Surgical Procedure Manual Surgical Procedure Manual

Surgical Procedure Manual
Table of Contents
PART I GENERAL; PREPARATIONS ................................................................................ 3
PART II Z-LASIK ............................................................................................................... 15 1
PART III Z-LASIK Z ............................................................................................................ 23
PART IV INTRA-STROMAL POCKETS (ISP) .................................................................... 31
PART V INTRA-CORNEAL RINGS ................................................................................... 37
PART VI LAMELLAR KERATOPLASTY (LKP) .................................................................. 45
PART VII PENETRATING KERATOPLASTY ...................................................................... 51
PART VIII RESECTION ........................................................................................................ 57
PART IX APPENDIX .......................................................................................................... 65
1 General .................................................................................................................................... 4
1.1 Indications for use................................................................................................................................. 4
1.2 About this manual................................................................................................................................. 4
1.3 How to use this manual ........................................................................................................................ 4
1.4 Supporting manuals ............................................................................................................................. 5
1.5 Notes and icons on safety .................................................................................................................... 5
1.6 Terms and abbreviations...................................................................................................................... 6
2 Preparations for femtolaser surgery ..................................................................................... 7

2.1 Sterile single-use material.................................................................................................................... 7
2.2 Sterile re-usable items .......................................................................................................................... 8
2.3 Install LDV laser unit in OR................................................................................................................... 9
3 Treatment parameter set-up ............................................................................................... 11

3.1 “Patient Information” Screen ............................................................................................................ 11
3.2 “InterShield Removal” screen ........................................................................................................... 11
3.3 “Procedure Pack” screen.................................................................................................................... 11
4 Sterile set-up of the FEMTO LDV for surgery .................................................................... 12

4.1 Assemble disposable parts on Handpiece ........................................................................................ 12
4.2 Treatment planning ............................................................................................................................ 13
4.3 How to proceed ................................................................................................................................... 13
5 Set-up of Z-LASIK treatment parameters .......................................................................... 16

5.1 Specific considerations pertaining to Z-LASIK ................................................................................. 16
5.2 “Resection Parameters” screen ......................................................................................................... 17
5.3 “Parameter verification” screen ........................................................................................................ 20
5.4 Proceed ................................................................................................................................................ 21
6 Set-up of Z-LASIK Z treatment parameters ....................................................................... 24

6.1 Specific considerations pertaining to Z-LASIK Z .............................................................................. 24
6.4 Proceed ................................................................................................................................................ 29
© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

7 Set-up of ISP Treatment Parameters ................................................................................. 32
7.1 Specific Considerations pertaining to ISP ........................................................................................ 32
2 7.4 Proceed ................................................................................................................................................ 36
8 Set-up of ICR treatment parameters .................................................................................. 38

8.1 Specific considerations pertaining to ICR ......................................................................................... 38
8.3 “Parameter verification“ screen ........................................................................................................ 42
8.4 Proceed ................................................................................................................................................ 43
9 Set-up of LKP treatment parameters ................................................................................. 46

9.1 “Resection Parameter” screen .......................................................................................................... 46
9.3 Proceed ................................................................................................................................................ 50
10 Set-up of PKP treatment parameters ................................................................................. 52

10.1 Specific considerations pertaining to PKP resections ..................................................................... 52
10.2 “Cut Parameter” screen ..................................................................................................................... 52
10.3 “Parameter verification“ screen ........................................................................................................ 55
10.4 Proceed ................................................................................................................................................ 55
11 Preparation of the patient ................................................................................................... 58
12 Dissection procedure ........................................................................................................... 59
13 Preparing the resection ....................................................................................................... 62

13.1 Lifting the flap ..................................................................................................................................... 62
13.2 Preparation of tunnel and pocket resections .................................................................................... 62
13.3 Preparations for lamellar or penetrating keratoplasty (LKP / PKP) ................................................. 63
13.4 Re-cut ................................................................................................................................................... 63
13.5 Contra-lateral eye ................................................................................................................................ 63
13.6 After completed resection .................................................................................................................. 64
14 APPENDIX A: Handling problems and complications ...................................................... 66

14.1 Incomplete dissection (“Tissue Bridge”) .......................................................................................... 66
14.2 No hinge ("Free Flap") ........................................................................................................................ 66
14.3 Suction loss ......................................................................................................................................... 66
14.4 Cutting process aborted ..................................................................................................................... 67
14.5 Applanation area too small ................................................................................................................ 67
14.6 Small or mis-shaped flap ................................................................................................................... 67
14.7 Flap not centered properly ................................................................................................................. 68
14.8 Slightly visible bandings in the stromal bed .................................................................................... 68
15 APPENDIX B: Nomogram for Z-LASIK ............................................................................... 69
16 APPENDIX C: Contact Information ..................................................................................... 70

PART I: GENERAL; PREPARATIONS 3

1 General
We would like to thank you for your decision to purchase this Ziemer product.
If the instructions in this Manual are carefully followed we are confident that this product will give you
reliable and trouble-free usage.
1.1 Indications for use

Ziemer’s FEMTO LDV Z Models (Z2, Z4 and Z6 systems; referred to in this document as “LDV”) are
4 medical instruments designed for exclusive use in ophthalmic surgery. The LDV is a precision
manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring
initial lamellar resection of the cornea such as LASIK, preparation of stromal pocket or tunnel incisions,
or lamellar or perforating keratoplasty.
1.2 About this manual

This Manual describes the entire femtolaser resection process with FEMTO LDV Z Models. It forms an
important element of the basic LDV operator training. It will be discussed with the customer and
customer's staff at the time of initial user training. It is important that all surgical team members are
trained and thoroughly familiar with this Manual.
Note: Depending on the laser model and software options purchased, several surgical procedures1 can
be performed with the LDV:
 Z-LASIK: planar resection, on xy-plane
 Z-LASIK Z: three dimensional resection (xyz), with angled side cut
 ICR – tunnels resection for Intracorneal Rings
 ISP – Intrastromal Pocket incisions
 LKP – Lamellar Keratoplasty
 PKP – Penetrating Keratoplasty
These types of procedures are described in separate sections of this manual, and specialized operator
training is required. Please consult a Ziemer representative for details.
1.3 How to use this manual

This addendum to the Operator Manual (see 1.4) provides important information regarding the use of
Ziemer’s FEMTO LDV Z2, Z4 and Z6 models for various types of femtolaser-aided surgical procedures
(see section 1.2). Physicians using a LDV system should read the Manual thoroughly prior to operating
the device. The Manual has been written in such a fashion that the surgical team can use it as a checklist.
It is recommended that you tick off each red bullet () as you proceed.
References and information concerning the surgical procedures found in this Manual are intended to
serve as recommendations or guidelines only. The attending physician and/or surgeon must decide
which surgical techniques are to be followed. The manufacturer or its representatives cannot be held
responsible or liable for the techniques chosen and used during the surgery.
If there are questions, unclear points or uncertainty remaining after reading this Manual, then the LDV
should not be used. In this case, please consult a Ziemer Customer Service representative before you
proceed.
1
Further applications in development.

This Manual is only applicable for FEMTO LDV Z2, Z4 and Z6 systems, with software versions #4.0 or
higher.
Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a physician.
1.4 Supporting manuals

5
The following documents are to be used in conjunction with this Manual:
Title Part number Document number
FEMTO LDV Z Models: Operator Manual REF 510.951.500 FL5940-0500
FEMTO LDV Z Models: Operator Manual (US version) REF 510.951.501 FL5940-0501
FEMTO LDV Z Models: Surgical Procedure Manual – REF 510.951.503 FL5940-0503

Advanced Settings
FEMTO LDV Starter Kit: Directions for Use FL5910-300-0614
Artificial Anterior Chamber: Directions for Use FL5913-001-0029
1.5 Notes and icons on safety

Throughout this manual, icons are used to alert the reader of special situations. The following symbols
are defined:
Symbol Name and significance
WARNING: A warning indicates an action or procedure which, if not performed correctly,

can result in injury or a safety hazard. Comply strictly with the instructions and proceed
with care.
CAUTION: A caution indicates an action or procedure which, if not performed correctly, can
result in incorrect operation or destruction of the device. Comply strictly with the
instructions.
Note: A note indicates an action or procedure which, if not performed correctly, can have
an indirect effect on operation or trigger an unexpected response on the part of the
instrument. The word ‘Note’ may be replaced by a meaningful title.

1.6 Terms and abbreviations
Abbreviation Meaning
AA Articulated Arm
AAC Artificial Anterior Chamber; device used for mounting a donor cornea for resection
with the LDV.
BSS Balanced Salt Solution
CW / CCW Clockwise / counterclockwise
6 Fs-laser Femtosecond Laser
HP Handpiece
ICR Intracorneal rings (inserted into an intracorneal tunnel created by the LDV)
ICRS Intracorneal ring segment
IS InterShield spacer
ISP Intrastromal pocket, for inserting corneal inlays
LASIK Laser Assisted In-Situ Keratomileusis
LKP Lamellar Keratoplasty
NaCl Sodium Chloride
OR Operating Room
PKP Penetrating Keratoplasty
PP Procedure Pack
SR Suction Ring
SS Slow Scan
TABO (derived from “Technischer Ausschuss für Brillen-Optik”; German technical board
for spectacle optics)
Counterclockwise coordinate system as used by LDV:
OD: 0º = nasal; 90º = superior; 180º = temporal; 270º = inferior;
OS: 0º = temporal; 90º = superior; 180º = nasal; 270º = inferior.
Trajectory Path followed by the laser during resection
Z-LASIK LASIK surgery, where the flap is created with a FEMTO LDV system

2 Preparations for femtolaser surgery
2.1 Sterile single-use material

2.1.1 Procedure Pack
Have one LDV Procedure Pack ready, selected according to Table 1. Make sure it has not expired and
contains the InterShield spacer and Suction Ring required for the planned procedure. The package
contains following individual sterile items, each separately packaged: 7
• 1 Set of Handpiece Casings.
• 1 Suction Ring Applicator with two identical InterShield spacers 2 and a disposable Suction Ring2.
• 1 Vacuum Tubing with strainer.
• 1 Surgical Drape.
Use only original Ziemer Procedure Packs. Use of any third-party disposables may lead to
malfunction of the LDV, to undesirable surgical results and/or clinical complications, and
will void any warranty.
Use only the auxiliary materials recommended in this manual.
Table 1: Procedure Packs to be used for the different surgical procedures
Method LDV Model Procedure Pack Handpiece
Z-LASIK Z2 LASIK PP MkII
Z-LASIK Z4 Z6 LASIK PP Z
Z-LASIK Z Z4 Z6 LASIK PP Z
ISP Z4* Z6 Corneal Surgery PP Z
ICR Z4* Z6 Corneal Surgery PP Z
LKP Z6* Advanced Corneal Surgery PP Z
PKP Z6* Advanced Corneal Surgery PP Z
* Optional; software license required.
2.1.2 Other sterile material

• Viscoelastic: Prepare Viscoelastic in a sterile 5 ml syringe with blunt 23G cannula, or use directly
from sterile single dose container.
For Z-LASIK procedures any of the three products below may be used with similar results (other
products have not been tested for compatibility):
- LaserVis® (sodium hyaluronate 0.25%) (manufactured by TRB Chemedica,
www.trbchemedica.com ); or
- Oasis Tears® (p/n OT6100) (manufactured by Oasis Medical; oasismedical.com); or
- Hyalein® (sodium hyaluronate 0.3%) (manufactured by Santen; www.santen.com).
2
Dimensions as indicated on the package label.

