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Summary of Contents for Moller Vibrasat Pro
- Page 1 ® Vibrasat The vibrating premium handpiece for aesthetic body contouring...
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Page 3: Read Carefully Before Use
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 in- structions for use is indicated by the version number on the last page. -
Page 4: Table Of Contents
® Vibrasat Contents Contents Contents ........................ 4 General safety information ................6 Explanation of the safety symbols used ..............6 1.1.1 Symbols in the instructions for use ..............6 1.1.2 Symbols on the device ..................6 1.1.3 Additional symbols on the retail packaging ............. 7 Explanation of the format conventions used ............ - Page 5 ® Vibrasat Contents 5.2.2 Switching the vibration on and off ..............24 5.2.3 Warning notices .................... 25 Cleaning and care ..................26 ® Vibrasat Pro Wand .................... 26 ® Vibrasat Pro Console ..................26 Help in the event of a fault ................27 Service ......................28 Software update ....................
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Page 6: General Safety Information
® Vibrasat 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, operating personnel and third parties, as well as for avoiding damages or malfunctioning of the device. -
Page 7: Additional Symbols On The Retail Packaging
® Vibrasat General safety information Input / Output (for energy and signals) USB host Applied part Type B Footswitch Start/Stop button Plus button (add / increase) Minus button (subtract / decrease) Existing connection Warning notice 1.1.3 Additional symbols on the retail packaging Consult instructions for use Packaging unit Production lot number, batch... -
Page 8: Explanation Of The Format Conventions Used
® Vibrasat General safety information Do not resterilise Single sterile barrier system Single sterile barrier system with protective outer packaging 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-med- ical.com/glossary-symbols 1.2 Explanation of the format conventions used In these instructions for use, different fonts are used to improve orientation. -
Page 9: Operator's Duty Of Care
® Vibrasat General safety information 1.4 Operator's duty of care The operator is responsible for the proper operation of the medical device. 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 ®... -
Page 10: Warning Notices
® Vibrasat General safety information 1.5 Warning notices • The devices must not be modified. • No liquids must be allowed to penetrate the current-conducting parts of the device. • When cleaning, ensure that no cleaning agent runs into the connector sock- ets. -
Page 11: Single Use
® Vibrasat General safety information 1.7 Single use Reuse of single-use devices creates a potential risk of infection for the patient or operator. Contamination of the device may lead to injury, illness or death of the patient. Cleaning, dis- infection and sterilisation may compromise essential material properties and product param- eters leading to device failure. -
Page 12: Intended Use
® Vibrasat Intended use 2 Intended use 2.1 Proper use – intended use Vibrasat ® ® The Vibrasat Pro, which consists of a control unit and a handle with a connection cable and vibrates cannulas, is used in particular to support the hand movement of the user during a surgical procedure in connection with liposuction cannulas. -
Page 13: Product Description
® Vibrasat Product description 3 Product description ® The Vibrasat Pro consists of two components • ® Vibrasat Pro Wand • ® Vibrasat Pro Console Figure 1: Overview drawing No. Designation No. Designation ® ® Cannulas 1-Pedal Liposat /Vibrasat Footswitch ®... -
Page 14: Vibrasat Pro Wand (Handle)
® Vibrasat Product description ® 3.1 Vibrasat Pro Wand (handle) The handle transfers very rapid vibrations in an axial direction to a cannula connected to the handle and thus supports the user’s hand movements. 1 2 3 Figure 2: ® Vibrasat Pro Wand Designation... -
Page 15: Vibrasat Pro Console (Control Unit)
® Vibrasat Product description ® 3.2 Vibrasat Pro Console (control unit) ® ® The Vibrasat Pro Console is the control unit for the Vibrasat Pro. Front: Designation Signal display Warning notice Plus button Start/Stop button Vibration speed Minus button Figure 4: Table 5: Screen Description... -
Page 16: Liposat ® /Vibrasat ® Footswitch
