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SIMEOX is intended to operate in the following environments:

In healthcare facilities, in medical or paramedical practices

At home

The essential performance of SIMEOX defined for magnetic compatibility, according to the result of the Risk Analysis

is as follows:

1

The device must remain operational during the tests.

2

If the outlet is physically blocked, either by simulation of an obstruction for example, the patient’s tongue,

or by the measuring instrument, SIMEOX should switch to status “outlet is blocked” if the negative pressure

level is above the limit of 160 mBar, and once in “outlet is blocked” status, should maintain this status,

regardless of the disturbances to which the device is subjected.

Electromagnetic compatibility

11

Using this device near or stacked on other appliances should be avoided because this could cause

a malfunction. If this use is necessary, this device and the other appliances should be monitored to

check they are operating normally.

Portable RF communication appliances should not be used (including peripherals such as antenna

cables and external antennae) closer than 30 cm (12 inches) to any part of SIMEOX including the

cables specified by the manufacturer. Otherwise, the performance of these appliances could be

impaired.

The use of accessories, transducers and cables other than those specified or supplied by PHYSIO-

ASSIST can cause an increase in electromagnetic emissions or a reduction in the immunity of this

device and cause inappropriate operation.

43

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