Use Instructions

55
Version C
Clinician Instructions for Use – Device and Mobile Application
The ADI CPM system is intended for use in the electromagnetic environment specified below. The customer or user
of the ADI CPM system should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR11
Class B
The ADI CPM system uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
CE Emissions
CISPR11
Group 1
Harmonic Emissions
IEC 61000-3-2
Class B
The ADI CPM system is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes
Voltage Fluctuations /
Flicker Emissions IEC
61000-3-3
Compliant
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ADI CPM system is intended for use in the electromagnetic environment specified below. The customer or user
of the ADI CPM system should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Electromagnetic Environment -
Guidance
Electro-Static
Discharge Immunity
Test
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical Fast
Transient / Burst –
IEC 61000-4-4
±2kV 100 kHz rate
±2kV 100 kHz rate
Mains power quality should be that of a
typical commercial or hospital
environment
Conductive Surge –
IEC 61000-4-5
± 0.5 kV, ±1 kV,
(Line to Line)
± 0.5 kV, ±1 kV,
±2kV (Line to Ground)
± 0.5 kV, ±1 kV, (Line
to Line)
± 0.5 kV, ±1 kV, ±2kV
(Line to Ground)
Mains power quality should be that of a
typical commercial or hospital
environment
Power Frequency /
Immunity to
Magnetic Field
IEC 61000-4-8
50Hz/60Hz
30 A/m
50Hz/60Hz
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical
commercial or hospital environment.
Voltage Dips and
Interruptions
IEC 61000-4-11
100 V/60Hz, 240V/
50Hz
0% U
T
for 0.5 cycle at
0°, 45°, 90°, 135°,
180°, 225°,270°,315°;
0% U
T
for 1 cycle;
70% U
T
for 0.5 s; 0%
U
T
for 5 s
100 V/60Hz,
240V/ 50Hz
0% U
T
for 0.5 cycle at
0°, 45°, 90°,135°,
180°, 225°, 270°,
315°; 0% U
T
for 1
cycle; 70% U
T
for 0.5
s; 0% U
T
for 5 s
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the device
requires continued operation during
power mains interruptions, it is
recommended that the device be powered
from an uninterruptible power source.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ADI CPM system is intended for use in the electromagnetic environment specified below. The customer or user
of the ADI CPM system should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Electromagnetic Environment - Guidance