Setup and Check-Out 3.02
Setup and Check-Out 3.02
OPERATING INSTRUCTIONS
INTRODUCTION
This section details a recommended setup and check-out procedure for the ,QÀQLWL®
Vision System. The steps on the following pages cover preparation for cataract lens
removal surgery including irrigation and aspiration, coagulation, and vitrectomy using
Alcon-supplied packs.
The procedures are divided into two columns and presume a surgical team of three
people: Surgeon and 6FUXE1XUVHLQWKHVWHULOHÀHOGDQGDCirculating Nurse in
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the Troubleshooting section of this manual. If questions still exist, contact the Alcon
Technical Services Department or your local Alcon representative.
POWER UP SEQUENCE
When the Power switch is turned on, and the Standby switch is pressed, the ,QÀQLWL®
logo screen appears while the system performs its self-test diagnostics. The ,QÀQLWL®
Vision System is capable of detecting and reporting a wide range of Event conditions.
Many of these are checked during the power up procedure. If a fault is detected
during power up, the instrument becomes non-operational until the failure/problem is
corrected. Upon successful completion of the self-tests, the system enters the Setup
screen.
1. Matching the red dot on the footswitch cable connector to the red dot on Circulating Nurse
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Ensure treadle and switches are not depressed/activated.
2. Plug main power cord into a suitable wall outlet or receptacle. Turn Circulating Nurse
Power switch ON located at the bottom of the rear panel next to the
power cord (this switch remains ON in the I position). Turn system
power ON using the Standby switch located at the top of the rear panel.
CAUTION
Do not use multiple portable socket outlets with this system.
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3. Extend the IV pole hook. Do not extend while IV pole is in motion. Circulating Nurse
4. The grayed-out Setup screen appears with the Doctor Name dropdown Circulating Nurse
list displayed. Press a Doctor Name button (Alcon Settings) to select an
available doctor, or add a doctor by following the steps presented on the
display. Verify that the displayed Handpiece, Tip, and Procedure Type
are correct; if not, select the correct settings.
WARNING!
Ensure that appropriate ,Q¿QLWL® system parameters and system
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5. Inspect the O-rings on the 8OWUDÁRZ® I/A handpiece tip. If damaged, Circulating Nurse
the O-rings must be replaced using the 8OWUDÁRZ® O-ring tool prior to
sterilization.
CAUTION
The U/S handpiece, 2=LO® torsional handpiece, 1HR6RQL;®
handpiece, and optional AquaLase® handpiece must be at room
temperature before use. Allow handpiece to air cool after steam
autoclave (at least 15 minutes). Never immerse in liquid to cool.
1. Extend instrument tray out from the right or left side of console. Pull to Circulating Nurse
extend wire loop on tray.
2. If remote control is to be used during surgery, place it in the instrument Circulating Nurse
tray well. Verify remote control is functional by slightly raising or
lowering the IV pole.
3. Peel lid from U/S surgical pack and aseptically transfer contents to Circulating Nurse
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4. Drape the tray support cover over the tray, remote control, and support Scrub Nurse
arm. Push tray support cover downward through open wire loop to form
pouch.
5. Grasp Fluidic Management System (FMS), remove paper band from Scrub Nurse
irrigation/aspiration (I/A) tubing, uncoil tubing and place in pouch.
7. Remove band from irrigation drip chamber tubing and aseptically Scrub Nurse
present drip chamber to Circulator.
8. Accept the drip chamber. Spike the irrigation bottle and hang it from the Circulating Nurse
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3/4 full.
CAUTION
IV pole rises automatically. To avoid stretching drip chamber
tubing, and possibly pulling drip chamber out of bottle, tubing must
hang freely with no interference on left side of console.
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pressure can result from exceeding drain bag maximum capacity and
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9. Connect the blue aspiration tubing luer to the white irrigation tubing luer. Scrub Nurse
10. The setup screen is automatically entered at startup or upon removal of Scrub Nurse or
the FMS after completion of a procedure. If not in setup screen, press the Circulating Nurse
Setup button, or access the setup screen via the remote control.
