Summary of Contents for Eclipse MICROPEN TR1000
- Page 1 T A T T O O R E M O V A L USER MANUAL USER MANUAL Don’t regret it... Remove it! METR Mechanized Epidermal Tattoo Removal...
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Page 2: Table Of Contents
TABLE OF CONTENTS PAGE 1. UNPACKING YOUR MICROPEN TR™ ................. 1 INTRODUCTION ........................1 2. DESCRIPTION ........................2 3. SETTINGS ..........................3 3.1 – SET UP ..........................5 4. USING THE MICROPEN TR™ ..................6 4.1 ADJUSTING THE SPEED OF THE MOTOR .............6 4.2 ADJUSTING THE INJECTION DEPTH ..............6 5. -
Page 3: Unpacking Your Micropen Tr
1. Unpacking Your Eclipse MicroPen TR™ Thank you for choosing the Eclipse MicroPen TR™. Please check the case contents as follows. Make sure that your case includes: Protocols, information and End-user manual registration of the patient 3 templates 1 USB key 3 needle’s connector 1 MicroPen TR™ device 1 power supply 1 MicroPen TR™ support 3 needles treatment 2 cleaning liquids 3 needles 50 mm of suction product 6 tubes 130 mm 3 Solution vials 1 Female to Female Luer Lok INTRODUCTION Mechanized Epidermal Tattoo Removal The (METR) technique is a modern version of an old technique used to remove tattoos. The technique is based on the theory of localized partial healing. Its advance over original... -
Page 4: Description
Repeat treatments are scheduled to treat the remaining pigmented areas. This technique allows the whole area of the tattoo to be progressively and sequentially covered, and then removed, in three-five sessions. A secondary healing phase commences using silicone topical to control desired healing characteristics. 2. DESCRIPTION MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 5: Settings
3. SETTINGS Assemble the MicroPen TR™ as follows: 1) Attach the needle connector to the needle The needle supplied with the MicroPen TR™ as a fixation system in its upper part. 2) Connection of the tube to the needle connector Screw the short drip in the needle connector. 3) Connection of the needle to the MicroPen TR™ Connect the tube to the output product. Insert the needle inside the needle support. The needle must be pushed up and fully seated into the nose assembly. MicroPen TR™ | Rev. 01 of 2/1/2015... - Page 6 4) Connection of the suction needle to a tube Screw the tube to the suction needle. 5) Connection of the suction needle to the vial Remove the cap and Allowing some NOTE: pierce the vial membrane air into the vial may be with the suction needle. necessary to obtain a regular flow of product to the needle. 6) Set up the METR vial Insert the vial in the upper housing chamber of MicroPen TR™. Connect the tube to the input port. MicroPen TR™ | Rev. 01 of 2/1/2015...
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Page 7: Set Up
3 .1 SET UP To prepare the MicroPen TR™ for use, POWER on the device. A green light shows current ON. PRESS continuously on the trigger button until the solution appears at the needle. Check for the presence of air or fluid in the supply tube. This process may take up to 30 seconds. Press continuously on the trigger button to set up the device. NOTE: It is necessary to set up the device before each session by PRESSING continuously on the trigger button to prime the fluid reservoir. THE OPERATOR SHOULD VISUALLY CONTROL THE AMOUNT OF FLUID IN THE NEEDLE RESERVOIR MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 8: Using The Micropen Tr
4 – USING THE MICROPEN TR™ 4.1 A DJUSTING THE SPEED OF THE MOTOR The speed must be adjusted when the motor in the ON position. Once the device is switched ON, maintain continuous pressure on the ON/OFF button. The motor will cycle from the minimum to the maximum speed. Release the button when the correct speed is attained. 4.2 A DJUSTING THE INJECTION DEPTH In order to treat different kind of tattoos and skin types, the injection depth of the MicroPen TR™ is adjustable. Each turn of the depth adjustment represents an increase or decrease. To adjust the depth, use the “depth-adjustment dial.” Depth adjustment dial Progressively INCREASE depth by rotating from left to the right. Progressively decrease by rotating from right to the left. MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 9: Important Information For Patients
