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Summary of Contents for Moller Vibrasat Pro
- Page 1 ® Vibrasat The new premium system for liposuction and infiltration...
- Page 2 IMPORTANT READ CAREFULLY BEFORE USE KEEP FOR FUTURE CONSULATION © 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
® Vibrasat Contents Contents General safety information ................5 Explanation of the safety symbols used ............5 1.1.1 Symbols used in the instructions for use: ..........5 1.1.2 Symbols appearing on the device: ............5 1.1.3 Symbols appearing on the packaging: ..........6 Explanation of the format conventions used ............ - Page 4 ® Vibrasat Contents Setup and commissioning ................15 Disassembly ....................17 Application and operation ................18 ® Vibrasat Pro Console description of the operating elements ......18 5.1.1 Display ....................19 Operation ...................... 19 ® 5.2.1 Setting the vibration speed Vibrasat Pro Wand ........
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Page 5: General Safety Information
® Vibrasat General safety information 1 General safety information 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, operating personnel and third parties, as well as for avoiding damages or malfunctioning of the device. -
Page 6: Symbols Appearing On The Packaging
® Vibrasat General safety information Start/stop button Up button to increase the stroke rate Down button to lower the stroke rate Device connected to superordinate control unit Control device warning message 1.1.3 Symbols appearing on the packaging: Consult instructions for use Catalogue number Batch code Serial number (the first 4 digits indicate the year and month of... -
Page 7: Explanation Of The Format Conventions Used
® Vibrasat General safety information Restriction on relative storage humidity Storage temperature limitation Manufacturer Conformity in accordance with the Medical Device Directive 93/42 Consult instructions for use Applied part Type B Keep in a place protected against sunlight Caution! Observe transport and storage conditions. Attention: Under US federal law, this device may be only sold to a physician or ordered by a physician. -
Page 8: Manufacturer's Responsibility
® Vibrasat General safety information 1.3 Manufacturer's responsibility The manufacturer may only be regarded as responsible for the safety, reliability and suitability for use of the devices if: • Assembly, expansions, resetting, changes or repairs are performed by individuals authorised by the manufacturer. •... -
Page 9: 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-carrying parts of the device. • When cleaning, ensure that no cleaning agent runs into the connector sockets. -
Page 10: Precautionary Measures
® Vibrasat General safety information Dispose of the used single-use product according to your hygiene requirements. 1.8 Precautionary measures The application results vary depending on the patient’s age, site of intervention and the surgeon’s experience. The application results may or may not be permanent. ®... -
Page 11: Intended Use
® Vibrasat Intended use 2 Intended use 2.1 Proper use – intended use Vibrasat ® ® The Vibrasat Pro, consisting of the control unit and a handle with a connecting cable has the intended use to vibrate cannulas n particular to support the hand movement of the user. 2.2 Contraindications •... -
Page 12: Product Description
® Vibrasat Product description 3 Product description Figure 1 ® Vibrasat Pro Wand handle Foot switch cable ® Vibrasat Pro Wand connecting cable On / Off switch ® ® Vibrasat Pro Console control device Connection socket for Vibrasat Pro Wand Mains cable Connection sockets for foot switch Mains plug... -
Page 13: Vibrasat Pro Console
® Vibrasat Product description ® 3.2 Vibrasat Pro Console ® ® The Vibrasat Pro Console (Figure 1, Point 3) is the control unit for the Vibrasat Pro. There is an On / Off switch on the rear of the device for the device standby mode and for the device interfaces for the foot switch (2 foot switches can be operated simultaneously) ®... -
Page 14: Setup And Commissioning
® Vibrasat Setup and commissioning 4 Setup and commissioning Make sure that the box is not damaged on delivery to you. The forwarder 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 15: Setup And Commissioning
® Vibrasat Setup and commissioning • Home healthcare Practices, lodgings (places of residence, nursing homes), hotels, guest houses and stationary vehicles, provided that the devices are not connected to the vehicle's DC power supply. ® The Vibrasat Pro is not approved for use in aircrafts or military applications. The appropriate EMC requirements for these environments have not been tested. - Page 16 ® Vibrasat Setup and commissioning Figure 2 1. Push the cannula holder (Figure 2, Point 1) onto the fork-shaped pin on the handle (Figure 2, Point 4). The tube connection can be aligned upwards or downwards as required. The alignment of the tube connection can be rotated by 180° if necessary. The O-rings (Figure 2, Point 2 and 5) must be in perfect condition.
