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Related Manuals for Moller Thermia Pro mounted
Summary of Contents for Moller Thermia Pro mounted
- Page 1 Thermia Pro mounted Thermia Pro stand-alone...
- Page 3 IMPORTANT READ CAREFULLY BEFORE USE KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION © Möller Medical GmbH All rights reserved. No part of this documentation may be reproduced or translated in any way whatsoever without prior written approval from Möller Medical GmbH. The status of the information, specifications and figures in these instructions for use is indicated by the version number on the last page.
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Page 4: Table Of Contents
Unpacking the devices and checking the delivered items ........15 Suitable operating environment ................16 Use with defibrillation and RF surgical devices ............16 Setup ......................... 17 Setting up the Thermia Pro mounted ...............17 Setting up the Thermia Pro stand-alone ..............19 Commissioning ....................20 Cleaning and care .................... 23 Help in the event of a fault ................ - Page 5 Thermia Pro Contents 12 Electromagnetic compatibility ................ 31 12.1 Electromagnetic emissions ..................31 12.2 Electromagnetic immunity ..................32 12.3 Recommended separation distances ...............34 13 Accessories ...................... 35 Page 5 of 36...
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Page 6: General Safety Information
Thermia Pro General safety information 1 General safety information 1.1 Explanation of the safety symbols used Important information is indicated visually in these instructions for use. This information is a prerequisite for preventing hazards to patients and operating personnel, as well as for avoiding damages or malfunctioning of the device. -
Page 7: Additional Symbols On The Retail Packaging
Thermia Pro General safety information Protection class II Standby switch Device switched on (Standby Off) Device switched off (Standby USB socket Input connection for external power supply Heat emission, general (Connection for Heating Tray) 1.1.3 Additional symbols on the retail packaging Consult instructions for use Date of manufacture (YYYY-MM-DD) Packaging unit... -
Page 8: Explanation Of The Format Conventions Used
Thermia Pro General safety information Contains or presence of phthalates Caution Stacking limit, do not store more than 3 packs high Attention: Under US Federal law, this device may be only sold to a physician or ordered by a physician. Further information about the symbols used can be found on our website: www.moeller-medical.com/glossary-symbols 1.2 Explanation of the format conventions used... -
Page 9: Operator's Duty Of Care
Thermia Pro General safety information 1.4 Operator's duty of care The operator is responsible for the proper operation of the medical devices. In line with the German Medical Device Operator Ordinance (MPBetreibV), the user must perform a wide range of duties and also assume responsibility when handling medical devices within the framework of his activities. -
Page 10: Warning Notices
Thermia Pro General safety information 1.5 Warning notices • The devices must not be modified. • No liquids must be allowed to penetrate the voltage-carrying parts of the de- vices. • When cleaning, ensure that no cleaning agent runs into the connector sock- ets. -
Page 11: Declaration On Dehp
Thermia Pro General safety information 1.7 Declaration on DEHP The Thermia Pro devices do not contain bis(2-ethylhexyl) phthalates (DEHP). 1.8 Precautionary measures Clean and disinfect all reusable components of the Thermia Pro as per the instructions (chap- ter 7) and replace all the disposable components before using the devices on another patient. 1.9 Target group (users) These devices should only be used by doctors with experience in human medicine who have sufficient experience in the use of infusion solutions in medical applications. -
Page 12: Intended Use
Thermia Pro Intended use 2 Intended use The Heating Trays from Möller Medical GmbH are designed to prevent hypothermic solutions. The Heating Trays are used in the field of body contouring and other medical applications. 2.1 Contraindications • No contraindications are stated for the Thermia Pro devices. 2.2 Complications •... -
Page 13: Product Description
Thermia Pro Product description 3 Product description 3.1 Thermia Pro Console Figure 1: Thermia Pro Console No. Designation No. Designation Connection socket for Heating Tray Bracket for cables and hoses USB interface Mains input socket Connection socket for Heating Tray Standby switch Table 2: Thermia Pro Console descriptions... -
Page 14: Thermia Pro Heating Trays Mounted
Suspension system for saline bag Temperature sensor Connecting cable to Thermia Pro Heating Tray Console Clamping device Table 3: Thermia Pro mounted descriptions 3.3 Thermia Pro Heating Trays stand-alone Figure 3: Thermia Pro Console stand-alone No. Description No. Description Hole for connecting cable to... -
Page 15: Setup And Commissioning
Only send the devices in their original packaging to prevent damage during transportation. The Thermia Pro mounted is delivered in 2 packaging units. Make sure that no parts remain in the packaging when unpacking. Scope of delivery: Packaging unit Contents •... -
Page 16: Suitable Operating Environment
Thermia Pro Setup and commissioning The Thermia Pro stand-alone is delivered in 4 packaging units. Make sure that no parts remain in the packaging when unpacking. Scope of delivery: Packaging unit Contents • 1 Thermia Pro Console • 1 unlocking key with USB port blocker •... -
Page 17: Setup
5.1 Setting up the Thermia Pro mounted ® The Heating Trays mounted may only be used in connection with the Vacusat power. • The operation of the Thermia Pro mounted without the attachment to the ® Vacusat power is prohibited. Figure 4:... - Page 18 3. Slide on the matching mains adapter. 4. Check the adapter for a tight fit. Setting up and connecting the Thermia Pro mounted: 1. Mount the hose holder with the opening facing upwards, on the left side (top view), on ®...