® Vibrasat Product description ® ® 3.3 Liposat /Vibrasat Footswitch 2 footswitches can be operated simultaneously. Both footswitches behave identically with equal precedence. The footswitches are optionally available, as an accessory. ® ® 3.3.1 Liposat /Vibrasat Footswitch (1-Pedal) ® By pressing the button, the Vibrasat Pro can be started and stopped. -
Page 17: Setup And Commissioning
® Vibrasat Setup and commissioning 4 Setup and commissioning Make sure that the box is not damaged on delivery to you. The forwarding agent must be notified immediately of any transport damage. Check all products for damage. Damaged products must not be used. Please contact your supplier immediately. -
Page 18: Suitable Operating Environments Vibrasat Pro
® Vibrasat Setup and commissioning ® 4.2 Suitable operating environments Vibrasat ® The Vibrasat Pro is suitable for environments in the following areas: • Professional healthcare facilities with specific requirements Clinics (rooms in A+E, hospital rooms, intensive care, operating theatres, except for in the proximity of active facilities of RF surgery devices or outside of the RF- shielded room for magnetic resonance imaging, first aid facilities). -
Page 19: General Information
® Vibrasat Setup and commissioning 4.3.1 General information • ® Place the Vibrasat Pro Console on a suitable, stable surface or, if available, use the ® ® Vibrasat Pro mounting kit. To do this, attach the Vibrasat Pro mounting kit to a standard ®... -
Page 20: Commissioning
® Vibrasat Setup and commissioning 4.3.2 Commissioning 1. Check the integrity of the two O-rings on the QuickLock. Replace the O-rings with a sterilised one if necessary. The O-rings prevent the components from loosening during use. 2. Place the circlip on the tip of the plunger (handle). 3. -
Page 21: Disassembly
® Vibrasat Setup and commissioning 4.4 Disassembly ® 1. Pull the tubing from the tubing connection of the QuickLock 2. Pull the tubing out of the tube clamp on the handle. 3. Press the lock of the cannula. ® 4. Pull the cannula from the QuickLock 5. -
Page 22: Application And Operation
® Vibrasat Application and operation 5 Application and operation Always note: • The handle may only be loaded in an axial direction. • The device switches off for safety reasons if subjected to strong radial force. • Large radial forces will damage the handle. •... -
Page 23: Screen Description
Minus button Reduction of the vibration speed 5.2 Operation Vibration stress for the user when using the Vibrasat Pro can lead to VVS (vibration-induced vasospastic syndrome). Therefore, a maximum total use time of 90 mins per day should not be exceeded. -
Page 24: Set The Vibration Speed
® Vibrasat Application and operation 5.2.1 Set the vibration speed The vibration speed is given in strokes per minute. The setting range is from 3,000–5,000. The setting can be made at any time with one of the following actions: • pressing the Plus/Minus key on the screen •... -
Page 25: Warning Notices
® Vibrasat Application and operation 5.2.3 Warning notices ® If impermissible operating conditions occur during vibration, the Vibrasat Pro Wand switches ® off. On the screen of the Vibrasat Pro Console the corresponding warning ID and the warn- ing symbol will appear. To continue, press the Start/Stop button or switch the console on and off. -
Page 26: Cleaning And Care
® Vibrasat Cleaning and care 6 Cleaning and care ® 6.1 Vibrasat Pro Wand ® The reprocessing of the Vibrasat Pro Wand is described in a separate document. If repro- cessing is performed by a third party, pass on the relevant information to the party performing the reprocessing. -
Page 27: Help In The Event Of A Fault
® Vibrasat Help in the event of a fault 7 Help in the event of a fault ® The Vibrasat Pro must not be opened by the user! ® This chapter describes certain problems that may occur in connection with the Vibrasat Pro. -
Page 28: Service
® Vibrasat Service 8 Service • ® Before disposing of or returning the Vibrasat Pro a suitable disinfection pro- cedure must be carried out to rule out the risk of possible infection. To this end, note the form provided on the manufacturer’s page for returning and labelling goods. -
Page 29: Software Update
® Vibrasat Service 8.1 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 30 ® Vibrasat Service 12. Plug the USB port blocker into the USB service interface. 13. Plug in the mains plug. 14. The installed software version is briefly displayed. 15. If this does not match the desired version, the previous steps must be repeated. 16.
