3
PADnet
®
AND VEINnet
™
USER GUIDE
L-128 Rev B Jan 2013
BioMedix
®
•
Saint Paul, MN 55101
•
www.BioMedix.com
•
Toll Free: 888-889-8997
•
Fax: 651-762-4014
Important EMC information. Read prior to installing or using BioMedix
®
medical devices:
•
Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of
BioMedix medical devices.
•
BioMedix medical devices have been tested and found to comply with IEC/EN 60601-1-2.
•
Computers, cables and accessories not tested to 60601-1-2 may result in increased emissions or decreased
immunity of BioMedix devices.
•
Verify normal operation if utilizing BioMedix medical devices adjacent to or stacked with other electrical
equipment.
EMC Information
Attention should be paid to the following EMC information prior to installing or using BioMedix
®
medical devices:
Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of BioMedix
medical devices.
BioMedix Vascular Solutions medical devices have been tested and found to comply with IEC/EN 60601-1-2.
Computers, cables and accessories not tested to 60601-1-2 may result in increased emissions or decreased immunity of
BioMedix devices.
Verify normal operation if utilizing BioMedix medical devices adjacent to or stacked with other
electrical equipment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emission and Immunity
Emissions Test
Compliance
Electromagnetic environment-guidance
RF emissions CISPR 16.1.1 2006
ANSI C63.4-2004
Group 1
BioMedix
®
equipment uses RF energy only
for its internal function. Therefore, its RF emissions are not
likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 16.1.1.2006
Group A
BioMedix medical devices are suitable for
use in all establishments including domestic establishments
and those directly connected to the public low-voltage power
supplies buildings used for domestic purposes.
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage Fluctuations/flicker
emissions
Not applicable
IEC 61000-3-3
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± KV contact
± 8 air
Pass
Criteria Class A
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%
Electrical fast
transient burst
IEC 61000-4-4
± 2 KV for power supply
lines
± 1 KV for input/output
lines
Pass
Criteria Class A
Mains power quality should be that of a typical commercial
or hospital environment.
Surge
IEC 61000-4-5
± 1 KV differential mode
± 2 KV common mode
Pass
Criteria Class A
Mains power quality should be that of a typical commercial
or hospital environment
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% UT (› 95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
‹ 5% UT (› 95% dip in UT)
for 5 sec
Criteria Class A
Criteria Class A
Criteria Class A
Criteria Class C
Mains power quality should be that of a typical commercial
or hospital environment. If the user of BioMedix
medical devices requires continued operation
during power mains interruptions, it is recommended that the
computer to be used is powered by an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Pass Criteria Class A
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
