CooperSurgical Koh Colpotomizer Instructions For Use Manual

The Koh Colpotomizer
Koh Cup Vaginal Fornices Delineator and
™
Colpo-Pneumo Occluder
Instructions for Use (English)
DESCRIPTION
Koh Cup Vaginal Fornices Delineator (KCS-Kit and KCP-Kit) is designed for
™
use with The RUMI System and Colpo-Pneumo Occluder
®
tomizer System is intended to be used in laparoscopic procedures where it is
™
desirable to locate the position of the vaginal fornices. The Koh Cups are avail-
able in sizes 3.0 cm, 3.5 cm and 4.0 cm. The Koh Cup is available in Ultem
Polmeric Resin for use during electrosurgery. The stainless steel Koh Cup is
available for use with laser or harmonic scalpel. These devices are non-sterile
and must be sterilized according to standard procedure prior to use.
The Colpo-Pneumo Occluder (CPO-6) is a sterile single-use medical grade
silicone device designed for use with The RUMI System and the Koh Cup Vaginal
Fornices Delineator. The Koh Colpotomizer System is intended for use in
laparoscopic procedures where it is desirable to minimize the loss of
pneumoperitoneum after a colpotomy incision has been made.
WARNINGS
The Colpo-Pneumo Occluder is designed to accommodate no more than 180 cc
of inflation. It is supplied as a sterile single-use device and should never be reused.
The Koh Cup Vaginal Fornices Delineator is non-sterile and should be sterilized
prior to use.
The Ultem Polymeric Resin Koh Cup is not intended to be used with harmonic
or other types of ultrasonic energy sources.
The stainless steel Koh Cup is not intended to be used with electrocautery. Use
of electrocautery may result in inadvertent injury to adjacent structures.
Insure that placement of the Koh Cup Vaginal Fornices Delineator and
Colpo-Pneumo Occluder on the RUMI Uterine Manipulator does not interfere or
restrict the operation of the uterine manipulator in any way. The RUMI Uterine
Manipulator with Koh Colpotomizer System devices attached should always be
inserted into the vagina slowly and under direct vision. The cervix should be
adequately dilated prior to insertion of the RUMI Uterine Manipulator Tip. Follow
the RUMI Uterine Manipulator Directions for Use for a detailed description of
cervix dilation.
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE
The Koh Colpotomizer System is indicated for use in laparoscopic procedures
where use of a uterine manipulator is appropriate and the surgeon intends to
remove or access intraperitoneal tissue through the vagina by use of a colpotomy
or culdotomy incision.
CONTRAINDICATIONS
The Koh Colpotomizer System 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 planning gamete intrafallopian transfer, and in cases where the
surgeon deems it inadvisable or finds it difficult to insert the silicone tip into the
cervix or uterus.
ADVERSE REACTIONS
During surgery, the Koh Colpotomizer System with Koh Cup Vaginal Fornices
Delineator and the Colpo-Pneumo Occluder become part of The RUMI System
Uterine Manipulator. Adverse reactions which have been suspected or reported
to be associated with the uterine manipulators are cramping, infection, uterine
perforation and uterine spasm with accompanying temporary physiologic
blockage of patent fallopian tubes. (The order of listing does not indicate
frequency or severity.)
INSTRUCTIONS FOR USE
1. Prepare the patient for surgery according to
standard surgical practices. Prepare the
RUMI Uterine Manipulator for use in
accordance with the RUMI Tip Directions for
Use.
2. Prior to patient insertion, slide the Colpo-
Pneumo Occluder over the RUMI disposable
tip to extend over the distal shaft of the uterine
manipulator. (See Figures 1 and 2.)
3. Select the appropriate size Koh Cup by
visually inspecting the diameter of the
patient's cervix. Choose a Koh Cup with
sufficient diameter to readily accept the cervix.
If in question, it is recommended that the
selected Koh Cup be tried on the cervix prior to
attachment to the uterine manipulator. To do
so, simply grasp the cup with an appropriate
grasper and place it over the cervix to ensure
that it fits correctly. (It is further recommended
that a Koh Cup that is slightly too large be
selected over one that is slightly too small.)
