6
•
Interconnections conditions require the applied parts of other medical
electrical equipment used within the configuration for hysteroscopic
application to be type BF applied parts or type CF applied parts
•
This equipment is designed and tested to minimize interference with
other electrical equipment. However, if interference occurs with other
equipment it may be corrected by one or more of the following
measures:
1.
Reorient or relocate this equipment, the other equipment, or both.
2.
Increase the separation between the pieces of equipment.
3.
Connect the pieces of equipment into different outlets or circuits.
4.
Consult a biomedical engineer. Electrical safety testing should be
performed by a trained biomedical engineer or other qualified
person.
•
It is the responsibility of the person(s) installing, utilizing and
decommissioning the Benesta
TM
Tissue Removal Device to ensure that
the electromagnetic environment does not exceed or deviate from the
specifications listed in Tables 1-4.
The following tables provide information on the electromagnetic
environment that the Benesta
TM
Tissue Removal Device is capable of
operating in safely.
Table 1. Declaration of Electromagnetic Emissions
The Benesta
TM
Tissue Removal Device is intended for use in the electromagnetic environment
specified below. The customer or the user of the Benesta
TM
Tissue Removal Device should assure that
it is used in such an environment.
Emissions test
Test Level/
Limits
Electromagnetic Environment / Recommendations
RF emissions CISPR 11 Class A
The EMISSIONS characteristics of this equipment make
it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate
protection to radio-frequency communication services.
The user might need to take mitigation measures, such
as relocating or re-orienting the equipment
Harmonic distortion
IEC 61000-3-2
IEC 61000-3-2
Class A
Not Applicable - device is battery operated
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Pst ≤1.0
Plt ≤ 0.65
dc ≤ 3.3%
dmax ≤4.0%
Not Applicable - device is battery operated
Table 2. Declaration of Electromagnetic Immunity
Immunity Test
Test Level / Limits
Electromagnetic Environment
/ Recommendations
Electrostatic
Discharge (ESD)
IEC 61000-4-2
8 kV (±) Contact
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
Transients
IEC 61000-4-4
±2 kV AC/DC power supply
±1 kV input/output lines
Not Applicable – device is
battery-operated
Surge
IEC 61000-4-5
±1 kV to line(s)
±2 kV to line(s) to earth
Not Applicable – device is
battery-operated
Radio Frequency
(RF) Common Mode
IEC 61000-4-6
3 Vms
150kHz to 80MHz
Not Applicable – device is
battery-operated
Power Frequency
Magnetic Field
IEC 61000-4-8
30 A/m
Power frequency magnetic fields
should be at levels typical
commercial or hospital
environments.
Voltage Dips and
Interruptions
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
Not Applicable – device is
battery-operated
U
T
is the A.C. mains voltage prior to application test level
Table 3. Guidance and Manufacturer’s Declaration of Electromagnetic
Immunity
The Benesta
TM
Tissue Removal Device is intended for use in the electromagnetic environment
specified below. The customer or the user of the Benesta
TM
Tissue Removal Device should assure that
it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted
Radiated
RF
IEC
61000-4-3
3 Vrms
3 V/m
80 MHz to
2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Benesta
TM
Tissue Removal Device, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance (in meters)
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 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, should be
less than the compliance level in each frequency range.
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.
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 Benesta
TM
Tissue Removal Device is used exceeds the applicable RF compliance
level above, the Benesta
TM
Tissue Removal 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 Benesta
TM
Tissue Removal Device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.