
Appendix
Appendix 1
State
Alarm condition delay
Alarm signal generation delay
Low voltage alarm
60 s
5 ms
SpO
2
alarm
1 s
5 ms
Pulse rate alarm
1 s
5 ms
Probe error alarm
16 ms
5 ms
Appendix 2
Guidance and manufacture's declaration
Guidance and manufacture’s declaration –
electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration –
electromagnetic emission
The
CMS50E Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer of the user of the
CMS50E Pulse Oximeter
should assure that it is used in such and
environment.
Emission test
Compliance
Electromagnetic environment
–
guidance
RF emissions
CISPR 11
Group 1
The
CMS50E Pulse Oximeter
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.
RF emission
CISPR 11
Class B
The
CMS50E Pulse Oximeter
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.
Guidance and manufacture’s declaration –
electromagnetic immunity
–
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration –
electromagnetic immunity
The
CMS50E Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer or the user of
CMS50E Pulse Oximeter
should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
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 floor are covered with
synthetic material, the relative humidity
should be at least 30%. the manufacturer
may recommend the ESD precautionary
procedures to user.
Power frequency
(50Hz) magnetic field
IEC 61000-4-8
30A/m
30A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
Guidance and
manufacture’s declaration –
electromagnetic immunity
–
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration –
electromagnetic immunity
The
CMS50E Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer or the user of
CMS50E Pulse Oximeter
should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance level Electromagnetic environment - guidance