FR - Mode d’emploi - LaBina One

LaBina ® Digital one pigmentation device
Instructions for use
EN

General information
Proper use
These instructions for use contain information on the safe and intended use of the
LaBina ® Digital One pigmentation device and the LaBina ® needle cartridges with
safety membrane provided for this purpose.
This product is aimed at people who directly or indirectly carry out permanent
make-up treatments. This includes all people who are responsible for assembling,
operating, servicing, maintaining or cleaning the pigmentation device.
To use the pigmentation device and the needle cartridges safely and as intended
and to avoid the risk of any malfunctions or damage to the pigmentation device or
needle cartridge, please observe the operating instructions.
We recommend that the currently applicable safety and hygiene regulations and
all other regulations for pigmenting or tattooing applicable in your country are also
observed. This also applies to the regulations on the use of cleaning and disinfecting
products as well as occupational safety.
For information on the use of needle cartridges as well as the accessories and
consumables, please refer to the associated instructions for use.
Area of application
The LaBina ® One pigmentation device is intended exclusively for the production
of permanent make-up. Permanent make-up is generally referred to as cosmetic
tattoos in which microscopically fine ink pigments are injected into the top layers
of skin using a special needle. The inks fade after 2-5 years, depending on the
condition of the skin.
In the permanent make-up segment, the pigmentation device is intended for
pigmenting eyebrows, eyelid lines and lips. Any use other than this shall be deemed
not to be intended and therefore cannot justify any warranty claims. Tattoos can
generally involve all parts of the body, permanent make-up is mainly intended for
areas of skin on the face. The needle penetration depth for permanent make-up
is also less than for tattoos. After using the pigmentation device, the used needle
cartridge must be disposed of in a needle disposal container. The needle cartridge
may only be used for one single treatment. Reconditioning or resterilisation is not
permitted.
Liability
Unauthorised changes to the pigmentation device, its accessories and consumables
exclude the manufacturer from any liability for damage resulting from this.
Incorrect use also applies if the pigmentation device is used differently to as
described in these instructions for use, or if the operating conditions are not
complied with.
PERMANENT-Line GmbH & Co. KG also assumes no liability for damages caused
by improper use and/or incorrect operation.
2

General safety instructions
Qualified personnel
For safety reasons, the LaBina ® pigmentation device should only be used by trained
qualified personnel. One exception is training when participants are supervised and
instructed by an expert during use.
People (including children) with physical, sensory or mental disabilities are
prohibited from using the pigmentation device, as they may have difficulties in
reacting appropriately when hazards occur.
Safety
Intended use also includes compliance with the safety regulations mentioned in
these instructions for use and the usual accident prevention measures. The LaBina ®
pigmentation device can only then be guaranteed to work safely.
These instructions for use must be read carefully and stored in a safe place. They
must be made available to people using, cleaning, storing or transporting the
pigmentation device.
All the instructions in these instructions for use are adapted to the use of needle
cartridges from LaBina ® .
• The LaBina ® PERFORMANCE handpiece is compatible with many of the competitor
needle cartridges on the market. Please note that the use of incompatible
needle cartridges may result in functional restrictions and increased wear of the
handpiece.
• We recommend that you only use original needle cartridges from LaBina ® because
they are adapted to the handpiece.
• When using handpieces from other manufacturers, please note that the needle
length may need to be adjusted differently to as described in these instructions for
use. In this case, please always follow the instructions in the device manufacturer’s
instructions for use.
Also note:
• Consideration should be given to the regulations for pigmenting in the respective
country.
• LaBina ® pigmentation devices must not be manipulated or modified.
• The conditions for use, transport and storage must be complied with.
• When using the pigmentation device, care must be taken that the needle
cartridges used are equipped with an internal membrane which reliably ensures
that no pigment ink, lymph or blood can enter the handpiece from the cartridge
and thus be transferred to another customer.
• The handpiece shown in the instructions for use is the LaBina ® PERFORMANCE,
which is supplied together with the LaBina ® One control unit.
Visionblue
Universal
Tattoo & PMU
Docking System
3

Product icons
Icons in these instructions for use
The icons described below can be found in these instructions for use, on the pigmentation device, AC adapter, needle cartridge and their packaging. The icons
provide information about the correct and safe use of the product.
Icon
Meaning
Icon
Meaning
Reference to the product’s instructions for use
Observe the temperature limit
Contact details for the product manufacturer
Product manufacturing date
Observe the humidity limit
The product meets the requirements of the EMC Directive 2014/30/EU
and the Low Voltage Directive 2014/35/EU
Do not reuse the product
The product meets the requirements of standard
DIN EN 61140 protection class II
Do not resterilise the product
The product may only be used indoors
The product complies with WEEE Directive 2012/19/EU for waste
electrical and electronic equipment
Indicates the polarity of the output connector on the AC adapter
connector cable. The centre (also called tip) is positive (+) and the
cylinder (ring) negative (−)
Voluntary testing of the product / production site according to TÜV
Süd’s test and certification regulations in Germany
The product complies with the requirements of Article 20 of the
Product Safety Act (ProdSG)
Store the product in a dry place
Hazards to people and the environment from biological substances or
organisms
Expiry date / Product can be used until date:
Sterilised with ethylene oxide
No reproducible germs such as microorganisms and viruses
Warning against cuts or needle-prick injuries
Product is unusable if the packaging is damaged
Internationally recognised, voluntary labelling of packaging and
materials used in them for recycling
The housing offers protection against coarse dust and drops of water
Catalogue number, order number
Device meets the requirements of the RoHS 2 Directive
Batch number as reference number for unique identification

