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Setup and Check-Out 3.02

SETUP2
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0% found this document useful (0 votes)
22 views

Setup and Check-Out 3.02

SETUP2
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 25

SECTION THREE

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 ,QÀQLWL® Vision System, including Alcon-approved consumables and accessories,


constitutes a complete surgical system and is intended exclusively for use by licensed
ophthalmic surgeons and their surgical teams. These surgical teams are experienced
DWFRQGXFWLQJSKDFRHPXOVLÀFDWLRQSURFHGXUHVLQDSURSHUO\PDLQWDLQHGVXUJLFDO
HQYLURQPHQW TXDOLÀHGSHUVRQQHODYDLODELOLW\RIEDFNXSHTXLSPHQW DQGDUHIDPLOLDU
with the operation of the equipment used as outlined in operator’s manuals and
directions for use (setup/checkout procedures to be completed before the surgical
procedure; processing of reusable devices; maintenance; etc.).

The procedures are divided into two columns and presume a surgical team of three
people: Surgeon and 6FUXE1XUVHLQWKHVWHULOHÀHOGDQGDCirculating Nurse in
WKHQRQVWHULOHÀHOG,QWKHOHIWFROXPQDGLUHFWLYHLVJLYHQLQWKHULJKWFROXPQWKH
UHVSRQVLEOHWHDPPHPEHULVLGHQWLÀHG

 $Q\SUREOHPVSHUWDLQLQJWRVHWXSDQGFKHFNRXWSURFHGXUHVVKRXOGÀUVWEHGLUHFWHGWR
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.

8065752899 FOR REFERENCE ONLY 3.1


INITIAL SYSTEM SETUP

1. Matching the red dot on the footswitch cable connector to the red dot on Circulating Nurse
WKHIRRWVZLWFKSOXJFDEOHLQWRIRRWVZLWFK3ODFHIRRWVZLWFKRQWKHÁRRU
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.

WARNING!
.HHSFOHDURIWKH,9SROHZKHQLWLVLQPRWLRQWRSUHYHQWVNLQKDLUDQGRU
FORWKLQJIURPEHFRPLQJWUDSSHGLQWKH,9SROHPHFKDQLVP7KH,9SROH
PRYHVGXULQJSRZHURQRIISULPLQJDQGERWWOHKHLJKWDGMXVWPHQWV

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
VHWWLQJV DUH VHOHFWHG SULRU WR VWDUWLQJ WKH SURFHGXUH 3DUDPHWHU DQG
V\VWHP VHWWLQJV LQFOXGH EXW DUH QRW OLPLWHG WR XOWUDVRXQG PRGH
XOWUDVRXQGSRZHUYDFXXPDVSLUDWLRQÀRZUDWHERWWOHKHLJKWHWF

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.

6. Sterilize the instruments according to hospital procedure. Circulating Nurse

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.

3.2 FOR REFERENCE ONLY 8065752899


STANDARD PHACOEMULSIFICATION SETUP

Prepare Contents of U/S Surgical Pak

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
VWHULOHÀHOG

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.

6. Hold )06E\KDQGOHDQJOHLWWRZDUGWKHOLSRQERWWRPRIÁXLGLFPRGXOH Scrub Nurse


and press top forward to insert into housing, all in one motion. Ensure
that the drain bag hangs freely, and that tubing does not fall out of 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
LUULJDWLRQSROH6TXHH]HGULSFKDPEHUXQWLOLWÀOOVDSSUR[LPDWHO\WR
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.

WARNING!
'R QRW H[FHHG PD[LPXP FDSDFLW\ RI GUDLQ EDJ  PO  ([FHVVLYH
pressure can result from exceeding drain bag maximum capacity and
SRWHQWLDOO\UHVXOWLQDKD]DUGRXVFRQGLWLRQIRUWKHSDWLHQW

8065752899 FOR REFERENCE ONLY 3.3


Prime, Vacuum, and Vent Test

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.

NOTE: After completion of priming, the vacuum test is performed.


