CritiCool Quick Reference Guide Ver 02

Step-by-Step Operation FRONT VIEW

Handle Control Panel Surface Sensor Socket

Core Sensor Socket

Water-in Quick Coupling Connector

Water-out Quick Coupling Connector

Water Feeder Tube

Water Level Indicator

REAR VIEW

Power Switch

Thumb Captive Screws (4)

3-Prong Power Socket

Air Outlet Grille

RS-232 Connector Rear Cover

6mm Threaded Hole for Equipotentiality Screw Installation Thumb Captive Screws (2)

Set: 1. Place CritiCool unit in the desired location and lock front wheels. 2. Pour cold tap water into water tank up to maximum level (between the two lines). 3. Turn power ON. • Following a short Self Test, the system automatically cools the water • Avoid further connections until patient arrival to the ICU • Place appropriate garment on bed or underneath patient (see Instructions of Use). • Connect Water tubes to garment and to CritiCool unit. The garment automatically fills up! (Lower water level in the reservoir is normal) • Check that clamps on garment are open and a clicking sound is heard.

Wrap: 4. Secure on patient

Cool: • Plug Gray sensor into Core socket and Green sensor into Surface socket of CritiCool unit.

• Once sensors are inserted to patient and valid feedback is obtained, algorithm is activated.

• The CritiCool unit will not Thermo regulate if core sensor is not properly inserted into patient

• Ensure no interference from other factors influence correct continuous temperature feedback readings.

• When feedback is unavailable predefined cooling program is set, an alarm sounds and a message appears. Re-warming: Gradual re-warming is advised (do not exceed more than 2 °C above actual temperature) * For Accidental hypothermia or fast re-warming: switch to Normothermia management mode

CONTROL PANEL

Core Temperature Surface Temperature

Mode Key

CoolingHeating Status System Function Status Energy Transfer to/from Patient Set Point Temperature

Alarm Mute Arrow Keys

Description and Operation

Step-by-Step Operation

Step-by-Step Operation 6. Monitor patient temperature and system messages. Use Arrow keys to select desired mode

Operation Mode

Temperature Graph

Stand-by Mode

Treatment Mode Selection Screen

Garment replacement / *Shut Down 1. Turn OFF CritiCool unit or switch to Stand-by mode. 2. Wait a few seconds and close clamps on garment. 3. Disconnect Water Tubes from garment. 4. Unwrap patient and dispose garment.

• Do not use garment to lift or move the patient. • Ensure garment is fully released. * Disconnect Water Tubes and remove Core and Surface sensors from patient and from CritiCool unit.

• Clean and prepare CritiCool unit and its accessories for future use. • For Disinfections / Sterilization of sensors use CIDEX / ETO only according to hospital protocol.

Controller Troubleshooting An alarm will sound to inform about any problem. The system will assist you in solving the problem.

Water leak between connecting tubes and CritiCool unit

Water tank overfilled

Possible Problem

Action to be Taken

Connecting tubes are not connected properly

Disconnect connecting tubes from machine and connect again

Damage to connecting tubes

Replace connecting tubes

Damage to quick coupling connector

Call Biomedical department

If necessary, drain water tank as follows: 1. Connect one end of the ThermoWrap connecting tube to the Water-out Quick Coupling Connector (beneath Core Sensor socket), or, Connect the gray-coded end of the CureWrap connecting tube to the Water-out Quick Coupling Connector (beneath Core Sensor socket). 2. Connect special male connector to connecting tube: For ThermoWrap, see Figure 1. For CureWrap, see Figure 2. 3. Turn CritiCool device ON. 4. Change to Operation mode. 5. Allow excess water to drain into a receptacle, pail or sink. 6. When desired water level has been reached, turn CritiCool device OFF.

Special Male Connector for Draining Water Tank

Figure 1

Special Male Connector for Draining Water Tank

Figure 2

Controller Troubleshooting

Observation

Controller Troubleshooting Message HALT - PLEASE RESTART

Probable Cause

Action to be Taken

Error during normal function

Turn OFF system for three seconds and then ON again. If problem persists, turn OFF CritiCool unit and contact your local service representative. Note the number that appears on screen

ATTENTION NO WATER – PLEASE ADD WATER

No water in tank

Refill water tank

Water tank float is jammed

Open water tank cap and insert long object to release float

ATTENTION OUT OF NORMOTHERMIA PRESS OK TO CONFIRM

Cooling Therapy Desired set-point is set to exceed 38°C (100.4oF) Normothermia Management Desired set-point is set above 38°C (100.4oF) or below current set point

