Femtosecond Laser
The SCHWIND ATOS is intended to create flap and lenticule in human cornea. Flap is a
necessary procedure for performing LASIK surgery with an excimer laser and enables the
customer to use this device with state-of-the-art femtosecond laser technology in conjunction
with SCHWIND’s advanced excimer technology.
SCHWIND ATOS delivers ultrashort laser pulses in the non-visible infrared wavelength regime.
The extremely short pulses deposit the lowest possible energy for a minimum collateral damage
of the surrounding corneal tissue. Precisely tuned sequences of laser pulses are scanned over the
predefined location within the corneal tissue creating µm-sized dissections via photo disruptive
effects. During this procedure, the patient’s eye is gently secured with vacuum against natural
eye movements with the aid of the SCHWIND ATOS Patient Interface. Its curved contact
surface allows for minimal applanation pressure on the patient’s eye.
Throughout the treatment, state-of-the-art safety systems monitoring the processes. For best
precision and efficiency, the SCHWIND ATOS performs integrity checks and calibration
procedures before every treatment, without the need for user inputs.
Three high resolution camera systems allow observation of the complete treatment from the
beginning of the docking via laser treatment to the opening of the flap or extracting the lenticule
under the accessory microscope. Two touch displays, the main Monitor and the Surgery screen
provide easy and intuitive interaction with the SCHWIND ATOS Application Software for
Treatment Planning, Settings, Manual access and progress monitoring.
Software Modules and Accessories
The SCHWIND ATOS application software offers the following modules for refractive
treatments:
• Flap
Instead of a mechanical microkeratome blade, the femtosecond laser creates a separating
layer in the corneal stroma. The resulting flap can be lifted to change the intrastromal shape
for refractive correction by laser ablation using an Excimer laser.
• Lenticule
A refractive correction is achieved by a series of separating layers inside the corneal stroma
using the femtosecond laser. With appropriate tools, the created intrastromal lenticule can be
dissected and removed though peripheral incision.
Indications of Patient Target Group
The intended medical indications of SCHWIND ATOS is Laser Vision Correction (LVC) for the
creation of e.g. flaps or lenticules. Regarding gender, there is no restriction for treatment with
SCHWIND ATOS. Concerning age limitations, observe local regulations and guidelines, since
there is no clinical data available specific to pediatric population treated with the
SCHWIND ATOS.
Further, the application software limits the entry of the age of the patient to be at least 18 years.
Lenticule creation is possible in all healthy myopic patients within the following refractive
ranges except of those patients having contraindications.
Spherical Equivalent [-0.50D to -14.00D]
Sphere [-0.50D to -12.00D]
Cylinder [-6.00D to +6.00D]
Functional diagram including beam delivery of the SCHWIND ATOS
Application Treatment Safety
Server Control Systems
Beam Delivery Scanning And Microscope
Vacuum
Unit beam Focusing and
System
( Laser Source) path System Accessories
Patient
Interface
Patient Support Table
DEVICE CONTROL AND OPERATION
The operation of the SCHWIND ATOS is only allowed by
trained medical personnel. Before operating the laser, make
yourself familiar with the safety regulations.
Pay attention to any errors and warnings which may be
indicated on the monitor
screen (main user interface) or surgery screen (secondary
user interface). Should you
have any questions, please contact your authorized local
SCHWIND representative or
SCHWIND directly.
Do not cover the air vents of the ATOS system. This could
cause overheating of the device during operation.
Before activating any movements of the device make sure,
there is no danger of compressive or clamping, neither for
patient nor for the user.
The laser shall not be operated in rooms where danger of
explosions exists and is not
suitable for use in the presence of flammable mixtures or
oxygen rich environment.
Use the system only in a room with a compatible electrical
supply.
Do not continue the treatment if there is any indication for
incorrect processing data.
Preconditions
Always check before surgery, that functional connections
like interlocks, e.g. towards
patient bed, are mounted, and that the Patient Interface
holder can easily float.
After a treatment, the system will release the vacuum from
the patient’s eye automatically. Also, patient bed will be
unlocked and can be moved again if patient bed joystick is
being used.
The SCHWIND ATOS Patient Interface is to be used only
in combination with the SCHWIND ATOS laser system.
Always check the sealing visually on all four sides of the
primary packaging before use is intended. The seal should
be intact and not appear to be broken during visual
inspection.
Check expiry before using the part. If already expired,
discard and dispose the part. Visually inspect the Patient
Interface for SCHWIND ATOS itself. In case you find any
damages, stains or foreign particles on the Patient Interface,
discard and dispose the Patient Interface
Treatment Device Preparation
After switching on SCHWIND ATOS, the system performs
its boot sequence and initial tests. The treatment device
Boot Sequence informs the user when it is ready to be used for preoperative
tasks. To gain access to the Application Software and to
prevent unauthorized use of the system, please log-in with
user account and password
A treatment cannot be initiated until the safety check is
complete. Please check the floating function of the Patient
Safety Check Interface holder by lifting the holder gently until the system
enters the safety state. While doing this, please confirm that
the movement of the patient interface holder is smooth and
without friction or any impediment.
Login Screen (Monitor: Main User Interface)
USER Enter username to log on to the software
PASSWORD Enter password to log on to the software
LOGIN Push <Log in> after user and password are successfully entered
SHUT DOWN Push <Shut Down> to safely terminate the system.
Main Screen (Monitor: Main User Interface)
PLANNING Push <Planning> for the start of patient eye(s) treatment planning
(lenticule or flap)
SETTINGS Push <Settings> for selection of user preferences prior to treatment
planning.
MANUAL Push <Manual> for user access to the Instruction for Use (IfU) of
SCHWIND ATOS
Push <Log Export> for the creation of a detailed logfile stored onto the
LOG EXPORT SD Card.
This logfile contains detailed information about the system status and
is intended
for analysis by SCHWIND Service Technicians only and password
protected.
LOGOUT Push <Logout> to get back to Login Screen, e.g for a new log in
SHUT DOWN Push <Shut Down> to safely terminate the system.
A. Prepare Patient
After accessing the operating room, the patient takes place on the SCHWIND Patient Bed.
The patient is then moved in a lying position under the surgical microscope by pressing the
corresponding button on the patient bed where he will be prepared for eye surgery.
TREATMENT FLOW
PLANNING
Lenticule
Parameters
IMPORT AN EXISTING
TREATMENT
Incision
Parameters
SELECT A TREATMENT
Flap METHOD
Parameters (LENTICULE, FLAP)
Hinge ENTER THE SPECIFIC
Parameters TREATMENT
PARAMETER
Refraction
REVIEW TREATMENT
PLANNING BACK
Pupil Data
SAVE
Cornea
Pre-Op
Cornea LOAD PLAN
Post-Op
WORKFLOW:
DUTY PLANNING A PURPOSE
SURGERY
For planning an eye treatment and for changing surgical
Planning parameters.
For checking the parameters to be applied to a patient.
Ophthalmologist Review Plausibility checks are performed by SCHWIND ATOS.
Nurse Operator If values are not
plausible a self-explanatory message will be shown.
For selection of the eye to be treated.
Plausibility checks are performed by SCHWIND ATOS,
Eye Selection correct placement
of the Patient Interface is checked.
A. Treatment Planning (“Plan”)
Treatment planning is performed by pushing <Planning> displayed on the monitor: The
treatment planning menu opens on the main user interface.
A patient-specific treatment plan can now be prepared via entering or importing clinical
data:
• Import an existing treatment plan and modify it accordingly (see below)
Or
• Change the patient demographics, if necessary
• Diagnostic data can be manually entered, selected or imported.
• Select a treatment method (e.g lenticule, flap) for the corresponding eye
• Enter the specific treatment parameter for the selected treatment
The following clinical data can be entered via <Edit> or imported based on diagnostic data of the
relevant eye via button <Import Diagnosis>
(Keep in mind that a SD-Card with data must be present).
The software will display warning messages or information if parameters require additional
attention and will provide recommendations for current settings.
The Application Software will perform plausibility checks for Gender, Name, Date of Birth to
determine whether the correct patient is being treated. Patient demographics are displayed on all
screens throughout the treatment workflow.
<Save Plan> enables the Treatment Planner to store a patient treatment plan, either a new or
updated plan.
<Load Plan> enables the Treatment Planner to open and use a pre-planned treatment plan, either
to modify the plan selected or to directly continue with treatment workflow via <Next>.
LENTICULE INPUT PARAMETER
The following limits will be checked automatically:
- Lenticule Thickness ≥ 25µm
- Lenticule Thickness ≤ 165µm
- Cap Diameter >Total Zone (Optical Zone (OZ) + Transition Zone (TZ))
- SEQ -0.5D to -14.00D
- Central Residual Stromal Thickness (CRST) ≥ 275µm
The Total Zone is calculated automatically.
Please pay attention to Optical Zone in case of patients with high treatment values.
The Optical Zone may be also optimized automatically if the maximum allowed lenticule
thickness.
FLAP INPUT PARAMETER
For changing the parameter, use the <Edit> button close to the intended parameter.
A window is shown representing buttons <+> and <-> to change treatment parameters
stepwise, either in small or bigger steps (depending on the size of the sign).
When eye tracking information is available, i.e. pupil offset and picture information from the
SCHWIND diagnostic devices (SIRIUS, SIRIUS+, MS-39, or PERAMIS [manufacturer: C.S.O.
S.R.L., Italy]), necessary data for cyclotorsion or pupil tracking are transferred to the eye tracker
for further guidance within the step “Docking”.
<Save> or <Cancel> to be used to close an edit box again.
Values with 0 as default will be set directly to minimum value, when the value is increased for
first time.
B. Review Planned Treatment (“Review”)
After entry of all treatment parameters the relevant ones are again highlighted to be reviewed and
checked for plausibility before treatment.
Push <Next> to continue with Eye Selection.
Push <Back> to modify the Treatment Plan.
PATIENT INTERFACE PREPARATION
SCHWIND ATOS operates in combination with a Patient Interface. The disposable Patient
Interface allows precise connection of the patient eye with the laser device by applied vacuum.
The Patient Interface is a single part component without any attachments. Once inserted into the
SCHWIND ATOS, all necessary connections, i.e. vacuum are already established. An integrated
filter inside the Patient Interface stops fluid and potentially created fumes and plumes to avoid
contamination of the laser device.
BEFORE USE:
• Check for expiration of the disposable Patient Interface.
• Discard and dispose the part if already expired.
• Visually check the seal on all four sides of the primary packaging before opening.
• The seal should be intact and not appear to be broken.
PREPARATION:
a. Peel away the lid of the primary packaging.
b. Upon peeling opens the primary packaging lid, invert the primary packaging and place it
on a table covered with a sterile medical drape.
c. Upon gently pressing the primary packaging on front and back between thumb and index
finger, the SCHWIND ATOS Patient Interface will release and easily come out.
d. Alternatively hold the PI from the PI handle and gently take-out from the Primary
packaging.
e. Visually inspect the SCHWIND ATOS Patient Interface.
f. In case you find any damage, stains, foreign particles or sharp edges on the Patient
Interface, discard and dispose of the Patient Interface.
g. Surgery Assistant gently guides the SCHWIND ATOS Patient Interface inside the
Patient Interface holder by touching only the handle.
h. Maintain sterility by wearing sterile gloves.
i. Audible feedback (click-like sound) indicates that the Patient Interface sits in its intended
location inside the Patient Interface holder.
j. Make sure to slide the Patient Interface parallel into the Patient Interface holder to ensure
correct positioning and avoiding collision with other parts.
DISPOSABLE PATIENT INTERFACE
Do not use the disposable Patient Interface when sterile packing is damaged or
already open! Sterile status is not valid anymore and may lead to infection or
microbiological hazards.
Do not use Patient Interfaces when the expiry date has exhausted as the sterile status
may not be valid anymore.
Handling of the sterile Patient Interface requires wearing of sterile gloves.
After the treatment, used Patient Interfaces can be disposed of with surgical waste.
Do not use the disposable Patient Interface for SCHWIND ATOS more than once!
Re-use may have negative influence on cutting performance and could lead to
operative complications.
Re-use may lead to infection or contamination with potentially infectious substances of
human origin. Thus, used Patient Interfaces should be disposed carefully to avoid
infection of the handling person.
Do not bring the Patient Interface in contact with any foreign materials or chemicals
to prevent a possible exposure of patient’s airways or tissue.
The transparent contact element at the lower side of Patient Interface should not be
touched during interaction as this may change the optical performance.
C. Eye Selection (“Eye Select”)
SCHWIND ATOS will allow further progress only if the Patient Interface is correctly inserted.
Selection of the patient eye to be treated first in a Treatment Plan that includes two eyes OD and
OS.
a. Make your choice and < OD> or < OS> for Eye Surgery.
b. Validate treatment screen information before starting the docking procedure.
c. Push <Back> to step to the Review section.
Do not touch or remove the Patient Interface after insertion and/or pressing <OD>
or <OS>. The position of the Patient Interface will be determined after pressing
<OD> or <OS>. Any movement or exchange of the Patient Interface will influence
the placement of the laser treatment. In case the Patient Interface is not correctly recognized by
SCHWIND ATOS, please insert a new Patient Interface.
WORKFLOW:
DUTY SURGERY PURPOSE
PROCEDURE
Docking For the alignment procedure towards the Patient
Interface.
Vacuum level is checked during this step. If values
are not plausible a self- explanatory message will
be displayed.
Linking For fixation of the eye with the system by applying
vacuum. This step indicates that the patient’s eye is
successfully linked. If re-docking is necessary, it
can be achieved by releasing vacuum
Ophthalmologist
(goes back to step docking).
Treatment For the laser treatment itself.
Only successfully linked eyes can be treated. If
there is a suction loss during treatment, the system
will go to a safety state TREATMENT_ABORT
For surgical manipulation after the laser treatment.
Release Vacuum will be released from the patient eye
automatically, so that e.g.
further manipulation of the eye can be performed.
A. DOCKING (“Docking”)
1. The eye needs first to be roughly aligned towards the Patient Interface in order to observe its
position via monitor and surgery screen.
2.The patient is advised to focus on a green fixation light which will be disabled before the
treatment start. The pupil center shall be targeted into a defined position of the patient
interface.
3. Use the SCHWIND Patient Bed to move upward so that the eye comes in contact with the
contact element in an aligned manner until the eye is applanated.
4. It is necessary to move the patient’s eye into a defined working position of the system. The
system supports the patient eye alignment via eye tracking system which detects the center
of the pupil position and displays it with a green cross.
The yellow cross represents the ideal position of the pupil center. It is displayed on the main and
second user interface.
The green and the yellow cross guides the surgeon for proper alignment during the upward
movement of the patient bed.
The green cross needs to be aligned with the yellow circle for optimal alignment within the target
working zone. No surgery is possible if the green cross is outside the red circle.
5. A proper working position is reached when the slider bar level approximately reaches the
middle of the green range.
B. LINKING or Applying Vacuum (“Docking” or “Linked”)
1. When the targeted working zone is reached and and the eye is properly aligned, vacuum can
be applied to enable the eye fixation via the button <Start vacuum> on the surgery screen.
2. After reaching a given vacuum level, the patient’s eye is successfully connected with the
Patient Interface.
3. Possible misalignment is checked and calculated by the eyetracker and should be verified by
the Surgeon. The system provides a status message if the eye alignment is out of the given
tolerance. The user is either able to continue or to re-dock.
Shown at the treatment mask and during the docking procedure. It has the following states:
Unknown : Always when no eye is attached to the system, hence vacuum towards the
patient eye cannot be established.
Low : Value is too low for for the procedure.
Good : Value is sufficient for the treatment.
4. If necessary, disable the eye fixation by pressing the <Stop vacuum> button on the monitor
or surgery screen and repeat the ‘Docking’ and ‘Linking’ process.
5. The <Start Treatment> button is enabled only if the vacuum level is okay and patient eye
alignment is valid and accepted or eyetracking is disabled.
6. A countdown is started by applying vacuum, limiting the suction time before start of the
treatment to 90 seconds. After the time passes, the eye will be released, and the system will go
back to state "Docking".
The integrated eyetracker software evaluates the pupil position during and after the docking
process to detect a pupil offset value (if entered) and improper centration of the eye to the
contact element. If the pupil cannot be detected, no green cross is displayed.
SCHWIND ATOS checks a potential decentration within defined limits before the system is
automatically ready for the laser treatment.
Treatment cannot be started if the decentration of the pupil is too large.
C. TREATMENT (“Linked” or “Treatment”)
Laser treatment will only start if:
• The Patient Interface is properly connected with the laser device.
• The proper vacuum level is reached.
• The patient’s eye was properly docked to the Patient Interface or the user
confirmed potential decentration to be acceptable and
• The <Start Treatment> button is pressed.
1. Start the laser eye surgery by pressing <Start Treatment> button on the surgery screen (small
monitor).
2. The fixation light switches off and the cyclotorsion measurement starts - if image information
from a SCHWIND diagnostic device is available and quality is suitable - with the patient eye
sufficiently aligned and fixed to the Patient Interface.
3. Either a lenticule or flap cut is created according to the plan.
In case of unforeseeable events, surgery can always be aborted by pressing
EMERGENCY STOP. Alternatively, it is possible to abort by pressing button “ABORT”
(secondary user interface) until the cutting process starts. The Surgeon should monitor the
progress of the treatment on the surgery screen and abort if anything unintended is observed.
D. RELEASE (“Release”)
• The vacuum will be automatically released whenever a cutting process is completed or
aborted.
• SCHWIND Patient Bed interlock is off and the patient eye can be moved to the observatory
position (microscope view) for lenticule removal. Flap opening is typically performed under
the microscope of the excimer laser device.
• Remove the used Patient Interface from the system before continuing with treatment of the
next eye.
• Pull the Patient Interface out of the Patient Interface holder by using the handle of the Patient
Interface.
• In a bilateral treatment (OD and OS) the surgical procedure of the second eye starts when
pushing <Next>. Otherwise the user is guided back to the main screen.
• When the surgery is completed, the patient is moved with the SCHWIND Patient Bed to the
release position by pressing the corresponding button on the patient bed.
• The patient is either guided out of the operating room (after a lenticule extraction treatment)
or prepared for flap lift followed by treatment with an excimer laser.
• The surgeon or surgery assistant clears the surgery area and ends the treatment routine.
• Preparation for a new laser eye treatment with SCHWIND ATOS afterwards is possible.
• After the treatment, the device generates a treatment report, which is stored onto the SD
Card. Please ensure whether a SD Card is inserted into the SD Card Reader behind the monitor
so that the treatment report can be generated.
CLEANING AND DISINFECTION
PARTS PROCEDURE
a. The laser aperture area shall be inspected by the user after
each patient:
• During surgery, liquids could spray from the canula into
Laser Aperture Area the laser aperture area.
• In case the patient’s face is not covered with sterile
tissue during surgery, parts of the patient’s face (e.g. nose
and eye socket) could encounter the laser aperture area.
b. Remove any fluid with a clean, dry and lint-free cloth.
c. Clean the area with a lint-free cloth dampened with
disinfection solution.
a. Normal dirt and grime of housing parts may be cleaned
using a moist (not wet!) cloth. Non-abrasive and non-
Housing aggressive cleaning solutions may be used for more stubborn
dirt and grime. Ordinary dry foam may also be used.
b. If necessary, wipe all surfaces with a lint-free cloth
dampened with disinfection solution.
c. To wipe off fluid (e.g. on patient bed) use a clean, dry and
lint-free cloth.
Screens, Keyboard and a. Wipe all surfaces of the following parts with a lint-free
Control Elements cloth dampened with disinfection solution.
Surgical Microscope a. The housing parts of the microscope can be cleaned with a
dry cloth.
b. At longer intervals painted surfaces may be cleaned with a
damp cloth, as required. Use an aqueous solution of a
commercial cleaning agent.
