KaVo ORTHOPANTOMOGRAPH OP 3D User And Installation Manual page 215

Table 3: RF immunity of non-life-support equipment or system IEC 60601-1-2
ed.4
PCX-1 issuitable for use in the specified electromagnetic environment. The purchaser or user of
PCX-1 should assure that it is used in an electromagnetic environment as described below:
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
*Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
performed. If the measured field strength exceeds the RF compliance level above, observe PCX-1 to verify
normal operation in each use location. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating PCX-1.
Guidance for actions taken can be found from AAMI TIR 18:2010, Guidance on electromagnetic compatibility
of medical devices in healthcare facilities.
NOTICE! Precautions to take if the use location is near (e.g. less than 1,5 km from) AM, FM or TV
broadcast antennas.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m. The Recommended
Separation Distances are listed in the next table.
NOTICE! These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
NOTICE! RF communications equipment can effect medical electrical equipment.
ORTHOPANTOMOGRAPH
Reviewed Suuronen Esa 2019-09-19 12:21
Approved Lassinen Juuso 2019-10-02 14:37
IEC 60601-1-2 Compliance
Test Level Level
3V 150kHz to 80 3V 150kHz to 80
MHz, 6 V in ISM MHz, 6 V in ISM
and amateur and amateur
radio bands radio bands
between 0,15 between 0,15
MHz and 80 MHz and 80
MHz according MHz according
to table to table
60601-1-2. Ed4. 60601-1-2. Ed4.
Table 5/8. Table 5/8.
10 V/m 80 MHz 10 V/m 80 MHz
to 2,7 GHz to 2,7 GHz
Immunity to Immunity to
proximity fields proximity fields
from RF wireless from RF wireless
communication communication
equipment, equipment,
levels according levels according
to table to table
60601-1-2 ed4 60601-1-2 ed4
table 9. table 9.
™
OP 3D
Electromagnetic Environment
Portable and mobile RF communications equipment
are used no closer to any part of PCX-1 including
cables, than the recommended separation distance
calculated from the equation appropriate for the
frequency of the transmitter.
Recommended Separation Distance:
150kHz-80MHz
80MHz to 800 MHz
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,* are less than the compliance level in
each frequency range.**
Interference may occur in the vicinity of equipment
marked with the following symbol:
10 Technical data
215
D519207, 19