MP TR_Instruction Manual_V3_030315.indd
Contents
1. Input product Trigger button Long touch boot Short touch starting for 12 seconds Needle support Depth adjustment LED control Green Working Flashing red Empty battery Red and green In charge Battery charge connector ESE ON OFF button 2 MicroPen TR Rev 01 of 2 1 2015 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 MicroPenTR Rev 01 of 2 1 2015 3 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 pierce the vial membrane with the suction needle NOTE Allowing some air into the vial may be 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 4 MicroPenTR Rev 01 of 2 1 2015 3 1 SET UP To prepare the MicroPen TR for use POWER on the device2. 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 ora partial result Risks of bad healing hyperpigmentation hyoopigmentation 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 O1 of 2 1 2015 9 10 GENE
3. 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 8 MicroPen TR Rev O1 of 2 1 2015 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 amp 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
4. 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 t 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 5 4 USING THE MICROPEN TR 4 1 ADJUSTING 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 ADJUSTING 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 6 MicroPen TR Rev 01 of 2 1 2015 Rotation from the right to the left Rotation from the left to the right w DEEP we DEEP VISU
5. AL 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 O1 of 2 1 2015 7 6 CHARGING THE BATTERY The MicroPen TR is equipped with an internal Lithium lon 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
6. ECLIPSE o MICROPEN TE TATTOO REMOVAL USER MANUAL Dont reget al kKemove itt METR Mechanized Epidermal Tattoo Removal OSN ECLIPSE AESTHETICS 4 TABLE OF CONTENTS PAGE lt UNPACKING OURO EIN TR contarte 1 A A e o OE ete A sent 1 PE a a EP UL SI IPP OPE PU E COCO PEO ee Senior E E 2 So A errr rerre re ter een Teme Renner Tere Crt rr i mtn nny ant perenne Teeter ter te 3 CIE A e E E SEE E AE A 5 da MONS THE MER IR ER Vida ti de 6 Al AIMS TING THE SPEED OF THE MOTOR sus 6 AUSTIN THE IJE G HON DER Riec i i 6 gt IMPORTANT INFORMATION FOR PATIENTS estancada 7 S1 PREPARATION OF THE PATENI BEFORE TREATMEN oirisensriitirai 7 GC HARGIN G TAE BATTERY serens ianen Ek EENE ESENE REENEN EKEREN 8 Te IAS EE AN SE tai io ici 3 MO E N ARTUN G O e o E d IC INTRAINDICA TON O eenean reesen enee E ARRERA ERANS EEEE e aAA RERE RESE 9 1U GENERAL FEATURE Spore E E E BE EVEEN EE 10 CADENAS NN tata idas 10 10 2 GENERAL CONFIGURATION sekinten nanesen eniak k eiir 10 L TECANICAL CP TD Sutil rss 10 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 registration of the patient 1 USB key ECLIPSE End user manual MIC ran oo eat st USER MANUAL 1 MicroPen TR device SS E iii Lit tit eee 1 MicroPen TR support Y 3 needles treatment 2 cleaning
7. RAL FEATURES 10 1 IDENTIFICATION Model TR1000 Manufactured for Owner of the homologation Eclipse Aesthetics LLC BFP Electronique 13988 Diplomat Drive Suite 160 Pole Technnologique de Vimenet Dallas Texas 75234 48100 MONTRODAT France 800 759 6876 33 034 66 32 44 99 Manufacturer of the device Idem 10 2 GENERAL CONFIGURATION Model reference MicroPen TR Tattoo Removal Serial number MG amm 0000 11 TECHNICAL CHARACTERISTICS Dimensions 23 x 10 x 3 cm Weight 170 g Voltage 5 V Protection IP 20 Power 8 W Battery Type Li lon Capacity 0 80 Ah Autonomy 2 hours Charging time 1 hour Charge voltage 5 V Electric security type B BH WARNING Refer to instruction manual Y Identification of waste electrical and electronic equipment CE 0459
8. liquids a 3 needles 50 mm of suction product 3 Solution vials 6 6 tubes 130 mm 130 mm EEN Y 1 Female to Female Luer Lok INTRODUCTION The Mechanized Epidermal Tattoo Removal 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 methods is to rely upon small surface area closely spaced partial thickness injuries with intervening skin bridges to return the tattooed area to normal skin color The use of closely spaced needles similar to those used in traditional tattoo devices is necessary to obtain defined penetration depths The needles facilitate penetration of the tattoo target to a defined depth where the special Tattoo Removal MicroPen TR fluid is introduced The tattooed area will reject the ink through cutaneous exfoliation and produce a scab or eschar The treated area will heal over a period of 2 to 3 weeks and the scab will fall away leaving clear skin beneath MicroPen TR Rev O1 of 2 1 2015 1 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 a silicone topical to control desired healing characteristics 2 DESCRIPTION Suction needle Short drip Output product
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