Safety Measures for the Dermapen Enpitsu Pro.7 in Compliance with GPSR (General Product Safety Regulation)

The safety of users is the top priority when using the Dermapen Enpitsu Pro.7. The following guidelines and safety measures, compliant with the European General Product Safety Regulation (GPSR), should be followed to ensure safe and effective use of the device.

1. Use by Trained Professionals Only

• The Dermapen Enpitsu Pro.7 should ideally only be used by trained professionals or individuals with a strong understanding of microneedling and LED light therapy.
• Carefully read the user manual before the first use.

2. Hygiene and Sterility

• Always use sterile disposable needle heads specifically designed for the Dermapen. After each treatment, the used needle heads must be disposed of.
• Clean and disinfect the Dermapen thoroughly before and after each use to avoid cross-contamination.
• Use the device only in a clean and hygienic environment.

3. Skin Preparation and Aftercare

• Ensure that the skin is thoroughly cleansed and disinfected before treatment.
• After treatment, soothe the skin with sterile products (e.g., serums or creams) to prevent irritation.
• Avoid direct sunlight and apply sunscreen (SPF 50) after treatment to protect the skin from UV damage.

4. Indications and Contraindications

Suitable for:

• Individuals with skin concerns like acne, scars, wrinkles, pigmentation spots, or stretch marks.
• Treatments on the face, body, and scalp, tailored to the specific needs of the area.

Not suitable for:

• Individuals with active skin infections, open wounds, eczema, or psoriasis.
• Pregnant or breastfeeding women, unless approved by a physician.
• Individuals prone to keloid scarring or other wound healing disorders.
• Users with pacemakers or other electronic implants (due to the LED light therapy).

5. Settings and Adjustments

• Speed Settings: Select the speed based on the sensitivity of the skin and the treatment area. Start with lower speeds for sensitive areas.
• LED Light Therapy Colors: Use the LED color therapy according to the skin concerns being treated (see user manual).
• Pressure Control: Do not apply excessive pressure to avoid skin injuries.

6. Protection Against Overheating and Malfunction

• Turn off the device after use and allow it to cool down.
• Avoid prolonged use of the Dermapen to prevent overheating of the motor.
• Use only the included charger to prevent damage to the battery.

7. Child and Animal Safety

• Keep the Dermapen out of the reach of children. The device is not suitable for use by children.
• Never use the device on animals.

8. Avoiding Side Effects

• Stop using the device immediately if redness, pain, or other skin reactions occur beyond a normal response to treatment.
• If in doubt, always consult a physician or dermatologist before starting the treatment.

9. Regular Maintenance and Device Inspection

• Regularly inspect the Dermapen for visible damage or wear.
• Do not use the device if it is damaged; contact the manufacturer for repairs or replacements.
• Charge the battery regularly to ensure consistent performance.

10. Disposal and Environmental Responsibility

• Dispose of used needle heads in accordance with local regulations for medical waste.
• Old or defective devices should be recycled in an environmentally friendly manner and must not be disposed of with household waste.

11. Additional Information in Compliance with GPSR

• This product complies with European safety standards as per the General Product Safety Regulation (GPSR).
• The manufacturer assumes no liability for damages caused by improper use or negligence of the safety guidelines.

Responsible Economic Operator According to GPSR

die2 GmbH
Von-der-Tann-Str. 45
86159 Augsburg

Contact:

• Phone: +49 (0) 821 50818900
• Fax: +49 (0) 821 50818909
• Email: info@die2-kosmetik.de

Important Note:
If you have any questions about the safe use of the Dermapen Enpitsu Pro.7, contact the manufacturer or an authorized distributor. Your safety and the effectiveness of the treatment are always the highest priority.