equipmed Dermapenworld Dermapen HOME User Manual
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equipmed Dermapenworld Dermapen HOME User Manual

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Summary of Contents for equipmed Dermapenworld Dermapen HOME

  • Page 1 User Manual...

  • Page 2: Table Of Contents

    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 ..................
  • Page 3 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 HOME App ..16 8.6 - Creating an Account ................17 8.7 - Registration of Dermapen HOME Account ........

  • Page 4: I - General Information

    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 HOME device or protocols are not designed to cure diseases.

  • Page 5: Warning Symbols Used In This User Manual

    1 - WARNING SYMBOLS USED IN THIS USER MANUAL Indicates a hazardous situation which, if not avoided, could result in injury, death or serious injury. Sharp hazard. Read the user manual before use. 1.1 - OTHER SYMBOLS USED IN THIS USER MANUAL AND ACCESSORIES Device capacity for Bluetooth Connectivity, Battery (DC) Operation or Mains Power (AC) Operation.

  • Page 6: Limitations Of Liability

    2 - LIMITATIONS OF LIABILITY 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.

  • Page 7: Device Description

    4 - DEVICE DESCRIPTION The Dermapen HOME system consists of the following components: • Dermapen HOME Device • Dermapen HOME Needle Cartridge • Dermapen HOME Battery Charger • Dermapen HOME Power Charging USB cable • Dermapen HOME 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 off and two separate toggle buttons to adjust frequency (speed) and needle depth.

  • Page 8: Contraindications

    5 - CONTRAINDICATIONS You should not use the Dermapen HOME device in the following cases: • You suffer 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. •...
  • Page 9 6 - WARNINGS AND PRECAUTIONS Dermapen HOME 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.

  • Page 10: Warnings And Precautions

    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.

  • Page 11: Medical Precautions

    6.2 - MEDICAL PRECAUTIONS If you are unsure if the Dermapen HOME device is suitable for you, please seek advice from your doctor or qualified medical practitioner. Take care when using the device if you have a history of post-inflammatory hyperpigmentation (PIH) (darkening of the skin).

  • Page 12: Warnings: Electrical Shock

    6.3 - WARNINGS: ELECTRICAL SHOCK Dermapen HOME is an electrical device, which under certain circumstances could present an electrical shock hazard to the user. Please read this user manual and follow directions stated to assure maximum safety during operation. NEVER use the Dermapen HOME device where it can fall or be pulled into water.

  • Page 13: Installation And Setup Instructions

    7 - INSTRUCTIONS & SETUP INSTRUCTIONS 7.1 - INITIAL SETUP Upon receipt of your Dermapen HOME , unpack the device and accessories and check them off using the list in Section 4. Contact your distributor or supplier if any parts are missing or appear damaged.

  • Page 14: Charging The Turbo-Cut Battery

    7.4 - CHARGING THE TURBO-CUT BATTERY Before charging the batteries, inspect the battery charger and cable. Do NOT use the battery charger or cable if they are damaged in any way. Plug the USB charger into a suitable AC power adapter. 2.

  • Page 15: Controls And Status Icons

    8.2 - CONTROLS AND STATUS ICONS + Increase Depth + Increase Speed - Decrease Depth - Decrease Speed Primary Button (multifunction, ON/OFF) Dermapen HOME Status ™ Sync/Update Notification Cartridge Status Battery Status Speed Ring Speed Arc Bluetooth Connection Depth Indication (mm) User Manual Dermapen HOME...

  • Page 16: Powering On The Device

    8.3 - POWERING ON THE DEVICE Press and hold the Primary Button until the Dermapen HOME beeps. This should take around 3 seconds. The Status LED lights blue and the Speed Indicator Ring will begin to flash. 2. Once the device is powered on, the Speed Indicator Ring and Depth Indicator Digits will be displayed.

  • Page 17: Creating An Account

    8.6 - CREATING AN ACCOUNT Open the Dermapen HOME app. 2. On the opening screen, tap Create new account. 3. On the Create Account screen, enter your first name, last name, account email address, account password, confirm your account password, and tap to confirm the privacy policy. Then tap Next.

