Centurion.

Vision System With ACTIVE SENTR\ Handpiece

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I The sensor-equipped handpiece initiates immediate
adjustments for a more consistent procedure
The CENTURION'Vision System with ACTTVE SENTRY" Handpiece is the latest
addition to The Cataract Refractive Suite by Alcon. lt redefines phacoemulsification
performance with an innovative design that empowers real-time surge reduction for
a new standard in safety, consistency and control.

Safety, Consistency and Control

. Unprecedented responsivenessl,z: The flrst and only phaco handpiece equipped
with a sensor that enables the system to respond to pressure changeis immediately
. Superior surge reduction3: The handpiece communicates with hardware and
software for more consistent procedures and improved patient safety3
' stability from start to finish3: Active Fluidicg" Technology works to maintain
target intraocular pressure (lOP), regardless of patient eye level (pEL), for more
confidence throughout the procedurd

The CENTURION@ Vision System with ACTTVE SENTR\@ Handpiece

is also supported by advanced procedural technologies designed to
add even more efficiency to the phaco experience.

I
Enhanced phacoemulsification4 6: The entire phaco system
helps surgeons conduct an exceptionally efficient procedure
that is easier on patients' eyesa 7
f;g

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W
The first and only handpiece
to feature a built-in fluidics
 -

Safeguard every outcome with the most

responsive phaco handpiece yet
Only the ACTIVE SENTRf Handpiece detects pressure and communicates with the
CENTURION'Vision System Fluidics Management System (FMS)for the fastest
surge response time and more consistent volume and lOPl'3

simulated Eve Volume After Occlusion Break'?

(loP5ommH8;vaisetting5o0mmHg;AspRate40cc/min)

I
,E
,5

Time After Occlusion Break (sea)

ACIIVE SENTRY1 Handpie(e -- lNi NlTf INTREPLDtr PLU5
-

As fluidfluctuation in the eye occurs, the handpiece works with QuickValvd

technology and Active Fluidics" Technology to trigger immediate adjustments
designed to stabilize fluid volume in the anterior chamber forsuperior occlusion
break surge reduction and consistency throughout the procedure.l 3

Technical Overview, -Surge Mitigation:

AcTlvE SENTRY" Handpiece
Surge Volume, IOP Setpoint = 55 mmHgq

0.14

l.i
J 01)
F

P o.oa

0-06

0.04

30! 350 400 4!0 500 550 600 650

V.<uum Limit Setdng fmmHgl _ CENTU RION! w/ ACTI€ SENIRY6 -575

1!'i,li.. T..hn^lno7-arq
 t_

Mitigating risk to provide a new standard of

safety for patients
The innovative, sensor-equipped ACTIVE SENTRY Handpiece addresses variables
as they arise, reducing the potential impact of issues that could endanger
patient outcomes.

IOP Error vs. PEL Offsete

'10

Automated patient eye level

(PEL) detection -/
!
. Sensor automatically recognizes -/
PEL in every case -/
. Helps maintain consistent targeted o
2 -/
lOP across cases
-/
PEL Vi9ual Alignment E.ror {inches)

cENflJRroNi
-

The ACTIVE SENTRY' Handpiece works with QuickValve- technology inside the
FMS. ln combination with Active Fluidics'" Technology, they immediately adjust
IOP to provide superior occlusion break surge reduction and consistency
throughout the procedure.1,3

IOP Error vs. lncision Leakage,

.20
Compensates for average
incision leakage t5 ,/
-
. Adjusts for incision leakage that E ,/
I0
can cause variance in IOP -
q Sensor automatically detects 9 -/
/
difference in aspiration and
irrigation rates 510 15 20 25

. lncreases fluid flow into the eye lncision Leakage {cclmin)

for consistent pressure _ CENTURION;

 Consistently preserving more volume for less
surge and greater safety3
The CENTURIoN'vision system with ACTtvt sENTRy'Handpiece preserves
more fluid volume in the anterior chamber of the eye forsafe, controlled phaco
performance.3
Phakic Eye Testinglo
70%