4. Slide the selected Koh Cup, small end first,
over the RUMI disposable tip and onto the tip
base until it is snugly attached to the tip base.
The distal end of the Colpo-Pneumo
Occluder will be between the Koh Cup and
the tip base when properly installed. (See
Figures 3 and 4.)
5. Test inflate the Colpo-Pneumo Occluder with
20-60 cc of sterile saline prior to patient
insertion in order to verify proper operation of
the occluding balloon and then deflate prior to
patient insertion. Test inflate the RUMI Tip
balloon according to the RUMI Directions for
Use.
6. With assembly complete, dilate the cervix to a
sufficient diameter to easily accommodate the
insertion of the uterine manipulator tip. Use a
speculum or a combination of vaginal
retractors to gain sufficient exposure of the
cervix for device insertion. Slowly insert the
manipulator device into the vagina and
manipulator tip into the uterus under direct
vision and in accordance with the RUMI
Directions for Use. Once insertion is complete
and the Koh Cup is fully engaged on the
cervix, the RUMI Uterine Manipulator may be
operated as normal.
7. Prior to making colpotomy incisions, inflate
the Colpo-Pneumo Occluder balloon with
sufficient sterile saline or water (do not use
air) to cause the inflated balloon to make
continuous radial contact with the vaginal
wall. 90 cc to 120 cc of inflation will generally
be sufficient. With the Koh Colpotomizer
System attached to the RUMI Uterine
Manipulator and properly inserted in the
patient, inflation of the Colpo-Pneumo
Occluder will not impede movement of the
RUMI's articulating tip and will prevent
leakage of the pneumoperitoneum from the
vagina during and after any colpotomy
incisions for as long as the Colpo-Pneumo
Occluder is inflated.
System
™
(CPO-6)
™
. The Koh Colpo-
™
Figure 1
Figure 2
Figure 3
Figure 4
8. Laparoscopic identification and delineation of the vaginal fornices is aided
by using the uterine manipulator to articulate the uterus into a position
opposite the point of desired delineation while applying cephalad pressure
to the uterine manipulator handle. This will increase tissue traction in the
desired area of delineation so that the location of the rim of the Koh Cup
(which marks the position of the vaginal fornices) may easily be
®
determined.
9. After dissection is complete, deflate the Colpo-Pneumo Occluder only.
Do not deflate the uterine manipulator tip balloon.
10. Extend a tenaculum into the vagina through one of the windows on the
Koh Cup and grasp the cervix.
11. Using the manipulator handle and tenaculum, pull the uterus into
the vagina.
12. Removal of the uterus and the Koh Colpotomizer System:
a. For vaginal closure, continue to use the tenaculum and manipulator to
pull the uterus through the vaginal canal until it is removed from the
patient. The Koh Colpotomizer System will be removed during this
process along with the uterus and uterine manipulator.
b. For laparoscopic closure, with the Colpo-Pneumo Occluder deflated,
leave the uterus lodged in the vaginal canal so that it may serve to
occlude the vagina. Once the pneumoperitoneum is reestablished,
closure may proceed in the usual manner. The Koh Colpotomizer
System will be removed along with the uterus and uterine manipulator
during this process.
c. Check carefully to be sure the system is intact and no parts remain
in the patient.
13. After surgery, discard the disposable components of the Koh Colpotomizer
System according to standard hospital practices.
REPROCESSING INSTRUCTIONS KOH CUPS
1. INTRODUCTION
This section is intended to provide detailed instructions for effectively processing
reusable Koh Cups. All reusable instruments should be thoroughly cleaned and
sterilized to prepare them for use.
Instruments which can be disassembled should be disassembled for cleaning
to ensure maximum contact between surfaces and cleaning tools and solutions
(see specific instructions for each instrument). CooperSurgical, Inc. has validated
the processes provided in these instructions to be capable of effective instrument
processing. Equipment, operators, cleaning agents and procedures all contribute
to the efficacy of processing. Healthcare facilities should ensure that selected
processing steps are safe and effective within their systems.
