LaBina PL-1000 Mobil User manual

PL-1000 Mobil
OPERATING MANUAL

PRODUCT OVERVIEW
7 8
6
5
23
4
1
ARTICLE DESIGNATION ARTICLE DESCRIPTION
1 Controller MAD-1.4
2 Needle cartridges See “4.3 Accessories and spare parts” on page 18.
3 Handpiece with connecting cable CN-1.3
4 Handpiece tray FG-AD1.0-1
5* Handpiece cover E-0610
6 Foot switch E-1010
7 Power supply unit E1165
8 Country-specific adapter EU: E-1154
* Not included with the delivery
2EN PL-1000 Mobil

6789
1
2
3
4
5
BUTTONS AND CONNECTIONS
1 Display
2GO button ( ) (white LED)
3Select Handpiece I/II buttons ( ) (white LED)
4Power LED indicator (white LED)
5Increase frequency button ( )/ decrease frequency button ( )
6 Connection for foot switch
7 Connection for handpiece I and II
8 Connection for power supply
9Device ON/OFF button
3EN PL-1000 Mobil

4EN PL-1000 Mobil
English
Version 1.0 – 07/2018
Translation of the original operating manual. The original operating manual was generated in German.
CONTENTS
1 About this manual 6
1.1 Presentation of warning symbols 6
2 Important safety instructions 7
2.1 General safety instructions 7
2.2 Product-specific safety instructions 7
2.3 Important health and safety precautions 8
2.4 Contraindications and side effects 10
2.5 Required qualification (user requirements) 11
2.6 Intended purpose, scope of application and proper use 12
2.7 Symbols on the product 13
3 Scope of delivery 16
4 Product information 17
4.1 Technical data 17
4.2 Operating conditions 17
4.3 Accessories and spare parts 18
5 Getting started 19
5.1 Positioning the device 20
5.2 Connecting the power supply 21
5.3 Connecting the foot switch (optional) 22
5.4 Connecting the handpiece 22
5.5 Cleaning and disinfecting the equipment 23
5.6 Inserting or replacing the needle cartridge 24
5.7 Pulling the handpiece cover on 25
5.8 Filling needle cartridges 26
5.9 Checking equipment 27
6 Use 27
6.1 Switching the control unit to operating mode or standby mode 27
6.2 Setting the needle protrusion depth 28
6.3 Setting the penetration frequency 28
6.4 Switching the handpiece on and off 29
7 Cleaning and maintenance 30
7.1 Inspection 30
7.2 Material compatibilities 30
7.3 Disinfecting surfaces 31

5ENPL-1000 Mobil
7.4 Cleaning surfaces 31
8 Transport and storage conditions 32
8.1 Controller, handpiece with handpiece cable, power supply and foot switch 32
8.2 Needle cartridge 32
9 Disposal 33
10 Questions and problems 33
11 Guarantee 34
12 Declaration of conformity 35

6EN PL-1000 Mobil
ABOUT THIS MANUAL
This operating manual applies to the PL-1000 Mobil (AD-1.4) and its accessories. It con-
tains important information about setting up, operating and looking after the device safely
and as intended for use.
This operating manual is restricted to all information essential for the safe use of the device.
For further information, required for the safe use of the device and its accessories, please
also read the following additional documentation:
OSafety datasheets for disinfectants and cleaning materials
OSafety at the workplace requirements and statutory provisions for micropigmentation
Presentation of warning symbols
Warning symbols highlight the danger to persons or objects and are set up as follows:
SIGNAL WORD
Type of hazard
Consequences
EPrevention
ELEMENT MEANING
Indicates risk of injury
Signal word Indicates the seriousness of the hazard (see following table)
Type of hazard the type and source of the hazard
Consequences describes possible consequences if ignored
Prevention indicates how the hazard can be prevented
1
1.1

