Moller Medical Liposat power User manual

Liposat®power
Instruction for use
en

IMPORTANT
READ CAREFULLY BEFORE USE
KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION

Liposat®power
Manufacturer
Page 3 of 36
Manufacturer
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
E-mail: [email protected]

Liposat®power
Liposat®power configuration
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Table of contents
Manufacturer......................................................................................................... 3
Table of contents.................................................................................................. 4
Product description.............................................................................................. 6
Intended use (intended purpose).......................................................................................6
Essential performance feature...........................................................................................6
Manufacturer.....................................................................................................................6
Product overview...............................................................................................................7
Using the Liposat®power ..................................................................................................8
Repeat technical safety monitoring..................................................................................11
Technical data.................................................................................................................12
General safety instructions ............................................................................... 13
Obligations to the operator..............................................................................................13
Explanation of the safety symbols that are used..............................................................15
One-time use...................................................................................................................17
Warnings.........................................................................................................................17
Precautions.....................................................................................................................17
Transport............................................................................................................. 18
Dimensions, weight, and transport instructions................................................................18
Assembly and start-up....................................................................................... 19
Unpacking the device and checking the content of the delivery.......................................19
Suitable operating environments.....................................................................................20
Application for defibrillation and electrosurgical devices..................................................20
Starting up the Liposat®power ........................................................................................21

Liposat®power
Table of contents
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Alarms and service personnel........................................................................... 24
Alarm conditions..............................................................................................................24
Workplaces of the service personnel...............................................................................24
Assistance with problems ................................................................................. 25
Service station.................................................................................................... 27
Cleaning and care............................................................................................... 28
Cleaning and disinfection ................................................................................................28
Maintenance....................................................................................................................28
Disposal..........................................................................................................................29
Accessories and consumables......................................................................... 30
Electromagnetic compatibility........................................................................... 31
Electromagnetic emissions..............................................................................................31
Electromagnetic immunity ...............................................................................................31
Recommended safety distances......................................................................................33
Liposat®power configuration............................................................................ 34

Liposat®power
Liposat®power configuration
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Product description
Any use of the product assumes preciseknowledge of the applicationand attention to these
instructions for use. This set of instructions does not replace professional instruction to the
user by a certified medical device consultant. The product should be used only by persons
who have the required training, knowledge and experience (§2 Section 2 MPBetreibV).
The use of parts that do not correspond to the original manufacture may
damage performance and safety.
Only the original parts as supplied by the manufacturer should be used.
Intended use (intended purpose)
“Liposat®power” is a pump that is used in the field of aesthetic body contouring.
“Liposat®power” is used to promote aqueous solutions for the production of
tumescence local anesthesia as well as body-owning, subcutaneous tissue and its
components in the body.
The tumescence pump ”Liposat®Pro” may only be used with the tube set “Tube set
for Liposat®power” from the Möller Medical GmbH.
Essential performance feature
The Liposat®power does not have any essential performance feature.
Manufacturer
The manufacturer can consider itself responsible for the safety, reliability and usability of
the device only if repairs and maintenance are performed by persons authorised to do so.
All work that requires the use of tools must be done by a technical service authorised by
the manufacturer or by the manufacturer itself.
Under the ElektroG [Electronics Act], the manufacturer is obligated to take back old devices.
Möller Medical GmbH
Wasserkuppenstraße 29-31
36043 Fulda, Germany
Tel.: [phone]; Fax: -49 (0) 661-94195-850
[e-mail] www.moeller-medical.com

Liposat®power
Product description
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Product overview

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Liposat®power configuration
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Using the Liposat®power
The device is turned on with the ON –OFF switch on the left side of the device.
The device then performs a self-test. The software version, the device number and the
manufacturer are shown on the display.
You can set the basic settings of the device with the soft key buttons.
The soft key button Speed sets the flow rate (ml/min) of the pump. The flow rate can be
raised with the Up button or lowered with the Down button at intervals of 10 from 40 ml/min
to 300 ml/min.
The maximum infiltration amount (ml) is adjusted with the soft key button Volume. The
infiltration volume can be raised with the Up button or lowered with the Down button at
intervals of 100 from 500 ml/min to 5000 ml/min.
The pump can be started or stopped at any time with the Start/Stop button. The Foot
switch (accessory) has the same function as the Start/Stop button.
Pump flow rate [ml/min]
(Infiltration volume per time unit)
Already infiltrated volume [ml]
Preselected infiltration volume
[ml]
Soft key buttons
Up button
Down button
RESET button
Start/Stop button

