LaBina PL-500 Control User manual

User‘s manual
LaBina PL-500 Control
www.LaBina24.de

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User’s manual
General information
User’s manual
This manual provides extensive operating instructions of the micropigmentation device LaBina®PL-500 Con-
trol and therefore helps to prevent risks. This manual must be read and respected by all persons using,
maintaining, caring and controlling the device. The manual is part of the device and must be available to the
respective user at all times. When passing the device over to a third party, the manual must be included.
Disclaimer
This device may only be operated by authorised, qualified personnel and may solely be used for the purpo-
ses listed in this manual! This instructions do not substitute a training which is mandatory for carrying out
micropigmentations.
• The contraindications in the respective chapter have to be considered by all means.
• The operator is obliged to comply with the principles of cleanliness and hygiene as well as to utilise so-
lely sterile, disinfected materials. Further information is provided in the chapter “important hygiene and
safety instructions”.
Inform your customers about potential risks prior to a treatment. There is a minor likelihood that risks due to
micropigmentation may occur. These risks are learned in a training. These risks include among others: the
risk of scarring or allergies.
The manufacturer will not assume any liability for any consequences resulting from an operation or utilisation
that deviates from the manual! The manual must be read thoroughly prior to operating the device! It has to
be considered that the injected pigments cannot be remmoved. Intense exposure to the sun and the visit of
tanning studios may however cause pigments to fade or to discolour – especially after a recent pigmentation.
Technological progress
The manufacturer reserves the right to changes according to technological progress.

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Important hygiene instructions
Prior to the treatment the patient’s skin must be pretreated with a mild detergent and disinfectant. Respec-
tive national guidelines regarding the selection of suitable disinfectants must be considered.
The operator has to protect himself from possible
infections by using disposable gloves. It is not al-
lowed to touch any non-sterile or not disinfected
objects while wearing gloves. Touching the freshly
pigmented and still open skin must be avoided.
This applies both to disposable gloves as well as
non-sterile objects.
New and sterile material has to be used for every
new customer and every new treatment. The hygi-
ene modules are sterilised and delivered in sterile
packaging by the manufacturer. Hygiene modules
are intended for one-off use only and have to be
removed from the sterile packaging immediately
before application. It is important to ensure that
the packaging is intact. In case of a damaged pa-
ckaging the sterility cannot be guaranteed. Sup-
plies must not be used after the expiration date.
The brackets and protective caps of the handpiece
must also be cleaned and disinfected immediately
before the treatment of every patient. For this purpose suitable disinfectant has to be used (in general: wipe
brackets with a soft, soaked cloth and immerse protective caps and handles).
Insertion of the hygiene module
When inserting the hygiene module, ensure that
the supplies are not touched in the front section
(i.e. needle or apex of the module). While opera-
ting it must also be ensured that the supplies are
not accidentally coming into contact with conta-
minated objects (e.g. clothing). If this might hap-
pen, new sterile supplies must be utilised.
Removal of the hygiene module
In case of removing the hygiene module it must be ensured that possible pigment residues do not enter the
handpiece. After the removal it must be ensured that the needle is completely retracted into the module in
order to prevent injuries. After the treatment the hygiene module and further supplies must be disposed as
clinical waste in a safety box. Local regulations regarding the proper disposal need to be considered.

User’s manual
Control unit
Operation
The device is designed as a tabletop system; therefore it must be placed on a firm and leveled base. Duri-
ng breaks the handpiece should solely be placed on the provided storage tray. The connection sockets for
the power supply and the handpiece are placed on the rear side of the control unit. The device is ready for
operation after the connection of the power supply. This is indicated by a red light. The device must only be
operated with the power supply that is mentioned on the type plate of the device. The voltage must match
the rated voltage stated on the imprint of the power supply! The device is designed for indoor use. It can be
operated at a room temperature between 10 °C and 35 °C without impairments. Prior to operating it must
be ensured that the device has adjusted to the room temperature as otherwise possible condensate could
damage the electronics (at least 3 hours at a temperature difference of 10 °C).
A riskless operation is not possible:
• if the device or the accessories show visible signs of damage
• if the device does not run properly
• after a long period of storage beyond the mandatory temperature range
• in case of damages caused by improper transport.
The device should be transferred to an authorised LaBina®supplier for inspections.
Operating the hygiene module handpiece
1.) The power supply is plugged into the socket and then linked with [N].
As soon as the power supply is supplied with electricity, the pilot lamp [B] lights up red.
2.) The hygiene module handpiece is now connected with [H].
3.) The foot switch has to be linked with connector [F].
4.) The control unit is switched on by pressing the button [E] on front of the device. The activation is singalled
by the green pilot lamp [K] that lights up beside the button [E]. The device is now ready for use. The device
can be turned off by pressing the button [A]. The green light of the pilot lamp [K] expires.
5.) The LED display [D] shows the recently selected velocity.
The desired velocity can be regulated via the plus button [P] and the minus button [M].
6.) The button [G] turns on the handpiece. By pressing repeatedly the handpiece can be turned off. The hand-
piece can also be turned on and off by pushing the foot switch. The pilot lamp [K] lights up yellow, as soon
as the handpiece is operating.
4