7ENPL-1000 Mobil
SIGNAL WORD MEANING
Danger Indicates a danger which will certainly result in severe or fatal injuries if the
danger is not avoided
Warning Indicates a danger which could result in severe or fatal injuries if the dan-
ger is not avoided
Caution Indicates a danger which may cause slight to medium-severe injuries if the
danger is not avoided
Attention Indicates a potential risk of damage to the environment, property or the
equipment if the danger is not avoided
Symbols used in this operating manual
SYMBOL MEANING
EAction required
OBullet points
- Sub-bullet points
IMPORTANT SAFETY INSTRUCTIONS
General safety instructions
ERead this operating manual carefully and in full.
EKeep this operating manual in a location which is accessible to all those using, cleaning,
disinfecting, storing or transporting the device.
EAlways include this operating manual when transferring ownership of the device.
EFollow the safety regulations for the micropigmentation in your country. Keep your work-
place hygienically clean and ensure that you have adequate lighting.
EOnly use the device, its accessories and all handpiece cables when in perfect condition.
EUse only original needle cartridges, accessories and spare parts from
MT.DERM.
Product-specific safety instructions
ENever modify the device, the needle cartridges or other accessories.
EChildren must be supervised and prevented from playing with the device.
EPrevent fluids from getting inside the device, the handpiece, the foot switch or the power
supply.
2
2.1
2.2

8EN PL-1000 Mobil
EAvoid sources of interference by ensuring that portable or mobile radio devices are not
operated in the vicinity of the device.
EWhen being handled, protect the handpiece and the handpiece cable from contamination
by bodily fluids or substances contaminated with bodily fluids by means of a handpiece
cover (see chapter "5.6 Inserting or replacing the needle cartridge" on page 24).
EIf the device is not being used, disconnect it from the power supply and place the hand-
piece in the handpiece tray so that it cannot roll away or fall.
EObserve the technical data provided in this operating manual and comply with the oper-
ating, transport and storage conditions (see chapter "8 Transport and storage condi-
tions" on page 32).
ESend the device to a specialist retailer for inspection if there are signs of damage, if it
does not function as normal or if liquids enter the device or handpiece.
EIt is recommended that the device is sent to a specialist retailer for inspection at regular
24 month intervals. In doing so, refer to chapter "7.1 Inspection" on page 30.
Important health and safety precautions
Please observe the following instructions in order to prevent contaminations or infectious
diseases being transmitted to the customers or users during treatment:
EFollow all of the steps for disinfecting the equipment before treatment (see chapter
"5.5 Cleaning and disinfecting the equipment" on page 23).
EUse disposable gloves made from nitrile or latex during the treatment and disinfect these
before use. Observe the applicable directives for your country when selecting suitable
disinfectants.
EClean the respective area of the customer's skin with a mild cleaning agent and disin-
fectant before treatment. Observe the applicable directives for your country when select-
ing suitable disinfectants.
EFor the treatment, use only micropigmentation inks that have been tested and approved
for insertion into human skin. Observe the applicable directives for your country when se-
lecting these. If micropigmentation inks that are not intended for permanent make-up
treatment or whose sterility is not guaranteed, are introduced into the skin, this can result
in infections or possible side effects.
EUse only new, sterile packaged needle cartridges for each customer. Before treatment
ensure that the packaging is undamaged and the expiry date has not passed. Note the
batch number of the needle cartridge used in the corresponding customer file in order to
be able to pass this on to the manufacturer in the event of any problems.
Eneedle cartridges are sterile disposable products (consumables) and are only ever per-
mitted to be used once!
EDispose of used or faulty needle cartridges as well as needle cartridges whose packag-
ing is damaged in a non-penetrable container (sharps container) in accordance with the
regulations applicable in your country.
2.3

