Amiea Med EXCEED User manual

INSTRUCTION FOR USE
EXCEED

Exceed
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TABLE OF CONTENTS
1 GENERAL INFORMATION ................................................................................................ 3
1.1 Instruction for Use .....................................................................................................3
1.2 Warning symbols and statements used in this Instruction for Use..................3
1.3 Limitation of liability ...................................................................................................4
1.4 Technological advances............................................................................................4
2 PURPOSE – INDICATIONS FOR USE............................................................................ 4
2.1 Required qualifications (user requirements).........................................................4
2.2 Intended use – requirements for safe use............................................................5
3 DEVICE DESCRIPTION ..................................................................................................... 6
4 CONTRAINDICATIONS...................................................................................................... 9
4.1 Risks and benefits .....................................................................................................9
5 WARNINGS AND PRECAUTIONS ................................................................................10
5.1 Operating precautions............................................................................................10
5.2 Operating conditions .............................................................................................12
5.3 Clinical precautions................................................................................................ 12
5.4 To reduce the risk of sharps injury or electrical shock..................................... 13
6 UPON RECEIPT OF YOUR EXCEED MICRONEEDLING SYSTEM .......................14
6.1 Initial setup ...............................................................................................................14
6.2 Switching the device to OPERATING or STANDBY MODE........................ 17
6.3 Configure control unit (menu) .............................................................................. 18
6.4 Switching handpiece ON and OFF..................................................................... 19
6.5 Controlling the device with the footswitch ........................................................ 20
6.6 Changing the puncture frequency....................................................................... 20
7 SAFETY NEEDLE CARTRIDGE AND BARRIER SLEEVE........................................21
7.1 Safe use of the safety needle cartridge ............................................................. 21
7.2 Fitting the handpiece cover .................................................................................. 21
7.3 Attaching the safety needle cartridge to the handpiece................................. 22
7.4 Removing the safety needle cartridge and the barrier sleeve from the
handpiece................................................................................................................. 23
7.5 Setting the needle protrusion depth ................................................................... 25
8 TREATMENT INSTRUCTIONS .......................................................................................27

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Congratulations on your purchase of this medical device which, as with all our medical de-
vices, was produced by ISO 13485-certified manufacturing plants located in Germany.
Version 18 – dated 10. September 2018
9 CLEANING INSTRUCTIONS...........................................................................................28
9.1 Compatibility to chemicals.................................................................................... 31
10 CARE AND MAINTENANCE...........................................................................................31
10.1 General care and storage ..................................................................................... 31
10.2 Routine maintenance.............................................................................................. 32
11 PARTS AND ACCESSORIES ..........................................................................................32
12 TROUBLESHOOTING ......................................................................................................33
13 DISPOSAL...........................................................................................................................35
14 WARRANTY........................................................................................................................35
15 TECHNICAL SPECIFICATIONS .....................................................................................36
16 ELECTROMAGNETIC COMPATIBILITY.......................................................................37
16.1Warning notices ...................................................................................................... 37
16.2Accessories .............................................................................................................38
16.3Guidelines and manufacturer's declaration - electromagnetic interference38
16.4Guidelines and manufacturer's declaration - electromagnetic noise
immunity....................................................................................................................39
16.5Guidelines and manufacturer's declaration - electromagnetic noise immunity
– for the device (without life-sustaining function)............................................40
16.6Recommended safety distances between portable and mobile HF
telecommunications devices and the device (without life-sustaining
function).................................................................................................................... 41
17 CLINICAL SUMMARY......................................................................................................44
17.1 Clinical Performance testing.................................................................................44
17.2 Demographics: ........................................................................................................44
17.3 Measurement of effectiveness..............................................................................44
17.4 Measurement of safety........................................................................................... 45
17.5 Results – Safety – Physician reported outcomes............................................ 45
17.6 Results – Safety – Patient reported outcomes ................................................46
17.7 Results – Effectiveness – Physician reported outcomes ...............................48
18 DEFINITION OF SYMBOLS ............................................................................................49

