts
1 1 200-00130 Qosina Filter Assembly
2 1 007-00334 Qosina Filter Bracket

7-6
Pump
The pump circulates water through the system at rates of 0.8-1.2 liters per minute.
The pump is a positive displacement type so it builds up pressure at the pump output.
This pressure is limited in two stages:
• Pres 1 at 0.9bar
• Pres 2 at 1.8 bar (safety)
The pump is digitally controlled from the controller board and is powered by 12VDC.
Removing the Pump

WARNING!!!You must drain the water tank before removing the pump.
 To remove the pump:

(see Figure 7-6):
1. Drain the water tank (see "Drain the tank" on page 7-6).
2. Open the rear cover (see Chapter 5 "Panels and Covers").
3. Disconnect the pump power connector.
4. Disconnect the water-in tube on the bottom of the pump coming from the water filter and
the water-out tube from the pump leading to the HCU connector of the pressurestat. Press
the release ring of each fitting and pull out the tubes.
5. Loosen the four pump screws leaving them in their rubber washers. These rubber washers
are shock absorbers for the pump.
6. Slide the pump out of the Thermoregulation device.
Note: To re-assemble the new pump, follow the same procedure in reverse order.
CAUTION: Do not over-tighten the four pump screws. Over tightening may cancel the effect of
the shock absorbers.

Figure 7-6: Pump Removal
Table 7-3: Pump Parts
1 1 200-00115 Pump Assembly
2 4 009-00009 Screw M4x16 Pan Philips s.s.
3 1 007-00232 Pump Shock Absorber

7-8
Pump Block Diagram
Figure 7-7: Pump Block Diagram
Table 7-4: Pump Block Parts
1 1 200-00115 RD5 Pump Assembly
2 2 002-00027 Quick Angle Connector for Tube

8mm
3 1 005-00156 Connector Male 3-pin Crimp Panel

Mount
4 2 005-00159 Pin Female Crimp 16 AWG
Solenoid Bypass Valve

Refer to Section "Solenoid Bypass Valve" in "Chapter 6: Electrical System".

Water-In and Water-Out Connectors

 To remove the Water-out Assembly:
2. Remove the right side cover.
3. Disconnect the 6mm pressure tube.
4. Disconnect the 8mm flow tube.
5. Unscrew the two Philips screws from the water bracket.
Note: To re-assemble the new Water-out assembly, follow the same procedure in
reverse order.
 To remove the Water-in Assembly

2. Remove the left side cover.
3. Disconnect the 8mm flow tube.
4. Unscrew the two Philips screws from the water bracket.
Note: To re-assemble the new Water-in assembly, follow the same procedure in
reverse order.
Figure 7-8: Water-in and Water-out Connectors

7-10
Table 7-5: Water Connectors Parts
1 4 009-00006 Screw M4x8 Pan Philips s.s.
2 1 200-00097 Water-in Female Assembly
3 1 200-00097 Water-out Female Assembly


7-12
CHAPTER 8:
SOFTWARE
Overview
The software handles all system inputs and outputs. It is downloaded through the RS-232 communication
port to the ROM or Flash and initialized each time the system is turned on.
Self-Test
On system restart, the software executes a self-test. The self-test verifies the correct functioning of the
Thermoregulation device:
• Screen and buzzer test
• Flow test
• CRC test
• Cooling and heating capability test
• Water preheating - Allon
• Normal operation test
Note: For details regarding Self Test, refer to the User Manual.
Safety Algorithm
The purpose of the Safety algorithm is to prevent device malfunction and risk to the patient by detecting
one or more of a set of safety conditions and then taking one or more of the following actions:
• Displaying a message
• Activating a buzzer
• Activating Bypass
• Turning off the TECs
• Disabling the keyboard

Software Thermoregulation® Service Manual
Some safety conditions are recoverable by operator action and are called Messages.
If the Safety algorithm detects a HALT condition, it disables the Thermoregulation device by turning
OFF the pump, turning OFF the TECs, activating the bypass, and turning ON the buzzer. In this condition
the soft-touch keys are disabled!
If the Safety algorithm activates the buzzer for a Message condition, the operator can mute the buzzer by
pressing the Alarm Mute button.
Halt Conditions
Several conditions require you to disable the Thermoregulation device to prevent possible hazard to the
patient or to the operator.
These conditions are called HALT CONDITIONS and are listed in Table 8-1:
Table 8-1: Halt Conditions
Message Possible problem
No power Power switch OFF
Power cord connected insecurely
Power in wall connector
Main Fuses 6.3A blown
Faulty AV voltage from transformer secondary
Halt 1 or 4 System detected a flow problem
HALT 2 Set point error. Test of the memory. Halt occurs when current Set point is
not equal to the Set point previously saved to memory(memory corruption).
Halt 3 System detected thermostat tripped, indicating a likely overheating condition
Halt 5 System indicating a likely program memory
Halt 6 or 7 Self test detected a problem with Heating/Cooling unit
Halt 8 Self test detected no reading in Water in sensor
Halt 13 System detected overpressure
Halt 17 (CritiCool only) Battery is bad.
Halt 18 (CritiCool only) Software error (patient not Adult and not Neonatal)
Halt 19 (CritiCool only) System shut down. When we get command “Shut down” from Monitor . End
case.

8-2
Technician Mode Error Messages

An error message displayed in Operation mode is a single error of the highest severity. The message
displayed in Technician mode is a coded error that simultaneously provides all the errors (see Section
"Technician Mode Screen in Appendix A "Technician Mode") present in the system.
The errors messages in technician mode are read from right to left in order of severity. Each character in
the error message is a hexadecimal number and represents a group of errors (see Table 8-2).
To view the error messages, enter Technician mode (see Appendix A "Technician Mode").
Explanation of Error Messages

In the following example, the third number from the right (C) represents Error Group 3 (errors 9–12).
When translated into binary code (see Table 8-3) it yields a four digit number read from right to left. Each
“1”, in conversion to binary, represents an activation of an error message.
Table 8-2: Error Messages
Error Group Description Error Number
00000001 Core readout too low 1

00000002 HALT SetPoint
00000004 Patient temperature less then 35.5?C - (95.9?F)
00000008 Patient temperature high then 38.500C - (101.3?F)
00000010 Water out temperature is less than 10.000C - (50?F) 2

00000020 Water out temperature is higher than 42.000C - (107.6?F)
00000040 Water level in water tank is too low
00000080 Internal pressure (pressure too low or too high)
00000100 Available for future use 3

00000200 Check ThermoWrap (pressure is higher then 0.8 bar)
00000400 Connect core sensor to the Thermoregulation device
00000800 Wrong core sensor is inserted to the Thermoregulation device

socket
00001000 Connect surface sensor to the Thermoregulation device 4

00002000 Wrong surface sensor is inserted to the Thermoregulation device
socket
00004000 Available for future use

Table 8-2: Error Messages
Error Group Description Error Number
00010000 Set point temperature is out of NormoThermia range 5

00020000 HALT Overpressure
00040000 HALT Thermostat
00080000 General electromagnetic interference in the sensor signal reading
00100000 Electromagnetic interference in the core sensor signal reading 6

00400000 Electromagnetic interference in the surface sensor signal reading
00800000 Electromagnetic interference in the water in sensor signal reading
01000000 Electromagnetic interference in the water out sensor signal reading 7

02000000 Core less than 30 C
04000000 Difference between SetPoint and Core more then 2C
08000000 Difference between SetPoint and Core more then 0.8C
10000000 Available for future use 8

Group 8 Group 7 Group 6 Group 5 Group 4 Group 3 Group 2 Group 1

0 0 0 0 2 C 0 1
Error Number 8 4 2 1
Hexadecimal 1 1 0 0
Table 8-3: Hexadecimal to Binary Translation
Hexadecimal Binary Decimal
1 0001 1
2 0010 2
3 0011 3

8-4
Table 8-3: Hexadecimal to Binary Translation
Hexadecimal Binary Decimal
4 0100 4
5 0101 5
6 0110 6
7 0111 7
8 1000 8
9 1001 9
A 1010 10
B 1011 11
C 1100 12
D 1101 13
E 1110 14
F 1111 15


8-6
CHAPTER 9:
PERIODIC MAINTENANCE
WARNING!!!The repair and servicing of the Thermoregulation System should be performed

only by MTRE Advanced Technology Ltd or authorized agents of MTRE Advanced
Technology Ltd.
WARNING!!!Follow all safety guidelines as described in Chapter 2: Warnings and Pre-

cautions. Failure to do so can cause serious personal injury.
Note: At the end of any maintenance procedure, connect a tube to bypass the Garment and
conduct a complete self-test.
This is to guarantee that the system is operational.
Overview of the Periodic Maintenance Procedures

This chapter describes the periodic maintenance procedures performed on the Thermoregulation
device. Periodic maintenance should be performed every twelve months.
The following steps outline the routine procedures in periodic maintenance:
1. Entering Technician Mode (see "Entering Technician Mode" on page A-4)
2. Draining Water Tank (see "Water Tank Assembly" on page 7-3) .
3. Removing the Cover (see "Removing the Cover" on page 9-20).
4. Replacing the Water Filter (see "Replacing the Water Filter" on page 9-2).
5. Activating the CritiCool Machine (see "Activating the CritiCool Machine" on page 9-2)
6. Verification
a. Human Sensors Verification (see "Activating the CritiCool Machine" on page 9-2).
b. Water Temperature Sensors (see "Water Temperature Sensors Verification" on page 9-4).
c. Thermostat Verification (see "Thermostat Verification" on page 9-6).
d. Pressure Verification (see "Pressure Verification " on page 9-8
e. TEC Current Test "TEC Current Test" on page 9-9
7. Checking for Water Leakage (see "Check for Water Leakage" on page 9-11).
8. Self-test (see "Self-test " on page 9-11

Periodic Maintenance Thermoregulation® Service Manual
Removing the Cover

Remove the following:
• Handle
• Top cover
• Rear cover
For instructions on panel removal, see Chapter 5: Panels and Covers.
Replacing the Water Filter

Replace the water filter. Follow the instructions in Chapter 7: Hydraulic System.
Activating the CritiCool Machine
 To Activate the Criticool Machine:

Activate Technician Mode: Turn on the Thermoregulation system and immediately, press
simultaneously the left (SILENCE) and right (UP) buttons. The Main Menu screen appears.
Human Sensors Verification

Your calibration tool kit may include either
• MTRE Temperature Calibration Unit (P/N 017-00184) or
• TP-400 FOGG Temperature Calibration unit (P/N 017-00284)
The verification procedure depends on the type of your calibration device.
 To test the proper functioning of the Human Sensors board using MTRE Temperature Cal-
ibration Unit (P/N 017-00184):
1. Enter Technician mode.
2. Connect the Core sensors calibration cable to the Output socket in the MTRE
Temperature Calibration Unit. Use the RED plug.
3. Connect the BLACK plug of the cable to the Core sensor socket on the
Note: The plugs on both sides of the cable are not identical. Be sure to connect the
proper plug into the correct socket.

