Inspiration TECOTHERM NEO Instructions For Use Manual
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Inspiration TECOTHERM NEO Instructions For Use Manual

Medical equipment for hypothermia of neonate and infants
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TEC COM GmbH
TECOTHERM NEO
MEDICAL EQUIPMENT for HYPOTHERMIA
of NEONATE and INFANTS
Instructions for Use
IfU TECOTHERM NEO TN300 EN - 01.doc

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  • Page 1 TEC COM GmbH TECOTHERM NEO MEDICAL EQUIPMENT for HYPOTHERMIA of NEONATE and INFANTS Instructions for Use IfU TECOTHERM NEO TN300 EN - 01.doc...

  • Page 2: Table Of Contents

    Alarm Fluid level too low............... 11.5 Alarm No Mains Power ..............11.6 Fluid escapes from the TECOTHERM NEO System ....... 11.7 Fault Software Update Error ............IfU TECOTHERM NEO TN300 EN - 01.doc Page 2 of 76 Ref No. TN300 EN-01...
  • Page 3 13.7 Safety, Reliability ................Technical Data, TECOTHERM NEO Specification ......Declaration of Conformity ..............Disposal ................... Abbreviations Instruction for Use Body Core Temperature System Failure IfU TECOTHERM NEO TN300 EN - 01.doc Page 3 of 76 Ref No. TN300 EN-01...

  • Page 4: Preface

    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.

  • Page 5: About Contraindications

    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. IfU TECOTHERM NEO TN300 EN - 01.doc Page 5 of 76 Ref No.

  • Page 6: Informations For Customers Service & Technical Support

    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 IfU TECOTHERM NEO TN300 EN - 01.doc Page 6 of 76 Ref No. TN300 EN-01...

  • Page 7: Short Description Of The System

    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.
  • Page 8 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...

  • Page 9: Symbols, Indications

    Key “Turn On” System failure. Temperature Alarm Alarm No or restricted Flow. Alarm Low fluid level. Symbol AUDIO paused No Mains Power Internal System Failure IfU TECOTHERM NEO TN300 EN - 01.doc Page 9 of 76 Ref No. TN300 EN-01...

  • Page 10: Warnings, Precaution Guidelines

     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.
  • Page 11  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.
  • Page 12  Ensure that placement of TECOTHERM NEO is not forming trapping zones for hands and fingers to avoid contusions and other injuries.  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.
  • Page 13 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 <...
  • Page 14 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 “...

  • Page 15: Tecotherm Neo Hypothermia System

    TECOTHERM NEO Hypothermia System 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 ...
  • Page 16 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.
  • Page 17 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)
  • Page 18 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.
  • Page 19 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.
  • Page 20 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.
  • Page 21 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 IfU TECOTHERM NEO TN300 EN - 01.doc Page 21 of 76 Ref No.
  • Page 22 37°C, and treatment time. Starting treatment rewarming is automatically run. The rewarming rate is shown on the display screen. The TECOTHERM NEO system will linearly increase the BCT until selected target temperature is reached. System then stops further re- warming and holds BCT at the selected value.
  • Page 23 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.
  • Page 24 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 Mattress temperature is permanently displayed on the screen in the display feature LARGE SIZE NUMBERS.
  • Page 25 USB stick, see section 7.3, 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.

  • Page 26: Tecotherm Neo Device Informations, Performance

    Informations on TECOTHERM NEO Hypothermia Device Essential Parameters, Performance TECOTHERM NEO is a light- weight efficient and powerful hypothermia system Options Cooling / Warming, Normothermia Dimensions 375 x 190/ 215 x 310 mm (W x L x H) Mass / Weight...
  • Page 27 It is fan cooled to remove heat produced by the Peltier elements. It is operating exactly to reach the target temperatures adjusted by the operator, and hold them constant according treatment protocol. IfU TECOTHERM NEO TN300 EN - 01.doc Page 27 of 76 Ref No. TN300 EN-01...
  • Page 28 0,5 bar. Micro Computer controlled Operating Board and Control Board, MENU TECOTHERM NEO is furnished with an Operating Board and a MENU as user interface, and with a Control Board to control its operation features. Both boards are based on their separate powerful micro computers which are in permanent communication (master OP –...
  • Page 29 Section 11 Alarms Details see next section 7.3 Mains Cable Cord TECOTHERM NEO is plugged via medical grade cable cord to a 230 or 110VAC shock- proofed mains socket. Cable should be 2,5 m long and approved for shock- proofed sockets only.