Alternative methods of processing these instruments outside the instructions
described in this document may be suitable for reprocessing; however, these
have not been evaluated by CooperSurgical, Inc. Operators and healthcare
facilities which choose to perform processes outside the instructions described
in this document must validate these processes before use. In the event that
national or regional government requirements conflict with the recommendations
provided here, these shall override the recommendations of CooperSurgical,
Inc., but must be validated before use.
Reusable instruments must be rinsed thoroughly after use and after cleaning
to ensure removal of gross soil and residual cleaners and solvents. Gross soil is
damaging to instrument surfaces and inhibits thorough cleaning and subsequent
sterilization. Residual cleaners and solvents can impede further processing and
may affect the surface finish of the instrument over time.
ClEANING
There are two methods for cleaning that have been validated by CooperSurgical,
Inc. Any healthcare facility should be able to perform the manual cleaning
process. For those facilities that use automated washer-disinfectors, an
automated method has also been validated.
Personnel are cautioned to use personal protective apparel due to the unknown
and potentially hazardous nature of biological fluids and soils present. Specific
detergents or cleaning solutions vary in requirements for concentrations and
temperatures required for optimal cleaning performance. Use temperatures in
this document as guidance, to be superseded by the detergent/cleaner
manufacturer's directions for use. Any processes outside the recommendations
in this document must be validated before use.
The quality of water used to prepare solutions and rinse reusable instruments
can affect the efficacy of the process and the instrument reuse life.
CooperSurgical, Inc. recommends the use of freshly prepared purified water or
sterile water for dilutions of solution and rinsing of instruments. Non-purified
water can add mineral deposits and recontaminate instruments with
microorganisms. Mineral deposits can impede sterilization and affect the
condition of the instrument, resulting in staining, corrosion, and/or other damage.
Equipment and Materials Required for Manual Cleaning
• Personal protective apparel/equipment as recommended by
cleaning solution supplier.
• Cleaning bath, sink, or other vessel large enough to accommodate
full immersion of instruments.
• Freshly prepared cleaning solution intended for manual cleaning
(use enzymatic, neutral, or alkaline detergents).
• Soft-bristled brushes and sponges.
• Clean, low-lint or lint-free cloth.
Equipment and Materials Required for Automated Cleaning
• Personal protective apparel/equipment as recommended by cleaning
solution supplier.
• Legally marketed (FDA-cleared and/or CE-marked) medical device
washer or washer-disinfector.
• Cleaning solution intended for automated cleaning (use enzymatic,
or neutral, alkaline detergents).
• Racks and accessories to hold and support instruments during processing.
POINT OF USE
During and immediately after the clinical procedure, instruments should be
treated to reduce and remove gross soil materials. Instruments should be wiped
with low-lint or lint-free absorptive materials, such as low-lint or lint-free wipes to
remove solid tissues and the majority of bodily fluids. Immediately after use, all
disposable single-use accessories should be removed and discarded into
appropriate biohazardous waste containers. Instruments should be placed into
a transport container that will protect them from damage during transport and
should be kept moist.
TRANSPORT TO PROCESSING AREA
Transport the instruments to the processing area as soon as practical. Minimize
holding time before removing organic debris. Ensure that lighter instruments are
not mixed with heavier instruments to avoid damage to the instruments due to
mechanical abrasion. Seal or enclose the transport container to prevent fluid loss
and the potential for cross-contamination of other areas.
PREPARATION
• Remove Koh Cup from RUMI or RUMI II Handle.
• Remove all single-use accessories and discard in an appropriate waste
container designed for biohazardous materials if this has not been
performed at point of use.
• The only devices used with the Koh Cup that are reusable are the RUMI or
RUMI II Handles and the Advincula Arch
instructions for the RUMI, RUMI II Handles and the Advincula Arch Handles
are included with packaging for these devices.
1
Koh Cup
™ RUMI
Colpo-Pneumo
Occluder
™
Handles. Specific reprocessing
™
Tip
®