9-2
4. Toggle the Calibration/Verification switch to "Verification" (017-00184).

5. Turn the Human Sensor Verification knob counter-clockwise to the number "42.9"
(017-00184). Record the value that appears on the display for "Core" in the "Physical"
column in the Verification form.
6. Turn the Human Sensor Verification knob clockwise to the next increment (37.5) and
record the new value that appears on the display.
7. Repeat the procedure for all the remaining increments according to 8.
8. At the end of verification, remove the cable from the Core sensor socket.
9. Connect the Surface sensor calibration cable to the "Output" socket in the MTRE
Temperature Calibration Unit. Use the RED plug.
10. Connect the SILVER plug of the cable to the Surface sensor socket on the
11. Turn the "Human Sensor Verification" knob counter-clockwise to the number "42.9".
Record the value that appears on the display for "Surface" in the "Physical" column in the
Verification form. See Table 9-1 for sample.
12. Repeat the procedure for all the remaining increments.
13. When all the increments have been recorded, Human Sensor verification is complete.
Remove the Surface sensor calibration cable.
Table 9-1: Verification Form—Human Sensors- using MTRE Temperature Calibration Unit
017-00184
Temp. [C] Max Min Surface [C] Core [C] Accept/Failed
42.90 43.10 42.70
37.50 37.70 37.30
36.20 36.40 36.00
33.30 33.50 33.10
27.10 27.30 26.90
22.90 23.10 22.70
18.50 18.70 18.30
You have completed the Human Sensors verification procedure. Summarize the verification
results and check to see that they are within the tolerance.

If either of the sensors is out of tolerance, refer to CHAPTER 10: Troubleshooting for the solution to this
problem.
 To test the proper functioning of the Human Sensors board using TP-400 FOGG Tempera-
ture Calibration unit (P/N 017-00284):
1. Turn the machine ON.
2. Core measurement; connect Core cable between temperature simulators to the tested
sensor socket.
3. Change the temperature value on the simulator according to Table 9-2.
4. Surface measurement; connect Surface cable between temperature simulators to the
tested sensor socket.
5. Change the temperature value on the simulator according to Table 9-2.
Table 9-2: Verification Form—Human Sensors- using Temp Probe Simulator TP400017-00284
20 20.30 19.70
25 25.30 24.70
30 30.30 29.70
35 35.30 34.70
36 36.30 35.70
38 38.30 37.70
40 40.30 39.70
Water Temperature Sensors Verification

The Water Temperature and Thermostat connectors are located on the Human sensors board.
Note: Perform this test in one shift. If the maximum water temperature measurements exceed
the allowed tolerance (+/-1.0), refill the water tank with fresh water!
 To perform the Water Temperature sensors verification test:

1. Add 1.5 liter of tap water to the water tank.
3. Turn the ON Thermoregulation device.

9-4
4. Scroll down to Operation Mode and press the Mode key to enter.
5. Change the set-point temperature with the arrow keys to 40oC.
6. Press Mode. Scroll down to Technician Mode and press the Mode key to enter.
7. Connect the Temperature Calibration Unit (P/N 017-00184 or P/N 017-00284) with the
Core Calibration cable P/N 300-00093 (red and black jacks) to the Thermoregulation
device.
8. Toggle the Calibration/Verification switch to "Calibration" (on P/N 017-00184).
9. Turn the Human Sensor Calibration switch to 36.7oC. For the CritiCool system, toggle
the Calibration/Verification switch to 39.8OC. with P/N 017-00284 pick 38.0o as the Core
temperature.
This state is intended to simulate the patient temperature of 36.7oC or 39.8o (or 38.0o with P/N
017-00284) on the CritiCool system with the desired set point of 40oC. In this state the
Thermoregulation device heats at its full capacity.
Note: Make sure that the Thermoregulation device is in Technician mode.
10. Connect the external bypass tube with the Thermocouple (200-00096) to the Water-out
connector under core socket and to the Water-in.
11. Connect the External Temperature meter P/N 017-00238 to the Thermocouple and turn it
ON.
12. Observe the Water Out line displayed on the Technician Mode screen. Wait a few minutes
until the temperature reaches its maximum.
13. Observe the maximum temperature of Water-out on the Technician screen and max
temperature on external Thermometer. Write down the values on report A-B and then
press the right button on the display to turn off the Heating/Cooling elements.
14. Observe the Water Out temperature displayed on the Technician Mode screen and list the
maximum temperature reading in the attached Maintenance Verification / Calibration
Report under Wout (B). At the same time, observe the maximum temperature readout on
the External Temperature meter and list it in the report under Max Temp (A).
15. Perform the calculation listed in the report (Δ = A - B). In the event that the result is
inside the listed tolerance (± 1.0), proceed as follows:
a. In the Technician mode screen, press the bottom right button to toggle the TECs on
and off.
b. Observe the decrease in temperature on the External Temperature meter.
For each increment listed in the report (38.00, 37.00, etc.), write down the corresponding temperature
reading from the Technician Mode screen in the Wout and Win columns in the report. See
Table 9-2" for sample.

16. Turn the Thermoregulation device OFF.

You have completed the Water Temperature sensors verification tests. Summarize the verification
results and check to see that they are within the tolerance.
If the verification tests pass, proceed to ""Thermostat Verification" on page 9-6".
If the verification tests fail, replace the faulty thermistor. Refer to Section ""Thermistors" on
page 6-23" in Chapter 6: Electrical System for thermistor replacement procedure.
Table 9-3: Verification Form— Water Temperature Sensors
Max Temp.[C] W out [C] Δ=A-B Accept/Failed

A B
Measured Accepted
±1.0
Temp. [C] Max Min Surface Core [C] Accept/Failed Temp. [C]
[C]
38 39 37
37 38 36
36 37 35
35 36 34
34 35 33
33 34 32
Thermostat Verification
 To check the thermostat:
2. Detach the thermostat sensor cable next to the water-out sensor socket on the right side of
the unit by pressing the latch.
3. Connect the two-pin Molex connector marked with the label "GO" on the Thermostat
Verification Tool to the Thermostat socket on the Human Sensors board (see Figure 9-1).

9-6
Figure 9-1: Thermostat Socket on Human Sensors Board
4. If the Thermoregulation device remains in normal operation in this position after 10

seconds, disconnect the Thermostat Verification Tool (see Figure 9-2) from the Human
Sensors board.
5. Connect the two-pin Molex connector marked with the label "NO GO" on the Thermostat
Verification Tool to the Thermostat socket on the Human Sensors board.
6. After 10 seconds in this position, the machine activates the buzzer and the following
message appears on the display: HALT PLEASE RESTART (3). This indicates that the
thermostat is within operating range.
If the buzzer is not activated and if the message does not appear on the display check the
following:
1. Check the resistance of the Thermostat Verification Tool with a Multi-meter.
• On the "GO" side the resistance should be –1100().
• On the "NO GO" side the resistant should be – 1020().
2. If the Thermostat Verification Tool is OK, replace the Human Sensors board (see Chapter
6: Electrical System) and start the test again.
Figure 9-2: Thermostat Verification Tool

Pressure Verification
Perform the pressure verification test with the Analog Flow and Pressure Calibration Unit or the
Digital Pressure Calibration Unit Assembly.
 To perform pressure verification:

1. Remove the handle and the top cover (see Chapter 5: Panels and Covers).
2. Open the valve before connecting the tubes.
3. Connect the connecting tubes from the Pressure Calibration Unit to the Thermoregulation
device.
4. Enter Technician Mode (refer to Appendix A: Technician Mode).
5. Slowly close the valve until the pressure on the pressure gauge registers at 0.5 bar.
Record the value for 0.5 bar that appears on the Technician Mode display for "Pres1" (water-out
pressure) in the "Physical" column in the Verification form. See Appendix C: Service Form for
sample.
Note: Do not close the tap too quickly. This will lead to improper measurement of the pressure
due to the reaction time of the system.
Perform this test fast after disconnecting connector J3.
6. Remove the cable connected to connector J3 (FUNK 2) on the Controller board located to
the right of the RS-232 cable when facing the right side of the Thermoregulation device
(refer to the Controller Board Component Placement figure in Chapter 6 "Electrical
System").
7. Gradually close the valve and raise the pressure to 1.1 bar. Record the value for 1.1 bar
that appears on the display for "Pres" (Pressure) in the "Physical" column in the
Verification form.
8. At the end of the test, open the valve.
Note: When performing this test on a CritiCool with Neonatal configuration use a simulate
core temperature (use Core temperature simulators P/N: 017-00184/017-00284.

