14
Guidance and Manufacturer
’
s Declaration
–
Electromagnetic Immunity
Adherus AutoSpray ET Dural Sealant is intended for use in the electromagnetic environment specified below. The
customer or user of Adherus AutoSpray ET Dural Sealant should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment-Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80MHz to 2.5GHz
Not Applicable
Battery
Operated
System with no
Digital Circuitry
Not Applicable
Battery
Operated
System with no
Digital Circuitry
Portable and mobile RF communications equipment
should be used no closer to any part of Adherus
AutoSpray ET Dural Sealant, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d
= 1.2√P
d
= 1.2√P
80MHz to 800MHz
d
= 2.3√P
800MHz to 2.5GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
, should
be less than the compliance level in each frequency
range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which Adherus AutoSpray ET Dural
Sealant is used exceeds the applicable RF compliance level above, the Adherus AutoSpray ET Dural Sealant
device should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Adherus AutoSpray ET Dural Sealant device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less the 3V/m
