Meditech ABPM-05 - EMC information; EMC Emission and Immunity Standards

BP5BB5LR_UMEN_V05-20170703 26
EMC information
Medical electrical equipment should be used with precautions according to EMC,
and must be installed according to the EMC notices disclosed in this manual as
mobile RF transceivers could adversely affect it.
Electromagnetic emission
Meditech ambulatory blood pressure monitors are suitable for use in the specified
electromagnetic environment. The purchaser or user of the device should assure
that they are used in an electromagnetic environment as described below.
Emission test
Compliance
Electromagnetic environment
Radiated and
conducted RF emission
CISPR 11
Group 1
ABPM-05/BlueBP-05 uses RF energy only for their
internal function. Therefore, the emission is very
low and it is not likely to cause any interference in
nearby electronic equipment. Except for Bluetooth
communication usage. (The Bluetooth
radiofrequency communication is carried out at the
2.4GHz frequency; class2, Bluetooth 2.0+EDR)
Radiated and
conducted RF emission
CISPR 11
Class B
ABPM-05/BlueBP-05 is suitable for use in
domestic establishments and in establishments
directly connected to the low voltage power supply
network which supplies buildings used for
domestic use.
Harmonic emission
IEC61000-3-2
Not applicable
---
Voltage fluctuations/
Flickers IEC61000-3-3
Not applicable
---
Electromagnetic immunity
Meditech ambulatory blood pressure monitors are suitable for use in the specified
electromagnetic environment. The purchaser or user of Meditech products should
assure that they are used in an electromagnetic environment as described below.
Monitor
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic environment
ABPM-05
Electrostatic
discharge (ESD)
IEC 61000-4-2
+ 6KV contact
+ 8 KV air
+ 8 KV air
Floors are wood, concrete or
ceramic tile, or floors are
covered with synthetic
material and the relative
humidity is at least 30
percent.
BlueBP-05
+ 6KV
contact
+ 8 KV air
ABPM-05 &
BlueBP-05
Electrical fast
transient/burst
IEC 61000-4-4
+ 2KV for power
supply
+ 1KV input/output
lines
Not
applicable
Mains power quality is that of
a typical commercial and/or
hospital environment.
ABPM-05 &
BlueBP-05
Surge
IEC 61000-4-5
+ 1KV differential
mode
+ 2KV common
mode
Not
applicable
Mains power quality is that of
a typical commercial and/or
hospital environment.