equipmed Dermapenworld Dermapen HOME User manual

TM
User Manual

TABLE OF CONTENTS
I - General Information ....................................................................................... 4
II - Intellectual Property ..................................................................................... 4
III - Disclaimer ........................................................................................................ 4
IV - Contact Details ............................................................................................. 4
1 - Warning Symbols Used in this User Manual ......................................... 5
1.1 - Other Symbols Used in this User Manual and Accessories ........... 5
2 - Limitations of Liability .................................................................................. 6
3 - Indications of Use ........................................................................................... 6
3.1 - Usage Environment ..................................................................................... 6
4 - Device Description ........................................................................................ 7
5 - Contraindications ........................................................................................... 8
6 - Warnings and Precautions ........................................................................ 10
6.1 - Warning and Precautions: Batteries ................................................... 10
6.2 - Medical Precautions .................................................................................. 11
6.3 - Warnings: Electrical Shock ................................................................... 12
6.4 - Warnings: Use of the Needle Cartridge ........................................... 12
7 - Installation and Setup Instructions ........................................................ 13
7.1 - Initial Setup ................................................................................................... 13
7.2 - Dermapen HOMETM Turbo-Cut Battery .............................................. 13
7.3 - Installing the Turbo-Cut Battery .......................................................... 13
7.4 - Charging the Turbo-Cut Battery ......................................................... 14
8 - Getting Started ............................................................................................. 14
8.1 - App System Requirements .................................................................... 14
8.2 - Controls and Status Icons ..................................................................... 15

TABLE OF CONTENTS (CONTINUED)
8.3 - Powering On the Device ........................................................................ 16
8.4 - Status LED and Audible Tones ............................................................ 16
8.5 - Installing and Downloading the Dermapen HOMETM App ......... 16
8.6 - Creating an Account ............................................................................... 17
8.7 - Registration of Dermapen HOMETM Account .................................. 17
8.8 - To Sync and Update Dermapen HOMETM ......................................... 18
8.9 - During Bluetooth Syncing/Updating ................................................ 18
9 - Fitting the Needle Cartridge ................................................................... 19
9.1 - Adjusting Puncture Frequency (Speed) ........................................... 21
9.2 - Adjusting Needle Depth ........................................................................ 22
9.3 - Carrying Out a Treatment .................................................................... 23
10 - Caring for Your Device ............................................................................ 25
10.1 - Cleaning Procedure for Dermapen HOMETM .................................. 25
11 - Troubleshooting: Dermapen HOMETM Device ................................... 26
12 - Specifications .............................................................................................. 28
13 - Electromagnetic Compatibility ............................................................ 29
13.1 - Electromagnetic Compatibility Guidelines .................................... 30
13.1.1 - Electromagnetic Emissions ................................................................ 31
13.1.2 - Electromagnetic Immunity ............................................................... 32
14 - Warranty Information ............................................................................... 33
15 - Disposal ......................................................................................................... 33
16 - Clinical Summary ....................................................................................... 34
16.1 - Clinical Summary: Results .................................................................... 38
16.2 - Clinical Summary: Measurement of Eectiveness ..................... 39

4Dermapen HOMETM User Manual
I - GENERAL INFORMATION
This Instruction Manual gives information about the safe use of
the Dermapen HOMETM microneedling device.
It is the responsibility of the user to carefully read all
information presented in this manual before starting to use
Dermapen HOMETM. This includes warranty information.
It is always the responsibility of the user to adhere to the
instructions in this manual.
It is the responsibility of the user/purchaser to be aware of local
laws and regional restrictions for microneedling.
Read this user manual carefully and in full.
Keep this Instruction for Use in a place that it is always accessible.
II - INTELLECTUAL PROPERTY
Dermapen HOMETM is a trademark of Equipmed USA LLC.
4695 MacArthur Court, Suite 1100, Newport Beach, CA 92660
III - DISCLAIMER
Equipmed USA LLC or its representatives hold no responsibility
for treatment outcomes as individual results may vary. The
DermapenHOMETM device or protocols are not designed to cure
diseases. The Dermapen HOMETM is to be used as directed.
IV - CONTACT DETAILS
Manufacturer Equipmed USA LLC
4695 MacArthur Court
Newport Beach CA 92660
Phone [phone]
Email [e-mail]
Website www.EquipmedUSA.com

