Delcath Systems CHEMOSTAT Mode D'emploi page 17

LIMITED WARRANTY
Delcath Systems, Ltd. ("Delcath") warrants that the Delcath Hepatic CHEMOSAT®
Delivery System ("Product") will be free of defects in material and workmanship at
the time of delivery and until the stated expiration date as indicated on the Product.
This warranty is available and extended only to the original end-user purchaser of the
Product. THE FOREGOING IS DELCATH'S SOLE WARRANTY.
Any Product, or part of the Product, that is judged by Delcath to be defective in
material or workmanship during the warranty period will be replaced or repaired by
Delcath at its sole option and its expense. Remedies available to the purchaser under
this warranty are limited to replacement of the entire Product or malfunctioning parts
of Product with the specific remedy subject to determination by Delcath in its sole and
reasonable judgement. Application for warranty coverage and remedy must be made
in writing to Delcath within ten (10) days of the apparent malfunction. All authorized
Product returns will be subject to Delcath's Return Goods Policy.
This warranty is void if the Product has been (a) improperly stored or handled; (b)
modified, altered or repaired in any way; (c) reused, reprocessed, or re-sterilized; (d)
improperly or negligently used or misused; (e) combined or used with a third party's
products; or (f) damaged by negligence, accident, or intentional misconduct.
THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE GOODS SOLD HEREUNDER.
EXCEPT AS EXPRESSLY PROVIDED HEREIN, DELCATH MAKES NO WARRANTY OF ANY
KIND, EXPRESS OR IMPLIED, ORAL, WRITTEN OR OTHERWISE, WITH RESPECT TO THE
PRODUCT(S) SOLD HEREUNDER, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE OR PURPOSE.
DUE TO BIOLOGICAL DIFFERENCES IN HUMAN PATIENTS AND BECAUSE DELCATH HAS NO
CONTROL OVER THE CONDITIONS UNDER WHICH ITS PRODUCTS ARE USED, DIAGNOSIS
OF THE PATIENT, TYPE OF TREATMENT, SURGICAL PROCEDURE, THE METHOD OR
ADMINISTRATION OF THE PRODUCT OR THE STORAGE AND HANDLING OF THE PRODUCT
AFTER IT LEAVES DELCATH'S POSSESSION, DELCATH DOES NOT WARRANT EITHER A
GOOD EFFECT OR AGAINST ILL EFFECT FOLLOWING THE USE OF THE DELCATH PRODUCT
AND DELCATH MAKES NO WARRANTY AS TO WHETHER OR NOT ANY PARTICULAR OR
DESIRED RESULT IS OBTAINABLE BY APPLICATION OR USE OF THE DELCATH PRODUCT.
DELCATH SHALL UNDER NO CIRCUMSTANCES BE LIABLE TO THE PURCHASER OR ANY
THIRD PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, CONSEQUENTIAL OR
EXEMPLARY DAMAGES OF ANY NATURE, WHATSOEVER, INCLUDING, BUT NOT LIMITED
TO, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS INTERRUPTION OF ANY NATURE,
LOSS OF PROFITS OR REVENUE, REAL OR PERCEIVED LOSS OF USE, LOSS ARISING FROM A
DEFECT IN DESIGN, MATERIAL AND/OR MANUFACTURE OR WORKMANSHIP AND/OR THE
FAILURE OF THE PRODUCT(S) TO PERFORM AS SPECIFIED, EVEN IF DELCATH SHALL HAVE
BEEN ADVISED TO THE POSSIBILITY OF SUCH DAMAGES.
IT IS REQUIRED THAT THE DELCATH PRODUCT BE OPERATED BY OR UNDER THE
IMMEDIATE, DIRECT SUPERVISION OF A LICENSED PHYSICIAN OR OTHER LICENSED
HEALTHCARE PROFFESIONAL QUALIFIED TO USE THE PRODUCT AND PERFORM THE
PROCEDURE. DECATH DISCLAIMS LIABILITY FOR ALL INJURIES, DEATHS, OR PROPERTY
DAMAGE ARISING FROM THE USE OF THE PRODUCT BY ANYONE, OTHER THAN QUALIFIED
PERSONNEL DESCRIBED ABOVE, OR THE IMPROPER, NEGLIGENT OR RECKLESS USE OF
THE PRODUCT, OR THE USE OF THE PRODUCT FOR ANY UNAPPROVED INDICATION OR
FOR ANY USE NOT SPECIFICALLY INDICATED IN THE INSTRUCTIONS FOR USE FOR THE
PRODUCT.
Catalog No.
Do not
resterilize.
Sterilized using
ethylene oxide.
Sterilize using Sterilized using
steam (or dry) heat.
steam or dry heat
Authorised Representative in
EU Authorized
the European Community. Representative
Keep Away From Sunlight.
Non-pyrogenic.
Legal
Manufacturer
Manufacturer
The Packaging of This Product
Delcath Systems, Inc. Contains Dry Natural Rubber .
566 Queensbury Avenue
Queensbury, NY 12801
USA
USA Customer Service: 800-XXX-XXXX
17
Do not use if package
Do not use if package
is damaged.
is damaged.
Use By
Batch Number
Keep Dry.
For single use only.
Do Not Reuse.
Do not reuse.
This Product Contains Contains or presence of
The Packaging of This Product
LATEX
Dry Natural Rubber.
natural rubber latex.
Contains Dry Natural Rubber .
Contains or presence of
DEHP
phthalate: bus (2-ethylhexyl)
phthalate (DEHP).
Federal Law (USA) restricts
ONLY
this device to sale by or on the
order of a physician.
Consult Instructions For Use