Neauvia PLASMA IQ Installation guide

TRAINING MANUAL
Neauvia North America Customer Service: 1-866-836-3113.

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TABLE OF CONTENTS
1. INTRODUCTION .................................................................................................................................... 3
2. PATIENT CONSULTATION ........................................................................................................................ 4
3. PREPARING THE DEVICE........................................................................................................................ 6
4. PRE-TREAMENT CARE........................................................................................................................ 7
5. TECHNIQUE ............................................................................................................................................. 8
5.1 Zig-zag pattern technique...................................................................................................................................8
6. SKIN LESION .................................................................................................................................................10
7. POST-TREATMENT RECOMMENDATIONS ....................................................................................11
8. DEVICE MAINTENANCE ................................................................................................................. 12

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1.0 Introduction
Introduction
PLASMA IQ utilizes a treatment method called plasma fulguration, which causes controlled skin damage. It offers a low risk
procedure, with minimal side effects. The device works through the generation of an electrical arc, which causes
epidermal fulguration, with minimal effect on surrounding tissue. The PLASMA IQ works by creating an arc between the
device tip and the skin, by ionizing the gas particles in the air. The resultant production of plasma causes fulguration of the
epidermis of the skin; turning a solid straight into gas. It creates 1mm
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or small treatment spots that show as tiny brown
carbon crusts or scabs. These will remain for approximately a week before dropping off.
This Training Manual is only a means of support in the correct operation of the device. The PLASMA IQ device should
only be used by medically licensed and certified practitioners who have undergone training conducted by authorized
Neauvia trainers or distributors. The manufacturer shall not be liable for any potential damage resulting from improper
operation of the device or treatments performed by untrained personnel who are not fully certified.
PLASMA IQ is used in the removal and destruction of skin lesions and the coagulation of tissue.
PLASMA IQ is Rx only.
WARNING:
PLASMA IQ DEVICE CAN CAUSE HARM TO THE USER AND/OR PATIENT IF NOT USED AS INSTRUCTED, USED FOR OTHER
PURPOSES, OR CONTRADICTORY TO THE INTENDED METHOD OF OPERATION DEFINED IN THIS USER MANUAL. THE USER
MUST FOLLOW TREATMENT PROCEDURES AND ABIDE BY THE GUIDELINES DEFINED IN THE USER MANUAL, AT ALL TIMES.
THE PLASMA IQ DEVICE MAY ONLY BE USED WITH NEAUVIA PROVIDED ACTIVE ELECTRODES.
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2.0 Patient Consultation
Communicating with your patient and establishing an environment where they feel cared for and comfortable is a
crucial step to set the tone of the treatment experience.
PLASMA IQ is used in the removal and destruction of skin lesions and the coagulation of tissue.
Take a moment to talk with your patient to understand:
• Why is the patient interested in a PLASMA IQ treatment?
• What indication does the patient want to address?
• What level of change is the patient looking for? Discuss the amount of treatments that would most likely support
this level of change.
Share before and after imagery to help set expectations for results.
WARNING:
NOT FOR USE IN THE GENITAL AND EYE AREAS.
USE CAUTION AROUND SENSITIVE SKIN AREAS SUCH AS THE LIPS.
WARNING:
Do not directly touch the output electrode of the product with sensitive parts such as the user’s eye or the
patient’s eye. In addition, treatments should not be performed within the orbital
rim, which includes the upper and lower eyelids.
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
• Pregnancy andbreastfeeding
• 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 priorsurgeries/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
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•
Swelling & bruising
• Scabbing & crusting
2.0 Patient Consultation
• Skin discoloratio n
•
Scarring
• Redness & tenderness
RISKS OF PLASMA IQ TREATMENT:

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3.0 Preparing the Device
To make sure your patient feels at ease and informed, be sure to help set expectations about what the treatment
entails.
Describe the process and prepare them for:
• What are the stages of thetreatments?
• What types of sensations can they expect throughout the treatment?
• What they should expect immediately after the treatment?
• What kind of after care they should follow to promote the best results?
At the end of the treatment:
• Review the post-treatment recommendations and treatment plan and schedule for your patient to achieve
desired results.
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3.0 Preparing the Device
Check component functionality
Before use, check that the device is working
properly. To do this, the following procedure should
be carried out:
• Connect the power supply and check that the
green LED is on the docking station
• Take out the PLASMA IQ from the docking
station, press the LOW button and check if the
yellow LED turns on
• Take out the PLASMA IQ from the docking
station, press the HIGH button and check that
the yellow LED lights up
On the device, there
are two buttons
used to provide
two different output
voltages, marked
with inscriptions
“H” high and “L” low.
Figure 1: Device PLASMA IQ
Preparing the device and equipment for work
Before starting work with the device, an active electrode should be inserted. In order to install
the active electrode, ensure that the device is off and follow the steps below and the drawing:
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Turn the spindle to the left;
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Insert the treatment electrode;
3
Turn the spindle clockwise until itstops.
spin
clockwise
WARNING:
Do not apply excessive force when tightening the spindle. Do not use any tools to unscrew or screw the spindle.
1.counterclockwise
spin
2. a new electrode
insert
3.
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4.0 Pre-Treatment Care
Pre-Treatment Recommendations:
Avoid sun exposure or tanning beds for 2-4 weeks before treatment. Ideally, begin
applying SPF 50 to prep skin for 2-4 weeks prior to treatment.
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5.0 Technique
Recommended Voltage Parameters
LOW voltage should be always be used as an initial measure before increasing voltage for more intensive fulguration. It
is recommended to use the LOW setting whenever possible for patient safety and comfort.
* button LOW - 650 V (Controlled fulguration, delicate areas of face, lip area)
* button HIGH - 950 V (Controlled fulguration)

