Moller Vibrasat Pro User manual

en Vibrasat®Pro
The new premium system for liposuction and infiltration
INSTRUCTIONS FOR USE

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. Möller Medical GmbH reserves the
right to make changes in terms of technology, functions, specifications, design and information at any time
and without prior notification.
Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany
Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany
Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany

Vibrasat® Pro
Contents
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Contents
1General safety information........................................................................... 5
1.1 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
1.2 Explanation of the format conventions used.................................................... 7
1.3 Manufacturer's responsibility........................................................................... 8
1.4 Operator's obligation to exercise diligence...................................................... 8
1.5 Warning notices.............................................................................................. 9
1.6 Non-product-related additional equipment....................................................... 9
1.7 Single use....................................................................................................... 9
1.8 Precautionary measures............................................................................... 10
1.9 Target group (user)....................................................................................... 10
2Intended use................................................................................................ 11
2.1 Proper use –intended use Vibrasat® Pro ...................................................... 11
2.2 Contraindications.......................................................................................... 11
2.3 Complications ............................................................................................... 11
2.4 Essential performance features..................................................................... 11
2.5 Combination with other products................................................................... 11
3Product description.................................................................................... 12
3.1 Vibrasat® Pro Wand (handle)......................................................................... 12
3.2 Vibrasat® Pro Console................................................................................... 13
3.3 Foot switch.................................................................................................... 13
3.4 Cannulas....................................................................................................... 13
4Setup and commissioning.......................................................................... 14
4.1 Unpacking the device and checking the scope of supply............................... 14
4.2 Suitable operating environments Vibrasat® Pro............................................. 14

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4.3 Setup and commissioning............................................................................. 15
4.4 Disassembly ................................................................................................. 17
5Application and operation.......................................................................... 18
5.1Vibrasat® Pro Console description of the operating elements........................ 18
5.1.1 Display.............................................................................................. 19
5.2 Operation...................................................................................................... 19
5.2.1 Setting the vibration speed Vibrasat® Pro Wand................................ 19
5.2.1.1 Boost function............................................................................ 19
5.2.2 Vibration control................................................................................ 20
5.2.3 Warning notices................................................................................ 20
6Cleaning and care....................................................................................... 21
6.1 Vibrasat® Pro Wand....................................................................................... 21
6.2 Vibrasat® Pro Console................................................................................... 21
7Help in the event of a fault.......................................................................... 22
8Service......................................................................................................... 23
8.1 Software update............................................................................................ 23
9Periodic safety checks ............................................................................... 26
10 Disposal....................................................................................................... 27
11 Appendix ..................................................................................................... 28
11.1 Key technical data......................................................................................... 28
11.2 General data................................................................................................. 29
11.3 Electromagnetic emissions ........................................................................... 30
11.4 Electromagnetic immunity............................................................................. 31
11.5 Recommended safety distances................................................................... 33
11.6 Accessories .................................................................................................. 33

Vibrasat® Pro
General safety information
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1 General safety information
1.1 Explanation of the safety symbols used
In these instructionsfor use, important informationis 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.
1.1.1 Symbols used in the instructions for use:
Caution! Hazard for patients, operating personnel and third
parties.
Information or help
1.1.2 Symbols appearing on the device:
Applied part Type B
Serial number (the first 4 digits indicate the year and month of
manufacture in YYMM format)
Conformity in accordance with the Medical Device Directive
93/42 EEC
Observe instruction manual
Manufacturer
Complies with ANSI/AAMI ES 60601-1
CAN/CSA 22.2 No. 60601-1-08
Alternating current
Return and disposal as per the WEEE Directive
O
Device switched off
I
Device switched on
Device selector switch on / standby
Foot switch

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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
manufacture in YYMM format)
Use by
YYYY-MM-DD
Sterilised using ethylene oxide
Not suitable for use with MRI
Single use
Do not resterilise
Do not use if package is damaged
Stacking limit, do not store more than 4 packs high
Keep dry

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General safety information
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Restriction on relative storage humidity
Storage temperature limitation
Manufacturer
Conformity in accordance with the Medical Device Directive 93/42
EEC
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.
1.2 Explanation of the format conventions used
In these instructions for use, different fonts are used to improve orientation.
Font
Use
Bold and italics
Buttons in instructions.
Small capitals
Dialogue fields and submenus in running text.
Italics
Device options, buttons and references to chapter
and sections in the running text.
The use of the Vibrasat® Pro is subject to thorough knowledge and observance of these
instructions for use, which are delivered as part of the product. Store the instructions for use
for the Vibrasat® Pro carefully. The device must be used only by persons who have the
required training or knowledge and experience.

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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.
•The electrical installation in the room in question complies with the
relevant requirements and regulations (e.g. VDE 0100, VDE 0107 or IEC
specifications).
•The devices are used in accordance with the instructions for use and the
country-specific regulations and national deviations are observed.
•The conditions stated in the technical data are observed.
Any other use exept those described in the operating instruction is not intended and will result
in an exclusion of warranty and liability
The manufacturer undertakes to accept old devices as per the German Electrical and
Electronic Device Act (ElektroG).
1.4 Operator's obligation to exercise diligence
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
framework of his activities. Only qualified personnel may operate the Vibrasat® Pro .
Whenever the Vibrasat® Pro is handled and used, precise knowledge and compliance with
these instructions for use is necessary. The devices may only be operated by persons with
the necessary training or knowledge and experience.
The devices are subject to special precautionary measures with respect to
electromagnetic compatibility (EMC) and must be installed 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.
Performance and safety may be impaired if Original Equipment Manufacturer device parts
are not used.
All work that requires tools must be performed by the manufacturer's technical service or
parties authorised by the latter.

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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.
•Disconnect the power cable before cleaning.
•The housing of the Vibrasat® Pro Console is only connected as
functional earth with the earth contact of the power supply.
•Replace connecting cables of all kinds even if they are only slightly
damaged; make sure not to roll over cables.
•Keep the cables away from heat sources. This prevents the insulation
from melting which could cause a fire or an electric shock.
•Do not use force to push plugs into sockets.
•When removing plugs, do not pull on the cables. To remove, release
the plug lock if necessary.
•Do not subject the devices to strong heat or fire.
•Do not subject the devices to hard impacts.
•If heat, fumes or smoke appear, disconnect the devices from the mains
immediately.
•When reprocessing the devices, observe the reprocessing instructions
in order to avoid damaging the products.
1.6 Non-product-related additional equipment
Additional equipment which does not belong to the device’s scope of supply and which are
connected to the device’s analogue and digital interfaces must be shown to satisfy the
relevant EN specifications (e.g. EN 60601 for electromedical devices). Anyone who connects
additional devices becomes the system configurator and is thus responsible for ensuring that
the valid version of the system requirements as per the standard IEC 60601-1 is observed.
If components are used that do not correspond to the original parts, the
performance, safety and EMC behaviour may be impaired.
1.7 Single use
Reuse of single-use devices creates a potential risk of patient or user infections.
Contamination of the device may lead to injury, illness or death of the patient. Cleaning,
disinfection and sterilisation may compromise essential material properties and product
parameters leading to device failure.

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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.
Sterilise all reusable components of the Vibrasat® Pro as per the reprocessing instructions
and replace all the disposable components before using the Vibrasat® Pro on another
patient.
1.9 Target group (user)
The Vibrasat® Pro is reserved for use by doctors who can demonstrate that they have the
necessary expertise through the relevant specialist training or approved, specialist further
training.