11. Press Prime FMS on the setup screen or Enter on the remote control. Scrub Nurse or
The IV pole automatically goes to the priming position and the system Circulating Nurse
performs three functions: prime, vacuum test, and vent test.
If the vacuum or vent test is not successful the system will display an
advisory.
12. Thread U/S tip onto U/S handpiece, 2=LO® torsional handpiece, or Scrub Nurse
1HR6RQL;®KDQGSLHFH7LJKWHQÀUPO\XVLQJWKHtip wrench. Remove tip
wrench and retain for future tip removal. If tip is not securely attached,
an Event message may be generated and/or inadequate tuning will occur.
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polymer tubing
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CAUTION
Do not use the disposable tip wrench for subsequent cases; stripping
of the tip wrench may occur.
13. Thread infusion sleeve containing the BSI onto handpiece over the U/S Scrub Nurse
tip. Match the proper color coding between the tip and sleeve. Adjust
sleeve so it clears bevel on tip by approximately 1-2 mm, and orient port
holes correctly.
14. Connect irrigation and aspiration tubing to the phaco step handpiece (U/S Scrub Nurse
handpiece, 2=LO® torsional handpiece, or 1HR6RQL;® handpiece).
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16. Hold handpiece with tip pointed down into test chamber. Press Enter Scrub Nurse
on the remote control (or Circulator press Fill on the setup screen). Fill
test chamber completely and slide it over end of handpiece. Ensure no
air bubbles are present in test chamber. Press handpiece into tray pouch
with tip pointed up. Ensure tubing is not kinked.
Place handpiece
vertically in pouch
formed with drape
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17. Press Enter on the remote control (or Circulator press Test Handpiece Scrub Nurse or
on the setup screen). After a very brief and successful tuning of the Circulating Nurse
handpiece, ÁRZFKHFNZLOOIROORZDXWRPDWLFDOO\$IWHUDVXFFHVVIXO
ÁRZFKHFNWKHtune status indicator will change from Not Tuned (red)
to Tuned (green). If only one handpiece is installed, the system will
advance to the surgery screen.
The IV pole returns to its last selected height, but if no memory has been
selected it returns to its default position.
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1. Extend instrument tray out from the right or left side of console. Pull to Circulating Nurse
extend wire loop on tray.
2. If remote control is to be used during surgery, place it in the surgical tray Circulating Nurse
well. Verify remote control is functional by slightly raising or lowering
the IV pole.
3. Peel lid from $TXD/DVH® surgical pack and aseptically transfer contents Circulating Nurse
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4. Drape the tray support cover over the tray, remote control, and support Scrub Nurse
arm. Pull to extend wire loop on tray. Push drape downward through
open wire loop to form pouch.
5. Grasp Fluidic Management System (FMS), remove paper band from all Scrub Nurse
tubing, uncoil tubing and place in pouch.
7. Insert $TXD/DVH®/Balanced Salt Solution bottle into bottle receptacle Circulating Nurse
on front panel, then push and rotate 1/8 turn clockwise to secure. When
inserting bottle, etched arrow on bottle must be in alignment with top of
receptacle.
9. Accept the drip chamber. Spike the irrigation bottle and hang it from the Circulating Nurse
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CAUTION
IV pole rises automatically. To avoid stretching drip chamber
tubing, and possibly pulling drip chamber out of bottle, tubing must
hang freely with no interference on left side of console.
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10. Connect the blue aspiration line luer to the white irrigation line luer. Scrub Nurse
11. The setup screen is automatically entered at startup or upon removal of Circulating Nurse
the FMS after completion of a procedure. If not in setup screen, press the
Setup button.
12. Press Enter on the remote control (or Circulator press Prime FMS on the Scrub Nurse
setup screen). The IV pole automatically goes to the priming position
and the system performs three functions: prime, vacuum test, and vent
test.
If the vacuum or vent test is not successful the system will display an
advisory.
13. Prepare $TXD/DVH® handpiece for use as described in the $TXD/DVH® Staff
handpiece DFU.
15. Install infusion sleeve over tip and onto end of $TXD/DVH® handpiece. Scrub Nurse
Adjust sleeve so it clears bevel on tip by approximately 1 mm, and orient
port holes correctly.