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1 GENERAL INFORMATION
1.1 Instruction for Use
This Instruction for Use gives information about the safe use of the Exceed
microneedling device. The Instruction for Use must be read in full before
starting to use the device.
It must be read and adhered to by all people who use, maintain and inspect this device. This
Instruction for Use is part of the device and must be available to the user at all times. If the
device is passed on to a third party, the Instruction for Use must be included.
ERead this Instruction for Use carefully and in full.
EKeep this Instruction for Use in a place that it is accessible at all times to all people who use, clean,
disinfect, store or transport the device.
EIn the event that you pass the device on to others, ALWAYS include this Instruction for Use.
This Instruction for Use is limited to all information required for safe operation of the device.
Please read the following documents for further information required for safe operation of
the device and its accessories:
OSafety data sheets for disinfectants and cleaning agents
OProvisions on workplace safety and legal requirements for microneedling
Information and content is supported by a clinical trial evaluating the effectiveness of the
Exceed microneedling device on facial wrinkles. A summary of this clinical trial is found in
Section 17.
1.2 Warning symbols and statements used in this Instruction for Use
Warning symbols
DANGER indicates a hazardous situation which, if not
avoided, will result in death or serious injury
WARNING indicates a hazardous situation which, if
not avoided, could result in death or serious injury
CAUTION indicates a hazardous situation which, if
not avoided, could result in minor or moderate injury
SHARP HAZARD

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1.3 Limitation of liability
Do NOT use the Exceed microneedling device in any way that is not exactly as specified in
this Instructions for Use.
Use of Exceed other than exactly as specified in this Instructions for Use has not been tested
and the risk is unknown. This device may ONLY be operated by healthcare professionals and
ONLY for the purpose stated in this Instruction for Use. Contraindications must be observed
without exception. The user is obligated to adhere to the principles of cleanliness and hygi-
ene and ONLY to use sterile or disinfected working materials (see section 5. Warnings and
precautions as well as section 9. Cleaning instructions ). This explicitly includes single use of
safety needle cartridges. Discard needle cartridge immediately after use. Before use, inform
the patient of the possible risks (see section 4.1 Risk and benefits ).
1.4 Technological advances
The manufacturer reserves the right to make changes to the device due to technological
advances. This device may not be modified by the user.
Do NOT modify the Exceed microneedling device in any way as this can cause high risk of
bodily injury or death, e.g. electrical shock.
2 PURPOSE  INDICATIONS FOR USE
The Exceed is a microneedling device and accessories is intended for the treatment of wrink-
les in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines,
periorbital lines and cheek folds in adults aged 22 years or older.
Federal law restricts this device to sale by or on the order of a physician.
2.1 Required qualifications (user requirements)
The device may ONLY be used by healthcare professionals who have acquired the following
skills:
- Medical training
- Fundamental knowledge of microneedling treatment (see this IFU)
- Knowledge of hygiene and safety requirements (see section 5.
Warnings and precau-
tions )
- Knowledge of risks and side effects (see section 4.
Contraindications )

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2.2 Intended use – requirements for safe use
Treatment must be administered in a dry, clean and smoke-free environment and under hygi-
enic conditions. The device must be used and maintained as set out in this Instruction for Use.
The applicable provisions relating to workplace design must be observed and the materials
used must be sterile. Intended use also implies that this Instruction for Use, and in particular
section 5. Warnings and Precautions , has been read in full and understood. Intended use
applies exclusively to the following patient groups: Adult men and women aged 22 years or
older who are in good health with Fitzpatrick skin types I, II and/or III. Improper use is when
the device or its accessories are used for purposes other than those described in this Instruc-
tion for Use or if the operating conditions are not adhered to. Do not add to the skin during
the procedure any products except those listed in the treatment instructions ( section 8 ).
Treatments of contraindications are expressly prohibited (see section 4. Contraindications ).
The device is designed to be placed on a flat surface. During the treatment, the handpiece is
held by the operator and is used on a patient who is ideally sitting or lying. The user operates
the device from a distance of maximum 70cm.