For 2D ISP procedures without vertical incision, using the following more viscous viscoelastic is
advised:
- VISIOL® (TRB Chemedica. www.trbchemedica.com)
For all other procedures (other than Z-LASIK and 2D ISP), no viscoelastic is required.
• Physiological Salt Solution (0.25 % NaCl or BSS): prepare 1 sterile 10ml syringe with blunt approx.
20G cannula (for irrigation of cornea).
• Distilled sterile water (H2O): pour approx. 10 ml into a sterile bowl (for moistening InterShield and
applanation window).
8 • Sterile sponge tips (e.g. Merocel spears; www.merocel.com)

• Sterile toothless forceps
2.2 Sterile re-usable items

Make sure the required re-usable items are sterilized before procedure starts.
• It is recommended to have several sterile Suction Rings ready to be prepared for last-minute
changes ordered by the surgeon. If you prefer using the titanium Suction Rings provided in the LDV
starter kit, have at least one SR of the required dimensions ready.
Note: Titanium Suction Rings are not available in the U.S.
• Open-wire lid speculum as specified by surgeon. Ziemer recommendation: Ziemer’s “Thorlakson

Eye Speculum” (REF 510.400.004).
• Smooth tipped (toothless) forceps for applying InterShield on Handpiece. Do not use any titanium
forceps.
• Sterile surgical instruments for opening and manipulating the flap according to surgeon's
specification. Ziemer recommends using the instrument provided in the LDV Starter Kit: “Thorlakson
Z-LASIK Flap Lifter” (REF 510.400.003) or flap-lifting forceps.
• Marker and ink pad for marking the cornea.
For pre-resection marking, gentian violet ink pads (e.g. Oasis Medical #0441) are
recommended. Some other inks have been reported to shade the cornea from the laser
beam, causing localized “tissue bridges” or “islands”.

2.3 Install LDV laser unit in OR
2.3.1 Preparation of LDV Laser
• Wipe Base Station with liquid disinfectant.
• Carefully wipe articulated arm and Handpiece with moist disinfection towel.
CAUTION: Check surface of applanation window for any particles or deposits. Rinse any
9
deposit from evaporated tears or salt solution with distilled water. Do not wipe when dry to
avoid scratching the glass (quartz is sensitive to scratching!).
• Wipe wheels with moist disinfection towel.

• Wipe touch-screen monitor, keyboard, mouse, and foot-pedal.
2.3.2 Other preparations (as directed by surgeon)

• Prepare pachymeter for use before and after resection.
• Prepare caliper for measuring flap diameter.
• Prepare video monitor and video recording.
• For LASIK: Prepare Excimer Laser for subsequent ablation procedure (according to Excimer
procedure instructions), surgical instruments and material required for the surgical procedure.
• Other methods: Prepare sterile OR with patient bed and operating microscope. Prepare surgical
instruments and material required for the surgical procedures following fs-laser resection.
2.3.3 Positioning of LDV

• Wheel the LDV into the operating theater.
• Position at 90° to operating bed (or at another preferred position checked and approved by Ziemer
installation personnel). Distance to bed should be such as to have the elbow of the articulated arm
centered above the patient's chest.
• Secure positioning of the LDV by activating the foot-brake.
• (recommended) Mark position of the LDV on the floor, using adhesive tape.
2.3.4 Starting up
• Plug the power cable into a regular 220V (or 110V) outlet.
• Secure power cable against unintentional unplugging by securing it on the floor with adhesive tape.
• Plug foot-pedal (if surgeon desires to use it) into the appropriate connector at bottom of Base
Station.
• Have wireless keyboard and mouse ready near the LDV.
• Start the LDV up at least 60 minutes before scheduled surgery time. Wait until run-up sequence is
completed (approx. 10 minutes) and log in using your user name and password.
2.3.5 Adjust height of LDV

Move top of Laser unit up or down to make sure forearm of articulated arm fits under the microscope
transom of the Excimer Laser.

2.3.6 Check and adjust laser output
The FEMTO LDV Z Models automatically check and adjust laser output power in regular intervals during
LDV idle time.
Automatic check and adjustment:
Before the automatic check & adjust sequence starts, a warning will be displayed. Click Cancel within 15
seconds if you wish to prevent the adjustment from taking place. The next procedure can only be started
when the sequence has been completed (approx. 3 minutes).
10 Manual check and adjustment:
It is recommended to perform this laser output check regularly throughout the day,
especially if the laser has not been used for several hours, or whenever environmental
conditions (room temperature and humidity) have changed by more than 4%.
For this procedure, the Handpiece must be placed in the HP holder (park position).
• Do not attempt to adjust until laser is warmed up (30 to 60 minutes after starting up).
• Look at the Laser Output gauge at the bottom center of the monitor. If the Laser Output reading is
less than 98%:
- Click on the colored round button in the lower left corner of the touch-screen monitor. A
window with a series of status indicators is presented. They normally should all indicate
"ready" (green).
- Touch Mirrors, then touch the Details button to display the mirror adjustment window.
- Touch Adjust to perform an automatic adjustment of the laser focusing mirrors, the power
output and attenuator setting (this will take a few minutes).
- “Laser Output” gauge should now indicate >98% of target power.

3 Treatment parameter set-up
Once logged in, select Cut to start programming the LDV for the surgical procedure:
3.1 “Patient Information” Screen

• Insert patient information, Last Name and First Name and/or Patient ID, and (optional) Date of Birth.
If a patient list is available (see Operator Manual for how to load a patient list), type the first few
characters of the desired Last Name or First Name or Patient ID and all matching entries will be 11
displayed. Select the desired entry and all patient’s details will be displayed in the corresponding fields.
• Method: Select the method required by the surgeon. The following options are available, depending
on LDV model and installed software licenses):
- Z-LASIK: planar resection, on xy-plane (see PART II).
- Z-LASIK Z: three-dimensional resection (xyz), with angled side cut (see PART III ).
- Intrastromal Pockets (ISP; see PART IV)
- Tunnels for Intracorneal Rings (ICR; see PART V )
- Lamellar Keratoplasty (LKP; see PART VI )
- Penetrating Keratoplasty (PKP; see PART VII )
• Touch Confirm if the correct HP is mounted (a confirmation message appears on the screen) and
continue to the next screen by touching Next.
3.2 “InterShield Removal” screen

• Verify that there is no InterShield spacer left from the previous procedure on the Handpiece. Click
Confirm.
IMPORTANT: For each procedure there must be ONE AND ONLY ONE InterShield spacer on
the applanation window. Carefully check whether there is no IS left on the Handpiece from
the previous procedure. DO NOT click Confirm unless you have positively confirmed that
there is no transparent IS spacer on the applanation window.
3.3 “Procedure Pack” screen

When the Procedure Pack screen is presented:
• Hold a new, unused Procedure Pack against the area marked ID on the front panel of the LDV Base
Station.
A beep will indicate successful reading. If the PP is successfully read, its serial number will appear, and
the SR dimension will be displayed. On the Z2 with MKII HP, the nominal cutting depth as determined by
the thickness of the InterShield will also be displayed.
• If the displayed PP dimension is consistent with the procedure you intend to perform, touch the
Confirm button. Then touch Next.
The Confirm button will activate only when the PP is identified as valid. Otherwise an error
message will be displayed. You may have used a label from a package that has already
been used, or one that has expired. Use a new package.

4 Sterile set-up of the FEMTO LDV for surgery
4.1 Assemble disposable parts on Handpiece

The entire assembly is performed while the HP is in parked position. All sterile parts shall be touched
only by a sterile person.
• Place sterile drape on top of LDV working surface. Secure with tape.
12 • Place contents of sterile packaging (Handpiece casings, tubing, applicator with InterShields and
disposable Suction ring) onto sterile drape on top of LDV.
• Place any additional titanium (re-usable) suction rings (if required) and forceps onto sterile drape.
4.1.1 Handpiece casing

• Assemble front and rear part of Handpiece casing and make sure the two parts are interlocked.
4.1.2 InterShield (transparent spacer)

• Apply one drop of sterile H2O to applanation window on LDV Handpiece by touching the window
with a sponge saturated with sterile H2O.
• Remove one InterShield from applicator with sterile toothless forceps. DO NOT TOUCH the center of
the InterShield.
• Apply InterShield concentrically to the applanation window on Handpiece, using the forceps. Avoid
bubbles under the InterShield by applying the spacer in a rolling motion, starting by holding just the
lower edge of the InterShield against the lower edge of the applanation window, and then laying the
InterShield gently down on the window.
VERY IMPORTANT: Make sure there are no particles or deposits on the applanation window
or on either side of the InterShield spacer. Impurities may cause incomplete laser dissection
or “tissue bridges” or “islands”.
4.1.3 Suction ring and vacuum tubing

• Check dimension of suction ring against surgery protocol.
• Fit the thin end of the vacuum tubing to the nipple on the suction ring (keep the SR attached to the
applicator).
• Attach SR, holding it with the applicator, to the bayonet socket on the applanation window on the
LDV Handpiece. Turn counterclockwise to secure, being careful to ensure proper fit. Do not use
force. Remove applicator.
VERY IMPORTANT: Convince yourself that the suction ring is mounted properly on the
Handpiece. There must not be any gap visible between suction ring and bayonet socket.
• Attach tubing to clamps on the Handpiece, proceeding backwards from the SR. Do not touch non-
sterile parts.
• Attach remaining (thicker) parts of vacuum tubing to the clamps on the articulated arm. Do not touch
the AA with your hands, as it is not sterile.
• Place the liquid trap into the recess located at the base of the articulated arm. Attach the end of the
vacuum tube to the vacuum connector, making sure it snaps into locked position.

4.2 Treatment planning
Special considerations are advised when planning the treatment of eyes that deviate in one or several
aspects from "standard" eyes:
• Hypotonic eyes require stronger suction and / or a reduced laser beam scan velocity.
• On a pronouncedly oblate cornea, it may be difficult to achieve a sufficiently large applanated area. If
you cannot applanate the cornea sufficiently, use a smaller suction ring (even if this sounds counter-
intuitive).
• In case of significant astigmatism, using stronger suction may be advisable.
13
4.3 How to proceed

Depending on the chosen procedure, proceed with either of the following chapters to enter all
procedure-dependent parameters:
- PART II: Z-LASIK (page 15)
- PART III: Z-LASIK Z (page 23)
- PART IV: INTRA-STROMAL POCKETS (ISP) (page 31)
- PART V: INTRA-CORNEAL RINGS (ICR) (page 37)
- PART VI: LAMELLAR KERATOPLASTY (LKP) (page 45)
- PART VII: PENETRATING KERATOPLASTY (PKP) (page 51)
Then continue with PART VIII: RESECTION (page 57).

