Moller Vacusat power User manual

Vacusat®power
Instructions for use
en
Vacusat®power

IMPORTANT
READ CAREFULLY BEFORE USE
KEEP THESE INSTRUCTIONS FOR FUTURE REFERENCE
© 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. 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

Vacusat®power
Table of contents
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Table of contents
Table of contents.................................................................................................. 4
1General safety information ........................................................................... 6
1.1 Explanation of 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
1.2 Explanation of the formatting conventions used..................................................9
1.3 Manufacturer's responsibility...............................................................................9
1.4 Operator's obligation to exercise diligence........................................................ 10
1.5 Warning notices................................................................................................ 11
1.6 Non-product-related additional equipment.........................................................12
1.7 Single-use.........................................................................................................13
1.8 DEHP Declaration............................................................................................. 13
1.9 Precautionary measures................................................................................... 13
1.10 Target group (users).........................................................................................13
1.11 Use with defibrillation and RF surgical devices ................................................. 13
2Intended use................................................................................................. 14
2.1 Indications.........................................................................................................14
2.2 Contraindications.............................................................................................. 14
2.3 Complications...................................................................................................14
2.4 Essential performance features.........................................................................14
2.5 Combination with other products....................................................................... 14
3Product description..................................................................................... 15
3.1 Design ..............................................................................................................16
3.2 Interface description..........................................................................................17
3.2.1 Hydrophobic bacteria and virus filter.............................................................17
3.2.2 Disposable bag system................................................................................. 17
3.2.3 Suction hose................................................................................................. 17
3.2.4 Applied part...................................................................................................17
3.2.5 Bacteria filter sheet....................................................................................... 17
3.2.6 Equipotential bonding cable..........................................................................17
4Installation and startup ............................................................................... 18
4.1 Transport and storage information....................................................................18
4.2 Unpacking the device and checking the scope of supply................................... 19
4.3 Suitable operating environment.........................................................................19
4.4 Commissioning .................................................................................................20
4.4.1 Assembling the foot stand............................................................................. 20
4.4.2 Assembling the hose holder..........................................................................22
4.4.3 Assembling the foot switch............................................................................ 22
4.4.4 Overflow protection / Hose coupling.............................................................. 23
4.4.5 Rail clamp interface ......................................................................................25
4.4.6 Assembling hoses.........................................................................................25
4.4.7 Installing multiple disposable bags (in series) ...............................................27
4.4.8 Connecting/disconnecting the mains cable ................................................... 29

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4.4.9 Assembling the storage tray.......................................................................... 30
4.5 Disassembly .....................................................................................................30
4.5.1 Ending the suction procedure........................................................................30
4.5.2 Emptying the suction canister ....................................................................... 30
4.5.3 Disassembling hoses.................................................................................... 31
4.5.4 Disassembling the overflow protection.......................................................... 32
5Use and operation ....................................................................................... 33
5.1 Function test..................................................................................................... 33
5.2 Suctioning.........................................................................................................35
5.2.1 Warning notices............................................................................................35
5.2.2 Switching Vacusat®power on ....................................................................... 36
5.2.3 Setting the vacuum....................................................................................... 36
5.2.4 Using the foot switch.....................................................................................37
5.3 Replacing the bacteria filter sheet..................................................................... 37
6Cleaning and disinfection........................................................................... 38
7Help in the event of a fault.......................................................................... 39
8Service.......................................................................................................... 41
8.1 Replacing the mains fuses................................................................................42
8.2 Repairs.............................................................................................................42
8.3 Rating plate....................................................................................................... 43
8.4 Sending the device ........................................................................................... 43
9Periodic safety checks................................................................................ 44
10 Disposal........................................................................................................ 45
11 Appendix ...................................................................................................... 46
11.1 Key technical data............................................................................................. 46
11.2 General data..................................................................................................... 46
11.3 Electromagnetic emissions ...............................................................................48
11.4 Electromagnetic immunity................................................................................. 49
11.5 Recommended safety distances....................................................................... 51
12 Accessories.................................................................................................. 52