  • Page 18: To Sync And Update Dermapen Home

    8.8 - TO SYNC AND UPDATE DERMAPEN HOME Ensure Bluetooth is enabled on the smart device being used. Ensure Dermapen HOME is turned off at this point. 2. Login to the app with the account email address and password. 3. The app should open on the products page, which will list the available pens.

  • Page 19: Fitting The Needle Cartridge

    9 - FITTING THE NEEDLE CARTRIDGE The microneedle cartridge is sterile and for single-use ONLY. Discard each and every safety needle cartridge after use. Switch OFF the handpiece before attempting to attach or remove a needle cartridge. 2. Check that the needle cartridge package is not damaged and torn.
  • Page 20 9 - FITTING THE NEEDLE CARTRIDGE (CONTINUED) 9. Keep the protective cap in place until immediately before treatment. 10. Switch ON the device. 11. If the needle cartridge is not installed properly, the LCD screen will display the Cartridge symbol flashing on and off. The Dermapen HOME will not operate until the cartridge is installed correctly.

  • Page 21: Adjusting Puncture Frequency (Speed)

    9.1 - ADJUSTING PUNCTURE FREQUENCY (SPEED) Use the Speed +/- buttons to increase or decrease the needle speed (puncture frequency). A single beep will be produced for each successful button press. 2. The Dermapen HOME 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.

  • Page 22: Adjusting Needle Depth

    9.2 - ADJUSTING NEEDLE DEPTH Use the Depth +/- buttons to increase or decrease the needle depth (respectively). A single beep will be produced for each successful button press. 2. The device will produce a double beep to indicate the new depth value has been set and the selected depth will be displayed on the Depth Indication Digits.

  • Page 23: Carrying Out A Treatment

    9.3 - CARRYING OUT A TREATMENT Thoroughly cleanse the skin with an appropriate cleanser. 2. Remove all residue of the cleanser with water. 3. Thoroughly wash and dry hands prior to performing a treatment and handing the sterile Needle Cartridge. 4.
  • Page 24 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 another region. 10. Needle depth may be increased within guidelines if necessary 11.

  • Page 25: Caring For Your Device

    10 - CARING FOR YOUR DEVICE 10.1 - CLEANING PROCEDURE FOR DERMAPEN HOME Do NOT attempt to clean the needle cartridge. The needle cartridges are for single use ONLY. The technique described below is a validated cleaning procedure and must be followed to ensure effective cleaning of the device. Before and after each treatment, follow the cleaning procedure.

  • Page 26: Troubleshooting: Dermapen Home

    11 - TROUBLESHOOTING: DERMAPEN HOME DEVICE If the suggested actions fail to fix the problems listed below, or the problem reoccurs, please contact your local distributor. Do NOT attempt to investigate any of the problems further. The device has no parts that you can repair. Problem Possible Cause Action...
  • Page 27 11 - TROUBLESHOOTING: DERMAPEN HOME DEVICE (CONTINUED) Problem Possible Cause Action Configuration Sync the Once powered on, the Dermapen HOME Error Dermapen HOME via Bluetooth. • Displays an orange Status LED • Displays a flashing Sync symbol • Emits a double beep. During operation, the Low Battery Replace or recharge...

  • Page 28: Specifications

    12 - SPECIFICATIONS Dermapen HOME Input Voltage/Current: 5V DC, 2.4A Dimensions: 180mm x 40mm x 70mm Weight: 155g IP Rating: IP22 Needling Motor ranges: from 80-110Hz Depth Ranges: 0.2-1.5mm (+0.02mm / -0.2mm) Maximum depth: 3mm (+0.0mm / -0.4mm) Dermapen HOME Needle Cartridge (Reorder code: DP4-NDL-ASH-5) Needle count: 16...

  • Page 29: Electromagnetic Compatibility

    13 - ELECTROMAGNETIC COMPATIBILITY FCC Class B Statement This product contains FCC ID: SH6MDBT42Q The Dermapen HOME is intended for use in an electromagnetic environment in which radiated Radiofrequency (RF) disturbances are controlled. The Dermapen HOME has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.