Z-LASIK
PART II: Z-LASIK 15

5 Set-up of Z-LASIK treatment parameters
Before continuing below, please ensure that all general preparations have been performed as detailed in
sections 2, 3, and 4.
5.1 Specific considerations pertaining to Z-LASIK

With the classic Z-LASIK method (as known from earlier generations of the LDV), the flap resection is
created in a planar mode (xy-plane), without vertical cut, at the requested depth (see Fig. 1). This method
of flap resection is similar to the resection performed with a microkeratome, meaning that:
(a): the flap diameter is determined by the size of the selected Suction Ring (±0.5 mm), and
(b): the angle of the flap border is always approximately 30 degrees, given by the movement of the focal
point in the x-y plane (co-planar with the applanation plate).
16
Corneal curvature (i.e. k-value) has only a minor influence on flap diameter. Between 40 D and 48 D, the
effect on flap diameter is only a few tenths of a millimeter. Therefore, it is recommended to select ring
size depending on desired flap diameter, without adjustment based on k-value.
Fig. 1: Z-LASIK flap resection
5.1.1 Selecting between resection methods

Two different types of border cuts are available with xy-planar Z-LASIK (Fig. 2), both resulting in a
smooth tapered border:
[a]: “Classic” Z-LASIK, simple “zigzag” resection for both stroma and border, or
[b]: “Crystal” Z-LASIK, with in-plane circular rim cut.
Fig. 2: ([a], left:) Z-LASIK Classic: resection with xy-linear movements.

([b]; right:) Z-LASIK Crystal: resection with in-plane circular rim cut.
Gold standard: Based on the experience of FEMTO LDV Crystal Line users, Ziemer
recommends using the Z-LASIK “Crystal” method [b] for the creation of LASIK flaps. The
cutting process is slightly faster and tends to furnish an easier-to-lift flap.

The dimensions of the hinge are defined by either
one of three characteristics (Fig. 3):
(a): Hinge width HW
(b): Hinge angle HA
(c): Hinge length HL
Desired hinge size can be entered either as HW (standard),
Z-LASIK
or as HA or HL. Fig. 3: Hinge geometry definitions
5.1.2 Nomogram for adjustment of Z-LASIK procedure parameters

The Nomogram table provided in APPENDIX B may be used to help determine appropriate settings for
specific anatomic characteristics of the patient’s eye. However, the tables should be understood as being
a recommendation and general guideline that cannot replace careful consideration of all patient-specific
factors that may influence the outcome of the treatment. Use good judgment to choose parameters for a 17
specific treatment situation.
5.2 “Resection Parameters” screen

Upon entry of the chosen method and scanning of the Procedure Pack (section 3), the Resection
Parameters screen will be presented. Its common features are described in the LDV Operator Manual,
section 8.12.
The screen for entering cutting parameters features several tabs that can be opened by touching the “+”
button, and closed by touching the “—“ button. Upon accessing the “Cut Parameters” screen, the
“Main” tab will be open.
On the left side of the screen, the resection trajectory corresponding to the currently chosen parameters
will be displayed. When parameters are changed, the trajectory graph will be adjusted dynamically. If
some entries are missing or incorrect, no graph will be visible, and an error message may appear (see
section 5.3).

Enter treatment parameters as specified on the patient sheet (or as instructed by surgeon):
“Main” Tab
18
"Cut Parameter" screen – Main Parameters

Target:
• Eye: Select eye to be treated (OD for right eye or OS for left eye).
• Suction Ring: the value read from the PP will be displayed. With this Z-LASIK option the flap
diameter is determined by the size of the selected Suction Ring. Recommended SR for standard
situations is 9 mm.
If surgeon requests a Suction Ring different from the one contained in the Procedure Pack
that was scanned in, replace the SR as requested AND (IMPORTANT!) change the Flap
Diameter parameter entry accordingly.
If there is a mismatch between SR used and dimension entered, undesirable surgical
outcomes are likely to ensue.
Flap:
• Diameter: (not enterable) the approximate flap diameter resulting from the chosen suction ring is
displayed here.
• Thickness: the resection depth (flap thickness) as defined by the IS spacer used (Z2 models) or by
the surgeon (Z4 and Z6 models) is displayed here.
Z2 models: If the IS is exchanged for another one after the PP has been scanned, the correct flap
thickness, as specified on the package used, must be entered here.
Hinge:
• Position: either one of the 4 cardinal positions (superior, inferior, nasal, or temporal), or any angle
from 0° to 359° can be selected (TABO system). Recommended hinge position for standard cases is
“superior”.

• Width: this value can vary from 0.3 to 0.8 mm according to doctor’s requirement. We recommend
0.6 mm to start with and do not recommend any hinge smaller than 0.5 mm. This is set auto-
matically if a Length or Angle are defined; or
• Angle: (appears in lieu of Width if software is set up to enter Hinge Angle; see Expert Tab). This value
can vary from 30 to 90° according to doctor’s requirement. This is set automatically if a Width or
Length are defined; or
• Length: (appears in lieu of Width if software is set up to enter Hinge Length; see Expert Tab). This
Z-LASIK
value can vary from approximately 3 to 5 mm, depending on flap ∅. This is set automatically if a
Width or Angle are defined.
Border:
• Border Type: the type of trajectory used for the flap resection can be selected here: “Z-LASIK
Classic” will generate the resection with xy-linear movements (Fig. 2 above, left); “Z-LASIK Crystal”
(recommended) will generate a resection with an in-plane circular rim cut (Fig. 2, right).
19
• Click on the Next button to continue with the procedure. If any additional parameter needs to be
modified, touch the Expert Tab.
“Expert” Tab
"Resection Parameters" screen (partial view) – Expert Parameters
The velocities, power level and geometry of the pattern with which the laser beam scans the
cornea (the "trajectory") are pre-set. It is recommended for new users to work with these
standard settings initially, until some experience has been acquired.
It is the surgeon's responsibility to use Expert settings that are appropriate and safe.
Assistants and technicians should use Expert mode only as directed by the surgeon.
Velocity:
• Stroma: Laser’s Slow Scan velocity, in mm/s, during resection of the flap stroma. This velocity is
individually optimized for each user at installation time. Typical setting is 11 mm/s.
• Border: laser’s Slow Scan velocity, in mm/s, during resection of the flap border. This velocity is
individually optimized for each user at installation time. Typical setting is 5.5 mm/s.
Power (available in Z-LASIK Crystal Mode only):
• Stroma / Border: Laser output power (in % relative to factory-set power output) used for cutting the
flap (separately for stroma and border regions). Normal setting is 93-95% for stroma and border.

Border: Width of the part of the pattern traveled at border velocity; “inner” and “outer” referring to the
edge of the applanated area:
• Inner Border: Values from 0 to maximum 2 mm can be entered.
The sum of inner and outer
Recommended value: 0.7 mm.
border must be > 0.6 mm
• Outer Border: Values from 0 to maximum 1.2 mm can be entered.
Recommended value: 0.8 mm.
Preferences:
• Flap Type: The normal setting for Z-LASIK procedures is “Full Resection”. This means that both,
stroma and border, will be cut as determined by the parameters entered. The other available option
is “Stroma only”, which is for re-cutting the stroma part, without a border cut, in cases of residual
tissue bridges or an incomplete resection.
• Hinge Definition: Enter your preference for specifying hinge size. Normal setting is “Width”.
20 Alternatively, “Angle” or “Length” are available.
Do not use Expert Mode if you are not fully familiar with Expert parameters.
Instrument malfunction, unexpected results or patient injury may occur if expert mode
settings are modified without a thorough understanding of their meaning and function.
“Advanced” Tab
This section contains special advanced parameters for custom-made trajectories, which are not
necessary for a standard procedure. Advanced parameters can be accessed and modified by Ziemer
Customer Service Technicians only. They are not described here (refer to the document “FEMTO LDV Z
Models: Surgical Procedure Manual – Advanced Settings”).
“Settings” Tab
“Resection Parameters” screen (partial view) – Vacuum Parameters

Vacuum Settings:
• Apply Mode: Select “Controlled” (standard; suction controlled to maintain vacuum at the requested
level), or “Full” (suction always on to achieve maximum vacuum).
• Release Mode: Select “Automatic” (standard; suction released upon completed resection) or
“Manual” (switch vacuum off manually).
• Vacuum: Select one of the preset values to set suction level (standard: 700 mbar).
• Unit: Pressure units used for specifying vacuum level. Select mbar (standard) or mmHg or psi.
5.3 “Parameter verification” screen

When all parameters have been entered:
• Check for any parameter mismatch errors being displayed in the lower right corner of the screen.
Make changes as directed by the error message(s), until no error message remains.

Example of a parameter mismatch error message
• Touch Next. The Verify screen appears. Check all entries against your surgical planning document
for correctness. It is recommended to have an assistant read all entries out aloud to the surgeon for
confirmation.
Z-LASIK
21
Verify screen (Z-LASIK procedure)
• If any mismatch is detected, touch the Back button and correct entries as required.
• Upon successful verification, touch the Next button.
5.4 Proceed
Your preparations are now complete. The LDV will initiate the laser startup sequence.
For starting the resection, proceed to PART VIII: RESECTION.

Z-LASIK Z
PART III: Z-LASIK Z
23

6 Set-up of Z-LASIK Z treatment parameters
6.1 Specific considerations pertaining to Z-LASIK Z

With this method, the flap resection is done in a three-dimensional mode, at the requested depth, with
the requested diameter and the desired border (side cut) angle.
24 Fig. 4: Z-LASIK Z: 3D flap resection produces an angled edge (side cut). Angle is selectable to
produce a 90º angled (C), beveled (D) or inverse-beveled (E) edge.
With Z-LASIK Z, the flap diameter is different at the top and bottom of the resection, depending on the
sidecut angle. If the sidecut angle is smaller or larger than 90°, then the flap surface will be larger or
smaller than the flap diameter. Flap Surface diameter is computed from Suction Ring diameter, flap
diameter and sidecut angle and is not enterable.

Parameters screen will be presented. Its common features are described in the LDV Operator Manual.
will be displayed. When parameters are changed, the trajectory graph will be adjusted dynamically. If
some entries are missing or incorrect, no graph will be visible, and an error message may appear (see
section 5.3).

„Main“ Tab
Z-LASIK Z
25
Z-LASIK Z "Cut Parameter" screen – Main Parameters

Target:
• Suction Ring: The values read from the PP will be displayed. With this Z-LASIK Z option the flap
diameter can vary from 6 mm to maximally the size of the selected Suction Ring minus 0.5 mm.
If surgeon requests a Suction Ring different from the items contained in the Procedure Pack
that was scanned in, replace the ring as requested AND (IMPORTANT!) change the Suction
Ring Diameter parameter entry accordingly.
If there is a mismatch between SR used and dimension entered, undesirable surgical
outcomes are likely to ensue.
Flap:
• Form: Circle (standard) or Ellipse can be selected.
• Thickness: The required resection depth (flap thickness) can be entered here. This value can vary
from 80 to 250 µm.
• Posterior diameter: Is the diameter, in mm, of the flap resection at the level of the stroma. For
circular flaps, enter desired flap diameter in mm (may be set with 0.01 mm precision). For elliptical
flaps, two values must be entered for long and short axis of the ellipse.
The flap diameter can be freely set in the software, with the maximal value depending solely
on applanation size and SR. Additionally the flap position can be adjusted / corrected within
the applanation area. Therefore, the use of a suction ring 0.5 to 1 mm larger than the
required flap diameter is recommended and very convenient.
• Anterior diameter: Is the computed diameter (not enterable), of the flap at the level of the epithelium.

