NHS ODFS Pace V1, User Instruction Manual

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Important Information (Contraindications/Warnings)
The clinician shall brief the user on any known contraindications and warnings to
the use of this system and any precautions to be taken. The clinician shall issue
and guide the user through the User Instruction Manual.
Contraindications
The ODFS
®
Pace (XL) should not be used on those who have a cardiac pacemaker, implanted
defibrillator, or other electronic implanted device unless investigations demonstrate that
there is no interaction between the devices.
Warnings
Neck stimulation
Stimulation should not be applied over the neck, because severe spasm of the muscles
may occur and the contractions may be strong enough to close the airway or cause difficulty
breathing. Stimulation over the neck (especially the carotid sinus) could have adverse effects
on heart rhythm or blood pressure.
Open or infected wounds
Stimulation should not be applied over open wounds or over swollen, infected or inflamed
areas or skin eruptions. Stimulation should only be applied to normal, intact, clean skin.
Dilated capillaries and movement caused by moving muscles may disrupt healing tissue.
Cancer
Stimulation should not be applied over, or in proximity to, cancerous tissues as increased
local blood flow may increase tumour growth.
Electronic monitoring equipment
Stimulation should not be applied in the presence of electronic monitoring equipment, such
as cardiac monitors and electrocardiogram alarms. Monitoring equipment may not operate
properly when the electrical stimulation device is in use.
Transcerebral stimulation
The effects of stimulation of the brain are unknown. Therefore, stimulation should not be
applied across the head and electrodes should not be placed on opposite sides of the head,
directly on the eyes or covering the mouth.
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