50%

3o%

10%

-.10%
zuo
200 3o0
300 400
400 500

Vacuum aevel(mmHg)
+ CENTURION! -G Signature* ir- EVA* {- Ste aris*

Aphakic Eye Testingro

70%

K,
s0%

30%

10%

-14%
200 300 400 5oo

*.,***o*.'::;:::1' :111. .+.sre.rs+

Whether the eye was phakic (lens intact) or aphakic (lens removed), the
CENTURIoN'vision system demonstrated the lowest surge response across all
vacuum levels,lo

.
 lnnovative FMS for the most advanced
phaco system
Each phaco system is designed to maintain IOB but as FMS technology evolves, so
do the benefits ofsafety, consistency and control.

Gravity fluidics
uses bottle height to regulate loP'

Hyper-pressurized fluidics
Uses air pump to achieve high irrigation pressure in bottle

Active Fluidics- Technology

Uses compression plates to maintain surgeon-selected target IOP

Active Fluidics^ Technology with ACTIVE SENTRY@ Handpiece

Combines Active Fluidics* Technology with irrigation pressure sensor in handpiece

Superior surge reduction and more consistent proceduresl.r

The CENTURION'Vision System with ACTIVE SENTRf Handpiece is designed
for quick recovery of the eye chamber during phaco.
' Pressure sensor communicates with the fluidics system
. QuickValve* technology opens to pull fluid from an internal reservoir in the FMS

3. Active Fluidics- Technology

Uses a compression plate to adjust
pressure on 8556 soiution bag,
compersatinB for eye

2, Fluidics pressure sensor

Detects €hanges in anterior
chamber stability as they occur

'1. ACTIVE SENTRYo Handpiece

slgnals to CEN-lURtON, Vision 4. Quickvalve- technology
Maintaining stability for control throughout
every procedure
Patients, conditions and pathology vary case by case, so Active Fluidics*
Technology detects and compensates for changes to help maintain
surgeon-selected IOP and safeguard outcomes. With the addition of the
pressure sensor in the ACTIVE SENTRY' Handpiece, variations can be
identified and corrected in real time. This way, there is less lop fluctuation
versus gravity and hyper-pressurized fluidics.3,11
IOP asAspiration Rate Rises3
Gravity vs. Active Fluidics*

Overall range of variability

due to aspiration: 70 to 40 mmHg
120

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o60
6
=Ai
U

20
tts CENTURIONo Vision System
AMO WHITESTAR Signature"
-
10 20 30 4A Lab testinB conditions
AN/O' set at 95 cm bottle height
Aspiration Rate (cclmin) CENTURION, set at 50 mmHg

IOP vs.Aspiration Flow Rater,rl Pressurized

Bottle Compared with Active Fluidics"
pressur€ = bottle height + pump
Arrows show range o,variability

120

^J.u0 100
E80
E
O- c:i
o""
:t!
zn
u
<20
r Systems with pressurized botle, e.9., 3&.1Stellaris"
CENTURIONe Vision System
- Lab testing cond tions
B&L* settins 70 cm boftle heishr with 70 mmHp added
Exceptional effi ciency to reduce time,
energy and risk4,5,7

Along with the advancements the ACTIVE SENTRY' Handpiece brings to the
CENTURION'Vision System, the system retains the efficiency benefits of
CENTURION' Energy Delivery.

The unique combination of innovative fluidics, the BALANCED Tip and OZil'
technology streamlines phaco procedures while making them easier on * and
safer for patients' eyes.4-7
-
. Accelerated cataract removal.,4,s . Reduced repulsionl2
. Reduced energy output4 . Less fluid usd,s
. Enhanced torsional efficienc/'6

cumulative Dissipated Energy Aspiration FIuid Used

Energy Useds Fluid Useds

5
l_11 39v" 52.68
1
14vo
lao 46-56 Reduction

q 'u
P20
20
2

CENTURIONO INFINIT16 CENTURIONO INFINITIO

€onf iguration Conf iguration Configuration Conf:guration
(n=98) (n=97) (n=98) (n=97)

Gtoup differcnce (95% conlidence intervol): Group tlifrerence (95% canfidence intert/dl):
-2.79 C3.44 to -2.1 i) percent-seconds; -6.12 (-9.82 to -2.43) nL; dqto reflect leost
doto rcflect least squores rneon ! stondord errcr. squorcs meon ! stondord error.

Aspiration Tim€
Times
200

6 r50

:= IOO

0
CENTURION@ INFINIT16
Cohfiguration Configuration
(n.98) (n=97)

Group .lifference (95% confiden@ inteNql):

-15.78 (-26.49 ta -5.07) secands; dota reflect
least squores mean !standord effoL
 Energy delivery designed to protect the cornea
and anterior chambera

ElliDs. Fx tR OZil@ Torsional tR

Temperature RecordingT Temperature RecordingT

Temporol plot of
Temporol plat of
temperdture 0t incision
temperdture ot incision

Versus traditional and Ellips. FX ultrasound modalities, OZil.

phaco and the BALANCED Tip deliverT:
. 50olo less temperature riseT
. Safer heat transferT

Temperature Rise
Under Cicclusion & Load?

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Eo s>
AE
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N/lini-bent Tip . BALANCED TiD'

with Ellips FX wirh OZit'
Lab testing conditions
Occluded Load
50o/o
-
Amplitude
Sophisticated performa nce with
versatile technology
The INTREPiD" BALANCED Tip, INTREPID'Transformer l/A Handpiece and
INTREPID'AutoSert' Handpiece round out the phaco experience to help
provide safety and efficiency at every step.

Efficiency at the surgeon's fingertips

INTREPID' BALANCED Tip offers:
. More lateral movement at tip, Iess shaft movement at incision site4
. Minimal heat production4
. Minimized corneal stromal changes and complicationsa
. Alternative "straight" tip for torsional phaco

Adaptability for a variety of cases

I NTREPID' Tra nsformer l/A Ha nd piece allows for:
. Coaxial or bimanual cortical removal
. All-in-one handpiece facilitates easy transitions

More control throughout the procedure

INTREPI D" AutoSert" Handpiece delivers:
. Less force to the eyd3,14
. Better wound integrity"3ra
. Less incisional stretchingl3r4
. Minimal wound disruption and traum43r4
DIMENSIONS Height No greaterthan 165 cm (65 in) PHACOEMULSIFICAT!ON
Width: No greaterthan 58.5 cm (23 in) (CE TURION'OZIL" HANDPIECE AND INFINITIO OZIL' I{ANDPIECE}
Depthi No qreaterthan 76cm (30 in) Submodes: Continuous, Burst, Pulse
LongitudinalTip Stroke @ 100910:.0084 t .0018 cm (.0033 1.007 in)
WEIGHT Unpackaged: No greater than 107 kg (235 lb)
Resonant Frequencyi 30 kHZ to 60 kHz
Packaged: No greater than 150 kg (3301b)
TorsionalTip Stroke @ 100yo; .0069 1 .0023 .m (.00271.0009 in)
ENVINONMENTAL LIMITATIONS OPERATING Resonant Frequencyi 30 kBZ to 60 kHz
Altitude: 3,000 m (9,842 ft)
- Pu,se Rate Range:1-250 pps
Temperature: 1ooc to 35oC (50oF ro 95oF) OnTime:01000/0
Relative 10Yo to 950,6 Burst OnTimer 2-500 m5
Humidiry: withoutcondensation BurstOffTime: 25O0-O mS
EI{VIRONMENTAL LIMITATIONS NON-OPERATING
Altitude: I2,191 m (40,000ft)
- ANTERIORVITRECTOMY
Submodes: Anterior Mtrectomy, Peripheral lridotomy, Epi'Vit.
Temperature: 40oC 1o 70oC (40oFto 158oF)
Visco Vit ULTRAVIT'Probe: 1 to 4,000cpm).
Relative 10o/o to 95%
Humidity: withoutcondensation
5HOCK, BUMP& DROP 10 watts max.,75 omh load

The system conforms to EN l50 15004-1 reqLlirements for vibration, 76Vpp @ 1,5 N4Hz ! 50,6,75 omh load
bumpand shock. Waveshape: Sinusoidal

CASTERWHEELS VACUUM @ SEA LEVEL

Unpa(kaged inslrument mustwithstdnd 2 impacts u nder cond ition s: Phacoem u lsification: 0-700 mmHg max
-3"free fall onto all four casters Vitreclomy: 0.700 mmHg max
-3"tiltdrop onto each caster (raise one caster 3"above thefloor, lrrigation/Aspiration: 0-700 mmHg max
then allow device to fallbackto normalposition) POWER IV POLE
CONSOLE STABILITY Height Ranger20 to 110.m
' ueets lf( 6O6Ot't placed on incline of 1 0 degrees from horizonta| IOP CONTROLLED INFUSION
WATERINGRESS Ranger 26 - 110 mmHg (35 - I50 cmH2O) (35 - 147 hPa)
Meets lPXo {console), IPXI (lR remote control), lPX8 (footswitch) as Accuracy: t
20o,4 ofsetpoint or 115 mmHg (20 hPa)
specifred in IEC 60601-2 2, clause 201.i 1.6.5 (footswitch) Aspiration Flow Rate:0 60 cclmin
IR REMOTE COI{TROL Usable Fluid Volume: > 350 cc
Method lnfrared VOICE CONFIRMATION
Channels:6 Range:0 ro 60 dB
Eatteries: (2x)AA
@ 1 METER
FOOTSWITCH 'ONEVOLUMES
Errors/Faults/lnvalid Key:40 to65 db, short tone
Dimension: 3"tallx9"widex12"deep Diathermy:40to 65 db, continuous tone
Weight: No greaterthan 5.4 kg {12 lbs) Advisory/Time Expire:0to 65 db, shorttones
Environmental: Footswitch construction is watertight in compliance Phaco/Vacuum:0 to 65 db, aontinuous tonej
with IEC 60601 1 and IEC 60601 2 2 Valid Key: Factory set a.d not adjustable
Ele.trical Footswiiah is configured for wireless tra nsfer Volume Accuracy:6 db
ahannels: 16
PROPORTIOiIAL AND CONTINUOUS. NEFLUX @ sEA LEVEL
AC ELECTRICAL REOUIREMENTS Pressu.e Rangei 26 to 140 mmHq
lnput Voltaqe-Domestic: I00-240VAC 50/60 Hz P.essu.e Accuracyr 110o/o of setpoint + 5 mmHg
'Total Available RefluxVolume: 7 cc replenishablevia aspiration
l\4aximum lnput Current i0A
PROTECTIOT{ AGAINST ELECTRICAL SHOCK:Class I INTREPID' AUTOSERT' IOL II{JECTOR
Max Speed:4.4 mm/sec
CIASSIFICATION OF ALLAPPLIED PARTS: Type BF

DATA cARDr UsB data stick:8 GB min

tor5ionrland oigiudiia ulfalou d modaLllies.

aqueou5vo urne lossassoalated wrih oosto(( usi
rm.nd t0ngre5!;Apri 2129,20l4iB05lon, MA.12. Va5avadaAR, et3l. (
2010r41(1)109114.13.A enD,HabibM,Stee D. ind lnos0ns/eafle,
manual l0l dellvery. Paper
presenied at:ASCRS-AS0Asymposium and Congresstl,lai6 25 2!,2011;5an 0 ego, (A.

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