TECOTHERM NEO Instructions for Use April 2010

1.

Contents and abbreviations page

2. 2.1 2.2 2.3 3. 4. 5. 6. 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7. 7.8 7.9 8. 8.1 8.2 8.3 8.4 8.5 8.6 8.7 9. 9.1 9.2 9.3 10. 10.1 10.2 10.3 10.4 11. 11.1 11.2 11.3 11.4 11.5 11.6 11.7

Preface ... Intended Use ... About Contraindications... Operator Profile ... Informations for Customers, Service & Technical support... Short description of the system... Symbols, Indications... Warnings , precaution guidelines ... TECOTHERM NEO Hypothermia System ... General description of the system, Operation modes... TECOTHERM NEO device Informations, Performance ... Indicators and Operation elements... Temperature Probes ... Hoses / Hydraulic lines ... Fill- Up set ... TECOmed circulation fluid ... Mattresses, Cool Wraps, Cool Pads, parts and protective layers ... MENU, operator interfaces, USB port... NEO Hypothermia System Putting into operationTECOTHERM ... Initial Set up / Initial Operation ... Initial Operation by the customer: Pre- operation Check up ... Initial Operation by the customer ... Stop operation/ Turn off device... Filling / Refilling Procedures... Preparation of empty or partially filled mattress... Application of mattresses... Hygienic Requirements... Cleaning and Disinfecting TECOTHERM NEO... Mattresses, thermally insulated hoses, tubing... Temperature Probes ... Storage ... Storage of the TECOTHERM NEO device... Storage of Mattresses... Storage of TECOmed ... Transport ... Alarms - Malfunctions - Failure - Signals and Troubleshooting ... System Alarm, System failure ... Temperature Alarm ... Alarm No Flow ... Alarm Fluid level too low... Alarm No Mains Power ... Fluid escapes from the TECOTHERM NEO System ... Fault Software Update Error ...

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12. 13. 13.1 13.2 13.3 13.4 13.5 13.6 13.7 14. 15. 16.

Training & Qualification of personnel ... Service, preventive maintenance, Software Update ... Service & Maintenance ... Cleaning the ventilation hole structure (device bottom)... Substitution of TECOmed fluid ... Substitution of TECOmed fluid in mattresses and cool wraps ... Software Update ... Check/ calibration of temperature probes... Safety, Reliability ... Technical Data, TECOTHERM NEO Specification ... Declaration of Conformity ... Disposal ...

72 72 72 72 72 73 73 73 74 75 76 76

Abbreviations IfU BCT

Instruction for Use Body Core Temperature

SF

System Failure

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2.

Preface

2.1

Intended Use

This Instructions for Use (IfU) presents a detailed introduction into the operation modes of TECOTHERM NEO from TEC COM GmbH. The Hypothermia System TECOTHERM NEO is designed for controlled comfortable cold & heat treatment procedures. By means of mattresses or cool wraps cold and heat is applied to the total body, body parts or areas of neonate depending on the therapy objective. One main application is induced hypothermia treatment of neonate affected with Hypoxic Ischemic Encephalopathy. The IfU contains a Technical Desription and technical data. TECOTHERM NEO of TEC COM exhibits SERVO CONTROL operation as a modern excellence feature using MENU assistance. TECOTHERM NEO of TEC COM has been equipped with two micro computers and with numerous monitoring and alarm features which guarantee a high standard of treatment and operation safety. We highly recommend that the operator is familiar with the operation modes and capabilities of the TECOTHERM NEO. Prior to putting into operation carefully read these IfU! This IfU is associated with a software version. The valid version number is displayed at the lower left part of operator’s MENU display screen after switching on the device. Note: The Manufacturer carries responsibility for basic safety, reliability and capability of the TECOTHERM NEO system only when  local electrical installation fully meets the requirements of the IfU.  initial operation is performed according prescribed Instruction procedure by authorized personnel.  TECOTHERM NEO is operated according to the instructions and statements of said IfU.