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3 DEVICE DESCRIPTION
US
2* 3a 3b
6*
47
1
5*
The Exceed microneedling device is intended to create many, very tiny, microscopic punctures
in the epidermal and dermal layers of the skin using sterile stainless steel needles.
The Exceed microneedling device consists of 7 component parts:
ARTICLE DESCRIPTION ARTICLE NUMBER
1Control unit MAD61MP
2* Safety needle cartridges
6-needle plate EMNPAED06USMP
3Handpiece (applied part: type B)
with Handpiece Cable
3a: CME21USMP
3b: 5E-G770
4Handpiece holder GAD60
5* Barrier sleeves 100L
6* Footswitch E100201USMP
7Power supply (with country adapter) E116503
*not included in the scope supply of delivery

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The control unit switches the device ON and OFF and contains the power source (5.5-12V,
DC (150mA). The control unit adjusts the frequency of the needle stroke from 100-150Hz
using a digital display and a keypad. The control unit receives power via a coaxial
connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output
of 15V. The handpiece contains a motor that moves the needles and a needle protrusion gau-
ge that allows the user to control the depth of the needle incision from 0 - 1.5 mm.
The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneed-
les of 1.5 mm length (0.35 mm gauge) and an internal rubber seal.
The needle penetration is adjusted by the needle protrusion setting dial, which can be adjus-
ted between 0.0 (min.) and 1.9 mm (max.).
When using the standard safety needle cartridge do NOT use a needle protrusion setting
>1.5 mm. Using a needle protrusion setting of >1.5 mm will NOT result in greater needle
penetration because the needle penetration is limited to 1.5 mm by constructional design of
the safety needle cartridge
For needle protrusion setting see section 7.5 - Setting the needle protrusion depth .
The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is
sterile and for single use ONLY. Discard each and every safety needle cartridge immediately
after use.

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789
3 4 5
1
6
2
CONTROL UNIT: KEYS AND CONNECTIONS
1Display
2Standby-LED
3Standby / On key
4Left key
5Right key
6SET key
7Socket for power supply
8Socket for handpiece
9Socket for footswitch

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4 CONTRAINDICATIONS
The use of the Exceed microneedling device is contraindicated in the following cases:
OHemophilia or other blood clotting disorders
OUnregulated diabetes
OPregnancy and nursing mothers
OSystemic infection or acute local skin infections (as Hepatitis disorders type A, B, C, D, E,
F or HIV infection)
OPatients taking high doses of anti-coagulants or blood-thinning substances, e.g. aspirin,
warfarin, heparin, acetylsalicylic acid
OPatients with any forms of active acne in the treatment area or patients currently taking
acne medication with the ingredient isotretinoin (such as Accutane™)
OPatients on courses of high dose of chemotherapy, radiotherapy, or high-dosage corticos-
teroid therapy
OPatients who have an allergy to topical anesthetics (local anesthetic)
OPatients who have an allergy to stainless steel
OPatients who have an allergy to ingredients of SupraGelTM which consists of Calcium chlo-
ride, Propylene glycol, Deionized water, Sodium Hydroxide, Sucrose, Pectin and Cellulose
gum (Blanose)
OPatients who are suffering from eczemas, exanthema or open wounds in the treatment
area
OPatients who have undergone plastic surgery of the face including dermal fillers within the
last 12 months or have any facial surgical scars < 12 months old
OPatients who have undergone Botox or other neuromodulator injections in the face within
the last 3 months
OPatients with scars < 6 months old in the treatment area
ODo not use for the treatment of mucous membranes
ODo not use to treat inside the orbital rim
ODo not use for treatment of areas of skin with dermatosis, e.g. skin tumors, keloids or in
case of predisposition to keloids, solar keratosis, warts, or birthmarks
4.1 Risks and benefits
4.1.1 Risks
The following side effects have been associated with microneedling:
OLocalized bleeding in the treatment area stopping within 5 -10 minutes
OPain during treatment. In a clinical study using the Exceed microneedling device, subjects
reported that they experienced moderate to moderate-severe pain
OPain and discomfort on the first day after treatment

