Cooper Surgical Advincula Arch Instrucciones De Uso

Advincula Arch
for use with the Advincula Arch
Directions for Use (English)
DEVICE DESCRIPTION
The Advincula Arch
attach the Advincula Arch Uterine Manipulator Handle to the Uterine
Positioning System
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.
53469
Adapter is a reusable device that is used to
™
exclusively.
™
Adapter
™
NON-STERILE
STERILIZE bEfORE uSE
CAuTION: U.S. Federal law restricts
this device to sale by or on the order
of a physician.
37340 • Rev. B • 9/11