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2.2

Contraindications for Use

No general contraindications are known. For possible adverse effects study the relevant treatment and therapy protocols. Avoid direct contact of mattress or cool wrap with patient’s skin! Avoid direct contact of mattress or cool wrap with fresh or non- closed wounds, infectious areas, areas with ulceration and abcesses, rash and burns.

2.3

Requirements: Operators Profile

Operating a TECOTHERM NEO requires  Healthcare Professional experienced in using life support and life sustaining equipment  Personnel must be trained in the use of the TECOTHERM NEO before operating the device.

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3.

Informations for Customers Service & Technical support

For Technical Support in German please contact: TEC COM GmbH Phone Fax E mail

+49 - 345 - 120 52 04 +49 - 345 – 120 52 11 [email protected]

For Technical Support in English please contact: Inspiration Healthcare Ltd Phone +44 - 1455 840555 Fax +44 - 1455 841464 E mail [email protected]

The manufacturer TEC COM or authorized representives will instruct and introduce the operation personnel prior putting the equipment into operation Information, technical support, additional manuals may be requested from any authorized distribution partner. Manufacturer

Type label

TEC COM GmbH Gesellschaft für Technik, Technologie und Vermarktung Böllberger Weg 170 D-06128 Halle/Saale Germany

TECOTHERM NEO Seriennummer 2010/07/01 230 V 50 Hz 1,5 A Si 2 x T 2,5 A / 250 V Schutzklasse I IP 20 TEC COM GmbH Gesellschaft für Technik, Technologie und Vermarktung Böllberger Weg 170 D-06128 Halle/Saale Made in Germany

0494 DIN EN 60601-1, DIN EN 60601-1-2

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4.

Short Description of the Equipment

The Hypothermia System TECOTHERM NEO is designed for controlled cold & heat treatment procedures and application of specific cold and heat doses to neonate and babies. The system applies cold and heat to total body, body parts and areas depending on therapy target by means of mattresses and / or cool wraps NEO PAD. One main application is hypothermia treatment of neonate affected with Hypoxic Ischemic Encephalopathy. Another application designed for controlled hypothermia treatment is Total Body Treatment of Children up to body mass of 50 kg.

TECOTHERM NEO consists of a unique cold & heat generating device, applied parts like mattresses and wrap, interconnecting hoses (tubing set), accessories. Applied parts are connected to the device via hoses by self- sealing quick- disconnect couplings. The patient is provided with cold and heat according therapy target in a fully controlled way by a circulating fluid. This physiologically safe water- based fluid is cooled or warmed in the device and flows through the mattress or wrap continuously supplying the patient with therapeutically prescribed doses.

Patient temperatures are measured with approved calibrated probes connected to the TECOTHERM NEO device. Temperature data is permanently communicated to the device Operational System. Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points and operating at set point temperatures accurately with max. deviation of +/-0,3°C, monitoring the treatment, and alarming when when exceeding or falling below temperature limits are Essential Performances of TECOTHERM NEO. TECOTHERM NEO is electronically divided into a Operational System and a Controlling System. Both sub systems are micro computer (µC) based. Both µC communicate permanently to ensure safe and proper operation according to therapy needs. A comfortable user MENU will guide the operator to the treatment modes, advise how to proceed the treatment and how to manage treatment details. Menu language may be preselected using Main Menu: English, Deutsch, Espanol …. .

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TECOTHERM NEO offers three separate treatment modes to induce hypothermia and to re- warm the patients. TECOTHERM NEO uses 2 independent temperature probes:  rectal probe for measuring Body Core Temperature (BCT) and  skin probe for measuring skin abdominal or forehead temperature etc The three treatment modes are (1)

SERVO CONTROL Programmable Complete Treatment Mode

(2)

SERVO CONTROL Constant Rectal Temperature Mode

(3)

Constant Mattress Temperature Mode

The Operator selects the treatment mode 1, 2 or 3 and treatment parameters for inducing hypothermia, normothermia or hyperthermia following the MENU instructions. Attention: Temperature probes must be properly placed before treatment procedure can start. Treatment and selection of treatment procedure is fully within the responsibility of the therapist, physician or trained qualified medical personnel. Attention For neonate and other patient hypersensitivity or restricted compatibility to hypothermia and / or hyperthermia is in general not known. Neonate receiving such treatment must be under careful observation.

