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Vectra® Neo Clinical Therapy System
GENERAL WARNINGS AND PRECAUTIONS
• 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.
• Make certain the unit is electrically grounded by connecting only to a
grounded electrical service receptacle conforming to the applicable
national and local electrical codes.
• 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.
• The safety of TENS waveforms for use during pregnancy or birth has
not been established.
• TENS is not effective for pain of central origin. (This includes
headache.)
• TENS waveforms have no curative value.
• Electronic monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when electrical stimulation is in use.
• TENS is a symptomatic treatment, and as such, suppresses the
sensation of pain which would otherwise serve as a protective
mechanism.
• Inspect the plastic lens of the laser head for blemishes, deformation,
pitting, scratches, discoloration, and cleanliness before each use.
• Do not drop the applicator or unit on hard surfaces or submerge in
water. These actions will damage the applicator and unit. Damage
resulting from these conditions is not covered under the warranty.
• Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous exposure to Laser
energy.
• This device should be kept out of the reach of children.
• Use of other accessories other than those specified in this User Manual
may increase electrical emissions and decrease electrical immunity of
the device.
• Contaminated sponges, 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.
• Use of electrode on multiple patients can lead to infection.
• Clean applicators after each use, otherwise it can lead to cross
contamination and infection.
• When the Laser Module is not in use, it should be protected against
unqualified use.
WARNING
WARNING
• Do not treat through clothing.
• Stop treatment immediately if patient experiences discomfort or pain.
• Do not apply laser on an area of skin that has lotion or ointments
applied as burns may occur.
• Do not use laser on or over a tattoo.
• The laser head must be cleaned with a disinfectant cleaner
(i.e. Virex® II 256) or germicidal cloth (i.e. PDI Sani-Cloth® Plus/Hb)
between each therapy session. Ensure no liquids enter into the laser
head while cleaning. Do not use any chlorine-based cleaners on the
laser head.
• The color of skin, age of lesion, depth of lesion, sensitivity of the
patient, tissue type, and medications that increase sensitivity to light
may affect therapy.
• Powered muscle stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
• In the event of all 300-Level or a 200-Level error message that cannot
be resolved, immediately stop all use of the system, and contact the
dealer or DJO for service. Errors and Warnings in these categories
indicate an internal problem with the system that must be tested by
DJO or a Trained Technician before any further operation or use of the
system.
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Use of a system that indicates an Error or Warning in these
categories may pose a risk of injury to the patient, user, or
extensive internal damage to the system.
• Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous exposure to
ultrasonic energy.
• 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.
• Disconnect the system from the power source before attempting any
maintenance, installation, removal, or replacement procedures to
prevent electrical shock and possible damage to system.
• Keep electrodes separated during treatment. Electrodes in contact
with each other could result in improper stimulation or skin burns.
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