VICTUS ™ Femtosecond Laser Platform

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VICTUS Femtosecond Laser Platform For international (non-US) use only; not approved in all countries

Transcript of VICTUS ™ Femtosecond Laser Platform

VICTUS™ Femtosecond Laser Platform

For international (non-US) use only; not approved in all countries

For international (non-US) use only; not approved in all countries

Content - General Features - SW Training - Trouble shooting

For international (non-US) use only; not approved in all countries

VICTUS™ Femtosecond Laser General information

For international (non-US) use only; not approved in all countries

For international (non-US) use only; not approved in all countries

The VICTUS Femtosecond Laser Platform is indicated for LASIK Flap, Arcuate Incisions, Capsulotomy and Lens Fragmentation,

and is also used to perform INTRACOR® procedures.

For international (non-US) use only; not approved in all countries

Marketing Points - Versatility: LRCS, Flap, Therapeutic, Intracor - Curved Patient Interface with Intelligent Pressure Sensor - Fast Procedures (160kHz Flap, 80KHz LRCS) - Realtime OCT

As of today Victus does Rhexis, Lens Frag., Flap, Intracor and AK (within Cataract mode)

Docking pressure

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Cataract Docking

0.3 N

Flap/Intracore Docking

0.45 N

0.85 N

1.0 N

2.0 N

3.0 N

4.0 N

5.0 N

Repetition rates

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Treatment VICTUS Pulse Rates (Laser Source)

LRCS 80 kHz (80 kHz)

LASIK-flap 160 kHz (320 kHz)

INTRACOR® 40 kHz (320 kHz)

(upcoming) THERAPEUTICS 80 kHz (80 kHz)

Note: Laser source operates at 80kHz for LRCS incl. AK. For other procedures at 320kHz whereby AOM (acousto optical modulator) picks out desired frequency

GUI – general information

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- Enter patient names and pre-plan treatments possible

- Two modi (Refractive 320kHz and Cataract 80kHz).

Wait minimum 20 minutes when changing the mode!

- System checks need to be repeated when changing the mode

- Two types of PIs (Cataract and Refractive)

- Two user login - admin (normal user mode, validated, for patient treatment)

- Developer (for application and service only)

- System requires license key - 5 license types - Cataract (rhexes + frag.)

- Flap

- Arcuate Keratotomy

- Intracor

- Therapeutic

VICTUS™ Femtosecond Laser Starting the GUI

For international (non-US) use only; not approved in all countries

Starting the System

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- Turn the key

- Wait 20 min (GUI starts automatically)

- press illuminated blue button near the key-switch

- Select Cataract or Refractive

- Wait until timer of 20 min has run out

- Login ‘admin’, PW ‘admin’ (customer login can be created in developer mode)

- Perform System Check

- Enter patient and treatment data

- Excecute procedure

Starting the GUI

After starting the system, GUI appears

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User login Wait time until system ready Min 20 min!!!

Procedure (cat or refractive)

VICTUS™ Femtosecond Laser System Check

For international (non-US) use only; not approved in all countries

System Check

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Grey: not done

Red: not passed

Green: OK

System Check - general

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Resets the DMS sensor (pressure sensor) to zero

DMS = Dehnungs-Mess-Streifen = pressure sensitive strips = z force sensor

System Check – LPS test

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Laser Position Sensor is checked. This test is only valid for 30 minutes!!!

System Check – suction clip test

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This check indicates, whether the vacuum pumps are able to create a vacuum and release it again.

Make sure only 1 bar on the suction control LEDs is illuminated. Test will fail otherwise

System Check – suction clip test

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System Check – PI contact sensor

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Important: Press ‘Reset DMS sensor’ before this check!

Get pressure on cone into the correct pressure range, insert number on scale into GUI, press ENTER

System Check – Power check (cat)

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Fire the laser after clicking “Start”

Enter number on powermeter into GUI, press ENTER

Repeat for both energy values

Wait some seconds after firing the laser until you press enter, otherwise emergency shutdown might happen! (wait for beeping to stop, then press enter)

System Check – Power check (refractive)

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Fire the laser after clicking “Start”

Enter number on powermeter into GUI, press ENTER

Repeat for both energy values

Wait some seconds after firing the laser until you press enter, otherwise emergency shutdown might happen! (wait for beeping to stop, then press enter)

System Check – Depth check

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IMPORTANT: Use refractive PI for this test!

