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Related Manuals for Moller Medical Thermia Pro mounted
Summary of Contents for Moller Medical Thermia Pro mounted
- Page 1 Thermia Pro mounted Thermia Pro stand-alone...
- Page 2 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 3: Table Of Contents
Unpacking the device and checking the scope of supply ............13 Suitable operating environment ................... 14 Use with defibrillation and RF surgical devices ..............14 Setting up ........................... 15 Setting up the Thermia Pro mounted ..................15 ® 5.1.1 Setup on the Vacusat power .................. - Page 4 Thermia Pro Table of contents Cleaning and disinfection ...................... 23 Help in the event of a fault ....................24 Service ..........................25 Software update Thermia Pro Console ................. 26 9.1.1 “First aid” ........................27 10 Disposal ..........................28 11 Annex ..........................29 11.1 Technical data........................
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Page 5: General Safety Instructions
Thermia Pro General safety instructions 1 General safety instructions 1.1 Explanation of the safety symbols used In these instructions for use, important information is indicated visually. These references are prerequisites for preventing hazards to patients and operating personnel, as well as for avoid- ing damages or malfunctioning of the device. -
Page 6: Symbols On The Retail Packaging
Thermia Pro Table of contents Input connection for external power supply Heat emission, general (Connection for Heating Tray) 1.1.3 Symbols on the retail packaging Consult instructions for use Catalogue number Serial number (the first 4 digits indicate the year and month of manufacture in YYMM format) Do not use if packaging is damaged Keep dry... -
Page 7: Explanation Of The Format Conventions Used
Thermia Pro General safety instructions Attention: Under US Federal law, this device may be only sold to a physician or ordered by a physician. Further information on the symbols used can be found on our homepage: www.moeller-medi- cal.com/glossary-symbols 1.2 Explanation of the format conventions used In these instructions for use, different fonts are used to improve orientation. -
Page 8: Warning Notices
Thermia Pro Table of contents The devices in the Thermia Pro series are subject to special precautionary measures with respect to electromagnetic compatibility (EMC) and must be in- stalled and operated in accordance with the EMC guidelines. If one of the devices no longer works properly due to a malfunction, the device must not be used any further and must be inspected by the technical service. -
Page 9: Non-Product-Related Additional Equipment
Thermia Pro General safety instructions 1.6 Non-product-related additional equipment Additional equipment which does not belong to the devices’ scope of supply and which are connected to the devices’ analogue and digital interfaces must be shown to satisfy the relevant EN specifications (e.g. EN 60601 for electromedical devices). Any operator connecting the additional devices is responsible for configuring the system and for ensuring that the current version of the system requirements satisfy standard IEC 60601-1. -
Page 10: Intended Use
Thermia Pro Table of contents 2 Intended use The heating trays from Möller Medical GmbH are intended to be used to avoid solutions to become hypothermic. The heating trays are used in aesthetic body contouring and other med- ical applications. 2.1 Contraindications •... -
Page 11: Product Description
Thermia Pro Product description 3 Product description 3.1 Thermia Pro Console Figure 1 Standby switch USB interface Holder for cable Connection socket for Heating Tray Connection socket for Heating Tray Mains input socket Page 11 of 36... -
Page 12: Thermia Pro Heating Trays Mounted
Thermia Pro Table of contents 3.2 Thermia Pro Heating Trays mounted Heating Tray right Heating Tray left Figure 2 Figure 3 Suspension system for saline bag Heating Tray Assembly / clamping device Connecting cable to Thermia Pro Console Temperature sensor 3.3 Thermia Pro Heating Tray stand-alone Figure 4 Suspension system for saline bag... -
Page 13: Setup And Commissioning
Damaged products must not be used. Please contact your supplier im- mediately. 4.2 Unpacking the device and checking the scope of supply The Thermia Pro mounted is delivered in 2 packaging units. Make sure that no parts remain in the packaging when unpacking. Scope of delivery:... -
Page 14: Suitable Operating Environment
Thermia Pro Table of contents It is advisable not to dispose of the packaging and to use it again for any service required. Only send the devices in their original packaging to prevent damage during transportation. 4.3 Suitable operating environment The devices in the Thermia Pro series devices are suitable for use in the following areas: •... -
Page 15: Setting Up
Operation without the fastening on the Vacusat power is not permitted. ® 5.1.1 Setup on the Vacusat power Prepare the devices in the Thermia Pro mounted series prior to initial use as per the instructions for use (see chapter7). Figure 5 Page 15 of 36... - Page 16 Thermia Pro Table of contents 1. Remove the Thermia Pro Console from the packaging and suspend it in the tube ® holder of the Vacusat power (see Figure 6). Figure 6 ® If there is no tube holder on the Vacusat power, attach this beforehand as shown in Figure Figure 7 2.
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Page 17: Setting Up The Thermia Pro Stand-Alone
Thermia Pro Setting up 3. Take the Thermia Pro Heating Trays mounted out of the packaging and secure one ® on the right and one of the left of the clamping rail of the Vacusat power (see Figure 4. Insert the connecting cables of the Heating Trays (see Figure 2, position 4) into the corresponding connection socket of the Thermia Pro Console (see Figure 1, posi- tion 4 or 5). - Page 18 Thermia Pro Table of contents Figure 10 Page 18 of 36...
