Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5222 Rev. 1 (EN) 9
10-2019
For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at
[e-mail] or go to www.orthosensor.com.
Table 4 - Guidance and manufacturer’s declaration – Electromagnetic Immunity and Emissions
The VERASENSE for Exactech Equinoxe and accessories have been tested and found to comply with the
electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2:2014.
Emissions/Immunity Test Compliance Level
RF Emissions
CISPR 11
Class A, Group 1
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact discharge
± 2, 4, 8 & 15kV air discharge
Radiated RF Immunity
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% at 1 kHz
Immunity to Proximity Fields from RF wireless
communication equipment
IEC 61000-4-3
28 V/m
Conducted Immunity
IEC 61000-4-6
0.15 - 80 MHz
3 Vrms & 6Vrms in ISM Band 1 kHz, AC Mains
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV AC Mains
5kHz & 100 kHz
Magnetic Immunity
IEC 61000-4-8
30 A/m
Voltage dips, short interruptions and voltage
variations on power supply input lines
IEC 61000-4-11
0% U
T
.5 cycle
0% U
T
1 cycle
70% U
T
25 cycles
0% U
T
5 Sec