roolip manipulator product catalogue
DESCRIPTION
1BrochuresSINGH ROOLIP MANIPULATORFEATURES 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 reusaTRANSCRIPT
1 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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
2 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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
3 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
4 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
5 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
6 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
7 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
8 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
9 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
10 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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.
11 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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
12 Brochures
J.SINGH INSTRUMENTS | 231 Timberlane Drive Woodvale WA 6026 O: +618 93093222 F: +618 930736 M: +61 417 905536 E: [email protected] ABN: 64 750 501 584 W: www.surgitools.net
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