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Cleaning and Sanitizing
The use of nonflammable agents for cleaning and sanitizing
is recommended. Flammable agents or solvents for cleaning
or sanitizing should be allowed to evaporate before use of the
NovaSure system.
The NovaSure RF controller is not sterile. Cleaning should be done
using a mild detergent and water solution to wipe surface areas
only. Do not immerse unit in liquid or introduce liquid into the
cooling vents or RF cable areas.
The NovaSure disposable device is a sterile disposable device for
single-patient use only.
• Do not use if the packaging is opened or damaged.
• Do not reuse or re-sterilize the disposable device.
Do not sterilize any component of the NovaSure impedance
controlled endometrial ablation system.
Parts List
Ordering information and related parts and accessories
Product Number Description
71978-001 NovaSure RF Controller, Model 09
RFC2010-115
814002
NovaSure RF Controller, Model 10
Power Cord, 115 Volts, North America
RFC2000-FS Foot Switch
815012US CO
2
(USP), Cylinder 5 Pack
NS2013US NovaSure Impedance Controlled Endometrial
Ablation Disposable Device Kit
NS2013KITUS NovaSure Kit: 3 NovaSure Impedance Controlled
Endometrial Ablation Disposable Devices packaged
with 3 SureSound devices
300001 Biohazard Kit
Warranty
Except as otherwise expressly stated in the Agreement: i) Equipment
manufactured by Hologic is warranted to the original Customer
to perform substantially in accordance with published product
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.
WARNING: Dropping the RF controller voids the warranty and could
damage the controller beyond repair. We strongly recommend a
stable cart which includes strapping or stabilizing the controller
to reduce the risk of being dropped. Please use extra care if
transporting the RF controller to an off-site facility. If you have any
questions regarding the RF controller, please call 1-800-442-9892
or (508) 263-2900.
Technical Support and Product Return Information
Service representatives
Should the NovaSure RF controller become inoperable, contact Hologic
Technical Support for instructions and a return materials authorization
number (RMA#). Clean and repackage the controller appropriately and
return it for repair or servicing to the authorized locations listed below. If
the controller is not under warranty, an appropriate handling and repair
charge will be established at receipt and examination of the NovaSure
RF controller.
For More Information
For technical support or reorder information in the United States, please
contact:
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Phone: 800-442-9892 (toll-free)
www.hologic.com
NOTE: Any disposable device-related incident or problem, which is
believed to represent a safety issue, should be reported to Hologic
Technical Support.
Federal law (USA) restricts this device to sale by or on the order of a
physician with appropriate training.
Service returns
Read these instructions prior to returning any used/unused
potentially defective product to Hologic.
Contact Hologic Technical Support if the NovaSure disposable device or
RF controller 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 RF controllers according to the instructions provided by Technical
Support. Be sure to clean the RF controller before returning it and include
all accessories in the box with the returned unit.
Return used or opened disposable devices according to the instructions
provided with the Hologic-supplied biohazard kit.
INSTRUCTIONS FOR USE ALL USERS
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