specifications for one (1) year starting from the date of shipment, or if Installation is required, from the
date of Installation ('Warranty Period'); ii) digital imaging mammography x-ray tubes are warranted for
twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12)
months and are warranted on a straight-line prorated basis during months 13- 24; iii) replacement
parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90)
days from shipment, whichever is longer; iv) consumable Supplies are warranted to conform to
published specifications for a period ending on the expiration date shown on their respective
packages; v) licensed Software is warranted to operate in accordance with published specifications; vi)
Services are warranted to be supplied in a workman-like manner; vii) non-Hologic Manufactured
Equipment is warranted through its manufacturer and such manufacturer's warranties shall extend to
Hologic's customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured
Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that
Products will operate with non-Hologic authorized third-party products.
These warranties do not apply to any item that is: (a) repaired, moved, or altered other than by Hologic
authorized service personnel; (b) subjected to physical (including thermal or electrical) abuse, stress,
or misuse; (c) stored, maintained, or operated in any manner inconsistent with applicable Hologic
specifications or instructions, including Customer's refusal to allow Hologic recommended Software
upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-release or 'as-
is' basis.
Technical Support and Product Return Information
6.9.3
Contact Hologic Technical Support for proper disposal of any part of the Fluent Pro Fluid Management
System if it fails to operate as intended. If product is to be returned to Hologic for any reason,
Technical Support will issue a Returned Materials Authorization (RMA) number and biohazard kit if
applicable. Return the Fluent Pro Fluid Management System according to the instructions provided by
Technical Support. Be sure to clean the product before returning it and include all accessories in the
box with the returned unit. Return used or opened product according to the instructions provided with
the Hologic-supplied biohazard kit.
Serious Incident Reporting
6.9.4
The Competent Authorities, for medical devices, are usually the individual Member States' Ministry of
Health, or an agency within the Ministry of Health. Report any complaints or problems in the quality,
reliability, safety, or performance of this product to Hologic. If the device has caused or added to
patient injury, immediately report the incident to Hologic Authorized Representative and Competent
authority of the respective member state or country.
Complaints Reporting:
6.9.5
Report any complaints or problems with the quality, reliability, safety, or performance of this product to
Hologic. If the device has caused or added to patient injury, immediately report the incident to Hologic
Authorized Representative and Competent authority of the respective member state or country. The
Competent Authorities for medical devices are usually the individual Member States' Ministry of
Health, or an agency within the Ministry of Health.
Contacting Hologic Technical Support
6.9.6
Contact Hologic Technical Support to arrange for proper disposal of the Fluent Pro Fluid Management
System in accordance with the WEEE Directive.
Hologic Technical Support
United States and Canada:
English
Fluent Pro Fluid Management System
Hologic, Inc
250 Campus Drive
Marlborough, MA 01752
Phone: 1.800.442.9892 (toll-free)
www.hologic.com
Supplementary Information
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