Nouvag Lipo Surg User manual

LipoSurg
Instructions for use
EN

©NOUVAGAG • 31648 • V20230330 • Allrightsreserved
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LIPOSURG INSTRUCTIONS FOR USE
SYMBOLS
General
warning sign
General
mandatory action
Refer to
instructions for use
Manufacturer Date of manufacture Distributor
Use-by date Separate collection
required (WEEE) Biological hazard
Do not use if package
is damaged Not for reuse Contains or presence of Phthalate
Batch code Catalog number Serial number
Medical device
Authorized represen-
tative in the European
Community
EOSTERILE Sterilized using
ethylene oxide
Type BF applied parts
are the instruments
used
Autoclavable at 134°C For thermal
disinfection
Indication of pump
flow direction Equipotentiality Foot switch
Protective ground Socket for Motor
IPX8
Water resistance
0197
European Conformity
mark
Certified by the TÜV
Rheinland North
America Group
CONGRATULATIONS ON YOUR PURCHASE OF A PRODUCT FROM NOUVAG.
We are pleased that you have chosen a quality product from NOUVAG and thank you very much for the trust you
have placed in us.
These instructions for use will familiarize you with the device and its functions so that you can apply and use
them correctly.

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INSTRUCTIONS FOR USE LIPOSURG
CONTENT
PRODUCT DESCRIPTION 4
Intended use and operation
Contraindications
Intended users
Target population
Ambient conditions
SAFETY INFORMATION 5
EMC Manufacturer’s Declaration of Conformity
Integrated peristaltic pump
Modification and misuse
Essential requirements
During use
SCOPE OF DELIVERY 7
DEVICE OVERVIEW 8
Front view
Rear view
SETUP 9
Device and accessories setup
Connection to the power supply
Device preparation
OPERATION 14
Switching the device on and off
Overview: Control elements
Infiltration «INFIL»
Liposuction « LIPO»
«COMBI-MODE »
Operation with VARIO pedal
Functional check
CLEANING AND STERILIZATION 18
Control unit and pedal
Handpiece cradle
Handle with Conform cannula handpiece
Electronic motor21
Tubing set REF 6022 and REF 6026
MAINTENANCE 19
Replacing the control unit fuses
Safety inspections
MALFUNCTIONS AND TROUBLESHOOTING 20
ACCESSORIES AND SPARE PARTS 22
Information on disposal
TECHNICAL DATA 23
WARRANTY COVERAGE 24
Post market surveillance
Service points
APPENDIX 25

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LIPOSURG INSTRUCTIONS FOR USE
PRODUCT DESCRIPTION
INTENDED USE AND OPERATION
The LipoSurg is a useful and precisely matched combination of devices consisting of a peristaltic pump for
infiltration of tumescent fluid and a motor drive for moving the liposuction cannula. This allows a tissue-gentle
liposuction with or without tumescent local anesthesia.
In conjunction with appropriate accessories, this system provides significant advantages in outpatient liposuc-
tion. When used properly optimal cosmetic results, reduced costs, simplified handling, and increased safety are
achieved.
CONTRAINDICATIONS
Infectious wounds Liposuction may only be performed after the treatment of the infection and necrotic
tissue.
In principle, generally poor health of the patient.
Liposuction shortly after a strict diet of the patient.
Morbid obesity (obesity) Large suction volumes increase the risk of death due to fluid shifts.
Intravascular infusion of liquids.
INTENDED USERS
The device is designed to be used by professional and trained users only, in professional contexts (e.g., hospital,
clinic). The device is not to be used by patients or by untrained users.
TARGET POPULATION
Not limited by age and gender. See contraindications for limiting health factors.
AMBIENT CONDITIONS
TRANSPORT AND STORAGE DURING USE
Relative humidity max. 90 % max. 80 %
Temperature 0 °C – 60 °C 10 °C – 60 °C
Atmospheric pressure 700 – 1’060 hPa 800 – 1’060 hPa

