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VisuMax Laser keratome SMILE Option User manual

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User manual VisuMax Laser keratome, SMILE option 000000-1345-518-GA-SM-GB-310511 31.05.2011 The present user manual is only valid in conjunction with the relevant user manual for the VisuMax Laser keratome Ophthalmic surgical laser. © 2011, Carl Zeiss Meditec AG, Jena All rights reserved in the event of granting of patents or registration as a utility patent. All names of companies and products cited in this manual may be trademarks or registered trademarks. Third party products are cited for information purposes only. This does not represent approval or recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products. Microsoft Windows® is a registered trademark of Microsoft Corporation, Inc. Other brand names, software and hardware names used in this user manual are generally subject to trademark or patent protection. The quoting of products is for informational purposes only and does not represent a trademark misuse. This user manual is protected by copyright. Unless expressly authorized in writing, dissemination, duplication or other commercial exploitation of this document or communication of its contents or parts of it is not permitted. In case of infringement, the violator may be liable to pay compensation for damages. Specifications due to technical developments are subject to change. This user manual is not subject to the revision service. Please contact the manufacturer or authorized dealer to request the latest edition of the manual.

Contents

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Contents

Contents................................................................................... 1

Notes on the user manual ........................................................ 2 Purpose and availability of documentation ...................................................2

Questions and comments ..............................................................................2

Explanation of symbols used.................................................... 3

Package check list.................................................................... 4

Country-specific information .................................................... 5 Indication for use ..........................................................................................5

Contraindications ..........................................................................................5

Side effects ...................................................................................................7

Intended user profile.....................................................................................9 User profile for the approval of treatment planning and execution.........................................9

Operation of the instrument................................................... 10 Treatment license........................................................................................10

Description of the procedure.......................................................................10

RSTP - Recommended Standard Treatment Procedures for VisuMax SMILE....12 General information ............................................................................................................ 12 RSTP for surgery preparation ............................................................................................... 12 Selection of treatment pack size .......................................................................................... 14 RSTP for the treatment ........................................................................................................ 15 Laser treatment of patient eye............................................................................................. 21 Follow-up examination/treatment........................................................................................ 23

Restart of treatment for SMILE ...................................................................24

Expert mode................................................................................................26

Optional accessories............................................................... 27

Technical data........................................................................ 28 Limit values of adjustment ranges ..............................................................28

Surgical instruments....................................................................................30

Abbreviations/Glossary........................................................... 31

Figures ................................................................................... 32

Index...................................................................................... 33

Notes on the user manual

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Notes on the user manual

Purpose and availability of documentation

This user manual and the online help information of this instrument explain the safety precautions, functions, usage and performance parameters of this option. In addition, the user manual for the VisuMax Laser keratome Ophthalmic surgical laser should be observed which contains information on the operation of the device. Correct operation of the device is imperative for its safe and successful function. You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using this option the first time. The user manuals and other documentation enclosed with this device should be kept accessible to users at all times to ensure that the information required for use of this product is readily available. Questions and comments

If you have any questions or comments concerning this user manual or the device, please contact Carl Zeiss Meditec customer service or your local dealer.

Explanation of symbols used

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Explanation of symbols used

The symbols used in this user manual refer to important safety information which may warn against possible health risks or fatal injuries and contain useful notes. Whenever you see these symbols, read the accompanying information carefully and observe all safety notes and information in this user manual and on device labels.

WARNING

Indicates a hazardous situation which may result in fatal or serious bodily injury if the appropriate safety precautions are not heeded.

CAUTION

Indicates a hazardous situation which may result in light injury if the appropriate safety precautions are not heeded.

CAUTION - PROPERTY DAMAGE

Indicates possible device damage if the appropriate safety precautions are not heeded.

Information, hints and advice for better understanding of the instructions to be observed in the operation of the device.

Package check list

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Package check list

The following accessories are supplied with this option: • License

• Documentation set

Country-specific information

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Indication for use

The VisuMax laser keratome is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:

• refractive corrections, particularly the treatment of myopia and myopia combined with astigmatism by creating a corneal lenticule.

Any use other than intended may result in health hazards and is thus not permitted.

Contraindications

The following contraindications do not permit treatment with the laser keratome for refractive surgery and surgical treatment requiring an initial corneal incision:

• Patient not being able to lie flat in a horizontal position

• Patient not being able to understand and give informed consent

• Patient not being able to tolerate local or topical anesthesia

• Autoimmune diseases

• Sicca syndrome, dry eye

• Herpes viral (herpes simplex) infections

• Herpes zoster

• Diabetes

• Pregnant or nursing women

• Treatment with medication which influence wound healing, e.g.:

– Steroids

– Antimetabolites

– Immunosuppressors

• Treatment with medication with ocular side effects, e.g.:

– Accutane®

– Cordarone®


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• Any residual, recurrent, or acute disease of the eye to be treated, e.g.:

– General infections

– Disorders of the cornea

- Corneal dystrophies Dystrophy of basement membrane

- Keratoconus

- Pellucid marginal degeneration of the cornea

- Other corneal deformities

- Corneal edema

– Cataract

– Age-related macular degeneration (exudative)

– Presumed ocular histoplasmosis syndrome (POHS)

– Glaucoma suspect (Intraocular pressure > 21 mm Hg)

• Any residual, recurrent, or acute abnormality of the eye to be treated, e.g.:

– Existing corneal implant

– Corneal lesion

– Unstable refraction

– Connective tissue disease

– Preoperative corneal thickness < 500 μm

– Residual stromal thickness < 250 μm

• Previous therapies, e.g.:

– Radial keratomy

Contraindications are not limited to this list. For a complete list of contraindications, please consult medical literature, associations and current legislation in your particular country.


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Side effects

The following side effects may arise during or after corneal incisions with the laser keratome:

Diseases of the eye

• Disorders of the cornea

– Keratitis

- Corneal ulcer - Sicca keratoconjunctivitis - Diffuse lamellar keratitis (DLK)

– Corneal scars and opacities

- Haze

– Corneal dystrophies

– Corneal neovascularization

– Striae

– Corneal deformities

- Corneal ectasia

– Iridocyclitis

- Iritis - Uveitis

– Corneal melting

– Loose corneal epithelium

– Epithelial ingrowths

– Central necrosis on the incision planes

– Corneal erosio

– Corneal infiltrate

– Central toxic keratopathy

– Keratocyte activation

• Disorders of vitreous body

– Crystalline deposits in the vitreous humour (muscae volitantes, floaters)

• Disorder of refraction

– Hypermetropia

– Myopia

– Astigmatism


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• Visual disturbance

– Subjective visual disturbance

- Visual halos

- Glare

- Increased light sensitivity

– Diplopia

– Night blindness

– Transient light sensitivity syndrome

– Low vision

- Loss of visual acuity

- Regression of operation success

• Subconjunctival hemorrhage

• Retinal detachments and breaks

• Retinal hemorrhage

• Ocular fundus retinopathy and retinal vascular changes

• Hyperemia

• Petechial bleeding

• Ocular pain

– Foreign body sensation

• Uncontrolled intraocular pressure

• Gas bubbles in the anterior chamber of the eye

Temporary limitations

• Temporary visual field defect during suction of the eye

• Temporary gas bubbles in the cornea

• Delayed visual recovery

Other complications

• Abortion of incision procedure

• Incomplete incisions

• Decentered incisions

• Unwanted incisions

• Incisions difficult to open


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Side effects and complications are not limited to this list. Please inform yourself about additional side effects from the relevant technical literature and medical associations.

Intended user profile

User profile for the approval of treatment planning and execution

The following training, knowledge and experience prerequisites must be fulfilled:

• Completed eye specialist training, ophthalmologist

• Experience with the Microsoft Windows operating system and applications based on it

• Knowledge of current ophthalmic diagnostic procedures and their measurement results for refractive surgery treatment planning

• Knowledge of current therapy methods in refractive surgery

• Knowledge of the effects of incorrect or inaccurate readings on the therapy

• Possible consistency checks against other measurement results

• Practical experience in corneal surgery

Operation of the instrument

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Detailed information on general operation of the VisuMax as well as the planning and execution of treatment is to be found in the user manual for the VisuMax Laser keratome Ophthalmic surgical laser.

The stromal thickness shown is a theoretical anticipated value. If changes occur in the course of the operation the achieved residual stromal thickness may deviate from the value shown. Please take into account that the calculation of residual stromal thickness is based on the pachymetry value entered, which is subject to measurement uncertainty.

Treatment license

The VisuMax laser keratome, SMILE option, requires prior activation by a treatment license for the SMILE option to carry out the surgery. The treatment license will be provided by Carl Zeiss Meditec or its authorized representatives based on the commercial agreement.

Description of the procedure

In the SMILE procedure the refraction is corrected by femtosecond lenticule extraction.

For this purpose an intrastromal lenticule is created with the femtosecond laser in a shape corresponding to the desired refractive correction in the intact cornea and the incision subsequently prolonged to the anterior corneal surface with an opening incision.

The complete femtosecond incision for a SMILE treatment consists of four parts which are completed in succession in the integrated procedure (see Fig. 1).

The access to the lenticule is later opened manually by the surgeon and the lenticule removed (see Fig. 2).


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1 Lenticule cut (underside of lenticule)

2 Lenticule side cut

3 Cap cut (concurrently upper side of lenticule)

4 Cap opening incision

Fig. 1 Incision geometry of SMILE procedure for femtosecond lenticule extraction

1 Lenticule

2 Cap opening incision

Fig. 2 Principle of femtosecond lenticule extraction for SMILE procedure


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RSTP - Recommended Standard Treatment Procedures for VisuMax SMILE

The purpose of this section is to describe the standard treatment procedures (RSTP) for femtosecond lenticule extraction treatment with the VisuMax laser system. General information

There are various ways of achieving successful surgery. Nonetheless, Carl Zeiss Meditec has compiled a list of recommended treatment procedures. This is the result of information from experienced surgeons and reflects the experience of many years of business in the field of refractive surgery. This list will enable physicians to perform treatments leading to high-quality results in the interest of their patients.

We therefore recommend using these standard treatment procedures. In each case we recommend a precise diagnosis of the ascertained clinical findings of the patient.

Together with our clinical researchers we constantly endeavor to further qualify these recommendations and regularly improve the recommended methods in line with new findings.

Your experience in using other lasers from Carl Zeiss Meditec or its competitors may be at variance with the VisuMax-optimized recommendations given here.

Reading these recommended standard operating procedures is not a substitute for the need to carefully study the complete user manual (VisuMax Laser keratome Ophthalmo surgical laser) or for the detailed training provided by Carl Zeiss Meditec, nor does it release you from the obligation to update your own expertise in keeping up with the latest results of general research in the field of refractive surgery on a regular basis.

RSTP for surgery preparation

Before making a decision to treat a patient and prepare the patient for an operation:

• Perform all the relevant examinations in good time before the proposed surgery.

• Ensure that the patient does not wear his/her contact lenses for a period of at least 3 to 4 weeks before the preliminary examination in the case of hard lenses and 1 to 2 weeks in the case of soft lenses.


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• Please take into account all contraindications (e.g. keratoconus, irregular corneal typography, etc.) stated in the literature published by medical associations1 and in the user manual and the laws applicable in your country.

• Repeat the examinations and review the decision to perform surgery immediately before the operation is due.

• At least a week before the operation, remind your patient to observe the following rules for at least three days prior to the operation:

– Not to wear contact lenses at any time

– Not to apply make-up or mascara

– To take a pre-operative topical antibiotics (optional)

1 e.g.:

Kommission Refraktive Chirurgie (Deutschland) [Refractive Surgery Commission (Germany)]: Bewertung und Qualitätssicherung refraktiv-chirurgischer Eingriffe durch die DOG und BVA [Evaluation and quality assurance for refractive surgery by the DOG and BVA] (May 2007)

ASCRS (USA): LASIK Surgery Screening Guidelines For Patients: The Eye Surgery Education Council Medical Advisory Board: Chair, Roger F. Steinert, MD; Douglas D. Koch, MD; Stephen S. Lane, MD; R. Doyle Stulting, MD


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Selection of treatment pack size

The treatment pack is available in sizes S, M and L. Each treatment pack is labeled with the relevant size.

The choice of size of treatment pack for surgery depends on the following criteria in this order:

• Diameter of suction ring < effective white-to-white diameter

• Effective maximum cap diameter ≥ proposed cap diameter

It is useful to select the smallest possible treatment pack. If the selected suction ring is too large, it may cause suction pressure on the conjunctiva, resulting in premature abortion of the treatment due to loss of suction.

We recommend the following treatment pack sizes for the specified minimum "white-to-white" diameters:

Size of treatment pack S M L

Minimum white-to-white diameter (mm) 11.2 11.7 12.4

The maximum possible incision diameter for each treatment pack size is indicated on page 28 in Section Technical data, and will be checked automatically by the treatment planning software for the selected treatment pack.


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RSTP for the treatment

Preparing the laser keratome and the patient for treatment:

1. Fully examine the patient's eye(s), including the retina; inquire also about your patient's working and living conditions, e.g. night driving.

CAUTION - RISK OF SURGICAL ERRORS

Observe all contraindications specified in the literature of medical associations and the current legislation of your particular country.

2. Check the refraction yourself or have it done by an appropriately

qualified person. In the case of myopia, work with subjective refraction.

3. Check pupil size in the dark (e.g. with a ProcyonTM or Colvard pupillometerTM or a WASCA Analyzer).

4. Determine corneal thickness at the thinnest point.


The pachymetry must be measured prior to surgery. A check must be made to ensure that the minimum corneal thickness conforms to the pachymetry in treatment planning. The residual stromal thickness after treatment should not be less than 250 μm, otherwise treatment planning is not possible.

5. Check the treatment diameter. Ideally the postoperative effective optical zone (lenticule diameter) should be slightly larger than the mesopic pupil diameter.

6. Check refraction immediately before commencing surgery.

7. Ensure that the ambient conditions satisfy the requirements (see Installation in the user manual for the VisuMax Laser keratome Ophthalmo surgical laser).

8. Start the laser keratome.

9. The monitor on the left-hand side and the keyboard/trackball are intended for the input of patient data and treatment parameters. Several treatments can be entered in advance.


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10. Enter the patient data and check it.

• Select the mode of treatment • Select eye (OS/OD) • Enter and check the treatment parameters for the eye to be treated.

11. Once the treatment planning has been completed, push the keyboard

back into the VisuMax housing. This procedure activates the treatment check on the touchscreen on the left-hand side.

12. Set the microscope according to your individual needs and adjust the magnification as required for the following steps.

13. Bring the patient into the operation room.

14. In the entry position, settle the patient into the patient supporting system so that his/her eye is comfortably and precisely positioned.

15. Approx. 2 minutes prior to surgery, insert a drop of a preservative-free anesthetic two to three times into the conjunctival sac.

16. Verify data for the patient and eye to be treated, e.g. by talking to the patient.

17. Swivel the patient supporting system into the observation position.

WARNING - RISK FROM INCOHERENT RADIATION

The light dosage from the illumination system is a product of light intensity and exposure time. In order to minimize radiation exposure, limit one of these parameters to the medically required level for observing the patient’s eye.

The optical radiation safety of VisuMax has been demonstrated for a single device without operation of other devices for a maximum observation time of 900 seconds.

18. Drape the operating area with a sterile self-adhesive surgical sheet and

fold it back so that the eyelashes and edge of the eyelid are completely covered.


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19. Use the lid speculum. A lid speculum with suction is recommended.

20. Open the lid speculum to comfortably accommodate the contact glass and as wide as the patient can just tolerate. Fine align the patient supporting system so that the iris is in the center of the palpebral fissure.

21. Mark the cornea asymmetrically with a suitable dye, e.g. gentian violet.

22. Remove any excess of liquid on the cornea and the surrounding area where the suction of the treatment pack will be applied. The surface should be moist but not wet.

23. Start the treatment routine in the software by selecting patient/eye mode on the right hand touch screen monitor and follow the steps of the treatment wizard.

CAUTION - GENERAL HAZARDS

Use only treatment packs expressly approved by Carl Zeiss Meditec. If treatment packs not expressly approved by Carl Zeiss Meditec are used, there is a risk of treatment errors.

CAUTION - RISK OF INFECTION

Examine the wrappings of the treatment pack to ensure there is no damage before removing the treatment pack. Do not use a treatment pack if you are not certain that it is sterile. In the subsequent procedure take steps to ensure that the treatment pack remains sterile! Treatment packs are disposable articles. The re-sterilization of treatment packs is not permitted. Considerable risk of injury to the patient exists in re-sterilization.

24. Remove the sterile treatment pack from its wrappings.

CAUTION - RISK OF SUCTION LOSS

Do not use a contacting agent, as the desired result will otherwise not be achieved.


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25. Connect the filter of the treatment pack to the control panel. Place the sterile contact glass on the laser aperture. The contact glass will now be under suction pressure.

CAUTION - RISK OF INFECTION

Ensure sterility, especially of the contact glass!


Ensure that the filter is correctly attached.

WARNING - RISK OF BODY INJURY

Upon connection of the treatment pack you will be asked via the graphical user interface to perform an excursion test. When testing the excursion by lifting the treatment objective, the latter must travel smoothly. If you feel that the treatment objective does not move freely, shut down the VisuMax and contact the Carl Zeiss Meditec customer service.

As soon as the treatment objective is moved, the system test will be started, a status bar on the display shows the progress and end of the test.

26. Re-check the preparations of the eye for surgery.

27. Click Start to move the patient supporting system into treatment position. The controls move the patient supporting system directly into the treatment position. You can stop the movement with the joystick any time. The automatic motion will stop as the eye approaches the contact glass on the treatment objective.

28. Ask patient to fixate upon the green fixation light and use the surgical microscope to inspect patient’s eye.


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WARNING - RISK FROM INCOHERENT RADIATION

The light dosage from the illumination system is a product of light intensity and exposure time. In order to minimize radiation exposure, limit one of these parameters to the medically required level for observing the patient’s eye.

The optical radiation safety of VisuMax has been demonstrated in isolation for a maximum observation time of 900 seconds.

29. Position the patient’s eye by moving the patient supporting system so

that the visual axis is exactly in the center of the contact glass and the eye meets the contact glass. When the eye is approaching the contact glass the reflex of the ring-shaped treatment illumination should be in the center of the observation area. Use the joystick to maneuver the patient supporting system. Observe all patient supporting system movements and repeatedly check the positions of the eye and contact glass in the microscope or on the left-hand side monitor. Use the concentric circles of the ocular reticule in the surgical microscope for centering the pupil. On the left-hand side monitor the reflection of the flashing green fixation light indicates the center of treatment. In the last step check the pupil center shift using infrared lighting for mesopic light conditions.

Turn the patient's head slightly so that the treatment pack does not come into contact with the nose.

A symmetrical form of the tear meniscus in the docking process is an indication for good centering.

30. Switch on the vacuum suction and allow the eye to be sucked onto the

contact glass.


Ensure that no liquid is allowed to enter the vacuum system. Risk of suction loss without termination of treatment.


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Suction on the conjunctiva due to incorrect size of the treatment pack may result in premature suction loss. If you notice that the eye is not properly centered, correct the position according to Step 29. Continuously optimize the eye position along the X and Y axes as the eye is brought closer to the contact glass.

CAUTION - RISK OF CENTERING LOSS

Take special care to ensure exact alignment of the patient’s eye. Manual alignment errors cannot be corrected by the VisuMax. They may have a negative impact on the treatment results. Encourage the patient to cooperate in achieving optimum results.

With sufficient suction on the eye at least four segments of the blue LED scale on the vacuum display of the control panel will light up and an acoustic signal will be heard.

CAUTION - RISK OF LASER RADIATION

The system is now in the Ready mode. When the foot switch is pressed, the laser beam is delivered.

If the device is in Ready mode, a live video image of the operation zone will be displayed on the monitor. The video recording of the treatment is saved automatically.


Total surgery time (centering, suction time) should be kept as short as possible, as there is otherwise a risk of suction loss. Ensure that conditions which may distract the patient (background noise, other activity in the surgery) are kept to a minimum while the eye is under suction.

31. Final check: Check again for proper centering and suction.


Carefully check centering and suction and do not begin laser treatment until all parameters are correct.

When the eye has been suctioned it is very important to start surgery immediately. The patient should be instructed not to talk or move.


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Laser treatment of patient eye

CAUTION - RISK OF TREATMENT ERROR

Observe the entire surgical procedure through the surgical microscope. The process must be stopped immediately if the size and position of the incision deviate from the intended treatment. This may otherwise result in treatment errors. Do not perform surgery if the incisions are incorrectly positioned! Consult the medical literature for information on possible follow-up surgery.


The formation of bubbles at the periphery of the suction zone is an indication of imminent suction loss. Encourage the patient to remain as calm as possible. There can be a relative shift of the pupil center during the operation and this does not necessarily entail a shift of the cornea.

32. Press the foot switch to start the treatment.

• Keep the switch depressed until the treatment has been completed. The laser treatment runs automatically.

• The operation will be interrupted if the foot switch is released. • Press the foot switch once again to resume the treatment.

The parameters cannot be changed during treatment.

If surgery is interrupted, a message will appear on the display. • Observe the entire surgical procedure through the surgical

microscope. • If either the extent or position of the incision deviate from

the intended treatment, stop the procedure immediately by releasing the foot switch.

• The operation is aborted by releasing the vacuum suction (press "SUCTION ON/OFF" button on the control panel).

If the treatment is interrupted by suction loss, the Restart treatment dialog will appear, offering suggestions for continuing the procedure.

At the end of the operation a message will appear in the information box of the Treatment dialog. In the event of abortion, safety queries and messages will appear.


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Upon completion of treatment, the suction will be switched off automatically and the patient's eye will be released from the contact glass.

33. Move the patient supporting system into the observation position to

inspect the laser treatment result.

34. After inspection of a complete cap and lenticule cut, the cap and lenticule can be separated and the lenticule can be extracted under the VisuMax surgical microscope using suitable surgical instruments.

First of all prepare the cap incision and then the lenticule incision, otherwise an overextension of the cap, striae or even penetration of the cap may result. We refer to the recommendations of clinical experts concerning the suitable surgical instruments and procedure. See, for example, Rupal Shah et al. 2010, NJOT or page 30.

During preparation it is important not to pull on or distort the lenticule.

35. In order to allow the patient to stand up move the patient supporting

system into its exit position.

The patient should stand up slowly and carefully, and leave the place of treatment (equipment platform) with the help of an assistant.

36. Clear up the operating area:

• Remove and dispose of the treatment pack. • Remove the surgical instruments.

37. Shut down the surgical management software:

• Click on Finish. • The main software dialog will open again. • It is now ready for the next operation.

Please consult the relevant literature, professional associations and the legislation applicable to your country.


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Follow-up examination/treatment

The patient should be examined after treatment on the day of the operation. In particular, an assessment of the cornea with the slit lamp is recommended.

A further examination should be made the following day and ideally at a subsequent post-operative appointment. This should include a measurement of the refractive and visual result. In addition, it is recommended that the interface be inspected at each examination with the slit lamp.

The administration of substitute tear fluid is recommended in the early post-operative phase. Depending on the indication, it may be necessary to administer

• anti-inflammatory glucocorticoids (e.g. medication containing dexamethasone such as DEXA EDO or DEXA SINE);

• antibiotics (e.g. FLOXAL EDO).

The attending physician is responsible for the selection of a suitable medication and its dosage.


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Restart of treatment for SMILE

WARNING - RISK OF LOSS OF VISUAL ACUITY

When resuming the laser treatment strict care must be taken to ensure that the centering of the initial treatment is reproduced as accurately as possible.

Lack of caution in manual post-treatment of the cut surface may cause fragments of cornea to be separated due to inexact alignment of incisions.

Should the treatment be interrupted during laser incision generation we recommend using the functions automatically offered by the device for continuing or resuming laser therapy.

The procedures automatically recommended by the device are based on progress information acquired from electronic process monitoring. This process monitoring does not substitute for monitoring by the physician and the automatic recommendation does not substitute for the physician's decision on the time and method of continuing treatment. This must ensue on the basis of one's own observation of the respective treatment, the RSTP and current information from medical literature by the physician in attendance.

The treatment should be resumed immediately after abortion of the previous treatment phase.

The following procedure is recommended:

Case 1: Interruption of the lenticule cut in the first 10 %

If laser treatment must be interrupted during the first 10 % of lenticule cut (underside of lenticule): repeat the entire procedure.

Case 2: Interruption of the lenticule cut between 10 % and 100 %

If laser treatment must be interrupted between 10 % and 100 % of lenticule cut (underside of the lenticule), we recommend aborting the SMILE procedure. After an appropriate waiting time, a refractive correction can be performed with an excimer laser instead.

In the event of continued treatment by LASIK, care must be taken that the flap cut does not penetrate into the lenticule cut already made. In the preparation of the excimer ablation, the flap cut may still be performed. If a LASIK treatment is to be performed at a later date, the Restart mode must be reactivated in order to carry out the flap cut for this patient.


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Case 3: Interruption of a lenticule side cut

If the laser treatment is interrupted during the creation of a lenticule side cut: repeat of the procedure from the start of the lenticule side cut.

It is at the discretion of the physician to increase the depth of the side cut or reduce the lenticule diameter. The increased depth of the lenticule side cut is to ensure that the underside of the lenticule is reached everywhere in the case of a change in incision depth. The reduced lenticule diameter is to ensure that the underside of the lenticule is reached by the side cut over its entire length even in the event of decentering.

Case 4: Cap cut interruption

If the laser treatment is interrupted during the creation of a cap cut (upper side of lenticule): repeat of the procedure from the start of the cap cut.

It is at the discretion of the physician to adjust the cap diameter to meet clinical requirements. At all events, the same cap thickness must be adopted as in the initial treatment. Alternatively, the procedure can be repeated from the start of the lenticule side cut with the setting options named under Case 3: Interruption of a lenticule side cut.

Case 5: Cap opening cut interruption

If the laser treatment is interrupted during the creation of a cap opening cut: if manual opening of the existing tissue bridge does not appear feasible in the display of the treatment stage at the time of interruption, a repeat of the procedure from the cap opening cut is suggested.

It should be noted that a substantial part of the side cut is located in the epithelium. Manual transection of the remaining tissue bridge is often easily achieved.

It is at the discretion of the physician to increase the depth of the side cut or reduce the cap diameter.

The purpose of increasing the depth of the cap opening cut is to achieve the cap cut over the entire width even if the incision varies in depth and penetrate the cut surfaces.

The cap diameter can be adjusted according to clinical requirements.

If needed, the complete treatment can be repeated using the same depth from the start of the cap cut as for the initial treatment.


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Expert mode

The Expert mode is an optional function which can be enabled by the application specialist in the course of applicative training, depending on the range of applications of the VisuMax and the training level reached.

In the Expert mode dialog the laser treatment parameters can be varied. The modified parameters will be immediately applicable to the next treatment.

For the SMILE option suitable parameters are set by the application specialist. Changes in the parameters for the SMILE option should only be made in consultation with the attending application specialist.


The parameters may have an impact on the clinical results (e.g. post-operative visual acuity).

Optional accessories

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Optional accessories

WARNING - GENERAL HAZARDS

Only accessories, including software, conforming to the requirements stated in this user manual may be used.

• Treatment Pack size S

• Treatment Pack size M

• Treatment Pack size L

For further information on treatment packs, particularly the choice of the right size, please refer to Section Selection of treatment pack size, page 14.

A complete up-to-date list of accessories can be obtained from your dealer.

Technical data

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Technical data

Limit values of adjustment ranges

Cap thickness 100 μm to 160 μm

Cap diameter 6.0 mm to 9.6 mm

Opening cut position 0° to 359°

Opening cut width min. 2 mm

Cap, side cut angle 45° to 135°

Sphere -0.5 D to -10.0 D

Cylinder 0 D to 5.00 D

Axis 0° to 179°

Lenticule diameter 5.0 mm to 8.0 mm

Lenticule, minimum thickness 10 μm to 30 μm (minimum edge thickness for myopia correction)

Lenticule, side cut angle 90° to 179°

The effective maximum cap diameter is given in the table below. It depends on the following:

• Size of treatment pack

• Cap thickness

• Corneal curvature radius

• Side cut angle

The cap diameter with VisuMax is always given as the diameter of the cap bed in the naturally relaxed eye. Therefore, the side cut angle may reduce the available maximum cap bed diameter slightly. Please observe the diagram of cutting geometry on the right side of the screen for treatment planning.

Technical data

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Size of treatment pack: L

Cap thickness (μm) Maximum cap bed diameter (mm) 80 100 120 140

6.5 9.2 9.2 9.2 9.2 6.8 9.3 9.3 9.3 9.2 7.1 9.4 9.4 9.3 9.3 7.4 9.4 9.4 9.4 9.4 7.7 9.5 9.5 9.5 9.5 7.9 9.5 9.5 9.5 9.5 8.2 9.6 9.6 9.6 9.6

Cor

neal

cur

vatu

re r

adiu

s (m

m)

8.5 9.7 9.6 9.6 9.6 Size of treatment pack: M


6.5 8.6 8.6 8.6 8.6 6.8 8.7 8.7 8.7 8.6 7.1 8.7 8.7 8.7 8.7 7.4 8.8 8.8 8.8 8.8 7.7 8.9 8.8 8.8 8.8 7.9 8.9 8.9 8.9 8.8 8.2 8.9 8.9 8.9 8.9

Cor

neal

cur

vatu

re r

adiu

s (m

m)

8.5 9.0 9.0 8.9 8.9 Size of treatment pack: S


6.5 7.8 7.8 7.8 7.8 6.8 7.9 7.9 7.9 7.8 7.1 7.9 7.9 7.9 7.9 7.4 8.0 8.0 7.9 7.9 7.7 8.0 8.0 8.0 8.0 7.9 8.0 8.0 8.0 8.0 8.2 8.1 8.0 8.0 8.0

Cor

neal

cur

vatu

re r

adiu

s (m

m)

8.5 8.1 8.1 8.1 8.0 We reserve the right to make changes to the product in light of technical developments.

Technical data

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Surgical instruments

The following instruments are in principle suitable for the preparation of caps and lenticules.

Designation Supplier (for example)

Task

Intralase flap lifter according to Seibel

Rhein Medical Loosening tissue bridges at the periphery

Fragment tweezers according to Kelman-McPherson

Geuder Removing the lenticule

Iris spatula Geuder

Roller Geuder

LASIK flap lifter according to Pfäffel

Geuder Loosening tissue bridges at the periphery; finding the lenticule level; lifting the cap level

Phaco spatula Geuder Loosening tissue bridges at the periphery; finding the lenticule level; lifting the cap level

Spoon or round knife with cutting edge upwards according to Blum

Geuder Tissue separation

Abbreviations/Glossary

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Abbreviations/Glossary

Fig. Figure

LASIK Laser in situ keratomileusis

μm Micrometer

mm Millimeter

RSTP Recommended standard treatment procedures

SMILE Minimally invasive method of femtosecond lenticule extraction

Figures

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Figures

Fig. 1 Incision geometry of SMILE procedure for femtosecond lenticule extraction ................................................................................... 11

Fig. 2 Principle of femtosecond lenticule extraction for SMILE procedure ........................................................................ 11

Index

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Index

A

Abbreviations ............................................................................................31 Accessories, optional .................................................................................27 Adjustment ranges ....................................................................................28

C

Contraindications ........................................................................................5

E

Expert mode..............................................................................................26

F

Figures ......................................................................................................32

G

Glossary ....................................................................................................31

I

Indication for use ........................................................................................5

O

Operation of the instrument ......................................................................10

P

Package check list........................................................................................4

R

Restart ......................................................................................................24

S

Side effects..................................................................................................7 SMILE, method..........................................................................................10 Surgical instruments ..................................................................................30 Symbols.......................................................................................................3

T

Technical data ...........................................................................................28 Treatment license ......................................................................................10 Treatment pack ...................................................................................14, 27

U

User profile..................................................................................................9

Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany

Phone: +49 3641 220 444 Fax: +49 3641 220 442 Email: [email protected] Internet: www.meditec.zeiss.com

000000-1345-518-GA-SM-GB-310511 VisuMax, SMILE option

Specifications subject to change

Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany

Phone: +49 3641 220 444 Fax: +49 3641 220 442 Email: [email protected] Internet: www.meditec.zeiss.com

000000-1345-518-DokS-SM-GB-310511 VisuMax, SMILE option

Specifications subject to change

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