Inspiration TECOtherm NEO Instructions For Use Manual
Hypothermia system
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- Quick setup manual (3 pages) ,
- Instructions for use manual (76 pages)
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Summary of Contents for Inspiration TECOtherm NEO
- Page 1 Distributed by: TECOtherm NEO Hypothermia System Instructions for use of devices from software version 063/02.18...
- Page 2 Distributed by: Note: Before use, read this information carefully to familiarize yourself with the system. This is the only way to ensure safe and proper use of the TECOtherm NEO hypothermia system. Distributed by: Inspiration Healthcare Ltd 2 Satellite Business Village, Fleming Way...
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Page 3: Table Of Contents
Introduction and Brief Description ..................10 System Description ......................10 Overview of system components ................10 TECOtherm NEO device ................... 12 4.2.1 TECOtherm NEO – Front Side ................12 4.2.2 TECOtherm NEO – Rear Side................13 4.2.3 Display Menu ...................... 14 Power cable ...................... - Page 4 6.2.1 Filling process ..................... 27 6.2.2 Refill process ....................... 29 6.2.3 Emptying TECOtherm NEO and mattress ............29 Commissioning and Operation of the TECOtherm NEO System ......30 6.3.1 Starting Treatment ..................... 32 6.3.2 Monitoring during treatment ................33 6.3.3 Ending treatment ....................
- Page 5 Recommended safe distances between portable mobile telecommunications equipment and TECOtherm NEO ............48 Service Information ......................49 APPENDIX – Equipment and Accessories ................50 APPENDIX – Internal cleaning ..................... 51 Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 5/52...
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Page 6: General Information
Socket for rectal temperature sensor Manufacturer Serial number Socket for skin temperature sensor CE marking to declare that the product "Switch on" button complies with applicable EU requirements Temperature alarm Flow rate alarm 6/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019... -
Page 7: Instructions For Safe Use
Touch the fan protection grid on the rear of the device with your other hand first. It is necessary to train all persons working with the TECOtherm NEO with regard to the importance of the ESD warning sign and ESD protection measures. -
Page 8: Intended Use Of The Device
Intended Use Of The Device Intended Use The TECOtherm NEO hypothermia system is used for the targeted, precisely controlled and comfortable stationary temperature treatment by means of a mattress, with which the temperature control (cooling or warming) of the entire body or of body parts takes place as a function of the therapy objective. -
Page 9: Requirements For Operators And Users
Distributed by: Requirements for operators and users TECOtherm NEO is intended for use by healthcare professionals only. The TECOtherm NEO may only be used and operated by persons who meet the following qualifications and requirements: • Medical training • Work experience in intensive care, especially for use in neonatological and child intensive care units (ICU) •... -
Page 10: Introduction And Brief Description
Distributed by: In the vicinity of the TECOtherm NEO, no equipment, devices and equipment may be in operation or put into operation during treatment that: • Generate ultraviolet radiation • Generate infrared radiation • Generate strong electromagnetic interference with high intensity (e.g., HF surgery equipment or magnetic resonance tomographs) •... - Page 11 Used for optional skin temperature measurement sensor Only the accessories specified in “I APPENDIX – Equipment and Accessories“ must be used with TECOtherm NEO. This is the only way to ensure safe operation of the hypothermic system! Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18...
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Page 12: Tecotherm Neo Device
Connector socket for rectal Used to connect a rectal temperature sensor temperature sensor (R= Rectal) Socket for skin temperature sensor Used to connect a skin temperature sensor (S = skin) 12/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019... -
Page 13: Tecotherm Neo - Rear Side
Connects a USB stick to store data behind the panel of the mains plug socket: 2 replaceable Fuses fuses (cf. type plate) Mains plug socket Connects a power cord to the power supply Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 13/52... -
Page 14: Display Menu
POP-UP windows. Power cable The power cable is used to connect the TECOtherm NEO to a protective contact socket for power supply. The power cable is only permitted for connection to protective contact sockets with 100-130 V or 200-240 V and 50-60 Hz. - Page 15 A suitable cover cloth is to be used on the mattress; cf. “I APPENDIX – Equipment and Accessories“. Fastener Coupler plug loops Head section Fastener loops Example figure: Disposable mattress Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 15/52...