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INSTRUCTIONS FOR USE LIPOSURG
SAFETY INFORMATION
It is essential to bear the following information in mind Every use of the LipoSurg different to the product descrip-
tion defined in section I    > causes risks for patients and trained personnel. If physical
examinations and therapies are carried out without use of the devices, then the devices must be removed from
the place of treatment.
EMC MANUFACTURER’S DECLARATION OF CONFORMITY
The use of (RF) Radio Frequency emitting devices and equipment as well as the occurrence of negative environ-
mental factors in the close area of the LipoSurg may cause unexpected or adverse operation. The connection or
the placing of other devices in close vicinity is not allowed.
Use only accessories and cables as specified in the product description. Further observe the EMC manufacturer
declaration of conformity.
INTEGRATED PERISTALTIC PUMP
The integrated peristaltic pump is used for infiltration of watery solutions into the human connective tissue. The
infiltration pump is not designed for intravascular infusion of liquids.

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LIPOSURG INSTRUCTIONS FOR USE
MODIFICATION AND MISUSE
Modification or manipulation of the LipoSurg and its accessories is prohibited. The manufacturer is not
liable for any damages resulting from unauthorized modifications or manipulations. The warranty will be
canceled.
Use of the LipoSurg outside the indications described in I    > is prohibited. The
user or operator is solely responsible for any such use.
ESSENTIAL REQUIREMENTS
Packaging must be integer. If the shipping box has holes or if the internal Styrofoam is damaged, please do
not use the device as it can be not visibly damaged.
The use of third-party products is the responsibility of the operator. Functionality and patient safety cannot
be guaranteed with third-party accessories.
Prior to using the device, before startup, and before operation, the user must always ensure that the device
and accessories are in good working order and are clean, sterile, and operational.
Repairs may only be performed by authorized NOUVAG service technicians!
Improper use or repair of the device and failure to observe these instructions relieve us from any obligation
arising from warranty provisions or other claims!
Only use Lubrifluid (REF 2128) to lubricate the electronic motor and the handpiece. The use of other care
products can lead to malfunctions. The warranty will be voided!
The LipoSurg may only be operated by qualified and trained personnel!
DURING USE
The device is not sterile on delivery. All sterilizable parts must be sterilized before use (see Chapter C
  >).
Handpieces may only be attached when the electronic motor is at a stand still!
At the choosing of the instrument the operator must make sure it’s biocompatible, according to
ENISO10993.
Never operate the clamping mechanism of the handpieces or contra angles while the system is running. This
could result in instrument damage.
Do not use device, motor, and pedal in the vicinity of flammable mixtures.
In extreme cases the handpiece may heat up excessively.
SAFETY INFORMATION

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INSTRUCTIONS FOR USE LIPOSURG
SCOPE OF DELIVERY
REF DESCRIPTION QUANTITY
3392 LipoSurg – Set 1
3362 LipoSurg control unit 1
1511nou VARIO foot switch 1
2101nou Electronic motor 21, 12’000 rpm 1
5077nou Conform cannula handpiece 1
5107 Handle complete 1
6022 Disposable tubing set, sterile, 4 m 1
6026E Disposable tubing set Ø 6.5 x 9 mm, sterile, 4 m 1
29061 Clip set, for tube set attachment to motor cable, PU 5 pcs. 1
1770 Stand for irrigation fluid bottle 1
1170 Handpiece tray 1
19584 Spray adapter with thread, for lubricant spray (REF 2128) 1
31648 LipoSurg instructions for use 1

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LIPOSURG INSTRUCTIONS FOR USE
DEVICE OVERVIEW
1 Control unit LipoSurg 2 Socket for VARIO pedal 3 VARIO pedal 4 Liposuction cannula (optional) 5 Handle with Conform
cannula handpiece 6 Handpiece cradle 7 Cannula adapter with Luer-Lock (optional) 8 Cannula adapter 9 Infiltration needle (opt
ional) 10 Display 11 Control panel 12 Connection for suction tube 13 Cable of electronic motor 14 Tubing set 15 Connection
socket, electronic motor 16 Peristaltic pump release button 17 Swivel arm with tubing set mount 18 Roller clamp 19 Vent
valve 20 Bottle cap with rubber membrane 21 Container with tumescent solution 22 Bottle holder 23 Type plate with type
designation, reference number, serial number, information on power supply and device fuse 24 Connection for potential equaliza-
tion 25 Power plug socket 26 Main switch 27 Fuse compartment 28 Spray nozzle for maintenance of Conform cannula handpiece
FRONT VIEW
REAR VIEW