  • Page 30: Indicators And Operation Elements

    Arrow Key: menu downwards or decrease value Female Coupling / socket for connecting hoses or mattresses Female Coupling / socket for connecting fill- up set for filling TECOmed IfU TECOTHERM NEO TN300 EN - 01.doc Page 30 of 76 Ref No. TN300 EN-01...
  • Page 31 Figure TECOTHERM NEO Rear side Mains Socket USB socket (10) Network socket (not operating) Further details see Section 7.9 IfU TECOTHERM NEO TN300 EN - 01.doc Page 31 of 76 Ref No. TN300 EN-01...
  • Page 32 33.5 Mattress Temperature 35.4 Rectal Temperature 33.6 Skin Temperature ----- 33.6 Constant rectal temperature for 01:34 hours 23.03.2010 08:55:42 Set Point 33.5 hour Options Details IfU TECOTHERM NEO TN300 EN - 01.doc Page 32 of 76 Ref No. TN300 EN-01...

  • Page 33: Temperature Probes

    Body core temperature BCT is measured with the rectal probe. Ensure that the probe is correctly inserted in the patient and that it is properly secured. Also ensure that the probe is properly connected to the TECOTHERM NEO socket marked R ! see Figure below.

  • Page 34: Hoses / Hydraulic Lines

    The hose set is composed of fluid tubing made of transparent polyurethane materia and a thermally shielding envelope made of silicone foam material. Mattresses, wraps and pads are connected to TECOTHERM NEO by means of the hoses. Hoses are connected to the device with male connectors, to the mattresses with female connectors.

  • Page 35: Fill- Up Set

    Figure Fill- up set TECOmed Thermalizing Fluid TECOTHERM NEO uses TECOmed as a circulating fluid to bring cold and heat to the patient. TECOmed is supplied in 5 l containers made of polypropylene or HD polyethylene. TECOmed is composed of 70% water, 30 % ethanol and additives. For details see Safety Data Sheet.

  • Page 36: Mattresses, Cool Wraps, Cool Pads, Parts And Protective Layers

    Mattresses of Aqua Therm Pad type are multi- use applied parts for total body cooling, see section 7.2 for sizes and details. Figure Cool wrap T NEO PAD 44 x 65 cm with male QDC connectors Eyelet IfU TECOTHERM NEO TN300 EN - 01.doc Page 36 of 76 Ref No. TN300 EN-01...
  • Page 37 IfU TECOTHERM NEO TN300 EN - 01.doc Page 37 of 76 Ref No. TN300 EN-01...

  • Page 38: Menu, Operator Interfaces, Usb Port

    Pushbuttons below display screen enable performing instructions like Select, Confirm, Cancel, Apply, Start etc. TECOTHERM NEO Main MENU always serves as a Starting point for navigation. Using Main MENU the operator selects a Menu language: entry Language., see section 8.3.
  • Page 39 After successful export unplug USB stick. For service: Socket (9) is an USB interface port. Plugging USB hardware stick is for updating firmware and detailed data export. IfU TECOTHERM NEO TN300 EN - 01.doc Page 39 of 76 Ref No. TN300 EN-01...

  • Page 40: Neo Hypothermia System Putting Into Operationtecotherm

    Plug the cable cord into rear socket. Then plug the system to the mains 230 V / 50 Hz into shock-proofed socket. The equipment is prepared for operation at 230VAC. Note Immediately after plugging to mains TECOTHERM NEO is in its Stand- by mode. Key (1) is lit light green. IfU TECOTHERM NEO TN300 EN - 01.doc Page 40 of 76 Ref No.
  • Page 41 Next Step Connect mattress / cool wrap to the TECOTHERM NEO Prior to connecting check whether  mattress / wrap is filled completely. If empty or only partially filled, see Section 8.6 for filling instructions.  defects like punctures and flaws are existing. If fluid escapes replace or repair defect mattress/ wrap.
  • Page 42 Press Pushbutton (1). The lit key changes to intensive Green The Initialisation Procedure is started automatically. Note TECOTHERM NEO is running a self- test to check internal functions followed by a test of the alarm functions. Display screen is illuminated, LED indicator (4) flashs blue, LED indicator (5) flashs green.
  • Page 43 Symbols and clearly hear the two alarm sounds? If NO: It is not allowed to run the device without working alarm functions. TECOTHERM NEO will shut off at after 30 seconds (Pop Up window appears) If YES TECOTHERM NEO Main MENU is displayed.
  • Page 44 When neonate is placed and all is prepared push key START once again to start the servo controlled treatment. Example How to perform hypothermia treatment in Treatment Mode 3 Exemplary approach: Treatment Mode 3 Constant Mattress Temperature IfU TECOTHERM NEO TN300 EN - 01.doc Page 44 of 76 Ref No. TN300 EN-01...
  • Page 45 Display feature DIAGRAM with treatment parameter boxes is displayed. Treatment starts. 60 seconds later display feature LARGE SIZE NUMBER appears displaying current mattress temperature. hour Options IfU TECOTHERM NEO TN300 EN - 01.doc Page 45 of 76 Ref No. TN300 EN-01...
  • Page 46 Treatment is started Normally TECOTHERM NEO reaches the set rectal temperature 33,5°C after 25 – 35 min (small mattress 30x 45 cm) and 30 – 35 min (cool wrap. Have in mind that cooling down rate is depending on weight of the patient and on the ambient conditions/ temperature: the higher the more time is required.
  • Page 47 The operator gets an information on the screen whether data export was successful. After successful export unplug USB stick. Data export Highlight and select designated data export Export new treatment data Export all treatment data Back Select IfU TECOTHERM NEO TN300 EN - 01.doc Page 47 of 76 Ref No. TN300 EN-01...

