BTL General Consent Form

INFORMED CONSENT

FOR BTL DEMONSTRATION TREATMENT
In consideration of the opportunity afforded to me to participate in an event (the “Event”) sponsored by BTL Industries, Inc. (the “Company”), I hereby agree as follows:

I hereby request and authorize the treatment of me using the "Treatment devices" below.
Treatment devices:
Product
Area(s) to be treated:
Emvital: The main contraindications include but are not limited to epilepsy, photosensitivity, medications affecting sensitivity to light, corticosteroids or injections of the treated area within the last 3 months, long-term use of corticosteroids, tattoos and other higher pigmented regions in the treated area, sensory loss in the treatment area, anticoagulant therapy, decompensated bleeding disorders, hemorrhage in the treatment area, deep vein thrombosis, major systemic diseases—e.g. uncontrolled diabetes mellitus, systemic lupus erythematosus—application over the thyroid or other endocrine glands, application within 4 to 6 months after radiation therapy, known or suspected malignancy, history of cancer in the treatment area, any type of malignancy, febrile conditions, active infection in the treatment area, pregnancy, electronic implants in the treated area, application over the eye or within the orbital area, and application over the genitals.
Exomind: The main contraindications include, but are not limited to, metallic objects in or near the head, implanted stimulator devices, drug pumps, application in the heart area, persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy), anticoagulation therapy, severe or life-threatening condition, pulmonary insufficiency, heart disorders, renal insufficiency, decompensated hemorrhagic conditions, decompensated blood coagulation disorders, decompensated cardiovascular diseases, malignant tumor or benign tumor, fever, and pregnancy. rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered. rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death. The safety and effectiveness of the therapy have not been established in the following patient populations or clinical conditions: age less than 22, suicide plan or recent suicide attempt, on concurrent antidepressant medication, i. e., cannot tolerate discontinuation of current antidepressant medication, history or concurrent use of electroconvulsive therapy or vagus nerve stimulation, substance-induced depression or depression secondary to a general medical condition, seasonal affective disorder, history of substance abuse, obsessive compulsive disorder or post-traumatic stress disorder, a psychotic disorder including schizoaffective disorder, bipolar disease, or major depression with, psychotic features, neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary, tumors in CNS, cerebral aneurysm, dementia, or movement disorders, history of increased intracranial pressure or head trauma, and nursing. The side effects that may occur include, but are not limited to the following: Across 37 published articles of randomized, sham-controlled studies in approximately 1,949 treated patients in the treatment of depression, 17% reported headache without mentioning the severity of the headache (326 events), 1% reported mild headache (26 events), 9% reported pain/discomfort at, or near, the site of application without mentioning of the severity of this adverse event (175 events), while 1% reported mild application site pain/discomfort and only 5 patients reported severe application site pain/discomfort. The most common adverse event being headaches, other sources of discomfort included stimulation site pain, facial/jaw pain, and muscle spasm. 3.5% of the patients reported muscle twitching (68 events), 2.5% of the patients reported insomnia (49 cases), 2.2% of depression (15 events), 0.4% of the patients reported tinnitus (8 events), 0.3% of the patients reported difficulty in concentration (6 events), one patient without any history of epilepsy had a seizure a few hours after the 12th rTMS session. No deaths or suicides have been reported in reviewed clinical articles. Increase in suicidality was reported by 4 patients.
Emface: The main contraindications include, but are not limited to, bacterial or viral infection, acute inflammations, impaired immune system, isotretinoin in the past 12 months, skin-related autoimmune diseases, radiation therapy and chemotherapy, poor healing and unhealed wounds in the treatment area, metal implants near treated area or neutral electrode, permanent implant near the area to be treated, pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body, current condition or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles, history of any type of malignant cancer, active collagen diseases, cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis), pregnancy/nursing or IVF procedure, history of bleeding coagulopathies, use of anticoagulants, any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea, any surgical procedure in the treatment area within the last three months or before complete healing, poorly controlled endocrine disorders, such as diabetes, tuberculosis, hepatitis, febrile conditions, acute neuralgia and neuropathy, kidney or liver failure, sensitivity disorders in the treatment area, varicose veins, pronounced edemas, skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment, electroanalgesia without exact diagnose of pain etiology, serious psychopathological disorders (such as schizophrenia), neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy), blood vessels and lymphatic vessels inflammation, and scarring in the treatment area. Side effects include, but are not limited to, erythema (redness) and mild swelling in the treated area (both will likely disappear within 2 to 24 hours), heating sensation during or just following the treatment, dry skin in the treated area during the first 12 post-treatment hours (it usually resolves within 48 hours), temporary damage to natural skin texture (crust, blister, and burn), muscular pain, and temporary muscle spasms.
Emsculpt Neo: The main contraindications include, but are not limited to, electronic implants, metal implants, drug pumps, malignant tumor, pulmonary insufficiency, injured or otherwise impaired muscles, cardiovascular diseases, disturbance of temperature or pain perception, hemorrhagic conditions, septic conditions and empyema, acute inflammations, systemic or local infection such as osteomyelitis and tuberculosis, contagious skin disease, elevated body temperature, pregnancy, postpartum period, nursing, menstruation and Basedow's disease.
Emsculpt: The main contraindications include, but are not limited to, cardiac pacemakers, implanted defibrillators, implanted neurostimulators, electronic implants, pulmonary insufficiency, metal implants, drug pumps, application in the head and heart area, malignant tumor, injured or otherwise impaired muscles, fever and pregnancy.
Emsella: The main contraindications include, but are not limited to, cardiac pacemakers, implanted defibrillators, implanted neurostimulators, pulmonary insufficiency, metal implants, drug pumps, application in the head and heart area, malignant tumor, fever and pregnancy.
Emtone: The main contraindications include, but are not limited to, bacterial or viral infections, acute inflammations, cardiovascular diseases, history of bleeding coagulopathies, skin cancer, pregnancy, nursing or ongoing IVF procedure, polypus in the area of treatment, permanent implant in the treated area, unhealed wounds in the treated area, sores, psoriasis, eczema, rash, pronounced edemas, ascites, exudates, skin related autoimmune diseases, recent surgical/ablative/non-ablative procedure in the treated area, acute neuralgia and neuropathy, local corticosteroid therapy, pacemaker or internal defibrillator, or any other active electrical implant in the body, metal implants, sensitivity disorders or anesthesia in the area of interest, impaired immune system, isotretinoin in the past 6 -12 months, radiation therapy and chemotherapy, poorly controlled endocrine disorders, such as diabetes, active collagen diseases, kidney or liver failure.
Exion: The main contraindications include, but are not limited to, bacterial or viral infection, acute inflammations, impaired immune system, isotretinoin in the past 12 months, skin related autoimmune diseases, radiation therapy and chemotherapy, poor healing and unhealed wounds in the treatment area, metal implants near treated area or neutral electrode, permanent implant near the area to be treated, pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body, current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles, history of any type of malignant cancer, active collagen diseases, cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis), pregnancy/nursing or IVF procedure, history of bleeding coagulopathies, use of anticoagulants, any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea, any surgical procedure in the treatment area within the last three months or before complete healing or poorly controlled endocrine disorders, such as diabetes, Tuberculosis, Hepatitis, Febrile Conditions, acute neuralgia and neuropathy, kidney or liver failure, sensitivity disorders in the treatment area or varicose veins, pronounced edemas, Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment.
I understand that I’m receiving this treatment for demonstration purposes only, and that I will not receive an entire series of treatments. I understand that completing a full treatment series is necessary to maximize treatment efficacy.

