RUMI DFU - CooperSurgical

TIP DISENGAGEMENT
With the instrument grip up, depress the trigger and return the grip to a straightened position. Connect
a syringe into the balloon catheter fitting and withdraw the saline from the balloon. Cut the balloon
catheter to assure that the balloon has been completely drained and that the tip cannot be re-used.
Using care, gently withdraw the tip from the cervix and remove the instrument from the patient.
Remove the tip using a twisting motion from the instrument and discard. Place the handle in water
immediately after use to facilitate cleaning.
UTERINE POSITIONING (Viewed from the patient’s head)
TO RETROVERT or insert into a retroverted uterus (photo 5). With the instrument in a grip up position,
counterclockwise rotation of the grip will result in the uterus being lowered to a retroverted position,
down to 50°. Release the trigger to hold the desired position.
TO ANTEVERT or insert into an anteverted uterus (photo 6). With the instrument in a grip up position,
depress the trigger and turn the grip clockwise lifting the uterus to achieve the desired degree of anteversion,
up to 90°. Release the trigger to hold the desired position.
The RUMI System
UTERINE MANIPULATOR INJECTOR
A device for positioning the uterus in the pelvis during
laparoscopic surgery. Also for use in chromopertubation.
DIRECTIONS FOR USE
LATERAL POSITIONING (combine photos 6, 7 and 8). With the instrument in the normal grip
up position, depress the trigger and turn the grip clockwise to raise the uterus to an angle of
approximately 50° (photo 6). Release the trigger. Lever the grip over towards the side you wish
to place the uterus (photo 7). For more extreme lateral uterine positioning continue by pushing the base
of the grip towards the patient’s thigh (photo 8).
5. Retrovert 6. Antevert 7. With uterus
anteverted lever grip
over to side
8. Extreme lateral
position
Legal Community Representative—
Leisegang Feinmechanik GmbH
Leibnizstraße 32
D-10625, Berlin GERMANY
CLEANING & STERILE PROCESSING
Remove the tip from the instrument handle and discard. According to local biological hazardous
material requirements. DO NOT ATTEMPT TO RE-USE A TIP. Thoroughly wash the handle in soapy
water. Repeat this procedure using enzymatic solution followed by water to thoroughly rinse. Autoclave
and package for the next procedure.
WARRANTY
The RUMI System Uterine Manipulator Injector is warranted by CooperSurgical for a period of 120
days from shipment. This warranty applies to only the original purchaser and only against defects in
workmanship or materials, which under normal use render the instrument inoperable.The original
purchaser shall prepay the shipping costs for returning a CooperSurgical instrument for warranty
service. CooperSurgical will, at its option and without charge, either repair or replace any instrument
which CooperSurgical determines to be defective in material or workmanship. Instrument damage
caused by misuse or accident, shall void this warranty.
See Instructions for Use
Single Use Only/Do Not Reuse
Batch Code/Lot
Expiration Date (e.g. 2002-09)
Ethylene Oxide Sterilized
Latex-Free
Caution: Federal law restricts
this device to sale by or on
the order of a physician.
REF # UMH600
NON-STERILE
CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.
PACKAGED 1 Handle
CooperSurgical disclaims any liability for special, incidental consequential, punitive or exemplary
damages arising out of the use of any CooperSurgical instrument. CooperSurgical’s liability in all events
is limited to, and shall not exceed, the purchase price paid. Except as expressly provided
in this limited warranty section, CooperSurgical makes no representations or warranties, expressed
or implied, as to the instruments, including warranties of merchantability and fitness for a particular
purpose, all of which are hereby expressly disclaimed and excluded. No warranty or affirmation of fact,
express or implied, other than as set forth in this limited warranty, is made or authorized by CooperSurgical.
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REF
Catalog/Reorder Number
The RUMI System is a trademark of CooperSurgical, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
©1995 CooperSurgical, Inc. All rights reserved.
U.S. PATENT NO. 5,409,496
PATENTS PENDING
DER GRÜNEPUNKT
95 Corporate Drive
Trumbull, CT 06611
Phone: (203) 601-5200
Toll Free: (800) 243-2974
Fax: (800) 262-0105
Part #34387 • Rev. C 6/04
95 Corporate Drive
Trumbull, CT 06611
Phone: (203) 601-5200
Toll Free: (800) 243-2974
Fax: (800) 262-0105

DESCRIPTION
The RUMI System Uterine Manipulator Injector consists of two principle components: a reusable
handle and an attached single-use sterile tip. These two components complete the instrument
assembly.
Constructed of medical grade autoclavable materials, the handle consists of a grip, shaft, snap drum,
and locking trigger. It is “L” shaped and measures 8 inches along the shaft and 4 inches along the grip.
The snap drum (distal end of the handle shaft) serves for attachment of the tip and rotates
the tip through a 140° arc.
The grip is oriented 90° to the handle shaft. Turning the grip while depressing the trigger permits the
rotation of the snap drum, thereby moving the position of the tip. When released, the trigger holds
the rotational position of the grip (and snap drum).
