CooperSurgical RUMI II Handle Mode D'emploi

RUMI II Handle
®
Reusable Uterine Manipulator 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.
DEVICE DESCRIPTION
The RUMI II Handle Uterine Manipulator Handle (Handle) is a reusable device used with a
®
sterile, single-use RUMI Uterine Manipulator Tip (Tip).
The RUMI II Handle along with the RUMI 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.
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.
• The tip is single use only. Never reuse a manipulator tip.
• Contents supplied sterile. Do not use if sterile barrier is damaged.
• Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another
Contamination of the device may lead to injury, illness or death of the patient. Dispose of in accordance with all applicable Federal, State, and local
Medical/Hazardous waste practices.
INTENDED USE / INDICATIONS FOR USE
The Handle is designed for use in operative endoscopy (laparoscopy), where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries
or vagina is desirable. These types of surgeries include laparoscopic tubal ligation, diagnostic laparoscopy and/or operative laparoscopy. The Tips also provide for
dye delivery in those procedures requiring chromopertubation.
CONTRAINDICATIONS
The Handle should not be used in patients who are pregnant or who are suspected of being pregnant, planned gamete intrafallopian transfer procedures, in
patients who have an IUD in place, in patients with suspected pelvic infections and in cases where the surgeon deems it inadvisable or finds it difficult to insert the
silicone tip into the cervix or uterus.
PRECAUTIONS
• Sterilize before use.
• Dilate the cervix to Hegar/Hank 8 (French 24) to ease patient insertion.
• Refer to the RUMI Uterine Manipulator Tip Directions for Use for further precautions.
• Inspect Handle prior to use for proper operation.
ADVERSE REACTIONS
The following adverse reactions have been suspected or reported to be associated with all uterine manipulators. The order of listing does not indicate frequency or
severity: cramping, infection, uterine and fallopian tube spasm with associative temporary physiological blockage of patient fallopian tubes and uterine perforation.
INSTRUCTIONS FOR USE
Note: Refer to the RUMI Uterine Manipulator Tips Directions for Use to ensure proper
selection of Tip size and Tip attachment/detachment instructions.
1. Select a Tip which is less than or equal to the sounded depth of the uterus and attach it to
the Handle.
2. Ensure the Tip catheters are secure in the catheter channels of the Handle (see Figure 1).
Instructions for Use (English)
1
RUMI II Handle
(UMH650)
Grip
Trigger
Catheter Channels
RUMI Uterine
Manipulator Tip
Grip in upward position
Trigger
Catheter Channels
Tip Catheters
Figure 1
Snap Drum
Arm
Tip