Rehan Electronics i-Pulz, Руководство пользователя

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9. Important information regarding EMC
9.1 General
Electronic devices such as portable and mobile RF-communication de-
vices and medical devices can be sensitive for electromagnetic interfe-
rence of similar devices. This malfunction may lead to faulty functioning
of the medical device, causing a potential unsafe situation. Also pay
attention that the medical device may not cause interference with other
devices.
Keeping an eye on the requirements to regulate EMC with the purpose
of preventing unsafe product situations, the EN50501-1-2 norm has
been implemented. This standard defines the rate of immunity for elec-
tromagnetic interferences and the maximum electromagnetic radiations
for medical equipment.
The i-Pulz is manufactured by Rehan Electronics Ltd and adheres to the
EN60601-1-2 norm, for both immunity and emission.
Nonetheless certain precautions must be taken:
The 2 cables of 1,2 meter (Rehan part number 200-01-0044) that are
supplied with the device ensure the connection between the i-Pulz and
the electrodes. The use of cables other than those supplied can lead to
a larger emission or decreased immunity of the device.
The i-Pulz contains no parts that can be replaced by the user, and unau-
thorized repairs can lead to increased emission or reduction of immu-
nity of the device.
The medical device may not be used alongside of or toghether with
other devices. Should this be necessary, it must be confirmed that the i-
Pulz is functioning normally in the configuration that the device is being
used in.
There are no known cases where the device creates an unacceptable
risk for the patient/user when an error should occur in the device.
For further directions regarding the EMC-environment in which the de-
vice should be, you can find more information in tables 1 to 4 below.