En Medical Control
En Medical Control
En Medical Control
1
TABLE OF CONTENTS.
1. Introduction and information about this manual 4 6. [MatriXneedling®] system therapy 20
2.3. Important precautions for the 7 6.3 Product selection facial treatment 32
2.4 Contraindications and side effects 8th 6.5 Product selection Special areas of application 42
2 3
1. INTRODUCTION AND INFORMATION ABOUT THIS MANUAL.
The device you have purchased allows you to work in two modes: in
wireless mode thanks to the built-in lithium battery or in mode powered
by a cord. INTRODUCTIONANDINFORMATION ABOUT THIS
MANUAL
These operating instructions deal with the technology and the range of functions of the
The MEDICAL CONTROL can be equipped with various accessories NeedlingPen MEDICAL CONTROL and its specific accessories. It contains important
information for safe installation, safe operation and care of the device and for its intended
(needle cartridges) are used to perform the following treatments: use. This manual is limited to all information essential for the safe use of the device.
• Medical microneedling
• Microdermabrasion
4 5
2. IMPORTANT SAFETY INSTRUCTIONS.
2.1 GENERAL SAFETY INSTRUCTIONS . 3 IMPORTANT PRECAUTIONS FOR 2 HEALTH AND SAFETY
• Read these operating instructions carefully and completely.
• This manual at one for all persons who use the Microdermabrasion requires special precautions for the
Use, clean, disinfect and store the NeedlingPen MEDICAL CONTROL Health and Safety that are included in the list.
or transport, store in an accessible place. Medical microneedling requires special health and safety precautions, as indicated in the list, and must only
• Hand over these operating instructions with each transfer of ownership of the NeedlingPen be carried out by a suitably trained person, according to the regulations and laws in force in different countries.
MEDICAL CONTROL.
• Follow the safety rules. Keep the workplace hygienically clean
and ensure adequate lighting.
• Only use the NeedlingPen MEDICAL CONTROL if the device is
accessories and all handpiece cables are in good condition.
• Follow all steps to disinfect the device prior to treatment.
• Only use original accessories and spare parts. • Wear disposable nitrile or latex gloves, eye and lip protection mask, disposable cap and gown before
beginning treatment and during all operations.
2.2 PRODUCT-SPECIFIC SAFETY NOTICES • The skin area of the patient before the treatment with
clean with a mild detergent and disinfectant.
• Never modify the NeedlingPen MEDICAL CONTROL , the needle modules or something else You can achieve ideal results with the procedure of the matrix needling system treatment.
accessories.
• Do not use 220V AC power as it may cause fire or malfunction. • Use only topical and sterile preparations for treatment
this type of application have been tested.
• Children must be supervised and are not allowed to use the needling • Use a new needle module in sterile packaging for each customer. Before treatment check that the
Play Pen MEDICAL CONTROL.
• Make sure that no liquids get into the handpiece or the power supply packaging is not damaged and that the expiry date has not passed. The batch number of the
penetration. needle modules used
• Avoid sources of interference by being near the NeedlingPen MEDICAL note down the relevant customer card in order to avoid any problems
CONTROLs no mobile devices are used. to report manufacturers.
• The handpiece during use by a handpiece cover • The needle modules are sterile disposable products (consumables) and
protection may only be used once.
• If the NeedlingPen MEDICAL CONTROL is not used or • The used or defective cartridges and their packaging
fully charged, disconnect from the power supply and store in the handpiece holder to prevent the is damaged, in a special container according to the regulations in your country
device from rolling or falling. dispose of in accordance with applicable regulations.
• The technical data given in this manual • Make sure that the needle modules are never in contact with contaminated objects, such as e.g. B. clothing
observe and comply with the operating, transport and storage conditions come into contact. Contaminated needle modules must not be used and must be disposed of immediately
• The NeedlingPen MEDICAL CONTROL for checking at a
Send to your dealer if it is damaged, if it does not work normally, or if liquid has entered the device
or the handpiece. • During use, the handpiece must be completely covered with a
protective film are covered. The handpiece must be before putting on
• We recommend that you use the NeedlingPen MEDICAL CONTROL as a rule of the needle modules are covered with a protective film.
to be sent to an authorized dealer for inspection at moderate intervals of 24 months. • The handpiece periodically for visible contamination
check.
