equipmed Dermapenworld Dermapen HOME User Manual Download Page 6

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Dermapen HOME

User Manual

Do NOT use the Dermapen HOME

microneedling device in any

way that is not as exactly specified in this Instructions for Use

user manual.

Use of Dermapen HOME

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.

Dermapen HOME

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.

Dermapen HOME

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.

Summary of Contents for Dermapenworld Dermapen HOME

Page 1: ...TM User Manual ...

Page 2: ... 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...

Page 3: ...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...

Page 4: ...al 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 result...

Page 5: ... 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 ...

Page 6: ...giene 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 suita...

Page 7: ... 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 o...

Page 8: ...chemotherapy radiotherapy or high dosage corticosteroid therapy You have an allergy to topical local anesthetics You have an allergy to stainless steel You are suffering 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...

Page 9: ...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 ...

Page 10: ...ance 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 storag...

Page 11: ...procedure other than those listed in this manual Protect freshly treated skin areas against physical stress contamination UV radiation and sunlight Do not use the Dermapen HOMETM device on any skin area except the facial zones described in this manual Do not perform more than one treatment per week To ensure that the required intensity of treatment is not exceeded avoid the risk of injury from exc...

Page 12: ...e use of needle cartridges which under certain circumstances pose the risk of a sharp s injury Injuries from contaminated needles in needle cartridges may lead to the transmission of diseases Dermapen HOMETM contains a re use protection feature built into the needle cartridge Do NOT attempt to reuse the needle cartridge Do NOT attempt to attach or remove the needle cartridge to or from the handpie...

Page 13: ... Turbo Cut Before commencing use of the device you will need to charge the Turbo Cut batteries Turbo Cut batteries are specific for Dermapen HOMETM Do not use any other type of rechargeable Lithium ion battery Use of other batteries may damage the device and will void your warranty Incorrect installation of the battery in the Dermapen HOMETM is hazardous and may result in fire personal injury and ...

Page 14: ...pen HOMETM device will alert the user by flashing the yellow status LED and battery indicator The device will emit an audible double beep every 10 seconds 6 If the battery is no longer capable of supplying sufficient power the Dermapen HOMETM will provide a Critical Battery Alert The device will display a red status LED display a flashing battery symbol emit three audible tones and power off after...

Page 15: ... STATUS ICONS Increase Speed Increase Depth Decrease Speed Decrease Depth Primary Button multifunction ON OFF Sync Update Notification Battery Status Bluetooth Connection Dermapen HOME Status Cartridge Status Depth Indication mm Speed Arc Speed Ring ...

Page 16: ...o activate Treatment Mode 8 4 STATUS LED AND AUDIBLE TONES The status LED displays 3 different states Blue Normal Operation Orange Attention Red Critical attention The Dermapen HOMETM emits the following audible tones beeps Single Beep Indicates a button press Double Beep Indicates Speed Depth setting has been set or there is an alert requiring attention Triple Beep Indicates a Critical Battery Al...

Page 17: ...MAPEN HOMETM ACCOUNT 1 Ensure the Dermapen HOMETM is powered off 2 Ensure Bluetooth is enabled on your smart device 3 If you are using an Apple iPhone or iPad ensure that Bluetooth is enabled for the Dermapen HOMETM app Settings Privacy Bluetooth Dermapen HOME 4 If you are using an Android device ensure that Location Services is enabled Settings Location 5 Login to the Dermapen HOMETM app with you...

Page 18: ... Adaptor during this process 8 When the app displays Pen Successfully Updated tap Done to complete the syncing and updating process 8 9 DURING BLUETOOTH SYNCING UPDATING 1 Dermapen HOMETM will display a blue Status LED a Sync Symbol a Bluetooth Symbol and the Speed Indicator Ring will spiral to indicate updating is in progress 2 Once successfully updated the device is ready to be used 3 If it has ...

Page 19: ... not damaged and torn 3 Do NOT use a needle cartridge if the sterile bag is damaged in any way 4 Do NOT use a needle cartridge if the USE BY date has been exceeded 5 The sterility of the needle cartridges is ONLY guaranteed if the packaging is undamaged and the cartridge is within its USE BY date 6 With clean hands remove the needle cartridge from its sterile pouch 7 Insert the drive ball end of t...