Safety instructions and warnings
The safety instructions and warnings draw attention to the risk of personal injury
or damage to property and are structured as follows:
The following icons are used to highlight the instructions in these
instructions for use.
Element
Signal word
Type of danger
Consequences of disregarding
the danger
Averting the danger
Meaning
The signal word is a labelling element that indicates the
extent of the danger. It is intended to alert the reader to
a potential danger.
Identifies the type and source of the danger
Describes the possible consequences of non-compliance
Indicates how to avoid the danger
Icon
Meaning
Meaning of the individual signal words:
Observe safety instructions and their measures. It is always
used where there are risks for the user or the device if the
safety instructions are not observed.
Useful information and recommendation for trouble-free
and efficient use.
Signal words according to DIN EN 82079
Signal word
Meaning
DANGER
Degree of danger
WARNING
CAUTION
DANGER
WARNING
CAUTION
is a signal word for serious hazard categories. It denotes an
imminent hazardous situation. If this is not avoided, it will
lead to death or the severest injuries.
denotes a possibly imminent hazardous situation. If this is
not avoided, it will also lead to death or the severest injuries.
identifies a possible hazardous situation that may lead to
minor or moderate injuries if it is not avoided.
Personal injury
NOTE
Damage to property
NOTE
means less serious hazardous categories. It is used to
draw attention to possible risks that may lead to damage
to the environment, property or equipment. Follow the
instructions to play it safe.
The safety instructions and warnings are indicated by icons in these instructions
for use. The warning icon highlights the safety instruction and specifies the type
of hazard. The safety instructions and warnings must be observed to prevent
personal injury, damage to property and accidents.
5

Transport inspection
Technical details
The pigmentation device is packed in a stable and transport-proof box. After
receiving the goods, check that the delivery is complete and intact
Despite careful checks, the goods may be damaged during transport. If the goods
are damaged or incomplete, please contact the manufacturer or the authorised
dealer immediately.
No warranty can be given for complaints later on.
Pigmentation device scope of supply:
Quantity Article name Item number
1 Control unit 230.135
1 Handpiece 2811926
1 Handpiece holder 2310176
1 Foot pedal 2301403
1 AC adapter HNP 18-150V2
1 Instructions for use GebrAnw.LaBina-One
Control unit
AC adapter HNP 12-120 12 volts DC
Mains connection voltage
Dimensions
Handpiece
Handpiece drive
Precision DC motor
90-264 volts AC
200 x 125 x 80 mm
Operating speed 50-150 Hz 50-150 strokes
per second
Mains connection voltage ???
Needle cartridge connection Diameter: 11 mm
Max. penetration depth
Mode of operation
Approx. 2.0 mm
Continuous operation
Dimensions Length | Diameter: L: 135 mm | Ø: 20 mm
Weights
Control unit
600 g
Handpiece Device with cable 120 g
Handpiece holder
110 g
AC adapter Device with cable 115 g
Foot pedal Device with cable 155 g
Instructions for use
Outer packaging
Total weight:
70 g
350 g
1.520 g
We reserve the right to make changes at any time during the manufacture of the
devices to adapt to technical progress.
6

Scope of delivery
Foot pedal
AC adapter
Control unit
Handpiece
Handpiece holder
7

Using the pigmentation device for the first time
Setting up the control unit
Always place the control unit and the handpiece with the handpiece holder on a
secure, firm and level surface.
It must be guaranteed that the pigmentation device can always be operated
during use
.
NOTE: Protect the pigmentation device from being dropped
Damage may occur as a result of the control unit or handpiece
being dropped.
Connecting the AC adapter
Figure:
Back of the control unit
WARNING: Risk of short circuit and electric shock
Due to excessive mains voltage, faulty electrical installation or
improper handling.
Only connect the control unit to a properly installed power socket.
The mains voltage must always match the input mains voltage shown on the AC
adapter type plate!
Only connect the AC adapter to an easy to access power socket so you can
quickly disconnect the power supply in the event of a malfunction.
Do not use any damaged equipment or accessories. Damage to cables or the
equipment significantly increases the risk of electric shock.
Ensure that all plugs and cables are clean and dry. Never connect the pigmentation
device cables using damp hands.
Connecting the foot pedal (optional)
Connect the power supply for the control unit in the following order:
Plug the connector from the AC adapter power cable into the green power
connection socket on the back of the control unit.
Then plug the supplied AC adapter into the power socket (230 V).
CAUTION: Tripping hazard due to cables
People may stumble over loose cables and injure themselves.
Figure:
Back of the control unit
Plug the foot switch connector into the green foot pedal connection socket.
The handpiece is activated (turned on) by pressing the foot pedal. The handpiece
remains activated until the foot pedal is no longer pressed.
The connecting cables from the pigmentation device must be laid so that no one
can trip over them.
8