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Page 19: Setting Up The Thermia Pro Stand-Alone
Thermia Pro Setup 5.2 Setting up the Thermia Pro stand-alone Figure 7: Connect the Thermia Pro stand-alone Figure 8: Mount console holder and plug in Console 1. Take the Heating Trays of the Thermia Pro stand-alone out of the packaging and place on a suitable firm surface. -
Page 20: Commissioning
Thermia Pro Commissioning 6 Commissioning Before commissioning, the Thermia Pro devices must be processed as per the hygiene guidelines (chapter 7). If the Thermia Pro devices are subject to temperature and humidity fluctuations during transportation or other changes in location, the devices must be allowed to acclimatise for at least 2 hours before being put into service. - Page 21 Thermia Pro Commissioning Recorded outlet temperatures of the saline solution at the tube outlet (cannula) The following were checked: Blue line Orange line REF 00004255 Thermia Pro stand-alone REF 00004255 Thermia Pro stand-alone ® ® REF 00003977 Liposat REF 00003974 Liposat Pro plus ®...
- Page 22 Thermia Pro Commissioning Either one or two Heating Trays can be connected to the Thermia Pro Console. The application is the responsibility of the user. The Heating Trays are activated using the standby switch on the Console. The standby switch switches all connected Heating Trays on or off simultane- ously.
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Page 23: Cleaning And Care
Thermia Pro Cleaning and care 7 Cleaning and care • No moisture must be allowed to enter the device. • Before cleaning and disinfecting the device surfaces, disconnect the mains plug. • Use a lint-free, soft cloth for cleaning and disinfecting. •... -
Page 24: Help In The Event Of A Fault
Thermia Pro Help in the event of a fault 8 Help in the event of a fault The Thermia Pro devices must not be opened by the user! This chapter describes certain problems that may occur in connection with the devices. The Thermia Pro Console must always be turned off when connecting and disconnecting plug connections. -
Page 25: Service
Thermia Pro Service 9 Service Before disposing of or returning the Thermia Pro devices, a suitable disinfection procedure must be carried out to rule out the risk of possible infection. Consumable materials should be disposed of in accordance with hygiene guide- lines. -
Page 26: Software Update
Thermia Pro Service 9.1 Software update • Observe the order of the update. Deviations can result in the software update being cancelled or unsuccessful. • Note that the USB port blocker key may break if used incorrectly. Explanation of symbols used Device switched on (Standby Off) Standby switch Device switched off... -
Page 27: First Aid
Thermia Pro Service 14. Remove the USB stick. 15. Plug the USB port blocker into the USB service interface. 16. Plug in the mains plug. ➔ The device is now updated. 9.1.1 “First aid” If the update is unsuccessful The LEDs flash yellow. ... -
Page 28: Disposal
Thermia Pro Disposal 10 Disposal These devices include materials that must be disposed of in an environmen- tally friendly manner. The European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2) applies to these devices. They thus bear the symbol with a crossed out bin on the rating plate. Process and return devices that are no longer used to Möller Medical GmbH. -
Page 29: Annex
Thermia Pro Annex 11 Annex 11.1 Technical data Article number Thermia Pro mounted REF 00004253 Thermia Pro stand-alone REF 00004255 Thermia Pro Console REF 00004249 Thermia Pro Heating Trays mounted (set of 2) REF 00002542 Thermia Pro Heating Trays stand-alone (set of 2) -
Page 30: General Data
Thermia Pro Annex 11.2 General data Transport and storage information Temperature -10°C to +50°C Air humidity < 90% relative humidity Dimensions with packaging: (Height x width x depth) Thermia Pro Console 110 mm x 300 mm x 210 mm Thermia Pro Heating Trays mounted 300 mm x 300 mm x 540 mm Thermia Pro Heating Trays stand-alone 300 mm x 300 mm x 540 mm... -
Page 31: Electromagnetic Compatibility
Thermia Pro Electromagnetic compatibility 12 Electromagnetic compatibility 12.1 Electromagnetic emissions The Thermia Pro devices are intended for use in the electromagnetic environment specified. The customer and/or operator of the Thermia Pro devices must ensure that the device is used in the electromagnetic environment described below. Measurement of electromag- Compliance Electromagnetic environment guidelines... -
Page 32: Electromagnetic Immunity
Thermia Pro Electromagnetic compatibility 12.2 Electromagnetic immunity IEC 60601 - testing Electromagnetic Immunity test Compliance level level environment / guidelines Floors should be wood, con- crete or ceramic tile. ±8 kV contact dis- ±8 kV contact dis- Discharge of static If floors are covered with charge charge... - Page 33 Thermia Pro Electromagnetic compatibility IEC 60601 - testing Electromagnetic Immunity test Compliance level level environment / guidelines Note: U is the AC mains voltage prior to application of the test level. The Thermia Pro devices satisfy all test levels in accordance with IEC60601-1-2 Edition 4 (table 4 to 9).
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Page 34: Recommended Separation Distances
Thermia Pro Electromagnetic compatibility Electromagnetic IEC 60601 - test- Compliance immunity/stand- Electromagnetic environment / guidelines ing level level Portable and mobile RF communications equipment should be used no closer to any 150 kHz to part of the Thermia Pro devices, including 80 MHz cables, than the recommended separation distance calculated from the equation appli-... -
Page 35: Accessories
Thermia Pro Accessories 13 Accessories Spare parts Thermia Pro Heating Trays mounted (Pack of 2 in a set) Catalogue no.: 00002542 Thermia Pro Heating Trays stand-alone (Pack of 2 in a set) Catalogue no.: 00002286 Thermia Pro Console holder (incl. mounting material) Catalogue no.: 92018061 Right hose bracket (incl. - Page 36 Revision status: 2023-05 V01 Software version: 104.00.01 Instructions for use catalogue number (REF) 93007595 Möller Medical GmbH Wasserkuppenstrasse 29-31 36043 Fulda, Germany Tel. +49 (0) 661 / 94 19 5 – 0 Fax +49 (0) 661 / 94 19 5 – 850 www.moeller-medical.com info@moeller-medical.com The instructions for use are part of the product.
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