Liposat®power
Product description
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Example of infiltration application
Adjusted flow rate = 180 ml/min
Adjusted infiltration volume = 2000 ml
After the pump was started, 180 ml/min will be infiltrated for 11.1 minutes (infiltration time).
All necessary information is shown on the display.
1 –Selected flow rate (ml/min)
2 –Selected infiltration volume (ml)
3 –Infiltrated volume (ml)
4 –Infiltrated volume (ml) –as a bar chart
5 –Infiltration time
6 –Heating dish 1 active
7 –Heating dish 2 active
If the pump is stopped by pressing the Stop button (9), you can delete the infiltrated volume
and infiltration time by using the Reset button (10).
Every patient needs a new sterile tube set in order to avoid infections, for example.
1
3
2
4
8
10
9
7
6
5

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Liposat®power configuration
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Before usage, inspect the original packed tube set for shelf life and damages. Do not use
expired, damaged, dirty or wet tube sets.
Load the pump tube segment into the pump. The pump tube segment can be found
between the adapters, which are intended to be attached into the adapter receptacle of the
pump. Follow the flow direction arrow on the pump. The pump rotates tothe left (counter
clockwise). Saline solution must be pumped out of its container towards the patient.
The pump tube segment is firmly attached to the 1.5-metre long PVC Afferent tube with its
spike, in order to draw saline solution out of the container.
Connect one side of the Efferent tube to the tube pump segments Luer connector. Connect
the other end of the Efferent tube to the distributor 3-way stopcock.
Always ensure that all hoses lie unencumbered and are not pinched or kinked.
Use the "Reset Function" to prime the tube set. For this purpose, start the pump with a
new tube setand previouslyselected data. The device will then flush thetube set with saline
solution. As soon as saline solution pours out of the infiltration cannula and no air can be
found in the tubing (tube set completely primed), stop the pump by using the Start/Stop
button.
Since the infiltration amount, which has been drawn so far and is now shown on the display
is meaningless for the application, delete these data by pressing the Reset button.
After puncturing with the cannula, restart the pump. The pre-selected infiltration amount and
infiltration time are now shown on the display.
Adapter
Pump tube segment
Pump
Container of
saline solution
Spike
Afferent tube
Distributor 3-way
stop-cock
Efferent tube
(towards patient)

Liposat®power
Product description
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Accessories may be attached to the Liposat®power. One or two heating dishes serve to
maintain the temperature of the pre-heated containers of saline solution.The heating dishes
will be turned on and off by using the soft key button Heating (8). Press the button Heating
to enter the settings menu. You can activate and deactivate the heating by pressing the two
middle buttons.The functioning of the heating dishes is displayed on the left side of the
display (6, 7 –see page 9).
As the infiltrationis completed, a soundwill be generatedand the pump stops automatically.
The infiltration may be interrupted at any time by pressing the Start/Stop button (9).
No settings will be changed by interrupting the infiltration. However, these settings can be
changed at any time.
The device does not require any technical maintenance by the user. Prior
to using, the device must be prepared according to the applicable hygiene
guidelines.
For device disinfection and cleaning, please refer to chapter Cleaning and on page 28.
Repeat technical safety monitoring
Annual safety check-up (STK according to the Ordinance on Medical Device Operation –
MPBetreiberV) is to be done every 12 months.
If the device is not functioning safely and/or is not to be operated safe, it must be send back
to technical service immediately. Technical service may only be performed by the
manufacturer ([e-mail]) or an authorized service provider.