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5.

Symbols, Indications

Important Information Attention, Caution, Warning Electrical Hazard ! Applied Part Type BF Rectal Temperature Sensor socket

R

Skin Temperature Sensor socket

S

Key “Turn On”

SF

System failure.

Temperature Alarm

Alarm No or restricted Flow.

Alarm Low fluid level.

Symbol AUDIO paused

No Mains Power

SF

Internal System Failure

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6.

Warnings, Precaution guidelines 

Warnings

 Do not open the device! Risk of electrical shock. Opening the device is restricted to service and other authorized personnel.  Do not remove cover part. Risk of electrical shock when touching inner parts and components  The TECOTHERM NEO device must be plugged to the mains only to shockproof sockets. Mains voltage must be 230 VAC/ 50 Hz or 110 VAC/ 60 Hz. Use only cord supplied with the device or a medical grade approved equivalent cord not longer than 2,5 m.  Repair and maintenance are restricted to authorised personnel only!  For a reliable and safe operation use only original components, applied parts and spare parts supplied or recommended by the manufacturer.  Only TECOmed (or approved substitute ) should be used as circulating fluid.  Use only temperature probes in accordance with IfU and with the technical specification of the manufacturer. Applying different probes may lead to incorrect and wrong temperature data. This is likely to put patients at significant risk!  Ensure that Rectal and Skin Temperature Probes are correctly placed in / on the patient and that probes are properly secured. Also ensure that probes properly connected to the TECOTHERM NEO socket marked "R" (Rectal for Body Core Temperature) and “S” (Skin for Surface Temperature). The same holds for bladder temperature probes measuring children’s BCT. Use probes with the correct mating connector to the “R” socket.

Caution When TECOTHERM NEO is run in the Constant Mattress Temperature Mode to lower body core temperature an independent temperature measurement is required to monitor hypothermia. Note that applied treatment temperature and duration do not allow a realistic estimation of the actual degree of lowering of patient’s BCT.  Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility and needs to be installed and put into service according to the Electromagnetic Compatibility information provided in the Technical Description and Service & Maintenance Manual.

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 Portable and mobile RF communication equipment can affect medical electrical equipment. Observe the recommended separation distances listed in the Technical Description.  The TECOTHERM NEO device should be subject to regular maintenance and service, see section 13  Fill and replace fluid regularly every 3 months, see section 8.5.  Only TECOmed (or approved substitute) should be used.  Note Circulation may stop, fluid flow stops. In such cases mattresses may cool neonate or patient slowly down. Especially during treatment re-warming phase neonate may suffer from extraction of body heat back into the mattress. Change such condition soon!  The user should not apply other cleaning, disinfecting and decontamination procedures than those recommended by the manufacturer. If in doubt contact your local representative.

Precaution Notes for placement Location  The unit must be placed horizontally onto a level support  The system is fan cooled. Sufficient space must be allocated so that a free flow of air from all sides can reach the bottom of the device when it is in operation.  Do not place the device into small cabinet compartment or onto small scale boards. Do not cover the device!  Device should be located so that there is a distance of at least 15cm between rear side and a wall or another limiting surface to ensure free outflow of the cooling air.  The unit should be placed avoiding air to be blown towards the patient.  The unit should be placed so that optical blink alarms are clearly seen and acoustic alarms are clearly audible.  Do not place mattresses and hoses onto hot or warm supports during operation  Do not place the device during operation near intensive heat sources.  Attention Ensure and leave enough space around the TECOTHERM NEO not to obstruct passage of acting personnel. Ensure that hoses, cable cord, temperature probes etc. do not form obstacles.

