9
15. Effectiveness is highly dependent upon the patient and the
selection of therapy by a person qualified in the management of pain.
16. Isolated cases of skin irritation have occurred at the site of the
electrode placement following long-term application. If this occurs,
discontinue use and consult your physician.
17. The electrodes are only to be placed on healthy skin. Avoid skin irritation
by ensuring that good contact is achieved between electrodes and skin.
18. If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a comfortable
level and contact your physician if problems persist.
19. This device should not be used while driving, operating machinery,
close to water or during any activity in which involuntary muscle
contractions may put the user at undue risk for injury.
20.
NEVER
use the device in rooms where aerosols (sprays) are used or
pure oxygen is being administered.
21.
DO NOT
use it near any highly flammable substances, gases or
explosives.
22.
DO NOT
use this device at the same time as other equipment which
sends electrical pulses to your body.
23.
DO NOT
confuse the electrode cables and contacts with your
headphones or other devices, and
DO NOT
connect the electrodes
to other devices.
24.
DO NOT
use sharp objects such as pencil point or ballpoint pen to
operate the buttons on the control panel.
25. Inspect applicator cables and associated connectors before each use.
26. Turn the device off before applying or removing the electrodes.
27. Electrical stimulator should be used only with the leads and
electrodes recommended for use by the manufacturer.
28. This device has no AP/APG protection.
DO NOT
use it in the
presence of explosive atmosphere of flammable mixture.
29.
DO NOT
pull on the electrode wire as that may damage the wire and
electrode.
30.
DO NOT
apply to broken skin.
31. The electrodes should be discarded when they are no longer
adhering to the skin.
32. The electrodes are intended for single patient use only.
33. If irritation occurs, discontinue use and consult your clinician.
34. Read the instructions for use of self-adhesive electrodes before
application.
35. Always use the electrodes with the requirements of the IEC/
EN60601-1, ISO10993-1/-5/-10 and IEC/EN60601-1-2, such as with
CE mark, or are legally marketed in the U.S. under 510(K)
procedures.
