• These Instructions for Use are designated only for persons with the required knowledge and training in a healthcare facility.
• Reusable surgical instruments are supplied in a non-sterile state and are not to be used without being cleaned, disinfected and sterilized.
• All reprocessing instructions provided are general guidelines and require validation by the end user at the point of use.
• Cleaning and disinfection processing equipment should be certified and validated.
• Any surgical procedures should be performed by licensed healthcare professionals trained and familiar with surgical techniques.

• Do not soak instruments in solutions containing chlorine or chlorides as these may cause corrosion and damage.
• Do not process microsurgical instruments in an automated washer unless it has a delicate cycle.
• Long narrow cannulations and blind holes require particular attention during cleaning. Automated or manual flushing should be performed thoroughly during cleaning.
• Instruments must be flushed without delay after surgery to remove tissue, blood, balanced salt solution and viscoelastic. Instruments must be properly cleaned prior to sterilization. If not, blood and residual debris may be baked onto the surfaces and instruments may become damaged.
• Do not keep instruments in salt or other aggressive solutions for a long time. This may cause surface deterioration, deformation of fine working parts, damage to instruments and reduced lifetime.
• High alkaline solutions, pH > 10, can cause damage to certain materials. Avoid using peroxide on titanium instruments or anodized surfaces to prevent discoloration.
• If the instrument was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease, CJD, the instrument cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination. Consult WHO and local regulations for further information.
• Do not use this IFU procedure for diamond knives.

• Surgical instruments require close care and gentle handling. Do not throw, drop, or expose instruments to other mechanical impact.
• Manual scrubbing with brushes should always be performed with the instrument below the surface of the cleaning solution to prevent aerosols and splashing. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents. Cleaning agents must be completely rinsed from device surfaces.
• Saline, cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringer’s Solution.
• Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other body fluids. Do not exceed 2 hours soaking in any solution.
• Working parts of instruments must be protected with suitable protective tips during storage. Protective tips must be removed before sterilization.
• Each instrument is intended for a specific purpose. Improper use may damage the instrument or reduce its lifetime.
• Do not use high acid, pH 4.0 or lower, or high alkaline, pH 12 or higher, products for disinfection. Neutral pH detergents are preferred.
• Titanium instruments are color anodized and may lose their color over time through normal use and reprocessing. This has no effect on instrument functionality.

Reprocessing according to the instructions provided has minimal effect on the instrument life and functionality. The useful life for metal surgical instruments is normally determined by wear and damage during intended use.

Point of Use

1. Following use, the instrument should be cleaned of excess soil using a disposable cloth or paper wipe as soon as possible.
2. The instrument should be kept moist to prevent soil from drying on the instrument.

Containment and Transport

1. The instruments should be reprocessed as soon as possible.
2. Always keep instruments in a suitable container to protect personnel from contamination during transport to the decontamination area.

Preparation for Decontamination and Cleaning

Universal precautions should be followed, including the use of suitable personal protective equipment, such as gloves, face shield, apron, etc., according to Universal Precautions, OSHA, and your institution’s policies.

1. Follow the instructions of the washer/disinfector manufacturer using only a delicate cycle.
2. Use only neutral pH cleaning solutions.
3. Instruments that can be disassembled should be cleaned in the disassembled state. Do not lose parts and do not mix with other parts.
4. If gross soiling is evident, manual pre-cleaning with a neutral pH cleaning solution may be necessary. To remove protein deposits, enzymatic cleaners should be used according to the cleaner manufacturer’s instructions. Rinse thoroughly.
5. Ensure that hinged instruments are open and that instruments with lumens can drain effectively. Where the washer has provisions for lumen adaptors, these should be used for lumened instruments.
6. Place instruments in suitable carriers so that they are not subject to excessive movement or contact with other instruments.
7. Process the instrument according to the conditions indicated below. Cleaning times and conditions may vary based on the amount of soiling present on the instrument.

8. Following processing, carefully inspect the instrument for cleanliness, any evidence of damage, and proper operation. If visible soil remains, the instrument should be reprocessed or manually cleaned.

1. Inspect the instrument for damage or corrosion. If necessary, disassemble the instrument as applicable.
2. Pre-rinse the instrument under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water.
3. Place the instrument into a suitable clean basin filled with fresh neutral pH cleaning solution prepared according to the manufacturer’s directions. Use only cleaning solutions labelled for use with medical devices or surgical instruments.
4. Gently scrub all surfaces using a soft cleaning brush while keeping the instrument submerged for at least 5 minutes. Clean until all visible soil has been removed.
5. If visible soil remains, repeat steps 1–4.
6. Rinse under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water.
7. Place the instrument in an ultrasonic bath filled with fresh neutral pH cleaning solution and sonicate for 5 minutes. Do not overload the bath or allow instruments to contact one another. Do not process dissimilar metals, such as stainless steel and titanium, in the same ultrasonic cleaning cycle.
8. The solution should be drained and changed frequently before visible soiling to avoid retaining bioburden on the instruments. The ultrasonic machine should be drained and cleaned after each use, or at least daily, according to the manufacturer’s instructions.
9. Repeat steps 7–8 if visible soil remains.
10. Rinse under warm tap water, 27°C–44°C / 80°F–100°F, for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water.
11. If the instrument has lumens, flush the lumens using a syringe filled with 50cc of warm distilled or deionized water. Repeat this flush 3 times.
12. Immerse the instrument in a clean basin containing fresh deionized or distilled water and soak for at least 3 minutes.
13. Immerse the instrument in a second clean basin containing fresh deionized or distilled water and soak for at least 3 minutes.
14. Perform a final rinse with sterile distilled or deionized water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water.

Manual Disinfection

Due to the potential for residual chemicals to remain on the instrument and cause an adverse reaction, Titan Medical does not recommend the use of enzymatic or liquid chemical disinfectants or sterilant with manually cleaned instruments. See Automated Cleaning and Thermal Disinfection above for thermal disinfection procedures in an automated washer/disinfector.

Drying

Dry the instrument with a lint-free surgical wipe or blow dry with micro-filtered pressurized medical grade air. When using pressurized air, ensure a secure grip on the instrument to avoid damage from air pressure.

Maintenance, Inspection and Testing

Following cleaning, inspect the instrument to ensure that all visible soil has been removed and that the instrument operates as intended. Carefully examine each surgical instrument for breaks, cracks or malfunctions before use. Check areas such as blades, points, ends, stops and all moveable parts. A microscope should be used whenever possible. Lubricate all moving parts, lock boxes, joints and catches with a physiologically safe lubricant.

Packaging

Package the instrument in a suitable sterilization pouch or instrument tray lined with soft silicone mats. Protective tips made of soft silicone of the proper size and thickness are recommended. Instruments should not touch each other.

• Use the sterilizer manufacturer’s instructions for operation and loading of steam sterilizers. There must be direct steam exposure to all surfaces of the instruments being sterilized, including internal surfaces and tube channels.
• Unless otherwise indicated in the Instruction for Use provided with the specific instrument, instruments and instrument trays may be sterilized by moist heat steam sterilization methods: pre-vacuum high temperature autoclave, standard gravity autoclave, and high speed flash autoclave.
• Warning: Flash sterilization processing should be reserved for emergency reprocessing only and should not be used for routine sterilization processing. Flash sterilized items should be used immediately and not stored for later use.
• The tables below represent variations in sterilizer manufacturers’ recommendations for exposure at different temperatures per ANSI/AAMI ST79:2010 and A1:2010 & A2:2011. Other time and steam temperature cycles may also be used. The user must validate any deviation from the recommended time and temperature.
• The instrument and/or instrument tray should be processed through a complete sterilization drying cycle, as residual moisture from autoclaves can promote staining, discoloration and rust.

Minimum Cycle Times for Gravity-Displacement Steam Sterilization Cycles

Minimum Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles

Additional Statement

New instruments and containment were validated for the following parameters: thermal disinfect washer at 90°C for 1 minute and steam sterilization at 134–137°C for 3 minutes.

Storage

Following sterilization processing, packaged instruments may be stored in a clean area free of temperature and humidity extremes in accordance with your institution’s policies. Indoor air should not contain foreign substances that could cause corrosion.

Additional Information

For additional information regarding the reprocessing of ophthalmic instruments, see:

• ASCRS/ASORN Special Report Recommendations for the cleaning and sterilization of intraocular cataract surgical equipment. J. Cataract Refract Surg. 2007; 33(6):1095–1100.
• ANSI/AAMI ST79:2010 and A1:2010 Comprehensive guide to steam sterilization and sterility assurance.

Warranty

All Titan Medical instruments, except custom ordered or custom etched instruments, are guaranteed to be free from defects in material and workmanship when used for their intended surgical purpose. Any Titan Medical instrument that proves defective in workmanship or material will either be repaired or replaced, at Titan Medical discretion, without any charge.

Warranties are not valid for instruments and products that prove defective as a result of improper care and cleaning or misuse. Instruments or products damaged in fire, flood, or other acts or disasters are also excluded from warranty. Titan Medical makes no other representations and warranties regarding its instruments or products, either express or implied. In no event will Titan Medical be liable for any incidental, special or exemplary damages or loss of profits in connection with the use of Titan Medical instruments and products.

Claims

Claims accompanied with this leaflet should be sent to the manufacturer’s address: Južná trieda 119, 04001 Košice, Slovakia, E.U.

Phone/Fax: +421 55 230 31 74

Statement of Compliance

Titan Medical instruments are in compliance with technical documentation.

Recycling

Instruments are non-toxic, pyrogen-free and recyclable. Before recycling, instruments must be disinfected. Country-specific laws and regulations must be observed for proper disposal.