Amiea Med EXCEED User manual

INSTRUCTION FOR USE
EXCEED

Exceed
1
EN
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

2
ENExceed
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

Exceed
3
EN
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

4
ENExceed
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 )

Exceed
5
EN
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.

6
ENExceed
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

Exceed
7
EN
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.

8
ENExceed
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

Exceed
9
EN
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