Directions For Use - CooperSurgical Koh-Efficient KC-RUMI-25 Instrucciones De Uso

® /Koh-Efficient
RUMI
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.
• The RUMI II Koh-Efficient is to be used ONLY with the RUMI II Handle (UMH650).
INTENDED USE/INDICATIONS FOR USE
The Koh-Efficient is a combination KOH Cup and Colpo-Pneumo Occluder that is indicated for use in
laparoscopic procedures where it is desirable to locate the position of the vaginal fornices, typically
during a total laparoscopic hysterectomy or supra-cervical laparoscopic hysterectomy.
CONTRAINDICATIONS
The Koh-Efficient should not be used in patients who are pregnant or who are suspected of being
pregnant, in patients that have an IUD in place, in patients with suspected pelvic infections or in cases
where the surgeon deems it inadvisable and finds it difficult to insert the silicone tip into the cervix or
uterus.
PRECAUTIONS
Always confirm that the Koh-Efficient is locked in place prior to starting the colpotomy.

DIRECTIONS FOR USE

RUMI
Uterine Tip Balloon
Uterine Tip
Colpo-Pneumo
Occluder
KOH Cup
For complete information on how to prepare The RUMI
Use for the RUMI II Handle (UMH650), the RUMI Uterine Manipulator Tips and the Cervical Sizer
(KC-SIZER).
1. Prepare the Handle for use by following the Handle's Directions for Use.
2. Attach the proper size Tip to the
Handle. Fully press the Tip
Catheters into the three channel
positions on the Arm
(see Figure 1).
3. Using the Sizer, determine the
proper size Koh-Efficient.
Tip
Catheters
™
• Directions for Use • English
(continued)
System (Assembled)
Trigger
Grip
Arm
Push Pad
II System, please refer to the Directions for
®
Arm
Channels
Figure 1
RUMIIIKOH-DFU • Rev. A • 11/14
® /Koh-Efficient
RUMI
4. With the Handle in the neutral position (see Figure 2), and the Koh-Efficient in the open position,
slide the Koh-Efficient over the Tip and Arm (see Figure 3) to where the arrow on the Koh-Efficient
meets the arrow on the Arm (see Figure 4).
Figure 2
Koh-Efficient in open position
5. Close the Koh-Efficient (see Figure 3) by firmly pressing it onto the Arm (see Figure 5).
Slide the Koh-Efficient back to the start position (see Figure 6).
Figure 5
6. Test inflate the Colpo-Pneumo Occluder with 20 to 60 cc of sterile saline, then deflate prior to
patient insertion.
7. Insert the Tip into the uterus and inflate as per Tip Directions for Use.
8. Press on the Push Pad and slide the Koh-Efficient forward until locked in place (see Figure 7)
and a "click" is heard. Confirm locked position by pulling back on the Push Pad. Visually confirm
that the indicator marks on the Koh-Efficient are lined up with the indicator line on the Arm (see
Figures 7 & 8) and the Push Pad is in line with the end of the arrow (see Figure 8). Note: The last
1/4" of travel will have increased resistance.
Locked Position
Figure 7
™
• Directions for Use • English
(continued)
Figure 4
Figure 3
Slide back to start position
Figure 6
Indicator Marks
Push Pad
Figure 8
RUMIIIKOH-DFU • Rev. A • 11/14