Vacusat®power
General safety information
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1 General safety information
1.1 Explanation of safety symbols used
Important information is indicated visually in these instructions for use. These indications are
necessary to prevent hazards to patients and operating personnel, as well as to avoid dam-
age and device malfunctions.
1.1.1 Symbols in the instructions for use
Caution! Hazard for patients, operating personnel and third par-
ties.
Information and help
Interference may occur in the vicinity of devices marked with this
symbol.
1.1.2 Symbols on the device
Serial number (the first 4 digits indicate the year and month of
manufacture in YYMM format)
Medical device
Unique identifier of a medical device
Consult instructions for use
Manufacturer
Alternating current
Return and disposal as per the WEEE Directive
Compliant with ANSI/AAMI ES 60601-1
CAN/CSA 22.2 No. 60601-1-08

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General safety information
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Device switched off
Device switched on
Foot switch
Increasing the vacuum
Reducing the vacuum
1.1.3 Additional symbols on the retail packaging
Follow the instructions for use
Catalogue number
Batch code
Packaging unit
Use by YYYY-MM-DD (year-month-day)
Sterilised using ethylene oxide
Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective outer packaging
Single sterile barrier system with internal protective packaging

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General safety information
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Not suitable for use with MRI
Do not re-use
Do not resterilise
Fragile, handle with care
Do not use if package is damaged
Stacking restriction: stack may consist of max. 3 packages
Keep dry
Restriction on relative storage humidity
Storage temperature limitation
Manufacturing date
Sales partner
Keep away from sunlight
Caution! Observe transport and storage conditions.
Attention: Under US Federal law, this device may only be sold to
a physician or if ordered by a physician.
Further information about the symbols used can be found on our website:
www.moeller-medical.com/glossary-symbols

Vacusat®power
General safety information
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1.2 Explanation of the formatting conventions used
In these instructions for use, different fonts are used to improve orientation.
Font
Use
Bold
Buttons in the operating instructions
Italics
Device options, buttons and references to chapter
and sections in the running text.
Table 1:
Explanation of formatting conventions
1.3 Manufacturer's responsibility
The manufacturer is responsible for the safety, reliability and serviceability of the device pro-
vided the following conditions are met:
Assembly, upgrades, adjustments, changes orrepairs are performed only by persons author-
ised by the manufacturer. The electrical installation ofthe medicinally used roommust comply
with the appropriate regulations (i.e. VDE 0100, VDE 0107 or IEC regulation) and the device
must be used according to the operating instructions. In addition, country-specific regulations
and national deviations must be complied with.
The manufacturer agrees to accept old devices as per the German Electrical and Electronic
Equipment Act (ElektroG).

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General safety information
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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 Operators Ordinance (MP BetreibV), the user must meet a wide
range of obligations and also assume responsibility when handling medical devices within
the framework of their activities.
All handling of the Vacusat®power requires precise knowledge and compliance with these
instructions for use. This instruction manual does not replace user training by the medical
device consultant. Clinical applications must always be instructed by qualified personnel.
The safety information in the operating manuals of the devices used in conjunction with the
Vacusat®power must also be followed.
The Vacusat®power is 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.
All work that requires tools must be performed by the manufacturer's technical service or
parties authorised by the latter.
Consumables and any bodily fluids must be disposed of according to the hygiene guidelines.
All serious incidents which occur in connection with the product must be re-
ported to the manufacturer and the competent authorities of the member state
in which the user and/or patient is based.

