BIOS Diagnostics ABP-01 - EMC Information

20. 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
BIOS Diagnostics
TM
ambulatory blood pressure monitor is 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
ABP-01 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.
Radiated and conducted RF
emission CISPR 11
Class B
ABP-01 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
BIOS Diagnostics
TM
ambulatory blood pressure monitor is suitable for use in the specified electromagnetic
environment. The purchaser or user of BIOS Diagnostics
TM
products should assure that they are used in an
electromagnetic environment as described below.
Monitor Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic
environment
ABP-01
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.
ABP-01
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.
ABP-01
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.