  • Page 48: Stop Operation/ Turn Off Device

    Push button (1) is lit as long as system is plugged to mains. Unplugging mains cause green push button light to turn off. NOTE Finally TECOTHERM NEO system should be put into and left in a state to guarantee properly starting a new hypothermia treatment. IfU TECOTHERM NEO TN300 EN - 01.doc Page 48 of 76 Ref No.

  • Page 49: Filling / Refilling Procedures

    Filling / Refilling Procedures TECOTHERM NEO’s hydraulic module is equipped with an internal fluid tank of 250 ml volume containing circulating TECOmed fluid. This container is prepared and prefilled by the manufacturer ready for operation. Filling circulating fluid into the TECOTHERM NEO device TECOTHERM NEO is put into operation, treatment is running.

  • Page 50: Application Of Mattresses

    If not prepared fill fluid bottle with TECOmed up to the upper mark 500 ml. After filling close bottle cap tightly. Filling procedure using filled TECOTHERM NEO device prepared for operation  Connect empty or partially filled mattress/ cool wrap with QDC directly or via hoses to the unit ports (6).
  • Page 51 (6) are on the same level, approximately.  Use only mattresses specified or recommended by TEC COM as the manufacturer of the TECOTHERM NEO systems, or authorised distributors.  Use thin disposable protective interlayer which must at least fully cover the mattress with 5 cm larger border area all around.
  • Page 52 Fixation tape Wrap neonate only to an extent that free access to the patient is ensured. Wrap creates a cool ambient around and near neonate. IfU TECOTHERM NEO TN300 EN - 01.doc Page 52 of 76 Ref No. TN300 EN-01...

  • Page 53: Hygienic Requirements

    Hygienic Requirements We draw your attention to the following minimal hygienic requirements for the application of TECOTHERM NEO hypothermia system, procedures and components To meet these minimal hygienic requirements we recommend a careful disinfecting cleaning of applied parts (mattresses etc.), hoses and QDC.

  • Page 54: Temperature Probes

    NEO device unit, electrical mains cable, fill- up set and hoses. Keep all parts together. Store equipment in a closed cabinet. Basic Unit The TECOTHERM NEO basic unit should be stored in a closed cabinet to protect it against mechanical damage and dust. Put it onto a solid board horizontally standing on feet.

  • Page 55: Storage Of Mattresses

    0,33 vol % of the denaturing agent Methyl- Ethyl- Ketone. 10.4 Transport TECOTHERM NEO is a light- weight hypothermia system with weight 7,2 kg when the reservoir is full. Carry it to move the device over short distances or use an appropriate trolley.

  • Page 56: Alarms - Malfunctions - Failure - Signals And Troubleshooting

    No system voltage due to mains power failure. NOTE When alarm is appearing push key T5 to silence audible alarm (AUDIO paused, is appearing at the display.) IfU TECOTHERM NEO TN300 EN - 01.doc Page 56 of 76 Ref No. TN300 EN-01...
  • Page 57 After Switch On of the TECOTHERM NEO the operation readiness of the alarm system is automatically checked through self- testing. Display screen is showing the Information TECOTHERM NEO A check of the internal functions has been performed and did not detect any malfunction.

  • Page 58: System Alarm, System Failure

     TECOTHERM NEO is switched If System alarm disappeared continue treatment. Note: Previous Treatment normally is continued after confirming Yes on the screen appearing just after power returned. IfU TECOTHERM NEO TN300 EN - 01.doc Page 58 of 76 Ref No. TN300 EN-01...
  • Page 59 Ser.-Nr. 2010/08/01 Rev. 023/01.32 Select If possible Replace TECOTHERM NEO device by a replacement unit or a spare unit. Put it into operation according IfU. IfU TECOTHERM NEO TN300 EN - 01.doc Page 59 of 76 Ref No. TN300 EN-01...
  • Page 60 The Control Board then 10 seconds later is switching off the device The operator can now analyse the situation. Turn ON the TECOTHERM NEO device to continue treatment operation. If SF indicator alarm reappears switch system Off. After 5 seconds Turn On device again and try to continue in Treatment Mode 3 Constant Mattress Temperature as the Fallback Mode, see section 7.1.

