1600751-4D
4 Intended Use: electrotherapy
4.1 Pain Management
Pain Management is the use of electrical stimulation for pain relief.
4.1.1 Indications/Contraindications
Indications:
• Symptomatic relief of chronic, intractable pain. Management of pain associated with
post-traumatic or postoperative conditions.
Contraindications:
• 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 transcereberally (trough 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.
Warnings:
• 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.
Precautions:
• 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.
Adverse Effects:
• Skin irritation and burns beneath the electrodes have been reported with the use of
therapeutic electrical stimulation.
4.1.2 Current Waveforms
For pain management the 6-series offers the current waveforms described in paragraph 4.3 -
4.3.9.b.