Precautions
Therapy shall be performed by qualified personnel trained and/or
experienced in the use of this device as outlined in an appropriate training
program.
Electromagnetic interference: This device may cause electromagnetic
interference to electronic devices
The emissions characteristics of this device make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this device
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
This device is suitable for use in hospital environments except for near active
HF surgical equipment or in the RF shielded room of magnetic resonance
imaging equipment where the intensity of EM disturbances is high.
WARNING: use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation.
Cross contamination: Patients with skin infection in the treatment area
should have precautions taken in order to avoid cross-contamination.
Consideration must be given to the current densities for any electrode used
with the Combination 860 unit. Current densities greater than 2 mA rms/cm
2
are not recommended because of the risk of burning. All the standard EMS
Physio conductive rubber electrodes may be used up to the maximum output
of the unit without exceeding this figure. When using other electrodes, the
maximum safe output current should be assessed before use. First estimate
the effective contact area of the electrode in square cm, and then apply the
following formula: -
rms output current (mA) = Area of electrode (cm
2
) x 2
The ratio of the rms to the peak current for the different operating modes is
given in the technical specification section of this manual.
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