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7

 

User Manual

 

 

 

 

 

 

5.

 

INDICATIONS FOR  USE

 

PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue. Target population: 
women and men aged 22 to  90.

 

 

6.

 

GUIDELINES FOR  USE

 

PLASMA IQ device is intended for use during non-invasive surgery. The PLASMA IQ device is intended for use 
only in professional health care settings. PLASMA IQ is Rx   only.

 

 

7.

 

WARNINGS FOR USE AND ADVERSE  EVENTS

 

Discuss contraindications with your patient and ensure that he/she doesn’t have any pre-existing conditions 
that would make a treatment ineffective or unsafe. PLASMA IQ is Rx   Only.

 

 

CONTRAINDICATIONS:

 

 

 

Birthmarks and Port-wine  Stains

 

 

Warts

 

 

Tattoos

 

 

Blood Coagulation (Hemophilia)

 

 

Auto-immune disorders  (Lupus)

 

 

Fitzpatrick Scale 4-6

 

 

Patients with an implanted  pacemaker

 

 

Patients with metal or electrically conductive 
implants

 

 

Cancer

 

 

Eye region/eye lids

 

 

Pregnancy and  breastfeeding

 

 

Cardiac Disorders

 

 

Cardiovascular Diseases

 

 

Uncontrolled Diabetes

 

 

Circulatory Disorders

 

 

Active Herpes or  Shingles

 

 

Skin Disorders including psoriasis, eczema, 
dermatitis, Vitiligo

 

 

Scars including hypertrophic, keloid scars or 
previous occurrences of keloid  scars

 

 

PRECAUTIONS: 

Consult with the patient on the  following

 

 

 

Hyper-pigmentation

 

 

Uncontrolled Epilepsy

 

 

Anemia

 

 

Medications or herbal  supplements

 

 

Eye conditions or prior  surgeries/treatments

 

 

Toxins, chemical peels, retinols, and/or dermal 
fillers in the treatment  area

 

 

Topical Anesthetic  Intolerance

 

 

Recent surgical  procedures

 

NOTE: 

Contact lens use during and after procedure is not  recommended

 

 

RISKS OF PLASMA IQ  TREATMENT:

 

 

Swelling & bruising

 

 

Scabbing & crusting

 

 

Skin discoloration

 

 

Scarring

 

 

Redness & tenderness

 

 

This device has not been studied in combination with any other   treatment.

 

Summary of Contents for PLASMA IQ

Page 1: ...USER MANUAL Neauvia North America Customer Service 1 866 836 3113...

Page 2: ...OPERATING CONDITIONS AND TRANSPORT 9 11 DISPOSAL OF EQUIPMENT 9 12 MEDICAL PRODUCT WARRANTY 9 13 CLEANING DISINFECTION MAINTENANCE 10 14 ELECTROMAGNETIC COMPATABILITY 11 15 OPERATING ACTIVITIES 12 16...

Page 3: ...3 User Manual 1 KIT CONTENTS The basic set includes PLASMA IQ device The docking station ACM12US15 Charger Starter Kit 10 electrodes Manual on USB stick...

Page 4: ...point on the patient s body resulting in temperature increase which in turn allows for controlled tissue destruction The microcurrent flow through the body can only take place at one selected point En...

Page 5: ...tal conditions of use Temperature 50 77 F Pressure 980 1060 hPa Humidity 93 max Environmental conditions Storage Temperature 32 122 F Pressure 980 1060 hPa Humidity 10 90 Electrical Safety Class Class...

Page 6: ...ype F AC Power Unit FRAGILE KEEP DRY F 32 F Handle with care keep dry Temperature storage and transport conditions Electrical Safety Class II 10 90 Humidity storage and transport conditions Caution Hi...

Page 7: ...ed pacemaker Patients with metal or electrically conductive implants Cancer Eye region eye lids Pregnancy and breastfeeding Cardiac Disorders Cardiovascular Diseases Uncontrolled Diabetes Circulatory...

Page 8: ...This may result in alternate site burns Use only all metal or all plastic trocar systems Warning Do not make any modifications to the device Warning Servicing must be performed only by persons authori...

Page 9: ...ISPOSAL OF EQUIPMENT The product contains electronic parts It should be disposed of in accordance with applicable law The product contains lithium batteries you must follow the regulations regarding t...

Page 10: ...l no longer visibly wet approximately 3 5 minutes Maintenance If you experience technical difficulty with your device contact Neauvia North America at 1 866 836 3113 email service neauvia us com PLASM...

Page 11: ...gnetic fields with radio frequencies in accordance with PN EN 61000 4 3 2007 A1 2008 A2 2011 Range 80 2700 mHz 3V m Proximity field 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 m...

Page 12: ...er will turn green when the device is fully charged 5 Remove the device from the charger Press the H or L on the device The LED on the device should light up indicating the device is ready to use Warn...

Page 13: ...ation ready not charging Docking station Red Charging of the battery in progress Warning Avoid using this device in close proximity to other devices or setting the device on or under another device be...

Page 14: ...14 User Manual 17 DESCRIPTION OF WORKING MODES MAX POWER 5 W IMPEDANCE RATED 54 k FREQUENCY 40 kHz MODULATION FREQUENCY N A...

Page 15: ...PTION OF WORKING MODES 17 1 Output power graph The following graphs shows dependency between device output power and load impedance The maximum output voltage levels for High Power the H 950 Vrms for...

Page 16: ...cking station press the HIGH button and check that the yellow LED lights up 18 2 Preparing the device and equipment for work Before starting work with the device an active electrode should be inserted...

Page 17: ...ds to be recharged Warning Do not leave the device uncharged or use the device before it is completely charged because it may damage or shorten the life of the battery inside the device Before chargin...

Page 18: ...e in the docking station Warning The active electrode is a part that does not have electrical insulation therefore when installing or removing the active electrode avoid touching the buttons that acti...

Page 19: ...esulting from improper maintenance inadequate power supply negligence or incompetence as well as faults or damage to parts subject to standard wear The warranty is void if the medical device has been...

Page 20: ...NORTH AMERICA Neauvia North America Customer Service 1 866 836 3113 2019 Neauvia North America 8480 Honeycutt Road Raleigh NC 27615 neauvia com PI NAM 01 190001 REV 022020...

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