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Page 16: Cover Cloth (Interlayer)
Hose kit The hose kit is used for coupling the mattress to the TECOtherm NEO device and consequently produces the circulation of the temperature regulation fluid. The hose kit consists of two inner liquid-conducting hoses and the jacket hose for thermal insulation. -
Page 17: Refill Sets
Distributed by: Refill sets The TECOtherm NEO device can be filled or refilled with temperature regulation fluid using refill sets. The refill set consists of a specially prepared 500 ml container with two connecting hoses and self-sealing coupling plugs. External temperature sensors TECOtherm NEO has connections for a rectal temperature sensor and an optional temperature sensor for measuring skin temperature. -
Page 18: Overview Of The Operating Modes
Distributed by: Overview of the operating modes 18/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019... -
Page 19: Description Of The Operating Modes
The treatment in automatic operation according to programs is planned and defined in advance by setting temperature-time profiles. Program 0: In the factory default state of the TECOtherm NEO system, program no. 0 is set, according to TOBY protocol with the following temperature-time profile: Rectal in the treatment phase cooling 33.5°... - Page 20 It is also possible to switch to phase 3 in the “Options“ menu before the second phase finishes. The TECOtherm NEO system increases the body core temperature linearly until the selected target temperature of the temperature retention phase is reached. In case of faults, the control system reacts in the same way as in phase 2.
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Page 21: Control To Constant Rectal Temperature
If you select a time of “0 h” to reach a target temperature, TECOtherm NEO will try to reach the target value as soon as possible. At selection of the duration, the user can also predetermine a cooling rate/warming rate himself. -
Page 22: Setting To Constant Mattress Temperature
The performance of the TECOtherm NEO is characterized by a very rapid cooling of the mattress temperature, e.g., the device cools down the mattress (without patient) within 10 minutes from the mattress temperature 20°... -
Page 23: The Fallback Mode - For Patient Safety
To be able to make an informed decision in such a case, the user must immediately obtain another temperature measurement source, independent of the TECOtherm NEO, to continue to measure the rectal temperature of the patient reliably. -
Page 24: Plausibility Limits Of The Rectal Temperature
Plausibility limits of the rectal temperature In accordance with the purpose of TECOtherm NEO, it is considered possible that the rectal temperature of a patient at the beginning of the treatment could be between 30° C and 38° C in an extreme case. -
Page 25: Fallback Mode In Cooling Phase
3.0° C to +3.0° C in the menu. The following options are available in the control menu: Modify the running program (individual setting of the mattress temperature by the user) End treatment, close log Test alarm function Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 25/52... -
Page 26: Installation Of The Device And Operation
Defective parts must not be used. The TECOtherm NEO must not be placed directly next to other devices and/or used stacked with other devices. Should this nevertheless be necessary, the TECOtherm NEO must be observed and the intended operation checked. -
Page 27: Commissioning
Distributed by: Commissioning TECOtherm NEO must be installed and put into service for the first time by the manufacturer or by a representative authorized by the manufacturer. The desired menu language is selected via the entry “Language” in the main menu. - Page 28 If the coupling plugs latch correctly, the metal release buttons protrude slightly upward. Switch on the TECOtherm NEO device. Fill the refill set with temperature regulation fluid up to the 450 ml mark.
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Page 29: Refill Process
6.2.2 Refill process The TECOtherm NEO system can also be refilled during operation or treatment. Refill at the latest when the alarm “Fill level too low” occurs. The treatment does not have to be interrupted. -
Page 30: Commissioning And Operation Of The Tecotherm Neo System
Distributed by: 11. Decouple the refill set and dispose of temperature regulation fluid via a water drain. TECOtherm NEO can now be filled with fresh temperature regulation fluid for treatment or stored empty. Commissioning and Operation of the TECOtherm NEO System Before commissioning, first prepare the required accessories and check for damage. - Page 31 Connect temperature sensor: Only temperature sensors approved by the manufacturer of TECOtherm NEO must be used (cf. “I APPENDIX – Equipment and Accessories“) Only these have been subjected to the necessary tests and ensure reliable temperature measurement even under unfavorable electromagnetic ambient conditions.
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Page 32: Starting Treatment
Starting Treatment Before starting treatment, check that the device has been correctly put into operation (cf. section “6.3 Commissioning and Operation of the TECOtherm NEO System“) Under certain circumstances, pre-warming of the mattress makes sense: If a patient is already in therapy and is to be transferred to a new mattress, this mattress MUST be pre-warmed to ensure treatment success. -
Page 33: Monitoring During Treatment
This time may be longer, depending on the size of the patient and the ambient temperature. If no cooling rate has been preselected in the menu, the TECOtherm NEO tries to reach the selected target temperature as quickly as possible in each operating program. -
Page 34: Displaying And Exporting Treatment Data
Go to the main menu. Select the “Switch off” menu item. Then TECOtherm NEO switches off. As long as the device is not disconnected from the mains, the on/off button remains lightly green. When you disconnect it from the mains by pulling out the mains plug, the light green light goes out completely. -
Page 35: Cleaning The Outside Of The Tecotherm Neo Device
8.3.1 Reusable temperature sensors The respective manufacturer's instructions must be observed for the cleaning of the reusable rectal and skin temperature sensors approved for the TECOtherm NEO. Details can be found in the operating instructions of the temperature sensors. 8.3.2... -
Page 36: Transport
The plug connection from the sensor to the adapter cable must always be kept dry for proper operation. Transport The TECOtherm NEO device is a powerful hypothermic device with a low weight of 7.2 kg. Transport from room to room over smaller distances can be done by hand or with a small trolley. -
Page 37: System Alarm
If there is a communication error between the operating system and the control system inside the device, the control system triggers an acoustic alarm after 10 s. The device switches off after another 10 s. Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 37/52... -
Page 38: Temperature Alarm
Rectal sensor has The rectal sensor must be properly reintroduced (partially) slipped out into the patient's rectum and securely fixed. from the patient. 38/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019... - Page 39 If error causes cannot be corrected, the device must be switched off. Exchange the device with a replacement device and inform the service department. Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 39/52...