Page 20: ...e Dermapen HOMETM will not operate until the cartridge is installed correctly 12 Switch OFF the device remove the needle cartridge and re install If the problem persists refer to section 11 Troubleshooting Dermapen HOMETM Device page 26 13 Only install a genuine Dermapen HOMETM cartridge at all times Installation of any other cartridge will risk damage to the device and pose risks to the user and ...

Page 21: ...OMETM will produce a double beep when the new speed value has been set and the selected speed will be displayed on the Speed Indicator Arc 3 The speed can be adjusted without a cartridge connected to the device 4 The device can operate at different speed levels according to user comfort Speed 1 80hz 80 revolutions per sec Speed 3 105hz 105 revolutions per sec Speed 2 90hz 90 revolutions per sec Sp...

Page 22: ... the selected depth will be displayed on the Depth Indication Digits 3 The depth can be adjusted without a Cartridge connected to the device We recommend the following suggested needle depth ranges Forehead 0 2 0 5mm Between eyebrows 0 2 0 5mm Nose 0 3mm Cheek bone 0 3 0 5mm Cheek 0 5mm Lip area 0 2 0 5mm Facial scars up to 0 5mm Around the orbital rim 0 2 0 5mm Note Treatments can be performed ar...

Page 23: ... refer to section 8 3 page 16 If required sync the device via Bluetooth refer to section 8 8 page 17 6 Remove the protective needle cap from the Needle Cartridge and throw it away into general household waste 7 Select the needle depth and speed of the Dermapen HOMETM refer to section 9 2 page 21 and section 9 3 page 22 8 Apply light pressure and move the Dermapen HOMETM in stripe line motions acro...

Page 24: ...nt pressure treat from side to side as shown left Third Pass While exerting a constant pressure treat in a diagonal direction as shown left Fourth Pass While exerting a constant pressure treat in the other diagonal direction as shown left 9 3 CARRYING OUT A TREATMENT CONTINUED 9 For each region complete a pass of all four directions as shown below Repeat these three to five times before moving to ...

Page 25: ...signs of contamination in the inside of the handpiece or you suspect contamination in the inside of the handpiece please contact your local distributor Using a disinfectant wipe or clean cloth damped with soap and water thoroughly wipe over all areas of the device Apply pressure with your finger and wipe the whole surface of each part Wipe the outer casing of the device paying particular attention...

Page 26: ...ed correctly If problem persists replace Needle Cartridge with a new one Once powered on the Dermapen HOMETM Displays an orange Status LED Displays a flashing Cartridge symbol Emits a double beep Needle Cartridge Error due to invalid Cartridge Replace Needle Cartridge with a new one Once powered on the Dermapen HOMETM Displays a solid Sync Symbol Displays days or hours on the Depth Indication Digi...

Page 27: ...e earliest opportunity to continue Once powered on the Dermapen HOMETM Displays a red Status LED Displays a flashing Battery symbol Emits three beeps Powers off after 10 seconds Critical Battery the device has insufficient battery charge to continue operation Charge the battery before recommencing use or switch to the Power App displays Error Code 303 Issue communicating to device via Bluetooth En...

Page 28: ...de DP4 PSU PN EM1012AVRS Input Voltage Current 100 240V AC 1 0 0 5A 50 60Hz Output Voltage Current 5VDC 2 4A IP Rating IP21 Protection against electrical shock Class II Battery Reorder code DP4 BTR Type 14500 Lithium ion rechargeable Voltage Current 3 7V DC 800mAh Battery Charger Reorder code DP4 CHG PN F7 Input Voltage Current 90 250V AC 1 0 0 5A 50 60Hz Output Voltage Current 4 2V DC 500mA per c...

Page 29: ...ncy The operator of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF communications equipment transmitters and the device of 3 metres Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment in proximity should...

Page 30: ...ay not be possible to maintain normal operation under the following conditions In the event an electromagnetic field not in accordance with those listed in the EMC table affects Dermapen HOMETM the device may shut off or the speed setting may change without the user pressing buttons If either of these are observed use of the Dermapen HOMETM should be temporarily postponed until the source of the i...

