2 . S a F e t y i N F O r M at i O N
10
EN
REVOLUTION WIRELESS™
Warning!
Patient hazard –
− 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 a patient.
− Only authorized individuals are allowed to operate the Revolution Wireless. Individuals
are authorized after receiving training in the operation of the unit and reading this
operating on manual.
− The long-term effects of chronic electrical stimulation are unknown.
− TENS is not effective for pain of central origin (including headache).
− TENS waveforms have no curative value.
− TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which
would otherwise serve as a protective mechanism.
− Before using the therapy unit, the operator must ascertain that it is in correct working
order and operating condition. The cables and connectors, in particular, must be checked
for signs of damage. Damaged parts must be replaced immediately, before use.
− Stop therapy immediately if you have doubts about the device settings and/or the
therapy protocol.
− Patients must be fully conscious while being instructed in the use of the therapy unit and
during therapy.
− Do not treat through clothing.
− Stop treatment immediately if patient experiences discomfort or pain.
− The choice of the therapy parameters to program, of the therapy protocols and electrode
placement is restricted to the responsible physician or therapist. It is the physician’s or
therapist’s decision whether or not to use the unit on a specific patient.
− The patient must be familiar with the functions of the Revolution Wireless remote
control with the modules and the remote control must be within easy reach of the
patient, allowing them to stop therapy, if needed. Patients unable to operate the
emergency stop function (either by stopping on the remote control or by turning off the
modules), e.g. paralytic patients, must never be left unattended during therapy.
− Use of accessories other than those specified in this User Manual may increase electrical
emissions, decrease electrical immunity or lead to unsafe conditions.
− The utmost caution is advised under the following conditions. Depending on the
judgement of the responsible physician, the unit may only be applied under supervision
and with the parameters defined by the responsible physician. Otherwise the exercise
may be too strenuous for the patients with:
1. hypertension (> stage 2), ischemic heart disease and cerebrovascular diseases
2. cardiovascular diseases