NOTE: Prevent damage to the pigmentation device
Condensate can damage the device
If the pigmentation device is moved from a very cold environment (e.g. after
transport in winter) into a considerably warmer environment, condensate can form
in the device in the event of large differences in temperature.
The electronics may be damaged or the functional range impaired due to moisture
in the device.
If there are large differences in temperature, wait until the pigmentation device
has reached room temperature (at least 3 hours for every 10°C difference in
temperature).
Ensure that the pigmentation device and its accessories are dry before using
them for the first time.
Ensure that the ambient temperature and relative humidity are maintained in
order to use the pigmentation device as intended.
Pigmentation device Operation Transport / storage
Ambient temperature
Relative humidity
Connecting handpieces to the control unit
Figure:
Back of the control unit
Plug the LaBina ® One handpiece connector into the green handpiece connection
socket (connection for handpiece 1).
Figure:
Back of the control unit
Handpieces with HiSence connection are plugged into the green
handpiece connection socket (connection for handpiece 2).
1
2
120
Note: The selection option for the handpieces is only shown on the pigmentation
device display if two handpieces are connected at the same time. The number of
the activated handpiece lights up red.
9

Using the pigmentation device for the first time
Turning on the device
Figure:
Back of the control unit
w Start the control unit by pressing the green On / Off key. The front panel lights
up.
w Turn off the control unit by pressing the greenOn / Off key again.
NOTE: Protect the pigmentation device from excessive
voltage Disconnect the control unit and mains adapter from the
power supply, when it is not needed.
Keys
Always start the handpiece with the needle
cartridge inserted to prevent damage to the
handpiece.
Speed keys
Start key
Start the handpiece
Pause key
Handpiece paused
Minus key
Reduce stroke speed
Plus key
Increase stroke speed
120
If the pigmentation device is not required for a long time, it is recommend that you
disconnect the control unit’s mains adapter from the power supply.
Display dimming in standby mode
To extend the display life and comply with the energy saving guidelines, the device
has a screen saver and an automatic
standby function.
The screen saver dims the screen after 10 minutes of no button being pressed
or handpiece being used. The automatic standby function takes effect after 60
minutes of no button being pressed or handpiece being used. To restart the control
unit, press the On / Off key on the back.
Date and time
11:06
04.05.2023
11:06
04.05.2023
LaBina ® One
w Pressing the Start key starts the selected handpiece and needle stroke. The
needle in the needle cartridge moves at the stroke speed shown on the display.
The Start key icon automatically changes to a pause icon.
w Pressing the Pause keystops the handpiece and the needle stops moving in the
needle cartridge. The Pause key icon changes back to the Start icon.
w The desired working speed can be set by pressing the Minus key and Plus key.
10

Additional features for the pigmentation device
Time measurement
Opening the submenu
Pressing the green
Arrow key opens the submenu:
Using the stopwatch
Open the time measurement by
pressing the Stopwatch key.
The following menu items can be found
in the submenu
Timer
Time measurement
Timer / stopwatch
Settings
11:06
04.05.2023
LaBina ® One
The time measurement starts when
the Start key is pressed.
The time from the beginning of the
measurement shown on the time
display.
The time measurement pauses
or ends when the Pause key is
01:24,56
pressed.
Reset the time display to 0 by
pressing the Stopwatch key.
Pressing the Back key closes the
time measurement and takes you
back to the submenu default view.
00:00,00
00:43,17
00:00,00
00:00,00
Closing the submenu
Pressing the Arrow key closes the
submenu.
LaBina ® One
NOTE: Using the stopwatch
The stopwatch can be used to measure treatment times.
11

Timer
Opening the timer menu
Pressing the Alarm key opens the
timer feature.
The default display for the timer is the
last selected timer time.
Setting the timer time
Pressing the Timer key again
changes the display to the timer time
setting feature.
00:30,00
00:30,00
Starting the timer
Pressing the Start key starts the time
display running backwards from the
defined time.
Pausing the timer
Pressing the Pause key pauses the
time display.
Restarting the timer
By pressing the Start key again
the time display continues running
backwards.
01:30,00
01:29,57
01:29,56
Use the Left and Right keys to
select the digit to be changed.
The underscore acts as the cursor
and moves to the selected position
with each tap of the key.
00:30,00
End of the timer
Just before the timer ends, the control
unit issues a beep in the last three
seconds.
Use the Up and Down keys to
change the values at the cursor
position.
Once the timer has expired, the time
display jumps back to the last stored
value.
01:30,00
Press the Confirm key to accept
the set values.
01:30,00
01:30,00
NOTE: Using the timer
The timer can be used to measure the anaesthetic exposure time.
12