• Always hold the handpiece firmly before turning it on or placing it on the shelf. If an unsecured handpiece
is turned on, it can move due to vibration and cause injury.
6 7
2. IMPORTANT SAFETY INSTRUCTIONS.
2 . 4 . 1 CONTRAINDICATIONSFORMICRONEEDLINGAND The NeedlingPen MEDICAL CONTROL may only be used by personnel who meet the following requirements:
MICRODERMABRASION:
• Individuals suffering from allergies, epilepsy, infections or autoimmune • Appropriate training from the manufacturer or its distributor or other competent body, both in relation to the
diseases, infections of the respiratory tract, cardiovascular system or the skin area to be treated. safety aspects (as indicated in the instructions for use) and the technical, hygienic and aesthetic aspects
of the treatments.
• Persons suffering from diseases or treated with medication
who alter the normal re-epithelialization of the skin (e.g. diabetes, Mediterranean anemia, etc.) or who • Basic knowledge of medical microneedling and microdermabrasion • Knowledge of hygiene and safety
are undergoing chemotherapy. regulations • Knowledge of the risks and side effects
8th 9
2. IMPORTANT SAFETY INSTRUCTIONS. 3. SCOPE OF DELIVERY.
1x handpiece tray
Correct use also means that this manual, in particular section "2.2 Product-specific safety instructions", 2x needle modules
has been read and understood in full.
The protective covers of the handpiece required for the treatments are not included in the scope of
delivery. Appropriate accessories for the handpiece can be requested from authorized dealers or our
online shop, see "4.3 Accessories and spare parts".
Correct use requires only the following patient groups:
• Healthy adult males and females
Improper use occurs when the NeedlingPen MEDICAL CONTROL or its accessories are used in a manner
other than that described in these operating instructions or when the operating conditions are not observed. 4. DEVICE INFORMATION.
The treatment is prohibited, especially in the case of contraindications (see paragraph “2.4 Contraindications”)
power consumption 1w
protection class 2
Danger!
frequency oscillation Speed 1: 108 pulses/sec
IP21
Speed 4: 119 pulses/sec
The housing offers protection against coarse dust and
Waterdrop Speed 5: 121 pulses/sec
10 11
4. DEVICE INFORMATION. 5. COMMISSIONING AND USE.
4.2 OPERATING CONDITIONS The NeedlingPen MEDICAL CONTROL can be operated in two different modes: in wireless mode
without a cable and in mode with a connected AC power supply cable.
ADVERTISEMENT.
Switch on / speed display
4.3 ACCESSORIES AND SPARE PARTS
The following accessories and spare parts can only be obtained from authorized dealers.
BUTTON.
Power on / speed button
Accesories Description article quantity
quantity
spare part description contents
Control unit – 1 1
Handpiece cable – 1 1
–
operation manual 1 1
12 13
5. COMMISSIONING AND USE.
TURN ON/OFF.
Switching on and off the
Needling Pen MEDICAL CONTROLs
ATTENTION!
When using the MEDICAL CONTROL NeedlingPen in corded mode, be careful not to trip over the cord. A misplaced cable can be a
tripping hazard.
• Ensure that all cables are routed so that no one will trip over them or they
can pull unintentionally.
ATTENTION!
Danger of a malfunction of the MEDICAL CONTROL needling pen Unsuitable accessories and spare
parts can impair the operation and safety of the MEDICAL CONTROL needling pen. The NeedlingPen MEDICAL CONTROL can
be damaged, fail or malfunction.
• Only the needle modules listed in chapter "4.3 Accessories and spare parts" on page 12,
Use accessories and spare parts.