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Page 19: Startup
Thermia Pro Startup 6 Startup Before commissioning, the devices in the Thermia Pro series must be pro- cessed as per the hygiene guidelines (see chapter 7.1). If the devices in the Thermia Pro series 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 20 Thermia Pro Table of contents Recorded outlet temperatures of the saline solution at the hose outlet (cannula) The following were checked: REF 00004255 Thermia Pro stand-alone REF 00004255 Thermia Pro stand-alone ® ® REF 00003977 Liposat REF 00003974 Liposat Pro plus REF 00002251 Tube sets for tumescent REF 00003997...
- Page 21 Thermia Pro Startup Either one or two Heating Trays can be connected to the Thermia Pro Console. Application is the responsibility of the user. Thermia Pro mounted Figure 11 Thermia Pro stand-alone Figure 12 The standby switch switches all connected Heating Trays on or off simultaneously.
- Page 22 Thermia Pro Table of contents Figure 13 The Heating Tray function is displayed via two LEDs on the front. A white LED signals that the Heating Tray is ready for use and there are no errors. Page 22 of 36...
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Page 23: Cleaning And Care
Thermia Pro Cleaning and care 7 Cleaning and care 7.1 Cleaning and disinfection • No moisture may 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 Table of contents 8 Help in the event of a fault The devices in the Thermia Pro series must not be opened by the user! This chapter describes certain problems which may occur in conjunction with the devices. When establishing or undoing plug connections, the devices in the Thermia Pro series must always be switched off. -
Page 25: Service
Thermia Pro Service 9 Service Before disposing of or returning the devices of the Thermia Pro series, a suitable disinfection procedure must be carried out to rule out the risk of possible infec- tion. Consumable materials should be disposed of in accordance with hygiene guide- lines. -
Page 26: Software Update Thermia Pro Console
Thermia Pro Table of contents 9.1 Software update Thermia Pro Console • When updating, it is important to carry out the steps in the right order. Deviations can cause the process to be discontinued and prevent suc- cessful completion of the software update. The Thermia Pro Console software can be updated via the UBS service interface on the side of the device (see Figure 1). -
Page 27: First Aid
Thermia Pro Service 9.1.1 “First aid” The update was not successful • Was the firmware file copied correctly on the USB stick? ➢ If necessary, unzip the firmware file and copy again onto the USB stick. • Was the voltage disconnected briefly whilst the firmware was being installed? ➢... -
Page 28: Disposal
Thermia Pro Table of contents 10 Disposal This device includes materials which 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. -
Page 29: Annex
Thermia Pro Annex 11 Annex 11.1 Technical data Catalogue no. Thermia Pro mounted REF 00004253 Thermia Pro stand-alone REF 00004255 Thermia Pro Console REF 00004249 Thermia Pro Heating Trays mounted REF 00002542 (2 pieces in set) Thermia Pro Heating Trays stand-alone... -
Page 30: General Data
Thermia Pro Table of contents Safety Protective class Electrical connection of the Thermia Pro Console Voltage 24 VDC (DC voltage) Current consumption Max. 2.5 A Safety Protective class 11.2 General data Transport and storage instructions: Temperature -10 °C to +50 °C Air humidity Less than 90 % relative humidity Thermia Pro Console... -
Page 31: Electromagnetic Compatibility
Thermia Pro Electromagnetic compatibility 12 Electromagnetic compatibility 12.1 Electromagnetic emissions The Thermia Pro series devices are suitable for use in the stated electromagnetic environ- ment. The customer and/or operator of the devices of the Thermia Pro series must ensure that the devices are used in the electromagnetic environment described below. Measurement of electromag- Compliance Electromagnetic environment - guidelines... -
Page 32: Electromagnetic Immunity
Thermia Pro Table of contents 12.2 Electromagnetic immunity IEC 60601 - testing Electromagnetic environ- Immunity test Compliance level level ment - guidelines Floors should be wood, concrete, or ceramic tile. If ±8 kV contact dis- ±8 kV contact dis- Discharge of static floors are covered with syn- charge charge... - Page 33 Thermia Pro Electromagnetic compatibility IEC 60601 - testing Electromagnetic environ- Immunity test Compliance level level ment - guidelines Note: U is the AC mains voltage prior to application of the test level. The devices of the Thermia Pro series satisfy all test levels in accordance with IEC60601-1-2 Edition 4 (table 4 to 9).
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Page 34: Recommended Safety Distances
Thermia Pro Table of contents Electromagnetic IEC 60601- Compliance immunity/stand- Electromagnetic environment - guidelines level test level Portable and mobile radio transmitting de- vices, including the cables, should be 150 kHz to used in proximity of the Thermia Pro se- 30 MHz ries within the recommended safety dis- Conducted RF... -
Page 35: Accessories
Thermia Pro Accessories 13 Accessories Thermia Pro Heating Trays mounted (2 pieces in set) Catalogue no.: 00002542 Thermia Pro Heating Trays stand- alone (2 pieces in set) Catalogue no.: 00002286 Thermia Pro Console holder (incl. assembly material) Catalogue no.: 20018061 USB-A Port Blocker Catalogue no.: 93006998 Right tube holder... - Page 36 Revision status: 2020-11 B Software version: 104.00.01 Catalogue number of instructions for use (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...
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