- Press ‘Start’

- Press ‘Next Circle’

- Keep footpedal pressed all the time

- Press ‘First Ablation’ when you see first laser entry in the PI

- Depress foot pedal and the click ‘Circle Complete’ when circle in PI is fully visible

Ranges: EHD: maximum 40 H0: -20 to 20

VICTUS™ Femtosecond Laser Entering Patient & Treatment Data

For international (non-US) use only; not approved in all countries

Starting the GUI

After login, user name appears

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Select patient

Starting the GUI

Patient Database is opened

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modify delete select

New patient

Starting the GUI – New patient

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Required fields.

Note: It is not possible to use the same ID on two patients

Starting the GUI - New patient, example

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Confirm

Starting the GUI

Patient appears in database

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Starting the GUI

After selecting patient, treatment database appears with treatments chosen for this particular patient (here: empty)

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New treatment

Starting the GUI – plan treatment

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VICTUS™ Femtosecond Laser Laser Refractive Cataract Surgery

(LRCS)

For international (non-US) use only; not approved in all countries

LRCS – treatment planning

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Any combination possible

LRCS – treatment planning, caps + lf

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Options:

- Radial Cuts only

- Circular cuts only

- Radial cuts plus circular cuts

- Quadrant cuts plus cross

LRCS – treatment planning, AK

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LRCS – treatment planning, all procedures

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LRCS – select treatment

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LRCS – surgeon screen

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LRCS – surgeon screen

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Alignment options appear after pressure is for 2 seconds in green or yellow range

After docking, switch illumination to two LEDs for better visibility of pupil!

LRCS – Alignment, xy centering

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Mark pupil with 3 mouse clicks, orange ellipse appears

Pattern is aligned on pupil center and resized to fit in the safety zone.

Orange: Pupil rim

Green: Safety zone

LRCS – Alignment, anterior lens marking

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Mark anterior capsule with 3 mouse clicks, red line appears

Yellow line indicates the anterior safety zone

Red: Anterior Capsule

Yellow: Safety Zone

LRCS – Alignment, posterior lens marking

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Mark posterior capsule with 3 mouse clicks, red line appears

Yellow line indicates the posterior safety zone

Lens Frag treatment zone is shown

Red: Anterior Capsule

Yellow: Safety Zone

LRCS – Alignment, 90° marking

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- OCT direction changed from 0° to 90°

- Repeat anterior and posterior capsule marking

- Largest possible pattern with respect to all safety zones is calculated

LRCS – Alignment, capsulotomy

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Move capsulotomy cut until overlay covers 360° OCT image of anterior capsule

De-/Increase height with scroll wheel

Best results when only 1/3 of cut is inside the lens

Red: Anterior Capsule

Yellow: Safety Zone

LRCS – Alignment, accept data

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After pressing ‘Accept Data’, patterns are calculated

LRCS – Alignment, accept data

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After calculation, ‘Ready for Execution’ appears

Execute Button appears, if force is in yellow or green range

LRCS – Alignment, start procedure

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After pressing ‘Execute’ Button, green frame appears.

ONLY now the foot pedal shall be pressed and not released until end of treatment

LRCS – end procedure

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After procedure, progress bars show ‘Executed’

Eye Suction is released (light turns orange)

LRCS – things you should know

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- Treatment can be started in green or yellow range. Try not to be in lower yellow

- Treatment is aborted when force is below 0.1

- Minimum posterior safety distance is 700µm

- Anterior safety distance should be 100-200µm if lens frag diameter is smaller than capsulotomy diameter. Otherwise minimum 600µm

- If AK is chosen, the maximum possible decentration is dependent on the AK diameter. Therefore the maximum diameter should be set to 9mm

GUI – high pressure

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Very high pressure (upper red range) can lead to posterior corneal wrinkles and can cause incomplete cuts

Wrong Patient Interface

Problem: If a wrong patient interface is attached, the following message appears:

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Solution: Use a right interface, select the treatment again.

