Stryker System 7 - Electromagnetic Immunity

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EN 7205-001-700 Rev-AA
Specifications (continued)
Guidance and manufacturer’s declaration - electromagnetic immunity
The System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 7 Dual Trigger Rotary Handpiece (REF
7205-000-000) should assure that it is used in such an environment.
NOTE: The values provided in the table below have changed due to 60601-1-2 4th Edition requirements.
Immunity test IEC 60601 test level Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
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 at 100 kHz
repetition frequency
for power supply lines
± 1 kV at 100 kHz
repetition frequency
for input/output lines
N/A N/A
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV
line(s) to line(s)
± 0.5 kV, ± 1 kV, ± 2
kV line(s) to earth
N/A N/A