Basic settings
Showing basic settings
The following settings are shown
in the submenu by pressing the
Settings key and changes can be
made, if necessary.
Setting audible sounds
Pressing the Loudspeaker key, gives
you the option of turning the device’s
audible sounds on or off.
The currently selected state is indicated
by the Loudspeaker icon.
AM
PM
Setting the date/time
After pressing the Clock key, the
settings menu opens to set the date
and time.
Use the Left and Right keys to select
the digit to be changed, with the
underscore moving to the selected
position as the cursor.
Use the Up and Down keys to
change the values at the cursor
position.
The Back key on the left can be used
to discard the changes made.
The Confirm key is used to apply the
changes, with the seconds being set
to zero.
11:12
04.05.2023
11:13
04.05.2023
11:12
04.05.2023
11:13
AM
PM
AM
PM
Operating time
Press the Info key to show the
operating time for the individual
handpieces.
Under the name: SW-Vers., the
installed software version of the
pigmentation device is shown.
Displaying the time
The manufacturer displays the time
in the default format as a 24-hour
display.
By pressing the green key, the time
and date display can be switched to
the Anglo-American preferred option
of 12-hour display with AM/PM.
AM
PM
AM
PM
1 > 00034:04,58
2 > 00001:14,36
SW-Vers.: 00.10 23.11.2022
24h
AM
PM
04.05.2023
13

Needle combinations
1-long-slim
3-long-slim
1-long-fine
3-long-fine
5-long-fine
5-long-basic
1-long-basic
3-long-basic
1-long-bold
3-long-bold
5-long-bold
3-medium-slim-tx
3-medium-fine-tx
5-medium-basic-tx
1-short-fat-tx
slim
0,18 mm
# 06
fine
0,25 mm
# 08
basic
0,30 mm
# 10
basic
0,30 mm
# 10
bold
0,35 mm
# 12
slim
0,18 mm
# 06
fine
0,25 mm
# 08
basic
0,30 mm
# 10
fat
0,40 mm
# 14
long
long
long
long
long
medium medium medium
short
Round Liner
Long Taper
Bug Pin - Polished
Round Liner
Long Taper
Standard - Polished
Round Shader
Medium Taper
Bug Pin - Textured
Round Liner
Short Taper
Standard - Textured
14

ITEM
Item name
REF
Item number
Gauge
Sizes
diameter
Needle
number
Type
needle type
Taper
pinpoint
Finish
top
Point
pinhead
Grind
needle cut
1-long-slim 06-18-1-RLLT # 06 0,18 mm 1 Round Liner Long Taper Polished Bug Pin 5 mm
3-long-slim 06-18-3-RLLT # 06 0,18 mm 3 Round Liner Long Taper Polished Bug Pin 5 mm
1-long-fine 08-25-1-RLLT # 08 0,25 mm 1 Round Liner Long Taper Polished Bug Pin 5 mm
3-long-fine 08-25-3-RLLT # 08 0,25 mm 3 Round Liner Long Taper Polished Bug Pin 5 mm
5-long-fine 08-25-5-RLLT # 08 0,25 mm 5 Round Liner Long Taper Polished Bug Pin 5 mm
5-long-basic 10-30-5-RLLT # 10 0,30 mm 5 Round Liner Long Taper Polished Bug Pin 5 mm
1-long-basic 10-30-1-RLLT # 10 0,30 mm 1 Round Liner Long Taper Polished Standard 5 mm
3-long-basic 10-30-3-RLLT # 10 0,30 mm 3 Round Liner Long Taper Polished Standard 5 mm
1-long-bold 12-35-1-RLLT # 12 0,35 mm 1 Round Liner Long Taper Polished Standard 5 mm
3-long-bold 12-35-3-RLLT # 12 0,35 mm 3 Round Liner Long Taper Polished Standard 5 mm
5-long-bold 12-35-5-RLLT # 12 0,35 mm 5 Round Liner Long Taper Polished Standard 5 mm
3-medium-slim-tx 06-18-3-RSMT # 06 0,18 mm 3 Round Shader Medium Taper Textured Bug Pin 2,5 mm
3-medium-fine-tx 08-25-3-RSMT # 08 0,25 mm 3 Round Shader Medium Taper Textured Bug Pin 2,5 mm
5-medium-basic-tx 10-30-5-RSMT # 10 0,30 mm 5 Round Shader Medium Taper Textured Bug Pin 2,5 mm
1-short-fat-tx 14-40-1-RLST # 14 0,40 mm 1 Round Liner Short Taper Textured Standard 2 mm
Needle size
The specified needle size refers to the point at
which it begins to taper.
Type of taper and length
The information relates to the length of the pointed
part of the needle and to how steep the angle in
the taper is. The taper shape determines the size
of the skin opening and thus how much pigment
ink can be applied under the skin in one go.
A long taper carries less pigment than a short
taper. Although a long-cut taper carries fewer
pigments, it causes fewer injuries to the skin, but
may feel sharp. The extremely thin tip creates a
smaller hole in the skin.
A short taper can carry more pigment ink than a
medium or long taper. Although a short-cut needle
dispenses more pigments, the needle may cause
more damage to the skin, as the needle leaves a
larger hole in the skin.
Long Taper - Bug Pin
Optimised for fine, precise pigmentation
Long Taper - Standard - Polished
Optimised for fine lines and shading
Medium Taper - Bug Pin - Textured
Optimised for large filling areas and shading
Short Taper - Standard - Textured
Optimiert für breitere Pigmentierungen
15

