Safety Information

1. Sofwave™

1.1. Indications For Use

1.2. Contraindications for Treatment

1.3. Precautions

1.4. Potential Adverse Events

1.1. Indications For Use

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.

1.2. Contraindications for Treatment

Treatment with the SofWave System is contraindicated for patients with any of the following
conditions:

  • Open wounds or lesions within the intended treat area.
  • Severe or cystic acne within the intended to treat area.
  • Pacemakers and electronic device implants in treated area.

1.3. Precautions

  • Pregnant or planning to become pregnant, having given birth less than three months
    ago, and/or breast feeding.
  • Presence of any active systemic or local infections.
  • Presence of active local skin disease that may alter wound healing.
  • History of chronic drug or alcohol abuse.
  • Significant scarring in the area to be treated.
  • Presence of a metal stent or implant in the facial area.
  • The SofWave system has not been evaluated for use over various materials.
  • Treatment is not recommended for use directly over areas with a dermal filler.
  • Taking Isotretinoin or other retinoid within the past 6 months; taking psychiatric drugs,
    anti-platelet or anti-coagulant within the past 2 weeks.
  • As per the physician’s discretion, any physical or mental condition which might make it
    unsafe for the patient to be treated.

 

1.4. Potential Adverse Events

Anticipated adverse events of ultrasound-based treatment could include significant pain,
tenderness, changes in skin pigmentation, persistent erythema and edema, ulceration/erosion
and/or bruising.

2. Pure Impact™

2.1. Indications For Use

2.2. Treating Attendant

2.3. General Precautions

2.4. Patient Safety

2.2. Contraindications for Treatment

2.3. Precautions

2.4. Potential Adverse Events

2.5. Contradictions for Treatment

2.6. Potential Adverse Events

2.7. Operational Safety

2.1. Indications For Use

The Pure Impact™ module is indicated to be used for:
• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of buttocks and thighs.

  • The Pure Impact Module™ is designed for use by health professionals under the supervision of a physician: nurses, aestheticians, physician assistants and any other health professionals working in the environment of aesthetic clinics (dermatologists, plastics, medical spa). Other intended users for service and training include Sofwave Medical authorized service, clinical application, and sales personnel.

WARNING:

• Use of controls or adjustments, or performance of procedures other than those specified herein, may be hazardous. Sofwave Medical does not authorize such changes.
• To avoid risk of electrical shock, always inspect the Pure Impact Module and cable before use. Do not use a damaged electrical cable or plug.
• Personnel operating and maintaining the System are REQUIRED to read this manual and to become thoroughly familiar with all its safety requirements and operating procedures BEFORE attempting to use or operate the System.
• Modification of this equipment is not allowed!
• Do not use the Pure Impact if the subject is connected to a high-frequency device instrument (any electrical medical device).

2.2. Treating Attendant

Personnel should not operate the Pure Impact Module until they have fully read this entire manual.

2.3. General Precautions

Only Sofwave Medical authorized personnel may service the Pure Impact Module, especially inside its protective covers.
• Keep all covers and panels of the System closed. Removing the covers creates a safety hazard.
• Keep the Pure Impact Module’s surface clean; check its integrity regularly.
• Do not use the System if there is any mechanical damage.
• Perform maintenance (cleaning) procedures according to paragraph 8.
• The Console is grounded through the grounding conductor in the power cable. This protective grounding is essential for safe operation.
• The use of accessories and cables other than those specified may result in increased emissions or decreased safety of the System. It is forbidden to connect any third-party equipment to the Pure Impact Module without written approval from Sofwave Medical Ltd.
• Never use the Pure Impact™ Module in the presence of explosive or flammable materials. If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before turning it on.
• Always use Pure Impact™ brand custom electrode pads that have the required conductivity properties.
• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or sensitivity to the electrode pads. The irritation can usually be reduced by using an alternate electrode placement.
• Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
• The device should be kept out of the reach of children.
• The wireless stimulation module and electrodes should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

NOTE:

• Use only Pure Impact electrode pads from Sofwave Medical, [insert link for purchase].
• Do not use the Console if the display is frozen or not responsive.
• The Pure Impact Module is to be used in an office or clinic setting.
• Do not use the System if there is visible damage to any of the Pure Impact wireless Stimulation Modules.
• Move the Console slowly and carefully, so it does not topple over.
• Make sure the castor wheels are locked when the System is in use.
• Do not use the device if there is any damage to the LCD display panel.
• In case of cyber security breach. Contact SofWave support immediately.