This is immediately followed by a vent test. After successful
completion of vacuum and vent tests the prime status indicator will
change from U/S FMS Not Primed (red) to U/S FMS Primed (blue).

If the vacuum or vent test is not successful the system will display an
advisory.

3.4 FOR REFERENCE ONLY 8065752899


U/S handpiece, 2=LO® Torsional handpiece, or 1HR6RQL;® Handpiece Setup
and Test

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.
US TIP/WRENCH ASSEMBLY

U/S TIP WRENCH

Figure 3-1 U/S Tip/Wrench Assembly

0DFNRRO series ultrasonic tips contain a polymer tubing. This necessary


part of the 0DFNRRO WLSSURYLGHVDGGLWLRQDOWKHUPDODQGÁXLGLFDGYDQWDJHV

polymer tubing

Mackool** Round Tip Mackool** Kelman® Tip

Figure 3-2 0DFNRRO** Tips

WARNING!
&KHFNIRUWKHSUHVHQFHDQGFRUUHFWSRVLWLRQRIWKHSRO\PHUWXELQJRQWKH
0DFNRRO WLSV1HYHUDWWHPSWWRUHPRYHWKHWXELQJ8VHRIWKH0DFNRRO**
WLSVZLWKRXWSRO\PHUWXELQJPD\UHVXOWLQDKD]DUGRXVFRQGLWLRQIRUWKH
SDWLHQW

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).

8065752899 FOR REFERENCE ONLY 3.5


15. 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 and plug
cable into console connector. (The 1HR6RQL;® handpiece must only be
plugged into the top phaco connector.) If the UltraChop step is enabled
and it is desired to use two phaco handpieces, then plug in the second
handpiece (with ALCON® 8OWUD&KRSSHU® tip) at this time.

A single handpiece may be used in support of the ALCON®


8OWUD&KRSSHU® tip. In this case, plug the handpiece into either the
top or bottom connector and install the 8OWUD&KRSSHU® tip. Enter the
Setup screen and prime and tune the handpiece. Then after use, the
8OWUD&KRSSHU® tip must be replaced with the desired phaco tip and the
handpiece reprimed and tuned prior to lens removal.

)LJXUH 3URWHFWLYH&DS5HPRYDO

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

Slide test chamber


over handpiece tip

BSS® irrigating fluid


in test chamber

Figure 3-4 3UHSDULQJ7HVW&KDPEHUDQG3ODFLQJ+DQGSLHFHLQ3RXFK

3.6 FOR REFERENCE ONLY 8065752899


WARNINGS!
,IVWUHDPRIÀXLGLVZHDNRUDEVHQWZKLOH¿OOLQJWHVWFKDPEHUJRRGÀXLGLFV
UHVSRQVHZLOOEHMHRSDUGL]HG*RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJ
IRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQÀRZSULRUWRHQWHULQJWKHH\H

(QVXUHWKDWWKHWXELQJVDUHQRWRFFOXGHGGXULQJDQ\SKDVHRIRSHUDWLRQ

:KHQXVLQJDELPDQXDOSURFHGXUHHQVXUHWKHLUULJDWLRQKDQGSLHFHDQG
VHWWLQJVKDYHVXI¿FLHQWÀRZFKDUDFWHULVWLFV8VHRILUULJDWLRQKDQGSLHFHV
RUVHWWLQJVZLWKLQVXI¿FLHQWÀRZFKDUDFWHULVWLFVPD\UHVXOWLQDÀXLGLF
LPEDODQFH DQG PD\ FDXVH D VKDOORZLQJ RU FROODSVLQJ RI WKH DQWHULRU
FKDPEHU

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.

If two handpieces have been installed in support of an UltraChop step,


then transfer the irrigation and aspiration tubing to the handpiece with
the ALCON® 8OWUD&KRSSHU® tip and repeat steps 16 and 17. When both
handpieces have been prepared, 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.

WARNINGS!
,IWKHKDQGSLHFHWHVWFKDPEHULVFROODSVHGDIWHUWXQLQJWKHUHLV
DSRWHQWLDORIORZLUULJDWLRQÀRZWKURXJKWKHKDQGSLHFHDQGPD\
UHVXOWLQDÀXLGLFLPEDODQFH7KLVLQWXUQPD\FDXVHDVKDOORZLQJRU
FROODSVLQJRIWKHDQWHULRUFKDPEHU

*RRGFOLQLFDOSUDFWLFHGLFWDWHVWHVWLQJIRUDGHTXDWHLUULJDWLRQDVSLUDWLRQ
ÀRZ UHÀX[ DQG RSHUDWLRQ DV DSSOLFDEOH IRU HDFK KDQGSLHFH SULRU WR
HQWHULQJH\H

8065752899 FOR REFERENCE ONLY 3.7


STANDARD AQUALASE® DEVICE SYSTEM SETUP (optional feature)

Prepare Contents of AquaLase® Surgical Pack

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
WRVWHULOHÀHOG

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.

 +ROG)06E\KDQGOHDQJOHLWWRZDUGWKHOLSRQERWWRPRIÁXLGLF Scrub Nurse


interface module, and top press forward to insert into housing, all in one
motion. Ensure that the drain bag hangs freely, and that tubing does not
fall out of 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.

8. Aseptically present drip chamber/irrigation tubing to Circulator. Scrub Nurse

9. Accept the drip chamber. Spike the irrigation bottle and hang it from the Circulating Nurse
,9SROH6TXHH]HGULSFKDPEHUXQWLOLWÀOOVDSSUR[LPDWHO\WRIXOO

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.

WARNING!
'R QRW H[FHHG PD[LPXP FDSDFLW\ RI GUDLQ EDJ  PO  ([FHVVLYH
pressure can result from exceeding drain bag maximum capacity and
SRWHQWLDOO\UHVXOWLQDKD]DUGRXVFRQGLWLRQIRUWKHSDWLHQW

3.8 FOR REFERENCE ONLY 8065752899


Prime, Vacuum, and Vent Test

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.

After completion of priming, the vacuum test is performed. This is


immediately followed by a vent test. After successful completion of
vacuum and vent tests the prime status indicator will change from
$TXD/DVH® FMS Not Primed (red) to $TXD/DVH® FMS Primed (green).

If the vacuum or vent test is not successful the system will display an
advisory.

8065752899 FOR REFERENCE ONLY 3.9


AquaLase® Handpiece Setup and Test

13. Prepare $TXD/DVH® handpiece for use as described in the $TXD/DVH® Staff
handpiece DFU.

14. Install $TXD/DVH® tip onto $TXD/DVH®KDQGSLHFH7LJKWHQÀUPO\XVLQJ Scrub Nurse


the tip wrench. Remove tip wrench and retain for future tip removal.

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!
,IVWUHDPRIÀXLGLVZHDNRUDEVHQWZKLOH¿OOLQJWHVWFKDPEHUJRRGÀXLGLFV
UHVSRQVHZLOOEHMHRSDUGL]HG*RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJ
IRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQÀRZSULRUWRHQWHULQJWKHH\H

3.10 FOR REFERENCE ONLY 8065752899


20. Press Enter on the remote control (or Circulator press Test Handpiece on Scrub Nurse
the setup screen). After a very brief and successful tuning of the handpiece,
ÁRZFKHFNZLOOIROORZDXWRPDWLFDOO\ For the $TXD/DVH® handpiece, a
momentary collapse of the test chamber is normal. After a successful
ÁRZFKHFNWKHWXQHVWDWXVLQGLFDWRUZLOOFKDQJHIURP1RW7XQHG UHG WR
Tuned (green). 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.

