DERMAPEN 4 User manual

User Manual
TM

SUBJECTS COVERING
1............................................................................................................... INTRODUCTION
1.1................................................................................................................ Purpose of Use
1.2....................................................................................................User Acknowledgment
1.3.......................................................................................................Usage Environments
1.4....................................................................................................Additional Information
2....................................................................................................DERMAPEN 4™ SYSTEM
2.1 ........................................................................................Dermapen 4™ Kit Components
2.2 .................................................................................................. Dermapen 4™ Features
2.3 ....................................................................................................Dermapen 4™ Buttons
2.4........................................................................................................LCD Display Layout
2.5 ............................................................................. AC/DC Adaptor and Battery Charger
3..........................................................................INSTALLATION & SETUP INSTRUCTIONS
3.1 ............................................................................................................Before You Begin
3.2 ..............................................................................................................Getting Started
3.3 .......................................................................................Powering on the Dermapen 4™
3.4........................................................................................Status LED and Audible Tones
3.5 .............................................................................................App System Requirements
3.5.1 ................................................Installing and Downloading the DermapenWorld™ App
3.5.2 ......................... Clinic Registration - location on DermapenWorld™ FREE Clinic Finder
3.5.3 .......................................................................................... Dermapen 4™ Registration
4...........................................................................................OPERATING INSTRUCTIONS
4.1...................................................................Syncing the Dermapen 4™ - Why Important?
4.2.................................................... Pairing and Updating the Dermapen 4™ via Bluetooth
4.3...................................................................................................................Demo Mode
4.4............................................................................................. Scar Treatment (ST) Mode
4.5...................................................................................... Powering o the Dermapen 4™
5................................................................................................. INSTRUCTIONS FOR USE
5.1 ...........................................................................................Installing a Needle Cartridge
5.2 .................................................................................................Adjusting Needle Speed
5.3 ....................................................Approved Depth Ranges & Depth Under Speed Guide
5.4.................................................................................................Adjusting Needle Depth
5.5 .........................................................................Potential Depth Ranges by Skin Region
6...................................................................................................ORDER OF TREATMENT
7................................................................................................. COMPATIBLE PRODUCTS
7.1 ............................................................................... Protocol Product Recommendations
7.2 ..........................................................Products to be avoided when using Dermapen 4™

8..................................................................................CARING FOR YOUR DERMAPEN 4™
8.1 .............................................................................................. Cleaning and Maintenance
8.2 ......................................................................................................................... Storage
9........................................................................................................TROUBLESHOOTING
9.1 ........................................................................................Dermapen 4™ Troubleshooting
9.2 ........................................................................................................Entering Test Mode
9.3 .......................................................DermapenWorld™ Companion App Troubleshooting
10 ....................................................................................WARNINGS & CONSIDERATIONS
10.1............................................................................................. Possible Contraindications
10.2.......................................................................... Possible Side-Eects of Microneedling
10.3................................................................................................. Possible Complications
10.4...................................................................................................... Sterile Environment
10.5..........................................................................................................Before Treatment
10.6..........................................................................................................During Treatment
10.7............................................................................................................Electrical Safety
10.8........................................................................................................................Disposal
11 .............................................................................................................SPECIFICATIONS
11.1........................................................................................... Dermapen 4™ Specifications
11.2............................................................................Acceptable Environmental Conditions
12............................................................................................ WARRANTY INFORMATION
13.................................................................................................................. STATEMENTS
14 .......................................................(inside back cover)........OTHER LANGUAGES MENU

