Model CB, CBm and CBSU Instruction Manual Rev F Feb 2017

This user manual describes every information related to the use and maintenance of CB-CBSU microkeratome (associated with a suction ring on a patient’s eye), its heads (reusable and single-use) and accessories. The latest version of user guides and additional information are available on Moria’s restricted-access website: http://www.moria-surgical.com. You must register to access it.

1 DISCLAIMER 1.1 MAINTENANCE The CB-CBm-CBSU system has been designed for optimal operation, provided that the recommendations listed in this user manual are followed carefully. If, for any reasons, the system does not perform properly, have it checked immediately by MORIA. In order to maintain the original performance of your microkeratome, MORIA strongly recommends annual maintenance and servicing of all its reusable products. As only MORIA and its agents are fully expert in MORIA products, servicing and maintenance must be carried out by MORIA or its approved agents. MORIA shall not be held liable for any malfunction or damage to the apparatus, poor results, or surgical complications due to maintenance being having been carried out by an unqualified operator or third party. Any such unauthorized intervention shall render the guarantee and any maintenance contract null and void. 1.2 USE OF GENERIC PRODUCTS AND REUSE OF SINGLE-USE CONSUMABLES The materials used in the microkeratome blade, blade holder, and head have been selected for their biocompatibility and sliding characteristics. The dimensions and tolerances of the blade have been determined in consideration of the dimensions and tolerances of the head of the keratome. MORIA’s manufacturing and inspection procedures guarantee there is no conflict in dimensions between head and blade, and that the blade will slide smoothly in the head. Single-use devices should not be re-used. Doing so will negatively affect their clinical performance and increase the potential for adverse events. The reuse of single-use products, or the use of consumables other than those supplied by MORIA, may entail serious surgical consequences for the patient and damage the microkeratome. MORIA shall not be held liable in the event of a malfunction or damage to the microkeratome, poor results or surgical complications due to the reuse of a single-use product, or the use of consumables other than those supplied by MORIA. MORIA handpieces must only be connected to MORIA devices (console unit, heads, suction rings, etc.). All warranties become null and void if the microkeratome degrades or malfunctions due to such practices.

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2 EQUIPMENT LIST Equipment described in this user guide

MORIA reference

Microkeratome CB manual suction rings (size H, -1, 0, +1, +2)

19309/H 19309/-1 19309/0 19309/1 19309/2

Microkeratome CB head

19307/xxx

Microkeratome CBm head

19332/110 19332/130

Box of 10 sterile CBm blades

19333

Box of 10 sterile heads CBSU (for LASIK surgery)

19312/110 19312/130

Devices associated with the equipment described in this user guide

MORIA reference

Pneumatic turbine hose

19353

Pneumatic turbine for CB microkeratome

19303

EVOLUTION 2 console

19350

EVOLUTION 3 console

19360

EVOLUTION 3E console (serial number 5000 and above)

19380

EVOLUTION 2 footswitch

19351

EVOLUTION 3 footswitch (also for EVOLUTION 3E serial number 7000 and above)

19361

EVOLUTION 3E footswitch

19381

EVOLUTION 3E (IPX8) footswitch

19381J

EVOLUTION 3E footswitch (for China)

19381C

Accessories

MORIA reference

Sterilization box for the turbine, turbine hose and metallic rings

22519139

Tonometer

19042

Aspiration tubing

19138

User information

MORIA reference

CB-CBm-CBSU user manual (for Lasik surgery)

65005

EVOLUTION 2 user manual (FR)

65015

EVOLUTION 2 user manual (EN)

65016

EVOLUTION 3 console user manual (FR)

65037

EVOLUTION 3 console user manual (EN)

65038

EVOLUTION 3E console user manual (serial number 5000 and above)

65060/INTL

Annexe “Guidance and manufacturer’s declaration: electromagnetic emissions and immunity”

65073

CB-CBSU nomogram (FR)

65025

CB-CBSU nomogram (EN)

65026

CB-CBSU nomogram (XX=other)(MORIA website)

65026XX

Information sheet for mounting the CB Single Use head (packaged with #19312/xxx)

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3 REGULATORY INFORMATION MORIA S.A. 15, rue Georges Besse - 92160 Antony - France Phone: +33 (0) 146 744 674 Fax: +33 (0) 146 744 670 [email protected] http://www.moria-surgical.com Customer Service Information EUROPE

Contact your local dealer or MORIA 0459 in compliance with European Directive MDD 93/42/EEC

USA

Registered with the Food and Drug Administration Caution USA only: Federal law restricts the use of this device to physicians or licensed practitioners.

Electrical Safety Standard

IEC 60601 - Classe II BF For EU customers only: this symbol indicates that within the European Union, the product must be discarded in a separate collection bin at the end of its useful life. This applies not only to this device, but also all accessories, including the pedal and electrical motors, regardless of whether those accessories are marked with the symbol. Do not dispose as unsorted municipal waste. For users out of European Union: please refer to local environmental regulatory regarding waste of electrical and electronic equipment.

4 LABELING INFORMATION XXXXXX

CATALOGUE REFERENCE QUANTITY

XX

YYYY/MM/DD XXXXXX

USE BY BATCH CODE STERILIZED USING ETHYLENE OXIDE DO NOT REUSE

XXXXXXX YYYY/MM/DD XXXXXX XXXXXX

MANUFACTURER DATE OF MANUFACTURE CAUTION : CONSULT ACCOMPANYING DOCUMENT(S) CONSULT OPERATING INSTRUCTIONS DO NOT USE IF PACKAGE IS DAMAGED STORAGE CONDITIONS: • TEMPERATURE: XX°C – YY°C / XX°F – YY°F • HUMIDITY RATE: XX% – YY% NON-STERILE

NON STERILE

KEEP DRY DISCARD IN A SEPARATE COLLECTION BIN CAUTION for USA only: US federal laws restrict this device to sale by, or on the order of, a physician.

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5 IMPORTANT INFORMATION 5.1 DESCRIPTION The CB microkeratome is a manual, mechanical, pivoting microkeratome. It has three components: • a pneumatic turbine • a manual metallic suction ring • a single use plastic head (CBSU) encasing a pre-inserted blade, or a metallic reusable head (CB, CBm). The CB microkeratome operates with the EVOLUTION 2, 3, and 3E control units. Please refer to the user guides. 5.2 INDICATIONS The CB microkeratome is indicated for the creation of lamellar corneal flaps on patients’ eyes when using CB, CBm, or CBSU heads in combination with a manual suction ring in corneas with preoperative pachymetry of 500 microns or greater, and keratometry between 39 D and 48 D. During laser in-situ keratomileusis (LASIK), the flap is then lifted to enable photoablation of the stroma with an excimer laser. 5.3 HEAD CALIBRATION VALUE AND FLAP THICKNESS Flap thickness is a key factor for LASIK surgery. Multiple parameters affect flap thickness and standard deviation. Numerous scientific studies have demonstrated that flap thickness is influenced by several patientrelated factors such as keratometry (K) readings, corneal anatomy, preoperative pachymetry and refraction, intraocular pressure (IOP), and also by surgery-related factors, such as corneal hydration and the speed of the pass (when using manual microkeratomes). Ultrasonic pachymetry measurements are not always accurate and reproducible, and results may also vary with surgeons’ techniques and calibration of the device. Thus, a head labeled «130» cuts on average a 160-micron flap: • 130 microns is a dimension on the head that can be measured and which corresponds to a distance from the cutting edge of the blade to the front plate of the head • 160 microns is the average flap thickness that will be cut by this head, with variations around this average value. In the example above, the “incremental value” for a 130 head is 30 microns on average.

Head calibration value

Incremental value

Average flap thickness

130

+30

160

MORIA can only guarantee the dimensional characteristics of the head, not the surgical result. The surgeon is strongly advised to carry out tests beforehand to determine the thickness and diameters of the expected cuts based on his/her own technique. 5.4 CONTRAINDICATIONS Patients who are not candidates for LASIK. Note: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to determine the risk/benefit ratio. Particular attention must be given before performing a keratectomy on a patient with any of the following conditions: • preoperative pachymetry under 500 microns • keratometry under 39 D • keratometry over 48 D • inability to withstand a transient rise in intraocular pressure. #65005-F-02.2017

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5.5 WARNINGS • • • • •

Single-use devices should not be re-used. Doing so will negatively affect their clinical performance and increase the potential for adverse events. Do not use disposable materials and/or components of a brand other than MORIA with the CB microkeratome. Blades must only be inserted in heads by hand. Never use any tools or spanners. Incorrect assembly may cause incomplete or uneven cuts due to lack of blade oscillation. The heads must only be screwed on by hand. Never use any tools or other spanners. Incorrect assembly may cause incomplete or uneven cuts due to lack of blade oscillation. CBm blades (#19333) are compatible with CB heads (#19307/xxx) and CBm heads (#19332/xxx). System

Head

CBm blade (#19333)

CB

19307/xxx

Compatible

CBm

19332/xxx

Compatible

CBSU

19312/xxx

Not compatible

5.6 POTENTIAL ADVERSE EVENTS As with any surgical procedure, there is risk involved. LASIK surgery requiring the use of a microkeratome that cuts a corneal flap, potential side effects of laser refractive surgery may include but are not limited to: visual anomalies, dry eye and flap related complications (free cap, incomplete flap, buttonhole, epithelial defect, flap dislocation, flap striae, wrinkles, etc.). Inappropriate use, deterioration of microkeratome and/or non-respect to contraindications (§ 5.4) and warnings (§ 5.5) expose patient at higher risk to adverse events. Note: Additional surgery may be necessary to correct some of these potential adverse events. 5.7 PRECAUTIONS • •

The keratectomy must be performed only by experienced refractive surgeons with specific training in the use of the CB-CBm-CBSU microkeratome. Preoperative and operative procedures, including knowledge of surgical techniques, proper head and ring selection, and assembly and placement of the microkeratome are important considerations in the successful use of the system by the surgeon. Furthermore, the proper patient selection and compliance will greatly affect the results.

For USA only CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Other preoperative, intraoperative, and postoperative warnings and precautions are as fellows: • PREOPERATIVE: o Only patients that meet the criteria described in the indications should be selected. o Care should be used in the handling and storage of the microkeratome components. They should not be scratched or otherwise damaged. The CB turbine should be protected during storage, especially from corrosive environments. o Check the label and expiration date on unopened packages of CBSU heads and CBm blades. o After opening the sterile package of CBSU heads, verify that head information is consistent with information on outer package labeling. o The head, suction ring, CB turbine, and the control unit should be fully inspected prior to use. The blade should be inspected on both sides under a microscope. o The surgeon should be familiar with the various components before using the microkeratome and verify that all parts and necessary instruments are present and properly assembled before the surgery begins. Additional sterile components should be available in case of an unexpected need. o The selection of the proper head, ring, and stop position for each eye is crucial to the success of the procedure: see MORIA nomogram (#65026).

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• INTRAOPERATIVE: o Breakage, slippage, or misuse of the microkeratome and its components may cause injury to the patient or operating personnel. o Before any usage, lubricate the eye, the suction ring, the head, and the blade with a physiological saline solution or another appropriate ophthalmic solution that is compatible with the CB-CBm-CBSU components. • POSTOPERATIVE: o The surgeon’s postoperative instructions to the patient and the corresponding patient compliance are extremely important. 5.8 PRODUCT COMPLAINTS Health care professionals (e.g., customers or users of this device) having any complaints about or dissatisfaction with the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify MORIA or its distributor by telephone, fax or written correspondence, and have the products checked by MORIA. When filing a complaint, please provide the component(s) name(s), reference(s), batch number(s), as well as your name and address, the nature of the complaint, and the relevant patient data. Also disinfect and return the components. 5.9 PACKAGING Packages of each of the components should be intact upon receipt. Damaged packages or products should not be used and should be returned to MORIA. Do not use single-use products if package is open or torn.

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6 INSTALLATION AND CONNECTION Related picture

Steps

What to do

1

Select the head

• CB-CBm: select the appropriate pre-calibrated head. The microkeratome head is labeled on its front side and indicates depth of cut. • CBSU: select the appropriate pre-calibrated head. The microkeratome head is labeled on its front side and indicates depth of cut. Disposable CBSU heads are supplied sterile and for single use only. Check that package is undamaged, unopened and within the expiration date.

A, B, C

2a

CB, CBm: Insert the blade into the blade housing of the head

• Lubricate the CB, CBm head with balanced salt solution or another appropriate ophthalmic solution. • Inspect the blade and particularly the cutting edge before and after insertion. Blades with spots, nicks, debris or other imperfections which could compromise performance should be discarded. • Insert the blade into the blade housing of the head, being careful not to touch the front edge of the blade. • Press gently on the blade and slide it completely into the head. In case the blade does not slide smoothly into the head, check for debris or deposits in the blade housing or on the blade itself. If, after careful checking of the blade housing, it does not slide, replace the blade with a new one. • Guide the blade into the head avoiding contact of the cutting edge with metal part of the head. • The blade design allows for only one direction for insertion and prevents incorrect assembly. • Before mounting the CB or CBm heads onto the turbine motor, make sure that the blade holder slot is centered within the head (centered within the female collar).

D, E

2b

CBSU: lubricate the head.

• CBSU heads are supplied sterile with pre-inserted blade to avoid blade manipulation. • Inspect the blade and particularly the cutting edge before and after insertion. Blades with spots, nicks, debris or other imperfections which could compromise performance should be discarded. • Place the protective case on a flat surface and lift the top of package with caution. • Fill the cavity of the plastic package with balanced salt solution or another appropriate ophthalmic solution to fully wet the head.

3

Assemble the head into the turbine

• CB-CBm: The turbine motor screws onto the reusable microkeratome head. Hold the microkeratome head firmly and screw the threaded nose of the turbine motor clockwise. Finger tighten only • CBSU: Keep the head in the package while screwing it onto the turbine motor (finger tight only). • Check that the head is securely screwed and tightened to the CB turbine motor; no rotation of the head should occur. • If the head is not completely screwed on, the pneumatic turbine shaft will not drive the blade holder and the blade will not move. Poor or irregular resection can result from incorrect assembly.

4

Inspect the head after assembly

• The head must be perfectly clean inside and outside and free from debris, particles, oxidation and deposits. There should be no scratches on the plates. If any, replace the head. • After assembly and using a microscope, carefully inspect the blade under high magnification to ensure that it is not damaged. If so: discard it (CBm blade, CBSU head) in an appropriate container and replace it.

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F, G

5

Assemble pneumatic turbine hose to CB turbine and console unit

• Check that the gaskets on the turbine connector and on the control unit connector are present and not damaged. • Check the turbine hose for cracks and possible damage. Replace if necessary. • Connect the pneumatic turbine hose to the back of the turbine. • Screw the metal collar of the turbine hose onto the back of the turbine motor. The connector shape allows only one possibility of connection and prevents from wrong assembly. Finger tighten only. • Place the turbine connector hose onto the control unit front panel connector. • The connector shape allows only one possibility of connection and prevents from wrong assembly.

H

6

Check for blade oscillation

• Refer to EVOLUTION 2, 3 or 3E user manual for operations prior use. • Activate CB turbine to check for smooth, strong and uninterrupted blade oscillation. • Do not use the CB turbine if the blade oscillation is not smooth, regular and uninterrupted.

7

Select suction ring according to nomogram, then inspect it

• Refer to the indicative nomogram for the selection of the ring size. • The suction ring must be carefully inspected prior to use; it must be perfectly clean, free from debris, particles and deposits. • Carefully check that the suction port is not obstructed. • The hinge will be placed facing the arrow on the suction ring.

I

8

Connect the suction ring to the aspiration tubing

• The aspiration tubing is supplied sterile and for single use only. • Check that package is undamaged, unopened and within the expiration date. • Inspect the aspiration tubing and in case of kinks or obstructions, replace it.

J

7 OPERATION Related picture

Steps

What to do

1

Preliminary check before any usage

• It is imperative to verify that the devices are perfectly clean and free of any organic or other residues.

2

Connect the CB turbine to the control unit. Check the pressure delivered by the console at the turbine (operating range between 2.5 and 3.5 bars).

• See EVOLUTION 2, 3 or 3E user manual for operations prior use.

H

3

Assemble the head in the suction ring

• The CB-CBm-CBSU head pivot opening should fit easily over the pivot post of the CB suction ring. • Align suction ring pivot post and CB head pivot hole. Carefully place the assembled CB keratome and CB turbine motor onto the suction ring. • Avoid inadvertent contact with suction ring pivot post and CB head blade area. If contact occurs, blade edge may become damaged, and a new blade should be used.

K

4

Check for blade oscillation

• Refer to EVOLUTION 2, 3 or 3E user manual for operations prior use. • Activate CB turbine to check for smooth, strong and uninterrupted blade oscillation. • Do not use the CB turbine if the blade oscillation is not smooth, regular and uninterrupted.

5

Position the suction ring on the eye. Activate vacuum by pressing the “Vacuum” footswitch once.

• Verify that the device will not interfere with any other medical devices used during the procedure.

IMPORTANT WARNINGS

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6

Check the intraocular pressure with the tonometer

• The tonometer must be perfectly dry and used only on dry eyes. • If the pressure is below 65 mm Hg, do not proceed with the surgery.

7

Lubricate the suction ring, the head and the blade

• Prior to use, lubricate the rails of suction ring, head, and blade with balanced salt solution or another appropriate ophthalmic solution. • The device should not be placed in contact with solutions for which the potential interactions are unknown.

8

Once the system is in position, activate blade oscillation by pressing the “Forward” footswitch. Manually rotate the CB microkeratome within the suction ring until the stop of the suction ring is engaged. Stop the turbine motor and manually reverse the CB microkeratome.

• See EVOLUTION 2, 3 or 3E console user manual. • Hold the suction ring by its handle; check that your fingers do not hinder the forward movement of the device. • Check nothing prevents or modifies head movement in the rails of the suction ring • Ensure that there are no obstructions (speculum, eyelashes, eyelids, etc.) in its path.

9

Release the “Vacuum” footswitch by pressing once. Remove the suction ring.

• Discard the disposable blade (CBm) or disposable head (CBSU) and aspiration tubing after each procedure in an appropriate container.

8 TROUBLESHOOTING For any further information and description, please refer to EVOLUTION 2, 3 or 3E console user manual.

9 CARE & MAINTENANCE The recommendations for cleaning, disinfection and sterilization are updated and available on MORIA’s restricted-access website: http://www.moria-surgical.com. You must register to access it. 9.1 INTRODUCTION In case of unusual vibrations or noises, do not use the unit and contact your distributor. Please contact MORIA for any other servicing. The following are only recommendations. They must be adapted according to the laws in the country of utilization. All the products and solutions for cleaning and disinfection must be used according to the manufacturer’s instructions. MORIA recommends • do not touch potentially contaminated areas, • use gloves during cleaning and decontamination operations. 9.2 INITIAL TREATMENT AND STORAGE To avoid risks of condensation inside the packaging, unpack and store the devices in a clean, dry environment. Do not store the instruments in an environment or next to other products that may possibly have a corrosive or magnetic effect. Avoid any contact between devices, especially those comprised of different materials. The device should be damage free and have no scratches or other surface defects. Fragile devices or those requiring particular manipulation must be handled separately, taking special care to protect delicate parts.

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9.3 CLEANING-DISINFECTION-STERILIZATION-STORAGE OF THE TURBINE The pneumatic turbine must be disconnected from its hose. It must be cleaned, disinfected, dried and sterilized after each surgical procedure. ACTIONS

IMPORTANT WARNINGS

1. Manual external cleaning • After use, clean the outside of the turbine with a lint-free cloth dampened with a cleaning solution (eg: Alkazyme® / Laboratoires Alkapharm) to remove any residue.

• Do not use abrasives or scrapers to clean items. It could damage their usability. • Do not immerse the turbine in any solution whatsoever, including water. • Cleaning is not disinfecting! Disinfection is a separate step described in point 2.

2. Manual external disinfection • After cleaning, dry every part of the turbine with a lintfree cloth dampened with a disinfecting solution.

• Use appropriate disinfection solutions in accordance with the manufacturer’s instructions. • Do not immerse the turbine in any solution whatsoever, including water.

3. Lubrication then cleaning before sterilization • Lubricate the handpiece using a KaVo spray only and the appropriate nozzle before every autoclave sterilization cycle. A single jet of KaVo spray is sufficient to lubricate the turbine while avoiding excess lubricant inside the turbine. • Clean the turbine with a lint-free cloth then keep it upside down for 20 minutes before the autoclave sterilization to expel excess lubricant.

• Use the recommended spray. Do not use other lubricant sprays, vaseline or grease. • Shake the spray before using. • Place the spray nozzle on the smallest hole of the turbine and press once only. • KaVo spray (ref 411-9630) is not sold by MORIA. It can be purchased from the Kavo website (www.kavo.com).

4. Sterilization • Place the turbine and its hose in the dedicated sterilization box. • Sterilize the turbine in the autoclave (134°C – 273°F) for 18 minutes.

• Remove the turbine from the sterilizer immediately after the sterilization procedure. • Never use the turbine immediately after sterilization. Let it cool down to room temperature first.

Sterilization in USA only: sterilize with an autoclave (steam sterilizer with a vacuum phase) at a minimum of 132°C for at least 4 minutes. 5. Storage • Once this sterilization cycle is completed, remove the handpiece as promptly as possible and store it upright until it cools down and is dry. • Once cooled down and dry, the handpiece can be stored in an enclosed dry place.

• To avoid oxidation, make sure that the turbine is perfectly dry before putting it in the storage box. • While it is not being used, the CB turbine must be kept in its storage box in a dry atmosphere (Photo L). • Before use, check that the handpiece has no lubricant on it. If it has, do not use it. Do not lubricate before use.

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9.4 CLEANING-DISINFECTION-STERILIZATION-STORAGE OF THE FLEXIBLE HOSE The flexible hose must be disconnected from the pneumatic turbine and from the generator, cleaned, decontaminated, sterilized, and dried after each intervention. Steps

What to do

1

Cleaning

➢ Do not immerse. ➢ The flexible hose can be cleaned on the outside with a lint-free cloth soaked with alcohol.

2

Disinfecting

➢ Do not immerse. ➢ The flexible hose can be decontaminated on the outside with a decontaminating solution.

3

Rinse and dry

➢ The flexible hose must be rinsed on the outside with a lint-free disposable cleaner soaked in sterile water. ➢ It must be then dried with a disposable lint-free cleaner.

4

Sterilization

➢ The flexible hose can be sterilized in the autoclave 134°C for 18 minutes. ➢ Sterilization in USA only: sterilize with an autoclave (steam sterilizer with a vacuum phase) at a minimum of 132°C for at least 4 minutes. ➢ It must be removed from the autoclave immediately after sterilization. ➢ Never use the flexible hose immediately after sterilization; let it cool at room temperature.

5

Storage

➢ The flexible hose must be kept in a dry place, away from dust. ➢ In order to avoid that the hose get damaged, it is important to store it carefully in its box (Figure L).

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IMPORTANT WARNINGS

9.5 CLEANING-DISINFECTION-STERILIZATION-STORAGE OF THE SUCTION RINGS Steps

What to do

1

Double cleaning • On leaving the operating theatre, immediately immerse the devices in an aldehyde-free detergent/disinfectant solution (e.g.: Alkazyme® / Alkapharm Laboratories) for at least 15 minutes according to manufacturer recommendations. • Manual cleaning (or use a machine, provided that it does not recycle the cleaning products, after disassembling the device where appropriate). • Rinse the circuit with water. • Immerse the device in an aldehyde-free detergent/disinfectant solution (a different bath from the one above). • Manual cleaning (or use a machine, provided that it does not recycle the cleaning products). • Rinse using filtered distilled or osmosis-treated water. • Wipe the device using a non-woven, lint-free, disposable cloth.

• Manual cleaning: mechanical cleaning of the medical device using soft brushes (metal brushes and scouring pads are prohibited). • IMPORTANT: Change the baths after each use. • Incompatibility: o Do not use bleach o Do not apply this protocol to products made of aluminium alloy. o Do not apply this protocol to heat-sensitive (motor and turbine).

2

Deactivation of NCTAs (Non-Conventional Transmitted Agents)

• Deactivation of NCTAs: for patients with a risk of Creutzfeldt-Jakob disease only • For France, see instruction no. DGS/ RI3/2011/449 of 1st December 2011.

3

Sterilisation Sterilise the sterilisation tray using an autoclave (moist heat steriliser) at a temperature of at least 134°C for 18 minutes. Sterilization in USA only : sterilize with an autoclave (steam sterilizer with a vacuum phase) at a minimum of 132°C for at least 4 minutes.

IMPORTANT WARNINGS

Bibliography: • December 2011 – Instruction no. DGS/RI3/2011/449 of 1st December 2011 updating recommendations aimed at reducing the risk of transmitting non-conventional transmissible agents during invasive procedures. • November 2005 - Guide from the Ministry on the treatment of medical devices for ophthalmology and contactology - http://www.sante.gouv.fr.

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10 WARRANTY 10.1 SCOPE OF WARRANTY Designation

MORIA references

Microkeratome CB manual suction rings (taille H, -1, 0, +1, +2)

19309/H 19309/-1 19309/0 19309/1 19309/2

Microkeratome CB head

19307/xxx

Microkeratome CBm head

19332/110 19332/130

Pneumatic turbine hose

19353

Pneumatic turbine for CB microkeratome

19303

Sterilization box for the turbine, turbine hose and metallic rings

22519139

EVOLUTION 2 console (except the battery)

19350

EVOLUTION 3 console (except the battery)

19360

EVOLUTION 3E console (serial number 5000 and above) (except the battery)

19380

EVOLUTION 2 footswitch

19351

EVOLUTION 3 footswitch (also for EVOLUTION 3E serial number 7000 and above)

19361

EVOLUTION 3E footswitch

19381

EVOLUTION 3E (IPX8) footswitch

19381J

EVOLUTION 3E footswitch (for China)

19381C

• • • • •

The above items as well as spare parts and labor necessary for their repair are covered by warranty. Any items returned must be sent it their original packaging, after having previously been disinfected. The maintenance operations and the replacement of spare parts will be exclusively carried out by technicians authorized by MORIA. Any defective part exchanged during the period of warranty becomes property of MORIA. Instruments and accessories that cannot be reused are excluded from this warranty. Future upgrades and/or improvements on the keratome are not implied by this warranty.

10.2 NON-APPLICATION OF WARRANTY The warranty will not be applicable under any of the following conditions: • Defects or malfunction that occur out of the warranty period (10.3). • Normal wear and tear. • Negligence or usage that does not comply with the specifications in the user manual. • The use of supplies, spare parts, or accessories other than those supplied by MORIA. • Any disassembly, modification or intervention carried out on the devices by a person not authorized by MORIA. 10.3 WARRANTY PERIOD • •

The warranty takes effect on the date the material is dispatched. The duration of the warranty is 12 months from the date of effect.

10.4 LIABILITY • •

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The liability of MORIA is limited to the supply of the services mentioned in paragraph 10.1. MORIA will not be held responsible of any direct or indirect damage suffered by the client owing to the interventions within the scope of this warranty. For any dispute concerning the interpretation or the execution of the present contract or the present general terms and conditions, the Commercial Court of Nanterre (France) will have sole jurisdiction. MORIA

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11 DRAWINGS A. CB HEAD 1 2 3 4

Head calibration value Female threaded collar Blade housing Sliding guide

B. CBm HEAD 1 2 3 4

Head calibration value Female threaded collar Blade housing Sliding guide

C. CBSU HEAD 1 2

Head calibration value Blade

D. CBm BLADE 1 2

J. CONNECTING THE SUCTION RING TO THE ASPIRATION TUBING 1 2

Aspiration tubing end Suction ring end

K. MOUNTING CB MICROKERATOME ON THE SUCTION RING 1 2

CB turbine with CBm head CB manual suction ring

L. STERILIZATION BOX 1 2 3 4 5

CB turbine Pneumatic turbine hose CB manual suction ring CBm heads Tonometer

Cutting edge Blade holder

E. CBm HEAD WITH INSERTED CBm BLADE 1 2

CBm head CBm blade

F. MOUNTING THE CBm HEAD ON THE CB TURBINE 1 2

CB turbine CBm head

G. MOUNTING THE CBSU ON THE CB TURBINE 1 2 3

CB turbine CBSU head Blister of the CBSU head

H MOUNTING THE PNEUMATIC TURBINE HOSE 1 2 3 4 5

Pneumatic turbine hose – turbine end CB turbine CBm head Control unit front panel Pneumatic turbine hose – console end

I. CB MANUAL SUCTION RING 1 2 3 4 5

Handle Sliding guide Stop pin Smooth pivot (manual ring) Aperture #65005-F-02.2017

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SOMMAIRE

1 1.1 1.2

AVERTISSEMENTS... 18 MAINTENANCE... 18 UTILISATION DE PRODUITS GÉNÉRIQUES OU RÉUTILISATION DE CONSOMMABLES À USAGE UNIQUE... 18

2

LISTE DES ÉQUIPEMENTS ET ACCESSOIRES ASSOCIÉS... 19

3

INFORMATIONS RÉGLEMENTAIRES... 20

4

INFORMATIONS FABRICANT SUR LES ÉTIQUETTES... 20

5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9

INFORMATIONS IMPORTANTES... 21 DESCRIPTION... 21 INDICATIONS... 21 ÉPAISSEUR DES VOLETS CORNÉENS... 21 CONTRE-INDICATIONS... 21 AVERTISSEMENTS... 22 EFFETS INDÉSIRABLES POTENTIELS... 22 PRÉCAUTIONS... 22 RÉCLAMATION PRODUIT... 23 EMBALLAGE... 23

6

INSTALLATION ET CONNEXION... 24

7

OPÉRATION... 25

8

EN CAS DE PROBLÈME... 27

9 9.1 9.2 9.3

MAINTENANCE... 27 INTRODUCTION... 27 TRAITEMENT INITIAL ET STOCKAGE... 27 PROTOCOLE DE NETTOYAGE-DÉSINFECTION-STÉRILISATION-STOCKAGE DE LA TURBINE... 28 PROTOCOLE DE NETTOYAGE-DÉSINFECTION-STÉRILISATION-STOCKAGE DU FLEXIBLE DE LA TURBINE... 29 PROTOCOLE DE NETTOYAGE-DÉSINFECTION-STÉRILISATION-STOCKAGE DES TÊTES MÉTALLIQUES ET ANNEAUX DE SUCCION... 30

9.4 9.5

10 GARANTIE... 31 10.1 CHAMP D’APPLICATION DE LA GARANTIE... 31 10.2 CAS DE NON APPLICATION DE LA GARANTIE... 31 10.3 PÉRIODE DE GARANTIE... 31 10.4 RESPONSABILITÉS... 31 11

FIGURES... 32

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SUMARIO

1 1.1 1.2

DESCARGO DE RESPONSABILIDAD... 34 MANTENIMIENTO... 34 USO DE PRODUCTOS GENÉRICOS O REUTILIZACIÓN DE CONSUMIBLES DE USO ÚNICO... 34

2

LISTA DE EQUIPAMIENTO... 35

3

INFORMACIONES REGLAMENTARIAS... 36

4

INFORMACIÓN DE ETIQUETADO... 36

5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9

INFORMACIÓN IMPORTANTE... 37 DESCRIPCIÓN... 37 INDICACIONES... 37 ESPESOR DEL FLAP... 37 CONTRAINDICACIONES... 37 ADVERTENCIAS... 38 EFECTOS ADVERSOS POTENCIALES... 38 PRECAUCIONES... 38 QUEJAS SOBRE PRODUCTOS... 39 EMBALAJE... 39

6

INSTALACIÓN Y CONEXIÓN... 40

7

FUNCIONAMIENTO... 41

8

SOLUCIÓN DE PROBLEMAS... 42

9 9.1 9.2 9.3 9.4 9.5

CUIDADO Y MANTENIMIENTO... 42 INTRODUCCIÓN... 42 TRATAMIENTO INICIAL Y ALMACENAMIENTO... 43 LIMPIEZA-DESINFECCIÓN-ESTERILIZACIÓN-ALMACENAJE DE LA TURBINA... 43 LIMPIEZA-DESINFECCIÓN-ESTERILIZACIÓN-ALMACENAJE DEL TUBO FLEXIBLE... 44 LIMPIEZA-DESINFECCIÓN-ALMACENAJE DE LOS ANILLOS DE SUCCIÓN... 45

10 GARANTÍA... 46 10.1 CAMPO DE APLICACIÓN DE LA GARANTÍA... 46 10.2 CASO DE NO APLICACIÓN DE LA GARANTÍA... 46 10.3 PERIODO DE GARANTÍA... 46 10.4 RESPONSABILIDADES... 46 11

ILUSTRACIONES... 47

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INDICE

1 1.1 1.2

ESCLUSIONE DI RESPONSABILITA’... 50 MANUTENZIONE... 50 UTILIZZO DI PRODOTTI GENERICI O RIUTILIZZO DI MATERIALI DI CONSUMO MONOUSO... 50

2

ELENCO DELLE PARTI... 51

3

DATI NORMATIVI... 52

4

ETICHETTE INFORMAZIONI... 52

5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9

INFORMAZIONI IMPORTANTI... 53 DESCRIZIONE... 53 INDICAZIONI... 53 SPESSORE DEL LEMBO... 53 CONTROINDICAZIONI... 53 AVVERTENZE... 54 POTENZIALI EVENTI AVVERSI... 54 PRECAUZIONI... 54 RECLAMI (RELATIVI AI PRODOTTI)... 55 CONFEZIONE... 55

6

INSTALLAZIONE E COLLEGAMENTO... 56

7

FUNZIONAMENTO... 57

8

RISOLUZIONE DEI PROBLEMI... 59

9 9.1 9.2 9.3 9.4 9.5

CURA E MANUTENZIONE... 59 INTRODUZIONE... 59 TRATTAMENTO INIZIALE E CONSERVAZIONE... 59 PULIZIA-DISINFEZIONE-STERILIZZAZIONE-STOCCAGGIO DELLA TURBINA... 60 PULIZIA-DISINFEZIONE-STERILIZZAZIONE-STOCCAGGIO DEL TUBO FLESSIBILE... 61 PULIZIA-DISINFEZIONE-STERILIZZAZIONE -STOCCAGGIO DEGLI ANELLI DI SUZIONE... 62

10 GARANZIA... 63 10.1 CAMPO D’APPLICAZIONE DELLA GARANZIA... 63 10.2 CASI IN CUI NON VIENE APPLICATA LA GARANZIA... 63 10.3 PERIODO DI GARANZIA... 63 10.4 RESPONSABILITÀ... 63 11

IMMAGINI... 64

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