WARNING!
8VH RI WKH 86 KDQGSLHFH 2=LO® WRUVLRQDO KDQGSLHFH 1HR6RQL;®
KDQGSLHFHRUAquaLase®KDQGSLHFHLQWKHDEVHQFHRILUULJDWLRQÀRZ
DQGRU LQ WKH SUHVHQFH RI UHGXFHG RU ORVW DVSLUDWLRQ ÀRZ FDQ FDXVH
H[FHVVLYHKHDWLQJDQGSRWHQWLDOWKHUPDOLQMXU\WRDGMDFHQWH\HWLVVXHV

,IWKHKDQGSLHFHWHVWFKDPEHULVFROODSVHGDIWHUWXQLQJWKHUHLV
DSRWHQWLDORIORZLUULJDWLRQÀRZWKURXJKWKHKDQGSLHFHDQGPD\
UHVXOWLQDÀXLGLFLPEDODQFH7KLVLQWXUQPD\FDXVHDVKDOORZLQJRU
FROODSVLQJRIWKHDQWHULRUFKDPEHU

*RRGFOLQLFDOSUDFWLFHGLFWDWHVWHVWLQJIRUDGHTXDWHLUULJDWLRQDVSLUDWLRQ
ÀRZ UHÀX[ DQG RSHUDWLRQ DV DSSOLFDEOH IRU HDFK KDQGSLHFH SULRU WR
HQWHULQJH\H

8065752899 FOR REFERENCE ONLY 3.11


IRRIGATION/ASPIRATION HANDPIECE SETUP

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.

3. Press )LOOEXWWRQXQWLOÁXLGVWUHDPVIURPERWKLUULJDWLRQDQGDVSLUDWLRQ Circulating Nurse


ports (if ,UULJDWLRQ)LOOLVHQDEOHGLQ6\VWHP6HWWLQJVÁXLGZLOORQO\
stream from irrigation port). Ensure no air bubbles remain in irrigation
or aspiration pathways before continuing procedure.

WARNING!
,IVWUHDPRIÀXLGLVZHDNRUDEVHQWZKLOH¿OOLQJWHVWFKDPEHUJRRGÀXLGLFV
UHVSRQVHZLOOEHMHRSDUGL]HG*RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJ
IRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQÀRZSULRUWRHQWHULQJWKHH\H

3.12 FOR REFERENCE ONLY 8065752899


INTREPID® AUTOSERT® IOL INJECTOR SETUP

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).

Plunger Removal Within the Sterile Field


 ,ILWEHFRPHVQHFHVVDU\WRUHSODFHWKHSOXQJHUZLWKLQWKHVWHULOHÀHOG
follow the steps below.

4. With plunger fully retracted, remove cartridge from IOL injector


handpiece.

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
KDQGSLHFHVRLWGRHVQRWGHÁHFWWKHSOXQJHU

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.

7. Re-attach nosecone onto IOL injector handpiece. Scrub Nurse

Grasp plunger here

and pull away from IOL handpiece

)LJXUH 5HPRYLQJSOXQJHUIURP,175(3,'® $XWR6HUW®,2/LQMHFWRU

8065752899 FOR REFERENCE ONLY 3.13


Load a Plunger
If a plunger needs to be installed, perform this procedure when an I/A
step or $XWR6HUW® injector step is entered.

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.

Make Final Adjustments

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
9HORFLW\7KH(QG9HORFLW\FDQEHVHWIRUÀ[HGRUOLQHDUGHOLYHU\E\ Scrub Nurse
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.

Cautions and Warnings for $XWR6HUW® IOL injector on next page

3.14 FOR REFERENCE ONLY 8065752899


CAUTIONS
‡ 'RQRWXOWUDVRQLFDOO\FOHDQWKH$XWR6HUW® IOL Injector connector. Ultrasonic
cleaning will cause irreparable damage.
‡ 8VHFDUHZKHQKDQGOLQJ$XWR6HUW® IOL Injector, particularly when cleaning. Always
clean handpiece over a surface cushioned with a pad or rubber mat.
‡ %HVXUHKDQGSLHFHFDEOHFRQQHFWRULVGU\EHIRUHFRQQHFWLQJLWWRWKHFRQVROH
‡ 'RQRWGLVFRQQHFWFDEOHFRQQHFWRUIURP,QÀQLWL® system console until the IOL
injector plunger is fully retracted.
‡ 'R QRW LPPHUVH WKH $XWR6HUW® ,2/ ,QMHFWRU LQ DQ\ ÁXLG ZKHQ WKH SOXQJHU LV QRW
retracted.
‡ $VSDUWRIDSURSHUO\PDLQWDLQHGVXUJLFDOHQYLURQPHQWLWLVUHFRPPHQGHGWKDWDEDFNXS
IOL injector be made available in the event the $XWR6HUW® IOL injector handpiece does
not perform as expected.

WARNINGS!
‡ 7KH ,175(3,'® $XWR6HUW® ,2/ ,QMHFWRU LV QRQVWHULOH DQG PXVW EH FOHDQHG DQG
VWHULOL]HGSULRUWRDQGLPPHGLDWHO\DIWHUHDFKXVH
‡ 1HYHULPPHUVHWKH,2/LQMHFWRULQOLTXLGDIWHUDXWRFODYLQJDOORZLWWRDLUFRROIRUDW
OHDVWPLQXWHV4XHQFKLQJFRXOGUHVXOWLQDSRWHQWLDOO\KD]DUGRXVFRQGLWLRQIRU
WKHSDWLHQW
‡ The $XWR6HUW® ,2/,QMHFWRUGHOLYHU\V\VWHPLVIRUWKHLPSODQWDWLRQRI$OFRQTXDOL¿HG
$FU\6RI®IROGDEOH,2/V8QTXDOL¿HGOHQVHVVKDOOQRWEHXVHGZLWKWKHV\VWHP6HH
,175(3,'® $XWR6HUW®,2/,QMHFWRU')8RU$FU\6RI®,2/')8RUFRQWDFW\RXU$OFRQ
UHSUHVHQWDWLYHIRUTXDOL¿HGOHQVFDUWULGJHFRPELQDWLRQV
‡ 7KH FDUWULGJH,2/ FRPELQDWLRQ OLVWHG LQ WKH ')8 DORQJ ZLWK$OFRQ VHWWLQJV KDV
EHHQYDOLGDWHGSHUVHFWLRQRI%6(1,62$SSURSULDWHXVHRILQMHFWRU
KDQGSLHFHVHWWLQJVLVLPSRUWDQWIRUVXFFHVVIXO,2/LPSODQWDWLRQ,QDSSURSULDWHXVH
RIVHWWLQJVPD\OHDGWRDSRWHQWLDOO\KD]DUGRXVFRQGLWLRQIRUWKHSDWLHQW
‡ Fully retract plunger before detaching nosecone from $XWR6HUW® ,2/ ,QMHFWRU
RWKHUZLVHWKLVFRXOGH[SRVHQRQVWHULOHSRUWLRQRIVKDIWDQGUHVXOWLQDSRWHQWLDOO\
KD]DUGRXVFRQGLWLRQIRUWKHSDWLHQW
‡ )RUWKHLQWHQGHG,2/WREHLPSODQWHGWKHSURSHU&DUWULGJHSUR¿OHPXVWEHVHOHFWHG
IURPWKHGULYLQJFRQVROHDQGWKHSURSHUSOXQJHUPXVWEHDWWDFKHGWRWKH$XWR6HUW®
,2/,QMHFWRU)DLOXUHWRGRVRFDQUHVXOWLQDSRWHQWLDOO\KD]DUGRXVFRQGLWLRQIRUSDWLHQW
‡ 7KHPHWDOUHXVDEOHSOXQJHUPXVWEHVWHULOL]HGDIWHUHDFKXVH7KHUHXVDEOHSOXQJHU
LVWREHLQVWDOOHGRQWRWKHKDQGSLHFHRULQWRWKHZUHQFKSULRUWRVWHULOL]DWLRQ

8065752899 FOR REFERENCE ONLY 3.15


ANTERIOR VITRECTOMY PROBE SETUP
(using Vitrectomy Setup screen)

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).

Figure 3-6 Vitrectomy Setup Screen - The 6ZLWFK3UREHEXWWRQDOORZVWKH


XVHUWRFKDQJHVHOHFWHGSUREHVLIWKHGHVLUHGSUREHLVQRWGLVSOD\HGWKLV
EXWWRQDSSHDUVRQO\LIKDUGZDUHIRU8OWUD9LW®SUREHXSJUDGHLVLQVWDOOHG
$IWHUSHUIRUPLQJDVHWXSVWHSSUHVVLQJWKH1H[W6WHSEXWWRQEULQJVXS
WKHVFUHHQIRUWKHQH[WVWHS7KH)LOOEXWWRQDOORZVWKHXVHUWRSULPHWKH
SUREHDQGWR¿OODWHVWYHVVHOIRUSURSHUWHVWLQJRIWKHSUREH3UHVVLQJWKH
7HVW EXWWRQ LQLWLDWHV DQ DXWRPDWHG WHVW VHTXHQFH ZKLFK YHUL¿HV VHFXUH
SQHXPDWLF FRQQHFWLRQV WKHQ DSSOLHV SQHXPDWLF DFWLYDWLRQ DW D UHGXFHG
FXWUDWHIRUYLVXDOYHUL¿FDWLRQRISUREHDFWXDWLRQ

 3HHOOLGDQGDVHSWLFDOO\WUDQVIHUFRQWHQWVRISDFNWRVWHULOHÀHOG Circulating Nurse

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.
3.16 FOR REFERENCE ONLY 8065752899
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
XQGHUVXUIDFHRIVWHULOHÁXLGSUHVVWKH7HVW button. The system intitiates
DQDXWRPDWHGWHVWVHTXHQFHFRQÀUPLQJVHFXUHFRQQHFWLRQVDQGIDFLOLWDWHV
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!
Do not test or operate vitrectomy probes unless tip of probe is
immersed in BSS®VWHULOHLUULJDWLQJVROXWLRQRUGLVWLOOHGZDWHURULV
LQ VXUJLFDO XVH ,UUHSDUDEOH GDPDJH WR WKH KDQGSLHFH DQG WLS FDQ
UHVXOWLIUXQGU\

$IWHU¿OOLQJDQGWHVWLQJDQGEHIRUHVXUJLFDOXVHYHULI\WKDWWKHSUREH
LVSURSHUO\DFWXDWLQJDQGDVSLUDWLQJ7KLVPD\UHTXLUHORZHULQJFXW
UDWHWRDFKLHYHJRRGYLVXDOL]DWLRQ7KHSRUWVKRXOGDOZD\VUHPDLQLQ
RSHQSRVLWLRQLQIRRWSHGDOSRVLWLRQ,IFXWWLQJSRUWLVSDUWLDOO\FORVHG
ZKLOHLQSRVLWLRQUHSODFHWKHSUREH3ULRUWRHQWU\LQWRWKHH\HDQG
ZLWKWLSRISUREHLQVWHULOHLUULJDWLQJVROXWLRQWKHVXUJHRQVKRXOG
VWHSRQWKHIRRWSHGDOIRUYLVXDOYHUL¿FDWLRQWKDWWKHSUREHLVFXWWLQJ
DOWHUQDWLYHO\SUHVVWKH7HVWEXWWRQRQWKH9LWUHFWRP\6HWXS6FUHHQLI
WKHFXWWHULVREVHUYHGWRQRWIXOO\FORVHRUGRHVQRWPRYHZKHQ
WKHSUREHLVDFWXDWHGUHSODFHWKHSUREH
‡ ,IFXWWLQJSRUWLVSDUWLDOO\FORVHGZKLOHLGOHUHSODFHWKHSUREH
‡ ,I DLU EXEEOHV DUH REVHUYHG LQ WKH DVSLUDWLRQ OLQH RU H[LWLQJ WKH
SUREHWLSGXULQJSULPLQJUHSODFHWKHSUREH
‡ ,IDUHGXFWLRQRIFXWWLQJFDSDELOLW\RUYDFXXPLVREVHUYHGGXULQJ
WKHVXUJLFDOSURFHGXUHVWRSLPPHGLDWHO\DQGUHSODFHWKHSUREH

8065752899 FOR REFERENCE ONLY 3.17


ANTERIOR VITRECTOMY PROBE SETUP
(without using Vitrectomy Setup screen)

To set up the vitrectomy probe without using the Vitrectomy Setup screen,
follow the instructions below.

 3HHOOLGDQGDVHSWLFDOO\WUDQVIHUFRQWHQWVWRVWHULOHÀHOG Circulating Nurse

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
FDQQXODLQDFXSRIVWHULOHÁXLG
 ‡ ,QGHSHQGHQWO\XVHLUULJDWLRQE\GHSUHVVLQJWKHIRRWSHGDOWRSRVLWLRQ
1 to remove air bubbles from the probe’s irrigation line, and then use
UHÁX[WRUHPRYHDLUEXEEOHVIURPWKHSUREH·VDVSLUDWLRQWXELQJ
 ‡ 8VHWKH)LOOFRPPDQGLIHQDEOHGLQ'RFWRU6HWWLQJVWRVLPXOWDQHRXVO\
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
WLSRISUREHDQGLUULJDWLQJFDQQXODLQDFXSRIVWHULOHÁXLGGHSUHVV
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.

– Always observe Warnings on previous page –


3.18 FOR REFERENCE ONLY 8065752899
COAGULATION HANDPIECE SETUP

1. Using aseptic techniques, plug new or sterilized handpiece cable Scrub Nurse
connectors into ,QÀQLWL® Vision System front connector panel.

2. Plug connector into new or sterilized coagulation handpiece. Scrub Nurse

3. Coagulation handpiece is ready.

8065752899 FOR REFERENCE ONLY 3.19


7+,63$*(,17(17,21$//<%/$1.

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.

For optimum performance, it is the user’s responsibility to schedule preventive


maintenance service on the system and its accessories at least one time each year.
Alcon’s Field Service Engineers are trained and equipped to provide the highest
quality of workmanship.
CAUTION
There are no operator replaceable parts other than the fuse. Contact Alcon
Technical Services for all servicing issues.

WARNING!
The ,Q¿QLWL® Vision System battery can only be serviced by a factory-trained Alcon
VHUYLFHHQJLQHHU$FFHVVE\XQWUDLQHGSHUVRQQHOFDQOHDGWRLQMXU\

8065752899 FOR REFERENCE ONLY 4.1


UPON COMPLETION OF THE DAY'S SURGERY SCHEDULE

STEP ONE: Clean handpieces, cables, forceps, etc., as instructed in DFU's supplied
with each accessory.

WARNING!
,ILQWKHPHGLFDORSLQLRQRIWKHSK\VLFLDQDSDWLHQWZLWKDprion related disease
XQGHUJRHV D KLJK ULVN SURFHGXUH WKH LQVWUXPHQW VKRXOG EH GHVWUR\HG RU EH
SURFHVVHGDFFRUGLQJWRORFDOUHTXLUHPHQWV

STEP TWO: Remove irrigation bottle from hanger and set aside. Remove spike from
irrigation bottle and discard tubing.

STEP THREE: Eject FMS and discard.

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!
.HHSFOHDURIWKH,9SROHZKHQLWLVLQPRWLRQWRSUHYHQWVNLQKDLUDQGRUFORWKLQJ
IURPEHLQJWUDSSHGLQWKH,9SROHPHFKDQLVP

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.

4.2 FOR REFERENCE ONLY 8065752899


STEP EIGHT: Inspect, and if required, clean footswitch bottom cover and under rear
section of treadle with water, alcohol, or mild soap and water. Remove any debris (see
Figure 4-1).
CAUTION
'HEULVLQFOXGLQJÁXLGUHVLGXHVWXFNRQIRRWVZLWFKERWWRPRUXQGHUUHDUVHFWLRQ
of treadle may cause temporary malfunction of the footswitch.

Clean and remove debris from


this area under the treadle, and
from bottom of footswitch.

)LJXUH )RRWVZLWFK&OHDQLQJ&OHDQXQGHUUHDUVHFWLRQRIIRRWVZLWFKWUHDGOHWRUHPRYH
GHEULVWKDWFDQLQWHUIHUHZLWKLWVRSHUDWLRQ

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.

8065752899 FOR REFERENCE ONLY 4.3


CARE AND CLEANING

The following tips are recommended for proper care of the ,QÀQLWL® Vision System:
 ‡ 7KHFRQVROHSDQHOVWKHIRRWVZLWFKDQGWKHUHPRWHFRQWUROPD\EHZLSHGZLWK
alcohol, mild soap and water, or any germicidal solution that is compatible with
the plastic parts; instructions begin on the prior page.
 ‡ 7KHWRXFKVFUHHQPD\EHFOHDQHGZLWKDVRIWQRQDEUDVLYHFORWKWRZHODQGDPLOG
commercially-available window cleaner. Apply the cleaner to the towel rather
than the touch screen.
 ‡ )ROORZFOHDQLQJDQGPDLQWHQDQFHVFKHGXOHVRXWOLQHGLQWKLVVHFWLRQRIWKHPDQXDO
 ‡ 3HULRGLFDOO\FKHFNFKDVVLVDSSHDUDQFH
 ‡ 3D\DWWHQWLRQWRFRUUHFWRSHUDWLRQRIFRQWUROVFRQQHFWRUVDQGLQGLFDWRUV
 ‡ Damaged hardware must be replaced to ensure safe operation. Call Alcon
Technical Services for assistance.

WARNING!
$TXDOL¿HGWHFKQLFLDQPXVWSHUIRUPDYLVXDOLQVSHFWLRQRIWKHIROORZLQJFRPSRQHQWV
HYHU\WZHOYHPRQWKV
 ‡:DUQLQJ/DEHOV VHHVHFWLRQRQHRIWKLVPDQXDO
 ‡3RZHU&RUG
 ‡)XVHV
,QFDVHRIDGH¿FLHQF\GRQRWXVHWKHV\VWHPFDOO$OFRQ7HFKQLFDO6HUYLFHV

$ TXDOL¿HG WHFKQLFLDQ PXVW FKHFN JURXQG FRQWLQXLW\ IRU OHDNDJH FXUUHQW HYHU\
WZHOYH PRQWKV WR HQVXUH WKH\ DUH ZLWKLQ WKH DSSOLFDEOH VWDQGDUGV IRU H[DPSOH 
(1,(& 9DOXHVPXVWEHUHFRUGHGDQGLIWKH\DUHDERYHWKHDSSOLFDEOH
VWDQGDUGVGRQRWXVHWKHV\VWHPFDOO$OFRQ7HFKQLFDO6HUYLFHV

4.4 FOR REFERENCE ONLY 8065752899


STERILIZATION INSTRUCTIONS

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)
6WDQGDUGVRU\RXUIDFLOLW\·VVWDQGDUGSURFHGXUHVIRUWKHPRVWFXUUHQWVSHFLÀFDWLRQV

$GGLWLRQDOO\SHUWKH6WHULOL]HU(TXLSPHQW0DQXDOWKHVWHULOL]HUUHVHUYRLULVWREHÀOOHGZLWKGLVWLOOHG
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
LQFOLQLFDOXVHLWLVQRWSRVVLEOHIRU$OFRQWRSURYLGHVSHFLÀFSDUDPHWHUVWRHQVXUH
an adequate sterility assurance level. Validation of the individual autoclave, and
YHULÀFDWLRQRIWKHVWHULOLW\DVVXUDQFHOHYHODFKLHYHGZLWKDJLYHQVWHDPVWHULOL]DWLRQ
cycle, must be performed by each surgical facility.

8065752899 FOR REFERENCE ONLY 4.5

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