Operating information
Removing the needle cartridge from the packaging
Needle cartridges are packaged individually in sterile blister packs.
Do not open the needle cartridge blister pack until just before the treatment is to
be carried out.
Hands must be sterilised and unused disposable gloves must be worn to remove
the needle cartridge.
Needle cartridges out of damaged or already opened blister packs may no longer
be used because it can no longer be guaranteed that the needle cartridge is
sterile.
Inserting the needle cartridge into the handpiece
NOTE: Preventing damage to the handpiece
Ensure that the pigmentation device is turned off before inserting a
needle cartridge into the handpiece.
Applying slight pressure, insert the dark green needle cartridge into the handpiece
opening as far as it will go. The cartridge is now securely in place in the handpiece.
Checking the needle cartridge before use
After inserting the needle cartridge and before beginning each treatment, check
that the cartridge is securely fixed in the handpiece.
Putting down the handpiece
DANGER: Transfer of dirt and germs
Always only place the handpiece with inserted needle cartridge on
the handpiece holder provided for this purpose.
Make sure that the needle cartridge and handpiece do not come into contact
with anything that it is not intended for. This will prevent the needle cartridge
from becoming contaminated and prevent people and objects from coming into
contact with any blood and lymphatic fluid possibly stuck on the cartridge or
handpiece.
Turn the needle cartridge a quarter of the way clockwise until you feel resistance.
16

Using the needle cartridge
Warning: Needle-prick injuries
There is a risk of a puncture injury.
CAUTION: Skin traumatisation
Skin traumatisation due to excessive working speed.
Do not touch the cartridge’s taper when the handpiece is off or on.
Hold the handpiece firmly in your hands before turning it on. When you start the
motor in the handpiece, there may be some jerky movements in the handpiece
for a short time, these may result in people injuring themselves. There is also the
risk that the handpiece may be damaged by being dropped.
Setting the needle length
Set the handpiece’s stroke speed to average on the control unit and then press
the On button on the pigmentation device. Observe how far the needle comes
out of the needle nozzle.
Unscrew the cap which the needle cartridge was inserted into until the needle
sticks out as far as to suit your requirements.
+
+
w If the working speed is too high, the risk of additional skin injuries increases.
When choosing the working speed, consider the condition of the customer’s
skin and the thickness of the skin in the area to be treated.
Filling the pigment ink into the needle cartridge
The pigment ink can either be filled through the filling opening in the needle cartridge
or drawn up through the taper.
CAUTION: Taper damage
Product damage due to impact with hard surfaces.
If you are using an ink pot, the taper may be damaged when sucking up the ink.
When inserting the needle into the ink, make sure that the taper does not touch
the edge or bottom of the ink pot.
Needles that have come into contact with the ink pot must not be used. If the
taper is damaged, the customer’s skin is injured more and it is to be expected
that the best treatment result cannot be achieved using a damaged taper.
+
–
–
17

Operating information
Removing the needle cartridge from the handpiece
NOTE: Preventing damage to the handpiece
Ensure that the pigmentation device is turned off
before removing a needle cartridge from the handpiece.
DANGER: Transmission of diseases
No more treatments using a previously used
needle cartridge.
Check whether the pigmentation device is turned off before removing a needle
cartridge from the handpiece.
To remove the needle cartridge from the handpiece, turn the cartridge a quarter
of the way clockwise until it can be removed from the handpiece.
The use of contaminated needles can lead to the transmission of diseases. LaBina ®
needle cartridges are intended for single use.
Disposing of the needle cartridge
DANGER: Transmission of diseases
If a previously used needle causes a puncture injury, diseases can
be transmitted between people.
w After removing the needle cartridge, check whether the needle has been fully
retracted into the plastic shaft of the needle cartridge.
Used needle cartridges which are
no longer required for the current
treatment must be disposed of
immediately after being removed
from the handpiece.
A suitable container must be
used for storage and subsequent
disposal in accordance with the
applicable regulations. Make sure
no one can injure themselves on
the needles
18

Cleaning
NOTE: Risk of short circuit
Always disconnect the device from the power supply before cleaning.
If the device is not disconnected from the power supply during cleaning, there is a
risk of electronic damage to the device.
If liquids such as cleaning or disinfecting products get inside the handpiece, control
unit or AC adapter during cleaning, a short circuit or functional impairments may
occur due to premature wear as a result of corrosion of the mechanical components.
Ensure that no liquids get into the control unit, handpiece and AC adapter.
Never immerse the control unit, handpiece or AC adapter in cleaning or
disinfecting products.
NOTE: Damage to the device due to liquids
Damage caused by unsuitable cleaning and disinfecting products
and improper use.
Cleaning surfaces
Dust and fingerprints can be removed from the display using a
lint-free microfibre cloth. Clean the display using slow, circular movements without
applying much pressure to the display.
Disinfecting surfaces
Disinfect all contaminated surfaces before and after each use. Use a soft, lint-free
cloth that leaves no traces of any fibres.
Disinfect the control unit, handpiece and handpiece holder using a mild disinfectant
with no aldehyde, which is suitable for disinfecting sensitive surfaces.
We recommend using Bacillol ® 30 or the Bacillol ® 30 quick surface disinfecting
wipes.
It is possible to use other disinfectants (observe the user instructions and ask the
supplier if necessary).
If unsuitable cleaning and disinfecting products are used (product not compatible
with the surfaces to be cleaned) and if these products are used incorrectly, the
surfaces may be damaged.
Never clean the control unit, handpiece or AC adapter in an autoclave or ultrasonic
bath.
Use a mild detergent for sensitive surfaces for cleaning.
Only use cleaning or disinfecting products that are approved for the materials to
be cleaned according to your country’s regulations.
19