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ONon-persistent inflammatory response, erythema and edema in the first one to six days
after treatment
OSkin irritation (e.g. itching or warming), which normally abates within 8 days
OTemporary flaking or peeling of the skin, which clears after 8 days
In addition to the common non-serious side effects, the following side effects have been
reported:
OFormation of blisters caused by the herpes simplex virus type 1 (HSV-I). This occurs in
approximately 62% of subjects who are predisposed to herpes simplex labialis (HSL).
Prophylactic anti-viral is recommended for patients with a history of HSL
OFormation of small pustules or milia within the first days after treatment
OHyperpigmentation with endogenous pigments, in particular on darker skin types, but
which generally disappear completely after a few weeks. Note: This device has not been
studied in patients with FST IV-VI
OPersistent inflammatory response, hematoma, erythema and edema lasting longer than
five days
ORetinoid reaction (slight reddening to skin peeling)
Protect freshly treated skin areas against UV-radiation and sunlight
4.1.2 Benefits
In a study of 48 patients with the Exceed microneedling device, 4 treatments of the face
spaced four weeks apart showed a significant improvement (≥ 1 grade change) in wrinkles,
150 days after commencing the treatment in the following facial areas:
- Glabellar frown Lines
- Periorbital lines
- Cheek Folds
5 WARNINGS AND PRECAUTIONS
5.1 Operating precautions
EThe Exceed microneedling device must ONLY be used by healthcare professionals with
proper medical training.
EONLY carry out treatments in a room suitable for medical treatments. Keep your workpla-
ce hygienically clean and ensure that there is adequate lighting.
EONLY use the Exceed microneedling device with authorized accessories. Using the
Exceed with unauthorized accessories may lead to harm to the operator and patient.
EBefore use, with the device switched OFF: Check the Exceed handpiece, safety needle
cartridge and power supply for signs of physical damage.

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EBefore and after each use: Clean the Exceed device according to cleaning instructions
(see section 9. Cleaning instructions ).
EALWAYS use the Exceed microneedling device with the appropriate handpiece covers.
EALWAYS use disposable gloves made of nitrile or latex and disinfect them before use.
EALWAYS switch OFF the device before attempting to clean or inspect any part of the
device.
EDo NOT use the Exceed handpiece, safety needle cartridges or power supply if there are
any visible signs of damage. Use of a damaged handpiece, safety needle cartridge or any
other component may lead to harm to the operator and patient. Contact your local distribu-
tor. For more information, please refer to section 10.2 Routine maintenance.
EWhen the handpiece is switched OFF, all needles of the safety needle cartridge must be
fully retracted into the cartridge. If all needles are NOT fully retracted, the safety needle
cartridge is faulty and must be immediately replaced. Take care when handling a faulty
safety needle cartridge as there is a greater risk of a sharps injury.
EDo NOT use a safety needle cartridge if its sterile bag is damaged or ripped or the use-by
date has been exceeded. Safety needle cartridges may ONLY be used in a sterile state.
The sterility of the safety needle cartridges is ONLY guaranteed if the packaging is unda-
maged. Safety needle cartridges are sterile single-use products (consumables), and must
ONLY be used once on a single patient. Discard needle cartridge immediately after use.
EDo NOT use the needle cartridge on more than one patient. Improper use of needle car-
tridge has a high risk of inadvertent transmission of bloodborne pathogens between pati-
ents. Discard the safety needle immediately after use.
EDo NOT dispose of safety needle cartridges in general domestic garbage. ALWAYS dis-
pose of safety needle cartridges in a suitable sharps container. Follow local guidelines for
disposal of sharps containers.
EDo NOT use a handpiece, that is contaminated, e.g. with bodily fluids or other substances.
Use of a handpiece contaminated with bodily fluids is not permitted due to the risk of
cross-contamination. Follow cleaning instructions (see section 9. Cleaning instructions ).
EDo NOT use the device in oxygen-enriched environments and near flammable materials.
The device is not tested for such conditions and the risk of fire may exist.
EDo NOT place the handpiece directly onto an unsterile surface. Use the handpiece holder
provided.
ENEVER modify the device, the safety needle cartridges or other accessories. A modifica-
tion may lead to an electrical shock or a needle stick injury with a contaminated needle.
EPosition the device to ensure that the recommended safe distance from possible sources
of electrical interference is maintained. You can find notes on the recommended safe
distances in section 16. Electromagnetic compatibility. Prevent sources of interference by
avoiding the use of portable or mobile wireless devices near the device.
EWhen not using the device, disconnect the power supply from the plug socket, so that it
is disconnected from the electricity supply system. Place the handpiece on the handpiece
holder to ensure that it cannot roll away and fall to the ground.
ENote the technical data specified in this Instruction for Use and ensure that the conditions
for operation and storage are met (see section 15. Technical specifications and section10.
Care and maintenance ).

