Kronner SIDE-KICK User manual

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The KRONNER SIDE-KICK
A uterine manipulator Holder
for holding the RUMI uterine manipulator*
Instructions for use
* Model UMH 600, manufactured by CooperSurgical
United States Patent 8,485,484.B2

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The Kronner SIDE-KICK uterine manipulator Holder firmly holds the Vcare and
other uterine manipulators* during laparoscopic surgery on female pelvic organs,
thus freeing staff for performing other tasks. The Side-Kick does not interfere with
re-positioning the uterus with the attached manipulator.
The Side-Kick is attached to either operating table rail behind the leg stirrup
attachment.
The manipulator is inserted into the patient using standard technique, then the
Side-Kick is joined to the manipulator.
With proper adapters the Side-Kick may be used with various other manipulators,
such as the RUMI and the Arch Koh.
Agas supply module, which can also be attached to the operating table rail,
transfers nitrogen or compressed air from the hospital wall or a portable tank to the
Side-Kick through two flexible lines. When the module 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.
Abranched gas line connects the supply module to two luers of the arm assembly.
Asingle gas line joins the gas supply module to the main pivot.
Only the arm components and adapters are steam sterilized. The disposable gas
lines are supplied sterile.
The KRONNER SIDE-KICK
A uterine manipulator Holder
Richard F. Kronner MD FACS
*See V-Care and Arch Koh literature for components required.
Intended 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.
"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
RUMI Uterine manipulator
Telescopic Arm,
pneumatically locking
Gas Lines to
supply module
Arm connection
Main Pivot,
pneumatically locking
Rail Grip
Operating Table Rail
Connector
RUMI
Adapter
Adapter attachment
Cross Rod
Holder assembly
Outer arm
Inner rod
GAS LINES
Operating table and patient not shown
supplied sterile,
shelf life 3 years,
see package label

FOOT PEDAL CONTROL
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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

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RUMI ADAPTER
HIGH PRESSURE GAS LINES
RUMI Adapter RUMI with Adapter attached
supplied sterile
shelf life three years

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1. After sterilization, insert the inner rod into the outer arm.
2. If resistance is met, gas pressure may not have been released from the luer of
the outer arm after the last use.
To remove the gas, attach a male luer from a branched gas line with one short
branch disconnected, or use a syringe with the plunger removed.
STERILIZABLE COMPONENTS
Joining the inner rod to the arm.
luer
Outer arm Inner rod
luer
RUMI Adapter
Outer arm, inner rod and uterine manipulator adapter.

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1. Set the joining screw so the RUMI
can be slid into the attachment recess.
2. Slide the RUMI into the attachment
recess. This connection is made just in
front of the RUMI handle.
3. Position the RUMI adapter in
front of the RUMI handle pin.
4. Make certain the capture pin is
past the RUMI edge.
joining
screw
recess
capture pin
handle
pin
RUMI
handle
RUMI
handle
5. Slide the adapter over the RUMI
handle pin.
joining screw
6. Tighten the joining screw.
JOINING THE RUMI TO THE ADAPTER
handle
pin
RUMI
adapter

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1. Attach the gas supply module to
the operating table rail at a position
where the flexible gas lines will
reach to the Holder gas line
connections. Usually this is just
beside the planned position for the
Holder rail grip.
Whenever possible attach the gas
module to the side of the table not
used for patient transfer.
2. Turn off the module switch. This
will prevent gas from leaking from
the luer connections prior to flexible
gas line connection.
3. Connect the gas supply line to the
hospital nitrogen* or compressed air
supply.
4. Set the supply to 130-150 PSI.
5. Position the attached foot pedal.
(Note that it cannot be disconnected
from the supply module.)
*not nitrous oxide
Setting up the Gas Supply Module
NON-STERILIZABLE COMPONENTS
to foot pedal
knob for Rail
attachment
luers for gas lines
on/off switch
supply
gas line
supply line
release
for table
rail
safety pres-
sure release
luer guard
Gas supply module, foot pedal assembly, main pivot, rail grip
activation
foot pedal
press to
disconnect

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The rail grip assembly can be placed on either rail
behind the attachment for the leg stirrup.
1. Rotate the rail grip handle counter-clockwise until the bottom
of the lower rail grip aligns with the index mark.
This setting will allow the rail grip assembly to be attached by
tilting it outward.
In order to attach it without tilting, more counterclockwise rotations
are required. index mark
lower
rail grip
4. Rotate the handle clockwise until it is tight, approximately
three full rotations.
Be sure the assembly is hanging straight downward in both
planes during this step and the rail grip upper notch is touching
the rail on both sides of the rail grip.
2. Select a position, on the rail, that will place the Holder arm
directly below the manipulator.*
3. Tilt the assembly outward and set it on the rail. Pivot it toward
the rail until the lower rail grip is below the rail.
Corrections can be made later by repositioning the main pivot
assembly.*
The rail grip can be released and slid on the rail to re-position if
necessary.*
*The design of the Holder allows for variability in these settings.
Attaching the Rail Grip assembly to the
operating table rail.
lower
rail grip
table rail
When placing the Sidekick
Rail Grip onto the table rail,
do not put it over the rail table
attachment or a table rail notch.
Placing it in these areas could
cause an unstable attachment.
Table rail notches
Rail table attachment
Sidekick rail grip

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4. Slide the main pivot until
the arm connection is located
below the planned connection
to the manipulator.
5. Firmly tighten the T-handle
clockwise.
This setting can be changed
later, if needed.
1. Rotate the T-handle
counter-clockwise to a stop
to open the connection joint
for the main pivot cross rod.
Attaching the main pivot assembly to
the connector of the rail grip assembly
3. Insert the cross rod into the
connection joint.
fully open
Main pivot
Arm connection
T-handle
connector
“UP”
2. Position the main pivot and
cross rod so “UP” is positioned
upward.

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1. Rotate the main pivot handle
counter-clockwise to a stop to
open the attachment joint.
3. Tighten the main pivot handle
clockwise.
Stops prevent the arm from falling
prior to pressurizing the system.
Do NOT overcome these stops.
4. Lower the arm sideways to
one of the stops or continue to
hold it during the next steps.
Attaching the arm to the main pivot.
2. Insert the arm assembly into
the attachment joint until the
telescoping rod will allow for the
required manipulator movement.
This setting can be changed later,
if necessary.
Arm attachment joint

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Attaching the gas lines
Warning: Do not attach a gas line to a uterine manipulator, extreme danger.
1. Connect the single gas line to
the main pivot luer.2. Connect the other end of the
single gas line to one of the gas
output luers of the supply module.
4. Connect the other end to the
remaining luer of the supply module.
3. Connect the branched line to
the two luers of the arm assembly.
luer
luer
luer
Firmly tighten all gas line luer connections.
luer
Note: The gas line connections to the arm may be made prior to joining the arm to
the main pivot assembly.
The single gas line may be connected to the pivot and the supply module prior to
arm attachment.
To avoid confusion, make these connctions prior to inserting the manipulator into
the patient.

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Attaching the uterine manipulator to the Holder
Turning the gas on
1. Insert the RUMI into a properly anesthetized
and restrained patient.
2. Connect the adapter to the arm by sliding
the two adapter notches over the arm pins and
rotating the adapter clockwise. Gas pressure
must be off during this step.
Hold the arm until the gas switch is turned on.
notch
pin
1. Grasp the manipulator.
2. Press the foot pedal to re-position the attached manipulator.
3. After releasing the foot pedal, allow gas pressure to build prior
to releasing the manipulator.
To use the Holder
1. Turn the supply module
switch to “ON”.
‘OFF”
“ON”