5Dermapen HOMETM User Manual
1 - WARNING SYMBOLS USED IN THIS USER MANUAL
1.1 - OTHER SYMBOLS USED IN THIS USER MANUAL
ANDACCESSORIES
Indicates a hazardous situation which, if not avoided,
could result in injury, death or serious injury.
Sharp hazard.
Read the user manual before use.
Device capacity for Bluetooth Connectivity, Battery (DC)
Operation or Mains Power (AC) Operation.
Dermapen HOMETM App is downloadable on the Apple
App Store. Search for Dermapen HOME.
Set up and Syncing of Dermapen HOMETM is completed
via Bluetooth Connectivity.
Speed Dial as seen on the LCD Screen.
(Refer to section 9.1, page 21.)
Product may not be thrown into the household waste.
Dispose properly as electronic waste.
Date of manufacture.
Manufactured by.
Lot / batch code.
Use by / expiry date.
Do NOT reuse.
Do NOT resterilise.
Sterilised by Ethylene Oxide.
Humidity range (lower and upper range) for safe storage.
Temperature range (lower and upper range) for
safe storage.
Keep dry.
%
40
°
°

6Dermapen HOMETM User Manual
2 - LIMITATIONS OF LIABILITY
Do NOT use the Dermapen HOMETM microneedling device in any
way that is not as exactly specified in this Instructions for Use
user manual.
Use of Dermapen HOMETM in any other way or for any other
indication other than those specified in this Instructions for Use has
not been tested and the risk is unknown.
This device may ONLY be operated for the purpose stated in this
user manual.
Contraindications must be observed without exception. The user is
obligated to adhere to the principles of cleanliness and hygiene
(refer to section 6, page 9, and section 10.1, page 25).
It is the responsibility of the user/purchaser to be aware of local
laws and regional restrictions for microneedling.
3 - INDICATIONS OF USE
Dermapen HOMETM is a microneedling device and accessory
intended to be used as a treatment to improve the appearance of
wrinkles in adults aged 22 to 65 years.
3.1 - USAGE ENVIRONMENT
Dermapen HOMETM is suitable for use in the following environments:
• Domestic (home) environments for personal use by lay users
to perform the treatment on themselves.
• Not intended for commercial or clinical use on patients.
• Treatment must be performed in a dry, clean and smoke-free
environment and under hygienic conditions. The device must
be used and maintained as set out in this user manual.

7Dermapen HOMETM User Manual
4 - DEVICE DESCRIPTION
The Dermapen HOMETM system consists of the following components:
• Dermapen HOMETM Device
• Dermapen HOMETM Needle Cartridge
• Dermapen HOMETM Battery Charger
• Dermapen HOMETM Power Charging USB cable
• Dermapen HOMETM Batteries x2
The Handpiece contains a drive train, a digital display to relay
information to the operator, an ON/OFF button to power the device
on and o and two separate toggle buttons to adjust frequency
(speed) and needle depth.
The Handpiece receives its power via removable lithium ion battery
(3.7 VDC).
The drive train encompasses a DC motor, eccentric cam and
rotational to linear drive converter to oscillate the Needle Cartridge.
The digital display shows battery status, cartridge status, sync/
update notifications and Bluetooth connectivity. The display also
contains a digital dial to convey frequency or motor speed and a
3-figure display showing current needle depth.
The frequency of oscillation (speed) can be set from 80-110Hz
(+/-10 Hz) and the needle depth from 0.2mm to 0.5mm.
The Needle Cartridge is a sterile, single-use consumable designed to
create micro incisions in the epidermis and dermis. Each cartridge
contains 16, 1.5mm, 33-gauge surgical grade stainless steel needles,
arranged in a circular pattern. Each Needle Cartridge employs a
bayonet feature to securely connect it to the Handpiece during
operation. Internal and external seals assist in the prevention of cross
contamination, while a safety cap helps avoid needle stick injury.
Each Needle Cartridge contains an RFID tag encoded with a unique
ID and a needle depth correction factor. This information is read
from the cartridge when it is first inserted into the Handpiece and
prevents reuse of the cartridge once the cartridge is removed from
the Handpiece.
The battery charger is capable of charging 1x 14500 Lithium cell.
The system batteries can only be charged when removed from the
Handpiece and inserted into the battery charger.
The equipment is not used to make measurements of any sort, or to
draw any conclusions regarding the indication to treat.
The Dermapen HOMETM is intended to be used by lay users.