9ENPL-1000 Mobil
EBefore the treatment, switch the handpiece off and check that the needles have been
completely withdrawn into the needle cartridge. If this is not the case, dispose of the
needle cartridge immediately.
EEnsure that needle cartridges never come into contact with contaminated items, such as
clothing for example. Contaminated needle cartridges shall not be used but rather must
be immediately disposed of.
EDuring use, the handpiece, the handpiece cable and the device including the integrated
handpiece tray must be completely covered with protective film. The handpiece must be
covered with the protective film sleeve before attaching the needle cartridge (see chap-
ter "5.7 Pulling the handpiece cover on" on page 25).
ECheck at regular intervals whether the handpiece is visibly contaminated by bodily fluids
running back or by the pigment ink being used. In this case, in addition to the regular dis-
infection observe the contents of the chapters "7.4 Cleaning surfaces" on page 31
and "7.2 Material compatibilities" on page 30 as well as chapter "2.2 Product-specif-
ic safety instructions" on page 7.
EIf a local anaesthetic is being used, this should be thoroughly removed before the treat-
ment.
EAlways hold the handpiece firmly before switching it on or place it in the handpiece tray.
If an unsecured handpiece is switched on, it may move due to vibrations and cause injury
to persons or prick persons (see chapter "6.4 Switching the handpiece on and off" on
page 29).
Injuries through contaminated needles or needle cartridges can result in the transmission of
diseases (see chapter "5.6 Inserting or replacing the needle cartridge" on page 24). In
the event of being injured by a contaminated needle, seek immediate medical attention from
a physician!
In order to prevent the intensity of the treatment exceeding the extent desired:
EAvoid risk of injury due to the needles protruding too deeply (see chapter "6.2 Setting
the needle protrusion depth" on page 28).
EAvoid risk of injury due to the penetration frequency being too high (see chapter
"6.3 Setting the penetration frequency" on page 28).
Please be sure to inform your customer to avoid contact with recently treated skin. Recently
treated areas of skin should also be protected from
OContamination and
OUV and solar radiation.
Additional irritants such as
OVisits to swimming pools or saunas
OAbrasive or chemical peelings
OHair removal at the treated areas or

10 EN PL-1000 Mobil
OSelf-tanning products
should be avoided by the customer in the first two to three days after the treatment.
Contraindications and side effects
The following contraindications and side effects are the results of a thorough analysis of the
professional clinical literature concerning micropigmentation. If the person responsible for
the treatment should have the smallest doubt that the safety of the customer being treated
cannot be guaranteed, for example due to secondary illnesses or conditions, the treatment
should be withheld or stopped immediately.
Contraindications
With the following contraindications, no permanent make-up treatment should be undertak-
en:
OHaemophilia or other blood-clotting disorders
OCurrently taking blood thinning medication (e.g. Warfarin, Heparin, aspirin, acetylsalicylic
acid)
OUncontrolled diabetes mellitus
OAny form of active acne in the area of the treatment
ODermatosis (e.g. Skin tumours, keloids or extreme tendency for keloid formation, solar
keratosis, warts and/or moles) in the area of the treatment
OOpen wounds and/or eczema and/or rashes in the area of the treatment
OScars in the treatment area
OSystemic infections and infectious diseases (e.g. Hepatitis type A, B, C, D, E or F; HIV in-
fection) or acute local skin infections (e.g. herpes, rosacea)
ODuring chemotherapy, radiotherapy or high-dosage corticosteroid therapy (recommenda-
tion: from four weeks before the start until four weeks after the end of the therapy)
OUp to twelve months after a plastic surgery operation in the area to be treated
OUp to six months after filler injections in the area to be treated
OAllergy to topical anaesthetics (local anaesthetic)
OUnder the influence of alcohol and/or drugs
OPregnancy and lactation
The treatment of mucous membrane and eyeballs is strictly forbidden.
The treatment must be immediately aborted in the event of:
OExcessive perception of pain
OFainting/dizziness
2.4
2.4.1

11ENPL-1000 Mobil
Side effects
In some cases, minor side effects can arise during and after the permanent make-up treat-
ment. These side effects are listed below.
Often:
OLocalised bleeding in the area of the treated skin
OPain and discomfort on the first day after the treatment
OShort-term inflammatory reactions, erythema and/or oedema up to six days after the
treatment
OSkin irritations (e.g. itching or temperature increase), which normally die out over the first
12 to 72 hours after the treatment
OFormation of scabs, which normally recede in the first five days
OTemporary peeling of the skin which normally subsides within eight days
Seldom:
OFormation of herpes simplex virus type I (HSV-I) blisters
OFormation of small pustules or milia as a result of inadequate cleaning of the skin prior to
treatment
OHyperpigmentation with the body’s own pigments, in particular with darker skin types, but
completely cleared up within a few weeks
OInflammatory reactions, haematoma, erythema and oedema
ORetinoid reaction (from slight reddening to peeling of the skin)
OPossible heating of the pigmented area under PET and MRT radiation
As a matter of principle, recently treated skin areas should be protected from UV and solar
radiation.
The following problems could also arise with the application of permanent make-up:
OColour tone differences
OLoss of pigment
OAllergic reactions to components of the aseptic pigment colour
Required qualification (user requirements)
The device and its accessories may not be used by persons with impaired physical, sensory
or mental capabilities or by children. The device and its accessories may not be used by per-
sons with no experience or knowledge unless they are being supervised or instructed (train-
ing).
The device may only be used by persons trained in the following:
OQualification for micropigmentation/PMU
2.4.2
2.5