9-8
Figure 9-3: FP Pressure Gauge
Table 9-4: Verification Form— Pressure
Pressure Verification
Pressure Setup (bar) Range (bar) Result (bar)
0.5 0.40-0.60
1.1 1.0-1.2
You have completed the Pressure verification tests. Summarize the verification results and check
to see that they are within the tolerances listed in the Verification form.
Note: If either Pressure is out of tolerance, you must replace the FP board.
If the verification tests passed, proceed to "TEC Current Test" on paragraph 9-12.
TEC Current Test

The TEC Current Test checks the current sent to each TEC from the TEC control board. Both
sides of the TEC control board must be checked.
The Tec Current Test is executed with both the TEC Current Verification Unit (Figure 9-4) and
with the MTRE Temperature Calibration Unit.

Figure 9-4: MTRE TEC Current Verification Unit
WARNING!!!Turn the Thermoregulation device OFF before connecting cables to the TEC
control board. Failure to do so can cause severe shock.
 To check the TEC current:

1. Turn the device OFF.
2. Remove the top cover.
3. Detach the cable leading from connector J1 on the TEC control board to the HCU (refer
to the TEC Control Board Figure 6-6 in Chapter 6: Electrical System).
4. Insert the plug of the cable leading from the HCU (detached from the TEC control board
in Step 3) to the TEC Current Verification Unit cable with the connector (female).
5. Insert the plug of the TEC Current Verification Unit cable to connector J1 on the TEC
control board.
6. Turn the device ON and enter Operation mode.
7. Connect the Human sensors calibration cable to the Core sensor socket on the
Thermoregulation device and to the Output socket on the MTRE Temperature Calibration
Unit.
8. Toggle the Calibration/Verification switch to "Verification". Set the "Human Sensor
Verification" knob to "36.2".
9. Adjust the set-point temperature to 370C. The system heats up to 40.80C Water-out.
10. Use a multi-meter set to DC current with the pair of test cables from the MTRE
Temperature Calibration Unit. Insert the probes of the cables to the pair (labeled "1") of
sockets in the TEC Current Verification Unit.
11. Measure the current and note the results.

9-10
12. Repeat the procedure for every pair of sockets on the TEC Current Verification Unit.
13. Lower the set-point temperature to 340C; the system cools.

14. Repeat the measurement for all four TECs.
Note: The average current of all four pairs should be a minimum of 3 Amps.
If any of the TECs are found to be out of tolerance, check the TECs and the TEC control board:
 To verify the fault of the TECs or of the TEC control board:

1. Turn the Thermoregulation device OFF.
2. Remove the TEC Current Verification Unit cable from connector J1. Leave the cable
leading from the HCU connected to the TEC Current Verification Unit cable with the
connector.
3. Detach the cable leading from connector J2l on the TEC control board to the HCU.
4. Insert the plug of the TEC Current Verification Unit cable J2L on the TEC control board.
6. Measure the current in all four pairs of sockets as performed previously.
If any of the TECs are still found to be out of tolerance, replace the HCU.
If all the TECs are within tolerance, replace the TEC control board.
7. Turn the device OFF.
8. Repeat the entire procedure for connector J2l on the other side of the TEC control board.
Check for Water Leakage

Dry the area around the Thermoregulation device. While running the system at high pressure,
check all tubes for water leakage.
Return all covers.
Self-test
At the completion of the routine maintenance procedure, activate the Thermoregulation device
and run a complete self-test.
Replacing Controller Board Fuses

To replace a blown fuse on the controller board, it is not necessary to remove the board from the
chassis. Replacement fuses (refer to Table 6-5, “TEC Control Board—Fuse List,” on page 6-9 in

Chapter 6: Electrical System) can be soldered to the print side of the controller board to the
specific fuse contact point.
 To replace a blown fuse on the controller board:

1. Remove the handle
2. Open the top cover.
3. Locate the blown fuse.
4. Solder the replacement fuse to the proper contact point (contact points are shown in
Figure 9-5).
5. Return the top cover and handle.
VENT1
F4=2A
SOL2
F2=2A
VENT2
F4=2A
V +8V
F6=3A
Figure 9-5: Controller Board Fuse Location

9-12
CHAPTER 10:
TROUBLESHOOTING
WARNING!!!The repair, calibration, and servicing of the Thermoregulation System should be

performed only by MTRE Advanced Technology Ltd or authorized agents of MTRE
Advanced Technology Ltd.
Halt Messages
Halt messgaes provide information in cases of problems that cause the system to shutdown.
Note: The Report Section columns in Table 10-1 indicate the relevant sections for
reporting the action item in the Maintenance Verification / Calibration or
Service Reports.
Table 10-1: Halt messages – System Shutdown
Message Possible Problem Action to be taken Report Sec.

No power Power switch OFF Turn power switch to ON position
Power cord connected insecurely Secure power cord
No Power in wall connector Use another wall connector
Main Fuses 6.3A blown Replace faulty fuses
Faulty AV voltage from trans- Replace transformer assembly Service report

former secondary
Halt 1 or 4 System detected a flow problem Replace the filter
Check FP harness connector Pressure
Check /Replace the pump Pressure
Check/replace FP board Pressure
Replace controller board Complete

Troubleshooting Thermoregulation® Service Manual
Table 10-1: Halt messages – System Shutdown
Message Possible Problem Action to be taken Report Sec.

Halt 3 System detected thermostat Check hardware thermostat with cali- Thermostat or HS
tripped, indicating a likely over- bration/verification tool. If failed the
heating condition GO / NO GO replace Human Sensor
(HS) board
Check HS harness HS
Check/Replace Thermistor Thermostat
Halt 5 System indicating a likely pro- Perform re-download Complete

gram memory
Halt 6 or 7 Self test detected a problem with Perform self test again
Heating/Cooling unit
Check Tec’s consumption
Replace TEC control board TEC Current test
Replace TEC-Transformer harnesses
Halt 8 Self test detected no reading in Perform self test again

Water in sensor
Check Water in connector
Replace water in connector
Replace Water in thermistor Water sensor
Replace HS board Verification
Replace Controller board Complete
Halt 13 System detected overpressure Check for tubes kinked
Check pressure verification points Pressure
Check FP harness Pressure
Check/Replace FP board Pressure

Check the Solenoid Valve Pressure

10-2
Text Messages
Note: The Report Section columns in Table 10-2 indicate the relevant sections for
reporting the action item in the Maintenance Verification / Calibration or
Service Reports.
Table 10-2: Text Messages
Message / Possible Problem Action to be Taken Report Sec.

Problem
Add Water Bottom float sensor in the water Refill water
tank is not activated
Check float movement freely
Check signal on float switch on J3

(pins 5 & 3). If there is no signal,
replace water tank assembly
Replace 300-00091 Level sensor

harness
CHECK WATER Pressure at Water-out exceeds Connect ThermoWrap

CONNECTION 0.9 bar
Check fuse F5 (solenoid valve)
Check fuse F8 (+12V) Pressure
Check FP board and cable to con- Complete

troller board
CHECK CORE SEN- Wrong decoding of sensor plug Connect proper sensor
SOR
Replace core sensor with the one HS

supplied with the system
Use a new core sensor
Check HS board and harness HS


Problem
CHECK SURFACE Wrong decoding of sensor plug Connect proper sensor
SENSOR
Replace surface sensor with the HS

one supplied with the system
Use a new surface sensor
CONNECT CORE No core sensor detected Replace core sensor

SENSOR
CONNECT SUR- No surface sensor detected Replace surface sensor HS

FACE SENSOR
WATER TEMP TOO Water temperature below 10°C If water temperature is not below HS
LOW 10°C, check HS board and harness
WATER TEMP TOO Water temperature above 42°C If water temperature is not above HS
HIGH 42°C, check HS board and harness
PATIENT TEMP Core temperature above 38.5°C No action needed

ABOVE 38.5°c
(101.3°F)
PATIENT TEMP Core temperature bellow No action needed

BELOW 35.5°C 35.5°C
(95.9°F)
CORE READOUT Core temperature reading If message appears when actual HS

TOO LOW below 30°C or 0.8C below Set core reading is adequate , check
Point HS board and harness
CORE READOUT Core temperature reading is 2C Select operation from the menu or HS
TOO LOW CHECK below Set Point/Target Temp fix the core temperature probe, If
CORE AND OPER- message appears when actual core
ATE reading is adequate , check HS
board and harness
No display Faulty controller board Replace controller board (see chap-

ter 6 Electrical System)
Faulty MMI Replace MMI (see chapter 6 Electri-

cal System)
Faulty controller board-MMI flat

cable

10-4

Problem
No display upon Faulty FP board Check fuse F6 on controller board
startup
FP board and MMI, sharing the Replace FP board
same line
Replace MMI Pressure


10-6
CHAPTER 11:
SPECIAL EQUIPMENT AND TOOLS
This chapter describes the following:

• The special equipment supplied to perform the verification procedures described in Chapter
9 "Periodic Maintenance"
• Standard tools for normal maintenance
• The calibration test for the MTRE Temperature Calibration Unit
Calibration Toolset: Verification and Calibration Units

Verification is executed by means of the Calibration Toolset while operating in Technician mode.
The Calibration Toolset consists of the components listed in Table 11-1 and are detailed in this
section.
Table 11-1: Calibration Toolset Part No. 017-00210
Item No. Part No. Description
1 017-00184 Temperature Calibration Unit
2 017-00284 Temp Probe Simulator TP400
3 017-00190 Analog Flow Pressure Calibration Unit
4 017-00290 Digital Pressure Calibration Unit Assy.
5 017-00189 T.E.C. Current Verification Unit
6 300-00093 Core Calibration Cable
7 300-00094 Surface Calibration Cable
8 017-00203 Downloading Plug
9 900-00127 RS-323 Communication Cable
10+11 017-00260 Download Cable (With Plug)

