Cardioline HD+, User Manual

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HD+
3.
ELECTROMAGNETIC COMPATIBILITY (EMC)
9
3. ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic compatibility during the use of the device is required with the surrounding devices.
An electronic device can generate or receive electromagnetic interference. The electromagnetic
compatibility test (EMC) has been carried out on the electrocardiograph in compliance with the international
EMC directive for medical equipment (IEC 60601-1-2). This IEC standard has been adopted as a European
standard (EN 60601-1-2).
The device must not be used above or next to other devices. If necessary, check the system during normal
use, depending on the configuration.
Fixed, portable and mobile equipment for RF communication may affect the protection of the medical
equipment. See par. 3.4 for the recommended separation distance between
the radio equipment and the device.
The use of accessories and cables other than those recommended by Cardioline SpA, may cause an increase
in emissions or a lowering in the protection of the system.
3.1. Guidance and manufacturer's declaration of electromagnetic
emissions
The device is intended for use in the electromagnetic environment specified in the table below. The
customer or the user should assure that the device is used in the appropriate environment.
Emission test Conformity Electromagnetic Environmental Information
Radio frequency emissions
(RF) CISPR 11
Group 2
Electromagnetic energy emissions depend on the use of the device.
Electronic equipment near the device may be affected.
Radio frequency emissions
(RF) CISPR 11
Class B
The device is suitable for use in all establishments other than domestic
environments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonics emissions
IEC 61000-3-2 Not
applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
3.2. Guidance and manufacturer's declaration on electromagnetic
immunity
The device is intended for use in the electromagnetic environment specified in the table below. The
customer or the user should assure that the device is used in the appropriate environment.
Emission test Conformity Compliance level Electromagnetic Environmental Information
Electrostatic discharge
(ESD)
+/- 6 kV contact
discharge +/- 6 kV contact
discharge Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the