Initials
I understand the results may vary from person to person and that an exact result cannot be predicted, neither guaranteed.

Initials
I understand that the treatment may involve risks of complications or injury from both known and unknown causes, and I freely assume these risks. I confirm that I was informed about possible contraindications and side effects.

Initials
I acknowledge the contagious nature of COVID-19 and the inherent risk of exposure to COVID-19 in any public place where people are present. I further acknowledge that the Company cannot guarantee that I will not become infected with COVID-19. I am voluntarily participating in the event and acknowledge that I am increasing my risk to exposure to the COVID-19. I assume all risks related to exposure to COVID-19 and I agree to hold the Company and its owners, agents, representatives, officers, shareholders, employees, partners, directors, attorneys, subscribers, successors and assigns harmless from and against all rights, actions, suits, claims or demands relating to any sickness, disease, or infection obtained in connection with the Event. I acknowledge that I must comply with all set procedures to reduce the spread while attending my demonstration. I have not had any COVID-19 symptoms (including but not limited to fever, cough, shortness of breath or difficulty breathing, etc.) in the last two (2) weeks and, if I have been tested for COVID-19 in the last two (2) weeks I have already received a "Negative" result.

Initials
I authorize the Company to use my name, voice, likeness and images (collectively, the “Assets”) in any and all lawful channels, including but not limited to social media, websites, printed or electronic materials, public forums, investor or employee conferences/meetings, news media, closed circuit television, advertisements or medical and/or educational training. The Assets may be used for any and all lawful purposes, including but not limited to education about the Company and its products, communications with regulatory agencies, investors, medical professionals and others, or general advertising. I agree to hold the Company and its owners, agents, representatives, officers, shareholders, employees, partners, directors, attorneys, subscribers, successors, and assigns harmless from and against all rights, actions, suits, claims or demands in the use of the Assets and likenesses as described above. I hereby waive all rights to inspect and approve the finished product, its use or such copy as may be used in connection therewith.

Initials
I certify that I have read this entire document and that I agree with all provisions. I certify that I have had the opportunity to ask questions and these questions have been answered in full to my satisfaction. I fully understand the treatment conditions, the procedure and possible side effects.

Initials
I hereby give my consent and authorization, and release the Company, the Administrator of the treatment and their respective owners, agents, representatives, officers, shareholders, employees, partners, directors, attorneys, subscribers, successors and assigns of any claims that I have in the future in connection with the described treatment.

First NameLast Name
Location

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Email
example@example.com
Signature
Date

MonthDayYear
2 digit month, 2 digit day, 4 digit year
BTL_Aesthetics_CLIN_Demo_Consent_EN100
Effective Date: June 26, 2020
Should be Empty:

INFORMED CONSENT