Kronner SIDE-KICK User manual

The KRONNER SIDE-KICK
A uterine manipulator Holder
for holding the Arch Koh uterine manipulator*
Instructions for use
* Model UMH 67, manufactured by CooperSurgical
United States Patent 8,485,484.B2

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The Kronner SIDE-KICK is a uterine
manipulator Holder which firmly holds
the Arch Koh and other uterine manip-
ulators during laparoscopic surgery on
female pelvic organs. The Side-Kick
does not interfere with re-positioning
the uterus with the attached manipula-
tor.
The Side-Kick Rail Grip is attached to
either side rail of the operating table. It
is placed behind the attachment for the
leg stirrup.
The manipulator is inserted into the
patient using standard technique, then
the Side-Kick is joined to it.
With proper adapters the Side-Kick
may be used with other manipulators,
such as the RUMI, and the V-Care*.
Agas supply module, which is also
attached to the rail of the operating
table, transfers nitrogen or compressed
air from the wall or a portable tank to
the Side-Kick through two flexible lines.
When the switch is turned off the Side-
Kick joints are decompressed.
Pressing a foot pedal, that is
connected to the gas supply module,
releases all the Side-Kick joints for
position changes. When the foot pedal
is released the joints lock.
A branched gas line connects the
supply module to two luers of the arm
assembly. A single gas line joins the
gas supply module to the main pivot.
Only the arm components and
adapters are pre-vac sterilized. The
disposable gas lines are supplied
sterile.
The KRONNER SIDE-KICK
A uterine manipulator Holder
Richard F. Kronner MD FACS
*See V-Care literature for required components.
Intended use:
The Kronner Side-Kick Uterine/vaginal Manipulator Holder is intended to assist the
surgical staff in mounting, positioning and holding a uterine manipulator during
gynecological laparoscopic surgical procedures. It is intended for use by trained
operating room personnel in an operating room environment.
"Caution: Federal law restricts this device to sale by or on the order of a physician.”
Adescription of the device and the intended use.

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Indications for use:
The Kronner Side-Kick Uterine Manipulator Holder is intended to assist the surgical
staff in mounting, positioning and holding a uterine manipulator during gynecological
laparoscopic surgical procedures. It is intended for use by trained operating room
personnel in an operating room environment.
Contraindications:
1. Adapter unavailable for chosen manipulator
2. Table rail unreliable
3. Gas supply is unreliable or unavailable at required pressure
4. Intended surgery does not require use of a uterine or vaginal manipulator.
See the uterine manipulator manufacturers’literature regarding instruction
for use, indications, contraindications and safety information.
Warnings:
1. Do not use with pressure greater than 150 psi.
2. Do not detach the gas supply module from the gas supply while the manipulator is attached.
3. Do not shut off the gas supply module switch while the manipulator is attached.
4. Do not use substitute flexible gas lines.
5. Do not use if gas leaks are detected.
6. Use only the specified adapter with the chosen manipulator.
7. On older operating tables with motorized perineal rests make sure the rest is in the down
position before adding the main pivot and the remainder of the assembly.
8. The gas module switch must be in the “on” position during use.
9. Do not use the sterile lines if the package is damaged or the 3 year expiration date is passed.
10. Do not attach the holder to a manipulator of a patient that is not under anesthesia or otherwise
immobilized.
11. Use only nitrogen or compressed air gas.
12. In the event the Side-Kick was disassembled without turning off the gas module switch, the
pneumatic joints may still be pressurized. To decompress, attach a male luer from a
branched gas line with one short branch disconnected, or use a syringe with the plunger
removed.
13. Do not attach the Sidekick rail grip over an attachment of the table rail to the table.
14. Attach the single gas line to the pivot and the branched line to the arm.
15. Remove the Sidekick arm before raising the lower end of the operating table.
16. Do not attach a gas line to a uterine manipulator, extreme danger.
Precautions:
1. Verify that the operating table rail is not loose.
2. Verify that the operating table end can be lowered or removed.
3. Restrain the patient from sliding on the table when the table is tilted.
4. Prevent the gas supply line from damage due to moving objects.
5. Check the uterine manipulator for defects.
6. Verify that the gas supply is steady and available at 140-150 psi.
7. Securely attach all flexible gas lines to the gas supply module and to the holder.
8. Read the instruction manual prior to use.
9. When making a patient transfer to or from the operating table to a cart with Sidekick in between
remove Sidekick or protect it from the cart.
10. Always support a connected manipulator when stepping on the gas pedal.

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COMPONENTS
pneumatically
locking ball joint
Arch-Koh
Uterine manipulator
Telescopic Arm,
pneumatically locking
Gas Lines from
supply module
Arm connection
Main Pivot,
pneumatically locking
Rail Grip
Operating Table Rail
Connector
Adapter
Adapter ball grip
Cross Rod
Holder assembly
Outer arm
Inner rod
GAS LINES
patient and table not shown
supplied sterile,
shelf life 3 years,
see package label

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GAS SUPPLY MODULE
to foot pedal
connection for
wall gas supply
knob for Rail
attachment
luers for gas lines
on/off switch
supply
gas line
supply line
release
for table rail
safety pressure release
luer guard
activation
foot pedal
press to
disconnect