Intended Use / Indications For Use; Contraindications; Adverse Reactions; Directions For Use - CooperSurgical RUMI II Griff UMH650 Gebrauchsanleitung

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.
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.

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
• 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.

DIRECTIONS 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).
Trigger
® Uterine Manipulator Tip Directions for Use for further precautions.
Grip in upward position
Tip Catheters
Figure 1
Catheter Channels
Tip