  • Page 61: Temperature Alarm

    Look at first the temperatures in the upper part of the display and check whether indicated temperatures are corresponding to the treatment section temperature settings and are plausible and make sense. IfU TECOTHERM NEO TN300 EN - 01.doc Page 61 of 76 Ref No. TN300 EN-01...
  • Page 62 The more it is slipped out the lower is the detected and indicated temperature (approaching ambient temperature.) If slipped out place probe into correct position and secure it. IfU TECOTHERM NEO TN300 EN - 01.doc Page 62 of 76 Ref No. TN300 EN-01...
  • Page 63 Power Off using arrow keys. Device is shut down. Do not switch on the device again! Contact your local service. In all cases If possible replace TECOTHERM NEO device by a replacement unit or a spare unit. Put new system into operation/ Start operation following IfU.

  • Page 64: Alarm No Flow

    How to proceeed see Section 11.1 Stop operation, shut off the device. Treatment is stopped. If possible Replace TECOTHERM NEO device by a replacement unit or a spare unit. Case 2 Inspect and check hoses, tubing, connecting couplings, mattress.
  • Page 65 (a few seconds). Then close bottle cap tightly. If you do not succeed If possible: Replace TECOTHERM NEO device by a replacement unit or a spare unit. Start treatment according IfU. Otherwise stop treatment and immediately contact your local service for assistance.

  • Page 66: Alarm Fluid Level Too Low

    When alarm is appearing push key T5 to silence audible alarm (AUDIO paused, is appearing at the display.) Caused by Leakage in the TECOTHERM NEO device / Hydraulic Module. Lack of fluid caused by leakage in hoses, at couplings or in mattress In the container Fluid volume is less than 1/3 for at least 10 seconds.
  • Page 67 In such cases, see instructions here in this Section 11.4. Attention After refilling, the TECOTHERM NEO is ready for use. Usually the added fluid has a different temperature than the system fluid.

  • Page 68: Alarm No Mains Power

    Internal defect in the TECOTHERM NEO device Elimination/ Management Check whether key T1 is lit slightly green. If not lit TECOTHERM NEO is disconnected from mains grid. If only the TECOTHERM NEO device is shut off (and no other equipment in the room) check that cable cord is tightly plugged to the mains socket and to the device rear socket.
  • Page 69 TECOTHERM NEO will continue the previous treatment mode automatically when mains supply reappears. TECOTHERM NEO is designed to continue operation in the previous treatment mode when mains voltage reappears. Treatment configuration is restored within an interruption period of max. 60 minutes The operator is asked to continue the interrupted treatment or not, see MENU picture below.

  • Page 70: Fluid Escapes From The Tecotherm Neo System

    Splashes and wetness at, near or below the device. Management/ Elimination STOP OPERATION, POWER OFF, UNPLUG MAINS. Replace TECOTHERM NEO device by a replacement unit or a spare unit. Put new system into operation/ Start operation following IfU Contact your local service.

  • Page 71: Fault Software Update Error

    MENU shows instructions how to proceed if software up date is not or only partially successful. System will reboot. If necessary customer should turn to the TECOTHERM NEO manufacturer TEC COM GmbH or Authorized Service Representative for assistance and support.

  • Page 72: Training & Qualification Of Personnel

    13.3 Substitution of TECOmed fluid The TECOmed fluid circulating in the TECOTHERM NEO system should be substituted every 3 months. Substitution should be performed in the Treatment Mode 3 Constant Mattress Temperature.

  • Page 73: Substitution Of Tecomed Fluid In Mattresses And Cool Wraps

    Start refilling according to section 8.5 of this IfU. Then repeat emptying procedure as described above. Final step: Refill TECOTHERM NEO as described in section 8.5 of this IfU. Substitution of TECOmed fluid is finished, TECOTHERM NEO is ready for operation.

  • Page 74: Safety, Reliability

    13.7 Safety, Reliability Caution For a reliable and safe operation of the TECOTHERM NEO use only original components, parts and spare parts supplied or licensed by the manufacturer. Use only such components, parts and accessories for hypothermia treatment with a...

  • Page 75: Technical Data, Tecotherm Neo Specification

    14. Technical Data / TECOTHERM NEO Specificatio Options Cooling & Warming Dimensions 375 x 190 / 215 x 310 mm (W x D x H) Weight without accessories approx. 7,2 kg Central Cooling Module Thermoelectrically based module Treatment temperature control ranges Neonate, Babies Mattress + 12 °C to + 38 °C...

  • Page 76: Declaration Of Conformity

    TEC COM GmbH Address: Böllberger Weg 170 D-06128 Halle, Germany The manufacturer, certified according ISO 13485 herewith declares that the actual device Hypothermia System TECOTHERM NEO fully complies to the requirements of Medical Device Directive 93/42/EEC Safety, general EN 60601-1: 2007...

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