Hinge:
• Position: Either one of the 4 cardinal positions (superior, inferior, nasal, or temporal), or any angle
from 0° to 359° can be selected (TABO system).
• Hinge Width: This value can vary from 0.3 to 0.8 mm according to doctor’s requirement. We
recommend 0.6 mm to start with. We do not recommend any hinge smaller than 0.5 mm. This is set
automatically if a Length or Angle are defined instead.
Side Cut:
• Angle: The angulation of the side cut can be set to one of the following pre-set angles: 30°, 60°, 90°,
120°, 150°, or freely at any angle between 30° (beveled) and 150° (inverse-beveled).
• Click on the Next button to continue with the procedure. If any additional parameter needs to be
modified, touch the Expert Tab.
“Expert” Tab
26
"Resection Parameters" screen (partial view) – Expert Parameters
The velocities, power level and geometry of the pattern with which the laser beam scans the
cornea (the "trajectory") are pre-set. It is recommended for new users to work with these
standard settings initially, until some experience has been acquired.
It is the surgeon's responsibility to use Expert settings that are appropriate and safe.
Assistants and technicians should use Expert mode only as directed by the surgeon.
Velocity:
individually optimized for each user at installation time. Typical value: 10 mm/s.
• Side Cut: Laser’s Slow Scan velocity, in mm/s, during resection of the flap border. This velocity is
Power:
• Stroma / Side Cut: Laser output power (in % relative to factory-set power output) used for cutting
the flap (separately for stroma and side cut regions). Normal setting is 93-95% for stroma and 100%
for side cut.
Stroma Resection:
• Lineal Trajectory: Sets the part of the flap area, in percent of the total area, which will be cut in the
standard, linear (“zigzag”) fashion. Remaining area will be cut by a spiraling trajectory.

Preferences:
• Flap Type: The normal setting for Z-LASIK Z procedures is “Full Resection”. This means that both
stroma and border will be cut as determined by the parameters entered. The other available options
are “Stroma only” (for re-cutting the stroma part, without a side cut, in cases of residual tissue
bridges or an incomplete resection), and “Side Cut only” (for recuts).
Do not use Expert Mode if you are not fully familiar with Expert parameters.
Instrument malfunction, unexpected results or patient injury may occur if expert mode
settings are modified without a thorough understanding of their meaning and function.
Z-LASIK Z
• Hinge Definition: Enter your preference for specifying hinge size. Normal setting is “Width”.
Alternatively, “Angle” or “Length” are available.
“Advanced” Tab
27
“Settings” Tab
See page 20.
“TVC (Venting Tunnels)” Tab

This section is intended for creating one to four venting tunnels, leading from the flap bed down and
out, to allow gas created in the cutting process to dissipate out of the stroma. This may help prevent
temporary whitening of the stromal tissue caused by trapped gas.
• Type: Two types of venting tunnels are available: “Radial” and “Straight”. Recommended is radial:
Radial: Creates 1 to 4 radial tunnels at user-determined positions along the edge of the flap:
"Resection Parameters" screen (partial view) – Parameters for Radial Venting Tunnels
• Number: Select the number of radial tunnels to be constructed (1 – 4). Recommended are 3 tunnels,
placed (1) at the position where the circular ring cut begins; (2) approximately 15º counterclockwise
from (1); and (3) at the position where the zigzag pattern of the stromal resection begins.
• Width: Enter a value (in mm) for the desired width of the tunnels. Typical value: 0.8 mm.
• External Diameter: Total diameter of the resection, including the tunnels. This parameter defines the
length of the venting tunnels. Enter a value in mm (typical value: 0.3 mm larger than flap diameter).

• Depth: Enter a value (in µm) for the desired depth of the outer end of the tunnels. Typical value:
200 - 250 µm.
• Power: Laser output power (in % relative to factory-set power output) used for cutting the tunnels
(separately for stroma and border regions). Normal setting is 100%.
• Velocity: Slow scan advances at this speed (in mm/s) for creating the tunnels. Typical value:
5.5 mm/s.
• Position 1 – 4: Position of the tunnels in degrees relative to flap position (the number of entry fields
for position values depends on / equals the number of tunnels entered). Typical values for the
pattern described above: (1) 35º, (2) 50º, (3) 330º.
Straight: Creates a straight tunnel along the hinge, leading to the outside:
28
"Resection Parameters" screen (partial view) – Parameters for Straight Venting Tunnel
• Width: is fixed at 0.8 mm.

length of the venting tunnel. Enter a value in mm, long enough to vent to the outside of the cornea.
Typical value: 10 - 11 mm.
• Depth: This parameter is not enterable; the depth is automatically set to the depth of the stromal
resection.
• Power: Laser output power (in % relative to factory-set power output) used for cutting the tunnel
• Velocity: Slow scan advances at this speed (in mm/s) for creating the tunnel. Typical value: 5.5
mm/s.

Z-LASIK Z
confirmation.
29
Verify screen (Z-LASIK Z procedure)
6.4 Proceed

ISP
PART IV: INTRA-STROMAL POCKETS (ISP)
31

7 Set-up of ISP Treatment Parameters
7.1 Specific Considerations pertaining to ISP

Pockets with an entry tunnel and an optional manipulation tunnel may be prepared with this module.
Device-specific parameter sets may be called up for specific types of inlay (currently: KAMRA™ Inlay by
AcuFocus, Inc., and Myoring™ Inlay by Dioptex GmbH). The user may also generate custom sets of
parameters for creating pocket incisions for other types of corneal inlays.
Please follow specific recommendations of inlay supplier regarding indications, contra-indications, and
inclusion and exclusion criteria.
An ISP Pocket resection is characterized by the geometrical features shown in Fig. 5 and listed in Table 2.
32
Fig. 5: ISP Geometrical parameters

The recommended method for creating an insertion tunnel is to extend the planar resection all the way
out to the edge, by setting Vertical Incision (in the “Expert” Tab) to “Yes” and to create an entry into the
insertion tunnel by means of a z-axis “side cut”. As a further option, a manipulation tunnel may be
prepared in the position opposite to the insertion tunnel, for supporting manipulation of the inlay with a
tool inserted through the manipulation tunnel.

section 8.12.
will be displayed. When parameters are changed, the trajectory graph will be adjusted dynamically.
7.2.1 Parameter definitions

Definitions, ranges and recommended values for all parameters controlling the ISP procedure are
summarized in in Table 2.

Table 2: Parameters for ISP procedures; recommended values are italicized.
“AF” = AcuFocus; “MR”=Myoring; “3D”= method with vertical incision; “2D” = method with planar incision
3D 2D
(Recommended) (Alternative)
Parameter Abbr. Definition Range AF MR AF MR
Target Eye OD / OS
Suction Ring 8.5 – 10 mm 10 9 10 9
Insertion Position Position of the insertion tunnel for inlay N, T, S, I T T T T
Tunnel insertion, according to TABO system 0-359º
Side Cut 30, 60, 90, 30 30 n/a n/a
Angle 120, 150º
200- 300 200- 300
Main
Resection Depth Distance from cornea anterior surface to the 50 – 850 µm

resection plane 250 250
Inlay Type Preprogrammed devices (or custom device) AcuFocus, AF MR AF MR
Myoring
Pocket ∅ PD Diameter of Pocket for tight fit inlay 6.5 8.0 6.5 8.0
(preset for selected device)
Incision ∅ ID Outer diameter of the pocket resection 5 – 10 mm auto auto 9.0 9.0
ISP
(pocket plus tunnels)
Tunnel Width TW Width of the access tunnel 3 – 5 mm 5.0 4.5 5.0 4.5
Velocity Stroma VS Laser’s slow scan velocity (Stroma) 2 – 25 mm/s 9 9 9 9
Border VB Laser’s slow scan velocity (Border) 2 – 12 mm/s n/a n/a 4 4
Incision VI Laser’s slow scan velocity (side cut) 2 – 25 mm/s 1.8 1.8 n/a n/a 33
Power Stroma (%) Laser output power 70 – 100%* 100 100 100 100
Border Laser output power for 2D border 70 – 100%* — — 105 105
Vert. Incision Laser output power for cutting the side cut 70 – 130%* 105 105 — —
Expert
Border Outer Border OB Width of outer border 0.3 – 0.5 mm n/a n/a 0.5 0.5
Inner Border IB Width of inner border OB+IB > 0.8 n/a n/a 1.0 1.0
Margin Pocket Diam. PDM Margin added to PD for “looser fit”. 0 – 1.0 mm 0 0 0 0
Tunnel Width TWM Margin added to TW for “looser fit”. 0 – 1.0 mm 0 0 0 0
Mani- Tunnel M Access opposite insertion tunnel for inserting a Yes / No N N N N
pulation tool for manipulating the inlay
Tunnel
Tunnel Width MW If M enabled, set its width 1 – 5 mm 3 2.5 3 2.5
Preferen- Vertical Enable z-axis incision (3D) in lieu of planar Yes / No Y Y N N
ces Incision incision (2D)
* Depends on LDV model being used.

7.2.2 Parameter entry
„Main“ Tab
ISP "Cut Parameter" screen (partial view) – Main Parameters

Target:
34 • Eye: Select eye to be treated (OD for right eye or OS for left eye).
• Suction Ring: The value read from the PP will be displayed.
Insertion Tunnel:
• Position: Either one of the 4 cardinal positions (superior, inferior, nasal, or temporal), or any angle
from 0° to 359° can be selected (TABO system).
• Side Cut Angle:
If Vertical Incision = “Yes” is selected in the “Expert” tab: The angulation of the side cut can be set to
any of the pre-set angles (30°, 60°, 90°, 120°, 150°, or freely at any angle between 30° (beveled) and
150° (inverse-beveled). Recommended angle for ISP: 30°.
If Vertical Incision = “No”: This parameter is not enterable.
Pocket:
• Inlay Type: select AcuFocus or Myoring to load appropriate pre-sets; or select Manual and enter
desired dimension settings individually.
• Depth: Enter desired resection following the specific recommendations of inlay supplier. Typical
values: For AcuFocus inlays: 190 – 220 µm
AcuFocus inlays post-LASIK: 200 – 250 µm
Myoring inlays: 300 µm
• Incision Diameter:
If Vertical Incision = “Yes” is selected in the “Expert” tab: Enter the total diameter of the incision,
including the insertion tunnel. Typical diameter: 9 mm.
If Vertical Incision = “No”: This parameter is not enterable.
• Pocket Diameter: Diameter of the pocket incision. Recommended value set automatically depending
on inlay model chosen. Not enterable except for the Manual inlay type.
• Tunnel Width: Width of the insertion tunnel. Recommended value set automatically depending on
inlay model chosen. Not enterable except for the Manual inlay type.