GUI – possible lens frag combinations

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Option name in GUI inner diameter [μm]

min. no. of cuts max. no. of cuts Default No of cuts when option selected

1 Circular Cuts only 500 (fix) 0 8 4

2 Radial Cuts only 2 (fix) 2 8 4

3 Circular and Radial Cuts radials: 2 (fix) 4 (fixed) 4 (fixed) 4

Circular: 500 (fix) 1 8 4

4 Quadrant and Radial Cuts radials: 2 (fix) 4 (fixed) 4 (fixed) 4

quadrant: 500 (fix)

1 8 4

GUI – cataract ranges and settings

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capsulotomy

lens frag

Preferred settings

7000+

7000+

GUI – preferred pattern by cataract grade

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Cataract grade pattern diameter no. of cuts

Clear lens / grade 1 Circular Cuts only 4000 – 4500 6-8

Grade 2 Circular and Radial Cuts 4000 – 4500 (both cuts)

6 (circular cuts)

Grade 3 Circular and Radial Cuts 4000 – 4500 (radial cuts) 1000 (circular cuts)

2 (circular cuts)

Grade 4 or higher Radial Cuts 4000 – 4500 4

- Preferred pattern may vary from surgeon to surgeon

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VICTUS Cataract Surgery – suction clip

For international (non-US) use only, not approved in all countries

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Speculum not necessarily needed

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VICTUS Cataract Surgery - docking

For international (non-US) use only, not approved in all countries

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VICTUS Cataract Surgery - treatment

For international (non-US) use only, not approved in all countries

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VICTUS Cataract Surgery - capsulotomy

For international (non-US) use only, not approved in all countries

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VICTUS Cataract Surgery – capsulotomy and lens fragmentation

For international (non-US) use only, not approved in all countries

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VICTUS™ Femtosecond Laser Flaps

For international (non-US) use only; not approved in all countries

LASIK FLAPS – Flap Options

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LASIK FLAPS – GUI

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Depth, Diameter and Hinge Position can be aligned ‘on the fly’

LASIK FLAPS – Recentration

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Centration possible after docking within maximum diameter of 9.5mm

Vector indicating amount and direction of decentration

LASIK FLAPS – Start Procedure

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After pressing ‘Accept data’ and calculation of pattern, ‘Execute’ Button appears

LASIK FLAPS – Start Procedure

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After pressing ‘Execute’ Button, green frame appears.

ONLY now the foot pedal shall be pressed and not released until end of treatment

Flaps – things you should know

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- Treatment is aborted when force is below 1 N

- There is a gap between the bed and rim cut (keep foot pedal pressed at all times)

GUI – recommended flap settings

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Recommended flap settings (can vary from machine to machine)

• Bed energy: 950

• Bed spot seperation: 5.8 / 5.8

• Rim energy: 1200

• Rim spot seperation: 2.0/4.5

LASIK FLAPS - Procedure

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• 12-20 second flap procedure

LASIK FLAPS - Opening

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LASIK FLAPS – flap opening

• Good flap quality (lifting and bed surface) and precision

LASIK FLAPS

• OCT Images show high precision of flap depth1

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Intended flap thickness 130μm

Intended flap thickness 120μm

1. JRS 06/06 p.556 -

561.Reproducibility of Flap

Thickness/Talamo et al

LASIK FLAPS – High Precision1

In first 10 cases performed at Dr. Göker‘s clinic in Istanbul

• Mean variance from intended is <1 µm

• Mean standard deviation is 3.5 µm

• The standard deviation for the individual eye (3-4 measurements per eye) was found to be (as averaged over 10 eyes): < 5 µm

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1. JRS 06/06 p.556 -561.Reproducibility of Flap Thickness/Talamo et al

VICTUS™ Femtosecond Laser Troubleshooting

For international (non-US) use only; not approved in all countries

Emergency Shutdown

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In case of an emergency shutdown, press

Reset and then confirm

Wait approx. 5 minutes. GUI will reconnect

Important: If blue light turns on, press button

Everything is frozen

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…or any other problem (e.g.: no camera,….)

IF GUI is running (and only if!!!)

- Turn key switch to off position

- After approx. 5 minutes the system is totally shut down (all fans are off, no more noise…)

- Turn key switch to on position

Important: If blue light turns on, press button

VICTUS™ Femtosecond Laser Mistakes

For international (non-US) use only; not approved in all countries

What happened here?

Iris structure is visible in the ringscan. Reposition or resize capsulotomy!

©2012 Bausch & Lomb Incorporated. BAUSCH + LOMB and VICTUS are trademarks of Bausch & Lomb Incorporated. TECHNOLAS and INTRACOR are trademarks of Technolas Perfect Vision GmbH.