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Page 31: Periodic Safety Checks
® Vibrasat Periodic safety checks 9 Periodic safety checks ® The service, upgrade or modification of the Vibrasat Pro must only be performed by Möller Medical GmbH or by a person specifically authorised by the manufacturer. All correspondingly trained persons have an appropriate certificate from the manufacturer which must be valid, as the certificates do expire. -
Page 32: Disposal
® Vibrasat Disposal 10 Disposal This device contains materials which must be disposed of in the interest of environmental protection. The European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2) applies to these devices. This device thus bears the symbol with a crossed out bin on the rating plate. Return devices which are no longer used to Möller Medical GmbH. -
Page 33: Annex
® Vibrasat Annex 11 Annex 11.1 Key technical data ® ® Vibrasat Pro Wand Vibrasat Pro Console Article number: REF 00003922 REF 00003921 Diameter x length Dimensions Width x height x depth: 52 mm x 300 mm 170 mm x 90 mm x 205 mm Weight approx. -
Page 34: General Data
® Vibrasat Annex 11.2 General data ® ® Vibrasat Pro Wand Vibrasat Pro Console Transport and storage instructions: Temperature -10°C to +50°C -10°C to +50°C Air humidity < 100% relative humidity < 90% relative humidity Weight with packaging 1.05kg 1.8kg Dimensions Width x height x depth: Width x height x depth:... -
Page 35: Electromagnetic Emissions
® Vibrasat Annex 11.3 Electromagnetic emissions ® The Vibrasat Pro is suitable for use in the stated electromagnetic environment. Customers ® ® and/or operators of the Vibrasat Pro should ensure that they use the Vibrasat Pro in such an environment. Emissions test Compliance Electromagnetic environment - guidelines... -
Page 36: Electromagnetic Immunity
® Vibrasat Annex 11.4 Electromagnetic immunity ® The Vibrasat Pro is suitable for use in the stated electromagnetic environment. Customers or operators of these devices should ensure that they are used in such an environment. Immunity test IEC 60601 - testing Electromagnetic environment - Compliance level standard... -
Page 37: Recommended Safety Distances
® Vibrasat Annex Immunity test IEC 60601 - testing Electromagnetic environment - Compliance level standard level guidelines Recommended separation distance: RF conducted disturb- Portable RF communica- 3 Veff 3 Veff ance acc. tions equipment (radio 150 kHz to 80 MHz 150 kHz to 80 MHz IEC 61000-4-6 equipment including its ac-... -
Page 38: Accessories
® Vibrasat Accessories 12 Accessories Sterile consumables TLA Luer-Lock Adapter Catalogue no.: 00004027 (Pack of 30 in a box) Accessories ® ® Liposat /Vibrasat Footswitch (1-pedal, 2 m cable length) Catalogue no.: 93003545 ® ® Liposat /Vibrasat Footswitch (1-pedal, 5 m cable length) Catalogue no.: 00003982 ®... - Page 39 ® Vibrasat Accessories Spare parts Unlocking key with USB port blocker Catalogue no.: 93006998 Circlip Catalogue no.: 93007034 (Pack of 10 in a box) O-ring Catalogue no.: 93007267 (Pack of 10 in a box) Lock nut Catalogue no.: 92016794 An up-to-date list of the available accessories can be found on our website www.moeller-medical.com or in our brochure.
- Page 40 Revision status 2023-05 V01 Software versions 99.00.13 Catalogue number of Instructions for use (REF) 93007103 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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