Bard Peripheral Vascular CROSSER GEN200 Instrucciones De Uso

ENGLISH
C Recanalization System
™
roSSEr
C Generator - Manual of Operations
™
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Instructions for Use
Warning! Carefully read all instructions prior to use. Observe all warnings and precautions noted
throughout these instructions. Failure to do so may result in complications.
Caution! Federal (USA) law restricts this device to sale by or on the order of a physician
Description
The C ™ Recanalization System consists of a re-usable electronic C
rosser
high frequency Transducer, the F M ® Injector (optional), and single-use C
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Catheter is connected to the electronic C
rosser
activate the system. The C ™ Generator and Transducer convert AC power into high frequency mechanical
rosser
vibrations which are propagated through a core wire to the metal tip of the C
of the C ™ Catheter is constructed from Pebax and a hydrophilic coating covers the distal portion of the
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C ™ Catheter.
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The C ™ Generator is packaged with the Transducer and Foot Switch.
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A timer on the front of the C ™ Generator displays the total activation time.
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The F M Injector is a sterile saline injector for use as an accessory to the C
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The F M Injector is sold separately by Bard.
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Indications
The C ™ Recanalization System is indicated to facilitate the intra-luminal placement of conventional
rosser
guidewires beyond chronic total occlusions.
The C ™ Generator is intended for use only with the C
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Refer to the C ™ Catheter Instructions for Use.
rosser
Transducer
C ™
roSSEr
Catheter
Irrigation Lumen
Figure 1 – The C
.
Reset
Figure 2- Front of C Generator
TM
roSSEr
™ Generator, Foot Switch,
rosser
™ Catheter. A C
rosser
™ Generator through the Transducer. The Foot Switch is used to
™ Catheter. The main body
rosser
™ Recanalization System.
rosser
™ Catheter.
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C ™
roSSEr
Generator
F M
®
Low atE
Injector
5 Caster. (IV Pole
not provided)
Foot Switch
™ Recanalization System
roSSEr
GEN200
XXXXXXXX
YYYY-MM
Figure 3- Rear of C
TM
roSSEr
Specifications
Model
Weight (all components)
Dimensions (C
rosser
Electrical
Power Cord
Safety
EMC
Ingress of Fluids
™
rosser Protection Against Electrical Shock
Fuses
Operating Frequency Range
Activation Time Limits
Transport and Storage Environment
Operating Environment
Mode of Operation
This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/
EEC (IEC 60601-1-2: 2007). The limits are designed to provide reasonable protection against harmful interference
in a typical medical installation. The equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with these instructions, may cause harmful interference to other devices in the
vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference with other devices, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected
• Consult the manufacturer or field service technician for help
Electromagnetic Environmental Guidance
™
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.
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Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
™
The C Generator is not suitable for interconnection with other equipment with the exception of the F
rosser
Portable and mobile RF communications equipment can affect operation of the C
The use of accessories and cables other than those specified, with the exception of cables qualified and sold by Bard for use with the
™
C Generator may result in increased emissions or decreased immunity of the equipment and may cause the equipment to
rosser
be non-compliant with requirements of IEC60601-1-2:2007.
™
The C Generator should not be used adjacent to or stacked with equipment other than the F
rosser
or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be
used.
Generator
1
GEN200
18 lbs (7 kg)
™ 15 x 12 x 4 in. (38 x 30 x 10 cm)
Generator)
100-120/220-240 V at 50/60 Hz 2/1 A
3 conductor, 6A, 250 V, 1.0 mm , HAR, VDE or OVE cord
2
Meets IEC60601-1, UL 60601-1, and CAN/CSA C22.2 No. 601.1
IEC60601-1-2: 2007
C ™ Generator/Transducer – IPX0, ordinary, Foot Switch – IPX8
rosser
Type CF Applied Part ; Degree: Class 1
Two fuses rated at 2 X T2AL, 250V
20.5 KHz ± 500 Hz
Single depress of foot switch 30 seconds maximum
C ™
Max per Catheter 5 minutes. Time accuracy is ± 1 second.
rosser
Temperature -10 ˚C (14 ˚F) to +55 ˚C (131 ˚F)
Relative Humidity 10% to 85% Non-condensing
Atmospheric Pressure: 50-106 kPa
Temperature +10 ˚C (50 ˚F) to +40 ˚C (104 ˚F)
Relative Humidity 30% to 75% Non-condensing
Atmospheric Pressure: 70-106 kPa
Continuous
Electromagnetic Emissions
Compliance Environmental guidance
Group 1 The equipment uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic equipment.
Class A The equipment is suitable for use in all establishments other than domestic, and may be
used in domestic establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes, provided the
Class A
following warning is heeded:
™
Warning: The C Generator is intended for use by health care professionals
roSSEr
Complies
™
only. The C Generator may cause radio interference or may disrupt the
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operation of nearby equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the equipment or shielding the location.
M Injector.
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™
Generator.
rosser
M Injector. If adjacent
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