16. Connect irrigation, aspiration, and black-striped $TXD/DVH® tubing to the Scrub Nurse
$TXD/DVH® handpiece.
17. Grasp black-striped $TXD/DVH® tubing spike from the pouch and spike Scrub Nurse
the $TXD/DVH®/Balanced Salt Solution bottle.
18. Remove protective cap from connector by retracting the sheath of Scrub Nurse
the connector and releasing cap. Line up red dot on handpiece cable
connector with red dot on ,QÀQLWL® Vision System front panel connector
and plug cable into console connector.
19. Hold handpiece with tip pointed down into test chamber. Press Enter Scrub Nurse
on the remote control (or Circulator press Fill on the setup screen). Fill
test chamber completely and slide it over end of handpiece. Ensure no
air bubbles are present in test chamber. Press handpiece into tray pouch
with tip pointed up. Ensure that tubing is not kinked.
WARNING!
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The IV pole returns to its last selected height, but if no memory has been
selected it returns to its default position.
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1. Remove the blue luer aspiration line and white luer irrigation line from Scrub Nurse
the U/S handpiece, 2=LO® torsional handpiece, 1HR6RQL;® handpiece, or
optional $TXD/DVH® handpiece and connect to the I/A handpiece.
2. This step is required when using 8OWUDÁRZ® I/A handpiece with threaded
tip adapter.
Attach sterile I/A tip to I/A handpiece using tip wrench supplied in the Scrub Nurse
phaco pack.
CAUTION
Use of a tool other than Alcon tip wrench may cause damage to the
I/A tip and handpiece.
Thread infusion sleeve, without bubble suppression insert (BSI), over Scrub Nurse
the I/A tip until sleeve clears the tip’s aspiration opening. Orient the
irrigation port holes on the sleeve.
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1. If $XWR6HUW® injector step is not already shown at bottom of Surgery Circulating Nurse
screen for this doctor, add it to the steps by enabling it in the &XVWRP or
'RFWRU6WHSV window. Scrub Nurse
2. Plug INTREPID® $XWR6HUW® IOL Injector Handpiece cable into top-right Scrub Nurse
handpiece connector on the front connector panel.
3. Enter the $XWR6HUW® injector step (or Irr/Asp step with $XWR6HUW® setup in Scrub Nurse
its Surgery Controls area).
5. Detach nosecone from IOL injector handpiece by rotating the nosecone Scrub Nurse
counter-clock-wise, then carefully sliding it away from the IOL injector
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6. With nosecone removed (see Figure 3-5), remove the plunger by Scrub Nurse
grasping it where indicated and pulling it away from IOL injector
handpiece.
8. Slide sterile plunger into sterile wrench, then connect plunger/wrench Scrub Nurse
onto nosecone of sterile IOL injector handpiece. Press Load Plunger
button (See $OFRQ® INTREPID® $XWR6HUW® IOL Injector Handpiece
DFU).
9. After plunger is loaded onto nosecone of sterile IOL injector handpiece, Scrub Nurse
remove wrench/assembly tool. The IOL injector handpiece is ready for
the IOL cartridge.
Preload an IOL
Prior to entering the eye, the plunger must be advanced forward to the
preload lens position.
10. Load IOL into cartridge, then insert loaded IOL cartridge onto tip of Scrub Nurse
IOL injector handpiece (See $OFRQ® INTREPID® $XWR6HUW® IOL Injector
Handpiece DFU).
11. Press Preload IOL button. The $XWR6HUW® handpiece is ready for use Scrub Nurse
when the preload sequence is complete.
12. In the $XWR6HUW® injector step, and prior to inserting the lens into the Circulating Nurse
patient's eye, set the doctor's preferred Initial Velocity, Pause, and End or
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clicking on its button.
PRECAUTION: The default values for the Initial Velocity and Pause ensure
proper IOL injection over a worst case range of IOL size and ambient
temperature conditions. Please refer to the INTREPID® $XWR6HUW® IOL
Injector DFU and consult with your Alcon representative for additional
guidance in adjusting these parameters.
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When the Anterior Vitrectomy step is entered, the Vitrectomy Setup screen
appears (see Figure below) unless turned Off in the Doctor Settings screen. This
setup screen assists the user through the proper set up and test of the selected probe.
If the Vitrectomy Setup screen is turned Off, you can either turn the Vitrectomy
Setup screen On (Custom/Doctor/General), or proceed to ANTERIOR
VITRECTOMY PROBE SETUP (without using Vitrectomy Setup screen).
2. Press the Ant Vit step button; the Vitrectomy Setup screen appears. Circulating Nurse/
Scrub Nurse
NOTE: In the next few steps the user will be instructed to press buttons
on the display screen. These buttons can be pressed on the display screen,
or they can be activated using the Forward/Back Arrow keys and Enter
key on the remote control.
3. Verify probe type - If desired probe is not displayed, press the 6ZLWFK Circulating Nurse/
3UREH button to select probe being used. Press 1H[W6WHS button. Scrub Nurse
4. Connect to console Vit ports - For 20 gauge ,QÀQLWL® vitrectomy probe, Scrub Nurse
connect clear tubing connector to left Vit port and turn clockwise until
connector clicks securely in place. For 23 gauge ,QÀQLWL® 8OWUD9LW®
probe, connect black and purple tubing connectors to left and right Vit
ports, respectively, and turn clockwise until connectors click securely in
place. Press 1H[W6WHS button.
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5. Connect aspiration tubing - Disconnect FMS irrigation and aspiration Scrub Nurse
tubing connectors from lens removal handpiece. Connect FMS blue
aspiration tubing connector to probe's blue aspiration tubing connector.
Press 1H[W6WHS button.
6. Connect irrigating cannula - Connect FMS white irrigation tubing connector Scrub Nurse
to irrigating cannula, or optionally for a 20 gauge ,QÀQLWL® vitrectomy
probe, to an irrigation sleeve added to probe's tip. Press 1H[W6WHS button.
7. Press Fill then press Test - Priming of the vitrectomy probe is required Scrub Nurse
prior to use. With tip of probe and irrigating cannula in a cup of sterile
ÁXLGSUHVVWKH)LOO button. Ensure all air bubbles have been removed
from all tubing connected to the probe prior to use.
Verify probe actuation - While observing cutting port of probe, held Scrub Nurse
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visualization of probe cutter by applying a brief period of reduced cut rate.
The cutter should fully open and close when actuated. Press the ([LW button.
8. The Vitrectomy Cut I/A or I/A Cut surgery screen appears on the front Circulating Nurse
display panel. Switching between Cut I/A and I/A Cut is done with the
Mode button at top center of surgery screen.
9. Press Irrigation Control up/down keys on the remote control (or Scrub Nurse/
Circulator press Bottle Height Adjustment Arrows on the setup screen) Circulating Nurse
to adjust bottle height. Vitrectomy probe is ready.
WARNINGS!
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To set up the vitrectomy probe without using the Vitrectomy Setup screen,
follow the instructions below.
2. Press the Ant Vit step button; the vitrectomy surgery screen appears. Circulating Nurse/
Scrub Nurse
3. If desired probe is not displayed in the button at the top of the vitrectomy Circulating Nurse/
surgery screen, press the button to select probe being used. Scrub Nurse
4. For 20 gauge ,QÀQLWL® vitrectomy probe, connect clear tubing connector Scrub Nurse
to left Vit port and turn clockwise until connector clicks securely in
place. For 23 gauge ,QÀQLWL® 8OWUD9LW® probe, connect black and purple
tubing connectors to left and right Vit ports, respectively, and turn
clockwise until connectors click securely in place.
5. Disconnect FMS irrigation and aspiration tubing connectors from lens Scrub Nurse
removal handpiece. Connect FMS blue aspiration tubing connector to
blue connector of vitrectomy probe.
6. Connect FMS white irrigation tubing connector to irrigating cannula, Scrub Nurse
or optionally for a 20 gauge ,QÀQLWL® vitrectomy probe, to an irrigation
sleeve added to probe's tip.