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INSTRUCTIONS FOR USE LIPOSURG
SETUP
1 Unplug the power cable.
2 Use a screwdriver to open the fuse slot.
3 Remove the fuse holder.
4 Remove the grey fuse holder and reinsert it so that the local mains voltage setting is shown in the small
window.
5 Slide fuse holder back in and close the fuse slot.
6 Check the mains voltage shown on the fuse slot.
7 Plug the power cable back into the device.
To prevent of risks of an electric shock, the device may only be connected to a power network with a PE
protective ground conductor.
Only a tested power cord may be used to connect the device to the power supply.
DEVICE AND ACCESSORIES SETUP
¬Place the LipoSurg and all required accessories and instruments on an even, non-slip surface and make sure
you have good access to all controls.
¬The installation of the device near other devices is prohibited due to EMC.
¬Do not allow the operating range of the device and accessories to be compromised by limiting factors.
¬The system display must be always fully visible.
¬The pedal must be placed within stepping distance between the patient and the surgeon.
¬It must be explicitly ensured that no objects can fall on the pedal.
¬The power plug at the rear of the device must be always accessible.
¬The motor ventilation slots must be kept clear to prevent the motor from overheating.
CONNECTION TO THE POWER SUPPLY
Before plugging the power cable into the power socket for the first time, you must check the supply voltage
setting next to the power switch!
If the voltage shown does not correspond to the local mains voltage, the grey fuse holder must be set to the cor-
rect voltage:

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LIPOSURG INSTRUCTIONS FOR USE
DEVICE PREPARATION
PREPARING THE ELECTRONIC MOTOR
Sterilize the electronic motor that drives the Conform cannula handpiece (the motor is not sterile on delivery). If
the motor has already been sterilized: when removing the motor from the sterile packaging, ensure that the ster-
ile packaging is not damaged and that the sterility indicator confirms sterility (if no sterility indicator is provided,
the sterile packaging must at least show the date on which the shelf life of the sterile item is due to expire).
PREPARING THE BOTTLE HOLDER
Insert the bottle holder stand for the suspension of the tumescent solution container into the stand holder at the
control unit and hang the container on it. The maximum load on the hook is limited at 2kg.
Heavier loads than allowed (2kg) on the bottle holder stand may cause the unit to tip over.
PREPARING THE PEDAL
Connect the pedal plug with the pedal socket at the rear of the control unit.
PREPARING THE HANDLE WITH CONFORM CANNULA HANDPIECE
Assemble the sterilized Handle with Conform cannula handpiece, electronic motor and all the accessories accord-
ing to the following instruction.
SETUP
1Liposuction cannula (optional) 2Cannula adapter with suction channel (REF 75705) 3Connection tube (REF 29063) 4Protec-
tive cap (REF 40376) 5Silicone sealing (REF 40377) 6Conform cannula handpiece (REF 5107) 7Closure 8 Electronic motor
(REF 2101nou) 9Suction pipe integrated in handle 10 Handle
SETUP

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INSTRUCTIONS FOR USE LIPOSURG
SETUP
ASSEMBLING THE HANDLE WITH CONFORM CANNULA HANDPIECE
1 Have the electronic motor ready.
2 Attach the Conform cannula handpiece onto the
motor and check that it is firmly seated.
4 Guide the closure, thread first, over the cable of
the electronic motor until just before the elec-
tronic motor.
6 Now screw the cap past the cable into the open-
ing of the Conform cannula handpiece.
5 Insert the electronic motor with attached Con-
form cannula handpiece into the opening of the
handle. Make sure that the Conform cannula
handpiece with motor are completely inserted.
7 Seat the silicone sealing via the tread onto the
Conform cannula handpiece.
3 First slide the closure over the motor connector
plug.