5
NH F
E
K
P
M
AK
G
B
D
Rear of the control unit
Front of the control unit

User’s manual
6
Handpiece
Application fields / intended purpose
The most common application fields for the micropigmentation instrument in the cosmetical sector are:
• Tiny hair drawing of eyebrows
• Drawing of eyeliners
• Full drawing of lips or optimisation of lip contours
• Application of body tattoos
The micropigmentation is also successfully used for follow-up treatments of surgeries, the retouching of
scars and the reconstruction of areolas.
Mode of action
During pigmentation colour pigments are visibly injected into the upper layers of the skin. A micropigmen-
tation lasts – depending on skin type and pigments – several years; however a minimum durability or a full
fading can not be guaranteed.
It is possible that the colour cannot be removed or that colour residues or scars could remain after the remo-
val. During the first 4 to 6 weeks the intensity of the injected pigments is reduced to the “permanent”level.
This is usual, as the epidermis (upper skin layer) is renewing itself and the pigments in this area are grown
out. The remaining visible colour therefore is located unde the epidermis. The thickness of the epidermis is
individually different and depends on the respective body section.
Note:
The handpiece – especially the contained motor therein – is a mechanical precision tool that may not be con-
taminated. Therefore no pigments should enter the motor. Damages that can be traced back to the entering
of pigments into the motor are not accepted as causes for complaints by the manufacturer. It furthermore
must be ensured that the cord of the handpiece is not buckled.
Insertion of the module
1. Plug the hygiene module onto the screw thread
2. Screw the hygiene module onto the handpiece with a clockwise rotation
1.
2.

Hygiene module
For the use of the hygiene module the chapters “important hygiene and safety instructions”have to be con-
sidered.
A label attached to each module states the batch
number, as well as the production and expiration
dates. The batch number enables the identifica-
tion of the precise batch and has to be communi-
cated to the manufacturer in case of issues. This
number has to be noted in the customer file. The
manufacturer guarantees the sterility for 5 years if
the packaging is closed and undamaged and if the
conditions in the chapter “Shipment and storage
requirements”are met. The modules have to be
stored in the original packaging.
Utilisation of pigments
The module must be filled with 2 to 3 drops of colour. Alternatively, the tip of the module can be immersed
into the colour for 2 to 3 seconds. The colour is sucked in when the device is switched on. Contact with the
paint container must be avoided.
Adjustment of needle stand-out
The adjustment of the penetration depth must be performed while the device is switched on. In order to
adjust the stand-out of the needle, the handpiece has to be hold at the rear section of the pen. The needle
can be adjusted individually by screwing the front section of the hygiene module with the second hand.
The correct stand-out of the needle depends on the respective treatment, the skin type, the desired effect
and other factors. This know-how is gained during training.
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Needle combination of hygiene modules
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1st-Liner hygiene module (0,4mm) Needle Art-No:
With its diameter of 0.4 mm the needle of the 1er
module optically resembles a pin.
Practical tip: Especially suitable for very exact,
neat and distincted lines with a high colour density.
The needle slightly penetrates the skin. Caution! If
repeatedly drawing the same line with a 1st need-
le, the skin suffers small cuts. This causes visible
scars! Beginners should not use the 1-er-Liner hy-
giene modules for lash thickening and fine eyeli-
ners.
PL-500 Control: E-0401
Application:
• Ideal for fine hairlines
• Perfect for sharp distincted lip contour
• Lip contour and fine inward lip shading
• Test point for allergy tests
1st-Micro hygiene module (0,18 mm) Needle Art-No:
The needle diameter of the 1st-Micro hygiene mo-
dule similar to the 1st-Liner hygiene module. Ho-
wever the needle is significantly grinded thinner to
a diameter of 0.18 mm in the front section.
PL-500 Control: E-0401C
Application:
•Especially suitable for expressive, fine lines
•Ideal for soft eyebrow hair lines
1st-Nano-Hygienemodule (0,2/0,25 mm) Needle Art-No:
Nano hygiene modules are the latest development
on extremely thin needles, which are ideal for the
finest hairlines in the eyebrows.
Practical tip: Perfect for finest hairlines which are
comparable of the width with microblading hair-
lines.
N1 (0,2mm)
PL-500 Control: E-0401N1
N 2 (0,25mm)
PL-500 Control: E-00401N2
Application:
•Recommended for the finest hairlines