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Page 17: Disassembly
® Vibrasat Setup and commissioning Figure 4 Figure 5 • Connect a suitable cannula for the application to the cannula holder. For this, hold the lock (Figure 4, Point 1) pressed down whilst attaching until the square of the cannula hold locks into place. -
Page 18: 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 excessive radial force. • Large radial forces will damage the handle. •... -
Page 19: Display
® Vibrasat Application and operation 5.1.1 Display 1. Segment display shows the set stroke rate per minute 2. Start / Stop – vibration button ON/OFF 3. Signal display – connected to the superordinate control unit 4. Minus - button to lower the stroke rate 5. -
Page 20: Vibration Control
® Vibrasat Application and operation ® 6000 is shown briefly on the Vibrasat Pro Console. 60 s is then decremented on the ® display. If during the boost, the foot switch or play button on the Vibrasat Pro Console is pressed, the vibration is switched off and the 60 s timer is reset. -
Page 21: Cleaning And Care
® Vibrasat Cleaning and care 6 Cleaning and care ® 6.1 Vibrasat Pro Wand ® You will find all the information on processing the Vibrasat Pro Console in the following ® section. The reprocessing of the handle Vibrasat Pro Wand is described in a separate document. -
Page 22: 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 Several causes with possible solutions are given for each problem. -
Page 23: Service
® Vibrasat Service 8 Service • ® Before disposing of or returning the Vibrasat Pro a suitable disinfection procedure 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 24 ® Vibrasat Service ® The Vibrasat Pro Console software can be updated via the USB service interface on the rear. To update, proceed as follows: ® 1. Disconnect the Vibrasat Pro Console from the power supply. Switch the mains ® switch on the rear of the Vibrasat Pro Console to ON.
- Page 25 ® Vibrasat Service Display of update warning Update Error description Solution warning ID The firmware on the USB stick is not valid Check the transferred firmware. firmware. Transfer of the firmware to the 2 - 8 Contact the service centre. ®...
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Page 26: 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 27: 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 this device. 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 28: Appendix
® Vibrasat Appendix 11 Appendix 11.1 Key technical data Article number ® Catalogue number Vibrasat REF 00003920 ® Catalogue number Vibrasat Pro Wand REF 00003922 (handle) ® Catalogue number Vibrasat Pro Console REF 00003921 (control unit) Dimensions ® Vibrasat Pro Console Width x height x depth = 170 mm x 90 mm x 205 mm ®... -
Page 29: General Data
® Vibrasat Appendix 11.2 General data Transport and storage instructions: Temperature -10°C to +50°C Air humidity Less than 90% relative humidity Weight with packaging: ® Dimensions Vibrasat Pro Wand with Width x height x depth: packaging: 400 mm x 85 mm x 190 mm ®... -
Page 30: Electromagnetic Emissions
® Vibrasat Appendix 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 31: Electromagnetic Immunity
® Vibrasat Appendix 11.4 Electromagnetic immunity ® The Vibrasat Pro series devices are suitable for use in the stated electromagnetic environment. Customers or operators of these device should ensure that they are used in such an environment. Immunity test / IEC 60601 - testing Compliance Electromagnetic environment -... - Page 32 ® Vibrasat Appendix Immunity test / IEC 60601 - testing Compliance Electromagnetic environment - standard level level guidelines Power frequency magnetic fields Magnetic field in should be at levels characteristic of a typical location in a typical power supply frequency commercial or hospital environment.
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Page 33: Recommended Safety Distances
® Vibrasat Appendix a) Field strengths from fixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed transmitters, an electromagnetic ®... - Page 34 Current revision 2019-03 B Software versions 99.00.04 Catalogue number of instructions for use Directive 93/42 EEC (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 http://www.moeller-medical.com info@moeller-medical.com...
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