General safety instructions
General customer hygiene
• The area to be pigmented must be cleansed of make-up and then disinfected or
treated with an antiseptic. The disinfectant exposure time should be taken into
account. Sterile swabs should be used.
• The skin should be cleansed during and after treatment using sterile water or
sterile solutions. When choosing suitable disinfectants, observe the applicable
guidelines in the respective country.
• If there are injuries to the skin or mucosa, the wound must be treated with an
antiseptic.
• The customer is given a protective cap and is covered with towels or disposable
towels. A towel is placed under the head.
• Wear disposable gloves for all applications.
Hygienic requirements at the workplace
• Treatment rooms should have wall surfaces and floors with impervious sealed
joints that are easy to clean and disinfect.
• Cables should be covered by plaster and routed in exterior ducts that are easy to
clean. Cavities must be sealed.
• All installations must be designed so that disinfection measures can be carried
out simply and effectively.
• Ventilation and air-conditioning systems should comply with the recognised rules
of sound engineering practice and be maintained according to the manufacturer’s
instructions and applicable regulations in the respective country.
• All surfaces in the treatment room such as the treatment couch, shelves, floors
and walls should be easy to clean and free of dust or impurities.
• Smoking, eating and drinking should be avoided in treatment rooms.
• The only utensils that should be found at the workplace are those required for
pigmenting.
• A washbasin in the treatment room is part of the basic equipment. However, in
order to avoid contamination of the workplace with spray, this hand washing area
should be at least one metre from the beauty therapist’s seat or a splash guard
should be provided.
• Liquid soap, hand disinfectants belong in dispensers and disposable towels are
used. Avoid hand soaps due to an increased risk of germs.
• Disposable sheets must be used for the treatment couch and instrument tray, and
disposed of immediately after treatment.
• Collect towels in a sealed container and then wash them separately at 90 degrees
Celsius.
• Wear disposable gloves while pigmenting.
• Needle cartridges should not come into contact with contaminated objects,
such as clothing. Contaminated needle cartridges must not be used but must be
disposed of immediately. The respective country’s regulations must be observed.
Other hygiene and safety regulations
Professional pigmentation specialists are obliged to observe the hygiene regulations
according to the state of the scientific and technical knowledge at the time Different
laws and regulations apply in the individual countries. The aim is to prevent the
transmission of pathogens and reduce the risk of injury.
20

Informing the customer before starting treatment
The customer should be fully informed about the possible risks of pigmentation
before treatment. We recommend documenting the treatment together with details
of the inks used and the needle cartridge and pigment ink batch numbers.
Customer’s state of health:
In principle, the customer should feel well and healthy before any treatment.
However, there are medical conditions that mean that treatment should not be
performed or at least should be postponed.
Health impairments that rule out treatment:
Pigmentation should not be performed if the following contraindications are present:
Infectious diseases, a severe cold, fever, conjunctivitis, facial shingles, neuritis,
pregnancy and lactation, infections caused by bacteria, viruses and fungi, blood
coagulation disorders, skin diseases in the area to be treated (for example, eczema,
keloids, pigment spots), various skin changes, for example: warts, moles and
unstable scars in the area to be pigmented. Furthermore, pigmentation should
not be performed on persons with acute cardiovascular problems or epilepsy.
In principle, it is no problem to perform a treatment in case of HIV or hepatitis,
however, the customer is asked to inform the practitioner before the treatment.
Alcohol and drugs must not be consumed before and during the treatment.
Performing a treatment only after consulting doctors:
In the case of the following illnesses and taking certain medications, a doctor
should be consulted before the planned treatment:
• Cancer or chemotherapy or radiation in the past twelve months
• Taking blood thinners (e.g. Marcumar, Eliquis, Aspirin), beta blockers, or antibiotics
• Autoimmune diseases (except alopecia)
• Cardiovascular diseases or diabetes (requiring insulin)
In these cases, it is necessary to consult a doctor and seek their approval of the
treatment.
Refusing treatment
If the professional pigmentation specialist has even the slightest doubt that the
safety of the customer to be treated cannot be ensured due to comorbidities or the
current state of health, the treatment must not be performed, or it must be stopped
immediately.
Discontinuing treatment
The pigmentation should be stopped immediately in the event of:
• Excessive pain
• Severe wound secretion
• Circulatory problems, dizziness and fainting
21

