The device is designed to only be used by or under the supervision of persons using
the medical device in the course of their work and in the framework of a professional
healthcare activity, who understand the benefits and limitations of electrotherapy and
ultrasound therapy. I.e.“professional users”.
Do not use this device on patients who have a cardiac pacemaker, implanted defibril-
lator, or other implanted metallic or electronic device, because this may cause electric
shock, burns, electrical interference, or death.
Do not use this device on patients whose pain syndromes are undiagnosed.
Do not apply stimulation over the patient’s neck because this could cause severe
muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure;
Do not apply stimulation across the patient’s chest, because the introduction of electri-
cal current into the chest may cause rhythm disturbances to the patient’s heart, which
could be lethal;
4.1 Intended Use Electrotherapy
4.1.1 Pain Management
Pain Management is the use of electrical stimulation for pain relief.
4.1.1.1 Indications Pain Management
Symptomatic relief and management of chronic, intractable pain. Management of pain
associated with post- traumatic or postoperative conditions.
4.1.1.2 Contra-indications Pain Management
Do not use this device on patients whose pain syndromes are undiagnosed.
4.1.1.3 Warnings Pain Management
4. Intended Use
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Rehab-Series
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