12 EN PL-1000 Mobil
OBasic knowledge of micropigmentation treatment (see chapter "6.3 Setting the penetra-
tion frequency" on page 28 and "6.4 Switching the handpiece on and off" on
page 29)
OKnowledge of hygiene and safety regulations (see chapter "2.3 Important health and
safety precautions" on page 8)
OKnowledge of risks and side effects (see chapter "2.4.1 Contraindications" on page 10
and "2.4.2 Side effects" on page 11)
Intended purpose, scope of application and proper use
Intended purpose
The intended purpose of the device is the minimally invasive injection of sterile or aseptic
pigment colours of mineral or organic origin into the dermis by means of micropigmentation
(permanent make-up).
There are no open wounds caused in the skin by this thanks to the minimally invasive punc-
turing of the epidermis (top skin layer) and the dermis (middle skin layer). Afterwards, the
skin requires only a very short regeneration phase in which the epithelial function will be re-
stored.
Scope of application
The most common applications for permanent make-up (PMU) are:
ODrawing hairs in the eyebrows
OApplying eye-liner
ODrawing fuller lips or improving the lip contours
OApplying body tattoos
Proper intended use
The treatment must be carried out in a dry, clean and smoke-free environment as well as
under hygienic conditions. The device must be prepared, used and looked after as de-
scribed in this operating manual. In particular, the applicable requirements concerning work-
place design must be observed and the materials to be used must be sterile.
Intended use also includes the assumption that this operating manual and in particular
chapter "2 Important safety instructions" on page 7, have been read in full and understood.
Intended use also assumes the following consumer groups exclusively:
OAdult men and women who are in good health
2.6
2.6.1
2.6.2
2.6.3

13ENPL-1000 Mobil
Improper use is when the device or its accessories are used in a manner other than as de-
scribed in this operating manual or if the operating conditions have not been complied with.
The treatment of contraindications in particular is forbidden (see chapter "2.4.1 Contraindi-
cations" on page 10).
Symbols on the product
The symbols described below can be found in this operating manual, on the device and on
its accessories or the packaging:
SYMBOL MEANING
Device complies with the requirements of directive 2006/42/EC & 2004/108/EC
Attention!
Housing offers protection from coarse dust and water drops
Housing offers protection from jets of water
Housing offers protection from foreign objects thicker than 1 mm
Applied part, type B: Applied part provides safety from electrical shock and leakage
currents
Handpiece
Foot switch
DC connection, inner pin positive
DC
AC
Observe operating manual!
2.7

14 EN PL-1000 Mobil
SYMBOL MEANING
Manufacturer
Date of manufacture
Catalogue number, order number
Serial number
Batch code
Sterilised with ethylene oxide
Can be used until
Temperature limit
Humidity limit
Air pressure limit
Protect from moisture
Only use indoors
Fragile
Do not use if packaging damaged

15ENPL-1000 Mobil
SYMBOL MEANING
Not for re-use
Dispose of in compliance with waste electronic appliances guidelines
Do not re-sterilise
Warning of cutting or penetrating injuries
JAPAN TUV R-PSE
Energy efficiency level VI
Device complies with Japanese VCCI standards
CHINA SJ/T 11364-2014
UL certification for components recognised in Canada and the USA
Double insulation / device protection class II
GHOST-R mark for Russia
Device complies with the requirements of RoHS 2
SIQ mark license EN60601-1
Ukraine UKRSepro
See operating manual for further information

16 EN PL-1000 Mobil
SCOPE OF DELIVERY
1 Controller
1 Handpiece with handpiece cable
1 Power supply
1 country-specific adapter (EU)
1 Foot switch
1 Handpiece tray
1 German operating manual
1 English operating manual
The handpiece covers (E-0610) required for operation are not included in the delivery. Suit-
able accessory parts for the handpiece can be obtained via authorised retailers, see
"4.3 Accessories and spare parts" on page 18.
3