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1 - INTRODUCTION
1.1 - Purpose of Use
Dermapen 4™ is an Digital Automated MicroNeedling system that creates fractional puncture
channels into the skin. The eect promotes natural collagen and elastin production, whilst
preserving epidermal integrity.
Dermapen 4™ may assist with the infusion of active ingredients, skin tightening, lifting
and rejuvenation. Other indications suitable for treatment include post-acne scars, fine lines,
wrinkles, enlarged pores and stretch marks. As part of combination therapies, alopecia may
also be treated.
Dermapen 4™ works to activate and facilitate the body’s own healing and regenerative cascade.
1.2 - User Acknowledgement
• It is the responsibility of the user to carefully read all information presented in this manual
before using the Dermapen 4™. This includes warranty information.
• It is the responsibility of the user/purchaser to be aware of local laws and regional
restrictions for microneedling.
• It is the responsibility of the user to obtain appropriate insurance cover, if applicable.
• A consultation with the patient to establish medical history, consent, risk assessment, pre-
post recommendations and skin preparations should have taken place before commencing
treatment.
• Only physicians or other qualified healthcare professionals should operate the Dermapen 4™
to a depth over 1.0mm. A ‘physician or other qualified health care professional’ is an individual
who is qualified by protocol education, training, licensure/regulation (when applicable) and
facility privileging (when applicable) who performs a professional service within his/her
scope of practice and independently reports that professional service.
1.3 – Usage Environments
Dermapen 4™ is suitable for use in the following environments:
• Qualified Physician or Health Care/Medical Professional (Dermapen 4™ Model 4MD)
• Qualified Clinical/Aesthetic Professional (Dermapen 4™ Model 4PRO)
During a professional procedure, the Patient usually reclines on a bed or chair. The Operator
operates the
Dermapen 4™ using one hand, while gently holding the Patient’s skin taut with
the other hand, utilising full sterile procedures and DermapenWorld’s recommended protocol
products.

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English
1 - INTRODUCTION
1.4 – Additional Information
For more information or protocol training contact your local Dermapen™ representative.
https://www.dermapenworld.com/contact-us and select your country.
2 - DERMAPEN 4™ SYSTEM
2.1 - Dermapen 4™ Kit Components
The Dermapen 4™ system consists of the following components:
a. Dermapen 4™ Device
b. Dermapen 4™ Needle Cartridge
c. Dermapen 4™ DpSleeve
d. Dermapen 4™ Battery Charger, 2 Batteries and AC/DC Power Adaptor
e. Dermapen 4™ Desk Stand
f. DermapenWorld™ companion app
*Dermapen 4™ Kit Components may vary.

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2 - DERMAPEN 4™ SYSTEM
2.2 – Dermapen 4™ Features
Digital LCD Display
DC Power Port
Power Port Liquid
Seal Flap
Battery Bay
Safety Cap
16 Needles
Guard Seals
Guard Seals
AOVN ™ Valves
Direct Drive Ball
*AOVN ™ : Advanced
Oscillating Vertical
Needling Technology

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English
2 - DERMAPEN 4™ SYSTEM
2.3 – Dermapen 4™ Buttons & 2.4 - LCD Display Layout
+ Increase Speed
- Decrease Speed
+ Increase Depth
- Decrease Depth
Primary Button
(multifunction, ON/OFF)
Sync/Update Notification
Battery Status
Bluetooth Connection
Dermapen 4 ™ Status
Cartridge Status
Depth Indication (mm)
Speed Arc
Speed Ring

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2 - DERMAPEN 4™ SYSTEM
2.5 -AC/DC adaptor and battery charger
Charging the
Dermapen 4™ Turbo-Cut Battery:
1. New batteries will need to be charged before they can be used for the first time.
2. Plug charger into AC power outlet. Insert battery into charger, ensuring correct polarity is
observed.
• Charger displays a red LED while batteries are charging, and a green LED once fully
charged.
• The battery takes approximately 2 hours to fully charge. The supplied battery provides
enough charge for 3-5 typical treatments. Battery life is approx. 2 to 2.5 hours in air
at low speed and approximately 2.5x ‘standard’ treatments (1 to 1.5 hrs), under load.
• If the battery is no longer capable of supplying sucient power, the
Dermapen 4™ will
provide a Critical Battery Alert. The Dermapen 4™ will display a red Status LED, display
a flashing Battery Symbol, emit three audible tones and power o after 10 seconds.
• Dermapenworld Turbo-Cut Batteries are specifically for the Dermapen 4
TM
- Do not
substitute at any time with other batteries.
Installing the Battery:
1. Remove the battery cover.
2. Insert battery into battery bay, ensuring correct polarity is observed.
3. Replace the battery cover and ensure that it is securely closed. If the Dermapen 4™ does
not operate, check positioning of the battery and ensure that it is fully charged.
Warning: Incorrect installation of the Battery in the Dermapen 4™ or Battery Charger is
hazardous and may result in fire, personal injury and damage to property.
If the Dermapen
4™
is not likely to be used for an extended period of time the battery should be removed.
Using the AC Power Adaptor with Dermapen 4™ :
1. Remove liquid seal flap from the DC power port.
2. Insert Power Adaptor pin into the Dermapen 4™ power port.
3. Turn Power Adaptor pin a quarter-turn, clockwise, to securely lock it in place.
4. Plug the Power Adaptor into an AC power outlet.
5. Ensure the power outlet switch is turned on.
The Dermapen 4™ can be powered from the AD/DC Power Adaptor with or without the
battery installed.