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Ihre Fachpraxis für Permanent Make-up
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Needle combination of hygiene modules
3rd-Liner hygiene module (0,3 mm) Needle Art-No:
The bundle with classical 3rd hygiene module round
needles is 0.65 mm wide (with a diameter of each
0.3 mm).
Practical tip: The needles cause a slightly wider
line. In order to create a soft start and a tapered pha-
se out of the eyeliner we recommend the 3rd-Outline
module.
PL-500 Control: E-0403
Application:
• Shading of eyebrow shape
• Soft, slightly wider lines at the lash line
• Suitable for broader eyeliners
3rd-Outline hygiene module (0,25 mm) Needle Art-No:
The needles of the 3rd-Outline hygiene have a dia-
meter of only 0.25 mm. Compared to the 3rd need-
le type they are grinded more delicately and are
bundled closer to each other.
Practical tip: Due to the closer bundling the 3rd-
Outline needle is not perceived to be as sharp as
a 1st needle. It enters the skin particularly well and
traces a fine line while at the same time allowing a
denser colour injection.
PL-500 Control: E-0430
Application:
•Lash thickening on the lower eyelid
•Especially suitable for a fine rise and phase out
on the broad upper eyeliner
•Also very popular for thin lip contours
4th-Flat hygiene module (0,4 mm) Needle Art-No:
In the 4th-Flat hygiene module, the needles are ho-
rizontally positioned in one line.
Practical tip: If a broader line is desired, make sure
that the needle is traced exactly at a right angle to
the line and the handpiece is held vertically to the
skin to enable all needle tips to inject the colour at
the same depth.
PL-500 Control: E-0404
Application:
•Recommended for wide lines
•Ideal for shading of larger areas

www.PermanentLine.de
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5th-Shader hygiene module (0,3 mm) Needle Art-No:
5th-Shader hygiene modules are bundled (5 x 0.3
mm).
Practical tip: Depending on how often the skin is
processed, soft to compact lines are feasible. We
recommend the 5er-Shader modules for shading
wide, almost transparent lines.
PL-500 Control: E-0405
Application:
• Shading of eyebrow shape
• Eyebrow priming and full shading
•Shading of lip edges in case of narrow lips
•Shading of full lips
3rd- and 5th-Slope hygiene module (0,4 mm) Needle Art-No:
In a sloping needle type, 3 or 5 needles are aligned
side-by-side at an angle of 32 degrees.
Practical tip: This needle combination developed
by Dr. Linda Dixon requires special training. If you
place the handpiece of the pigmentation instrument
in a writing posture, the needles all pigment at the
same depth. This allows a more efficient work.
PL-500 Control: E-0403S
PL-500 Control: E-0405S
Application:
•Recommended for lines and shading of eye-
brows and lips

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Needle combination of hygiene modules
5er-Magnum-Hygienemodul (0,3 mm) Needle Art-No:
The 5th-Magnum hygiene module contains 2 + 3
needles with a diameter of each 0.3-mm that are
aligned in a double row.
Practical tip: To achieve a more intense lip
contour pigment lengthwise, for shading and colour
filling widthwise.
PL-500 Control: E-0405M
Application:
•Eyebrow shading and wider eyeliner
•Lip shading and lip colour filling
•Scars and areo
7th-Round hygiene module (0,3 mm) Needle Art-No:
The 7th hygiene module has 7 circularly arranged
needles of each 0.3 mm.
Practical tip: Idealy suited for wide defined contour
lines and shading. Due to the multitude of needles the
customers experience less pain. Ideal colour injection
and shorter treatment time.
PL-500 Control: E-0407
Application:
• Broader lip contour
• Colour filling of the lips
• Areola and scars
9th-Magnum hygiene module (0,3 mm) Needle Art-No:
In the 9th-Magnum hygiene module the needles are
positioned horizontally, similar to the 4er-Flat need-
les. The first row contains 4, the second row (arran-
ged closely behind) contains 5 needles. Each needle
with a diameter of 0.3 mm.
Practical tip: If a broader line is desired, make sure
that the flat needle is traced exactly at a right angle
to the line and the handpiece is held vertically to the
skin to enable all needle tips to inject the colour at the
same depth.
PL-500 Control: E-00409
Application:
• Ideal for shading of eyebrows, areola and
scars
•Perect for colour shading and colour filling of
the lips

A make-up
that accompanies you regardless which weather.

