Troubleshooting - Bard Peripheral Vascular CROSSER GEN200 Instrucciones De Uso

Set Up
Note: This symbol (IEC 60417-5021) denotes the Potential Equalization Conductor that is defined in
IEC 60601-1 3 edition as,
rd
Conductor other than a Protective Earth Conductor or a neutral conductor, providing a direct
connection between electrical equipment and the potential equalization busbar of the electrical
installation.
Medically used rooms in most countries have no facilities for the use of detachable Potential
Equalization Conductors. If however the C
Equalization Conductors are used, the appropriate requirements have been satisfied.
1. Set up C ™ Generator on a 5 caster IV pole not more than 1.5 meters above ground. Position Foot Switch
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and cable to minimize potential tripping hazard.
Note: Refer to other sections of this operations manual for proper use and set up, cleaning and maintenance of the
C ™ Generator, Transducer and Foot Switch.
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2. Connect power cord to back of C ™ Generator and then to the wall receptacle. Make sure the power cord
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is positioned to minimize tripping hazard.
Note: To ensure grounding efficiency is maintained only connect the C
'Hospital Use' receptacle.
3. Connect Foot Switch to C ™ Generator.
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Warning! Do not switch on C ™ Generator without first connecting the Foot Switch.
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4. Connect C ™ Catheter to transducer.
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Note: See C
™ Catheter IFU for details on C
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Note: This connection to the C ™ Catheter is considered a connection to an applied part.
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5. Switch on C ™ Generator using power switch on back of C
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Operational Use
Activation
Activation occurs when the Foot Switch is depressed. An audible tone may be heard whenever the C
Recanalization System is activated.
Timer Display
The timer will record C ™ Catheter activation time in minutes and seconds. The C
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stop functioning once 5 minutes of activation has been achieved.
Warning! Do not exceed 5 minutes of activation time. If 5 minutes of activation time is achieved, exchange
for a second C ™ Catheter and press the RESET button on the face of the C
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to reset the timer. Using a C ™ Catheter for more than 5 minutes of activation time may cause
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C ™ Catheter malfunction and is NOT permitted.
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Warning! Only reset the C ™ generator when a new C
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Note: C ™ Generator will only deliver energy for a maximum of 30 seconds with one continuous depression
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of the Foot Switch and will not deliver more than 5 minutes total time without resetting the C
Shutdown Procedure
1. Refer to C ™ Catheter IFU for catheter removal from patient and Transducer.
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2. Switch the C ™ Generator 'off'. The power switch is located at the mains connection on the back panel.
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Cleaning
Warning! Only use a mild detergent solution to disinfect the unit.
Caution! Always disconnect the power cord before cleaning.
1. Clean the Transducer and Foot Switch with a cloth that has been dampened in the solution.
Caution! Do not immerse the Transducer in the solution.
2. Clean the C ™ Generator by wiping with a cloth that has been dampened in the solution. Do not use any
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abrasive cleaners.
Caution! Do not immerse the C ™ Generator. The C
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ingress of fluids. Damage to the C ™ Generator and electrical shock could occur.
roSSEr
Maintenance
Performance of preventive maintenance is not essential. Routine inspection can, however, identify potential
problems before they become serious, thus enhancing the instrument's reliability and extending its useful operating
life. All National requirements for periodically inspecting the general condition of the device and other checks shall
be followed by the user.
Warning! To reduce the risk of electrical shock, do not open the equipment's inner housing. Refer
servicing to qualified personnel only. Removal of panels by unauthorized personnel will void the unit's
warranty.
™ Generator is installed in locations where Potential
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™ Generator to a 'Hospital Grade' or
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™ Catheter attachment.
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™ Generator.
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™ Generator will
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™ Generator
roSSEr
™ catheter is connected.
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™ Generator.
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™ Generator unit is not sealed against the
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Note: Follow local governing ordinances and recycling plans regarding disposal or recycling of device components.
How Supplied
The C ™ Generator, Foot Switch and Transducer are supplied ready for use.
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Troubleshooting

Symptom
Power switch is ON but front
panel display is OFF
Power switch is ON,
front panel display is ON,
Transducer not activating
when Foot Switch is
depressed
Excessive vibration noise
coming from Transducer
Poor performance
™
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Warranty and Servicing
Bard Peripheral Vascular warrants to the first purchaser of this product, that this product will be free from defects
in materials and workmanship for a period of one year from the date of first purchase and liability under this limited
product warranty will be limited, to repair or replacement of the defective product, in Bard Peripheral Vascular's sole
discretion, or refunding your net price paid. Wear and tear from normal use or defects resulting from misuse of this
product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU
OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO
EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be
entitled to additional remedies under the laws of your country.
An issue or revision date and revision number for these instructions are included for the user's information on the
last page of this booklet. In the event 36 months have elapsed between this date and product use, the user should
contact Bard Peripheral Vascular to see if additional product information is available.
Contact Bard for servicing information.
3
Cause Solution
Power cord not properly connected to Check connections
™
wall receptacle or C Generator rosser
Replace fuses
Fuses blown
Check wall receptacle
Wall receptacle defective or not
supplying correct voltage
Return to manufacturer for servicing or replacement
Foot Switch not connected or not
Check connection at C
connected properly
Foot Switch is defective
Return to manufacturer for servicing or replacement
Transducer is defective
Return to manufacturer for servicing or replacement
Power switch turned off/on too quickly or
Turn off, wait 5 seconds, turn on
unit unplugged during last use without
first switching off
™ Tighten connection
Transducer/C Catheter
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connection loose
™
C Catheter is not tightened Refer to C
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properly to Transducer proper connection procedure
Locking collar is not engaged Slide locking collar on Transducer distally over proximal
hub of the C
™
C Catheter kinked or broken
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Transducer defective
Return to manufacturer for servicing or replacement
™
Generator
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™
Catheter Instructions for Use for
™
Catheter
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™
Catheter