Maintenance, Troubleshooting, And Service; Maintenance/ Cleaning; Troubleshooting; Service - Boston Scientific Vessix Generator Mode D'emploi

MaIntenance, troUBleshootInG, anD servIce

Maintenance/ cleaning

Clean the Vessix™ Generator before the first use and between each treatment procedure: use a soft cloth to apply a
cleaning/disinfecting solution to all non-disposable components. Use of non-flammable agents for cleaning and
disinfecting is recommended. If the generator will not be used for an extended time, fully charge the battery prior to
storage (four hour charge time from full discharge is typical).
Warning: Flammable agents or solvents used for cleaning and disinfection of the Vessix Generator should be allowed to
evaporate before high-frequency therapy.

troubleshooting

If a fault occurs (error message appears and red Fault LED indicator may turn on), photograph or write down the Alert Code
and two sub-codes. Then perform the "User Corrective Action" matching the error code from the Generator Alert Codes
table, below. If the condition persists, remove from service and contact a Boston Scientific customer service representative.
error severity
301 User-Correctible
302 User-Correctible
303 User-Correctible
310 User-Correctible
311 User-Correctible
401 User-Correctible
402 User-Correctible
ALL OTHERS Service Required
If display is not on, check power cord and DC power supply connections. If the condition persists, remove from service and
contact a Boston Scientific customer service representative.
In the Section "Using the Vessix™ System", if the patient extension cable/catheter is not detected and the connection to
the Vessix Generator has already been checked, substitute with another patient extension cable. If the problem persists,
replace the catheter. If this does not resolve the problem, remove from service and contact a Boston Scientific customer
service representative.

service

The Vessix Generator does not require any user service or maintenance other than cleaning (see Maintenance/ cleaning
for details).
If the system does not operate correctly, remove from service and contact Boston Scientific. National regulations may
require that the user, manufacturer or manufacturer representative periodically perform and document safety tests of the
device. If such testing is required in your country, follow the testing interval and extent of testing as regulated in your country.
If you do not know the national regulations in your country, please contact your local Boston Scientific representative.
If IEC 62353 is a required standard in your country, but no specific testing or interval is specified, we recommend that the
customer make arrangements to evaluate the unit for testing as specified in IEC 62353 at an interval of every 24 months.
Warning: The Vessix Generator has no user-serviceable parts inside the unit. To avoid the risk of severe electric shock
and maintain the product warranty, do not attempt to disassemble or repair the system.
note: A Returned Goods Authorization (RGA) number must be issued by Boston Scientific prior to returning any product.

Warranty

Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this
instrument. this warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express
or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or
fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors
relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC's control directly affect
the instrument and the results obtained from its use. BSC's obligation under this warranty is limited to the repair or
replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense
directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to
assume for it, any other or additional liability or responsibility in connection with this instrument. Bsc assumes no liability
with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including
but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.
Black (K) ∆E ≤5.0
system error Description
TOUCHING ELECTRODES SUSPECTED
DEFECTIVE CATHETER DETECTED
INTERMITTENT CATHETER
CONNECTION
GENERATOR IS VERY HOT
GENERATOR IS VERY COLD
BATTERY LOW
INTERNAL RESET IN PROGRESS
SERVICE REQUIRED
10
User corrective action
POSITION BALLOON AND INFLATE
PLEASE REPLACE CATHETER
RECONNECT OR REPLACE CATHETER
PLEASE WAIT
PLEASE WAIT
SHUTDOWN IMMINENT,
CONNECT CHARGER NOW!
PLEASE WAIT
CALL BOSTON SCIENTIFIC