Informed Consent Form Legend Pro

Informed Consent Form Legend Pro
Personal Information
Name

First NameLast Name
Phone Number
Please enter a valid phone number.
Email
example@example.com
Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Time and days you would find most convenient for treatment:
Health Questionnaire
Existing or recent illness
Hospitalization/Surgery
Medication
Medication intolerance/Allergy/Sensitivity
Aesthetic procedures in the treatment area

Do you have any of the following conditions? (Please mark the relevant conditions, if any)

	Mark if relevant
Under 18 years of age
Pacemaker or internal defibrillator, implanted neuro-stimulators or any other internal electric device
Arrhythmia (irregular heartbeat)
Metal implants or other implants in the treatment area
Pregnancy or nursing (when did you give birth?)
Myomas/ Menorrhagia (massive bleeding)
Current or history of cancer, especially skin cancer, or pre-malignant moles
Impaired immune system due to such as Hepatitis (B, C) AIDS and HIV, or use of immunosuppressive medications
Hepatitis B, C
Autoimmune diseases
Severe concurrent conditions such as cardiac disorders, or metabolic disorders
Condition that could be negatively affected by heat. History of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, and that may only be treated following a prophylactic regime
Diminished or exaggerated perception of temperature changes
Skin disorders like dermatitis or any active condition in the treatment area, such as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema, rash, active acne and rosacea
Collagen disease such as keloid scarring, abnormal wound healing, as well as very dry and fragile skin
Bleeding disorders, coagulopathies such as hemophilia, vascular disorders such as vasculitis, DVT or use of anticoagulants
Blood disorders such as anemia, porphyria
Poorly controlled endocrine disorders such as diabetes, hyperthyroidism, hypothyroidism, etc.
Central/ peripheral nervous system disorders such as epilepsy, Bell’s palsy
Lymphatic system disorders
Eating disorders (such as bulimia, anorexia, etc.)
Psychiatric disorders
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. Ibuprofen containing agents) one week before and after each treatment session
Use of Isotretinoin (Accutane) within 6 months prior to treatment
Tattoo or permanent make up in the treated area
Excessively tanned skin from sun, tanning beds or creams within the last two weeks prior to treatment
Any surgical, invasive, ablative procedure in the treatment area within three months prior to treatment or before complete healing. With signs of delayed healing response, at least six months should pass before treatment
Face lift, eyelid surgery, skin resurfacing, deep chemical peeling, liposuction or deep dermabrasion in the treatment area within three months prior to treatment or before complete healing
Injected chemical substance, threads, and synthetic fillers in the treated area
Fillers, collagen, fat injections or other injected bio-material in the treated area within three months prior to treatment and not before complete healing has occurred. Botox in the treated area within 2 weeks prior to treatment
Excessive allergic reactions such as difficult breathing or swelling (hives), or taking medications, herbal preparations or having medical condition that might impair skin healing, require pre-testing on a small area, to assess the skin condition 1-2 days following the test patch

I, the undersigned pledge to inform of all changes in my physical condition. I agree to undergo the treatment as detailed in this document.

VoluDerm TM treatmentTriPollar treatmentVoluDerm TM + TriPollar treatmentVoluDerm TM/TriPollar combined with other treatment (mark Other below), which I have a signed consent for.Other
I was explained, and I understand the expected results, the chances of success and the course of the treatment that is required.

I confirm that I do not suffer from any of the above described conditions.

I have had the opportunity to consider the following information, ask questions and have had these answered satisfactorily by the Physician/Therapist/
Practitioner.
The VoluDermTM (VO) applicator is intended for dermatological procedures requiring
resurfacing of the skin for texture improvement.

- It treats the skin in a fractional manner, leaving areas of untreated skin between
the affected zones, for improving the healing process
- The VO technology uses a disposable sterile micro needle treatment tip, attached
to the distal end of the VO applicator
- The tip is placed on the skin for treatment
- The micro needles ablate the skin using Radio Frequency (RF) energy, inducing
controlled tissue heating
- During the treatment you might feel some pain, vibration, a stinging sensation and
heat
- The TriPollar RF-based applicators are indicated for the non-invasive treatment of
mild-to-moderate facial wrinkles
- The system has a biofeedback control switch. In case of excessive discomfort, you
may press the button to terminate the treatment immediately

I understand that receiving the course of treatment is my choice.

- I was told that post VO treatment, tiny scabs in the form of the electrodes or micro
needle matrix configuration will usually form within 24 hours to 3 days post
treatment and last for a few days
- I was instructed to avoid scratching off the scabs and to apply sunscreen daily
- I was told about the possible side effects of those treatments including: local pain,
excessive skin redness (erythema), excessive swelling (edema), damage to the
natural skin texture (crust, blister, and burn), fragile skin, change of pigmentation
(hyper-pigmentation or hypo-pigmentation), bruising, scarring or transient skin
breakouts such as acne and pimples. Although these effects are rare and expected
to be temporary, any adverse reaction should be reported immediately
- I was told to avoid heat, exposure to sun and UV and to apply high SPF sun screen
several times a day
- I was told that in case of excessive swelling, redness or heat, I may apply a cold
pack (not ice) to the area and contact my treating physician
I confirm that I have read and understand the above information and agree to undergo the treatment out of my own free will.
Client Signature

Clear
Client Name

First NameLast Name
Date

MonthDayYear
Date
Permission for use of photographs (optional)
I First Name Last Name grant permission to (Clinic) Type a label and to
Lumenis® Ltd to use photos and digital images of my treated areas for the purposes of
professional publications, training and education, marketing or sales.
Client Signature

Clear
Client Name

First NameLast Name
Date

MonthDayYear
Date
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