User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 6
nature of the test and any actions that are required (e.g. removal of the recorder for
a shower, manual activation of recordings etc.).
The ECG strips recorded by the R.Test 4 during the procedure are then analysed to
determine the presence (not the absence) of a pathological arrhythmia.
The R.Test 4 should not be used on patients with potentially life-threatening
arrhythmias who require inpatient monitoring or on patients who the attending
physician thinks should be hospitalised.
R. Test 4 is intended for use in an electromagnetic environment in which disturbances due to RF
radiation are controlled.
Electromagnetic compatibility
This medical device complies with the applicable electromagnetic compatibility standards and will
ensure that any electromagnetic interference, from radio frequency transmitters or other electronic
devices, does not create an additional hazard.
The user of the medical device can help to avoid electromagnetic interference by maintaining a
minimum distance, depending on the maximum power of the radio frequency transmission
equipment.
Warning: RF portable communication devices (including peripherals such as antenna cables and
external antennas) should not be used closer than 30 cm (12 inches) to any part of R.Test 4, including
the cables specified by the manufacturer. Otherwise, the performance of these devices may be
impaired.
Warning: The R.Test 4 should not be used next to other devices, or stacked with them, because this
may cause a malfunction. If this is necessary, this unit and other devices should be observed for
normal operation.
Warning: The use of accessories other than those specified or sold by NOVACOR as replacement
parts may result in increased emission or decreased immunity of the medical device and may cause
improper operation.
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