Approve action

ATTENTION CHECK CORE SENSOR

Misplacement of sensor in core socket

Connect core sensor to appropriate socket

Core adapter is connected to CritiCool unit without disposable temperature sensor

Connect disposable sensor

11

Misplacement of sensor in surface socket

Connect appropriate surface sensor to socket

Surface adapter is connected to CritiCool unit without disposable temperature sensor

Connect disposable sensor

XX

ATTENTION CHECK SURFACE SENSOR 12

- Indicates alarm activated

Disapprove action

Controller Troubleshooting

ATTENTION CONNECT CORE SENSOR*

ATTENTION WATER TEMP TOO LOW

Probable Cause No Core Sensor inserted in socket

Water Temperature < 10oC (50.0F)

16 ATTENTION WATER TEMP TOO HIGH

Water Temperature > 42oC (107.6F)

17 ATTENTION CORE READ OUT TOO LOW 18 Patient temp ABOVE 38.5ºC (101.3ºF)**

Action to be Taken Connect Core Sensor

Turn OFF system for three seconds and turn ON again. If problem persists, turn OFF CritiCool unit and contact your local service representative Turn OFF system for three seconds and turn ON again. If problem persists, turn OFF CritiCool unit and contact your local service representative

Cooling Therapy: Core temperature is more than 2°C below set point Normothermia management: Core temperature is less than 27.0ºC (80.6ºF)

Re-warming: Do not attempt to increase more than 2 ° C above actual core temperature Insert core sensor into patient

Core temperature reading above 38.5°C (101.3°F)

Inform physician

- Indicates alarm activated * The alarm is activated again after 30 minutes if no action is taken. ** Pressing Alarm Mute silences buzzer for this present condition and any re-occurrence of this condition for thirty minutes. ATTENTION ELECTRO-MAGNETIC INTERFERENCE 22

The CritiCool unit detects electromagnetic field higher than allowable standard

The message will disappear after ten seconds If message appears for more than ten seconds, replace Core Sensor

ATTENTION CONNECT SURFACE SENSOR

No Surface Sensor inserted into socket

Connect Surface Sensor to socket

Controller Troubleshooting

Message

Garment Models

°CureWrap

Adult Model

Patient Height cm (in.)

3500

Fits All Adult Sizes

Pediatric ThermoWrap

Pediatric Model

Patient Height cm (in.)

3131

79 – 91 (31 – 36)

3136

91 – 104 (36 – 41)

3141

104 – 122 (41 – 48)

3148

122 – 135 (48 – 53)

Garment Models

Infant ThermoWrap Infant °CureWrap

Infant Model

Weight Kg (Lb)

3118 / 3518*

2.5 – 4.0 (5.5 – 8.8)

3121 / 3521*

4.0 – 7.0 (8.8 – 15.4)

3125 / 3525*

7.0 – 11.0 (15.4 – 24.2)

*NEW Infant °CureWrap models

Garment Models

POSITIONING THE PATIENT

°CureWrap

Pediatric ThermoWrap Indicates Head Positioning

Infant ThermoWrap

-------- Indicates Armpit Line

•The garment should be filled with water prior to wrapping and securing to patient. •Do not use garment to lift or move patient. •Avoid handling garment with sharp objects. •Make sure garment is not folded or clamped. •Before moving patient from the operating table, ensure garment is fully released.

Garment Troubleshooting An alarm will sound to inform about any problem. The system will assist you in solving the problem. Observation Garment leak

Possible Problem

Action to be Taken

Accidental puncture of garment during course of operation

Turn OFF CritiCool unit and allow water to return to reservoir Replace garment if possible

Water leak from connector between garment and connecting tube

Connecting tubes are not connected properly

Close garment clamps. Disconnect connecting tubes and connect again Ensure click sound is heard

ATTENTION Check ThermoWrap

Damage to connecting tubes

Replace connecting tubes

Connecting tubes are not connected

Connect connecting tubes

Garment is blocked due to incorrect wrapping

Check for snarls, folds, or objects that obstruct water flow in garment

Garment clamps are closed

Check clamps

10

- Indicates alarm activated

QUICK REFERENCE GUIDE Catalog No. 014-00082

Ver: 02

Copyright © 2007 MTRE Advanced Technologies 4 Ha-Yarden Street, Yavne, P.O. Box 102, Rehovot 76100, Israel TEL: 972-8-932 3333 FAX: 972-8-932 8510 Website: www.mtre.com