“Expert” Tab
ISP "Cut Parameter" screen (partial view) – Expert Parameters

Velocity:
ISP
• Stroma: Laser’s Slow Scan velocity, in mm/s, during resection of the pocket stroma. This velocity is
individually optimized for each user at installation time.
• Border: Laser’s Slow Scan velocity, in mm/s, during resection of the pocket border. This velocity is
individually optimized for each user at installation time (this field is only active if Vertical Incision = 35
“No”).
• Side Cut: Laser’s Slow Scan velocity, in mm/s, during resection of the incision. This velocity is
individually optimized for each user at installation time (this field is active only if Vertical Incision =
“Yes”).
Power:
• Stroma / Vertical Incision: Laser output power (in % relative to factory-set power output) used for
cutting the flap (separately for stroma and side cut regions). Normal setting is 93-95% for stroma and
100% for side cut.
Border:
• Inner Border: Typical value: 0.3 – 0.5 mm. The sum of inner and outer border
must be > 0.8 mm
• Outer Border: Typical value: 0.3 – 0.5 mm.
Margin: Incremental margins may be added to pocket diameter and tunnel width, to generate a “looser
fit” for easier insertion of the inlay.
• Pocket Diameter: Typical margin: 0 - 0.2 mm
• Tunnel Width: Typical margin: 0 – 0.2 mm
Manipulation Tunnel: creates an auxiliary access opposite to the insertion tunnel, for inserting a tool for
manipulating the inlay.
• Tunnel: Select Yes or No (usually not required).
• Tunnel Width: Typical value: 2.5 – 3 mm.
Preferences:
• Vertical Incision: Select Yes or No. (Recommended method: “Yes”.)

“Advanced” Tab
“Settings” Tab:
See page 20.

36 confirmation.
Verify screen (ISP procedure)
7.4 Proceed

ICR
PART V: INTRA-CORNEAL RINGS (ICR) 37

8 Set-up of ICR treatment parameters
8.1 Specific considerations pertaining to ICR

Circular and semi-circular tunnel incisions may be prepared with this module. Device-specific parameter
sets may be called up for a variety of commercially available intracorneal ring segments (ICRS; models
by Keraring3, Intacs4, Ferrara5, and CornealRing6 are currently supported).
For all ring dimensions available for each type of ICRS, appropriate recommended tunnel dimensions
are set from an internal database. ICRS manufacturers3 - 6 will provide recommendations for choice and
positioning of the appropriate model based on patient data. A suction ring sufficiently larger than the
ICRS diameter should be chosen.
The software allows for creating tunnels with different dimensions for the two ring segments, or for
creating only one semicircular tunnel. Symbols and are used in the user interface to designate the
tunnels positioned CW and CCW from the incision, respectively. The tunnel incisions are accessed by
means of a vertical incision, which is created by means of the z-axis feature (recommended standard
procedure), or by means of a diamond knife.
In order to facilitate insertion of ring segments into the circular tunnel incision, it is recommended to (a)
cut a short incision tunnel that is wider than the ring tunnel, and (b) to make the tunnels slightly wider
(by the width margin) and longer (by the arc length margin) than determined by the ring dimensions.
An ICR Tunnel resection is characterized by the geometrical features shown in Fig. 6:
38
Fig. 6: ICR Geometrical parameters
3
Keraring is a trademark of Mediphacos Ltda., Belo Horizonte, Brazil. www.mediphacos.com/en
4
Intacs® is a trademark of Addition Technology, Inc., Sunnyvale, CA, USA. www.intacsforkeratoconus.com
5
Ferrara Rings is a trademark by Ferrara Ophthalmics, Ltda., Belo Horizonte, Brazil. www.ferrararing.com.br
6
CornealRing is a trademark of Visiontech, Ltda., Nova Lima, Brazil. www.cornealring.com

section 8.12.
8.2.1 Parameter definitions

Definitions, ranges and recommended values for all parameters controlling the ISP procedure are
summarized in in Table 3.
Table 3: Parameters for ICR Procedures; recommended values are italicized.
Parameter Abbr. Definition Range Recommended

Target Eye OD / OS
Suction Ring 8.5 - 10 9.5
Incision Position IP Position of common insertion point for the 2 N, T, S, I
segments. Set according to supplier’s 0 - 359º
recommendation.
Main
ICR
Resection Depth / According to supplier’s recommendation. 50 - 850 µm
Ring type Select from menu
Model / According to supplier’s designation; Select
from menu
AL In degrees; according to supplier’s
39
Arc length /
designation; Select from menu
Velocity Stroma Slow scan velocity for resection of tunnels 2 – 25 mm/s 6 mm/s
Insertion Area Slow scan velocity for resection of entry 2 – 12 mm/s 6 mm/s
incision
Vertical Incision Slow scan velocity for resection of vertical 1 – 4 mm/s 1.6 mm/s
incision
Power Stroma Laser output power (in % of factory-set 70 – 100 %* 100 %
output) for resection of tunnels
Expert
Vertical Incision Laser output power (in % of factory-set 70 – 135 %* 105 %

output) for resection of vertical incision
Margin Width / WM Margin added to WM for “looser fit”. 0 – 0.3 mm 0.1 mm
Arc length / AM Margin added to AM for more freedom of 0 – 20º 10º

positioning the segments
Insertion Width / Wider opening area for easier insertion of ring 0.8, 1.3, 1.5, 1.8 mm 1.3 mm
area segments
Length / 0 - 30º 15º
Pref’s. Vertical Incision IV Yes / No Yes
* Depends on the LDV model being used.

8.2.2 Parameter entry
„Main“ Tab
ICR "Cut Parameter" screen – Main Parameters

Target:
40
• Suction Ring: The value read from the PP will be displayed. Make sure a SR with a sufficiently large
diameter has been selected (≥ 9.5 mm for Intacs, ≥ 9.0 mm for other types).
Incision
• Position of the common incision point for the two segments according to the individual patient’s
topography. Any angle from 0° to 359° can be selected (TABO system).
Rings
• Depth and : Resection depth, in µm, of tunnels CW and CCW from incision. Set depth for both
segments according to ICRS suppliers’ recommendation. Unless otherwise specified, depth for both
segments will be automatically set to be equal.
• Type: Select one of the models available from the
drop-down menu, or select Manual to specify
parameters for a custom device.
Ring type selection menu.

If Manual entry for a custom device is selected, then fields for ring dimensions are presented:
Manual resection selection menu
- Inner diameter and : Enter inner diameter of your device in mm; must be smaller than
outer diameter.
- Outer diameter and : Enter outer diameter of your device in mm; must be smaller than
suction ring diameter.
- Arc length and : Enter arc length of your device in degrees (max = 180°).
• Model and : Depending on the selected ring type, available models will appear in the drop-
down menu. If insertion of only one ring segment is intended, leave the appropriate field empty.
• Arc length and : Depending on the selected ring type, available arc lengths will appear in the
ICR
drop-down menu.
“Expert” Tab
41
ICR “Cut Parameter” Screen – Expert Parameters

Velocity:
• Stroma: Laser’s Slow Scan velocity, in mm/s, during resection of the tunnel. This velocity is
individually optimized for each user at installation time.
• Insertion Area: Laser’s Slow Scan velocity, in mm/s, during resection of the entry incision. This
velocity is individually optimized for each user at installation time.

• Vertical Incision: Laser’s Slow Scan velocity, in mm/s, during vertical resection of the vertical
incision. This velocity is individually optimized for each user at installation time.
Power:
• Stroma / Vertical Incision: Laser output power (in % relative to factory-set power output) used for
cutting the flap (separately for stroma and side cut regions). Normal setting is 93-95% for stroma and
100% for side cut.
Margin:
• Width and : adds incremental width (in mm) to the tunnel resection for “looser fit” of the ring
segment. Recommended value is approx. 0.1 mm.
• Arc Length and : adds incremental length (in degrees) to the tunnel resection for more
freedom in positioning the ring segment. Recommended value is approx. 10º.
Insertion Area:
To facilitate insertion of ring segments, it is recommended to widen the resection near the incision
point, by selecting width and length of the insertion area
• Width and : enter desired width (in mm) of the opening. Select one of the presets (0.8, 1.3,
1.5, 1.8 mm). Recommended value is 1.3 mm.
• Length and : enter desired width (in degrees) of the opening. Recommended value is 15º.
Preferences:
• Vertical Incision: For recommended standard procedure, select Yes. If surgeon intends to prepare
incision manually (with Diamond knife), set Vertical Incision to “No”.
“Advanced” Tab
42 This section contains special advanced parameters for custom-made trajectories, which are not
“Settings” Tab
See page 20.
8.3 “Parameter verification“ screen

confirmation.

Verify screen (ICR procedure)
8.4 Proceed
ICR
43

LKP
PART VI: LAMELLAR KERATOPLASTY (LKP)
45

9 Set-up of LKP treatment parameters
9.1 “Resection Parameter” screen

The common features of the Resection Parameters screen are described in the LDV Operator Manual,
section 8.12.
46
LKP “Cut Parameter” screen – Main Parameters
9.1.1 Resection of donor buttons and of host tissue

Both host and donor cornea for a transplant procedure may be prepared with this module. By using
identical or matched geometrical parameters for both resections, an optimum fit of the donor button into
the recipient resection can be ascertained. Both resections can be prepared within the same procedure. It
is important to determine the central corneal thickness of donor and recipient eye beforehand.
The donor cornea is prepared first, using the Ziemer Artificial Anterior Chamber (AAC). Refer to the AAC
instructions for use (see section 1.4). Recommended height for the infusion is 80 – 100 cm.
It is recommended to remove the epithelium from both donor and recipient cornea.
“Main“ Tab
Target:
• Eye: Select eye to be treated (OD for right eye or OS for left eye), or donor cornea to be treated
(Donor OD or Donor OS)7.
7
“Donor OS” or “Donor OD” is related to the position of the AAC and not to the operated eye.

• Suction Ring: The SR size read from the PP will be displayed. Make sure a SR with a sufficiently
large diameter (approx. 1 mm larger than the intended graft) has been selected. (Note that a SR must
be read in even for cutting the donor button, although no SR is required for use with the AAC).
Resection:
• Depth: Select one of the presets, or select “(Value)” to enter the intended thickness of the graft (in
µm).
The resection depth for LKP should not be closer than 50 µm to the endothelium.
• Form: Circle (standard) or Ellipse can be selected.

• Diameter: This is the diameter, in mm, of the resection at the level of the stroma. For circular grafts,
enter desired graft diameter in mm (may be set with 0.01 mm precision). For elliptical grafts, two
values must be entered for long and short axis.
Important: The graft diameter used for the recipient cornea should be 0.2 to 0.3 mm smaller
than the value used for the donor.
The graft diameter can be freely set in the software, with the maximal value depending solely
on the applanation size. Additionally, the position of the recipient resection can be adjusted /
corrected within the applanation area. Therefore, the use of a suction ring 0.5 to 1 mm larger
than the required graft diameter is recommended and very convenient.
Side Cut:
• Angle: The angulation of the side cut can be set to one of the following pre-set angles: 30°, 60°, 90°,
120°, 150°, or freely at any angle between 30° (beveled) and 150° (inverse-beveled). Recommended
LKP
angle for LKP: 90°.
“Expert” Tab
47
LKP “Cut Parameter” screen (partial view) – Expert Parameters

Velocity:

• Side Cut: laser’s Slow Scan velocity, in mm/s, during resection of the flap border. This velocity is
Power:
• Stroma / Side Cut: Laser output power (in % relative to factory-set power output) used for making
the resection (separately for stroma and side cut regions). Normal setting is 105% for stroma and
140% for side cut.
Border:
• Inner Border / Outer Border: (As LKP procedures should always be performed using z-axis vertical
resection, border widths need not be set and will therefore appear grayed.)
Preferences:
• Vertical Incision: For recommended standard procedure, select “Yes”.
• Flap Type: For recommended standard procedure, select “Full Resection”.
“Advanced” Tab
“TVC (Venting Tunnels)” Tab

This section is intended for creating one to four venting tunnels, leading from the resection bed down
and out, to allow gas created in the cutting process to dissipate out of the stroma. This is optional and
may help prevent temporary whitening of the stromal tissue caused by trapped gas.
Resections deeper than 200 µm do not require venting tunnels. For resections at < 200
µm, using a venting tunnel is recommended.
Using venting tunnels is advised only for experienced surgeons trained in their use.
• Type: Two types of venting tunnels are available: “Radial” (recommended) and “Straight”:
48
Radial: Creates 1 to 4 radial tunnels at user-determined positions along the edge of the flap:
LKP "Cut Parameters" screen – Parameters for Venting Tunnels
• Numbers: Select the number of tunnels to be constructed (1 – 4): It is recommended to use 1 -2

tunnels. The first tunnel should be set at the position where the zigzag pattern of the stromal
resection begins. An optional further tunnel may be placed at the opposite position.