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EAs part of the maintenance of the device, a regular inspection (biennial service) is required
at intervals of 24 months. For this inspection please contact your local distributor. For more
information, please refer to section 10.2 Routine maintenance .
5.2 Operating conditions
Ambient temperature +59° to + 77°F
Relative humidity 30 to 75%
Air pressure 700 to 1070hPa
5.3 Clinical precautions
EBefore commencing a treatment, complete a full review of the patient's medical history
and previous aesthetic treatments.
EFor patients with a history of herpes simplex infection (cold sores or fever blisters) ensure
the patient has prophylactic anti-viral therapy.
ETake care when treating clients with a history of post inflammatory hyperpigmentation
(PIH) (darkening of the skin). Clients with a history of PIH are more likely to pigment after
microneedling. Note: this device has not been studied in patients with FST IV-VI.
EBefore use, the patient's skin must be treated with a mild cleaning agent and disinfec-
tant. When selecting the appropriate disinfectant, follow the applicable guidelines in your
country.
EDo not add to the skin during the procedure any products except those listed in the treat-
ment instructions (section 8 ).
EProtect freshly treated skin areas against physically stress, contamination, UV radiation
and sunlight.
ETo ensure that the required intensity of treatment is not exceeded: Avoid the risk of injury
from excessive needle protrusion (see section 7.5. Setting the needle protrusion depth ).
Avoid the risk of injury from an excessive puncture frequency (see section 6.6. Changing
the puncture frequency ).
EEnsure that the safety needle cartridges do NOT come into contact with contaminated
objects such as clothing or worktop. You must dispose of contaminated safety needle
cartridges immediately after use in the appropriate biohazard container (see section 7.4
Removing the safety needle cartridge from the handpiece).
EThe needles of the safety needle cartridges are made of stainless steel (1.4310, X10Cr-
Ni18-8, AISI 301).). The needle cartridge housing is made of polycarbonate (PC).
ENote the batch number of the safety needle cartridges used in the relevant patient record
so that you can inform the manufacturer in the event that problems arise.