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English
3 - INSTALLATION & SETUP INSTRUCTIONS
3.1 – Before You Begin
Before commencing treatment, it is important to carefully read and acknowledge all
Safety Warnings and Operating Instructions presented in this manual. Refer to 10 – Safety
Warnings.
3.2 – Getting Started
To get started with the Dermapen 4™, first register your clinic and the Dermapen 4™ with the
DermapenWorld™ Companion App. The App must be first downloaded to a compatible
smartphone or device.
3.3 - Powering on the Dermapen 4™
1. Press and hold the Primary Button until the Dermapen 4™ emits an audible tone. This
should take around 3 seconds. The Status LED lights blue and the Speed Indication Ring
will begin to flash.
2. Once the Dermapen 4™ is powered on, the Speed Indication Ring and Depth Indication
Digits will be displayed. The Status LED will light blue to indicate device is ready for
normal operation.
3. Adjust the Speed Indication Ring and Depth Indicator Digits as required.
4. Press the Primary Button once to activate Treatment Mode.
3.4 – Status LED and Audible Tones
The Status LED displays three dierent states:
• Blue: Normal Operation
• Orange: Attention
The Dermapen
4™ emits the following audible tones:
Single Tone: Indicates a button press
Double Tone: Indicates Speed/Depth setting accepted, or there is an alert requiring attention
Triple Tone: Indicates a Critical Battery Alert or Motor Error (refer to 9 – Troubleshooting)

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3 - INSTALLATION & SETUP INSTRUCTIONS
3.5 - App System Requirements
• iPhone/iPad with iOS 11/12 and Bluetooth functionality, or
• Android Phone with Android 7/8/9 and Bluetooth functionality
3.5.1 - Installing and Downloading the DermapenWorld™ App
1. Open the Apple or Android App Store on your compatible smartphone
2. Search for “DermapenWorld”
3. Tap the ‘Get’ or ‘Install’ button on the app page to install the app
The App is free and will not cost any money to download or use.
3.5.2 - Clinic Registration - location on DermapenWorld
TM
FREE Clinic Finder
1. Open the DermapenWorld™ app.
2. On the Login screen, tap Create New Account or Login if your clinic already has a
DermpenWorld.com PROZONE account. (Proceed to Step 3.5.3).
3. Read and confirm The General Privacy Agreement and The Terms and Conditions.
4. On the Create Account screen enter in your clinic name, first name, last name, clinic email
address, password and clinic phone number. Then tap Next.
5. Enter your first name, last name, email address and password, then tap Next.
6. On the Register a Clinic screen, enter the name and address of your clinic. Check the
location on the map, then tap Next.
Note – Please take care to enter the correct data as directed by the user prompts on each field.
3.5.3 - Registration of Dermapen 4™ to your Clinic
1. Ensure Bluetooth is enabled on your smart device.
2. Login to the app with your email address and password.
3. On the Home page, tap My Pen.
4. Tap the + button at the top-right of screen.
5. Tap Register a Pen for an Existing Clinic, and select your clinic from the list presented.
6. When prompted, hold the Dermapen 4
TM
Primary Button for 1.5 seconds until you hear an
audible tone. The Dermapen 4™ will power on and begin the Bluetooth pairing sequence.
During Bluetooth Pairing: - The Dermapen 4™ will display a blue Status LED, a Sync Symbol and
a flashing Bluetooth Symbol. The Depth Indication Digits will cycle a 6-digit Bluetooth passkey.
7. Enter the passkey into the app when prompted to complete the pairing process.
8. Once paired, the Dermapen 4™ will attempt to sync.
9. Once the sync is complete, the Pen Successfully Registered screen is displayed.
10. Tap Done to complete registration.
Your Dermapen 4™ is ready to begin treatments, see section 5 - Instructions for Use.
English