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Liposat®power configuration
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Technical data
Article number
00002274
Dimensions of the device:
(WxHxD) 270 mm x 220 mm x 180 mm
Weight:
approx. 10 kg
Minimum operating life:
8 years
Electrical connection:
Mains voltage:
100 –240 VAC (alternating current)
Mains frequency:
50 –60 Hz
Current use:
1.5 –0.7 A
Protection class:
I
Applied part B:
Schlauchset für Tumeszenzpumpe
Liposat®power
REF-Nr.: 00002251
General characteristics:
Permissible operating conditions:
Temperature:
Humidity:
+10°C to +40°C
30 to 75% relative humidity
Permissible transportation and
storage conditions:
Temperature:
Humidity:
-10°C to +50°C
Less than 90% relative humidity
Protection:
IP 30
Flow rate range of the pump:
40 ml/min to 300 ml/min
(variable adjustment)
Pumping precision:
15%
Disposal:
The device has a lithium battery, which must be
disposed separately at the end of the life of the
device

Liposat®power
General safety instructions
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General safety instructions
Obligations to the operator
The operator takes responsibility for the proper operation of the medical device. The
Ordinance on operation places a number of obligations on the user and responsibility as
part of his activity in using medical devices.
The device should beused onlyby medically trained professionals and bypersonnel trained
to use the device. Read the IFU of all system components thoroughly and completely before
using.
Follow the IFU and pay attention to the warnings before use.
Make yourself familiar with all system components.
If you have no experience with similar products and / or need training, contact the
manufacturer or its sales representatives in order to arrange for a training session. The
manufacturer publishes information about licensed sales agents around the world.
The device should not be operated with electrical supply networks that have questionable
earth connections. The mains voltage must correspond to the information on the
identification plate. No liquids should get into the electrical parts. Unplug the device plug
before cleaning.
The plug connections to the Liposat®power (mains cable, foot switch, heating dishes)
should be plugged in or unplugged only when the device is turned off.
Only the original parts that are supplied should be used.
The heating dishes (accessory) for the sodium chloride package should be reviewed for
mechanical damage before each use. If the sodium chloride package is preheated, the user
should make sure that the temperature of the sodium chloride solution does not exceed
38°C. The temperature sensor of the heating dishes gives the temperature of the sodium
chloride package. This must be inserted in the heating dish at least 5 minutes before use.
If the temperature sensors record a temperature greater than 38°C, the pump will turn off
and the notice "Bag too hot” will appear in the display
No other objects should be attached between the heating dish and the
sodium chloride package, since these could prevent from a correct
recording of the temperature by the sensors.
The heating dishes serve to hold the sodium chloride packages at the proper temperature
of approximately 38°C.
The heating dishes do not heat up the sodium chloride package from lower temperature
level.

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Liposat®power configuration
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The sodium chloride package must always lie with its surface solidly on the temperature
sensor.
The user must decide whether monitoring the body temperature of the patient is necessary
and at what intervals that should occur in order to avoid any medical risks (hypothermia,
hyperthermia, etc.).
A maximum of two heating dishes (accessories) may be attached to the Liposat®power
tumescence pump.
The Liposat®power can be used either standing up straight (e.g., on a table) or hanging
on the surgical suction device Vacusat®power (a product of Möller Medical GmbH).
If using this latter device combination, one should assemble the fasting hooks set on the
back side of the Liposat®power using the screws that are supplied.
The manufacturer can consider itself responsible for the safety, reliability and usability of
the device only if:
assembly, expansions, new settings, changes or repairs are done only by
authorised persons who have the necessary professional knowledge, and
the electrical installation of the room in question corresponds to requirements, and
the device is used according to the instructions for use, which is a part of the
product, and
the personnel who operate theproduct meetthe given, pertinent requirements, such
as those regarding medical qualification.
The operator should dispose the device according to currently applicable rules and
standards.
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.

