Idmed Algiscan, Руководство пользователя

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User Manual AlgiScan 34
Temperature 10°C to +40°C
Humidity 35% to 90% (without condensation)
Pressure 700 hPa to 1060 hPa
Technical specifications
Safety
• Eyecup (part in contact with the patient). Latex free
• Conforms to European directive CEE 93/42
• Visible and infrared lighting conforms to IEC 62471 safety standards
• CE marking (certifying body 0459 LNE/G-Med) – Class 2a.
• Compliant with standards IEC 60601-1. Class II equipment.
• Compliant with standards IEC 60601-2-10.
• EMC: IEC 60601-1-2
EMC Emission
Emission test Compliance EMC Instructions/cautions
RF Emissions CISPR 11
Group 1
The AlgiScan uses RF energy only for internal
functions. Therefore RF emissions are very low and
should not disturb other nearby devices.
RF Emissions CISPR 11
Harmonics IEC 61000-3-2 Class B
The AlgiScan must be used in professional
healthcare facility environment
Voltage fluctuations Class A
and flicker IEC 61000-3-3 Compliant
The AlgiScan can be connected to the public mains
network
EMC Immunity
Phenomenon
Basic EMC
standard
Professional
healthcare
facility
environment
Immunity Test
Levels
Compliance
levels
EMC
Instructions/precautions
ELECTROSTATIC
DISCHARGE
(ESD)
IEC
61000-4-2
± 8 kV contact ± 8 kV contact
In order to reduce ESD, the device
must be used in a 35% humidity
environment or more
± 2 kV, ± 4 kV,
± 8 kV,
± 15 kV air
± 2 kV, ± 4 kV,
± 8 kV air
Radiated RF EM
Fields
IEC
61000-4-3
3 V/m
80 MHz – 2,7
GHz
80 % AM at
1 kHz
3 V/m
80 MHz – 2,7
GHz
80 % AM at
1 kHz
Use of this equipment adjacent to or
stacked with other equipment should
be avoided because it could result
in improper operation. If such use is
necessary, this equipment and
the other equipment should be
observed to verify that they are operating
normally
Proximity fields
from RF
wireless com-
munications
equipment
IEC
61000-4-3
Complies to
table 9 of IEC
60601-1-2
(2014)
Complies to
table 9 of IEC
60601-1-2
(2014)
In order to prevent electromag-
netic disturbance, keep minimum
separation from RF communication
equipment of 30cm