User's Guide

29
Electromagnetic Compatibility
These devices are intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that the device is used in such an environment.
Portable and mobile RF communication interference may have an impact on the device.
Please use the cables and accessories provided. The cable information is as follows:
#
Item
Lengthm
Shielded?
Notes
1
PDA CHARGING CABLE
1.0m
YES
EUT DC 5V
The use of accessories other thanthose specified for the device is not recommended. They
may result inincreased emissions or decreased immunity of the device.
The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The basic performance is described in the table below:
Performance
Description
Measurement
Accuracy
When the glucose concentration is >75mg/dL, the sensor
accuracy deviation does not exceed ±20%;
When the glucose concentration is 75mg/dL, the accuracy
deviation does not exceed ±20mg/dL
IEC60601-1-2 Table 201
Guidance and manufacturer's declaration electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF Emissions CISPR 11
Group 1
The device 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 CISPR 11
Class B
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply.
Harmonic Emissions IEC
61000-3-2
Class A
Voltage
Fluctuations/Flicker
Emissions
IEC 61000-3-3
Complies
IEC 60601-1-2Table 202
Guidance and manufacturers declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic environment -
guidance