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Electromagnetic Immunity
™
The C
Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the
rosser
™
C
Generator should assure that it is used in such an environment.
rosser
Immunity test
IEC 60601 test level
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
Electrical fast
±2 kV for power supply lines
transient/burst
±1 kV for input/output lines
IEC 61000-4-4
Surge
±1 kV line(s) to line(s)
IEC 61000-4-5
±2 kV line(s) to earth
Voltage dips, short
<5 % U
(>95 % dip in U
) for
T
T
interruptions and
0,5 cycle
voltage variations
40 % U
(60 % dip in U
) for
T
T
on power supply
5 cycles
input lines
70 % U
(30 % dip in U
) for
T
T
IEC 61000-4-11
25 cycles
U
= 230 Vac
T
<5 % U
(>95 % dip in U
)
T
T
for 5 sec
Power frequency
3 A/m
(50 Hz) magnetic
field IEC 61000-4-8
Electromagnetic Immunity
™
The C
Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the
rosser
™
C
Generator should assure that it is used in such an environment.
rosser
Immunity test
IEC 60601 test level
Compliance level
Conducted RF
3 V
3 V
rms
rms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m 80 MHz to
3 V/m
IEC 61000-4-3
2,5 GHz
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 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 equipment is used exceeds the applicable RF compliance level above, the equipment
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the equipment.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance level
Environmental guidance
±6 kV contact
Floors should be wood, concrete or ceramic
±8 kV air
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
±2 kV for power
Mains power quality should be that of a
supply lines
typical commercial or hospital environment.
±1 kV for input/output lines
±1 kV line(s) to
Mains power quality should be that of a
line(s)
typical commercial or hospital environment.
±2 kV line(s) to earth
<5 % U
(>95 % dip in U
) for
Mains power quality should be that of a
T
T
0,5 cycle
typical commercial or hospital environment.
40 % U
(60 % dip in U
) for
If the user of the equipment requires
T
T
5 cycles
continued operation during power mains
70 % U
(30 % dip in U
) for
interruptions, it is recommended that
T
T
25 cycles
the equipment be powered from an
No anomalies
uninterruptible power supply or a battery.
95% dip meets requirements.
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Environmental guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the equipment including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
3.5
d = [
] √ P
V
1
3.5
d = [
] √ P 80 MHz to 800 MHz
E
1
7
d = [
] √ P 800 MHz to 2.5 GHz
E
1
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
a
frequency range.
b
Interference may occur in the vicinity of known RF transmitting
devices and equipment marked with the following symbol:
Recommended separation distances between portable and mobile RF communications equipment and the C
™
The C
Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are
rosser
controlled. The customer or the user of the C
rosser
minimum distance between portable and mobile RF communications equipment (transmitters) and the C
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
150 kHz to 80 MHz
W
3.5
d = [
0.01
0.12m
0.1
0.37m
1
1.17m
10
3.69m
100
11.67m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
Warnings and Precautions
• The C
™ Recanalization System should only be used by individuals trained in percutaneous
roSSEr
transluminal angioplasty (PTA or PTCA).
• Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• Warning: No modification of this equipment is allowed.
• Warning: Risk of injury or death to operator or patient can result from unauthorized modification to
C
™ Generator.
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• Note: Position C
™ Generator to allow easy access to separable power cord during use.
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• Prior to use, the C
™ Generator, Foot Switch and Transducer should be inspected for signs of
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damage. Never use damaged components. Contact manufacturer for a replacement.
• The C
™ Generator is not protected against the ingress of fluids (IPX0). Do not place fluids above
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or on the C
™ Generator as damage to the C
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• Explosion Hazard: Do not use in the presence of flammable anesthetics.
• Electrical Shock Hazard: Do not attempt to service C
Contact manufacturer for servicing requirements.
• In the event of a power outage, power interruption, or system reset, replace C
restarting recanalization procedure.
• This device generates, uses, and can radiate radio frequency energy and should only be used and
installed according to these instructions for use.
• DO NOT activate the C
™ Recanalization System without proper irrigation. Make sure to establish
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proper irrigation prior to introduction into guide catheter.
• Do not exceed 5 minutes of activation time as C
of activation time is achieved, exchange the device for a new C
C
™ Generator.
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• Position Foot Switch and cable to minimize potential tripping hazard.
• Ensure C
™ Generator is securely mounted to a 5 caster IV pole with minimum caster diameter of
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7.62cm (3 inches) and a minimum base diameter of 55.9cm (22 inches) no higher than 1.5 meters off the
ground.
• Should high frequency vibration fail to stop when Foot Switch is released, power C
'OFF' or unplug from power receptacle.
• Keep out of reach of patients. The C
patient.
• Caution! The unit is equipped with an exhaust vent. Do not block the openings or internal heat build-up
may occur, causing heat build-up or damage to the equipment.
Required for Use
A C
™ Catheter is required for use with the C
rosser
2
™
Generator can help prevent electromagnetic interference by maintaining a
Separation distance according to frequency of transmitter
80 MHz to 800 MHz
3.5
] √ P
d = [
] √ P
V
E
1
1
0.12m
0.37m
1.17m
3.69m
11.67m
™ Generator or shock may result.
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™ Generator, Foot Switch or Transducer.
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™ Catheter malfunction may occur. If the 5 minutes
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™ Catheter before resetting the
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™ Generator must be at least 1.5 meters away from the
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™ Generator.
rosser
™
Generator
roSSEr
™
Generator as
rosser
800 MHz to 2.5 GHz
7
d = [
] √ P
E
1
0.23m
0.95m
2.33m
9.49m
23.33m
™ Catheter before
™ Generator
roSSEr
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