2.4. Patient Safety

It is crucial to carry out all necessary physical examinations adequately to rule out all contraindications. A complete patient history should be completed prior to scheduling treatment with the Pure Impact Module. Patients should be fully informed of the treatment protocol, the likely results and any risks associated with the treatment.

WARNING:
• The long-term effects of chronic electrical stimulation are unknown.
• It is crucial to carry out all necessary physical examinations adequately to rule out all contraindications (see Section 3.5.1).
• Use this System only after you have read this manual and understand how to operate the System.

NOTE: If any problems occur during System operation, discontinue the treatment in
progress, and refer to paragraph 9, Troubleshooting Guide.

2.5. Contradictions for Treatment

Treatment with the Pure Impact Module is contraindicated for patients with any of the following conditions:
• Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
• Osteosynthesis equipment. Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
• Pregnancy.
• Blood clotting disorder.
• Serious arterial circulation disorders in lower limbs.
• Abdominal or inguinal hernia.
• Current condition of any type of cancer.
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Impaired immune system due to immunosuppressive diseases such as HIV, autoimmune disorders, or use of immunosuppressive medications.
• Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.
• Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).
• Any surgical procedure in the treatment area within the last 6 months or before complete healing.
• As per the practitioner’s discretion, refrain from treating any condition which might make it unsafe for the patient.
• Muscle atrophy.
• Persistent pain at the treated area.
• Need for muscle rehabilitation.

NOTE:

  • In case of uncertainty regarding applicability or potential side effects, consult with a medical doctor or have the patient consult his/her physician and bring written consent for treatment.
  • The device is for adult use only
  • Caution should be used for patients with the following conditions:
    • Suspected or diagnosed heart problems.
    • Suspected or diagnosed epilepsy.
    • Over the menstruating uterus.
    • Over areas of skin that lack normal sensation.

2.6. Potential Adverse Events

The risks associated with use of the Pure Impact Module have been demonstrated to be minimal. Anticipated adverse events may include the following:
• INCREASED HEART RATE – This procedure has a risk of increasing a patient’s heart rate.
• DISCOMFORT/PAIN & MUSCLE SORENESS – Moderate discomfort during treatment is to be expected. Some discomfort, tenderness and muscle soreness in the treatment area may persist for a few hours following treatment, potentially extending to a few days.
• MUSCLE FATIGUE – muscle fatigue in the treatment area may persist for a few hours following treatment, potentially extending to a few days.
• RANDOM MUSCLE CONTRACTIONS – May be experienced after the procedure.
• FREQUENT URINATION/BOWEL STIMULATION – May be caused by the procedure.
• INCREASED HUNGER – Increase in metabolic rate results in feeling hungry more frequently. Please be aware of this and refrain from overeating post-treatment.
Additional potential adverse events include the following:
• SKIN IRRITATION / HYPERSENSITIVITY / BURNS – Some patients may experience skin irritation or hypersensitivity or burns due to the use of powered muscle stimulators.
• ALLERGIC SKIN REACTION TO HYDROGEL – May occur under the area where the disposable electrode pads are applied.
• TINGLING/NUMBNESS – Tingling and/or numbness in the treatment area may
occur.
• BRUISING – May occur in the treatment area.

WARNING:
In the event of adverse effects or injury/illness, contact Sofwave Medical Ltd. immediately (see contact information on page 2).

2.7. Operational Safety

NEVER APPLY THE ELECTRODES:
• Near the head.
• On the neck.
• On or near injuries of any kind (wounds, swelling, burns, irritations, eczema, cancerous lesions etc.).
• Stimulation should not be applied transthoracically.
When not performing a treatment, do not leave the system unattended

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