30
i-Pulz 2
Nonetheless, certain precautions must be taken:
•
The 2 cables of 1.2 meter (
Rehan part number 200-01-0062
) that
are supplied with the device ensure the connection between the
i-Pulz 2 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 2 contains no parts that can be replaced by the user, and
unauthorized repairs can lead to increased emission or reduction of
immunity of the device.
•
The medical device may not be used alongside or together with
other devices. Should this be necessary, it must be confirmed that
the i-Pulz 2 is functioning normally with the configuration that the
device is being used.
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 device
should be, you can find more information in tables 1 to 4 below.
Table 1. Emissions Guidance for users
Guidance and Manufacturer’s declaration -
electromagnetic emissions
The i-Pulz 2 (T1) is intended for use in the electromagnetic environment
specified below. The customer or the user of i-Pulz 2 (T1) should assure that it
is used in the following environment:
Emission Test
Compliance
Electromagnetic Environment -
guidance
RF emissions
CISPR11
Group 1
The i-Pulz 2 (T1) uses RF energy
only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
CISPR11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
The device is battery powered
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Not applicable
The device is battery powered
Summary of Contents for i-Pulz 2
Page 1: ...USER MANUAL i Pulz 2...
Page 35: ......