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5.4 To reduce the risk of sharps injury or electrical shock
The Exceed microneedling device is an electrical device, which under certain circumstances
could present an electrical shock hazard to the user. Please read this Instruction for Use tho-
roughly and follow directions stated to assure maximum safety during operation.
ENEVER connect the Exceed microneedling device to an electrical outlet that does not
contain a reliable protective earth/ground system or voltage.
ENEVER use the Exceed microneedling device where it can fall or be pulled into water.
ENEVER use the Exceed microneedling device if you think it has been immersed in water
or if you have spilt liquids on it.
ENEVER remove any covers of the Exceed handpiece or power supply. Opening or re-
moving covers may expose you to dangerous voltage or other risks. Incorrect reassembly
could cause an electric shock when the Exceed microneedling device is used again. There
are no self-service-able parts on the Exceed microneedling device.
ENEVER attempt to repair the Exceed microneedling device. ONLY approved technicians
can carry out repairs or servicing of the Exceed microneedling device.
EDo NOT modify the Exceed microneedling device in any way. Modifying the Exceed
microneedling device in any way will void the manufacturer’s warranty and could endanger
the user and/or patient.
The Exceed microneedling device comes with safety needle cartridges as accessories, which
under certain circumstances pose the risk of a sharps injury. Injuries from contaminated
needles in safety needle cartridges may lead to the transmission of diseases. Please read
this Instruction for Use thoroughly and follow directions stated to assure maximum safety
during operation.
EDo NOT attempt to attach or remove the safety needle cartridge to or from the handpiece
while the device is ON. The safety needle cartridges may ONLY be attached and removed
when the handpiece is switched OFF. Failure to follow this precaution may lead to a sharps
injury.
EDo NOT touch the needles and tip of the cartridge at any time. Contact with the needles
may lead to a sharps injury or contamination.
EUse ONLY original safety needle cartridges for the device that fit your handpiece.
ENEVER depress the needle plunger so that the needles are exposed outside of the needle
cartridge.
EALWAYS dispose of a used or contaminated safety needle cartridges in a suitable sharps
container immediately after use. Follow local guidelines for disposal of sharps containers.
EOpen the sterile needle cartridge packaging at the PEEL mark .
EDo NOT place the handpiece directly onto a worktop. Use the handpiece holder provided.
EBefore switching on the handpiece motor, ALWAYS hold the handpiece firmly or place it
on the handpiece holder.

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ENeedle Cartridge for Single Use Only! – Discard Needle Cartridge Immediately After Use!
6 UPON RECEIPT OF YOUR EXCEED MICRONEEDLING
SYSTEM
Damage caused by condensation
If the device is exposed to high differences in temperature (e.g. during shipment) condensati-
on may form on the inside and cause damage to electronic components which under certain
circumstances could present an electrical shock hazard to the user.
EAfter unpacking and before first time use, make sure that the device has reached ambient
temperature.
EUse the device ONLY at an ambient temperature of +59°F to +77°F and at a relative
humidity of 30% to 75%.
Damage to the product from dropping
Dropping the control unit or handpiece can damage them.
EALWAYS place the control unit on its rubber feet on a flat, stable surface so that it cannot
fall off.
EAfter each use, place the handpiece on the handpiece holder in order to secure it.
EIf you do drop the control unit or handpiece, carry out a visual inspection of the compo-
nents.
EIf the components show visible signs of damage or are not working properly, contact your
local distributor.
6.1 Initial setup
Risk of short circuit and electric shock
In the event of visible damage to cables or cable connections, there is a risk of electric shock
and damage to electronic components. Do not connect or use damaged cable. If cables are
damaged contact your local distributor.
Trip hazard from cables
If cables are not laid properly, people can trip and injure themselves.

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Limited functionality due to electromagnetic interference
The emission of electromagnetic radiation from portable and mobile RF communication de-
vices such as mobile phones or wireless routers may impair the functionality of the device.
Safe operation of the device can then no longer be guaranteed.
EUnpack the system from its outer shipping container.
EOpen the inner Exceed microneedling device box and check off all of the parts listed in
the device description.
EContact your distributor immediately if you observe missing parts or accessories.
ECarry out a visual inspection of the equipment.
EDo NOT use the device if you observe visible signs of damage.
EThe device is designed to be used on a solid level surface (such as a table top).
EPosition the device to ensure that the recommended safe distance from possible sources
of interference is maintained. You can find notes on the recommended safe distances in
section 16. Electromagnetic compatibility . Prevent sources of interference by avoiding the
use of portable or mobile wireless devices near the device. Inform your patients that they
have to keep their mobile devices away from the treatment area.
EPlace the control unit on a clean, stable and level surface. Do NOT position or operate the
device on or under any other equipment.
ELay all cables so that nobody can trip over them. NOT allow the cables to be kinked.
EPosition the control unit so that the power supply is accessible at all times.
6.1.1 Connecting the power supply
If the right adapter for your country is not included in delivery, please contact your local dis-
tributor.
To remove the current country-specific adapter if required:
EPull and hold back the bracket for the adapter and lift the country-specific adapter out of
the recess in the power supply.
To insert the required country-specific adapter:
EInsert the country-specific adapter into the recess in the power supply unit as shown
below.
EPress the adapter firmly against the bracket until you hear it clicking into place.