User’s manual
14
Important safety instructions
Caution: risk of injuries
The supplies include needles that can cause injuries if not used properly. That is why the needle or the tip
of the needle should never by touched - no matter if the handpiece is turned on or off. Injuries with a conta-
minated needle can cause the transmission of dangerous diseases. In this case a doctor should be visited
immediately. The whole device as well as the handpiece must be cleaned with a cloth that has been soaked
with a disinfectant and cleansing agent prior to usage or every treatment.
The handpiece and the device must never be directly soaked in a desinfectant agent, as this may cause inner
parts to corrode. If a protective cap is used for storage purposes during a treatment, the protective cap must
be sterile. It is possible to order sterile protective caps from the distributor. Otherwise the used protecitve
cap must be cleaned and sterilised.
Protective foil
During the treatment the handpiece, the cable of the handpiece, the device, as well as the handpiece tray
must be covered with a protective foil. The handpiece is covered with the protective foil before docking the
needle module.
Layout of the working place
Pigmenting has to take place in a clean room. A strict no-smoking policy must be complied. Please also
consider local regulations regarding the layout of the working place.

Contraindications
It is not permitted to perform pigmentations on people under the following circumstances:
• Haemophilia
• Feverish infects / infectious diseases
• Hepatitis A, B, C, D, E, F
• Skin disorders in the respective treatment area
• HIV-positive
• Diseases of the immune system
• Keloid formation
• Epilepsy
• Severe cardiovascular problems
• Allergies
• Diabetes II
• Conjunctivitis (contraindicated for pigmentation of eyeliners)
• Pregnancy or breastfeeding
• Under influence of alcohol or narcotics
• blood thinning/coagulation inhibiting drugs or drugs regarding menstruation problems
• Use of certain medication (consult the prescribing doctor)
• If there is the slightest doubt regarding the safety of the patient, the treatment must not be started or the
treatment has to be interrupted and the approval of a doctor is necessary
The treatment must immediately interrupted if:
• Excessive experience of pain
• Excessive leakage of wound fluid
• Unconsciousness/dizziness
Particular caution is necessary in the following cases:
• If the patient suffers from herpes simplex, a pigmentation of the lips usually causes herpes labialis (cold
sores). A prior consultation of a doctor (as well as a perspective prophylaxis) is recommended.
• Patients undergoing chemotherapy should not receive a pigmentation 4 weeks before and 4 weeks after
the therapy, as the pigments cannot be absorbed into the skin properly during this timeframe.
Pigments
Only dermatologically harmless pigments with ingredients that meet local regulations must be utilised. In
Germany the European resolution ResAP(2008) and the German tattooing regulation must be abided. In or-
der to prevent allergies caused by pigments the declaration of ingredients must be considered by all means.
Furthermore it must be ensured that the expiration dates are not exceeded and that the pigments are stored
properly.
Skin anaesthetic
If a skin anaesthetic has been applied, it must be wiped off before pigmentation. The patient must be observed
afterwards. Only a sterilised pen assigned for skin marks may be used to mark the skin.
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User’s manual
Maintenance and care
Prior to all cleaning and maintenance activities, the power plug must be removed from the socket! The
control unit should externally be cleaned with a soft cloth every now and then (possily soaked in a mild dis-
infectant, e.g. 50 % aqueous 1 propanol solution). The handpiece must be cleaned before and after every
utilisation. Only disinfectant agents approved by the DGHM and compatible with the materials and surfaces
of the device may be applied. The manufacturer recommends Lysetol®Med from the Schülke & Mayr com-
pany. The handpiece must never be directly soaked in a desinfectant agent, as this may cause inner parts to
corrode. Such damages are not part of the warranty.
Compatibility of materials
Resistant against:
• weak acids (e.g. boric acid, 10% acetic acid, 10% citric acid)
• aliphatic hydrocarbons (e.g. pentane, hexane)
• Ethanol as well as most inorganic salts and their aqueous solutions (e.g. sodium chlorid, calcium
chloride, magnesium sulfate)
Not resistant against:
• strong acids (e.g. 20% hydrochloric acid, 50% sulphuric acid, 15% nitric acid)
• oxidising acids (e.g. peracetic acid)
• lyes (e.g. sodium hydroxide, ammonia)
• all substances with a pH level higher than 7, aromatic/halogenated hydrocarbons (e.g. phenol,
chloroform) as well as acetone and petrol.
The handpieces must be protected from damage and should be stored in the tray after utilisation.
Safety inspection
A safety inspection of the pigmentation instrument should be carried out every 24 months.
Malfunction, repair and complaints
In case of a malfunction all components such as the power supply and the handpiece should be removed
from the device. The device should run smoothly after you checked or newly adjusted the connections. If the
malfunction should not be resolved, the device must be presented to an authorised LaBina®supplier. The
supplier must be contacted for any complaints.
Warranty statement
You purchased a high-quality product. The reliability of the device is guaranteed by newest testing proce-
dures. A statutory warranty of 2 years is applicable in case of malfunctions that can be traced back to mate-
rial failures or defects in workmanship. There is no liability for possible consequential damages. For damages
resulting from improper handling or disregard of our instruction manual, we categorically do not assume any
liability.
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Transport and storage conditions
Ambient temperature: -40 °C to +40 °C
Relative humidity: 30% to 75%
Air pressure: 500 to 1060 hPa.
If the device cannot be operated safely anymore, it must be removed from operation and protected from
unintentional or unauthorised operation. In order to rule out damages caused by the transport, a visual in-
spection of the device should be performed prior to the initial operation. Please note: The device may be
transported in the original or an equivalent packaging only.
Technical parameters
Symphony hygiene module handpiece
Rated voltage: 12 V – (DC)
Power input: 1.5 W max
Operating conditions:
Ambient temperature: +10 °C to +35 °C
Relative humidity: 30% bis 75%
Operating frequency: 50-140 stitches per second
Drive: Precision engine - DC
Operating mode: continuous operation
Length, diameter: 135 mm, 19 mm
Overall weight: 400 g
Weight of the handpiece: approx. 50 g
LaBina®PL-500 Control pigmentation instrument
Art-No: LaBina-PL500-Control
Control unit
Rated voltage: 15 V – (DC)
Power input: 7 VA max
Wall wart: as stated on the type plate
Level of protection: 2
Operating conditions:
Ambient temperature: +10 °C to +35 °C
Relative humidity: 30% to 75%
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Supplies
For the Symphony hygiene module hand-
piece of the LaBina®PL-500 Control the
hygiene modules listed on the left are
required. Every unit contains 15 hygiene
modules.
Manufacturer:
MT.Derm GmbH
Gustav-Krone-Straße 3 14167 Berlin
Germany
Distributor and vendor for devices,
accessories and supplies
PERMANENT-Line GmbH & Co. KG
Mengeringhäuser Str. 15
34454 Bad Arolsen, Germany
Telephone: [phone]
E-Mail: [email protected]
Internet: www.Labina24.de
Description Art-No:
1st-Liner hygiene module E-0401
1st-Micro hygiene module E-0401C
1st-Nano-N1-Hygienemodule E-0401N1
1st-Nano-N2-Hygienemodule E-0401N2
3rd-Liner hygiene module E-0403
3rd-Outline hygiene module E-0430
3rd-Slope hygiene module E-0403S
4th-Flat hygiene module E-0404
5th-Shader hygiene module E-0405
5th-Magnum hygiene module E-0405M
5th-Slope hygiene module E-0405S
7th-Round hygiene module E-0407
9th-Magnum hygiene module E-0409
Microlift module needle plate E-MM00020

Unsere allgemeinen GeschäftsbedingungenManufacturing and distribution
Warranty
LaBina®PL-500 Control pigmentation instruments are manufactured in
Germany. The manufacturer grants a warranty of two years starting from the
purchase date on the product.
In case of a malfunction after the expiration of the warranty period we will pro-
vide a substitutional device that is free of charge for the duration of the repair.
Distribution
PERMANENT-Line GmbH & Co. KG
Complementary:
PERMANENT-Line Schneider Kosmetik GmbH
Mengeringhäuser Str. 15, 34454 Bad Arolsen
Deutschland
Telefon: [phone]
Telefax: [phone]
Internet: www.LaBina24.de
Shop: www.LaBina24.de
E-Mail: [email protected]
Authorized managing director:
Marcus Schneider, Mengeringhäuser Str. 15, 34454 Bad Arolsen
Telefon: [phone]
Register court: Korbach HR A1546
VAT identification number: according to § 27 a Value Added Tax Act: DE 02735560108
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