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 Ensure that placement of TECOTHERM NEO is not forming hands and fingers to avoid contusions and other injuries.

trapping zones for

 Check type of mattress and interlayer. Use thin disposable interlayer which must at least fully cover the mattress with some border. Such interlayer must be coated at lower side with plastic coating to prevent penetration of blood, liquids or liquid media onto the upper surface of the mattress and to protect the patient.  Note: Place mattress/ cool wrap onto a  10 - 20 mm thick foam material that has good thermal insulation during operation.

Using an incubator When using an incubator to perform hypothermia treatment  Pay attention that there is enough space to properly place mattress or cool wrap. Otherwise kinking of hose set and / or tubing near mattress and mattress folding may cause restricted fluid flow, bad circulation or even flow blocking  Place the hoses set in a way that the hoses are in a straight line. Fasten the hoses in such a way to avoid kinking of the tubing near the mattress  Note: Place mattress onto a  10 - 20 mm thick foam material that has good thermal insulation during operation.  Note: Do not put mattress directly onto compact silicon inlays used in incubators or the like.  Attention Ensure that incubator heaters are shut off! Ensure that there is no forced air circulation. It may cool down the neonate in a re- warming phase of the treatment.

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Indications for hazardous substances TECOTHERM NEO does not contain parts or substances stemming from derivatives of blood or human/ animally tissues. TECOTHERM NEO does not contain parts made of Latex or its derivatives. TECOTHERM NEO Applied Parts do not contain parts made of PVC with DEHP softener/ plasticizer Thermalizing Fluid TECOmed is made of 70 % water, 30% pure Ethyl alcohol. Very small quantity < 0,3 % denaturing agent Methyl- Ethyl- Ketone MEK is added. Details see Safety Data Sheet.  Caution

Do not swallow or ingest fluid.

 Skin contact with TECOmed fluid is harmless.  Note

After use close TECOmed containers tightly

Ambient Conditions To ensure a proper operation in normal use pay attention to the following conditions  Protection The device should be protected from dampness and wetness (e.g. splash water.)  To have full cooling power ambient temperature should not exceed 27°C. Otherwise the TECOTHERM NEO system may not achieve the lowest possible set temperature of a big mattress.  Relative Humidity during treatment within a range of 30 % - 80 %  Ensure that during treatment/ operation no installations, systems, devices and the like are operating or are intended to operate next to TECOTHERM NEO and producing strong electromagnetic radiation ultraviolet radiation intense infrared radiation mechanical shocks, vibrations.  Do not intensively illuminate the device.

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

NOTE

Information and Advice for operators

Users and Operators should intensively read the I f U to become familiar with all instructions and technical details To acquaint operators and users with instructions and measures to handle alarms and situations under single fault conditions is important. Operator is requested to become mentally familiar with the treatment equipment as a physiological closed- loop control system PCLCS *) , see section 7. Note for operators and users To be familiar with instructions and measures to handle alarms and situations under single fault conditions is important. Note for operators and users When placing the TECOTHERM NEO device positions and motions of patient, operators and other personnel have to be taken into consideration. Circumstances and situations near TECOTHERM NEO site before, during and after treatment have to be considered. Note for operators Consider possible mechanical means for positioning, supporting or erecting the patient during treatment. They may block or reduce fluid circulation We recommend that operator should independently monitor patient temperatures during treatment. *) PCLCS and Mental Model To develop an imagination on cause and effect in TECOTHERM NEO treatment mode 1, Section III, a realistic single fault condition scenario is assumed: Rectal Temperature Sensor is slipped out the patient’s rectum. The probe now detects a much lower temperature measuring ambient air temperature near the neonate rectum. This temperature shown at the display screen strongly deviates from the BCT 33,5 °C (cause). To reduce the deviation TECOTHERM NEO is increasing the fluid / the mattress temperature (effect): the Control Board responds with activation of warming to increase the “ pretended BCT, appearently to low “. After 5 minute period the device indicates temperature alarm. Display is showing confusing temperature data: Low rectal temperature, normal skin temperature, high mattress temperature. But a mentally prepared operator decide to immediately inspect and check the position of the rectal probe.

