Informational Error Messages; Supplier's Declaration Of Conformity; 47 Cfr § 2.1077 Compliance Information; Obtaining Technical Assistance - Boston Scientific Rezum Manuel D'utilisation

Informational Error Messages

Table 15: Informational Error Message Table
Code Error Title Error Cause
Text
250 Prime Paused Vapor
Activation
Button
Released
251 Pre-Treatment Vapor
Paused Activation
Button
Released
341 Prime Paused RF Power
Tolerance Limit
Exceeded
342 Pre-Treatment RF Power
Paused Tolerance Limit
Exceeded
343 Treatment RF Power
Halted Tolerance Limit
Exceeded
41000 Export Error USB Drive Not
Present or
Invalid
41002 Export Error USB Drive
Export Error
Note: The error message dialog boxes associated with errors 250 and 251 close when
the user engages the delivery device vapor button. The error message dialog boxes
associated with errors 341, 342, and 343 close automatically when the RF Power
Supply reset is complete.

Supplier's Declaration of Conformity

47 CFR § 2.1077 Compliance Information
Unique Identifier: Rezūm™
Responsible Party – U.S. Boston Scientific Corporation
Contact Information 300 Boston Scientific Way
Marlborough, MA 01752
508-382-9555
www.bostonscientific.com
FCC Compliance Statement: This device complies with Part 18 of the FCC Rules
For further information, see FCC web site for a complete description of all
requirements.

Obtaining Technical Assistance

For technical information and assistance, contact:
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
US Technical Assistance Center (TAC)
(+) 1-800-949-6708
Monday - Friday: 4:30 a.m. to 5:00 p.m. PT
CETechSupportUSA@bsci.com
European Technical Assistance Center (TAC)
(+) 31 45.546.7707
Monday - Friday: 8:30 a.m. to 5:00 p.m. CET
CEtechsupportEMEA@bsci.com
Black (K) ∆E ≤5.0
Error Message
Delivery Device button was released
before priming completed. Press and
hold Vapor Activation Button (blue) to
continue priming.
Delivery Device button was released
before pre-treatment vapor cycle
completed. Press and hold Vapor
Activation Button (blue) to restart
pretreatment vapor cycle.
Wait for RF Power Supply reset
to complete.
Wait for RF Power Supply reset
to complete.
Wait for RF Power Supply reset
to complete.
Re-insert USB flash drive and try
again. If problem persists, replace
USB flash drive.
Insert a valid USB flash drive with
sufficient available memory.
M006D2201-0031 GTIN 08714729996996
G2200-003 GTIN 0855357006003

WARRANTY

These warranties cover the following Boston Scientific products (Warranted Product):
Equipment
• Rezūm Generator
Disposable Devices
• Rezūm Delivery Device
Equipment Warranty. Except as indicated otherwise below, Boston Scientific warrants
for one year from the Warranty Commencement Date (as defined below) that the
Equipment will be free from defects in title, material and workmanship under normal use
and service. This warranty covers parts and is available only to end-users that purchase
the Equipment from Boston Scientific or its authorized distributors. Any sale, rental
or other transfer or use of Equipment Warranted Product to or by a user other than
the original purchaser shall cause this warranty to terminate immediately. Customers
purchasing through an authorized distributor must contact Boston Scientific promptly
following such purchase to enable this warranty.
Customers purchasing Boston Scientific's Service Plans extend their Equipment
Warranted Product coverage beyond the one year Warranty period (Total Care Plan;
Essential Care Plan).
Disposable Device Warranty. Disposable Devices carry a warranty of the earlier of
first use or expiration date of the products. The reuse of Disposable Devices voids this
warranty for all Warranted Product (including Equipment) otherwise covered. Any sale
or other transfer or use of Disposable Devices Warranted Product to or by a user other
than the original purchaser shall cause this warranty to terminate immediately.
Warranty Commencement. The warranty period begins (the "Warranty Commencement
Date") on the date Warranted Product is sold to the Customer. The warranty period for
any Warranted Product or component furnished to address a warranty claim will be
the longer of the unexpired term of the warranty applicable to the repaired or replaced
Warranted Product or 90 days. Boston Scientific warrants all Equipment that is loaned
or otherwise remains the property of Boston Scientific as part of Boston Scientific's
Agreement with the Customer.
Remedies. If Customer promptly notifies Boston Scientific of Customer's warranty claim
during the warranty period and makes the Warranted Product available for inspection
and service, Boston Scientific will, at its option replace (with new or exchange
replacement parts) the non-conforming Warranted Product or components of the
Warranted Product. The foregoing remedies are Customer's exclusive remedies and
Boston Scientific's sole liability for warranty claims.
Limitations. Boston Scientific shall not have any obligation to Customer hereunder if the
warranty claim results from or arises out of (i) the use of the Warranted Product in a
manner or environment, or for any purpose for which Boston Scientific did not design it,
or in violation of Boston Scientific's recommendations or FDA cleared Instructions For
Use; or (ii) any alteration, modification or revision of the Warranted Product by Customer
or any third party. In addition, these warranties do not cover: (i) any defect or deficiency
that results, in whole or in part, from any improper storage or transport from location
to location, use or handling, failure to maintain the Warranted Products in the manner
described in any applicable instructions or specifications or any cause external to the
Warranted Products or other causes beyond Boston Scientific's reasonable control; (ii)
the payment or reimbursement of any facility costs arising from repair or replacement
of the Warranted Products.
THIS WARRANTY AND REMEDIES SET FORTH ABOVE ARE EXCLUSIVE AND IN LIEU
OF ALL OTHER WARRANTIES, REMEDIES AND CONDITIONS, WHETHER ORAL OR
WRITTEN, EXPRESS OR IMPLIED. BOSTON SCIENTIFIC SPECIFICALLY DISCLAIMS ANY
AND ALL IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. IF BOSTON
SCIENTIFIC CANNOT LAWFULLY DISCLAIM IMPLIED WARRANTIES UNDER THIS
LIMITED WARRANTY, ALL SUCH WARRANTIES, INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED IN
DURATION TO THE DURATION OF THIS WARRANTY. NO BOSTON SCIENTIFIC AGENT
OR EMPLOYEE IS AUTHORIZED TO MAKE ANY MODIFICATION, EXTENSION, OR
ADDITION TO THIS WARRANTY.
BOSTON SCIENTIFIC IS NOT RESPONSIBLE FOR DIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR
CONDITION, OR UNDER ANY OTHER LEGAL THEORY, INCLUDING BUT NOT LIMITED
TO LOST PROFITS, DOWNTIME, GOODWILL, DAMAGE TO OR REPLACEMENT OF
EQUIPMENT AND PROPERTY OR FROM DELAYS IN SERVICE OR THE INABILITY TO
RENDER SERVICE.
Super Sani-Cloth is a registered trademark of PDI, Inc.
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