The single-use tip is manufactured with a USP class VI (medical grade) silicone body, a stainless steel
internal support rod, and a USP class VI silicone balloon affixed to the distal outside of the tip. When
inflated properly, the balloon secures the tip in the uterus.
Two silicone catheters extend from the tip and serve as extensions of the balloon and dye delivery
lumens. The 12 inch long balloon catheter has a white syringe fitting with a hose clamp and white luer
lock fitting. The clamp is manually opened and closed to seal off the balloon. The dye catheter is clear,
24 inches in length, and features a white luer lock connector for attachment of a dye syringe.
To accommodate different uterine sizes, the tips are available in the following shaft diameters and shaft
lengths (diameter x length): 6.7mm x 6cm (white), 6.7mm x 8cm (blue), and 6.7mm x 10cm (green) and
5.1mm x 6cm (lavender).
INDICATIONS FOR USE
The RUMI System is designed for use in operative endoscopy (laparoscopy), where a uterus is
present and where positioning of the uterus, fallopian tubes, and ovaries is desirable. These types of
surgeries include laparoscopic tubal ligation, laparoscopic tubal occlusion, diagnostic laparoscopy,
and/or operative laparoscopy. The RUMI System also provides for dye delivery in those procedures
requiring chromopertubation.
CONTRAINDICATIONS
The RUMI 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.
WARNINGS
The uterus must be probed (sounded) for both depth and direction prior to application of the device.
DO NOT use the RUMI as a uterine sound.
NEVER use a tip which is longer than the sounded depth of the uterus.
NEVER attempt to use the device in utero without first performing the balloon test inflation procedure.
Inflate the balloon with sterile saline only. DO NOT use air for inflation of the intrauterine balloon.
NEVER use the device with the intrauterine balloon deflated. A non-inflated balloon may result in the
expulsion of the tip from the uterus during use.
NEVER attempt uterine manipulation without a clear laparoscopic view of the uterus.
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
spasm with associative temporary physiological blockage of patient fallopian tubes, and uterine injury
(perforation).
DIRECTIONS FOR USE
TIP SELECTION
Use an open-sided vaginal speculum to expose the cervix. Probe the uterus for depth and direction
using standard surgical techniques. Select a manipulator tip which is less than or equal to the
sounded depth of the uterus.
TIP ATTACHMENT
To ease tip attachment, manipulator tip has been pre-lubricated. Grasp the base of the tip and handle
shaft as shown (photo 1). With grip straight, insert the tip support rod into the hole in the snap drum
nose. With a back and forth twisting motion, force the tip base completely over the snap drum nose
(photo 2). The tip will snap into place around the snap drum nose (photo 3). Visually inspect to ensure
that the tip base is seated completely over and around the snap drum nose and that the catheters exit
to the sides. A slight tug on the tip will verify that it is on securely (photo 4).
Balloon
Support Rod
Snap Drum
Base
Balloon
Catheter
Dye
Port
Luer Lock
Hose Clamp
Luer Lock
Dye Catheter
Shaft
Grip
Locking
Trigger
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 RUMI System has only been tested for use with patients who have been anesthetized. Due to the
need to dilate the cervix, The RUMI System is not recommended for use in non-anesthetized patients.
THE TIP IS SINGLE-USE ONLY • NEVER RE-USE A MANIPULATOR TIP
PRECAUTIONS
Dilate the cervix using standard technique, as required, to accommodate the tip diameter selected, and
lubricate the tip to ease patient insertion.
Test inflate and fully deflate the balloon prior to patient insertion. 3cc to 5cc of saline is the
normal amount necessary to inflate the balloon for engagement in the uterus. If additional saline is required
to engage the tip properly in the uterus, adding an additional 2cc is the maximum
recommended (5cc to 7cc) total.
When injecting any dye media, always closely follow the media manufacturer’s instructions.
1. Insert rod into
snap drum
2. Twist while
pushing on
3. Snap into place 4. Pull to verify.
(catheters must exit
to the sides)
BALLOON TEST INFLATION PROCEDURE (Prior to Surgery):
Depress the trigger and test the instrument for full range of motion and response of the snap drum to
grip rotation through its 140° arc. Test the balloon by using a syringe to inject 3cc sterile saline into the
catheter (marked BALLOON). Check that the balloon remains inflated. Following this test, completely
withdraw all of the saline from the balloon prior to patient insertion.
INSERTION
Use an instrument to grasp the anterior lip of the cervix. Sufficiently dilate the cervix to ease tip
insertion. Lubricate the balloon and tip.
Following the direction the uterus was sounded, SLOWLY insert the instrument into the uterus
until the tip base meets flush against the cervix.
While maintaining a slight pressure of the tip base against the cervix, SLOWLY inject 3cc to 5cc
of sterile saline into the balloon and remove the syringe. Gently pull on the device to test for proper
engagement of the tip in the uterus. If additional saline is required for proper engagement add
no more than 2cc additional (not to exceed 7cc total).
With the instrument properly engaged in the uterus, the speculum and cervical grasping device may
now be removed.
REUSABLE HANDLE
If dye injection is desired, attach a dye syringe to the DYE catheter. The instrument is ready to use.
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