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LIPOSURG INSTRUCTIONS FOR USE
8 Also place the protective sleeve over the thread
on the Conform cannula handpiece.
10 Connect the connection tube to the suction pipe.
11 Adjust the alignment of the hose by loosening
the closure on the back of the handpiece.
12 Screw the cannula onto the cannula adapter.
9 Screw the cannula adapter through the opening
of the protective cap onto the thread of the Con-
form cannula handpiece.
SETUP

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INSTRUCTIONS FOR USE LIPOSURG
PREPARING THE TUBING SET
Use only NOUVAG tube set REF 6022 for infiltration, otherwise the correct function cannot be guaranteed.
Check the expiry date of the tubing set and ensure that the packaging is not damaged. Using non-sterile
tubing sets can result in serious infections and worst case can be fatal.
When inserting the tubing set, observe the arrow on the cover of the pump compartment. It indicates the
flow direction of the infiltration solution.
The integrated peristaltic pump is used for the infiltration of the tumescent solution.
Do not regulate the amount of irrigation fluid using the roller clamp on the tubing set; with the LipoSurg,
this is regulated instead using the integrated pump. For this reason, make sure to open the roller clamp as
far as it will go (refer also to O: C  >).
1 Press release key for tubing set bracket (on top
of the control unit) to open the pump.
2 The compartment with the integrated tubing
bracket opens.
5 Insert the spike at the end of the tubing set into
the irrigation fluid bottle and hang the bottle
onto the stand.
6 Open the roller clamp on the tubing set as far as
it will go.
3 Place the tubing set into the tubing bracket pro-
vided in such a way that the part of the tubing
set with the spike exits the pump towards the
rear of the device. Make sure the tubing is secure.
4 With the tubing set inserted, press the compart-
ment downwards until it clicks into place.
7 Open the bleed valve beneath the drip chamber.
8 Connect the control unit to the power socket.
SETUP

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LIPOSURG INSTRUCTIONS FOR USE
OPERATION
SWITCHING THE DEVICE ON AND OFF
The power switch « I/O» (at the rear) is used to switch the control unit on and off. The device can be switched off
at any time irrespective of any procedure for switching off the device.
OVERVIEW: CONTROL ELEMENTS
A Display —Display of various parameters.
I « INFIL» >,  L « LIPO » > , « COMBI-MODE » >  
B «INFIL » key —Selection of the function «Infiltration».
By pressing the «INFIL» key, the volumetric displacement is increased.
By pressing the «INFIL» key, the volumetric displacement is reduced.
C «LIPO » key —Selection of the function « Liposuction ».
By pressing the «LIPO» key, the number of cannula strokes is increased.
By pressing the «LIPO» key, the number of cannula strokes is reduced.
By pressing both «INFIL »and«LIPO » keys simultaneously, the «COMBI-MODE» is activated. In this case INFIL and
LIPO are both active at the same time.

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INSTRUCTIONS FOR USE LIPOSURG
A Selected function « INFIL»
By pressing the «INFIL» key, the «INFIL function » (Infiltration) is displayed up left.
By pressing the pedal, the display shows «INFIL in operation» up right.
B Setting the maximal by pedal retrievable volumetric displacement of the peristaltic pump.
The output limit of the tumescent solution can be regulated in 10 % steps, beginning with 10 %.
C Real-time display of the pump delivery rate, which is retrieved by pedal.
Bar graph shows the percentage of flow rate of the peristaltic pump, retrieved by pedal.
The pump does not begin to operate until the motor has been activated by pressing the pedal.
LIPOSUCTION  LIPO
A Selected function «LIPO »
By pressing the «LIPO» key, the LIPO function (Liposuction) is displayed up left.
By pressing the pedal, the display shows «LIPO in operation» up right.
B Setting range of the number of cannula strokes.
Display of the range of possible cannula strokes.
C Regulating the cannula strokes.
By pressing the pedal the Conform cannula handpiece is running with the preset value.
COMBIMODE
Selected function « INFIL & LIPO»
By pressing both «INFIL »and«LIPO » keys simultaneously, the « COMBI-MODE» (Infiltration & Liposuction) is
displayed. Set values for both functions just as mentioned above.
OPERATION
INFILTRATION  INFIL 