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General safety information
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1.5 Warning notices
•The products of Möller Medical GmbH may only be used if they are in a
fully functional condition. Check for proper condition and full functionality
before use.
•No modifications to the Vacusat®power are permitted.
•Do not insert any objects into the housing. External objects inserted into
the device may result in electric shock.
•Fluids must not penetrate the parts of the Vacusat®power under voltage.
•Disconnect the power cable before cleaning.
•When cleaning, ensure that no cleaning agent runs into the connector
sockets.
•Replace connecting cables of all kinds as soon as they are slightly dam-
aged; avoid rolling 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.
•Before connecting the mains plug, check that the mains voltage is the
same as the value indicated on the rating plate. The Vacusat®power can
only be disconnected from the power supply by unplugging the mains plug.
•The Vacusat®powermay only be connected to power supplies with ground
wire connection.
•When removing plugs, do not pull on the cables.
•To remove, release the plug lock if necessary.
•Do not subject the Vacusat®power to excessive heat or fire.
•Do not subject the Vacusat®power to strong impacts.
•If heat, fumes or smoke occur, immediately disconnect the Vacusat®
power from the power supply.
•When cleaning and disinfecting the Vacusat®power, follow the instructions
to avoid damaging the product.
•Do not operate the Vacusat®power within the AP-M area. The product has
no explosion protection and is not intended for use in hazardous explosive
AP-M areas.
•The Vacusat®power may not be used for suctioning flammable or explo-
sive liquids.
•Risk of infection from using no or a defective hydrophobic bacteria and
virus filter. When suctioning, secretions enter the suction pump. Clean and
disinfect the Vacusat®power and have it repaired by a service technician
authorised by Möller Medical GmbH.

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General safety information
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•These instructionsfor use do not include information on using components
or accessories from other manufacturers. You must observe the instruc-
tions for use of the relevant manufacturer.
•Always observe the information on electromagnetic immunity (see appen-
dix). The function of other electrical devices can be affected when they are
used in the vicinity of the Vacusat®power.
•To prevent an infection or bacterial contamination when suctioning and
disposing of secretions, the relevant hygiene guidelines must be followed.
Note the intended purpose of the bacteria filter. When suctioning, always
use sterile suction catheters and ensure that the patient is not injured. Al-
ways wear gloves when working.
•Do not operate the Vacusat®power without the bacteria filter sheet. The
bacteria filter sheet provides additional protection against contaminating
the surrounding air.
•The Vacusat®power may only be operated with the overflow protection
connected, otherwise it is not protected against over-suctioning. A hydro-
phobic filter provides additional protection against over-suctioning. It shuts
off the gas flow to the product in the event of over-suctioning. Particles in
the gaseous phase can lead to clogging of the hydrophobic filter.
•Carry out a function test and eliminate any defects. If the ambient condi-
tions were exceeded or not reached during transport, storageor operation,
function may be impaired.
•Increased ultraviolet radiation on the plastic parts of the housing leads to
premature material fatigue, which can cause the material to break. Protect
the Vacusat®power from direct sunshine.
•Place the Vacusat®power in a horizontal position during operation. The
device may only be operated when the caster brakes are set. If the product
is not in a horizontal position, the proper function of the mechanical over-
flow protection is not ensured.
•Do not carry or lift the Vacusat®power by its push handle.
1.6 Non-product-related additional equipment
Additional equipment which does not belong to the device’s scope of supply and which is
connected to the device’s analogue and digital interfaces must be shown to satisfy the rele-
vant EN specifications (e.g. EN 60601 for electromedical devices). In addition, all
configurations must be in accordance with the current valid version of the system require-
ments as per the standard IEC 60601-1 +A1:2012. The person who connects additional
equipment is the system configurer and thus responsible for ensuring compliance with the
current version of system requirements according to IEC 60601-1 + A1:2012.
If components are used that do not correspond to the original parts, perfor-
mance, safety and EMC behaviour may be impaired.

