Cooper Surgical RUMI II Instrucciones De Uso

RUMI
Directions for Use (English)
DEVICE DESCRIPTION
II
®
The RUMI
II
®
the RUMI
Positioning System™ exclusively.
PRECAUTIONS AND WARNINGS
• Failure to properly follow instructions for the RUMI II Adapter
(Adapter), including instructions supplied with the Uterine
Positioning System (UPS, 371550-03) and the RUMI II Uterine
Manipulator Handle (Manipulator Handle, UMH650), may lead to
injury and result in improper functioning of the system.
• The Adapter is only intended for use with the RUMI II
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 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.
®
Adapter is a reusable device that is used to attach
Uterine Manipulator Handle to the Uterine
Adapter
53468
NON-STERILE
STERILIZE BEFORE USE
CAUTION: U.S. Federal law restricts
this device to sale by or on the order
of a physician.
37331 • Rev. B • 3/11