CooperSurgical RUMI II UMH650 Instrucciones De Uso

DEVICE DESCRIPTION
®
The RUMI Uterine Manipulator Handle is a reusable device used with a sterile, single-use
RUMI Tip.
The RUMI Uterine Manipulator Handle (Handle) along with the RUMI Uterine Manipulator Tip
(Tip) is used for positioning the uterus during laparoscopic surgery and in dye delivery where
chromopertubation is necessary.
The Grip, Trigger, Arm and Snap Drum are constructed of medical grade autoclavable materials.
The Snap Drum serves for attachment of the Tip.
Turning the Grip while depressing the Trigger permits the movement of the Snap Drum, thereby
moving the position of the Tip. When the Trigger is released, it locks into the
desired position.
Not made with natural rubber latex.
Grip
Trigger
WARNINGS
• The uterus must be sounded for both depth and direction prior to application of the device.
• DO NOT use the Handle as a uterine sound.
• NEVER attempt uterine manipulation without a clear view of the uterus.
• As with all uterine manipulating devices, a careful clinical evaluation should be performed prior
to use.
• Certain clinical conditions may present a uterus which is more prone to perforation
and bleeding.
• Dye injection should be performed SLOWLY. Because of the efficient air/liquid seal created at
the internal cervical os by the balloon, rapid injection of fluids (dye) may create intrauterine
pressures, which could cause uterine damage and/or result in fallopian
tube spasms.
• The Handle has only been tested for use with patients who have been anesthetized. Due to the
need to dilate the cervix, the Handle is not recommended for use in non-anesthetized patients.
RUMI
Reusable Uterine Manipulator Handle
Directions for Use (English)
RUMI
(UMH650)
Arm
Catheter Channels
®
Handle
UMH650
NON-STERILE
STERILIZE BEFORE USE
CAUTION: U.S. Federal law restricts this device to sale
by or on the order of a physician.
Handle
Snap Drum
RUMI Uterine
Manipulator Tip
UMH650-DFU • Rev. A • 4/14