Rotation from the Rotation from the left to the right: right to the left: DEEP DEEP VISUAL CONTROL OF THE DEPTH SETTING IS IMPORTANT BEFORE ANY TREATMENT 5 – IMPORTANT INFORMATION FOR PATIENTS Removing tattoos induces a definitive visual modification of the body. It is important to explain to the patient all aspects of the treatment phase and the aftercare regimen required to ensure a successful result. An informed consent document should be reviewed by the patient and signed. See Advice and Procedure Description documents. ONLY ADULT PATIENTS WHO ARE OVER 18 YEARS OF AGE ARE ELIGIBLE FOR TREATMENT. PARENT OR GUARDIAN CONSENT IS REQUIRED FOR UNDER-AGE PATIENTS. 5.1 - Preparation of the Patient before treatment Treatment with MicroPen TR™ should be preceded by a review of the patient care instructions and compliance rules for a successful outcome. Use the document package supplied with pen to ensure the patient is adequately informed about risks and benefits. MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 10: Charging The Battery
6 – CHARGING THE BATTERY The MicroPen TR™ is equipped with an internal Lithium/Ion battery which has a life of 2 hours treatment time. The battery level is indicated by the light indicator on the device: - Full battery: Green Light - Empty battery: Red flashing Light - On charge: Green and red Light simultaneous When a red flashing light appears, the battery should be recharged by plug the power supply into the mains. Charging time is approximately about 1 hour. NOTE: MicroPen TR™ may be used while the battery is charging. 7 – MAINTENANCE If MicroPen TR™ is not used daily, the system should be ‘bled’ to remove old treatment fluid. Place the suction needle in sterile solution (saline or sterile water) and press the trigger button for 40 seconds in order to flush any old fluid from the needle. Regularly clean the device with a soft, lint-free wipe or cloth. Do not use proprietary cleaning solution on any component of MicroPen TR™. Parts in contact with patient must be changed between each patient or sterilized according to the manufacturer’s instructions. SINGLE-USE PARTS: MICROPEN TR™ NEEDLE – SHORT DRIP – SUCTION NEEDLE – METR VIAL MUST BE CHANGED BETWEEN EACH PATIENT. REUSABLE PARTS: NEEDLE CONNECTOR MUST BE REPLACED OR DECONTAMINATED IN A COLD SOLUTION OF 2% GLUTARALDEHYDE BEFORE EACH USE. Please check individual state, local, federal and country regulations for correct care and sanitation of each component used in the MicroPen TR™ process. MicroPen TR™ and the battery are guaranteed for one (1) year from the date of purchase. MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 11: Cautions & Warnings
The MicroPen TR™ components and its battery are subject to strict environmental rules and should be disposed of according to local, state, federal and country regulations. 8 – CAUTIONS & WARNINGS THE OPERATION OF MICROPEN TR™ IS STRICTLY LIMITED TO HEALTH CARE PROFESSIONALS WHO HAVE RECEIVED SPECIFIC TRAINING IN THE USE OF THE DEVICE AND HAVE BEEN CERTIFIED BY THE COMPANY OR ITS REPRESENTATIVE. All users must know and understand the risks and contraindications associated with MicroPen TR applications and treatments. The METR fluid product used with the MicroPen TR must not come in contact with the eyes, the mouth or mucous membranes. In case of accidental contact, rinse well with water. ONLY THE METR FLUID PRODUCT SUPPLIED BY THE MANUFACTURER OF THE MICROPEN TR CAN BE USED BY THE HEALTH CARE PROFESSIONAL SUPERVISING THE TREATMENT. Failure to adhere to this warning, absolves the manufacturer of any and all liability. The practitioner must acknowledge the possibility of a negative or a partial result. Risks of bad healing, hyperpigmentation, hypopigmentation or allergies to the technique can occur. Please review the supplied documentation covering Risks and Contraindications to treatment. 9 – CONTRAINDICATIONS The METR treatment is contraindicated for the following conditions: - Pregnancy - Patients who has demonstrated allergy to hydroxypropanoic acid - Patients who has demonstrated healing difficulties - Patients with suppressed immune response - Patients with hemophilia It is necessary to be particularly vigilant for the following patients: - Diabetic patients - Patients with poor healing capacity - Patients undergoing long-term steroid treatment - Patients immunocompromised either through drug or disease MicroPen TR™ | Rev. 01 of 2/1/2015... -
Page 12: General Features
Model: TR1000 - Owner of the homologation: BFP Electronique Pôle Technologique de Vimenet Owner of the homologation: - M anufactured for: 48100 MONTRODAT - France BFP Electronique Eclipse Aesthetics, LLC. : +33 (0)4 66 32 44 99 Pole Technnologique de Vimenet 13988 Diplomat Drive, Suite 160 48100 MONTRODAT - France Dallas, Texas 75234 - Manufacturer of the device: Idem +33 (0)4 66 32 44 99 800-759-6876 10.2 GENERAL CONFIGURATION...
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