14 15
5. COMMISSIONING AND USE.
5.5 SETTING THE STIMULATION FREQUENCY AND SPEED 5 . 6 ATTACHING PROTECTIVE COVERTO HANDPIECE AND CABLE
When the NeedlingPen MEDICAL CONTROL is in the operating mode, the stimulation frequency can be To protect the handpiece and its cable from contamination during treatment, we recommend fitting a
changed or regulated by briefly pressing the on button. The device can be operated at a total of six different disposable cable cover with a diameter of 20-27 mm to the handpiece.
speeds. The handpiece starts at low speed and transitions to high speed.
• The needle modules are shipped in sterile packaging. Just before that
Remove use from sterile packaging.
ATTENTION! • Always place the handpiece on the handpiece holder so that the needle module is not
rests on the surface.
Condensation damage: If the NeedlingPen MEDICAL CONTROL is exposed to large temperature fluctuations, e.g. during • Turn off the handpiece.
transport, condensation can collect inside and damage the electronic components. • Hold the base of the cartridge to insert it into the handpiece.
• Ensure that the NeedlingPen MEDICAL CONTROL has reached room temperature before use. If the NeedlingPen
MEDICAL CONTROL has been exposed to temperature fluctuations, at least 3 hours per 10 °C before using it
ATTENTION!
Decreased functionality due to electromagnetic interference. • Turn the needle cartridge clockwise until you feel
Portable and mobile HF communication devices: Devices such as mobile phones or WLAN routers can affect the operation of resistance. The needle module is now in place
the NeedlingPen MEDICAL CONTROL by emitting electromagnetic radiation. Safe operation of the NeedlingPen MEDICAL
CONTROL is no longer guaranteed. firmly in the handpiece.
• Avoid sources of interference by ensuring that no portable or mobile • Check that the needle module is correctly
devices are used in the vicinity of the NeedlingPen MEDICAL CONTROL. positioned.
• Educate patients about the risk of interference sources.
• To remove the needle module,
rotate the needle cartridge counterclockwise and out of
the handpiece
take.
16 17
5. COMMISSIONING AND USE.
ATTENTION!
• The degree of protrusion (needle length) depending on the treatment (medical
microneedling or microdermabrasion), the indication and the corresponding needle mode.
For better visual control, it is advisable to adjust the degree of protrusion with the handpiece switched on.
The handpiece body is equipped with a patented PD/DS technology double adjustment system, the
Performance Deep / Double System, which indicates the set degree of protrusion.
This setting system enables the operator to work precisely, as he always knows exactly how far the needle
module protrudes for all types of treatment (microneedling, micropricking and microdermabrasion).
A NOTICE.
How to adjust the degree
of protrusion.
18 19
6. APPLICATION: [MATRIXNEEDLING ® ] SYSTEM THERAPY.
THE SYSTEMIC
TREATMENT OF
PROBLEM ZONES.
In order to carry out the medical micorneedling treatment systematically, you also need
sterile serums and care products in addition to the device.
Specially coordinated active ingredients enable you to get the best out of the treatment.
Active Ingredients: Ceramides, Bamboo Extract, Allantoin, Witch Hazel, Vitamin E Active Ingredients: Matrixyl®, Niacinamide, Hyaluronic Acid, Gatuline Expression AF, iActive-Complex, Prodew 500,
Prickly Pear Water
After the basic cleansing, the skin is optimally prepared for the treatment with an enzyme peeling. After the treatment, immediate first aid is required. Our Post Treatment Repair Balm delivers exactly
This not only removes dead skin cells, but also sets the course for rapid skin renewal after the that. The cream strengthens the weakened skin barrier and brings the skin balance back into balance.
procedure. We use encapsulated papaya enzymes and bromelain in our Enzymatic Treatment It also regulates the pH of the skin. Intensively caring, repairing and constructive. For better use, the
Peeling, as both active ingredients have proven to be particularly gentle. cream is hygienically packed in individual sachets.
