Advincula Arch
™
Adapter
for use with the Advincula Arch
53469
Directions for Use (English)
CAuTION:
U.S. Federal law restricts
this device to sale by or on the order
of a physician.
Note:
The parameters listed on the previous page are only a
recommendation. Sterility of the device is the responsibility of the
hospital or site performing the sterilization. (Refer to the sterilizer’s
manufacturer’s manual for detail about the sterilization unit.)
Following steam sterilization, allow all components to cool to
room temperature. Sudden changes in temperature may damage
the components.
NON-STERILE
STERILIZE bEfORE uSE
PRECAuTIONS AND WARNINGS
•
Failure to properly follow instructions for the Advincula Arch Adapter
(Adapter), including instructions supplied with the Uterine Positioning
System (UPS, 371550-03) and the Advincula Arch Uterine
Manipulator Handle (Manipulator Handle, UMH750), may lead to
injury and result in improper functioning of the system.
• The Adapter is only intended for use with the Advincula Arch
Manipulator Handle and the UPS. Use of this device with any other
Manipulator is not recommended, and could lead to injury and
improper functioning of the device.
• Surgical procedures requiring vaginal instrumentation are not sterile.
Conventional operating room procedures for maintaining sterility
must be observed when the UPS is in use.
• The Adapter is supplied non-sterile and must be cleaned and
sterilized prior to use.
• Verify that the correct Adapter is being used with the Manipulator
Handle.
• Refer to the UPS Directions for Use for further instructions.
• ALWAYS position the patient and the OR table prior to attaching the
UPS to the Manipulator Handle.
• ALWAYS have the patient under general endotracheal anesthesia
when the UPS is attached to the Manipulator Handle.
CONTRAINDICATIONS
Refer to the Manipulator Handle (UMH750) Directions for Use for
applicable contraindications of the device.
CAuTION
U.S. Federal law restricts this device to sale by or on the order of a
physician.
Neutrad® is a registered trademark of Decon Labs, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
All other marks bearing the symbols “TM” and “®” are trademarks and
registered trademarks of CooperSurgical, Inc.
© 2011 CooperSurgical, Inc. All rights reserved.
CAuTION:
U.S. Federal law restricts this device
to sale by or on the order of a physician.
REf
Reorder Number
LOT
Batch Code
!
ExPLANATION Of SymbOLS
LATEx
Latex Free
ATTENTION:
See instructions for use.
R
x
O
NLy
Authorized Representative in the European
Community.
EC REP
Product conforms to the Medical Device Directive
93/42/EEC
DEVICE DESCRIPTION
The Advincula Arch™ Adapter is a reusable device that is used to
attach the Advincula Arch Uterine Manipulator Handle to the Uterine
Positioning System™ exclusively.
DISPOSAL
Dispose of in accordance with all applicable Federal, State and local
Medical/Hazardous waste practices.
37340 • Rev. B • 9/11
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
www.coopersurgical.com
37340 • Rev. B • 9/11
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
EC REP
International
Phone: (203) 601-9818
Fax: (203) 601-4747
Made in the USA
Manufactured for:
