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SINGH ROOLIP MANIPULATOR

FEATURES

 Colpotomizer System for vaginal vault delineation

 Range of uterine movements provided

 Anatomical landmarks provided for dissection

 Provides pneumoperitoneum for vaginal vault closure

 Used in association with other laparoscopic instruments

 Similar advantages to other comparable vaginal delineators for


laparoscopy procedures

 Funnels available in 3 sizes to fit different sized vaginas

 All parts are autoclavable

 All parts are reusable

 Easy to assemble and use system

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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CLINICAL INTRODUCTION OF PRODUCT

The Singh Roolip Manipulator System is designed by Dr Jiwan Steven Singh,


a Consultant Gynaecologist from Perth, Western Australia. The product is
used widely in Australia.

The system provides uterine manipulation and visualization of the vaginal


fornices at laparoscopy during gynaecological surgery. This allows the
surgeon to make colpotomy incisions in the vaginal vault to access or remove
intraperitoneal tissue from the pelvic cavity.

The system is easy to use and is placed in position by the Gynaecologist after
the patient is positioned, cleaned and draped for laparoscopic surgery. After
the system is placed in the vagina, it is held in position by a pelvic assistant or
uterine positioner. The assistant then moves the manipulator at the direction
of the Gynaecologist during laparoscopic surgery.

PRODUCT ASSEMBLY AFTER STERILIZATION

Items to be assembled (refer to photos in ordering information):

 curved inner rod

 straight inner rod

 cervical screw

 tail screw

 uterine manipulator shaft

 funnel

 white O ring

 white O ring screw

 vaginal plug

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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DESCRIPTION OF CLINICAL USE

Patient preparation for operation

General anaesthesia and positioning of the patient for laparoscopic surgery is


performed according to the hospital infection control and occupational health
and safety departments’ protocol for laparoscopic surgery.

The patient is cleaned and draped for laparoscopic surgery according to the
hospital’s infection control procedures for laparoscopic surgery.

Sterilization of the instruments for surgical use is carried out in accordance


with the hospital infection control department procedure for sterilization of
reusable surgical products.

Assembly of instruments before use

The uterine manipulator is assembled by attaching the cervical screw and tail
end screw to the shaft of the uterine manipulator. See photo below.

A standard cervical tenaculum is attached to the anterior lip of the cervix.

A standard uterine sound is inserted into the uterine cavity to measure its
length.

A suitable inner rod is chosen after measurement of the uterine cavity and
passed through the tail end screw.

A curved rod is used for most laparoscopic procedures. See photo below.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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The straight rod is used for short uterine lengths (less than 5 centimeters) or
when a subtotal laparoscopic hysterectomy is performed. See photo below.

Choose a funnel to fit the vagina.

There are three funnel sizes available for use. See photo below.

The middle sized funnel is most commonly used for women who have children
by vaginal delivery. The smallest funnel is used for women who have not had
children or have had children by Caesarean section only. The largest sized
funnel is used for women with large vaginas.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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Directions for use

After attachment of a standard cervical tenaculum to the cervix, the uterine


length is measured. See photo below.

The appropriate inner uterine rod is chosen and passed through the tail end of
the uterine manipulator.

The inner rod is pushed out to half the length of the uterine cavity. See photo
below.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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The inner rod is inserted into the uterine cavity and the cervical screw rotated
in a clockwise direction till the red O Ring is at the level of the external os. See
photo below.

Remove the cervical tenaculum.

Pass the appropriately sized funnel through the tail end of the uterine
manipulator and push the funnel up to the vaginal vault. See photo below.

The white O Ring is placed behind the funnel shaft to hold the funnel against
the vaginal vault. See photo below.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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The instruments are held in place by a pelvic assistant or a uterine positioner


just below the white O Ring. See photo below, showing instruments being held by a
uterine positioner.

Laparoscopy is performed by the Gynaecologist and correct entry is


confirmed by visualizing the abdominal and pelvic organs.

The uterus is anteverted and, under laparoscopic vision, the inner rod is
advanced slowly to the tip of the uterine cavity by the pelvic assistant or
Gynaecologist. See photo below.

Visualization of the uterine fundus whilst the inner rod is advanced should
prevent the incidence of uterine perforation at laparoscopy.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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The pelvic assistant rotates the funnel lip to lift segments of the vaginal vault
for colpotomy incisions to be performed by the Gynaecologist. See photo below.

Alternatively, when using a uterine positioner, the Gynaecologist manipulates


the uterus and rotates the funnel as required. See photo below.

After dissection is completed, the white O Ring and funnel are removed from
the vagina (in that order).

The uterine manipulator is removed from the vagina and a cervical tenaculum
is attached to the cervix to enable the uterus to be pulled into the vagina.

For laparoscopic closure of the vaginal vault, the uterus is left in the vagina to
maintain pneumoperitoneum during suturing of the vaginal vault.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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If the uterus is removed from the vagina, the pneumoperitoneum can be


maintained during suturing of the vaginal vault by placing the funnel (with a
vaginal plug attached) back into the vagina. The straight inner rod should be
used. See photo below.

After laparoscopic closure of the vaginal vault, the uterus or instruments are
removed from the vagina.

The vagina is inspected to ensure there is no bleeding.

The instruments are inspected to confirm that all parts are intact and the
instrument count is confirmed by the operating room staff according to the
hospital’s operating room practice.

INDICATIONS FOR USE


The Singh Roolip Manipulator is indicated for use by a surgeon in
laparoscopic procedures where uterine manipulation and the visualization of
the position of the vaginal fornices for colpotomy incisions into the vaginal
vault is required. The surgeon makes the colpotomy incisions to access or
remove intraperitoneal tissue from the pelvic cavity.

CONTRAINDICATIONS
The Singh RooLip Manipulator should not be used in pregnant women or
when pregnancy is suspected.

WARNINGS
The Singh RooLip Manipulator is provided as a non-sterile product and should
be sterilized according to the hospital infection control department procedures
for sterilization of non-sterile products.

Ultrasonic energy will mark the vaginal funnel during use and the item should
be discarded if surface damage is present upon inspection after cleaning.

The inner uterine rod should only be inserted up to the uterine fundus under
direct laparoscopic vision to prevent uterine perforation.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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Post operative uterine cramps and pelvic infection has been associated with
the use of uterine manipulators.

CLEANING OF THE SINGH ROOLIP MANIPULATOR

 Dismantle all parts before cleaning.

 Rinse and brush with cold water to haemolyse blood left on the
instruments for easy removal.

 Wash with warm water and detergent recommended by the hospital


infection control department.

 Rinse with copious warm water.

 Inspect instruments for cleanliness.

 Inspect instruments for surface damage.

 Dispose of any damaged funnels.

STERILIZATION

WARNING

The Singh RooLip Manipulator consists of non-sterile items.

These products can be sterilized by steam autoclave sterilization or ethylene


oxide sterilization.

Thorough cleaning and sterilization of these products should follow the


hospital infection control department’s strict protocol for the cleaning and
sterilization of reusable products.

Inspection of instruments prior to sterilization to detect any surface damage


should be performed. Damage may occur after repeated use, especially to the
funnels. Damaged parts should be replaced prior to sterilization.

STEAM AUTOCLAVE STERILIZATION

 All parts should be dismantled and cleaned according to the hospital’s


infection control department protocol for cleaning reusable instruments.

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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 Follow the Autoclave manufacturer’s instructions for loading and


unloading of instruments.

 Ensure direct steam exposure is delivered to all instrument surfaces


that require sterilization.

 Autoclave temperatures should not exceed 280ºF (137ºC).

 Confirm validation of the completed sterilization cycle according to the


autoclave manufacturer’s instructions.

 Allow instruments to cool before clinical use.

A STANDARD CYCLE of 270ºF (132ºC) for 10 minutes is recommended for


sterilization of the device parts before clinical use.

GRAVITY DISPLACEMENT CYCLES


270 - 275ºF for 10 minutes.

PREVACUUM CYCLES
270 - 275ºF for 3 to 4 minutes.

ETHYLENE OXIDE STERILIZATION

 All parts should be dismantled and cleaned according to the hospital’s


infection control department protocol for cleaning reusable instruments.

 Follow the ethylene oxide sterilizer manufacturer’s instructions for


loading and unloading of the sterilizer.

 Confirm validation of the completed sterilization cycle according to the


ethylene oxide manufacturer’s instructions.

 All parts should be packaged separately to ensure complete


sterilization.

ORDERING INFORMATION
STAINLESS STEEL PRODUCTS

SUC01CS UTERINE MANIPULATOR CERVICAL SCREW

SUC475CR INNER ROD CURVED


J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026
O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net
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SUC475ST INNER ROD STRAIGHT

SUC500S UTERINE MANIPULATOR SHAFT

POLYPROPYLENE PRODUCTS

SUC01TS UTERINE MANIPULATOR TAIL SCREW

FN02 SMALL FUNNEL OUTER DIAMETER(OD) 37mm

FS02 STANDARD FUNNEL OD 45mm

FXL02 EXTRA LARGE FUNNEL OD 50 mm

SUC01OR ORING

SUC01ORS ORING SCREW

SILICONE PRODUCT

SUCROR CERVICAL SCREW RED O RING

J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026


O: +618 93093222 F: +618 930736 M: +61 417 905536 E: surgitoolsau@gmail.com
ABN: 64 750 501 584 W: www.surgitools.net