Enraf Nonius Endomed 482, Operating Instructions Manual

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6
4 Intended Use
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”.
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 of chronic, intractable pain. Management of pain associated with post-
traumatic or postoperative conditions.
4.1.1.2 Contra-indications Pain Management
•
This device should not be used for symptomatic pain relief unless etiology is established or
unless a pain syndrome has been diagnosed.
• This device should not be used on patients with demand-type cardiac pacemakers.
• This device should not be used over cancerous lesions.
•
Electrode placements that apply current to the carotid sinus region (anterior neck) must be
avoided.
•
Electrode placements that apply current transcerebrally (through the head) must be avoided.
• Electrode placements that apply current transthoracically (the introduction of electrical current
into the heart may cause cardiac arrhythmias) must be avoided.
4.1.1.3 Warnings Pain Management
•
Benefits of TENS currents have not been established for pain of central origin.
• This device is to be used as a symptomatic treatment for pain and has no curative value.
Patients should be cautioned and their activities regulated if pain that would otherwise serve as a
protective mechanism is suppressed.
•
The long-term effects of chronic electrical stimulation are unknown.
•
Safety has not been established for the use of therapeutic electrical stimulation during pregnancy.
• Stimulation should not be applied over swollen, infected, or inflamed areas of skin eruptions e.g.,
phlebitis, thrombophlebitis, varicose veins, etc.
•
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
4.1.1.4 Precautions Pain Management
• Isolated cases of skin rash may occur at the site of electrode placement following long-term
applications. The irritation may be reduced by use of an alternate conductive medium or an
alternative electrode placement.
•
Effectiveness of this treatment is dependent upon patient selection.
•
See also chapter 3, Precautionary Instructions, for general Warnings and Precautions.
4.1.1.5 Adverse Effects Pain Management
•
Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic
electrical stimulation.
4.1.1.6 Current Waveforms Pain Management
•
For pain management the following current waveforms are recommended.
4.1.3.1, 4.1.3.2, 4.1.3.3, 4.1.3.5, 4.1.3.6, 4.1.3.7, 4.1.3.8, 4.1.3.9.2.
4.1.2 Muscle Stimulation
Muscle Stimulation is the use of electrical stimulation to treat muscle dysfunction.