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LIPOSURG INSTRUCTIONS FOR USE
In «Normal » Pedal Mode (variable) it is required
to press or move the pedal permanently to vary the
infiltration up to the preset maximum value, while at
liposuction the stroke of the cannula works always
with the preset stroke rate.
OPERATION
OPERATION WITH VARIO PEDAL
The pedal can be used in two different modes for not having to press the pedal permanently during infiltration or
liposuction.
In «ON/OFF » Pedal Mode the pedal behaves like a
switch. By shortly pressing the pedal, infiltration and
liposuction is carried out with the preset values. It is
not necessary to keep pressing the pedal. If the pedal is
pressed shortly again, the device stops immediately.
PEDAL MODE SELECTION
The pedal mode is set on the operation panel.
1 Press keys « (1)» and « (2)» simultaneously.
Pedal Mode « ON/OFF» is active in function « INFIL».
2 Press keys « (1)» and « (3)» simultaneously.
Pedal Mode « Normal» is active in function « INFIL».
1 Press keys « (1)» and « (2)» simultaneously.
Pedal Mode « ON/OFF» is active in function « LIPO».
2 Press keys « (1)» and « (3)» simultaneously.
Pedal Mode « Normal» is active in function « LIPO».
Infiltration in « Normal » Pedal Mode
Liposuction in « ON/OFF » Pedal Mode
NORMAL  PEDAL MODE VARIABLE
STEP PLATE... CANNULA STROKE PERISTALTIC PUMP
not pressed No cannula stroke Pump off
pressed gently Cannula works with maximal speed Pump runs with the speed shown by the bar graph
ON/OFF  PEDAL MODE
STEP PLATE... CANNULA STROKE PERISTALTIC PUMP
not pressed No cannula stroke Pump off
pressed shortly Cannula works with preset value Pump runs with preset value
Pedal Mode
« ON/OFF »
Pedal Mode
« Normal »
Pedal Mode
« ON/OFF »
Pedal Mode
« Normal »

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INSTRUCTIONS FOR USE LIPOSURG
FUNCTIONAL CHECK
Prior to every startup of the LipoSurg, or the use of accessory equipment, the user must always ensure that each
individual component is in good working order, free from defects, and is clean, sterile and operational. All inscrip-
tions on the device and its accessories must be readable and there must be no loose parts in the device. Once the
device is switched on, the most recent settings entered appear on the display.
ELECTRONIC MOTOR
The functional check of the electronic motor is carried out without the Conform cannula handpiece attached.
1 To activate the liposuction mode, press the key « LIPO».
2 Press the « LIPO» key to increase the speed to its maximum value.
3 Press the pedal.
The electronic motor starts running and accelerates up to its maximum speed. When releasing the pedal, the
electronic motor decelerates and finally comes to a stop.
The motor ventilation slots must be kept clear, to prevent the motor temperature from becoming excessive.
When the electronic motor is placed in the handle, built in channels ensure sufficient cooling of the motor.
PERISTALTIC PUMP
1 Activate the infiltration mode by pressing the «INFIL » key.
2 Press the « INFIL» key to select the maximum speed of the pump (100 %).
3 Press the pedal all the way down.
The pump starts working and quickly speeds up to its maximum speed. At the outlet of the tube respectively at
the infiltration needle or at the infiltration cannula the liquid is spurting out.
OPERATION

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LIPOSURG INSTRUCTIONS FOR USE
CLEANING AND STERILIZATION
The instructions described here are intended for the parts supplied in the set. The cleaning, disinfection and steril-
ization instructions for extensions and accessories are described in their respective operating instructions.
The following points are important regarding the caring for the material:
Perform cleaning, disinfection and sterilization after every treatment!
Always autoclave the material in sterilization packaging.
Make sure that the sterilization packaging is not more than 80% filled.
Autoclave material for at least 5minutes at 134°C.
If sterilized material is not used immediately, the sterilization packaging must be labeled with the steriliza-
tion date.
NOUVAG recommends including a sterility indicator.
CONTROL UNIT AND PEDAL
The control unit and pedal do not come into contact with the patient.
Wipe the outside using micro-biologically tested surface disinfectant or a 70% isopropyl alcohol solution. The
front plate of the control unit is sealed for this purpose and can be wiped clean.
HANDPIECE CRADLE
Soiled handpiece cradles are cleaned using a neutral cleaning agent and then sterilized in accordance with the
same instructions as for electronic motor 21.
HANDLE WITH CONFORM CANNULA HANDPIECE
For the reprocessing instructions of the Handle with Conform cannula handpiece, please refer to the instructions
for use supplied with the Conform cannula handpiece.
ELECTRONIC MOTOR21
For the reprocessing instructions of the electronic motor 21, please refer to the instructions for use supplied with
the electronic motor.
TUBING SET REF 6022 AND REF 6026
Single-use tubing sets may not be reused!
Used tubing sets must be disposed of properly.
Don’t use tube set when packaging is already opened or damaged!
Do not use tubing set if expired.
Use only NOUVAG tubing sets with REF 6022 and REF 6026.
Sterility cannot be guaranteed by reusing and re-sterilization of tubing sets. The characteristics of the mate-
rial may change resulting in serious infections or, in worst case, the death of the patient.

