User manual
SENSUS
™
Pain Management User Manual
40
APPENDIX F:
Prescribing Information CONT.
• Accessory equipment connected to the USB port must be
certied to the respective IEC standards (e.g. IEC 60950 for
data processing equipment and IEC 60601-1 for medical
equipment). Most computers manufactured by major suppliers
meet the IEC 60950 standard. If in doubt, consult with
your local information technology support.
Adverse Reactions
• Patients may experience skin irritation and burns beneath the
stimulation electrodes applied to the skin.
• Patients may experience headache and other painful sensations
during or following the application of electrical stimulation near
the eyes and to the head and face.
• Patients should stop using the device and should consult
with their physicians if they experience adverse reactions
from the device.
Warnings
• Do not apply stimulation over the neck because this could
cause severe muscle spasms resulting in closure of the airway,
difculty in breathing, or adverse effects on heart rhythm or
blood pressure.
• Do not apply stimulation across the chest because the
introduction of electrical current into the chest may cause
rhythm disturbances to the heart, which could be lethal.