PEELING REPAIR
Active ingredients: papaya extract, bromelain, mannitol, vitamin E Active ingredients: Bifida Ferment Lysate, Allantoin, Urea, Hyaluron
In general, you have two options for combining the microneedling application with an active substance You can protect your skin well after the treatment by your personal behavior. For external influences -
therapy (serum). Either you work in a sterile serum directly with the needling pen or you use an after-care such as UV radiation - you have our UV Protect Cream SPF50+. It is a UV-protecting, repairing, thin
serum after the treatment. and very quickly absorbed sun protection cream with a high sun protection factor of 80. It is based on
Due to the pharmaceutical purity and the higher effectiveness, we recommend using a sterile active proven UVB and UVA filters, as well as nourishing ingredients for skin stabilization.
SERUM PROTECT
ingredient ampoule. With 13 sterile meso serums, we offer a unique variety with which you can specifically
treat aesthetic blemishes. For intensive hydration, an initial treatment with the Hyaluron Booster is often Active ingredients: DNA repair enzymes, proteins, plankton extract
advisable.
The composition of active ingredients varies greatly in each field of application.
We are the pioneers in microneedling and collagen induction therapy in Germany. Get more out of your treatment. With day creams specially tailored to your treatment goal, you can
When needling with the electric needling pen, a needle head is moved up and down, resulting in up to optimally supplement the treatment. We carry treatment day creams for anti-aging, cellulite, pigment spots,
18,000 strokes per minute with high-performance devices. During this up and down movement, the scars or oily skin. To do this, use the cream as day care on all days between your treatments. The
needling pen is guided over the skin, leaving small vertical puncture channels in the skin's surface, the composition of active ingredients varies greatly in each field of application.
NEEDLING DAILY CARE
so-called perforation. This process triggers a series of biological processes that help the skin "repair" and
renew itself. A large number of skin problems can be treated effectively in this way. The aim is 200 to
250 punctures per cm² for an optimal result.
20 21
6.1 NEEDLE HEAD / SPEED LEVELS.
DANGER:
Only use original DERMIDA® accessories for the appropriate device.
The needle heads of the X-tra CONTROL or SMART CONTROL needling pen do not fit on the MEDICAL
CONTROL and vice versa, as they have different locking techniques.
SPEED LEVELS:
The combinations listed here are only guide values. The actual settings used may vary
based on practitioner preference or skin type.
0.2mm-0.5mm 1 to 2
0.5mm - 1.0mm 2 to 3
1.0mm - 1.5mm 3 to 4
1.5mm - 1.0mm 4 to 5
2.0mm - 2.5mm 5 to 6
9s
Scars, acne scars, stretch marks, cellulite, local fat deposits, deep
wrinkles, melasma, wrinkles, coarse pores, hyper pigmentation, skin
No. DA130055-2 discoloration
22 23
6.2 FIELDS OF APPLICATION.
Argireline +
*
Peptide Boosters
Argireline +
*
Peptide Boosters
eye area
0.25mm 0.25mm-0.5mm 1
(crow's feet, eye wrinkles,
bags under the eyes)
Hyaluronic booster
superior
0.5mm 0.5mm - 1.0mm 1-3
cheekbones
Intense Anti-Aging*
mouthpart
(corners of the mouth, marionettes 0.5mm - 1.0mm 1.0mm - 1.5mm 2-4
and nasolabial folds)
Argireline +
*
Peptide Boosters
scars and
1.0mm - 1.25mm 1.5mm - 2.0mm 3-5
acne scars
Retinol + Vitamin C
booster
Strong wrinkles
0.75mm - 1.0mm 1.0mm 3-4
(In total)
Intense Anti-Aging*
cellulite reversal
Lipolysis Booster
28 29
6.2 FIELDS OF APPLICATION.
lip booster
DM Cell Brightening
Foundation*
No. DA161206 No. DA143732 No. DA155601-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
No. DA161206 No. DA143732 No. DA180051-3 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
DEEP WRINKLES
No. DA161206 No. DA143732 No. DA155613-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
FOREHEAD WRINKLES
No. DA161206 No. DA143732 No. DA155614-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
No peeling
advisable.
No. DA161206 No. DA155614-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
No peeling
advisable.
