Moller Medical Vibrasat power User manual

Vibrasat® power
Instructions for use
en

IMPORTANT
READ CAREFULLY BEFORE USE
KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION

Vibrasat® power
Manufacturer information
Manufacturer information
Möller Medical GmbH
Wasserkuppenstraße 29-31
36043 Fulda, Germany
Tel: [phone] - 0
Fax: [phone]
E-mail: [email protected]
Internet: www.moeller-medical.com
© Möller Medical GmbH.
All rights reserved.
No part of this document may be reproduced or translated in any form or by any means without the
prior written permission of Möller Medical GmbH. The latest version of the information, specifications
and illustrations provided in this instruction manual is indicated by the version number on the last
page. Möller Medical GmbH reserves the right to make changes to the technology, functions, specifi-
cations, design and information at any time and without prior notification.

Vibrasat®power
Table of Contents
page 4 of 38
Table of Contents
Manufacturer information.................................................................................3
Table of Contents ................................................................................................. 4
1General safety instructions........................................................................... 6
Explanation of safety symbols used................................................................. 6
Manufacturer's responsibility............................................................................9
Precautionary duties of the operator................................................................9
Non-Product Additional Equipment................................................................ 11
Single use...................................................................................................... 11
Warning Section ............................................................................................ 12
Precautions Section....................................................................................... 12
2Intended use (purpose)................................................................................ 13
Contraindication............................................................................................. 13
Essential features .......................................................................................... 13
3Product description ..................................................................................... 14
Structure........................................................................................................ 14
Application description of the Vibrasat®power .............................................. 15
Three-pedal foot switch.................................................................................. 16
Liposuction cannulae..................................................................................... 16
4Installation and commissioning.................................................................. 17
Transport and storage information................................................................. 17
Unpacking the device and checking the deliver.............................................18
Suitable operating environment .....................................................................18
Assembly....................................................................................................... 19
Device connections........................................................................................ 20
5Operation...................................................................................................... 21
Description of user for Vibrasat®power......................................................... 21

Vibrasat® power
Table of Contents
page 5 of 38
Description of the operating elements............................................................ 21
6Handle reprocessing.................................................................................... 22
7Troublesshooting......................................................................................... 23
8Service .......................................................................................................... 24
9Recurring safety inspections...................................................................... 25
10 Disposal........................................................................................................ 26
11 Appendix....................................................................................................... 27
Technical Data............................................................................................... 27
Accessories of the Vibrasat®power............................................................... 29
Electromagnetic emission.............................................................................. 32
Electromagnetic immunity.............................................................................. 33
Recommended protective distances.............................................................. 36
12 Liposat power configuration....................................................................... 37

Vibrasat® power
General safety instructions
page 6 of 38
1 General safety instructions
Explanation of safety symbols used
Important information is visually highlighted in the instructions for use. These references
are prerequisites for preventing hazards to patients and operating personnel, as well as
for avoiding damage to or malfunctioning of the device
Symbols used in the instruction manual
Caution
Information
Symbols appearing on the device
Type BF applied part
Refer to instruction manual/booklet
Class II equipment
Manufacturer
Serial number
Alternating current

Vibrasat® power
General safety instructions
page 7 of 38
“ON” (power)
“OFF” (power)
Return and disposal according to WEEE Directive
Start-stop key
SET button for service functions
Down button to reduce the number of strokes
Up button to increase the number of strokes
Attention: Under US Federal law, this device may be only sold to a
physician or ordered by a physician.
Symbols on the packaging
Type BF applied part
Refer to instruction manual/booklet
Class II equipment

Vibrasat® power
General safety instructions
page 8 of 38
Manufacture
Catalog number
Serial number
Return and disposal according to WEEE Directive
Attention
Temperature limit
Humidity, limitation
Keep dry
Stacking limit, do not store more than 4 packs high
Use by
YYYY-MM-DD
Batch code
Sterilized using ethylene oxide

Vibrasat® power
General safety instructions
page 9 of 38
Do not re-use
Do not resterilise
Do not use if package is damaged
Contains or presence of phthalates
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-medical.com/glossary-symbols
Manufacturer's responsibility
The manufacturer can only be considered responsible for the safety, reliability and ser-
viceability of the device, if repairs are carried out by persons that it has authorised. All
work requiring the use of tools must be carried out by the technical service of the manu-
facturer.
The manufacturer agrees to take back used devices in accordance with the Electronic
Equipment Act.
Precautionary duties of the operator
The owner of the device must accept responsibility for the proper operation of the medical
device. The user is obliged to fulfil all duties in accordance with the Medical Devices Di-
rective and is fully responsible for all his activities when using medical devices.
Only qualified personnel may operate this device.
Read prior usage of this device the instruction manual carefully. Consider all instructions
and warnings to avoid any insuries to you or the patient. Also ensure that you are familiar
with the operation principle to the decvice and all its accessories. If you are not familiar
with the operation principle please contact Möller Medical GmbH for additional training
possibilities.
The device must not be operated if connected to mains power supplies that may not have
a correctly functioning protective earth conductor. The supply voltage must match the de-