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To connect the power supply:
EPlug the power supply unit's DC plug into the socket for the power supply on the back of
the control unit.
EPlug the power supply into a suitably grounded wall socket (100-250V). The standby LED
turns blue.
EThe power supply MUST be accessible at all times.
6.1.2 Connecting the footswitch (optional)
EPlug the jack for the footswitch into the socket for the footswitch on the back of the con-
trol unit.
EPlease, be aware that at first delivery the default footswitch mode is CONTINUAL (see
section 6.3.2 Select footswitch mode ).

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6.1.3 Connecting the handpiece
In case no handpiece is connected to the control unit, the following message appears on the
display:
E
Plug in to start
Handpiece
detached!
Connect the connection cable jack included to the connector on the device's handpiece.
EPlug the connection cable's FireWire jack into the output socket on the control unit. The
handpiece is detected by the control unit and the puncture rate appears on the display. If
the connected handpiece is not detected, please read section 12. Troubleshooting .
6.2 Switching the device to OPERATING or STANDBY MODE
OPERATING MODE
EEnsure that the power supply is connected (see section 6.1.1
Connecting the power sup-
ply ).
EPress the Standby/On key .
EThe standby LED turns off. The start screen appears on the display. "WARNING Needle
Cartridge for Single Use Only! – Discard Needle Cartridge Immediately After Use!"
accompanied by an audible beep.
Press the "Set Key" to acknowledge the Warning prompt .
Note: The device will not operate until the user accepts the Warning notice by pressing
the set key .
If a handpiece is connected, the default puncture frequency of 120 punctures per second
appears. If an error message is displayed, please read section 12. Troubleshooting .

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STANDBY MODE
EPress the Standby/On key .
The display turns off and the standby LED turns blue.
6.3 Configure control unit (menu)
After 1 minute without input, the menu closes automatically.
To access the menu:
EPress the left and right keys on the control unit simultaneously.
The KEY TONES menu item appears on the display.
To switch between the three menu items:
EPress the right key to navigate forward to the next menu item.
EPress the left key to navigate back to the previous menu item.
To exit the menu:
ENavigate to the EXIT menu item
EPress the SET key .
Alternatively:
EPress the Standby/On key .
Alternatively:
EPress the two left and right keys simultaneously.
Alternatively:
EWait 1 minute. The menu closes by itself.
6.3.1 Switching key tones ON or OFF
You can switch the tones played when keys are pressed ON or OFF.
ENavigate to the KEY TONES menu item.

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EPress the SET key to change the setting for the key tones (ON or OFF).
6.3.2 Select footswitch mode
You can choose between two modes for the operation of the footswitch:
OON/OFF MODE allows the operator to use the footswitch as an ON/OFF switch.
OCONTINUAL MODE allows the operator to use the footswitch as a pressure switch.
ENavigate to the FOOTSWITCH menu item.
EPress the SET to change the setting for footswitch mode.
6.4 Switching handpiece ON and OFF
Risk of injury when operating the handpiece
Do NOT switch on the device unless you are holding the handpiece or the handpiece is pla-
ced on the handpiece holder. Failure to observe this action can result in injury or piercing of
the skin.
To switch the handpiece ON:
EEnsure that the power supply is connected (see section 6.1.1).
EEnsure that the control unit is switched to OPERATING MODE (see section 6.2).
EEnsure that the handpiece is properly connected (see section 6.1.3).
EEnsure that you have accepted the “WARNING Needle Cartridge for Single Use Only! –
Discard Needle Cartridge Immediately After Use!”
EPress the SET key on the control unit.
While the handpiece is running, the display on the control unit shows a rotating symbol. If
the connected handpiece will not start, please read the section 12. Troubleshooting.