Information to be passed onto the customer
Planning the treatment
We recommend that you inform the customer of the following points even before
treatment:
• LaBina ® needle cartridges are made of stainless steel, which contains a small
amount of nickel. LaBina ® is not aware of any case so far where pigmenting using
these needles has caused allergic reactions. However, it cannot guarantee this
as no studies have been carried out. Therefore, people with a nickel allergy are
advised to talk to their doctor or, in case of doubt, refrain from treatment.
• After treatment, the treated area should not be touched and should be protected
from contamination and sunlight. Visits to swimming pools and saunas, hair
removal or chemical and abrasive peels should also be avoided. Self-tanning
products may only be applied after a few days. We recommend waiting a few
days before applying creams, lotions and oils.
• Swelling or redness is to be expected in the treated areas for two to three days. If
this lasts longer, a doctor should be consulted.
• If the customer is prone to herpes infections, a doctor should be consulted to
clarify whether a prophylaxis two to three days before the treatment is appropriate.
• The customer should avoid household tasks such as cleaning garages and cellars,
where contamination with dirt and germs is possible.
• With all treatments the fresh drawing looks roughly one shade more intense than
agreed on together before the treatment. This lasts for 3 to 5 days due to the
scab. The reason for this is that in the first few days after the beauty treatment
excess ink remains in the dry, absorbent top layer of the skin. But it gradually
drops off. The inks only shimmer subtly through the skin once a new top layer
has formed over the embedded pigments after about a week when the maximum
natural colour effect then develops.
• In Germany, the following applies: If medical costs arise as a result of the
treatment, these are to be met by the customer themselves. If a permanent
make-up treatment results in medical treatment, the statutory health insurance
companies may require their members to contribute to the costs on the basis
of Article 52 II SGB V (German Social Insurance Code). This states: “If insured
persons have contracted a disease through a medically unnecessary aesthetic
operation, tattoo or piercing, the health insurance company shall contribute an
appropriate amount to the costs and shall refuse or recover the sickness benefit
in whole or in part for the duration of this treatment.”
22

Side effects of a permanent make-up treatment
Possible reactions after treatment
After a permanent make-up treatment, temporary unpleasant side effects may occur in the first few hours or days. It makes sense to choose a time for treatment when shortterm
limitations will be least disruptive to the normal daily routine.
Common reactions:
• Swelling and redness: In contrast to the insensitive brow area, eyelids and lips
are sometimes slightly swollen and slightly red after treatment. People with a
sluggish lymphatic flow tend to react to the pigmentation with slight swelling, but
this disappears on its own after a few hours. After treatment in the eye and mouth
areas, we recommend the customer cools the pigmented area slightly several
times and moves around as much as possible. This stimulates the natural lymph
flow.
• Minor bleeding: Localised bleeding may occur in the area of the tattooed/
pigmented skin.
• Mild pain: The customer may experience mild pain on the first day after the
pigmentation.
• Temporary inflammatory reactions: Erythema and/or oedemas may occur for up
to six days. Skin irritations usually disappear within two days.
• Skin scab and peeling: These reactions may last for up to a week.
Rare reactions:
• Formation of herpes simplex virus blisters: Customers who have had lip blisters
(herpes simplex) one or more times during their lifetime may get herpes a few
days after permanent make-up treatment on the lips and/or around the mouth.
The herpes viruses responsible for the blisters lie dormant in the customer’s body.
Once they have been triggered by the treatment, it takes about three days before
the typical symptoms appear. The occurrence of lip herpes may be reduced by
taking preventive tablets before treatment.
• Allergic or allergic-like reactions: These may occur in rare cases, sometimes
proving to be severe (granulomas, permanent skin changes, pigment disorders,
dryness, sensitivity, peeling, swelling, etc.). Skin irritation (redness, reaction to
the products used, conjunctivitis, injury to the top layer of skin) is also possible.
• Hyperpigmentation: Hyperpigmentation may occur due to the body’s own
pigments, particularly with darker skin types.
• Heating the pigmented area using PET and MRI irradiation, if the customer has
been pigmented with a pigment ink that contains iron oxide beforehand.
23

Conduct in the event of an emergency due to needle-prick injury
Providers of permanent make-up, like tattoo artists in Germany, are obliged to
train themselves in first aid measures for injuries that may typically occur in their
respective specialist area.
We recommend that you keep proof of your training handy, as well as a first aid kit
that is regularly checked to ensure it is complete and everything works. Both must
be presented in the event of a check.
Warning: Needle-prick injury
There is a risk of infection.
Risk number 1 in pigmenting or tattooing is an unintentional needle-prick injury for
the beauty therapist or tattooist and the customer, which poses a risk of infection
with hepatitis B, C and HIV.
Risk number 2 is spatter (blood and other body fluids) on mucous membranes such
as the mouth, nose or eyes.
In both cases, immediate action should be taken and a doctor should be consulted
after first aid is administered.
The following emergency procedures are well established:
1. Stop pigmenting or tattooing immediately.
2. Change your gloves.
3. If the skin is intact, wash the area of the needle-prick injury under running hot
water using mild liquid soap and treat with antiseptics for skin that are effective
in combating viruses.
4. If the skin is damaged, gently rinse the area of the needle-prick injury using an
antiseptic for skin that is effective in combating viruses.
5. In the case of puncture wounds, stimulate the bleeding by pressing on the
tissue around the needle-prick injury, then rinse with an antiseptic for skin that
is effective in combating viruses for at least ten minutes.
6. Do not use brushes to treat the skin.
7. If eyes or nose are affected by the needle-prick injury, rinse with 2.5% PVP
iodine solution for at least ten minutes, if this is not available, use water (be
aware of iodine intolerances).
8. If the needle is contaminated with oral mucosa, rinse with 2.5% PVP iodine
solution or with water (be aware of iodine intolerances).
9. Apply a plaster to any cuts or puncture sites that have been caused.
10. If there is contamination of intact skin over a large area, the clothing must be
removed and everything must be washed with plenty of water. It is important
that a doctor is contacted as soon as possible after the incident (emergency
ambulance). Prophylactic treatment should be given within one hour and no
later than 72 hours after the incident. The incident must be documented by
everyone involved. The company owner must also be informed of the incident
in a timely manner.
24