No. DA161206 No. DA155607-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
BIG PORES
No. DA161206 No. DA143732 No. DA155608-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143727
No. DA161206 No. DA143732 No. DA155605-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143731
No. DA161206 No. DA143732 No. DA155606-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143730
36 37
6.4 PRODUCT SELECTION BODY TREATMENT.
No. DA161206 No. DA143732 No. DA155605-1 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143731
BODY WRINKLES
No. DA161206 No. DA143732 No. DA155608-1 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143727
No. DA161206 No. DA143732 No. DA155610-1 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143728
No. DA161206 No. DA143732 No. DA155606-1 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143730
No. DA161206 No. DA143732 No. DA155612-1 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143728
TONING
No. DA161206 No. DA143732 No. DA180051-3 No. DA300165 No. DA143723-1 No. DA141852 No. DA113200 No. DA143728
40 41
6.5 PRODUCT SELECTION SPECIAL AREAS OF APPLICATION.
Treatment Purifying enzymatic Acne & Oily Skin needling pen Hydration Face Mask post-treatment UV protect Daily treatment care
cleanser Treatment scrub reversal 0.25mm - 1.0mm Repair Balm Cream SPF 50+ Oily Skin Series
No. DA143725 No. DA143732 No. DA155609-1 No. DA300165 No. DA143722-1 No. DA141852 No. DA113200 No. DA143729
Our tip.
HAIR GROWTH Use the Hair Growth
Booster serum after cleaning and disinfecting the
scalp.
We recommend a combination treatment with
0.25 mm and 0.5 mm.
No. DA180061 No. DA180060 No. DA155611-1 No. DA300165 No. DA143727
SERUM NEEDLING DAILY CARE Acrylic rack for 24 sterile sera DA142087
42 43
6.6 INSTRUCTIONS: STEP BY STEP.
4 . NEEDLINGPEN.
Decide whether you want to carry out the treatment in mains operation or wirelessly.
Attach the desired needle attachment to the device and make sure it is secure and not
damaged. Put the needling pen into operation with the ON/OFF button. The desired
needle length can only be set when the device is switched on.
PREPARATION AND DISINFECTION.
Before treatment, make sure you have the needle attachments you want and all Now tighten the skin area that you want to treat with two fingers. Glide the pen
the products you need. Keep the workplace hygienically clean and ensure adequate over the skin in the desired pattern.
lighting. Before using the pen, you must thoroughly clean the skin area that you want to Be sure to needle each area of skin between 5 and 8 times.
treat and disinfect it with Alcoderm®. Important note: During the treatment, a needling pen must never be turned upside down (needle head points upwards).
Liquid in the needle head could run into the engine compartment and cause irreparable damage (liquid backflow).
1. CLEANING. 5. HYDRATION.
Remove make-up and clean the body parts to be treated with plenty of water and the After the treatment, your skin channels are open for about 15 minutes and are particularly
mild Treatment Cleanser. Take a small amount of Cleanser and mix it with some
receptive to highly effective masks. Remove the DER MIDA ®
lukewarm water. Hydration Mask of the packaging. If present, remove the two protective films and
Now a gentle and intensive care foam is created. Spread this foam on the body part. place the mask on the treated part of the body.
Massage it in gently and then wash it off thoroughly. Now relax for 10 to 15 minutes and let the mask do its work. Then remove the mask
and gently massage in the excess serum.
2. ENZYME PEELING.
6. REPAIR.
The next step is to remove dead skin cells from your skin. For this purpose, the
enzymatic treatment peeling is applied undiluted to the skin with a mask brush. Be sure Microneedling puts a strain on your skin. Sensitive and sensitive skin types now use the
to avoid the mouth and eye area. Leave on for about 5-10 minutes. Then remove with DERMIDA® Post Treatment Repair Balm. This is an intensively moisturizing and anti-
plenty of water and a sponge without leaving any residue. Gently pat dry and spray the irritant care balm for immediate use after needling. The Repair Balm is hygienically packed
skin areas undiluted with the Alcoderm® skin disinfectant (residence time 30 seconds). in individual sachets. Tear open the sachet and spread the balm over the skin with circular
movements. Allow it to fully absorb.
