CooperSurgical Advincula Arch Handle Mode D'emploi

Advincula Arch
Reusable Uterine Manipulator Handle
UMH750
NON-STERILE • STERILIZE BEFORE USE
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The Advincula Arch Handle (Handle) is a reusable device used with a
™
sterile, single-use RUMI ® Uterine Manipulator Tip (Tip).
The Advincula Arch Handle along with the RUMI Tip is used for positioning the
uterus during laparoscopic surgery and in dye delivery where chromopertubation is necessary.
The grip, shaft and snap drum are constructed of medical grade autoclavable materials.
The snap drum serves for attachment of the Tip.
Not made with natural rubber latex.
WARNINGS
• The uterus must be sounded for both depth and direction prior to application of the device.
• DO NOT use the Handle as a uterine sound.
• NEVER attempt uterine manipulation without a clear view of the uterus.
• As with all uterine manipulating devices, a careful clinical evaluation should be performed prior to use.
• Certain clinical conditions may present a uterus, which is more prone to perforation and bleeding.
• Dye injection should be performed SLOWLY. Because of the efficient air/liquid seal created at the internal cervical os by the balloon, rapid injection of fluids
(dye) may create intrauterine pressures, which could cause uterine damage and/or result in fallopian tube spasms.
• The Handle has only been tested for use with patients who have been anesthetized. Due to the need to dilate the cervix, the Handle is not recommended for
use in non-anesthetized patients.
INTENDED USE / INDICATIONS FOR USE
The Handle is designed for use in operative endoscopy (laparoscopy), where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries or
vagina is desirable. These types of surgeries include laparoscopic tubal ligation, diagnostic laparoscopy and/or operative laparoscopy. The Tips also provide for dye
delivery in those procedures requiring chromopertubation.
CONTRAINDICATIONS
The Handle should not be used in patients who are pregnant or who are suspected of being pregnant, planned gamete intrafallopian transfer procedures, in
patients who have an IUD in place, in patients with suspected pelvic infections and in cases where the surgeon deems it inadvisable or finds it difficult to insert
the silicone tip into the cervix or uterus.
PRECAUTIONS
• Sterilize before use.
• Dilate the cervix to Hegar/Hank 8 (French 24) to ease patient insertion.
• Refer to the RUMI Uterine Manipulator Tip Directions for Use for further precautions.
• Inspect Handle prior to use for proper operation.
ADVERSE REACTIONS
The following adverse reactions have been suspected or reported to be associated with all uterine
manipulators. The order of listing does not indicate frequency or severity: cramping, infection, uterine
and fallopian tube spasm with associative temporary physiological blockage of patient fallopian tubes
and uterine perforation.
INSTRUCTIONS FOR USE
Note: Refer to the RUMI Uterine Manipulator Tips Directions for Use to ensure proper selection of Tip size
and Tip attachment/detachment instructions.
1. Select a Tip which is less than or equal to the sounded depth of the uterus and attach it to the Handle.
2. Ensure the Tip catheters are secure in the catheter channels of the Handle (see Figure 1 and Figure 2).
REPROCESSING INSTRUCTIONS FOR THE ADVINCULA ARCH HANDLE
1. INTRODUCTION
This section is intended to provide detailed instructions for effectively processing reusable Advincula Arch Handles.
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.
Handle
™
Instructions for Use (English)
1
Advincula Arch Handle
(UMH750)
Shaft
Snap Drum
Catheter Channel
Tip Cathe-
ters
Figure 1
Figure 2
RUMI Uterine
Manipulator Tip
Tip
Catheter Channel