Vibrasat® power
General safety instructions
page 10 of 38
tails specified on the nameplate. No liquid must be allowed to penetrate live electrical
components. Disconnect the device plug before cleaning.
Only plug in or unplug Vibrasat® power connectors (power cable, foot switch, hand grip) if
the device is switched off. Only the supplied original parts may be used.
Position the Vibrasat® power so that it can be easily disconnected from the mains power
supply.
Any modifications to the Vibrasat® power are prohibited.
A sterile suction tube should be inserted prior to each application in order to eliminate risk
of infection. Do not bend inserted liposuction cannulas. Only use sterile Möller Medical
GmbH liposuction cannulas.
Before the first use and after every use the hand grip must be prepared again as de-
scribed on page 22.
The hand grip must be checked by Möller Medical GmbH's Service depart-
ment after 200 autoclavings!
The operator must dispose of the device according to the relevant regulations and stand-
ards.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.

Vibrasat® power
General safety instructions
page 11 of 38
Non-Product Additional Equipment
Any additional equipment that is connected to the analogue and digital interfaces of the
device must be proven to meet the requirements of the relevant EN specifications, (e.g.
EN60950 for data processing devices, and EN60601 for electrical medical devices). All
device configurations must also satisfy the applicable version of the electrical system
safety standard EN60601-1. Any operator connecting the additional devices is the system
configurer and is therefore responsible for ensuring that the system safety standard
EN60601-1 is upheld. In the event of queries, please contact the manufacturer.
Single use
The reuse of single-use articles involves a potential risk of infection for the patient or op-
erator. Contaminated articles can cause damage to health, disease or even death of the
patient. Cleaning, disinfection or sterilisation can adversely affect essential material prop-
erties and product parameters and thus result in article failure.
Dispose of used single-use articles according to hygiene regulations.

Vibrasat® power
General safety instructions
page 12 of 38
Warning Section
This device will not, in and of itself, produce significant weight reduction.
This device should be used with extreme caution in patients with chronic medical condi-
tions, such as diabetes, heart or lung disease, circulatory diseases or obesity.
The volume of blood loss and endogenous body fluid may adversely affect intra and/or
postoperative hemodynamic stability and patient safety. The capability of providing ade-
quate, timely fluid replacement is essential for patient safety.
Precautions Section
This device is designed to contour the body by removing localized deposits of excess fat
through small incisions. Use of this device is limited to those physicians who, by means of
residency training or sanctioned continuing medical education, have demonstrated profi-
ciency in suction lipoplasty.
Results of this procedure will vary depending upon patient age, surgical site, and experi-
ence of the surgeon. Results of this procedure may or may not be permanent. The
amount of fat removed should be limited to that necessary to achieve a desired cosmetic
effect.
All reusable components of the device must be sterilized and all disposable components
replaced before using the device system on another patient.
After an autoclave cycle of the Vibrasat® power handpiece ensure that the
handpiece is fully cooled down before continue of operation. This is due to
avoidance of excessive wear or fatigue of the handpiece

Vibrasat® power
Intended use (purpose)
page 13 of 38
2 Intended use (purpose)
The Vibrasat® power, which consists of a control unit and a handle with connection cable
and induces cannulas in vibration, has the purpose of aesthetic body contouring and is
used in particular to support the hand movement of the user.
The Vibrasat® power may only be used in conjunction with the Möller Medicals’s liposuc-
tion cannulas.
Contraindication
Absolute contraindications
Known allergies to anaesthetics or local anaesthetics of tumescence anaesthesia
Relative contraindications
Known tendency to spasms (epilepsy)
Taking of coagulation inhibiting medicines
Too high expectations of the patient on the outcome of the operation
Severe heart conditions
Severe lung conditions
Severe liver damage
Severe kidney damage
Risk of thrombosis (thrombophilia)
Essential features
The Vibrasat® power has no essential performances.

