Adverse Reactions - CefarCompex CEFAR PERISTIM PRO Gebrauchsanweisung

intend to use it for a prolonged period of time (more than 3 months). Extended storage of the batteries in the
device might lead to batteries and device damage.
• Cable. The cable is best preserved if left attached to the stimulator between sessions. Do not jerk the cable or
connection.
• Heat and Cold products. The use of heat or cold producing devices (e.g. electric heating blankets, heating pads or
ice packs) may impair performance of the electrode or alter the patient's circulation/sensitivity and increase the
risk of injury to the patient.
• Pulled muscles. Do not apply electrodes over pulled muscles. Using the stimulator on a previously extended mus-
cle might further pull such muscle. The higher the stimulation intensity, the higher the risk to further overextends
such muscle.
• Additional Precautions for TENS
– TENS is not effective for pain of central origin, including headache.
– TENS is not a substitute for pain medications and other pain management therapies.
– TENS devices have no curative value.
– TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would
otherwise serve as a protective mechanism.
• Effectiveness of TENS is highly dependent upon patient selection by a practitioner qualified in the management
of pain patients.
3.4. DANGERS
• Electrodes. Any Electrode with a minimum active area of 16 cm² may be used with this device. Use of an electrode
with an area less than 16 cm² can cause burns when the unit is used at higher intensities. Consult your clinician
prior to using any electrode less than 16 cm².

3.5. 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.
• Precaution: Do not disconnect any stimulation cables during a session while the stimulator is switched on. Switch
the stimulator off first. Always turn off the stimulator before moving or removing any electrodes during a session.
• Precaution: Do not use electrodes with an active area less than 16 cm2, as there will be a risk of suffering a burn
injury. Caution should always be exercised with current densities more than 2mA/cm2.
• Precaution: Do not apply stimulation in the vicinity of metal. Remove jewelry, body piercings, buckles or any other
removable metallic product or device in the area of stimulation. Never use the electrodes contra-laterally, i.e. do
not use two pins connected to the same channel on opposite segments of the body.
• Precaution: Never carry out an initial stimulation session on a person who is standing. The first five minutes of
stimulation must always be performed on a person who is sitting or lying down. In rare instances, people of a
nervous disposition may experience a vasovagal reaction. This reaction is connected with fear of the muscle
stimulation as well as surprise at seeing one of their muscles contract without having intentionally contracted it
themselves. A vasovagal reaction causes heart to slow down and blood pressure to drop, which can make you
feel weak and faint. If this does occur, stop the stimulation and lie down with the legs raised until the feeling of
weakness disappears (5 to 10 minutes).
• Precaution: Sudden temperature changes can cause condensation to build up inside the stimulator. To prevent
this, allow it to reach room temperature before use
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