17ENPL-1000 Mobil
PRODUCT INFORMATION
Technical data
Device type AD-1.4
Nominal voltage 15 V - DC
Power consumption max. 7 VA
Power supply model Model number: GTM96180-1817.9-2.9
Part number: WR9QG1200CSPCR6B2958 (Globtek)
Protection class 2
Penetration frequency 50-150 Stiche/Sekunde
Drive Precision motor – DC
Operating mode Continuous operation
Dimensions (W x H x D) 230 mm x 45 mm x 185 mm
Handpiece weight approx. 100 g
Total weight approx. 1100 g
Operating conditions
Ambient temperature +15°C to +35°C
Relative humidity 30% to 75%
Air pressure 700 hPa to 1070 hPa
4
4.1
4.2

18 EN PL-1000 Mobil
Accessories and spare parts
The following accessories and spare parts can be purchased from authorised retailers.
ACCESSORIES ARTICLE DESCRIPTION SCOPE OF
DELIVERY PIECE/VPE
Needle cartridges E-0021 - 1-liner
E-0021C - 1-micro
E-0021N1 - 1-nano n(1)
E-0021N2 - 1-nano n(2)
E-0023 - 3-liner
E-0023P - 3-power
E-0024 - 4-flat
E-0025 - 5-shader
E-0025M - 5-magnum
E-0025P - 5-power
E-0025R - 5-round
E-0027 - 7-round
E-0027P - 7-power
E-0029 - 9-magnum
E-0030 - 3-outline
E-0030MIC - 3-micro
E-0030S3 - 3-slope
E-0030S5 - 5-slope
E-0251N1 - 1-nano n(1)
E-0251N2 - 1-nano n(2)
E-0021N3 - 1-Nano NT ST
E-0025N4 - 5-Nano Slope
E-0023N4 - 3-Nano Slope
E-0023N4-A - 3-Nano Slope
E-0025N4-A - 5-Nano Slope
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
Handpiece cover E-0610 – 16
SPARE PART ARTICLE DESCRIPTION SCOPE OF
DELIVERY PIECE/VPE
Controller MAD-1.4 1 1
Handpiece CN-1.3 1 1
Foot switch E-1010 1 1
Handpiece tray FG-AD1.0-1 1 1
4.3

19ENPL-1000 Mobil
SPARE PART ARTICLE DESCRIPTION SCOPE OF
DELIVERY PIECE/VPE
Power supply E1165 1 1
Country-specific
adapter
EU: E-1154 1 1
Operating manual 7EAD14001DE (DE)
7EAD14001EN (EN)
1
1
1
1
GETTING STARTED
CAUTION
Cable tripping hazard
An incorrectly laid cable can constitute a tripping hazard and cause injury.
EEnsure all cables are positioned so that no one can trip over them or pull on them un-
intentionally.
CAUTION
Danger of injury and of device malfunctions
Unsuitable accessories and spare parts can impair the function and safety of the device
The device can be damaged or can fail or malfunction endangering persons.
EUse only the needle cartridges, accessories and spare parts listed in chapter "4.3 Ac-
cessories and spare parts" on page 18.
ATTENTION
Danger of short-circuit
There is a risk of damage to electronics if there is visible damage to cables or cable con-
nections.
ECheck the device and the cables by visually checking for damage such as a defective
cable connection for example.
ENever kink the product's cable.
5

20 EN PL-1000 Mobil
ATTENTION
Damage from condensate
If the device is exposed to high temperature variations e.g. during transport, condensate
may accumulate inside and damage the electronics.
EEnsure that the device has reached ambient temperature before using it. If the device
has been exposed to high temperature variations, wait for at least 3 hours per 10 °C of
temperature difference before using it.
EUse the device only with an ambient temperature of +15°C to +35°C.
Positioning the device
CAUTION
Reduced functionality due to electromagnetic interference
Portable and mobile HF communications devices, such as mobile phones or WLAN rout-
ers, can influence the functionality of the device through the transmission of electromag-
netic radiation. Safe operation of the device can no longer be assured.
EAvoid sources of interference by ensuring that portable or mobile radio devices are not
operated in the vicinity of the device.
EInform your customers about the risk of sources of interference.
ATTENTION
Damage to the device due to inadequate stability
If the device is not positioned safely, safe operation is not guaranteed. The device could
fall and get damaged during operation.
EPlace the device on a clean, firm and level surface.
EEnsure that the buttons and the display of the device remain freely accessible during
use.
ENever place the device on or underneath other devices.
EPlace the device on a clean, firm and level surface.
5.1