Warranty ∙ Complaints ∙ Repairs
Environmental protection and recycling
As the manufacturer, PERMANENT-Line GmbH & Co. KG, Mengeringhäuser Str.
15, 34454 Bad Arolsen, Germany provides a warranty of 24 months for the whole
device. Warranty claims only exist for defects and malfunctions due to material
defects and processing defects.
Please note the following:
Any interference by unqualified or unauthorised persons or improper use leads to
the loss of warranty.
Excluded from warranty:
• Visible damage, such as scratches or discolouration, e.g. due to incorrect cleaning.
• Damage caused by the device being dropped and vandalism.
• Improper handling, e.g. broken cable due to bending.
• Damage and consequential damage resulting from improper use or nonobservance
of the instructions for use.
• Damage caused by liquids or dirt getting inside the handpiece, control unit or AC
adapter.
Procedure in case of a pending repair or inspection
Please inform the dealer who you purchased the pigmentation device from by
telephone or email if you have the impression that the pigmentation device is not
working properly. Repairs may only be carried out by the manufacturer.
If the problem cannot be solved after consultation with your distributor, please
send the pigmentation device directly to the manufacturer.
After the manufacturer has received the defective device, they will be happy to
send you an equivalent device as a free loan for the duration of the inspection /
repairs. This service is free of charge and non-binding.
If any repair costs are incurred, you will be sent a quote by the manufacturer that
you must accept and approve, before the repairs can be carried out. Repairs can
take up to 6 weeks.
NOTE: Recycling packaging
Products that display this icon can be reused.
The product is packed carefully and ecologically-friendly for transport. Recycle
reusable packaging to help protect the environment.
NOTE: Recycling waste equipment
Products that display this icon may not be treated as normal household
waste.
In accordance with the applicable regulations for waste electrical and electronic
equipment (recycling of valuable recyclable materials) and for the protection of the
environment or the health of people, these must be delivered to an acceptance
point for the recycling of electrical and electronic equipment or sent back to the
manufacturer or distributor of this device, who will dispose of it properly and
professionally.
25

EC declaration of conformity
EG-Konformitätserklärung mit gefordertem Inhalt gemäß ISO/IEC 17050-1
EC Declaration of Conformity with required content in accordance with ISO/IEC 17050-1
Der Hersteller
The manufacturer:
PERMANENT-Line GmbH & Co. KG
Mengeringhäuser Str. 15
34454 Bad Arolsen Deutschland
erklärt hiermit, dass das folgendes Produkt:
declares that the following product:
Produktbezeichnung:
Product designation: Permanent Make-up Gerät
Produktname:
Product name: LaBina One
Modellbezeichnung:
Model designation: 230.135
Artikelnummer:
Item number: 2452826
den grundlegenden Anforderungen entspricht, die in den nachfolgend
bezeichneten Harmonisierungsrechtsvorschriften festgelegt sind:
complies with the essential requirements of the following harmonization Iegislation:
Folgende harmonisierte Normen wurden angewandt:
The following harmonised standards were applied:
EN 60335-1:2012
+ AC:2014
+ A11:2014
+ A13:2017
+ A1:2019
+ A2:2019
+ A14:2019
EN IEC 61000-6-3:2021
EN IEC 61000-6-1:2019
Sicherheit elektrischer Geräte für den
Hausgebrauch und ähnliche Zwecke
Teil 1: Allgemeine Anforderungen
Elektromagnetische Verträglichkeit (EMV)
Teil 6-3: Fachgrundnormen - Störaussendung
von Geräten in Wohnbereichen
Elektromagnetische Verträglichkeit (EMV)
Teil 6-1: Fachgrundnormen - Störfestigkeit für
Wohnbereich, Geschäfts- und Gewerbebereiche
sowie Kleinbetriebe
2014/30/EU
2014/35/EU
2011/65/EU
2006/42/EG
EMV-Richtlinie
Niederspannungsrichtlinie
RoHS-Richtlinie
Maschinenrichtlinie
Diese Erklärung wird im Namen des Herstellers abgegeben von:
Marcus Schneider
Position: Unterschriftsberechtigter Geschäftsführer
Datum: Bad Arolsen, den 01.06.2023
26

Online instructions for use
27

LaBina ® ist eine Handelsmarke von:
PERMANENT-Line GmbH & Co. KG
Mengeringhäuser Straße 15
34454 Bad Arolsen, Germany
+49 5691 89530
Info@LaBina24.de
www.PermanentLine.de
LaBina24de
LaBina24_de
www.LaBina24.de