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5.1 Technique: Zig-Zag Pattern Technique
Zig-zag pattern technique protocol
1. Apply short energy pulses in non-linear pattern working in a zig-zag motion to ensure distribution of energy
pulses for patient comfort.
2. Pulses should be at least 1mm apart.
Zig-zag pattern technique step-by-step
1. Apply numbing cream to treatment area as prescribed by physician and allow 10-20 min to take effect.
2. Carefully remove numbingcream.
3. Cleanse the skin using gauze and a non-alcohol antiseptic.
4. Dry area completely with gauze.
5. Attach single use, disposable electrode to the PLASMA IQ device as instructed on page 6.
6. Press L button to set voltage parameters to low.
7. Apply short energy pulses in non-linear pattern working in a zig-zag motion to ensure distribution of energy
pulses for patient comfort.
8. Pulses should be at least 1mm apart.
9. Continue until the full treatment area iscovered.
10. When area is complete, move to next area and repeat steps 2-9.
11. Cleanse treated area with gauze and non-alcohol antiseptic.
12. Apply moisturizer such as petroleum jelly as directed by physician.

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6.0 Skin Lesion
Skin lesion treatment protocol
Treatment Parameters:
Begin at Low (L) and move to High (H) if needed
Treatment Time:
About 1-2 min.
Treatment Frequency:
1 treatment
Skin lesion treatment technique step-by-step
1. Apply numbing cream to treatment area as prescribed by physician and allow 10-20 min to take effect.
2. Carefully remove numbingcream.
3. Cleanse the skin using gauze and a non-alcohol antiseptic.
4. Dry area completely with gauze.
5. Attach single use, disposable electrode to the PLASMA IQ device as instructed on page 6.
6. Ensure power setting is correct for treatment area/type.
7. Use arc in random pattern to cover the skin lesion.
8. Cleanse treated area with gauze and non-alcohol antiseptic.
9. Apply moisturizer such as petroleum jelly as directed by physician.
10. Protection of the treatment site is recommended.

7.0 Post-TreatmentRecommendations
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Post-Treatment Recommendations:
Apply moisturizer such as petroleum jelly as directed by
physician. Avoid touching or cleansing the area for at least 12
hours post procedure and ensure that hands are clean when
applying moisturizer. In case of infection, consult with a
physician.
You may experience some stinging in the treated area immediately
following treatment. This is normal and typically only lasts for about
an hour, though some variation in time may occur.
Continue to apply moisturizer such as petroleum jelly twice a day
after gentle cleansing. Additional moisturizer can be applied as
needed if dryness occurs.
Do NOT pick at or scratch at scabs as this may delay healing or
affect outcomes.
Avoid sunlight, exercise, heat, steam or sweat for 48 hours post
treatment.
After 2 days, begin applying at least SPF 50 to the treated area
daily.
Do NOT use makeup, mascara, or creams other than sunblock on
treated area until scabs have healed, approximately 1 week.
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8.0 Device Maintenance
Shutting down the device
To stop working with the device and shut it down, release all buttons, remove active electrode and place device on
docking station.
WARNING:
To avoid personal and/or material damage, remove the electrode from the device after completing the procedure
and when placing the device 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 activate the device.
WARNING:
Place the active electrode in the correct position as described in the manual. If the electrode is mounted incorrectly
it may affect the performance of the device.
WARNING:
Tighten the active electrode holder securely. Improper tightening of the handle can lead to the electrode slipping
out of the handle during the surgery.
Charging the device
If the yellow LED does not turn on or a significant power drop is noticeable,
it means that the PLASMA IQ needs 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 charging the device, do the following:
1. Remove the electrode used during the procedure;
2. Clean the device as it is described in the user manual;
3. Put the device on the docking station;
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8.0 Device Maintenance
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Cleaning and disinfection
• Plasma IQ device does not directly contact the patient. The Operator of the Plasma IQ device is advised to use
proper protective equipment including gloves. The Plasma IQ device should be cleaned before and after each
use. The active electrode is for single use only and must be discarded after the treatment.
• Do not use abrasives and free chlorine and oxygen - they may damage the case.
• Clean the device with a cleaning product such as 70:30 IPA or facility approved cleaning agent for 3-5 minutes
and disinfect with a disinfecting product such as with Caviwipes or facility approved disinfectant for 3-5 minutes.
Ensure that the device remains wet per the specifications of the chosen disinfectant. Refer to the cleaning and
disinfection label for specific time frames. Allow to air dry until 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 or email
[e-mail]. PLASMA IQ devices in the United States and Canada should not be serviced by third
party technicians. The warranty is void if the medical device has been opened, tampered with or repaired by an
unauthorized technician. Neauvia North America will arrange to supply the customer a means to ship the defective
device to the Neauvia North America service department for necessary repairs and will ensure that the customer is
supplied a temporary device for use during the repair process in a timely manner.
The device is not equipped with any fuses that can be replaced by third party operators or service personnel. There
are no serviceable parts inside the device. Service Personnel must hold a valid certificate issued by manufacturer to
perform any repairs of this equipment.
No parts of the equipment should be serviced or maintained while in use with a patient.
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Neauvia North America Customer Service: 1-866-836-3113.
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