Special Equipment and Tools Thermoregulation® Service Manual
Table 11-1: Calibration Toolset Part No. 017-00210
12 017-00211 Tool Box
13 005-00440 Red Probe for T.E.C. Verification Unit
14 005-00441 Black Probe for T.E.C. Verification Unit
15 017-00238 Mobile Thermometer Model 305
16 200-00096 Thermo couple
17 017-00229 Thermostat verification tool GO – NO GO
18 017-00236 Tool for Board Disassembly
MTRE Temperature Calibration Unit P/N: 017-00184

The MTRE Temperature Calibration Unit tests the Human temperature sensors.
The MTRE Temperature Calibration Unit consists of:
• The calibration unit
• One cable for verification of the Core Human sensors
• One cable for verification of the Surface Human sensors
MTRE Temperature Calibration Unit - Controls

The controls are as follows:
• A toggle switch for Calibration or Verification
• Human sensor switches:
a. Calibration
b. Verification
• Water Temperature switches:
a. Calibration
b. Verification
• Cable output jack for Thermoregulation calibration
• Two cable jacks for calibration check of the Temperature Calibration Unit

11-2
Figure 11-1: MTRE Temperature Calibration Unit (P/N 017-00184)—Front Panel
Note: The TP400 (P/N 017-00284) replaces the MTRE Temperature

Calibration Unit P/N: 017-00184 (see Figure 11-10)

Analog Flow and Pressure Calibration Unit

P/N 017-00190
The Flow and Pressure Calibration Unit tests the pressure of the Thermoregulation device at 0.9
bar and at 1.1 bar.
The Flow and Pressure Calibration Unit has two connecting tubes with a valve, flow meter, and
pressure gauge.
Figure 11-2: MTRE Flow and Pressure Calibration Unit
Digital Pressure Gauge P/N 017-00290
Figure 11-3: Digital Pressure Gauge P/N 017-00290
 To install the digital pressure gauge:

1. Connect w-out (Figure 11-4) and w-in (Figure 11-5) tubes to the gauge panel according to Figure

11-4
11-3 The labels on the panel indicate where to connect the tubes.
Figure 11-4: W-OUT
Figure 11-5: Figure 11- 5 : W-IN
The pressure gauge is connected and ready to use.

Figure 11-6: Pressure Gauge connected
WARNING!!!Do not change the setting of the gauge; the gauge is calibrated according to the
transducer connected and the fixed setting as you received it.
TEC Current Verification Unit

The TEC Current Verification Unit tests the current sent to the TECs on both sides of the
Thermoregulation device from the TEC control board.
The TEC Current Verification Unit has two cables. The cable with the plug is inserted to
connectors J1 and J2L of the TEC current board. The cable with the connector (female) is fitted to
the cable leading from the HCU.
Figure 11-7: TEC Current Verification Unit

11-6
Calibration Cables
The cables needed for verification tests and calibration checks are shown below.
Core Calibration Cable
Figure 11-8: Core Calibration Cable
Surface Calibration Cable
Figure 11-9: Surface Calibration Cable

Standard Tools
• Crescent wrenches:
▪ 3/4"
▪ 9/16"
▪ 13/16"
• Large long-nosed pliers
• Small long-nosed pliers
• Scissors
• Retractable utility knife
• Cutters
• Set of Allen millimeter wrenches
• Philips-head screwdrivers
▪ 2x200mm
▪ 2x100mm
▪ 1x80mm
▪ 0x60mm
▪ Bulldog 1x25mm
• Flat-head screwdriver 70mm length 4x35mm
• Flat-head bulldog screwdriver 4x20mm
• Socket extension—5/8"
Calibration Test for the MTRE Temperature Calibration

Unit
The calibration test for the MTRE Temperature Calibration Unit must be performed once in 24
months with a calibrated multi-meter. Use the pair of test lead cables that are supplied with the
MTRE Temperature Calibration Unit.
Note: The multi-meter must be calibrated once in twelve months.

11-8
Thermostat Verification Tool

The Thermostat Verification tool tests the tolerance of the thermostat in the Thermoregulation
device.
The tool has two sides, both with two-pin Molex connector. Each side is labeled on the main wire.
Figure 11-10: Thermostat Verification Tool (P/N
PCB Extraction Tool

The PCB Extraction tool is used to release PCB spacer supports.

Figure 11-11: PCB Extraction Tool

11-10
Thermoregulation® Service Manual Specifications
CHAPTER 12:
SPECIFICATIONS
The following specifications are included:

• Allon
• CritiCool
• CritiCool Pro

A Member of Mennen Medical Group
CRITICOOL
ALLON 2001
Technical
TechnicalSpecification
Specification
Thermal Regulation System - Specification
Servo controlled, Non Invasive, thermal regulation using water circulating ThermoWrap and CureWrap
Garments covering up to 85% of body surface
Displays Net Weight

• Mode of operation • 33 kg / 77 lb
• Set point temperature
• Core Temperature Electricity Input power
• Surface Temperature
• Alarm displays • 230/115 VAC with isolation transformer 50/60 Hz
• Pump On/Off icon • Medical multiple isolation transformer: 230/115 VAC
Default mode Maximum Current
• Normothermia management
• 230/115 VAC 6.3 amp
Controller range Operation Ambient Temperature
• 10ºC–40°C (50ºF–104ºF)
• Water Temperature (outflow) 13-40.8ºC (55-105.4ºF)
• Set Point Temperature 30-40ºC (86-104ºF) Storage and Transport
• Maximum storage time without calibration is 26 weeks
Sensors accuracy
• An ambient temperature range of -40°C to +70°C
• Patient Temperature ± 0.3ºC (0.4ºF) (-40°F to 158°F)
• A relative humidity range of 10% to 100%n
Water temperature accuracy • An atmospheric pressure range of 500 hPa to
1060 hPa.
• Water Temperature ± 0.3ºC (0.4ºF)
Warranty
Water tank—Maximum Volume
• 6 liters (1.6 gal.) • One year
Sensors Protection against electric shock

• 014-00020 Reusable core • Type BF
• 014-00021 Reusable surface
• 014-00005 Reusable infant core Languages
• 014-00028 Disposable adapter core • German
• 014-00129 Disposable adapter surface • English
Garment size • French
• Finish
• Sizes range from 40 cm–196 cm (1'4"–6'5") • Italian
Garment Duration of use • Dutch
• Spanish
• ThermoWrap – 28 hours • Portuguese
• CureWrap – 72 hours • Swedish
• Norwegian
Quick coupling connectors
Auxiliary Systems
• Prevent water leakage
• CliniLogger
Safety mechanism
Regulatory
• Prevents extremely high pressure and temperature
• CE 0473
Physical Dimensions • Allon 2001 FDA Clearance - K024128
• 260 mm W x 625 mm D x 940 mm H / • EN 60601-1
(10.23"W x 24.6"D x 37"H) • EN 60601-1-2
• Type BF - Degree of protection against electrical shock
DGT-063-000 Rev B 07/2012 (A4)

MTRE Advanced Technologies Ltd. All rights reserved. Specification subject to changes without notice
CritiCool Specification
The CritiCool, one of MTRE’s Temperature Regulating systems, induces, maintains, and reverses hypothermia in an effective and precise manner. The desired tempera-
ture is preset by the physician with a possible range of target temperature from Hypothermia to Normothermia. The system is composed of two elements, the CritiCool
device, and the CureWrap. The CritiCool device functions as a control unit constantly monitoring the Patients' core temperature and as a cooling/heating pump which
brings the circulating water to the required temperature by using its on-board body temperature control algorithm. 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.
HARDWARE SOFTWARE
Heat Exchangers Displayed Information
● Peltier Technology (TECs)
● Mode of operation
Water tank ● Set point temperature (Range: 300C - 400C)
● Tap water usage ● Core Temperature
● Tank Capacity: 6 liters (1.6 gal.) ● Surface temperature
● System status and alarms
Water Temperature ● Technician mode display
● Water Temperature Accuracy ± 0.3ºC (0.4ºF)
● Water Temperature (outflow) 13-40.8ºC (55-105.4ºF) Operating Modes
Pump ● Mild Hypothermia (Cooling):
● Water Circulating Pump ◊ Adult/Neonatal Mode
● Pump Rate: 1.2 L/min ● Auto Re-Warming
● Protected by 263 micron filter ● Normothermia
● Stand-By
Patient Temperature Channels ● Emptying
● 2 Channels: Core, Surface
● YSI 400 Series Probes Languages
● Body Temperature Range:150C to 440C (590F to 111.20F) ● German
● Body Temperature Accuracy ± 0.3ºC (0.4ºF) ● English
Temperature and Pressure Sensors ● French
● System Sensors:
● Finish
◊ 3 Internal Temperature Sensors: ● Turkish
Water in, Water out, Thermostat ● Italian
◊ 2 Pressure Detectors ● Dutch
● Safety measures:
● Spanish
◊ Over pressure protection and alarm ● Portuguese
● Swedish
◊ High water temperature protection and alarm
● Norwegian
Physical Dimensions ● Danish
● Mobile Unit with 4 wheels and 2 brakes User Interface (GUI)

● 260 mm W x 625 mm D x 940 mm H / ● 4 soft push buttons
(10.23"W x 24.6"D x 37"H)
Net Weight ACCESSORIES
● 34 kg / 75 lb
Temperature Sensors
Electricity Input Power ● Reusable core (Adult, Infant)
● 230/115 VAC with isolation transformer 50/60 Hz ● Reusable surface
● Disposable core (one size)
Maximum Current ● Disposable adapter core
● 230 VAC 2.5A-3A ● Disposable surface (one size)
● 115 VAC 4.8A-5A ● Disposable adapter surface
Environmental Operating Conditions CureWraps