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7.

TECOTHERM NEO Hypothermia System

7.1

Description of the System

TECOTHERM NEO Hypothermia system, system components and accessories  TECOTHERM NEO device  Application parts like mattresses, cooling wraps, cooling pads  Temperature probes with connectors to the device  Hose set, thermally shielded to connect application parts to the device  Fill-up set, includes necessary components for filling/ re- filling TECOmed  5 litre TECOmed fluid, canned in PE or PP container  Thin protective interlayer  Electrical Power cord, up to 2,5 m Optional  Repair set for small mattress defects like punctures and flaws  Fluid Emptying Aid for mattress  Storage boxes

Cooling wraps for total body cooling of neonate and infants for Multiple Use Mattresses for Total Body Cooling are Therm Aqua Pad 30 x 45 cm (small size) and 50 x 90 cm (medium size) IfU TECOTHERM NEO TN300 EN - 01.doc

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Interlayer separate mattresses/ wraps from patient body preventing intimate direct contact. For total body cooling treatment the TECOTHERM NEO device pumps TECOmed along the hydraulic lines through mattresses / wraps or pads to lower or increase body core temperature to the set value. Users may preselect the most appropriate treatment procedure and target temperatures. During circulation the micro computer of the Control Board is permanently comparing/ analysing the measured and set rectal temperatures. The larger the deviation between the two temepratures the more cooling or heating power is to be supplied by the TECOTHERM NEO device. Rectal temperature stands for body core temperature BCT.

Treatment procedure temperatures for inducing hypothermia in neonate are strictly limited  Rectal Temperature standing for BCT (lower limit / upper limit) in the treatment mode 1

32°C/ 35°C

 Mattress temperature

12°C/ 39°C

Device internal temperature alarm limits

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Treatment and operation modes of TECOTHERM NEO TECOTHERM NEO is designed as a physiological closed- loop control system PCLCS , see this section. Three treatment and operation modes of TECOTHERM NEO 1 Programmable Complete Treatment Mode (Servo controlled mode) 2 Servo Control Mode (constant rectal temperature) 3 Constant Mattress Temperature Mode

Note: The operator can permanently follow the Rectal Temperature on the display screen, see section 7.3.

Treatment Mode 1 Programmable Complete Treatment Mode (Servo controlled mode) (automatic mode, treatment protocol)

Note This mode is limited to temperatures and profiles stated in the TOBY Study protocol (see reference) for inducing hypothermia in neonate suffering from Hypoxic Ischemic Encephalopathy

temperature

System is designed for inducing hypothermia in a patient by total body cooling. Details for inititial operation see section 8.

time

Rectal temperatures can be selected and set within a range 32°C to 38°C. Temperature is accurately adjusted and finely tuned. Necessary TECOTHERM NEO system equipment to run treatment is    

TECOTHERM NEO device Mattress for total body cooling, filled, protecting foil interlayer Rectal Temperature Probe, Skin temperature probe Themally shielded hoses to connect mattress to the device.

All equipment parts should be checked and prepared to start treatment, see section 8 of this IfU. Patient – neonate – should be placed onto the mattress/ cool wrap. Rectal probe should be inserted and secured. To start treatment you have to follow and observe the instructions of the MENU. Operation Mode 1 has five (5) treatment sections/ phases.

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Treatment section I (optional)

Thermal preparation of the mattress

Prior to start hypothermia treatment you may prepare the mattress thermally. Following treatment procedure will be performed by the system independently on this section. Whether such preparation is appropriate depends on your information state on the neonate you have to treat. A mattress precooled to 18 – 22°C may shorten the coolingdown treatment section II. Treatment section II

Rapid Cooling- Down Phase

TECOTHERM NEO is operating to cool down as fast as possible. The system is operating with maximum cooling power. Body heat from the patient/ neonate is eytracted by the cooling mattress and transferred to the circulating fluid. The central device cooling unit extracts the heat and cools the fluid on demand. When rectally measured BCT is reaching the target temperature 33,5°C the system will reduce the cooling power automatically. Control board microcomputer determined a sufficiently small deviation of measured and set temperature to start power reduction. Control system approaches set temperature without remarkably overshooting/ undershooting.