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1 2 3 4 5
INSTRUCTIONS FOR USE LIPOSURG
MAINTENANCE
REPLACING THE CONTROL UNIT FUSES
Users can replace faulty control unit fuses themselves. These are located at the rear of the device in the fuse slot
beside the power switch:
1 Switch off device.
2 Unplug the power plug.
3 Open the fuse slot using a screwdriver.
4 Replace the faulty fuse T 3,15A, 250 V AC.
5 Slide the fuse holder back in and close the fuse slot.
6 Check the mains voltage shown on the fuse slot.
7 Plug in the power plug again.
SAFETY INSPECTIONS
The essential requirements have been defined and assessed within the risk analysis. The results of the analysis
are stored in the risk management file of the manufacturer.
The performance of safety inspections on medical devices is required by law in several countries. The safety
inspection is a regular safety check that is compulsory for those operating medical devices. The objective is to
ensure that device defects and risks to patients, users or third parties are identified in time.
The STI (Safety Technical Inspection) for the LipoSurg shall be executed every 2years by authorized experts.
Results shall be documented. The service manual, wiring diagrams, and descriptions are available upon request
from the manufacturer.
NOUVAG offers a safety inspection service for its customers. Addresses can be found in the appendix of this
instructions for use under S  >  . For further information please contact our technical service
department.
1 Fuse slot locking mechanism 2 Display window for voltage setting 3 Fuse slot 4 Fuse 1 5 Fuse 2

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LIPOSURG INSTRUCTIONS FOR USE
MALFUNCTIONS AND TROUBLESHOOTING
MALFUNCTION CAUSE SOLUTION REFER TO INSTRUCTIONS FOR USE
Device is
not functional
(Indicator
light is off)
Control unit not switched on Set the power switch « I/O» to
« I »
S      >
Power connection not
established
Connect the control unit to the
mains power supply
C     >  
Incorrect operating voltage Check the mains voltage C     >  
Faulty fuse Replace fuse R     >
Processor error Set the power switch to « O»,
wait10seconds and switch
back to position « I»
S      >
No stroke
movement at
the Conform
cannula
handpiece
« LIPO » function is not
selected
Select function « LIPO » O: C  >
Motor to drive cannula not
activated
Activate motor to drive cannula
by pressing pedal
O  VARIO  >  
Motor to drive cannula not
connected
Insert motor plug into the
socket at the devices front
D  >  
P  H  C
  >
Conform cannula handpiece
is not connected properly to
the motor
Press the Conform cannula
handpiece firmly to the motor
until it engages
P  H  C
  >
No delivery
of infiltration
solution at the
cannula
« INFIL » is not selected Select function « INFIL» O: C  >
Peristaltic pump is not
switched on
Activate peristaltic pump by
pressing the pedal
O  VARIO  >  
Tube set not properly
inserted
Insert tube set correctly P    >
Tube set is blocked Replace the tubing set P    >
Infiltration container is not
ventilated
Open air bleed valve at
tube set
P    >
Tube set is dripping Replace tube set P    >
Roller clamp is closed Open the roller clamp all the
way
P    >
Pedal is
not functional
Pedal not connected Insert the pedal plug into the
socket at the devices back
P   >
D  >  
Control unit is not switched
on
Use mains switch, in the back
of the device, to switch on
S      >
Incorrect operation Check operating instructions O  VARIO  >  
If the problem cannot be solved please contact your supplier or an authorized service center. Addresses can be found in the appendix of this instruc-
tions for use under S  >  .