● Temperature: +5°C to +40°C (41°F to 104°F) ● Sizes range from 40 cm–196 cm (1'4"–6'5")
● Humidity: 10 to 93 percent, non-condensing ● Duration of use: 72 hours
● Ambient temperature range of -15°C to +68°C (-40°F to ● Each garment contains a 33mg chlorine tablet
158°F)
External Water Tubes
Environmental Storage Conditions
● Adult—Triple connector to garment
● Humidity: 10 to 93 percent, non-condensing ● Pediatric/Infant—Dual connector to garment
● Maximum storage time without calibration is 26 weeks
External Ports CliniLogger (Optional)
● 1X Isolated Serial Port ● Up to 240 hours of CritiCool data storage
● Connector: DB9 F Type
LCD Display ● CliniLogger Viewer software for PC
● Size: 5.5”
● Resolution: 128x240 REGULATORY
● CE 0473
● Health Canada - 64184
● FDA Clearance - K083662
● EN 60601-1
● EN 60601-1-2
● Type BF - Degree of protection against electrical shock
● IP X0
DGT-136-000 Rev. C 05/2013. Page 1/1

CRIT
Technical Specification
Technical Spe
CritiCool Pro Thermal Regulation System - Specification
Servo controlled, Non Invasive, thermal regulation using water circulating CureWraps covering up to 85% of
body surface
CritiCool Pro is composed of two elements:
Thermal Regulation System – The CritiCool & the CureWraps
Patient monitor – The VitaLogik 4000/4500
Displays Net Weight
• Mode of operation • 33 kg / 77 lb
• Set point temperature
• Core Temperature Electricity Input power
• Surface Temperature
• Alarm displays • 230/115 VAC with isolation transformer 50/60 Hz
• Pump On/Off icon • Medical multiple isolation transformer: 230/115 VAC
Default mode Maximum Current
• Mild Hypothermia
• 230/115 VAC 6.3 amp
Controller range Operation Ambient Temperature
• 10ºC–40°C (50ºF–104ºF)
• Water Temperature (outflow) 13-40.8ºC (55-105.4ºF)
• Set Point Temperature 30-40ºC (86-104ºF) Storage and Transport
• Maximum storage time without calibration is 26 weeks
Sensors accuracy
• An ambient temperature range of -40°C to +70°C
• Patient Temperature ± 0.3ºC (0.4ºF) (-40°F to 158°F)
• A relative humidity range of 10% to 100%n
W temperature accuracy
•Water • An atmospheric pressure range of 500 hPa to
1060 hPa.
• Water Temperature ± 0.3ºC (0.4ºF)
Warranty
Water tank—Maximum Volume
• 6 liters (1.6 gal.) • One year
Sensors Protection against electric shock

• 014-00020 Reusable core • Type BF
• 014-00021 Reusable surface
• 014-00005 Reusable infant core Languages
• 014-00028 Disposable adapter core • German
• 014-00129 Disposable adapter surface • English
Garment size • French
• Finish
• Sizes range from 40 cm–196 cm (1'4"–6'5") • Italian
Wrap Duration of use • Dutch
• Spanish
• CureWrap – 72 hours • Portuguese
• Swedish
Quick coupling connectors • Norwegian
• Prevent water leakage • Danish
Auxiliary Systems
Safety mechanism
• CliniLogger
• Prevents extremely high pressure and temperature
Regulatory
Physical Dimensions
• 260 mm W x 625 mm D x 940 mm H / • CE 0473
(10.23"W x 24.6"D x 37"H) • FDA Clearance – K102112
• EN 60601-1
• EN 60601-1-2
• Type BF - Degree of protection against electrical shock
DGT-136-001 REV.B 7/2012. 1/3

MTRE Advanced Technologies Ltd. All rights reserved. Specification subject to changes without notice
Monitor Specificat ion
Hardware and Parameters ◊ Three vital signs areas with 8 mm Waveform and 25 mm height numeric Vital
Signs
VitaLogik 4000 / 4500 is a compact monitor with a built-in 12.1”
display and battery back-up. User Controls
Available in two versions: • 5 Fixed keys
VitaLogik 4000: Non Invasive monitor • Quicknob
• 3/5/12 lead ECG • Remote Control Keypad (optional)
• Respiration • Touch Screen—ELO IT (optional)
• NIBP • Keyboard and mouse
• SpO2 (Masimo®/ Nellcor®)
Patient Data storage
• 2 Temperatures
• Demographic info
VitaLogik 4500: Invasive monitor • Charts - Numerical
• 3/5/12 lead ECG • Trend - Graphic
• Respiration • Full Disclosure All leads ECG waveform
• NIBP • Overview - All Waveforms with top ECG
• SpO2 (Masimo® / Nellcor®) • Event Strips – 20 Seconds of all ECG and Vital signs waveforms
(10 sec pre & post event)
• 2 Temperatures
• 2 x IBP (optional 4 IBP available)
Storage Basic 1 GB Optional 8 GB Optional 16 GB
• CO / 2 additional Temperatures
Tabular Chart 10 Days 80 Days 80 Days
Both versions offer
• Microstream EtCO2 (optional) Graphic Trends 10 Days 80 Days 80 Days
• Anesthetic Gases supported via UIM Port Full Disclosure 6 Hours 4 Days 30 Days
• 2 x Universal Input Module (UIM)
• Either 4 channels Analog output or Remote control Overview 6 Hours 4 Days 30 Days
• Integrated 3 Channel Recorder (optional) Event Strips 75 75 75

• External Video Output
Saved Patients 3 10 10
Universal Input Module - ”UIM”
• 2 x RS232 ports
• Interface to other vendor devices (A4800, EVITA, BISx, Vigilance, Matisse, Saturn Default Alarms
Evo, IRMA, CritiCool) • User defined
• Fixed or calculated values
CPU Details • Alarm levels:
• Via X86 Core Fusion CPU ◊ Clinical levels: C1, C2, C3, C4
• Sound Blaster 2W audio power / 4Ω ◊ Technical levels: T1, T2.
• Mass storage: 1 GB compact flash, optional 8 GB and 16 GB
• Operating System: QNX 4.25
• Window manager: Photon Recorder (Optional)
• SW upgrades via network or memory card • Integrated Recorder up to 3 channels
Dimensions\Weight Analog Output (4 channel)
HxWxD: 301x324x180 mm (11.9x12.8x7.1 inches) • ECG II – 1Volt/mV
Weight: 5.9Kg. (13.00 lb) (for basic configuration with battery) • ECG V1 – 1Volt/mV
Power requirement • QRS – 5 Volt
• 100-120 VAC, 2A, 50/60 Hz • ART – 1Volt/100 mmHg
• 230-240 VAC, 1A, 50 Hz Clinical Specifications
Battery ECG (3 / 5 / 12 Lead)
• Battery power (Basic) – Lithium Ion 14.8V / 5.2A • Leads: ECG cables for 3/5/10-lead surface ECG with defibrillation
MTRE Ltd. All rights reserved. Specification subject to be changed without notice.
Work on battery time: 3 hours, Charge time: 3 hours • protection in the cable.
• Battery power (extended) – Lithium Ion 14.8V / 10.4A • Input Dynamic Range: ±5 mV peak to peak
Work on battery time: 6 hours, Charge time: 6 hours • Input DC Offset: ±530 mV
• Baseline Correction: Automatic recovery of waveform within 100 msec
Environmental Operating Conditions
• Notch Filtering: Custom: 50Hz or 60Hz
• Temperature: +50C to +400C (41°F to 104°F)
• Frequency Response:
• Humidity: 10 to 93 percent, non-condensing
◊ Diagnostic 0.05 to 150Hz
Environmental Storage Conditions ◊ Monitoring 0.5 to 40Hz
• Temperature: -15CO to +68CO (5°F to 154°F) ◊ ST 0.05 to 40Hz
• Humidity: 10 to 93 percent, non-condensing ◊ Exercise 1 to 25Hz
• Sensitivity: 0.25, 0.5, 1.0, 2.0, 4.0, 8.0 mV/cm
Network • Common Mode Rejection: 120 dB minimum
• LAN Physical: IEEE 802.3 Ethernet interface 10/100 BaseT • Noise: 30 µV
• Protocol: TCP/IP • Input Impedance: 2.5 megaΩ
• Serial Interface RS232 (optional) • Defibrillator Pulse Protection: Yes
• Connectivity to: Ensemble (CNS), Enguard, Enscribe (recorder) • Baseline Recovery: < 8 sec
and network printer • Lead Fault Sense: Based on impedance with driven lead
• Wireless LAN (optional) • Digital Sample Rate: 640Hz
include: • Sample Resolution: 24 bit
◊ Utilizes an industry-standard 802.11b/g IEEE compliant radio card • Pacemaker Detection and Rejection of Pacer Artifact.
◊ Dual-diversity dipole antenna • Pacer Detection Flag inserted into ECG waveform.
◊ Signal strength indicator • 3 Detection Modes:
◊ WPA security and encryption 1. Fixed Threshold 2mV
2. Adaptive 1 Threshold ½mV High Sensitivity
Display 3. Adaptive 2 Threshold > 2mV High Immunity
• NEC 12.1” XGA (1024x768) LCD • Auto Cable Detection
• Interface to a Remote Display • Audio Indicator: QRS Beep
• Very “Big Numbers” mode • QRS Detection Range
◊ One or Two Lead ECG WF, 34 mm height HR
DGT-136-001 Rev.B 7/2012. Page 2/3