Note: From a needle length of 0.75 mm, it may be advisable to use an anesthetic cream afterwards
(e.g. Emla cream). Please note the manufacturer's exposure times
3. SERUM.
7. PROTECT.
Microneedling is perfect at any time of the year. If the treated part of the body is
In general, you have two options for combining the microneedling application with an
exposed to the sun, special UV protection with a high sun protection factor is required.
active ingredient therapy (serum). Either work in a sterile serum directly with the
To do this, remove the thin and very quickly absorbing sun protection cream DERMIDA®
needling pen or use an after-care serum after the treatment. Due to the pharmaceutical UV Protect
purity and the higher effectiveness, we recommend using a sterile active substance
Cream SPF 50+ and apply to the treated area.
ampoule. You take the serum with the supplied fine dosing syringe. To do this, carefully
remove the white cap from the ampoule. Pierce the gray septum with the collection
syringe and pull the syringe open. The cannula can then be easily removed to safely
spread the serum on the skin. The serum is highly effective and contains 10 ml. You
only need 2 to 3 ml for a facial treatment, more on the body depending on the size of 8th . DAILY CARE.
the treatment area.
Avoid touching your skin with your hand for the next two hours. Avoid heavy sweating,
steam baths and direct sunlight on the day of treatment. Don't wear makeup.
Sleep is now your skin's best rest. If necessary, you should change your pillowcase
beforehand. In the days that follow between treatments, you can further improve
your treatment results with the special day care creams from DERMIDA® .
44 45
7. CLEANING AND MAINTENANCE.
• Disconnect the power supply before all cleaning and maintenance work.
The surfaces of the NeedlingPen MEDICAL CONTROL are not resistant to:
• strong acids
(e.g. hydrochloric acid ÿ 20%, sulfuric acid ÿ 50%, nitric acid ÿ 15%)
• oxidizing acids (e.g. peracetic acids)
• alkaline solutions
(ie caustic soda, ammonia and all compounds with pH > 7)
• aromatic/halogenated hydrocarbons (e.g. phenol, chloroform)
• Acetone and gasoline
46 47
8. TRANSPORT AND STORAGE CONDITIONS. 9. TRAINING.
ambient temperature -15°C to +25°C YOYU BRANDS GmbH rejects any liability for personal injury or damage to property
caused by unauthorized tampering with the device, missing or insufficient maintenance
Relative humidity 30% to 65%
and non-compliance with the regulations contained in this manual.
48 49
11. WARRANTY. 13.INSTRUCTIONS ON DISPOSAL OF THE DEVICE.
TWELVE MONTHS WARRANTY The NeedlingPen MEDICAL CONTROL that you have purchased requires the
use of special materials and substances in its manufacture. It may also contain
12
M O NA The device is guaranteed against defects in materials and assembly ex works for a period
TE
of twelve months. hazardous substances which, if improperly released into the environment, may have an
1 YEAR impact on the environment and human health.
GARA NTIE Not covered by the warranty are parts subject to wear and tear through normal use,
and parts that have failed due to misuse or poor maintenance.
In order to prevent the release of hazardous substances into the environment and to
promote the conservation of natural resources, the manufacturer must facilitate the
reuse, recovery and recycling of the materials contained in the device when the user
intends to discard the device. Public authorities take appropriate measures so that users,
distributors and manufacturers contribute to the collection of WEEE and oblige them to
reuse or recycle them. When disposing of the device, please note that special national
legal regulations apply:
1 2 . CONDITIONS NOT COVERED BY WARRANTY.
ATTENTION!
The device may malfunction or stop if it is not serviced regularly by YOYU GmbH or an authorized service
center. Please contact a service center approximately every 24 months after use and wear and tear of the
internal components.
50 51
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MAYKOSMETIK
Laurenzentorgasse 12
CH-5000 Aarau
+41 62 822 71 87
[email protected]