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General safety information
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1.7 Single-use
The re-use of a single-use product presents a potential risk of infection for the patient or
operator. Contaminationof the devicemay leadto injury, illness or deathof the patient. Clean-
ing, disinfection and sterilisation may affect essential material properties and product
parameters to the extent that this leads to failure of the articles.
Dispose of used single-use products according to your hygiene guidelines.
1.8 DEHP Declaration
The Vacusat®power contains no bis(2-ethyhexyl) phthalate (DEHP).
1.9 Precautionary measures
Application results vary depending on the patient’s age, the intervention site and the sur-
geon’s experience. The application results may or may not be permanent.
Clean and disinfect all reusable components of the Vacusat®power according to Section 7
“Cleaning and ” and replace all disposable components before using the Vacusat®power on
another patient.
1.10 Target group (users)
The Vacusat®power is reserved for use by doctors who can demonstrate that they have the
necessary expertise in liposuction through relevant specialist training or approved, specialist
further training.
1.11 Use with defibrillation and RF surgical devices
The use of the Vacusat®power in combination with RF surgery or defibrillation devices is not
allowed.

Vacusat®power
Intended use
Page 14 of 54
2 Intended use
2.1 Indications
The Vacusat®power is a powerful, low-noise suction device designed for continuous operation
and is suitable for high flow and high vacuum. It can be used to suction tumescent solution,
body fats, fat cells (secretions, blood and serous fluids) and the particles they contain from
artificial body orifices and is intended for use on patients in: surgery, liposuction and aesthetic
body contouring. The Vacusat®power should be used by trained personnel in a clinical setting
or doctor's practice. The Vacusat®power is not suitable for direct application by the patient in
home care situations and nor is it suitable for drainage suction. The suction device may not be
used in cardiac surgery or operations on the central nervous system.
2.2 Contraindications
•Clotting disorders or intake of anticoagulant medication
•Massive hernias
•Serious heart diseases
•Serious lung diseases
•Serious liver damage
•Serious kidney damage
•Risk of thrombosis (thrombophilia)
•Diabetes
2.3 Complications
•Vascular injuries
•Nerve injuries
•Tissue injuries
•Organ injuries
•Death
2.4 Essential performance features
The Vacusat®power has no essential performance features.
2.5 Combination with other products
Only accessories that have been specified and approved by the device man-
ufacturer should be used. Please contact the device manufacturer if you are
unsure.

Vacusat®power
Product description
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3 Product description
All handling of the device requires precise knowledge and compliance with these instructions
for use. These instructions do not replace the user training provided by the medical device
consultant. The device must only be used by persons who have the required training or
knowledge and experience (Sec. 2 (2) German Medical Device Operators Act/MPBetreibV).
•Only the original parts supplied may be used.
•Performance and safety may be impaired if Original Equipment Manufac-
turer device parts are not used.

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Product description
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3.1 Design
Figure 1:
Overview of the Vacusat®power
1
Suction pump
9
Push handle
2
Control panel
10
Hose holder
3
Vacuum meter
11
Device rail
4
Control lamp for foot switch
12
Cover for bacteria filter
5
ON switch
13
Foot switch
6
Control lamp for operation
14
Hose coupling
7
OFF switch
15
Mains cable
8
Control knob
16
Storage tray

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Product description
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3.2 Interface description
3.2.1 Hydrophobic bacteria and virus filter
It is not necessary to use a hydrophobic bacteria and virus filter if a suitable
hydrophobic bacteria and virus filter is integrated for specific use in the secre-
tion container when disposable bags are used.
The hydrophobic bacteria and virus filter protects against contaminants that may be present
as particles or aerosol in the intake gas. Furthermore, the hydrophobic filter is also used as
overflow protection; it shuts off the gas flow to the product in case of over-suctioning. In its
function as a bacteria and virus filter, it prevents bacteria and viruses from entering the pump.
3.2.2 Disposable bag system
With the disposable bag system, fluids and secretions are collected during medical proce-
dures and then disposed of.
The disposable bag system is not sterile.
3.2.3 Suction hose
The suction hose is the connection between the hose connector on the secretion container
cover on the patient side and the applied part.
3.2.4 Applied part
The Möller Medical GmbH liposuction cannulas are applied parts. The applied part is used to
suction tumescent solutions, body fats, fat cells (secretion, blood and serous fluids) and the
particles they contain out of artificial body orifices.
3.2.5 Bacteria filter sheet
The bacteria filter sheet prevents contamination of the surrounding air. Only Möller Medical
GmbH bacteria filters may be used.
3.2.6 Equipotential bonding cable
The equipotential bonding cable is the connection between the suction pump and the equi-
potential output pin with equipotential rail for protection against electric shock.

