J.

SINGH INSTRUMENTS
231 Timberlane Drive, Woodvale, Western Australia 6026
Tel: +618 93093222 Fax: +618 93093736
www.surgitools.net
Email surgitoolsau@gmail.com
singhmed@yahoo.com.au

J.S. SINGH ABN 64 750 501 584

LABEL
SINGH RooLip Uterine Manipulator

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Indications for use:

The Singh RooLip Manipulator is indicated for use by a surgeon in laparoscopic procedures requiring uterine manipulation and visualization of the position of the vaginal
fornices for colpotomy incisions into the vaginal vault.
NOTE: Funnels should be discarded after 10 uses. If there is surface damage or discoloration on any item, that item should be replaced and not used again.

CLEANING.
Warning: always follow your hospital’s infection control department protocol for cleaning of reusable instruments.
Recommended Manual Cleaning Procedure:
 Dismantle all parts of the instrument prior to cleaning.
 Inspect items for surface damage or discoloration and discard damaged or discolored items before proceeding to manual or automated cleaning. (Note that use of
harmonic shears increases chances of surface damage.)
 Rinse and brush each component with cold water until visually clean.
 Dilute Renu-Klenz detergent (dilution 1/4 oz/gal) in warm tap water and fully immerse instrument in the diluted detergent.
 Clean entire surface of instrument with soft bristled brush until visually clean.
 Brush lumens with pipe cleaner.
 Remove instrument from detergent and rinse with warm tap water until all evidence of detergent is removed.
 Dry instruments with clean, soft cloth.
 Visually inspect instruments, especially areas which are not easily accessible, to ensure that all visible soil has been removed.
Recommended Automated Cleaning Procedure:
 Dismantle all parts of the instrument prior to cleaning.
 Inspect items for surface damage or discoloration and discard damaged or discolored items before proceeding to manual or automated cleaning. (Note that use of
harmonic shears increases chances of surface damage.)
 Rinse and brush each component with cold water until visually clean.
 Dilute Renu-Klenz detergent (dilution 1/4 oz/gal) in warm tap water.
 Fully immerse instrument in the diluted detergent and run a 10 minute ultrasound cycle.
 (Continues overleaf)

1
J. SINGH INSTRUMENTS
231 Timberlane Drive, Woodvale, Western Australia 6026
Tel: +618 93093222 Fax: +618 93093736
www.surgitools.net
Email surgitoolsau@gmail.com
singhmed@yahoo.com.au

J.S. SINGH ABN 64 750 501 584

 Transfer the instrument into mesh baskets and load into the washer.
 Perform pre-wash in cold tap water for 2 minutes.
 Perform enzyme wash in hot tap water for 1 minute, using EnzyCare 2 detergent diluted to ¼ oz/gallon.
 Perform wash cycle at 65.5ºC for 2 minutes, using Renu-Klenz detergent diluted to ¼ oz/gallon.
 Perform rinse cycle with hot tap water for 0.15 mins.
 Perform drying cycle at 115ºC for 7 minutes.
 Remove instrument from washer and dry with a soft, clean cloth.
 Visually inspect instruments, especially areas which are not easily accessible, to ensure that all visible soil has been removed.

STERILIZATION
This product is supplied non-sterile. It must be sterilized before use.
Warning: always follow your hospital’s infection control department protocol for sterilization of reusable instruments.
Steam sterilization recommended procedure:
 After manual or automated cleaning, the instrument is placed in the sterilization chamber on appropriate instrument trays.
 Follow the Autoclave manufacturer’s instructions for loading and unloading instruments.
 Ensure direct steam exposure is delivered to all instrument surfaces that require sterilization.
 Sterilization type: prevacuum.
 Preconditioning pulses: 3.
 Minimum temperature: 132ºC
 Full cycle time: 4 mins.
 Minimum dry time: 30 mins.
 Allow instruments to cool before being placed on instrument trolley for clinical use.
Ethylene Oxide (EO) sterilization recommended procedure:
 After manual or automated cleaning, the instrument is placed in the sterilization chamber on appropriate instrument trays.
 Follow the Autoclave manufacturer’s instructions for loading and unloading instruments.
 Ensure direct steam exposure is delivered to all instrument surfaces that require sterilization.
 Sterilization type: prevacuum.
 Preconditioning pulses: 3.
 Minimum temperature: 132ºC
 Full cycle time: 4 mins.
 Minimum dry time: 30 mins.
 Allow instruments to cool before being placed on instrument trolley for clinical use.