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Page 40: Flow Rate Alarm
“Alarm mute”. The suppression of the alarm sound is indicated by the symbol “Alarm paused” in the display. If the fault is not rectified, the audible alarm will sound again after eight minutes. 40/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019... -
Page 41: Power Failure/Mains Outage Alarm
“Alarm mute” button. This permanently deactivates this alarm. Visual displays Cause Measure Dark display and the LED Device was switched Switch the device back on. (9) lights brightly off unintentionally. Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 41/52... -
Page 42: Maintenance And Service
Inspections are to be carried out in accordance with applicable legal provisions and regulations, usually every 12 months. In addition, basic electrical safety (STK) must be inspected and documented annually. 12.1.1 Preventive maintenance To maintain reliable operational readiness of the TECOtherm NEO hypothermia system, we recommend the following preventive measures: • Cleaning“... -
Page 43: 12.1.2 Software Updates
It MUST be delivered to a corresponding collection point or suitable disposal company or returned to the dealer or manufacturer. Technical Specifications No significant performance characteristics were determined for the TECOtherm NEO. Specification Device General Dimensions (H x W x D) - Page 44 • Not protected against water ingress. Standards applied: DIN EN 60601-1, DIN EN 60601-1-2, DIN EN 60601-1-6, DIN EN 60601-1-8, DIN EN 60601-1-10, DIN EN 60601-2-35 E/F Conformity mark 0494 44/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019...
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Page 45: Electromagnetic Compatibility (Emc)
Electromagnetic Compatibility (EMC) Electromagnetic compatibility (EMC) guidelines apply to medical-electrical devices such as TECOtherm NEO. The user must ensure that the device is installed and operated according to the following instructions. Portable and mobile HF communication devices can influence the function of medical electrical devices. -
Page 46: Guidelines And Manufacturer's Declaration - Electromagnetic Interference Emission
½ period for ½ period business or hospital environment. and fluctuations of If the TECOtherm NEO user requests the supply voltage 40% U 40% U continued operation even if power according to IEC... -
Page 47: Guidelines And Manufacturer's Declaration - Electromagnetic Interference Emission
If the measured field strength at the location where the TECOtherm NEO is used exceeds the above compliance level, the TECOtherm NEO must be observed to demonstrate proper functioning. -
Page 48: Recommended Safe Distances Between Portable And Mobile Hf Telecommunications Equipment And Tecotherm Neo
14.1.4 Recommended safe distances between portable and mobile HF telecommunications equipment and TECOtherm NEO The TECOtherm NEO is intended for operation in an electromagnetic environment, in which HF disturbances are controlled. The user of the TECOtherm NEO can help prevent electromagnetic... -
Page 49: Service Information
Inspiration Healthcare Ltd 2 Satellite Business Village, Fleming Way, Crawley RH10 9NE GREAT BRITAIN Tel.: + 44 - (0) 1455 - 840555 Fax: + 44 - (0) 1455 - 841464 Email: info@inspiration-healthcare.co.uk Version: 21.1 18/06/2019 TECOtherm NEO from software version 063/02.18 49/52... -
Page 50: Appendix - Equipment And Accessories
Distributed by: I. APPENDIX – Equipment and Accessories Due to national restrictions, accessories may not be available in your country. For information or orders, contact your local distributor or Inspiration Healthcare Limited. Accessories Article Manufacturer, Article number TECOtherm NEO device ·-... -
Page 51: Ii. Appendix - Internal Cleaning
TC-NEO-KSB II. APPENDIX – Internal cleaning For the safe operation and maintenance of the performance of the TECOtherm NEO over the entire service life, it is necessary to clean the internal circuit of the device and the application parts (mattresses and hose kit) regularly. Cleaning is recommended after each treatment. - Page 52 The device and the application parts are now cleaned and ready for further storage. If you need the device immediately afterward for a treatment, proceed according to “6.2.1 Filling process“. 52/52 TECOtherm NEO from software version 063/02.18 Version: 21.1 18/06/2019...
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