Vibrasat® power
Product description
page 14 of 38
3 Product description
Each use of the device requires precise knowledge of and compliance with this instruction
for use. This instruction for use is not intended to replace instruction of the user by the
medical device consultant. The device must be used only by persons who have the re-
quired training or knowledge and experience. (§2 Sect. 2 Regulations on Sale of Medical
Devices).
Only use the supplied original parts (e.g. power cable, hand grip and foot
switch).
Use of components not corresponding to the original design may impair per-
formance and safety.
Structure

Vibrasat® power
Product description
page 15 of 38
Application description of the Vibrasat®power
The device is switched on using the On/Off switch on the device's reverse side via the
primary voltage.
After the display test, the last set stroke rate value (strokes per minute) appears in the
display. The last set stroke rate value is always retained when switching the device on
and off.
Up –button
Down –button
SET - button
Start/Stop - button
The stroke rate can be set using the “Down –button" or "Up –button".
Adjustment takes place in steps of one hundred.
The stoke rate can be set in the range from 3000 to 5000 strokes per minute.
The stroke rate can be adjusted in both stationary and vibrating mode.

Vibrasat® power
Product description
page 16 of 38
Three-pedal foot switch
The 3-pedal foot switch connected to the back of the device can be used to perform the
same stroke rate adjustment functions. The foot switch has the same functions as the
"Up", "Down" and "Start/Stop" buttons.
The device is started or stopped with the "Start-stop" button at the control unit or with the
3-pedal foot switch. The device is switched off using the On/Off switch at the back of the
control device.
The Vibrasat® power is maintenance-free. Before first use prepare the con-
trol unit according to hygiene guidelines. Only mild detergents / disinfectants
(e.g. 70% alcohol) may be used for cleaning the control unit.
Liposuction cannulae
The handgrip must only be used in combination with tested and approved can-
nulas by Möller Medical.
On / Off
Down –button Start/Stop - button Up –button

Vibrasat® power
Installation and commissioning
page 17 of 38
4 Installation and commissioning
Transport and storage information
In order to avoid damage to device and other materials when transporting the device, it is
imperative to observe the following safety information.
It is imperative to observe transport information on the packaging.
Observe prescribed storage conditions.
Observe prescribed stacking height. Parts stacked too high can col-
lapse.
When transporting, do not stack more than 4 cartons above one another.
The external packaging is a folding corrugated cardboard box. The internal packaging is
made from polyethylene foam rubber.
Fire hazard due to easily inflammable packaging material. Do not employ open fire and
do not smoke!
Dimensions of Vibrasat® power
with packaging
420 mm * 390 mm * 230 mm
Weight
approx. 5 kg
Transport - storage conditions
Temperature
-10 °C to +50 °C (14 °F to 122 °F)
Humidity
less than 90% rel. humidity
It is advisable not to dispose of the packaging and to use it again if servicing
is required.

Vibrasat® power
Installation and commissioning
page 18 of 38
Unpacking the device and checking the deliver
The Vibrasat® power delivery always consists of one carton
Ensure that the packaging is delivered undamaged.
Transportation damage should be reported immediately to the carrier.
When unpacking Vibrasat® power, ensure that no parts remain in the package.
The scope of delivery comprises (1 item each):
Control unit
Power cable
Three-pedal foot switch
Hand grip with connecting cable
Instructions for use "German"
Instructions for use "English"
Vibrasat® liposuction cannulae
Suitable operating environment
The Vibrasat® power 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, ex-
cept 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).
The Vibrasat® power is not approved for use in aircrafts or military applications. The ap-
propriate EMC requirements for these environments have not been tested.

Vibrasat® power
Installation and commissioning
page 19 of 38
Assembly
Prior operation ensure that the device is cleaned and sterilsed in accordance
with the cleaning instructions, see chapter “Handle Preprocessing” page 22.
The control unit has to be cleaned in accordance to the hygenic standards.
Mild detergents / disinfection fluids (e.g. 70% based alcohol) are recom-
mended.
The Vibrasat® power must be safely positioned in a suitable location.
Please proceed in the stipulated sequence:
Remove the device from the package and place it in a suitable, stable location.
Now remove the hand grip with the connecting cable from the carton. Insert the con-
necting plug of the hand grip into the connecting socket at the back Vibrasat® power.
Now remove the three-pedal foot switch from the package and also connect it to the
back of the device.
Finally, insert the power cable into the back of Vibrasat® power casing and into a
socket with connected protective earth conductor. Observe the voltage indicated on
the identification plate.
Consider not to stack or place other devices in the near vincinity as this may result in
malfunction of the Vibrasat® power or the other devices. If not possible test and ob-
serve the function of the Vibrasat® power and the other devices for correct function.
It is not allowed to operate the Vibrasat® power with HF chirugy devices.
Switch the device on ready for use with the On/Off switch. For operating instructions refer
to chapter 5 of this manual.