• Width: Enter a value (in mm) for the desired width of the tunnels. Typical value: 0.8 mm.
length of the venting tunnels. Enter a value in mm (typical value: 0.3 mm larger than the intended
graft diameter).
• Depth: Enter a value (in µm) for the desired depth of the outer end of the tunnels. Typical value:
approx. 100 µm below the resection depth, but minimum 100 µm above posterior corneal surface.
• Power: Laser output power (in % relative to factory-set power output) used for cutting the tunnels
• Velocity: Slow scan advances at this speed (in mm/s) for creating the tunnels. Typical value:
8.0 mm/s.
• Position 1 – 4: Position of tunnels in degrees relative the 0º position of the trajectory (The number of
entry fields for position values depends on / equals the number of tunnels entered). Typical value:
330º.
Straight: Creates a straight tunnel at 90 degrees relative to the 0º position of the trajectory.
LKP
• Width: This parameter is not enterable. It is factory-set at 0.8 mm. 49
length of the venting tunnel. Enter a value in mm. Typical value: 11 mm.
• Depth: This parameter is not enterable; the depth is automatically set to the depth of the stromal
resection.
• Power: Laser output power (in % relative to factory-set power output) used for cutting the tunnel
• Velocity: Slow scan advances at this speed (in mm/s) for creating the tunnel. Typical value: 5 mm/s.
“Settings” Tab
See page 20.

confirmation.
50
Verify screen (LKP procedure with radial venting tunnel)
9.3 Proceed

PKP
PART VII: PENETRATING KERATOPLASTY (PKP)
51

10 Set-up of PKP treatment parameters
10.1 Specific considerations pertaining to PKP resections

In order to deal with the higher power and resection time requirements associated with deep penetrating
resections, the total resection depth TD (Fig. 7), which extends through the entire corneal thickness and
well into the anterior chamber, is split into the anterior depth AD and the posterior depth PD. The AD
part of the resection can be performed with less power and at a higher velocity than the PD part. The
borderline between AD and PD is called “the interface”.
If desired, a small part of the PD resection can be left uncut to create a “Tissue Bridge” TB. This helps to
prevent spontaneous expulsion of the resected button. This could occur, e.g. if the transplantation is not
performed in situ immediately after the resection.
Fig. 7 Schematic cross-section of applanated cornea in a PKP procedure:

AD = Anterior Depth, corresponding to interface depth; PD = Posterior Depth; TD = Total resection Depth;
CT = Corneal Thickness at the resection position; TB = Tissue Bridge.
10.2 “Cut Parameter” screen

The common features of the Resection Parameters screen are described in the LDV Operator Manual,
section 8.12.
52 will be displayed. When parameters are changed, the trajectory graph will be adjusted dynamically.

PKP “Cut Parameter” screen – Main Parameters
10.2.1 Resection of donor buttons and of host tissue

Both host and donor cornea for a transplant procedure may be prepared with this module. By using
identical or matched geometrical parameters for both resections, an optimum fit of the donor button into
the recipient resection can be ascertained. Both resections can be prepared within the same procedure. It
is important to determine the peripheral corneal thickness of both donor and recipient beforehand.
The donor cornea is prepared first, using the Ziemer AAC Artificial Anterior Chamber. Refer to the AAC
instructions for use (see section 1.4). Recommended height for the infusion is 80 - 100 cm.
It is recommended to remove the epithelium from both donor and recipient cornea.
PKP
„Main“ Tab
Target:
• Eye: Select eye to be treated (OD for right eye or OS for left eye), or donor cornea to be treated
(Donor OD or Donor OS).8 53
• Suction Ring: The SR size read from the PP will be displayed. Make sure a SR with a sufficiently
large diameter (approx. 1 mm larger than the intended graft) has been selected. (Note that a SR must
be read in even for cutting the donor button, although no SR is required for use with the AAC).
Resection:
• Total Depth: Select one of the presets, or select “(Value)” to enter the intended value (thickness of
graft / recipient cornea at the position of the side cut. Recommended value: At least 80 µm deeper
that the measured thickness of the cornea at the position of the button’s edge. (It is no problem to
cut too deep, into the anterior chamber).
• Interface Depth: is the virtual borderline between the anterior and the posterior part of the resection.
It is usually set at an intermediate depth, making sure it will not be close to the posterior border of
the cornea. A typical value for ID will be approximately 80 µm less than the thickness of the cornea at
the button’s edge.
8
“Donor OS” or “Donor OD” is related to the position of the AAC and not to the operated eye.

• Anterior Diameter: Is the diameter, in mm, of the resection at the level of the epithelium. For circular
grafts, enter desired graft diameter in mm (may be set with 0.01 mm precision).
Important: The diameter used for the recipient cornea should be 0.2 to 0.3 mm smaller than
the value used for the donor.
The graft diameter can be freely set in the software, with the maximum value depending solely
on the applanation size. Additionally, the position of the recipient resection can be adjusted /
corrected within the applanation area. Therefore, the use of a suction ring 0.5 to 1 mm larger
than the required graft diameter is recommended and very convenient.
Tissue Bridge (TB):

• Depth: Surgeons sometimes prefer to leave a thin un-cut portion of tissue, which will then be
severed manually when the donor button is about to be inserted. The tissue bridge is usually set just
below the interface depth (i.e. at interface depth + 20 µm). The TB must be placed deeper than the
interface value.
• Thickness: The thickness of the tissue bridge is typically set to about 10 µm.
“Expert” Tab
PKP “Cut Parameter” screen (partial view) – Expert Parameters

Velocity
• Anterior: laser’s Slow Scan velocity, in mm/s, during resection of the flap stroma. This velocity is
54 individually optimized for each user at installation time. Typical value: 40 mm/s.
• Posterior: laser’s Slow Scan velocity, in mm/s, during resection of the flap border. This velocity is
individually optimized for each user at installation time. Typical value: 25 to 30 mm/s.
Note: The total resection time is a function mainly of anterior and posterior velocity,
and of total depth and interface depth. If the total resection time resulting from the
settings chosen for these parameters exceeds an internal limit, an error may occur. If
this happens, modify the parameters to reduce total time.
Power:
• Anterior / Posterior: Laser output power (in % relative to factory-set power output) used for making
the resection (separately for anterior and posterior part of the resection). Normal setting is 140% for
anterior and 160% for posterior part.

“Advanced” Tab
“Settings” Tab
See page 20.
10.3 “Parameter verification“ screen

confirmation.
PKP
55
Verify screen (PKP procedure)
10.4 Proceed

PART VIII: RESECTION
57

11 Preparation of the patient
• Prepare patient for surgery as usual, according to local procedures for the procedure in question.
• Place patient on the patient bed of the excimer laser or on the operating table below an operating
microscope.
• Double check which eye is scheduled for treatment. Apply local anesthesia to the eye to be treated.
• Double check that there is no contact lens in the eye to be operated on.
A contact lens remaining inadvertently in the patient’s eye will cause a thinner than intended
flap, or no flap at all, to be formed.
• Apply lid speculum. Make sure you have 20mm diameter space for the suction ring in-between the
brackets of the speculum.
Insufficient space between speculum brackets will cause smaller than expected flaps and
will cause patient discomfort from the Handpiece pushing down on the speculum against
the eye.
• (recommended) Perform central pachymetry and note result.

• Rotate patient's head sideways (for OS, tilt head to right and vice versa), and up/down to optimize
access for the LDV Handpiece.
• Focus and center patient's eye in your field of view through the oculars of your operating
microscope while the patient is fixating on the fixation light (if available). (This is best done under
higher magnification.)
• Set operating microscope to lowest magnification.
• If desired, you may mark the cornea lightly with a marker and gentian violet ink (see 2.2).
• Rinse the cornea with BSS / salt solution.
• Apply a few drops of viscoelastic if required:
For Z-LASIK procedures:

• Apply a few drops of viscoelastic to the apex of the eye (see 2.1.2). Be sure it coats all
360° around where edge of applanated cornea will be. Use a sponge tip to remove
excess material from the sclera.
For ISP procedures:
• If the planar (“2D”) mode is used, apply some viscoelastic9 (see 2.1.2)at the planned
entry position for the inlay. Be sure it coats the area where the access tunnel will be, at
58 the edge of the applanated cornea.
• Use a sponge tip to remove excess material from the sclera.
• IMPORTANT: Do not apply VISIOL® over the entire cornea. This viscoelastic is very dense
and it may cause “islands” if placed in the center of the applanation area.
For Z-LASIK Z, ICR, ISP 3D, LKP, and PKP procedures:
• Do not use any viscoelastic.
• Use a sponge to remove excess material from the sclera.
9
For ISP procedures, due to the higher resection depth it is necessary to use a more viscous viscoelastic than the
one required for LASIK procedures. Hence the recommendation for VISIOL® (TRB Chemedica).

12 Dissection procedure
12.1.1 Applying the handpiece
• Re-check patient's head position. Have patient fixate on excimer's or handpiece’s fixation light.
• If necessary, move patient bed (or microscope optics) to re-center the eye in field of view.
• (recommended) Start the video recorder to record the microscope view.
• (Assistant) When prompted by surgeon, remove articulated arm from parking position and swivel
around towards the patient. Place the handle of the Handpiece (casing) into the surgeon's hand.
• Position the Handpiece over patient's eye and hover about 2.5 cm (1") above the eye. Center the
applanation window over the pupil in the desired position.
• When the Handpiece is placed over patient's eye, the microscope’s illumination should be turned off
to avoid glare on the monitor.
• Keeping the pupil centered, hold the Handpiece level so that the black alignment ring on the upper
window is centered over the lower applanation window.
Very important: have the patient acknowledge fixation on the excimer’s fixation light
through the windows of the Handpiece, or on the fixation light integrated into the HP.
• If pupil, applanation window, and black alignment ring do not all look concentric with your field of
view at this point, retract the Handpiece and re-center the eye.
• If all looks concentric, push gently down to applanate the cornea. Make sure the black alignment ring
on the upper window remains concentric with suction ring and pupil. This ensures that Handpiece is
held evenly without tilting it.
• The applanated area (appearing as a darker circle) must fill the applanation window almost
completely (at least 75%). You may also observe centration on the LDV’s touchscreen monitor: make
sure applanated area extends beyond the displayed black circle in all meridians.
• If you cannot applanate the cornea sufficiently, the patient's nose or brow bone may be touching the
Handpiece or the blades of the speculum may be interfering. To correct, tilt patient's head away from
the Handpiece sufficiently to avoid contact between Handpiece and patient's anatomy. DO NOT tilt
the Handpiece to achieve suction.
• If there is no obstruction and yet you cannot applanate the cornea to the required extent try using a
smaller suction ring (e.g., a sterilized titanium suction ring).
Be sure the entered suction ring size on the touchscreen monitor is changed along with the
actual suction ring on the Handpiece.
59
For Z-LASIK and planar ISP (2D) procedures:
• Apply another drop of viscoelastic onto the cornea before re-applying the Handpiece.
Repeated attempts to applanate and achieve suction may render the patient's eye hypotonic.
Proper applanation and suction is not possible if eye is hypotonic, and mis-shaped or
incomplete flaps may occur. Upon repeated unsuccessful attempts, it is strongly
recommended to abort the procedure and to continue when normal IOP is re-established.