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1. Support the arm.
2. Turn off the gas module switch prior to disconnecting the gas lines.
This will decompress the holder joints.
3. Detach the Side-Kick adapter from the manipulator, reverse steps 1-6
page 8 entitled “JOINING THE RUMI TO THE ADAPTER” or detach the
adapter and manipulator from the arm. Reverse step 2 page 14 entitled
“Attaching the uterine manipulator to the Holder”.
4. Remove the manipulator following instructions from the manufacturer.
5. Detach the manipulator and disassemble Side-kick by reversing the
assembly steps.
6. Remove the Sidekick arm before raising the lower end of the
operating table.
Removing Sidekick
Problems with Sidekick
In the rare event Side-Kick interferes with required uterine manipulation or
fails to hold the uterine manipulator, the uterine manipulator should be
disconnected from Side-Kick. Reverse steps 1 to 6, page 8 (Joining the
RUMI to the adapter)
If necessary, the arm can be detached from the main pivot. Reverse
steps1 to 3 page 12. (Attaching the arm to the main pivot).

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Cleaning Components
of the
Kronner Side-Kick
a uterine manipulator holder
Manual Cleaning:
1. Remove the inner rod from the outer arm.
2. Disconnect the manipulator adapter from the inner rod assembly at the ball joint and
remove the manipulator joining screw from the manipulator adapter, see pg. 7.
3. Inspect parts for defects, such as parts not fitting together or misshapen parts.
Contact Sidekick sales reps. regarding defects.
4. Use Enzol® enzymatic detergent, and prepare according to the manufacture’s recommendations
of 1 oz. per gallon of warm tap water, (or FDA approved equivalent)
5. Soak the outer arm, inner rod and adapter for five minutes in the prepared solution.
6. Maneuver movable parts to loosen trapped soil. Use a soft bristled brush (M16) to gently
scrub to remove any visible soil and actuate all moveable parts while scrubbing in order to loosen
trapped soil. Use an appropriate size lumen brush (45-541) for internal channels.
7. Repeat steps 5 and 6 two additional times for a total of three times.
8. Prepare a tap water bath at 38-49º C.
9. Agitate the assembly by hand for a minimum of one minute in the prepared bath.
10. Rinse the assembly under running tap water for at least one minute.
11. Dry the exterior of the assembly with a clean, lint free cloth.
The rail grip, main pivot assembly,
gas supply module with foot pedal are not sterilized.
Cleaning the sterilizable components:
Outer arm, inner rod, adapter

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Sterilizing Components
of the
Kronner Side-Kick
a uterine manipulator holder
Sterilizing the Outer arm, inner rod, and adapter:
1. Place items in the Kronner Sterilizer tray as illustrated
2. Sterilization wrap : Kimgard KC400 (or FDA approved equivalent)
3. Pre-vacuum temperature: 270 F, (132C)
4. Exposure time: 4.0 minutes
5. Drying time: 45 minutes

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Kronner Medical
1443 Upper Cleveland Rapids Road
Roseburg, Oregon 97471
Phone: [phone] or [phone]
Fax: [phone]
E-mail: [e-mail]
The Kronner Side-Kick
Auterine manipulator Holder
Parts List for the RUMI instrument holder
KSK-5000 The Kronner Side-Kick
1. 5100-5150-5200 Rail grip and connector assembly
2. 5300 Main pivot assembly
3. 700-5800 Pneumatic foot pedal and Gas supply module
4. K-1120 Gas supply hose, (attaches to hospital gas wall outlet)
5. 5400 Outer Arm assembly
6. 5500 Inner rod with pneumatically locking ball joint
Required adapter
1. 5650 RUMI manipulator adapter
2. 1752 Replacement joining screw
Disposable components, provided sterile,
(one set required for each procedure)
1. HPL1-BL1-V2 Branched gas line set contains:
a. Branched line with two male luer-lock fittings on the distal
end and one luer-lock female fitting with a luer activated valve
on the proximal end, length: 96 inches.
b. Straight gas line, with one male luer-lock fitting on the
distal end and one luer-lock female fitting with a luer activated
valve on the proximal end, length: 96 inches.
c. Shelf life: 3 years