• Height: 0.25 to 5.0 millivolt or 0.15mV, Width: 70 to 120 milliseconds In Cardiac Output mode:
• Heart Rate Counting ◊ Cardiac Output
• Range: 15 to 350 BPM ◊ Hemodynamic Calculation results
• 15-300 Accuracy: ±2 BPM, 300-350 Accuracy ±4 BPM ◊ Measuring time
• Note: Values below 20- forced to zero In Two Temp mode:
• Heart Rate Alarm Settings ◊ Temperatures and Delta-Temp
• High and low rate: 20 - 350 BPM non-overlapping ◊ Temperature Alarms
• Leads analyzed for Heart Rate and Arrhythmia Configuration: Non-Invasive Blood Pressure
• Top two displayed
• Oscillometric Method
• ECG Leads:
• Displayed Parameters: Systolic, Diastolic, Mean pressure values
◊ I, II, III (3 Lead cable) • Time of last measurement, measurement interval, cuff size and heart rate
◊ I, II, III, aVR, aVL, aVF, V (5 Lead cable)
• Cuff Size: Adult, Pediatric, Infant, Neonatal
◊ I, II, III, aVR, aVL, aVF, V1-V6 (12 Lead module) • Inflation Rate: Within 5 sec.
• Data Storage:Beat notification, RR Interval, Heart Rate, ST values, Arrhythmia,
• Initial inflation target: 150 mmHg, Adult/Pediatric
Alarms, Parameter settings, Cycle time and measurement time, Markers, Alarm
event markers • Initial inflation target: 100 mmHg, Neonatal
• Over pressure limit : 290 mmHg, Adult/Pediatric
Respiration • Over pressure limit : 145 mmHg, Neonatal
• Leads: RA-LA or Leads: RA-LL • Cycle Times
• Excitation: 65 kHz, < 1 mA • Deflation time (typical): 30 sec.; BP time-out: 60 - 180 sec.
• Frequency Response: 0.13 to 2.5Hz • Measurement Ranges, Adult (in mmHg)
• Impedance Range: 100 to 3000 Ω • Systolic: 30 to 255; Diastolic: 15 to 220; Mean: 20 to 235
• Input Sensitivity Range: 0.2 to 5 Ω • Measurement Ranges, Neonatal (in mmHg)
• Digital Sample Rate: 640 Hz • Systolic: 30 to 135; Diastolic: 15 to 110; Mean: 20-125
• Sample Resolution: 24 bit • Modes: Auto, Manual, STAT
• Respiration Rate Counting Range: 0 to 150 breaths/min • Automatic intervals 1,2,3,4,5,10,15,20,30,60,120,180,240,360, 480 minutes
(Less than 8 BPM is considered apnea) • Pressure: Transducer Accuracy ±3 mmHg or ±2%, whichever is greater
• Respiration rate: Accuracy +/- 1 per minute • Heart Rate: 30 to 240 BPM, Adult/Pediatric; 40 to 240 BPM Neonatal
• Respiration Alarm Settings • Data Storage: Measurement time markers, S/D/M, Alarm even markers
◊ Low rate: 0 - 150 BPM
◊ High rate: 0 - 150 BPM Temperature
◊ Apnea: User configurable • YSI400
◊ Cardiac coincidence alarm • Body temperature: 00C to 450C (320F to 1130F) +/- 0.1 0C
• Data Storage: • Temperature Alarm Range: 250C to 450C (770F to 1130F)
◊ Respiration rate • Range + / - 45 0C
◊ Respiration rate Alarms
◊ Apnea alarms Delta Temperature
◊ Alarm event markers • Delta temp Accuracy: +/- 0.1 0C
Invasive Blood Pressure End Tidal CO2 Microstream (EtCO2)

• Site Labels: BPx, ART, PAP, CVP, RAP, LAP, ICP • Flow rate: 50 ml/min (accuracy: -7.5ml/min + 15ml/min )
• Input Sensitivity: 5 µVolt/Volt/mmHg • Displayed Data:
• Dynamic Range ◊ Waveform labels and annotations
◊ Pressure range: -50 to +350 mmHg ◊ EtCO2, in CO2 and respiration rate values
◊ Zero range: ±150 mmHg • CO2 Display Range: 0-99 mmHg
◊ Total dynamic range: -200 to +450 mmHg • Measurement Resolution: Typical Accuracy
• Transducer Excitation Voltage: +5 VDC ◊ ±2 mmHg for CO2 range of 0-38 mmHg
Separate excitation driver for each channel ◊ ±5% for CO2 range of 39-99 mmHg
• Zero Accuracy: ±0.2 mmHg ◊ +0.08%for every 1 mmHg above 38 mmHg
• Zero Drift • Respiration Rate:
Less than ±0.2 mmHg in 24 hours, (at constant temperature) ◊ 0 to 70 bpm: ±1 bpm,
• Blood Pressure Accuracy ◊ 71 to 120 bpm: ±2 bpm,
±2 mmHg or ±2%, whichever is greater, exclusive of transducer ◊ 121 to 150 bpm: ±3 bpm
• Blood Pressure Linearity: within 1% across entire range • Rise Time: 190 msec (10% - 90%)
• Waveform Frequency Response: 0 - 40 Hz • Delay Time: 2.7 Sec (10% - 90%) typical
• Sampling Rate: 640 Hz • Start-up Time: 30 sec typical
• Sample Resolution: 24 bit • Automatic Compensation: At least once per hour
• Fault Detection; Transducer in/out, Cable out • Ambient Temperature: 0-65°C,
• Data Storage:Systolic, Diastolic and Mean; Alarms Humidity: 10-95% RH, non-condensing
• Barometric Pressure: 430-795 mmHg (-1250 to 15,000 ft. ; -380 to 5200 meter)
Pulse Oximetry (Sp02)
• Calibration required: Initially—after 1200 operating hours and then once a year or
• Nellcor® Oximax or Masimo® SET Technology 4000 operating hours
• Plethysmograph waveform • CO2 Alarm Limits: 0 to 100 mmHg; 0 to 10%; 0 to 15 kPa
• Saturation Range: 1% to 100% Sp02
MTRE Ltd. All rights reserved. Specification subject to be changed without notice.
• Respiration Rate Alarm Limits: Neonatal - 0 to 150 BMP; Adult - 0 to 50 BPM
• Extreme Alarm Capability • Data Storage:EtCO2, inCO2 and Respiration Rate values, Alarms, Apnea Alarm
• Sp02 Accuracy: SpO2 % ±1% standard deviation • Exhaust Gas Outlet
• Pulse Rate Range: 20 to 250 BPM ±3 BPM
• Saturation alarm limits: 0% to 100% Languages
• Data Storage:Heart rate and O2 saturation, Alarms • English, Dutch, French, Italian, Spanish, Espanol, Portuguese, Turkish, Russian,
Polish.
Integrated Thermo Dilution Cardiac Output
• Adapter and Compatibility Cables: Regulatory Approvals
◊ CO Set interface cable • EN 60601-1
◊ Ice Bath YSI-400 cardiac output interface cable • EN 60601-1-1
◊ Dual temperature interface cable (YSI-400) • EN 60601-1-2
• Temperature Range • Degree of protection against electrical shock
◊ Blood temperature: 270C to 450C (810F to 1130F) ◊ ECG / RSP, IBP, CO and TEMP = Type CF
◊ Injectate temperature: 00C to 250C (320F to 770F) ◊ NIBP, SpO2 and EtCO2 = Type BF
◊ Body temperature: 00C to 450C (320F to 1130F) • CE Mark 0473
• Accuracy ±0.1OC over the entire range • FDA Clearance - K073140
• Digital Sample Rate: 160 Hz
• Sample Resolution: 24 bit
• Frequency Response: 0 to 15 Hz
• Cardiac Output Determination Range: 0 to 20 liters per minute
• Injectate Volumes: 1, 3, 5, and 10cc
• Displayed Data: Cardiac Output, Cardiac Index, Stroke Volume, Stroke Volume Index,
Blood Temperature, Injectate Temperature, Trial Number
• Data Storage:
DGT-136-001 Rev.B 7/2012. Page 3/3

Specifications Thermoregulation® Service Manual

12-6
APPENDIX A:
TECHNICIAN MODE
Technician Mode
Verification and calibration tests are done while the Thermoregulation device is in Technician
mode. This mode displays the readings of the verification and calibration tests, as well as
additional information as to the status of the Thermoregulation device and error codes that are
necessary in the analysis and correction of failure.
Following is a detailed description of these functions.
Technician Mode Screen
Figure A-1: Technician Mode Screen
MTRE Advanced Technologies Ltd. A-1

Technician Mode Screen—Details

1. Software Version Number
2. Date and Time (dd/mm/yy hh/mm/ss)
3. Functions
The following functions are listed in the Technician Mode screen:
• Core sensor (Core)
• Surface sensor (Surf)
• Water-in sensor (Win)
• Water-out sensor (Wout)
• Pressure (Pres1)
• Internal pressure (Pres2)
The "Physical" and "ADC" columns next to each function list the readings when performing the
verification and calibration (see Chapter 9 "Periodic Maintenance").
The following values (-1) and (-2) are displayed in the "Physical" column for Core and Surface
and they denote that the sensor is not connected/ that the wrong sensor has been inserted into the
socket:
Table A-1: “Physical” Values
Core Sensor Surface Sensor
-1 Denotes that the sen- Denotes that the sensor is

sor is not connected not connected
-2 Denotes that the Denoted that the sensor is

wrong sensor has connected incorrectly in its
been inserted into the socket
socket
4. Error
For a detailed error list and explanation, see Chapter 8 "Software".
5. Time—value listed is in tenths of a minute
6. CRC
Software confirmation number indicating successful download
A-2 MTRE Advanced Technologies Ltd.

