CooperSurgical Koh-Efficient KC-RUMI-25 Instrucciones De Uso

® /Koh-Efficient
RUMI
9. Confirm that the distal end of the cup resides in the fornices.
Note: If it is necessary to move the Koh-Efficient, push the release tab to disengage
fingers from Arm (see Figure 9) and slide Koh-Efficient back.
10. The Tip can now be articulated by pressing the trigger on the Grip and rotating the Grip. When
the Trigger is released, the Tip will be locked in position.
11. Just prior to making colpotomy incisions, inflate the Colpo-Pneumo Occluder
balloon with 60 to 120 cc of sterile saline or water (do not use air).
12. When it is time to remove the uterine manipulator from the patient, you must first
deflate the Colpo-Pneumo Occluder balloon.
13. Remove the Koh-Efficient by spreading outward and down the Removal Flats
(see Figure 9).
14. Dispose of in accordance with all applicable Federal, State and local Medical/
Hazardous waste practices.
EXPLANATION OF SYMBOLS
Reorder Number
REF Do not use if package
is damaged
Batch Code
LOT
2
Do Not Reuse
Use By
!
Caution
STERILE EO
Consult instructions
Ethylene Oxide Sterilization
for use
2
LATEX Not made with natural
Do not resterilize
STERILIZE
rubber latex
The marks bearing the symbols "TM" and "®" are trademarks and registered trademarks of CooperSurgical, Inc.
Ultem ® is a registered trademark of SABIC Innovative Plastics
© 2014 CooperSurgical, Inc. All rights reserved.
International
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (203) 601-9818
Phone: (800) 243-2974
Fax: (203) 601-4747
Fax: (800) 262-0105
www.coopersurgical.com
RUMIIIKOH-DFU • Rev. A • 11/14
™ • Directions for Use • English
(continued)
Removal Flats
Figure 9
Release Tab
Manufacturer
U.S. Federal law restricts
R Only
this device to sale by or on
x
the order of a physician.
Product conforms to the
Medical Device Directive
93/42/EEC
Authorized Representative
EC REP
in the European Community
EC REP
KC-RUMI-25 (2.5 cm) • KC-RUMI-30 (3.0 cm) KC-RUMI-35 (3.5 cm) • KC-RUMI-40 (4.0 cm)
Koh-Efficient
KCS-RUMI-25 (2.5 cm) • KCS-RUMI-30 (3.0 cm) KCS-RUMI-35 (3.5 cm) • KCS-RUMI-40 (4.0 cm)
STERILE
SINGLE-USE
DEVICE DESCRIPTION
II/Koh-Efficient™ is a sterile, single-use vaginal fornices delineator with an integrated
®
The RUMI
Colpo-Pneumo Occluder™. It is made of medical grade plastics with an Ultem
Cup™. The Harmonic Scalpel/laser compatible version (KCS-RUMI) is equipped with a stainless steel
distal surface. Not made with natural rubber latex.
The RUMI II/Koh-Efficient (Koh-Efficient) is compatible with the RUMI
RUMI ® Uterine Manipulator Tip (Tip). These three products, used in conjunction with the Cervical Sizer
(Sizer), enable unobstructed placement of a standard Tip into the uterus. Once in place, the
Koh-Efficient is advanced along the Arm of the Handle and locks into place around the cervix.
RUMI
(UMH650)
WARNINGS
• Contents supplied sterile. Do not use if sterile barrier is damaged.
• The integrated Colpo-Pneumo Occluder is designed to accommodate no more than 180 cc of
inflation.
• The Koh-Efficient is single-use only, and should NEVER be reused.
• Using an incorrect size KOH Cup could result in patient injury.
• The Ultem KOH Cup is not intended to be used with Harmonic or other types of ultrasonic or laser
energy sources.
• The stainless steel KOH Cup is not intended to be used with electrocautery. Use of electrocautery
CooperSurgical, Inc.
95 Corporate Drive
may result in inadvertent injury to adjacent structures.
Trumbull, CT 06611
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may
EMERGO EUROPE
compromise the structural integrity of the device and/or lead to device failure which, in turn, may
Molenstraat 15
2513 BH, The Hague
result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk
The Netherlands
of contamination of the device and/or cause patient infection or cross-infection, including, but not
Made in the USA
/Koh-Efficient
®
RUMI
Vaginal Fornices Delineator & Colpo-Pneumo Occluder
for use with the RUMI
Koh-Efficient ™ for Electrocautery
™ for Harmonic Scalpel and Laser
Directions For Use (English)
Handle
Cervical Sizer
(KC-SIZER)
™
™
®
Handle
0086
® Polymeric rigid KOH
II Handle (Handle) and the
®
RUMI
RUMI
Uterine
Koh-Efficient
Manipulator Tip
(KC-RUMI or
KCS-RUMI)
RUMIIIKOH-DFU • Rev. A • 11/14