8Dermapen HOMETM User Manual
5 - CONTRAINDICATIONS
You should not use the Dermapen HOMETM device in the
following cases:
• You suer from Hemophilia or other blood clotting disorders.
• You take high doses of anti-coagulants or blood-thinning
substances; e.g., aspirin, warfarin, heparin, acetylsalicylic acid.
• You have unregulated diabetes.
• You suer from systemic infections or acute local skin
infections (such as Hepatitis disorders type A, B, C, D, E, F or
Human Immuno deficiency virus (HIV) infection).
• You suer from any forms of active acne in the treatment area
or are currently taking acne medication with the ingredient
isotretinoin (such as AccutaneTM).
• You are on courses of high dose of chemotherapy,
radiotherapy, or high-dosage corticosteroid therapy.
• You have an allergy to topical (local) anesthetics.
• You have an allergy to stainless steel.
• You are suering from eczema, skin rashes or have open
wounds/broken skin in the treatment area.
• You have undergone plastic surgery of the face or dermal fillers
within the last 12 months or have any facial surgical scars less
than 12months old.
• You have undergone Botox or other neuromodulator injections
in the face within the last 3 months.
• You are under the age of 22 or over the age of 65.
• Do not use to treat the delicate skin around the eye (inside the
orbital rim).
• Do not use for the treatment of skin inside the mouth or
nostrils (mucous membranes).
• Do not use if you are suering from any of the following
in the treatment area; skin cancers, keloids or in case of
predisposition to keloids, solar keratosis, warts, or birthmarks.

9Dermapen HOMETM User Manual
6 - WARNINGS AND PRECAUTIONS
Dermapen HOMETM is intended for personal use only and NOT
intended to be used to deliver treatment to patients in a commercial
setting. Keep out of reach of children; some small parts may pose a
choking hazard.
Do not use Dermapen HOMETM with Topical Local Anaesthetic (TLA)
if you are pregnant or nursing.
NOT to be used by people under the age of 22 or over 65.
As the clinical supporting documentation for Dermapen HOMETM was
based on patients between the ages of 22 to 65, it is reccomended
to seek medical before utilising this device if outside this age range.
Dermapen HOMETM must ONLY be used with the authorised
accessories. Using Dermapen HOMETM with unauthorised accessories
will void any warranty and may lead to harm.
Dermapen HOMETM is not intended to be used with topical products
such as cosmetics, drugs, or biologics.
Before use, with the device switched OFF, check the handpiece
and needle cartridge. Do NOT use the handpiece and/or needle
cartridges if there are any visible signs of damage.
ALWAYS switch OFF the device before attempting to clean or
inspect any part of the device.
Before and after each use, clean the Dermapen HOMETM device
according to cleaning instructions (refer to section 10.1, page 25).
NEVER share Dermapen HOMETM with others. This may result in
infection or transmission of diseases.
Take care when handling needle cartridges as there is a risk of a
sharps injury. When the handpiece is switched OFF, all needles of
the needle cartridge should be fully retracted into the cartridge. If
all needles are NOT fully retracted, the needle cartridge is faulty and
must be immediately replaced. Take care when handling a faulty
needle cartridge as there is a greater risk of a sharps injury.

10Dermapen HOMETM User Manual
6 - WARNINGS AND PRECAUTIONS (CONTINUED)
Do NOT use a needle cartridge if its sterile bag is damaged or
ripped or the use by date has been exceeded. Needle cartridges are
sterile single-use products (consumables) and must ONLY be used
once. Discard needle cartridge immediately after use.
Do NOT use the needle cartridge more than once. Repeated use of
the needle cartridge may result in infection or injury. Discard the
needle immediately after use in household waste.
Do NOT use a device, that is contaminated; e.g., with bodily fluids
or other substances. Use of a device contaminated with bodily fluids
is not permitted due to the risk of cross-contamination. Follow
cleaning instructions (refer to section 10.1, page 25).
NEVER modify the device, the needle cartridges or other
accessories. A modification may lead to an electrical shock or a
needle stick injury with a contaminated needle.
Position the device to ensure that the recommended safe distance
from possible sources of electrical interference is maintained.
Prevent sources of interference by avoiding the use of other
portable or mobile wireless devices near the device (section 13).
When not using the device, store it in a clean, dry environment.
Do not place on an unsterile surface.
Read the technical data specified in this user manual and ensure
that the conditions for operation and storage are met.
Use only the Dermapen HOMETM Needle Cartridges [DP4-NDL-ASH-5]
supplied with this product. The device is not compatible with
other cartridges. The cartridge product code is prominent on the
packaging. Use of non-approved accessories may damage the
device, cause risk to the user and will void your warranty.
6.1 - WARNING AND PRECAUTIONS: BATTERIES
Use only the Battery [DP4-BTR], Battery Charger [DP4-CHG] supplied
with this product.
Incorrect installation of the Battery in Dermapen HOMETM or Battery
Charger is hazardous and may result in fire, personal injury and
damage to property. Always carefully check the polarity before
installing or using batteries.
Do NOT dispose of the Dermapen HOMETM batteries in household
waste. Follow local guidelines for correct disposal.