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VitalStim® Plus Electrotherapy System
WARNING
• U.S.A. Federal Law restricts these devices to sale by, or on the
order of, a physician or licensed practitioner. This device should be
used only under the continued supervision of a physician or
licensed practitioner.
• Be sure to read all instructions for operation before treating
patient.
• Care must be taken when operating this equipment around other
equipment. Potential electromagnetic or other interference could
occur to this or to the other equipment. Try to minimize this
interference by not using other equipment in conjunction with it.
• Electronic monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when electrical stimulation is in
use.
• Do not drop the unit on hard surfaces or submerge in water. These
actions will damage the unit. Damage resulting from these
conditions is not covered under the warranty.
• This device should be kept out of the reach of children.
• Use only cables and accessories that are specially designed for the
VitalStim® Plus unit. Do not use accessories manufactured by
other companies on the VitalStim® Plus unit. DJO is not
responsible for any consequence resulting from using products
manufactured by other companies. The use of other accessories or
cables may result in increased emissions or decreased immunity
of the VitalStim® Plus unit.
• Contaminated electrodes, lead wires, and gel can lead to
infection.
• Use of electrode with degraded hydrogel can result in burn to the
skin.
• DO NOT operate this unit in an environment where other devices
are being used that intentionally radiate electromagnetic energy
in an unshielded manner.
WARNING
• Use of electrode on multiple patients can lead to infection.
• Stop treatment immediately if patient experiences discomfort or
pain.
• Long term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied transcerebrally.
• Stimulation should not be applied over swollen, infected, and
inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,
varicose veins, etc.
• Stimulation should not be applied over, or in proximity
to, cancerous lesions.
• Using the supplied stimulation electrodes, the current density will
not exceed 2mA/cm2. Using smaller electrodes or needle
electrodes may lead to current density greater than 2mA/cm2. In
such cases, special caution is to be exercised when adjusting the
current level as too high values may cause skin irritation or
possibly burns. Consult the Electrode Current Density table in
Appendix 3.
• The VitalStim® Plus Electrotherapy System optional accessories are
designed for use only with the VitalStim® Plus Electrotherapy
System.
• Medical electrical equipment needs special precautions
regarding EMC. Portable and mobile RF communication
equipment can be affected by other medical electrical
devices.
• Common RF emitting devices (e.g., RFID) and electromagnetic
security systems (e.g., metal detectors) may interfere with the
operation of the VitalStim® Plus Electrotherapy System. The
VitalStim® Plus Electrotherapy System has been tested in the
presence of these types of devices and while no adverse event
occurred, the device should not be operated within the vicinity or
environment as another RF emitting device.
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GENERAL INFORMATION
WARNING
• Before administering any treatment to a patient you should
become acquainted with the operating procedures for each mode
of treatment available, as well as the indications,
contraindications, warnings and precautions. Consult other
resources for additional information regarding the application of
each mode of treatment.
• Simultaneous connection of a patient to high frequency surgical
equipment may result in burns at the site of the stimulator
electrodes and possible damage to the stimulator.
• Keep electrodes separated during treatment. Electrodes in contact
with each other could result in improper stimulation or skin burns.
• Electrodes should be inspected before each use for resistance. (i.e.
hydration level, tack, discoloration and impurities) Follow the
manufacturing guidelines on electrode packaging.
• Extra care should be taken when this unit is used with children.
DANGER
• Stimulation should not be applied over the carotid sinus
particularly in patients with a known sensitivity to the carotid
sinus reflex.
• Use only electrodes and accessories designed specifically for use
with the VitalStim® Plus Electrotherapy System. Use of other
accessories and/or techniques not approved under the VitalStim®
Plus certification training may result in death, injury, or adverse
effects to patient or undesirable and ineffective results.