7. Priming of the vitrectomy probe is required prior to use, and can be Scrub Nurse
performed using one of two methods. With tip of probe and irrigating
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1 to remove air bubbles from the probe’s irrigation line, and then use
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remove air bubbles from the irrigation and aspiration lines, then return
to Ant Vit mode.
Ensure all air bubbles have been removed from all tubing connected to
the probe prior to use.
8. Testing of the vitrectomy probe should be performed prior to use. With Scrub Nurse
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footpedal to the cut position and observe probe's cutting port (to facilitate
visualization, reduce cut rate). The cutter should fully open and close
when actuated, and remain open when footpedal is released to position 0.
9. Switching between Cut I/A and I/A Cut is done with the Mode button at Circulating Nurse
top center of surgery screen.
10. Press Irrigation Control up/down keys on the remote control (or Scrub Nurse/
Circulator press Bottle Height Adjustment Arrows on the setup screen) Circulating Nurse
to adjust bottle height. Vitrectomy probe is ready.
1. Using aseptic techniques, plug new or sterilized handpiece cable Scrub Nurse
connectors into ,QÀQLWL® Vision System front connector panel.
3.20 FORPAGE
LAST REFERENCE ONLY
OF THIS SECTION 8065752899
SECTION FOUR
CARE AND MAINTENANCE
INTRODUCTION
This section of the manual is designed to inform the operator of basic care and
maintenance of the instrument. If a problem occurs on the instrument, contact
Alcon Technical Support or your local Alcon representative and give details of the
breakdown circumstances and effects. If there is an Event message, write down
the number and message exactly as it appears on the screen. From these elements,
a specialized technician will evaluate the problem and determine the maintenance
requirements.
WARNING!
The ,Q¿QLWL® Vision System battery can only be serviced by a factory-trained Alcon
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STEP ONE: Clean handpieces, cables, forceps, etc., as instructed in DFU's supplied
with each accessory.
WARNING!
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STEP TWO: Remove irrigation bottle from hanger and set aside. Remove spike from
irrigation bottle and discard tubing.
STEP FOUR: Flip the irrigation bottle holder to its storage position.
STEP FIVE: Select Custom/Shutdown from the Surgery Screen. Select OK. IV pole
will go down to storage position before unit shuts off.
or
Press Standby power switch located at top of rear panel to remove operating power
from the system. IV pole will go down to storage position before unit shuts off.
WARNING!
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STEP SIX: Turn the Main power switch OFF. It is located at the bottom of the rear
panel above the power cord.
STEP SEVEN: Disconnect the power cable from the wall receptacle and wind the
cable around the cord wrap.
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STEP NINE: If required, the console panels, the footswitch, and the remote control
may be wiped with alcohol, mild soap and water, or any germicidal solution that is
compatible with the plastic parts.
CAUTIONS
'RQRWclean console or accessories using solvents, abrasives, or any cleaner
that is not compatible with plastic parts made of GE Cycoloy CU 6800 and
LEXAN 920A. Damage may result.
$YRLGVSLOOLQJBSS® solution, or moisture of any kind, around the electrical
handpiece connectors.
STEP TEN: Place the footswitch and cable in its drawer at the bottom of the front
panel.
The following tips are recommended for proper care of the ,QÀQLWL® Vision System:
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alcohol, mild soap and water, or any germicidal solution that is compatible with
the plastic parts; instructions begin on the prior page.
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commercially-available window cleaner. Apply the cleaner to the towel rather
than the touch screen.
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Damaged hardware must be replaced to ensure safe operation. Call Alcon
Technical Services for assistance.
WARNING!
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Please consult the accompanying Directions For Use (DFU) for cleaning, reprocessing, and
sterilization instructions for Alcon approved reusable accessories. The DFU will provide the
recommended time and temperature guidelines for steam autoclave cycles performed by Alcon, Inc.
The sterility assurance level achieved with these parameters must be validated by each surgical
facility. Please refer to Association for the Advancement of Medical Instrumentation (AAMI)
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or deionized water.
NOTE: The reusable items will withstand steam autoclave cycles at 134° C (273°F). Due to
the variations found in steam autoclaves and the variable bioburden on devices
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an adequate sterility assurance level. Validation of the individual autoclave, and
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cycle, must be performed by each surgical facility.