• Verify that:
- applanation is achieved
- the eye is properly centered (be aware of possible Bell’s phenomenon from patient trying to
close eye)
- Handpiece is level (not tilted)
For Z-LASIK procedure:
In case of a slight decentration, you may shift the position of the Handpiece slightly while applanated,
but before suction is applied. If pupil is not centered, or you suspect Bell’s phenomenon, remove
Handpiece and start over, re-applying viscoelastic.
For PKP and LKP procedures with patients under total anesthesia:
It may happen that the eye rolls away while trying to applanate. In this case the eye may be stabilized by
trying to hold it from the temporal side with a dry sponge tip with a long shaft. If this is not successful,
e.g. due to anatomic reasons, it may be necessary to fixate the globe with one or two long sutures that
can be used to bring the cornea center into the desired position.
12.1.2 “Cutting” screen
Cutting screen (LASIK and Z-LASIK)
60 For a detailed discussion of the Cutting screen, refer to the Operator Manual.
12.1.3 Suction
• Apply vacuum by pushing the large green button on the touch screen (or push foot-pedal to activate
vacuum). A series of beeps with increasing pitch indicates build-up of suction, and the numerical
value of the vacuum is displayed in the vacuum monitor graph.
IMPORTANT: Make sure it is clearly established between surgeon and assistant as to who
will activate vacuum. If activation is engaged twice, procedure will unexpectedly abort.

When suction is established or while suction is building up, you may move the center of the flap slightly
by touching the up / down / left / right buttons repeatedly, to correct for minor HP misalignment.
For Z-LASIK procedure:

Do this only to align the applanation area with the circle marking the flap size; if part of the
circle moves outside the applanation area, an incomplete flap will result. Moving the center,
perpendicular to the hinge, slightly away from the pupil center will result in a smaller hinge
width.
For Z-LASIK Z and other procedures:

The flap can only be displaced within the applanated area; therefore, if the flap is very
decentered, the flap diameter may need to be reduced.
• Stop pushing on the patient's eye with the Handpiece. Lift Handpiece slightly to ensure its weight is
not pushing down on the eye, and convince yourself you have good suction.
DO NOT continue if eye is not properly aspired or if you hear a slurping sound.
• If the vacuum is not stable, release vacuum by clicking on the Back button on the touchscreen
monitor. Re-apply vacuum and continue.
12.1.4 Resection
• Once suction is assured, instruct assistant to push the large green Start Resection button on the LDV
touch-screen monitor (or push foot-pedal to initiate the cutting process).
• The progress monitor bar will countdown the seconds remaining until completion of the resection.
• Hold Handpiece steady while cutting is in progress. Do not push down on patient's eye with the
Handpiece. Do not tilt the Handpiece.
• While the laser is cutting, blue LEDs around the base of the monitor pole will blink. When cutting is
complete, suction will be released automatically (or upon pushing on foot pedal, depending on
preference settings in system software).
• After flap is complete, before lifting Handpiece from eye, check for full bubble pattern coverage.
Consider immediate stromal recut if bubble pattern is incomplete.
• Lift Handpiece off the eye and pass it back to the assistant, who will swivel the articulated arm back
and place the Handpiece in parking position.
• Turn illumination of microscope back on.
61
• Increase magnification of the microscope.

13 Preparing the resection
13.1 Lifting the flap

• If so desired, place ink marks over the edge of the flap.
• Lift the edge of the flap immediately after the cut has been created (before bubbles disappear) or it
will be difficult to see where the edge of the flap is. Use either technique A or B as described below:
13.1.1 Flap lifting technique Version A

Recommended for novice users, for manipulating thin (sub-Bowman) flaps, and in situations where
parts of the flap are not fully dissected and resistance to lifting is felt. This technique is described in
more detail (with illustrations) in the “FEMTO LDV Starter Kit: Directions for Use” (see 1.4).
• With the hook of the Thorlakson Z-LASIK Flap Lifter prepare two small entries on either side of the
hinge.
• (optional) Guide the Flap Lifter along the edge of the incision all around to the opposite side of the
flap, always moving away from the hinge. Repeat from the other end of the hinge around to the
opposite side of the flap, connecting back to the separation created with the first pass.
• Introduce now the Flap Lifter along the hinge underneath the center of the flap, and then carefully
pull the instrument away from the hinge toward the opposite side of the flap. Repeat this with the
other half of the flap until the entire flap is separated from the bed.
• Lay the flap back. All bubbles will instantly disappear.
13.1.2 Flap lifting technique Version B

Suggested for expert users, with normal, completely dissected flaps. This technique is DISCOURAGED
for manipulating thin (sub-Bowman) flaps, and in situations where parts of the flap are not fully
dissected and resistance to lifting is felt.
• Separate the flap edge from the bed at the position opposite the hinge (i.e. between 5 and 7 o’clock
in case of a superior hinge), using a spatula.
• With the flap-lifting forceps, grasp the flap at the edge opposing the hinge; slowly and gently pull
towards the hinge.
• If any resistance is felt, stop and revert to flap lifting technique A (section 13.1.1).
The exposed stromal bed is usually smooth and dry. It is recommended NOT to rinse or touch the
stromal bed.
• (recommended) Perform pachymetry before the resection and on the open stromal bed. Calculate
the difference and note the result.
62 • (recommended) Measure flap diameter with caliper. Note result.
• Proceed to excimer procedure according to LASIK protocol.
13.2 Preparation of Tunnel and Pocket resections (ICR / ISP)

• Introduce a small spatula into the entry created by the LDV, to ensure entry is free.
• (ICR only:) The instrument used for separation must be smaller than the width of the vertical cut.
• (ISP only:) Gently move the spatula around the entire pocket resection, to ensure pocket is entirely
open. Separate the pocket with gentle movements in order to avoid damage the stromal surfaces.

The appropriate corneal inlay (intracorneal ring or disk) is now inserted using the special tools and
techniques provided by the supplier of the inlay.
13.3 Preparations for Lamellar or Penetrating Keratoplasty (LKP / PKP)

• Loosen the edge of the resected button using a small Sinskey-type hook (on the other side of the
recommended Thorlakson spatula). Then gently separate the stroma interface with the spatula side
of the instrument. It is important to find the resection interface This can be felt as the place where
there is no or very little resistance to separation. If significant resistance is felt, it is likely that the
spatula was forced into the stroma at the wrong depth. If this happens, stop and start again in
another location along the edge.
In deep lamellar resections, the tip of the spatula should not be pressed downwards but rather
upwards to avoid unnecessary stress to the nearby endothelium.
• Remove resected tissue button using standard surgical techniques. Store the button in the storage
liquid of the donor cornea.
• For PKP, separate the vertical edge completely, using a thin spatula or a cannula. It can happen that
small remaining tissue bridges are encountered. It is preferable to dissect them with a knife inserted
vertically, or with a curved cornea scissors. DO NOT PULL.
• After the button is removed, proceed to insertion of graft according to standard keratoplasty
protocols.
13.4 Re-cut
If, due to incomplete resection or related problems (as discussed in section 14, Handling Complications)
re-cutting the edge and / or the stroma is required, proceed as follows:
• Scan a new Procedure Pack to re-activate the laser.
• Modify conditions as suggested in section 14 and as directed by the surgeon.
• Exchange Procedure Pack components as required (but you may leave previously used parts (e.g.
suction tubing, HP covers etc.) in place).
• Continue from section 11.
13.5 Contra-lateral eye

If the second eye of the patient is also scheduled for treatment10, proceed as follows:
VERY IMPORTANT: Make sure there are no particles or deposits on the applanation window
or on either side of the InterShield spacer. Even minor impurities may cause incomplete
laser dissection and "tissue bridges" or "islands".
63
• Wash any residues away with a few drops of sterile water. Pick up excess water with a wet sponge.
• If InterShield cannot be cleaned, disassemble Suction Ring and InterShield, carefully clean
applanation window, and use a new InterShield (two identical InterShields are provided in each
Procedure Pack).
• Touch the Continue button; then the Cut OD / Cut OS respectively.
• Continue from section 11 for second eye.
10
Treatment of contra-lateral eye within the same session is available for Z-LASIK, Z-LASIK Z, and ICR procedures
only. ISP, LKP, and PKP are monolateral treatments. For LKP and PKP, however, two resections, for donor and
recipient, can be performed.

13.6 After completed resection
Nurse / technical assistant will perform the following final steps:
• Wait until surgeon has successfully lifted the flap before disassembling the Handpiece (he/she may
request a re-cut).
• Remove all disposable parts (Handpiece casings, suction tubing, suction ring11, InterShield and
surgical drape) from the Handpiece and the LDV and place in appropriate disposal container.
• Clean Handpiece (wipe carefully with moist disinfecting towel).
• Clean working surface of LDV, articulated arm, and touch-screen monitor, using moist disinfecting
towels.
64
11
If a re-usable titanium suction ring has been used, clean and sterilize it according to the “FEMTO LDV Z Models:
Operator Manual” (section 1.4).