7. BAT: Good
Indication of RAM battery condition
8. SetPoint
Indicates the set-point temperature
9. DesireTmp
Indicates the desired water-out temperature
10. TECs
The number on the left side indicates how many TECs are working at the present time. For
example:
0/4—no TECs are working
1/4—one pair of TECs is working, one TEC on each side of the Thermoregulation device
11. Heat/Cool
Denotes if the TECs are heating or cooling the water
12. Pump
Denotes if the pump is operating
13. ThermoWrap
ON—Thermoregulation device pumps water to the Garment
OFF—The Thermoregulation device is on by-pass
14. Use right button to toggle TECs, TECs are: ON /OFF

This function is used to switch OFF the heating/cooling elements when checking water
temperature sensors.
MTRE Advanced Technologies Ltd. A-3

Entering Technician Mode

Verification procedures listed Chapter 9 are performed while the Thermoregulation device is in
Technician Mode.
 To enter the Technician Mode:

1. Turn the Thermoregulation device OFF for more than 10 seconds and then ON again for more
then 10 seconds and then verify that self test is executed.
2. After a few seconds, simultaneously press the Alarm Mute and Arrow Up keys. This adds
the Technician Mode to the menu.
3. Wait for Self Test to complete or skip to OPERATION by pressing the MODE key.
4. Press the MODE key to display the MENU.
5. Scroll down to TECHNICIAN and press the ENTER key to enter.
Figure A-2: Technician Mode Available
A-4 MTRE Advanced Technologies Ltd.

APPENDIX B:
SPARE PARTS LIST
Disclaimer
Due to continuing product innovation, specifications in this List, as well as Typos are subject to
change without notice.
Company shall not be liable for delays or for failure to manufacture and/or deliver due to causes
beyond its reasonable control or due to compliance with any government regulations.
Spare Parts Prices are provided by MTRE Service Department. Always use the Service Call
Form, for reporting on failures, assistance request and Price Requests.
Upon Receiving a Board for Exchange (EX), You should send back the Faulty one Freight
Prepaid, to the Factory within 30 Days.
CritiCool™ – Cooling Control Unit
Figure B-1: CritiCool Control Unit
MTRE Advanced Technologies Ltd. B-1

●Non-Invasive approach to Cooling Therapy

●Precise Temperature Control
●Maximal Energy Transfer
●Early Treatment Initiation
●Minimal Staff Labor
●Pressure relief algorithm
●Optimal Patient Surface Coverage
●Unique Heat removal Approach
●Body-Shaped 3-Dimentional CureWrap™ Garment for Intuitive use
●Latex Free CureWrap™ with Simultaneous Water Flow through Numerous Channels, Provides
Superior Heat Exchange Capacity
●Biocompatible, Latex-Free and Anti-Static CureWrap™ Suits any Hospital Setting
●Includes: Control Unit, CureWrap Connecting tubes, ThermoWrap Connecting Tubes, Spare Water
Filter, Core & Surface Temperature Sensors, Drain Water Tank Connector, User Manual
CritiCool™ – Spare Parts List

Note: When Ordering Boards For Exchange (EX), Fill Up a Service Call Form
and return to the Factory the Faulty Board within 30 Days.
Part Number Description
Controller board
300-00118
300-00118EX Exchange of Controller board
300-00117 TEC control board
300-00117EX Exchange of TEC control board
B-2 MTRE Advanced Technologies Ltd.

Human sensor board
300-00016
Controller board—TEC control board harnessx2
300-00098
Transformer—TEC control board harnessx2
300-00102
Controller board—human sensor board harness
300-00100

Controller board—flow & pressure board harness
300-00099
Controller board—RS-232 connector harness
300-00101
Main harness right side
300-00050
Main harness left side
300-00051

Level sensor harness
300-00091
Controller board—pump harness
300-00080
Top panel assembly (display & cover)
200-00140

Water filter assembly
200-00130
Pump assembly
200-00115
Single thermistor unit assy (water in)
200-00132
Double thermistor unit assy(w.out +thermostat)
200-00131

Flow & pressure board
300-00015
Solenoid valve assembly
200-00078
Heating & cooling unit assembly (HCU)
200-00054
Line filter
006-00002

Transformer assembly
200-00059
Water tank assembly
200-00104
Right side cover
200-00143

LEFT SIDE COVER
200-00144
TOP COVER
200-00145
FRONT LOWER COVER
007-00352
REAR COVER
200-00146

HANDLE
007-00365
Filter bracket
007-00334
Trolley front wheel with lock
007-00049
Trolley rear wheel
007-00047

TROLLEY ASSEMBLY
200-00141
Water out\ in female connector
200-00097
Service set of screws
200-00121
Service tubing kit
200-00119

Connecting water tubes 2 by 2-way (metal connectors)
200-00109
Female connector for connecting water tubes
002-00124
200-00147

Drain Tube
020-00013
Buffer Tube
200-00069
Image not available
Draining Qcc
002-00069
Qc T – 8X6X8
002-00019

Surface sensor
014-00021
Core sensor
014-00020
Surface sensor adaptor cable
014-00029
Core sensor adaptor cable
014-00028

Pediatric core sensor
014-00005
Fuse 7A pack of 10
005-00483
Image not available
Power cord
014-00016
Image not available
Reusable packaging for Allon 2001

015-00062
Image not available
SOLENOID VALVE COIL
003-00011
SOLENOID VALVE ASSEMBLY
200-00122

SOLENOID PLUG
003-00012
Calibration Verification Tool Set

017-00210
Image not available
Calibrating the Tool Set at the Factory (Labor Only)

017-00240
Image not available
Digital Pressure Measuring Device

017-00290
Image not available

Allon 2001™ – Warming Control Unit, Version-05

●Maintains Normothermia of 36.5°C – 37.5°C
●Controls Induced Hypothermia and Provides Precise Rewarming
●Physician Presets Targeted Patient Temperature
●Real Time Dynamic Feedback Loop
●Proprietary Temperature Management Algorithms
●Supports a Wide Range of Preoperative Procedures
●Single Piece Design of ThermoWrap™ with Three Dimensional Coverage
●Maximum Available Patient Surface Coverage
●Pressure relief algorithm
●Latex Free ThermoWrap™
●Includes: Control Unit, ThermoWrap Connecting Tubes, Spare Water Filter, Core & Surface
Temperature Sensors, Drain Water Tank Connector, User Manual
Allon 2001™ – Spare Parts List For, Version-05

Note: When Ordering Boards for Exchange (EX), fill fp a Service Call Form and
return to the Factory the Faulty Board within 30 Days.
Upgrade Package for Allon 2001™ Warming Control Unit

Upgrade Kit for Allon Version 04 Units to Allon Version 05
Table B-1: Upgrade Kit for Allon Version 04 Units to Allon Version 05
200-00002 Upgrade V4 to Allon 2001 Ver. 05, Warming Control Unit (230V)
200-00001 Upgrade V4 to Allon 2001 Ver. 05, Warming Control Unit (115V)

Controller board
300-00114/118
300-00114EX Exchange of Controller board (Image not available)
TEC control board
300-00117
300-00117EX Exchange of TEC control board (Image not available)
Human sensor board
300-00016
300-00016EX Exchange of Human sensor board
300-00015 Flow & pressure board
300-00015EX Exchange of Flow & pressure board

Controller board—TEC control board harnessx2
300-00098
Transformer—TEC control board harnessx2
300-00102
Controller board—human sensor board harness
300-00100
Controller board—flow & pressure board harness
300-00099

Controller board—RS-232 connector harness
300-00101
Main harness right side
300-00050
Main harness left side
300-00051

Level sensor harness
300-00091
Controller board—pump harness
300-00080
Top panel assembly (display & cover)
200-00062

Water filter assembly
200-00130
Pump assembly
200-00115
Single thermistor unit assy (water in)
200-00132
Double thermistor unit assy(w.out +thermostat)
200-00131

Flow & pressure board
300-00015
Solenoid valve assembly
200-00078
Heating & cooling unit assembly (HCU)
200-00054
Line filter
006-00002

Transformer assembly
200-00059
Water tank assembly
200-00104
Right side cover
200-00112

Left side cover
200-00113
Top cover
200-00133
Front lower cover
007-00243

Rear cover
200-00135
Handle
007-00333
Filter bracket
007-00334

Trolley front wheel with lock
007-00049
Trolley rear wheel
007-00047
Trolley assembly
200-00067
Water out\ in female connector
200-00097

Service set of screws
200-00121
Service tubing kit
200-00119
200-00109

APPENDIX C:
SERVICE FORM
For technical assistance / service request fill the following form and send to neomi@mmi.co.il.
MTRE Advanced Technologies Ltd. C-1

MTRE Advanced Technology LTD.
4 Hayarden Street, Yavne,. P.O.B. 102 Rehovot 76100, Israel.
Tel: 972‐8‐9323333. Fax: 972‐8‐9328510.
Service Call, Technical Assistance Request Form
To : Technical Support Department neomi@mmi.co.il Date : *
A ‐ Customer Details
From : * E‐mail : *
Firm Name : * Fax # : *
B ‐Technical Problem Details
Model Unit Part # Description Serial # Software
B1
* * * *
Top Assembly
Parameter Sub Unit Part # Description Serial # Q’ty
B2‐1
* * *
Sub Assembly 1
B2‐2

Sub Assembly 2
Fault Description: full details *
B2‐3

C ‐ Customer Request:
C1 Exchange * RMA : Price : Delivery :
C2 Send For Repair * RMA : Price : Delivery :
C3 Buy Item* Price : Delivery :
C4 Information * Customer Order Number if Exchange or Repair : *
C5 Replacement Part # if exch. Description Serial # S.W.
Needed
C6 For Mennen Internal use only: MRB: YES NO
D ‐ Shipment Instructions, Customer request, after repair or exchange: *
D 1 Fedex Courier
D 2 Airfreight
D 3 Other
ACG-000-023 Rev A Service call, technical assist request
Please send the form to neomi@mmi.co.il
APPENDIX D:
PERIODIC MAINTENANCE
for CritiCool / Pro and Allon -
P/N 200-00136/063
Period maintenance description is divided into two parts according to the type of simulator used:
• For Stimlator: TP-400 FOGG
• For Stimulator MTRE Temperature Calibration Unit
For Stimlator: TP-400 FOGG

P/N : _____________________ Rev: ____ Contact: MTRE SERVICE
S/N : _____________________ E-mail: service@mmi.co.il
Hospital: _________________ Tel: 972-89328510
Country: _________________ FAX: 972-89323333
CRC #: __________________ Tested By: _______________
1. Water Filter Assembly Maintenance

Replaced
Replace water * Simulator: TP-400 FOGG Temperature
filter Calibration unit 017-00284
2. Core & Surface Temperature Test
20 20.30 19.70
25 25.30 24.70
30 30.30 29.70
35 35.30 34.70
36 36.30 35.70
38 38.30 37.70
40 40.30 39.70
MTRE Advanced Technologies Ltd. D-1

3. Sensors Win & Wout Test
Max Temp.[C] W out [C] Δ=A-B Accept/Failed

A B
Measured Accepted
±1.0
Temp. [C] Max Min Surface Core [C] Accept/Failed Temp. [C]
[C]
38 39 37
37 38 36
36 37 35
35 36 34
34 35 33
33 34 32
D-2 MTRE Advanced Technologies Ltd.