Page 31: ...5 Subpart B Class B Conducted Emissions FCC Part 15 Subpart B Class B RF Emissions CISPR 11 Group 1 Class B Conducted Emissions Mains Terminal Disturbance Voltage CISPR 11 Group 1 Class B RF Emissions EN55032 Class B Harmonic Current Emissions IEC 61000 3 2 Class A Voltage Change Fluctuation and Flicker IEC 61000 3 3 Complies ...

Page 32: ...r hospital environment Surges IEC 61000 4 5 0 5 kV 1 kV Line to line 0 5 kV 1 kV Line to line Mains power quality should be that of a typical commercial or hospital environment Conducted Disturbances induced by RF fields IEC 61000 4 6 3 V 150 kHz to 80 MHz 6 V in ISM bands between 150 kHz and 30 MHz 80 AM at 1 kHz 3 V 150 kHz to 80 MHz 6 V in ISM bands between 150 kHz and 30 MHz 80 AM at 1 kHz Min...

Page 33: ... electric current connection faults Faults caused by the user s own intention or unauthorised repair Damages caused by natural disaster fire flood earthquake lightning etc Full warranty details can be found on www EquipmedUSA com Terms and conditions apply 15 DISPOSAL Performance testing has supported a maximum lifetime of the Dermapen HOMETM of 3 years Depending on the frequency of use this corre...

Page 34: ...ed to remove all makeup and a numbing cream containing a local anesthetic was applied to the skin After incubation the numbing cream was removed from the patient s face The operator began treatment using a minimum depth of 1mm and a frequency setting of 4 corresponding to 120Hz Needle depth and frequency was adjusted until pinpoint bleeding occurred Measurement of Safety and Effectiveness Adverse ...

Page 35: ... two n 22 patients were enrolled into the study twenty two patients completed their required treatments The mean age of the patient group was 38 years range 23 55 years and the group comprised of 4 18 males and 18 82 females Fitzpatrick phototypes ranged from I to V average FP III Three patients identified as non Hispanic 19 identified as Hispanic At baseline the mean global acne grading according...

Page 36: ... grade Patients presenting Range Global grade 3 2 4 Icepick 1 10 0 4 Rolling 2 17 0 3 Boxcar 2 17 0 4 Sex N Male 4 18 Female 18 82 Fitzpatrick skin type N I 1 5 II 6 27 III 6 27 IV 6 27 V 3 14 Ethnicity N Hispanic or Latino 19 86 Non Hispanic 3 14 White 21 95 Black 1 5 16 CLINICAL SUMMARY CONTINUED Patient Demographics continued ...

Page 37: ...tor 2 Evaluator 3 0 0 0 0 1 0 0 0 2 8 6 6 3 10 13 13 4 4 3 3 Average grade 2 8 2 9 2 9 Treatment parameters The operator began treatment using a minimum depth of 1mm and a frequency setting of 4 corresponding to 120Hz Needle depth and frequency was adjusted until pinpoint bleeding occurred The lowest needle depth and frequency to achieve pinpoint bleeding was recorded as 1 mm and a speed setting o...

Page 38: ...tment Patient evaluation of pain on the evening of day 1 showed a mean pain score of 1 5 mean of 3 treatments range 0 7 down by 1 6 from immediately after the treatment Mean pain scores receded to 1 by day 2 range 0 4 and receded further to 0 5 by day 4 range 0 4 Erythema grading by the patient appeared to be consistent over the initial two treatments with patients grading between minor erythema a...

Page 39: ...ts who went on to have three treatments improved Patient reported outcomes All patients reported that they noticed an improvement of their acne scars in the treatment area All patients apart from one patient 1 22 5 stated that they would recommend the treatment to friends and family When asked to characterise the treatment eighteen 18 22 82 were very satisfied with the treatment and four 4 22 18 w...

Page 40: ...Product code ASH MANUAL V1 Manufacturer Equipmed USA LLC 4695 MacArthur Court Newport Beach CA 92660 Phone 1 949 798 5500 Email admin EquipmedUSA com Website www EquipmedUSA com ...

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