Treatment section III

Cooling Phase

Reaching the set temperature 33,5°C the system continues treatment to hold BCT of the patient constant. Treatment time is preselected by the operator (default 72 h). The Rectal (BCT) temperature is pre-selected (default 33,5 °C). The control board permanently compares measured rectal temperature with set BCT 33,5°C. The central cooling unit is permanently adjusting the temperature of the circulating fluid to hold BCT at 33,5°C. If during treatment section III BCT of the patient is increasing/ decreasing caused by disturbances the difference between measured and set rectal temperature increases. The system initially will respond with more cooling power or increasing warming. If deviation exceeds 0,5 °C in any direction, for some longer time the internal monitoring system will detect this discrepancy. TECOTHERM NEO starts alarming. Treatment section IV

Re- Warming Phase

After cooling phase III the system automatically starts the re- warming phase. Re-warm target Rectal (BCT) Temperature and time to achieve this are pre-selected (Default BCT 37°C and 7 hours). The TECOTHERM NEO system will linearly increase the BCT until selected target temperature 37°C is reached. System then stops re- warming. BCT remains at the selected value. In case of disturbances the system is responding as described in section III.

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Treatment section V (optional)

Holding BCT at Normal Temperature

The operator can continue the treatment. TECOTHERM NEO will automatically continue to hold neonate at the selected BCT 37°C or at a modified temperature. Operator can finish such treatment at any time. Having in mind the PCLCS in this treatment mode 1 Along all treatment phases the Control Board is permanently - every 2 seconds analysing temperatures and temperature differences. It instructs the central cooling unit to cool or warm the circulating fluid depending on the results of this analysis. The circulating fluid then extracts or transfers thermal energy from/ to the patient. Circulation is monitored by the Control board. All temperatures / time dates are recorded/ logged and can be read out/ transferred to an USB stick, see section 7.3 for the USB port. NOTE: All parameters can be changed from set position at ANY TIME should the need arise. Changes will be stored on the TECOTHERM NEO and can be seen on later analysis

NOTE: All parameters can be changed from set position at ANY TIME should the need arise. Changes will be stored on the TECOTHERM NEO and can be seen on later analysis

Attention

Fallback Mode

If treatment is interrupted or any reason for stopping operation in Automatic Treatment Mode 1 you may continue treatment using Treatment Mode 3 Constant Mattress Temperature which is a manual mode. Note Such treatment is a true alternative solution to continue treatment under mode 3 conditions (Fallback Case) Note Study details of treatment mode 3 prior to change treatment, see below. Note

Transition from automatic mode to Treatment Mode 3 Constant Mattress Temperature must be performed by the operator:

 TECOTHERM NEO rectal temperature probe should be disconnected and removed.

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 BCT monitoring requires installation of another independent accurate calibrated temperature probe (rectal probe or bladder catheter sensor) with a separate display showing the rectal temperature.

 Note Operator may continue to use the skin sensor connected to port “S” of the TECOTHERM NEO device as an auxiliary means if no other probes are available. That temperature is displayed on the screen in the small parameter boxes in the upper part of the display feature DIAGRAM and as temperature profile in the display feature DIAGRAM, see section 7.3 of this IfU.  Change to the Main MENU and select treatment mode 3 Constant Mattress Temperature Mode.  If transition to fallback mode must be done during treatment section II (cooling down): To cool down fast and efficiently to reach BCT 33,5°C select low mattress temperatures ( 12 – 15°C). Then follow the instructions of treatment mode 3, see below this section.  During treatment phase III or IV: Follow instructions of treatment mode 3, see this section below.

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