4. Thermostat Test
Status Result Pass/Failed
GO No Halt
NOGO Halt 3
5. Pressure Test
Pressure [bar] Range [bar] Measured [bar] Accept/Failed

(Press 1 )
0.5 0.4-0.6
1.1 1.0-1.2
6. Tech's Current Testing.
Range (amp) Measured(amp) Accept/Failed
Left side of HCU

Tech A 3.5 – 5.0
Tech B 3.5 – 5.0
Tech C 3.5 – 5.0
Tech D 3.5 – 5.0
Right side of HCU
Tech A 3.5 – 5.0
Tech B 3.5 – 5.0
Tech C 3.5 – 5.0
Tech D 3.5 – 5.0

7. Fan's Test
Accept/Failed
Left side HCU
Visual test fan is working properly
Right side HCU
TEST SUMMARY: PASS FAIL
Remarks: _________________________________________________
_________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Signature _________________ Date ____________

For Stimulator MTRE Temperature Calibration Unit

P/N : _____________________ Rev: ____Contact: MTRE SERVICE
S/N : _____________________E-mail: service@mmi.co.il
Hospital: _________________Tel: 972-89328510
Country: _________________FAX: 972-89323333
CRC #: __________________Tested By: _______________
1. Water Filter Assembly Maintenance

Replaced
Replace water * Simulator: Temperature Calibration
filter unit 017-00284
2. Core & Surface Temperature Test
Temp. [C] Max Min Accept/Failed Core [C] Surface [C]
42.90 43.20 42.60
37.50 37.80 37.20
36.20 36.50 35.90
33.30 33.60 33.00
27.10 27.40 26.80
22.90 23.20 22.60
18.50 18.80 18.20

3. Sensors Win & Wout Test
W out [C] Max Temp.[C] Δ=A-B Accept/Failed
B A
Accepted Measured
±1.0
Temp. [C] Max Min Accept/ W out [C] W in [C]

Failed
38.00 39 37
37.00 38 36
36.00 37 35
35.00 36 34
34.00 35 33
33.00 34 32
4. Thermostat Test
Status Result Pass/Failed
GO No Halt
NOGO Halt 3

5. Pressure Test
Pressure [bar] Range [bar] Measured [bar] Accept/Failed

(Press 1 )
0.5 0.4-0.6
1.1 1.0-1.2
6. Tech Current Testing.
Range (amp) Measured(amp) Accept/

Failed
Left side of HCU

Tech A 3.5 – 5.0
Tech B 3.5 – 5.0
Tech C 3.5 – 5.0
Tech D 3.5 – 5.0
Right side of HCU
Tech A 3.5 – 5.0
Tech B 3.5 – 5.0
Tech C 3.5 – 5.0
Tech D 3.5 – 5.0

7. Fan Test
Accept/
Failed
Left side HCU
Right side HCU
TEST SUMMARY: PASS FAIL
Remarks: _________________________________________________
_________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Signature _________________ Date ____________

APPENDIX E:
DOWNLOADING UPDATED CRITICOOL
SOFTWARE
 To download updated CritiCool software to your PC:

1. Turn on the PC.
2. Double-click My Computer.
3. In drive C, create new folder, and name it MTRE _PC_Download.
4. Copy the Pc_Download.exe file from the CD or e-Mail to the MTRE_ PC_Download.
folder.
5. Copy the CLINIC_Ver_*_xyz.BIN file (CLINIC_Ver_5_4B4.BIN in the current
version) from the CD or e-Mail the to the MTRE _PC_Download folder.
 To download and install the update on CritiCool:

1. Turn on the PC.
2. Verify that the MTRE serial cable is connected between the PC and CritiCool.
3. Browse to the MTRE_ PC_Download folder and double-click the Pc_Download.exe
file to open the installation program.
Figure E-1: MTRE - PC Download Window
4. From the COM Port drop-down list, select the number of the COM port you connected
to the serial plug on your PC.
MTRE Advanced Technologies Ltd. E-1

5. From the Speed drop-down list, select 19200.

6. From the Board Type drop-down list, select the board type (Boards 300-00118 are type
'6' the other are type '5' ).
7. Press NEXT to continue.
The Select File window is displayed.
Figure E-2: Select File Window
8. From the Current drive drop-down list select the C: drive.

9. Double-click the MTRE _PC_Download folder.
Note: Make sure that the File types box displayes the MTRE_BIN(*.bin) type.
10. Select CLINIC_Ver_*_xyz.BIN (for example: CLINIC_Ver_5_4B4.BIN) file and

verify the file is highlighted.
11. Click OK and verify that
The File Download window is displayed.
12. Open the top cover of CritiCool and turn CritiCool on.
13. In the File Download window, click Start to start the download process.
During the download, a progress indicator appears on the File Download window and a
Program Burn label appears, indicating the burn precentage.
E-2 MTRE Advanced Technologies Ltd.

Figure E-3: File Download window
LEDs 4 and 5 on the Control Board of CritiCool flicker during the download process. At
the end of the download process, both LEDs should cease to flicker and remain lit.
IMPORTANT! Should one of them turn off, the download process is incomplete and you need
to perform the download process again.
At the end of the download process, the following message appears.
Figure E-4: Download Complete Message
14. Turn CritiCool OFF

15. Close the CritiCool cover and disconnect the MTRE serial cable from CritiCool.
16. Turn CritiCool ON.
17. Enter Technician Mode (see Appendix A - Technician Mode). Check that the new version
is listed on the top of the screen and verify that the checksum (CRC) number is equal to
the one in the Download Complete message.
MTRE Advanced Technologies Ltd. E-3

Figure E-5: Technician Mode Screen
If the checksum (CRC) in the Download Complete message (in Figure E-4:) is equal to
the value displayed at Technician Mode, the software download was successful.
18. Click Exit.
IMPORTANT! If the checksum (CRC) does not match, turn the system OFF, and reperform
Download.
E-4 MTRE Advanced Technologies Ltd.

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Thermoregulation

For CritiCool machines with

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices

Copyright © MTRE Advanced Technologies Ltd. 2013 All RIGHTS RESERVED

Registered trademarks are the intellectual property of their respective holders.

Copyright 2013 by MTRE

ii MTRE Advanced Technologies Ltd.

Field Repairs Statement

Training and Qualification

MTRE Advanced Technologies Ltd. iii

iv MTRE Advanced Technologies Ltd.

MTRE Advanced Technologies Ltd. iv

v MTRE Advanced Technologies Ltd.

MTRE Advanced Technologies Ltd. vi

Allon 2001™ – Warming Control Unit, Version-05 .......................................................................... B-17

vii MTRE Advanced Technologies Ltd.

MTRE Advanced Technologies Ltd. 1-1

MTRE Advanced Technologies Ltd.

CAUTION! Indicates a condition that may damage the equipment.

MTRE Advanced Technologies Ltd. 2-1

MTRE Advanced Technologies Ltd.

MTRE Advanced Technologies Ltd. 2-3

Figure 2-1: Label Placement for the CritiCool Thermoregulation Device

MTRE Advanced Technologies Ltd.

Figure 2-2: Label Placement for the Allon Thermoregulation Device

MTRE Advanced Technologies Ltd. 2-5

Table 2-1: Key for Label Symbols

Location of surface sensor socket

Equipment not suitable in the presence of flammable anesthetic

xx-yyyy Machine Version - Machine serial number

Water-out connector indicator

MTRE Advanced Technologies Ltd.

CAUTION!Never place the Thermoregulation device on its rear or side.

MTRE Advanced Technologies Ltd. 3-1

Figure 3-1: Front View

MTRE Advanced Technologies Ltd.

Figure 3-2: Side View

MTRE Advanced Technologies Ltd. 3-3

Figure 3-3: Rear View

1. Human Temperature Sensors

MTRE Advanced Technologies Ltd.

• Reusable Core Sensor (Part No. 014-00020):

Model No. Name Description Accuracy Resolution Type

014-00020 Core Inner body ± 0.3°C ± 0.1°C Medical Grade

014-00021 Surface Skin temp ± 0.3°C ± 0.1°C Medical Grade

014-00005 Core Infant Infant Inner ± 0.3°C ± 0.1°C Medical Grade

MTRE Advanced Technologies Ltd. 3-5

2. Detachable Electric Power Cable and Plug

3. .Connecting Tubes for CureWrap (Part No. 200-00147)

4. Connecting Tubes for ThermoWrap or CureWrap Garments (Part No. 200-00109)

5. Male Connector for Draining Water Tank (Part No. 002-00069)

6. Spare Water Filter (Part No. 200-00130)

MTRE Advanced Technologies Ltd.

Unpacking and Inspection

Assembling the Handle

MTRE Advanced Technologies Ltd. 4-1

Figure 4-1: Handle Assembly

MTRE Advanced Technologies Ltd.

The Thermoregulation system includes one of the following accessories kits:

Allon 2001™ Accessory Kits