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Installation and startup
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4 Installation and startup
Upon delivery, make sure that the boxes are not damaged. Check the Va-
cusat®power for damage. In the event that the product has defects, it should
not be used and the supplier must be informed accordingly.
4.1 Transport and storage information
A maximum of 3 cartons may be stacked for transport.
Risk of fire from the highly flammable packaging material. Do not use open flames and do
not smoke.
Dimensions of the Vacusat®power
With packaging
Width x height x depth
1030 mm * 360 mm * 420 mm
Weight
approx. 30 kg
Transport and storage information
Temperature
-15°C to +30°C
Air humidity
10 to 95 % relative humidity

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Installation and startup
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4.2 Unpacking the device and checking the scope of supply
The delivery of the Vacusat®power Vacusat®power consists of one carton. Make sure that
no parts remain in the packaging when unpacking the Vacusat®power .
The scope of delivery of the Vacusat®power includes:
•Basic device (consisting of: 1 device, 1 vacuum connecting
hose, 1 mains cable, 2 foot stands with 2 casters each
(with brake), 2 hose holders, 1 assembly set (8 screws,
4 spring washers, 4 plastic discs, 4 filler plugs, 1 hex key)
REF 00002252
•UK power cable
REF 93004210
•Mains cable, straight, Switzerland
REF 93004725
•Mains cable, hospital grade
REF 93006957
•2 containers for disposable bags
REF 00002257
•2 disposable bags, 3 litres
REF 00002256
•2 rail clamps for device holders
REF 00002258
•1 foot switch
REF 00002656
•Hydrophobic filter
REF 00002297
•Overflow protection with chamber for hydrophobic filter
REF 00002299
•Serial hose with elbow
REF 00002260
•Vacuum serial hose, silicone
REF 00002259
•Instructions for use Vacusat®power
REF 92007308
•Instructions for use Vacusat®power
REF 92007309
It is advisable to keep the packaging and use it again should service be re-
quired.
Always send the Vacusat®power in its original packaging in order to avoid
damage during transport.
4.3 Suitable operating environment
The Vacusat®power is suitable for environments in the following areas:
Professional healthcare facilities with specific requirements:
•Clinics (A&E rooms, hospital rooms, intensive care, operating theatres, except in
the proximity of active facilities with RF surgery devices or outside of the RF-
shielded room for magnetic resonance imaging, first aid facilities).
The Vacusat®power is not approved for use in aircraft, vehicles or military applications. The
appropriate EMC requirements for these environments have not been tested.

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Installation and startup
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4.4 Commissioning
The Vacusat®power must be set up in a suitable place. Proceed in the following order:
4.4.1 Assembling the foot stand
If the foot stands are incorrectly assembled there is a risk of tipping over. En-
sure that there is a right and a left foot stand and that they are assembled
correctly.
Figure 2:
Assembly position
Assembly position
•Remove the foot stands, assembly set
and accessories from the packaging.
•Place the base device (1) on the edge
of the packaging with the back facing
upwards.
Figure 3:
Pre-assembling the foot stand
Pre-assembling the foot stand
•Guide the screw (1) with spring washer
(2) through the drill hole in the foot
stand (3).
•Place the plastic disc (4) over the
screw.
•Assemble the remaining screw connec-
tions in the same way.
Figure 4:
Mounting the first foot stand
Mounting the first foot stand
•Place the red dot on the foot stand (1)
on the red dot of the base device (2).
•The longer section of the foot stand (3)
points towards the floor.
•Screw in and slightly tighten the screws
with the hex key (4).