Liposat®power
General safety instructions
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Explanation of the safety symbols that are used
Important notices are specially marked off in this instructions for use. These notices are a
condition forpreventing dangers to the patient and the service personnel aswell as to avoid
damage to the product or functional disturbances.
Caution
Information
Typ B applied part
“ON” (power)
“OFF” (power)
Start-stop button
Reset button for infiltrated volume and infiltration time
Down button for the reduction of the infiltration speed and
volume
Up button for the increase of the infiltration speed and volume
Alternating current
Return and disposal according to WEEE Directive
Consult instructions for use

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Liposat®power configuration
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Serial number
Catalog number
Batch code
Use by
YYYY-MM-DD
Sterilised using ethylene oxide
Do not re-use
Do not resterilise
Manufacturer
Do not use if package is damaged
Contains or presence of phthalates
Stacking limit, do not store more than 3 packs high
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

Liposat®power
General safety instructions
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One-time use
Reuse of one-time use articles carries the potential risk of infection for the patient or the
user. Contaminated articles can lead to injuries, illness or death of the patient. Cleaning,
disinfection and sterilisation can damage important material characteristics and product
parameters in a way that leads to the breakdown of the product.
Warnings
Use of this product does not automatically lead to significant loss of weight.
Use of this product must occur with special care. Chronic diseases of the patient
(e.g., diabetes, heart disease, vascular disease, lung disease, obesity), the status
of the tissue, the use of medications, blood coagulation, wound healing and the age
of the patient all affect the outcome and must be taken into consideration.
Loss of body materials (blood, lymph, tissue fluid, etc.) can occur through intra-
operative or post-operative use of the product and may negatively affect the
patient's haemodynamic situation. A substitution of body materials is therefore to be
considered by the user.
Precautions
This product should be used only by doctors experienced in human medicine who
have sufficient experience in lipoplasty.
Factors that may affect the success of the operation and subsequent results depend
on the level of experience of the operator, the possible combination with other
products and the prevailing hygienic conditions.
Results of the operation may change over time and are not necessarily permanent.
All reusable parts of the product must be sterilised. All parts that are not reusable
must be changed before use on the next patient.

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Liposat®power configuration
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Transport
The following safety points must absolutely be followed when transporting the device.
Damage to the device and other material damage can thereby be avoided.
Absolutely follow the transport instructions on the package.
Follow the prescribed storage conditions.
Follow the prescribed maximum storage height.
Parts that are piled too high may fall over or be damaged.
Dimensions, weight, and transport instructions
Dimensions of the Liposat®power
with packaging:
(LxWxH) = 390 mm x 330 mm x 335 mm
Weight:
approx. 12 kg
Transport and storage conditions
Temperature:
-10°C to +50°C
Humidity:
Less than 90% relative humidity
A maximum of 3 cartons may be piled on one another during transport.
The outer packaging consists of a corrugated cardboard folding carton. The packaging
inner parts are made of PE foam.
A danger of fire exists because of the easily flammable packaging material. Use no open
fire and do not smoke!
For any possible service, it is recommended that you save the packaging.
Do not throw it away. Use it for any shipment. Product damage may occur
during transportation in improper containers or by inappropriate packaging.
The sender has the responsibility for proper packaging.

Liposat®power
Assembly and start-up
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Assembly and start-up
Make sure that the package has been delivered to you undamaged.
Immediately report any transportation damage to the shipper.
Unpacking the device and checking the content of the delivery
The delivery of the Liposat®power always consists of a cardboard box.
When unpacking the Liposat®power, make sure that no parts remain in the package.
The following are part of the delivery: (one piece each)
Liposat®power
Mains cable
Instructions for use
Instructions for use in "English"
Fastening hooks for the device combination with the
Vacusat®power (Möller Medical GmbH), including fastening screws
Additional equipment that is not part of the scope of delivery of the device
Additional equipment attached to the analogue and digital interfaces of the device must
give evidence of their corresponding EN specifications (e.g., EN 60950 data processing
devices and EN 60601 for electro medical devices).
In addition, all configurations must conform to the current version of system standard
EN 60601-1.
The person who attaches additional devices is the one configuring the system and is
therefore responsible for the maintenance of the current version of the system standard EN
60601-1.
For further questions, contact the manufacturer.
(MDD: 13.6.c, IEC 60601-1: 16)

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Liposat®power configuration
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Suitable operating environments
The Liposat®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, 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).
The Liposat®power is not approved for use in aircrafts or military applications. The
appropriate EMC requirements for these environments have not been tested.
Application for defibrillation and electrosurgical devices
It is not permitted to use the Liposat®power together with electrosurgical devices.