Inhoudsopgave
Advertenties
English
EMC declaration for IEC 60601-1-2, Edition 4.1
General information
This device was tested for electromagnetic compatibility using
accessories from the list of accessories. Other accessories may
only be used if they do not compromise the electromagnetic com-
patibility. The use of non-compliant accessories may result in
increased electromagnetic emissions or decreased electromag-
netic immunity of the device.
This device may be used in the direct vicinity of other devices only
if Dräger has approved this device arrangement. If no approval
has been given by Dräger, it must be ensured that this device func-
tions correctly in the desired arrangement before use. The instruc-
tions for use for the other devices must be followed.
Electromagnetic environment
This device may only be used in environments specified in section
"Environment of use" on page 7.
Emissions
Radiated emissions
Conducted emissions
NOTE
The emissions characteristics of this equipment 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 equipment 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. The radiated emissions testing was
conducted according to CISPR 16-2-3 as an alternate test
method.
Immunity against
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Fast transient electrical distur-
bances (bursts)
(IEC 61000-4-4)
Impulse voltages (surges)
(IEC 61000-4-5)
Magnetic fields at mains fre-
quency (IEC 61000-4-8)
Voltage dips and short inter-
ruptions in the supply voltage
(IEC 61000-4-11)
Radiated high-frequency dis-
turbances (IEC 61000-4-3)
Conducted high-frequency dis-
turbances (IEC 61000-4-6)
18
Compliance
Class A, group 1
(30 MHz to 1 GHz)
Class A, group 1
(150 kHz to 30 MHz)
Test level and required elec-
tromagnetic environment
Contact discharge: ±8 kV
Air discharge: ±15 kV
Power cable: ±2 kV
Longer signal input lines/out-
put lines longer than 3 m (10
ft): ±1 kV
Voltage, line – line:
±1 kV
Voltage, line – ground:
±2 kV
50 Hz: 30 A/m
Voltage dips at various
phase angles according to the
IEC 60601-1-2 standard
80 MHz to 2.7 GHz: 3 V/m
150 kHz to 80 MHz: 3 V,
ISM bands: 6 V
Immunity against
Electromagnetic fields in the
vicinity of wireless communica-
tion devices
Proximity magnetic fields
(IEC 61000-4-39)
Recommended separation distances from wireless
communication devices
To ensure that the functional integrity of this device is maintained,
there must be a separation distance of at least 1.0 m (3.3 ft)
between this device and wireless communication devices.
The gas analyzer SCIO Four modules complies with the require-
ments of IEC TR 60601-4-2.
Relevant standards
This medical device meets other standards in addition to those
listed here. Additional information is available on request.
–
IEC 60601-1 (Edition 3.2)
Medical electrical equipment
Part 1: General requirements for safety
–
IEC 60601-1-2 (3rd edition)
Medical electrical equipment
Part 1-2: General requirements for safety, collateral stan-
dard: Electromagnetic compatibility;
Requirements and tests
–
IEC 60601-1-2 (Edition 4.1)
Medical electrical equipment
Part 1-2: General requirements for safety, collateral stan-
dard: Electromagnetic disturbances;
Requirements and tests
–
ISO 80601-2-55:2018
Medical electrical equipment
Part 2-55: Particular requirements for basic safety and
essential performance of respiratory gas monitors
Test level and required elec-
tromagnetic environment
Various frequencies were
tested according to table 9 of
IEC 60601-1-2
134.2 kHz: 65 A/m
13.56 MHz: 7.5 A/m
Supplement Scio Four modules
Advertenties
Hoofdstukken
Inhoudsopgave
