Johnson & Johnson Surgical Vision Veritas, Руководство оператора

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Specifications
Z370584 Rev. D Electromagnetic Compatibility
12-7
Table 12.7 – Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
(*) When ±2 kV, ±4 kV & 6 kV contact discharge were applied to all metal parts of the ACP and ALP Foot Pedal,
performance interruption occurred. ACP Foot Pedal loses communication to the system. It requires user intervention
to recover all its function without losing stored data. Per client declaration it is an acceptable performance criteria.
Below is client justification for the observed EUT performance.
Foot pedals (wireless & wired mode): If the wireless connection is lost during surgery, the console will be placed into a
safe state, causing the surgical procedure to halt. Upon reconnection of the foot pedal cable, the error is removed and
the procedure can recommence.
The VERITAS Vision System is intended for use in the electromagnetic environment specified below. The
customer or the user of the VERITAS Vision System should assure that it is used in such an environment.
Immunity
test IEC 60601 test
level Compliance
level Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the VERITAS
Vision System, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
(6 Vrms in ISM radio
Bands within 150kHz
- 80MHz)
3 V/m
80 MHz to 2,7 GHz
3 Vrms
3 V/m
Recommended separation distance:
d = 1.2

P
d = 1.2

P 80 MHz to 800 MHz
d = 2.3

P 800 MHz to 2.7 GHz
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:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: 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 predicted 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 the VERITAS Vision System is used exceeds the
applicable RF compliance level above, the VERITAS Vision System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
VERITAS Vision System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.