  • Page 30: Electromagnetic Compatibility Guidelines

    13.1 - ELECTROMAGNETIC COMPATIBILITY GUIDELINES The device is ONLY intended for operation with original accessories, in an environment like the one described below. The user of the device must ensure that it is operated in such an environment. Essential Performance The Dermapen HOME microneedling device has been tested for electromagnetic immunity and emissions.

  • Page 31: Electromagnetic Emissions

    13.1.1 - ELECTROMAGNETIC EMISSIONS Emissions Test Compliance Notes Radiated Emissions Class B (FCC Part 15, Subpart B) Conducted Emissions Class B (FCC Part 15, Subpart B) RF Emissions Group 1, Class B (CISPR 11) Conducted Emissions - Group 1, Mains Terminal Class B Disturbance Voltage (CISPR 11)

  • Page 32: Electromagnetic Immunity

    13.1.2 - ELECTROMAGNETIC IMMUNITY Compliance Electromagnetic Immunity Test 60601-1-2 Level Environment Guidance Test Level Electrostatic ±8kV ±8kV Floors should be wood, Discharge Contact Contact concrete, or ceramic tile. (ESD) If floors are covered with ±15kV Air ±15kV Air synthetic material, the (IEC 61000-4-2) relative humidity should be at least 30%.

  • Page 33: Warranty Information

    14 - WARRANTY INFORMATION This product is manufactured under strict quality control and inspection processes. Standard warranty of the Dermapen HOME device is to cover the operating period 2 years after the purchase.* Standard warranty for Battery Charger and Battery is 12 months. If this product goes out of order under normal customer use, it will be repaired/replaced free of charge during the warranty period (not including return costs).

  • Page 34: Clinical Summary

    16 - CLINICAL SUMMARY The objective of this post-market clinical follow-up study is to assess the safety and effectiveness of the Dermapen HOME microneedling device in reducing scarring of atrophic acne scars. The primary effectiveness endpoint of the study was to show a reduction in acne scarring in accordance with the Acne Scar Assessment Scale as used by Skinpen (Bellus Medical (DEN160029)
  • Page 35 16 - CLINICAL SUMMARY (CONTINUED) Patient Demographics Thirty-two patients were screened for suitability, twenty-two (n=22) were suitable and took part in the study. Of the 10 volunteers that were deemed unsuitable, five (5) were suffering from active acne vulgaris, two (2) subjects were suffering from melasma in the treatment area and three (3) were suffering from facial scars resulting from Varicella zoster.
  • Page 36 16 - CLINICAL SUMMARY (CONTINUED) Patient Demographics (continued) All patients Age (years) Mean Minimum Maximum Male Female Fitzpatrick skin type Ethnicity Hispanic or Latino Non-Hispanic White Black Mean Goodman Patients Mean grade Range & Baron baseline presenting grading Global grade Icepick Rolling Boxcar...
  • Page 37 16 - CLINICAL SUMMARY (CONTINUED) Baseline grading of acne scarring using ASAS Baseline grading of acne scarring using ASAS is given in the below table. The average grade across all evaluators was 3, equivalent to moderate severity, >50% of acne scars visibly apparent with direct lighting.

  • Page 38: Clinical Summary: Results

    16.1 - CLINICAL SUMMARY: RESULTS Measurement of Safety 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 of 4 (120Hz) The highest needle depth and speed setting to achieve pinpoint bleeding was recorded as 2.5mm and a speed setting of 4 (120Hz).

  • Page 39: Clinical Summary: Measurement Of Effectiveness

    16.2 - CLINICAL SUMMARY: MEASUREMENT OF EFFECTIVENESS Effectiveness conclusions For the Acne Scar Assessment Scale (ASAS), 17 of the 22 subjects (77%) had a 1-point improvement on the ASAS for both blinded evaluators when comparing baseline to 4 weeks post-second treatment. The mean grading score across the 3 evaluators, 4 weeks after the second treatment was 1.4, representing a mean improvement from baseline of 1.5 of a grade.
  • Page 40 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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