PART IX: APPENDIX 65

14 APPENDIX A: Handling problems and complications
14.1 Incomplete dissection (“Tissue Bridge”)

Problem: A small area inside the resection area resists lifting:
• If the area is very small (< 1mm2): separate the "tissue bridge" by gently pushing against it, from all
sides, with a flat spatula.
• If the area is larger, do not attempt to sever the un-cut area with your flap separator, as the flap may
tear, resulting in a buttonhole. Lay the partially opened flap back, carefully aligning it; then perform a
repeat pass with the LDV*), using the same suction ring as for the first pass. Regardless of the
suction ring used, enter “8.5” in the treatment parameter list. Always use a new InterShield.
* Please note that for performing a repeat pass, a new, unused ProcedurePack must be
scanned. See section 13.4.
• If you have access to Expert Mode, reduce the Stroma Velocity by 1 mm/s, and set Border Overlap to
zero. You may also use the "Stroma Re-cut" option in the Expert Mode window.
• Increase vacuum level to at least 700 mBar.
• Apply the Handpiece at the same position as before and perform a re-cut. Open and fold back the
flap carefully.
• If the cornea has suffered from attempts to open the flap, or if the procedure described above is not
successful, it is recommended to reposition the flap and schedule a repeat procedure in a few weeks'
time when the wound has healed. Treat the wound as appropriate (bandage lens, steroids etc.).
14.2 No hinge ("Free Flap")

Problem: A cutting edge is visible around 360° (this may occur as a consequence of incomplete or
insufficient applanation and / or if the hinge width was set too small (e.g. <0.4mm)).
• Remember that the edge is not completely dissected by the LDV. Therefore you can retain a hinge in
any selected position simply by not opening the edge all around. Guide your edge opening
instrument around an approx. 300° section only. Then open the flap carefully, avoiding pulling on
the intended hinge position. A suitable technique may be to grasp the flap with a forceps at the
position opposite the hinge, and to pull towards the hinge rather than away from it.
14.3 Suction loss
14.3.1 Problem: Partial loss of suction

If vacuum temporarily drops but stays in the green range on the suction gauge, system will attempt to
re-pump and maintain suction while continuing the cutting process.
If vacuum drops to the yellow range on the suction gauge, the LDV will suspend (stop the pass)
automatically while maintaining / re-pumping suction.
66
• Check for suction to reach again the green range and make sure the Handpiece remains properly
centered on the cornea.
• Press Continue Cut and proceed normally. The cut will be resumed at the position where it stopped.

14.3.2 Problem: Complete vacuum loss
If vacuum drops to the red range on the suction gauge, suction is lost and the safety system will abort
the cutting process. In this situation, it is not possible to resume the cut.
• Lift the Handpiece off the eye. Perform a Re-cut as described in section 13.4. Re-apply Viscoelastic;
then re-position the Handpiece, applanate and proceed normally.
• If you are unsure about centration, consider repeating the cut after a few weeks rather than
immediately to give the wound time to heal. Treat the wound as appropriate (bandage lens, steroids,
etc.).
14.4 Cutting process aborted

Problem: The cutting pass may be stopped by the system's "watchdog" before complete, due to some
error status being detected.
• Reset any errors posted on the monitor. If you can reactivate the laser, start the procedure all over,
considering the alternatives presented below.
- If the LDV cannot be restarted, do not continue with the procedure; i.e. do not attempt to open
the flap. The patient will most likely not experience any visual impairment. Consider repeating
the procedure at a later date. Treat the wound as appropriate (bandage lens, steroids, etc.).
• If you are confident that you can re-position the Handpiece in the same, centered position, perform a
new cutting procedure using the same parameters and the same suction ring and InterShield.
• Alternatively, performing a surface ablation (PRK) may be another option. This should preferably be
postponed to a later date.
14.5 Applanation area too small

Problem: In Z-LASIK procedures, when the shape of the globe prevents the suction ring from being
pushed down further, or when treating a flatter than usual cornea (e.g. <40D), it may happen that the
pre-cut applanation area is smaller than intended and consequently, a smaller than nominal flap may
result.
Try to avoid such situations by taking corrective action BEFORE performing the resection:
• Consider using the next-smaller suction ring in such situations, in order to achieve the required 75%
applanation area.
• On the TopView Camera image, the required size of the applanation area is shown on the monitor as
a black circle. Make sure the applanated area extends beyond the displayed black circle in all
meridians.
14.6 Small or mis-shaped flap

Problem: A mis-shaped flap may occur if the Handpiece is not held level while cutting, or if the
applanated area is too small as described in section 14.5. In such a situation, DO NOT ATTEMPT TO
OPEN THE FLAP. The bubbles disappear normally in less than 10 minutes. Remember the displaced
position of the flap and re-treat after the bubbles are not visible anymore.
67
• Re-position patient's head to make sure you can hold the Handpiece level. Make sure you have good,
stable suction.
• Reduce Stroma Velocity and Border Velocity slightly (by 1-2 mm/s approximately).
• Re-cut (according to section 13.4) a thicker flap (140 instead of 110 um) using a larger suction ring
and positioning the hinge at 90° from the initial position.

• Start to open the flap at a place where the former flap was not cut, to be sure that the flap is opened
in the correct (=deeper) plane.
• Open the border completely and then separate the stroma in the deeper plane.
• Lift the flap cautiously.
Alternatively; consider repeating the cut after a few weeks rather than immediately, to give the wound
time to heal.
• Treat the wound as appropriate (bandage lens, steroids, etc.).
14.7 Flap not centered properly

This may happen especially to surgeons less experienced with the LDV, if the surgeon does not pay
close attention to the position of the Handpiece (positioning ring not concentric with the suction ring).
While a minor decentration is often inconsequential, the result in more serious cases can be
(a) a decentered flap with a hinge much too large and near the optical zone; or
(b) no hinge at the planned position, but an uncut area on the opposite side; or
(c) an incomplete border cut on one side of the flap.
In such a case, DO NOT ATTEMPT TO LIFT THE FLAP. The bubbles disappear normally in less than 10
minutes. Remember the displaced position of the flap. Wait one hour and until the bubbles are not
visible anymore, then re-treat, observing the following details:
• Reduce Stroma Velocity and Border Velocity slightly (by 1-2 mm/s approximately).
• Re-cut a thicker flap according to section 13.4 (140 instead of 110 µm) using a larger suction ring and
(optional) positioning the hinge at 90° from the initial position.
• Make sure you have good, stable suction.
• Check centration by watching the camera image on the monitor. Have the patient acknowledge
fixation of the excimer’s or the LDV’s fixation light.
• Start to lift the flap at a position where the former flap was not cut, to be sure that the flap is lifted in
the correct (=deeper) plane.
• Open the border completely and then separate the stroma in the deeper plane.
• Lift the flap cautiously.
Alternatively; consider repeating the cut after a few weeks rather than immediately, to give the wound
time to heal.
• Treat the wound as appropriate (bandage lens, steroids, etc.).
14.8 Slightly visible bandings in the stromal bed

Occasionally, this phenomenon may occur if the slow scan speed is set too slow. These bands will not
affect visual outcome and can be ignored. You may try to minimize these bands, if you have access to
Expert Mode and have been trained on working with Expert Mode:
68 • Increase Stroma Velocity in increments of 0.5 mm/s. Observe if the flap can be lifted easily.
• Adjust the speed after each successive cut until the flap can still be lifted easily and the bandings
have disappeared.
Alternatively, contact Ziemer Customer Support and request re-tuning of the factory settings.

15 APPENDIX B: Nomogram for Z-LASIK
This Nomogram applies to Z-LASIK (Classic and Crystal) procedures. It is a recommendation, which
should not replace careful consideration of all patient-specific factors that may influence the outcome of
the treatment.
DO NOT USE this table for Z-LASIK Z and other procedures.
Recommended Suction Ring:

Recommended
Keratometry White-to-White < 11.5 mm White-to-white >11.5 mm Hinge Width
38 – 41 dpt 9.5 mm ≥ 9.5 mm ≥ 0.6 mm
42 – 46 dpt ≤ 9.0 mm ≥ 9.5 mm ≥ 0.5 mm
47 – 49 dpt 8.5 mm ≤ 9.0 mm 0.5 mm
If required, e.g. if a bigger or a smaller flap is needed or wished, then other suction ring sizes can also be
used.
Additional special considerations:

 Hypotonic eyes require stronger suction (≥ 700 mbar) and / or a reduced laser beam scan velocity.
 In case of significant astigmatism (> 5D), using stronger suction may be advisable (> 700 mbar).
69

16 APPENDIX C: Contact Information
As your first point of contact for support we strongly recommend to always contact the distributor from
whom you purchased your instrument. The list of distributors can be found at
http://www.ziemergroup.com/service-support/femto-ldv-support.html
Your contact address for installations in the USA and Canada:
Ziemer USA, Inc. phone: 866-708-4472

a Ziemer Group company e-mail: [email protected]
620, E 3rd St.
Alton, Illinois 62002, USA
Your international contact address for installations in Europe and anywhere else around the world:
Ziemer Ophthalmic Systems AG phone: +41 848 943 637

a Ziemer Group company e-mail: [email protected]
Allmendsrasse 11
CH-2562 Port (Switzerland)
www.ziemergroup.com
www.femtoldv.com
70

NOTES
71

72

Doc. No. FL5940-0502-01
Version 1.1 / Oct. 2012
Ziemer Ophthalmic Systems AG

Allmendstrasse 11
CH-2562 Port, Switzerland
www.ziemergroup.com

Surgical Procedure Manual Surgical Procedure Manual

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What are the different parts of the manual?

What are the different parts of the manual?

What are the steps for sterile set-up of the FEMTO LDV for surgery?

What are the steps for sterile set-up of the FEMTO LDV for surgery?

Surgical Procedure Manual

2 Preparations for femtolaser surgery ..................................................................................... 7

3 Treatment parameter set-up ............................................................................................... 11

4 Sterile set-up of the FEMTO LDV for surgery .................................................................... 12

5 Set-up of Z-LASIK treatment parameters .......................................................................... 16

6 Set-up of Z-LASIK Z treatment parameters ....................................................................... 24

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

8 Set-up of ICR treatment parameters .................................................................................. 38

9 Set-up of LKP treatment parameters ................................................................................. 46

10 Set-up of PKP treatment parameters ................................................................................. 52

11 Preparation of the patient ................................................................................................... 58

12 Dissection procedure ........................................................................................................... 59

13 Preparing the resection ....................................................................................................... 62

14 APPENDIX A: Handling problems and complications ...................................................... 66

15 APPENDIX B: Nomogram for Z-LASIK ............................................................................... 69

16 APPENDIX C: Contact Information ..................................................................................... 70

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

1.1 Indications for use

1.2 About this manual

1.3 How to use this manual

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

1.4 Supporting manuals

Title Part number Document number

FEMTO LDV Z Models: Operator Manual REF 510.951.500 FL5940-0500

FEMTO LDV Z Models: Surgical Procedure Manual – REF 510.951.503 FL5940-0503

FEMTO LDV Starter Kit: Directions for Use FL5910-300-0614

Artificial Anterior Chamber: Directions for Use FL5913-001-0029

1.5 Notes and icons on safety

Symbol Name and significance

WARNING: A warning indicates an action or procedure which, if not performed correctly,

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

2.1 Sterile single-use material

Table 1: Procedure Packs to be used for the different surgical procedures

Method LDV Model Procedure Pack Handpiece

Z-LASIK Z2 LASIK PP MkII

ISP Z4* Z6 Corneal Surgery PP Z

ICR Z4* Z6 Corneal Surgery PP Z

LKP Z6* Advanced Corneal Surgery PP Z

PKP Z6* Advanced Corneal Surgery PP Z

* Optional; software license required.

2.1.2 Other sterile material

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

8 • Sterile sponge tips (e.g. Merocel spears; www.merocel.com)

2.2 Sterile re-usable items

Note: Titanium Suction Rings are not available in the U.S.

• Open-wire lid speculum as specified by surgeon. Ziemer recommendation: Ziemer’s “Thorlakson

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

• Wipe wheels with moist disinfection towel.

2.3.2 Other preparations (as directed by surgeon)

2.3.3 Positioning of LDV

2.3.5 Adjust height of LDV

© 2012 Ziemer Ophthalmic Systems AG Doc. No. FL5940-0502-01

10 Manual check and adjustment: