Standards Applied; Electromagnetic Compatibility; Special Instructions - Ambu aScope Duodeno Manual Del Usuario

8.6. Remote Switches
Possible Problem
Remote switches
are not working
or not working
properly

9. Standards Applied

The system conforms to the standard of IEC 60601–1 / ANSI/AAMI ES60601-1, IEC 60601–1–2 and
IEC 60601–2–18.

10. Electromagnetic Compatibility

General
information
Special
Instructions
Recommended safety distance between portable and mobile HF telecommunications
systems and the aScope™ Duodeno. The system is intended for operation in an
electromagnetic environment in which HF interference is controlled. The user of the system
can prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile HF telecommunications systems and the system, depending on the
output power of the communication unit, as specified below.
Nominal power, P, of
transmitter, measured
in watts [W]
0.01
0.1
1
10
100
For transmitter whose maximum nominal power is not specified, the recommended safety
distance can be determined by use of the formulas above.
24
Possible Cause
Endoscope connector is not
properly connected to the
aBox™ Duodeno
Remote switches
configuration changed
Wrong remote switch operated
aScope™ Duodeno defective
aBox™ Duodeno defective
Medical electrical equipment is subject to special precautions with
respect to EMC and must be installed according to the instructions in
the accompanying documentation.
The manufacturer can only guarantee compliance of the equipment if the
accessory parts listed in the accompanying documentation are used.
The device is intended for use exclusively by trained medical
personnel. This device can cause radio interference or interference
with the operation of other equipment in its close vicinity. It may be
necessary to take suitable corrective measures, such as readjustment,
a different system layout, or shielding.
Regulations applying to medical devices require to provide you with
the following information. (See the following pages of all tables.
• Table 1 Recommended safety distances.
• Table 2 Electromagnetic compatibility 1.
• Table 3 Electromagnetic compatibility 2.
• Table 4 Electromagnetic transmission.
Table 1 Recommended Safety Distance
Recommended safety distance, d, expressed in meters, based on
the nominal transmitter power and transmission frequency
150 kHz – 80 MHz
d=3.5/3 √P
0.12
0.37
1.2
3.7
12
Solution
Connect the endoscope connector
properly to the aBox™ Duodeno
Return to the standard
configuration of the remote
switches or change the settings
Operate the correct remote switch
Connect a new aScope™ Duodeno
Contact support
80 MHz – 800 MHz
d=3.5/3 √P
0.12
0.37
1.2
3.7
12
800 MHz – 2.5 GHz
d=3.5/3 √P
0.23
0.74
2.3
7.4
23