Disc Preparation Instruments Instructions for Use

Part Number

48970132

Description and Translation Kerrison 3mm, Non-Bayonetted Kerrison, non à baïonnette/ Piyuitario, mordida hacia arriba, sin forma de bayoneta/ KerrisonRongeur, ohne Bajonett/ Kerrison, senza baionetta/ Kerrison, zonder bayonet/ Kerrison sem baioneta/ Kerrison, χωρίς μπαγιονέτ/ Kerrison, uden bajonet/ Kerrison, pistimetön/ Kerrison, fără baionetă/ Kerrison, ikke-bajonett/ Kerrison, niebagnetowy/ Kerrison, fără baionetă/ Kerrison, без

GTIN

00190776141059

шип/ Kerrison, Bayonetsiz/ Kerrison，非刺刀式/ Kerrison, 비총검형

48970133

Kerrison 5mm, Non-Bayonetted Kerrison, non à baïonnette/ Piyuitario, mordida hacia arriba, sin forma de bayoneta/ KerrisonRongeur, ohne Bajonett/ Kerrison, senza baionetta/ Kerrison, zonder bayonet/ Kerrison sem baioneta/ Kerrison, χωρίς μπαγιονέτ/ Kerrison, uden bajonet/ Kerrison, pistimetön/ Kerrison, fără baionetă/ Kerrison, ikke-bajonett/ Kerrison, niebagnetowy/ Kerrison, fără baionetă/ Kerrison, без

00190776141066

шип/ Kerrison, Bayonetsiz/ Kerrison，非刺刀式/ Kerrison, 비총검형

48970056

Single Sided Rasp Râpe simple face/ Lima de un lado/ Einseitige Raspel/ Raspa monolaterale/ Eenzijdige rasp/ Raspador de face simples/ Ράσπα μονής πλευράς/ Enkeltsidet rasp/ Yksipuolinen raspi/ Raşpel cu o faţă/ Enkeltsidet rasp/ Skrobaczka jednostronna/ Raşpel cu o faţă/ Едностранна пила/ Tek Taraflı Raspa/

00190776140960

单侧骨锉/ 단일 면 뼈막막리기

48970057

Double Sided Rasp Râpe double face/ Lima de dos lados/ Doppelseitige Raspel/ Raspa bilaterale/ Dubbelzijdige rasp/ Raspador de dupla face/ Ράσπα διπλής πλευράς/ Dobbeltsidet rasp/ Kaksipuolinen raspi/ Raşpel cu două feţe/ Dobbelsidet rasp/ Skrobaczka dwustronna/ Raşpel cu două feţe/ Двустранна пила/ Çift

00190776140977

Taraflı Raspa/ 双侧骨锉/ 이중 면 뼈막박리기

48970058

Penfield 4mm, Bayonetted Penfield, à baïonnette / Penfield, en bayoneta / Penfield-Dissektor, mit Bajonett / Penfield, a baionetta / Penfield, met bayonet / Penfield com baioneta/ Penfield, με μπαγιονέτ / Penfield, med bajonet / Penfield, pistimellinen / Penfield, tip baionetă / Penfield, bajonett / Penfield, bagnetowy /

00190776140984

Penfield, tip baionetă / Penfield, с шип / Penfield, Bayonetli / Penfield，刺刀式 / Penfield, 총검형

48970059

Penfield Reverse 4mm, Bayonetted Penfield inversé, à baïonnette / Con cambio Penfield, en bayoneta / Penfield-Rückwärts-Dissektor, mit Bajonett / Penfield inverso, a baionetta / Penfield omgekeerd, met bayonet / Penfield Inverso com baioneta/ Ανάστροφο Penfield, με μπαγιονέτ / Penfield, omvendt, med bajonet / Penfield, käänteinen, pistimellinen / Penfield inversat, tip baionetă / Penfield revers, bajonett / Penfield odwrócony, bagnetowy / Penfield inversat, tip baionetă / Penfield обратен, с шип / Penfield Ters,

00190776140991

Bayonetli / Penfield 翻转，刺刀式 / Penfield 후방용, 총검형

48970062

Knife Handle, Bayonetted Manche de couteau, à baïonnette / Mango de cuchilla, en bayoneta / Messergriff, mit Bajonett / Impugnatura coltello, a baionetta / Messenheft, met bayonet / Cabo de bisturi com baioneta / Λαβή μαχαιριού, με μπαγιονέτ / Knivhåndtag, med bajonet / Veitsenkahva, pistimellinen / Mâner cuțit, tip baionetă / Knivhåndtak, bajonett / Trzonek do ostrza, bagnetowy / Mâner cuțit, tip baionetă /

00190776141004

Дръжка за нож, с шип / Bıçak Sapı, Bayonetli / 刀柄，刺刀式 / 나이프 손잡이, 총검형

48019301

Slap Hammer Impacteur marteau/ Martillo de dos caras/ Ausschläger/ Martello percussore/ Slaghamer/ Martelo cirúrgico/ Σφυρί / Kirurgisk hammer/ Slap-vasara/ Ciocan chirurgical/ Kirurgisk hammer/ Wybijak/

00190776138271

Ciocan chirurgical/ Чук/ Cerrahi Çekiç/ 手术锤/ 슬랩 해머 48970098

Mallet Maillet / Mazo / Schlägel / Mazzetta / Hamer / Malhete / Ξύλινο σφυρί / Hammer / Vasara / Ciocan /

00190776141318

Klubbe / Pobijak / Ciocan / Чукче / Çekiç / 槌 / 망치

48970067

Frazier Suction 11Fr Canule d'aspiration type Frazier/ Tubo de aspiración de Frazier/ Frazier-Ansaugschlauch/ Aspirazione di Frazier/ Frazier afzuiging/ Tubo de aspiração Frazier/ Βεντούζα Frazier/ Frazier sugeanordning/ Frazier-imu/ Tub de aspirație Frazier/ Frazier sug/ Rurka odsysająca Frazier/ Tub de aspirație Frazier/

00190776141011

Аспирационна тръба Frazier/ Frazier Emme/ Frazier 吸引 / 프레이저 흡입기

48970127

Frazier Suction 14Fr Canule d'aspiration type Frazier/ Tubo de aspiración de Frazier/ Frazier-Ansaugschlauch/ Aspirazione di Frazier/ Frazier afzuiging/ Tubo de aspiração Frazier/ Βεντούζα Frazier/ Frazier sugeanordning/ Frazier-imu/ Tub de aspirație Frazier/ Frazier sug/ Rurka odsysająca Frazier/ Tub de aspirație Frazier/ Аспирационна тръба Frazier/ Frazier Emme/ Frazier 吸引 / 프레이저 흡입기

RD_IFU-0007 Rev. C

Part List and Label Glossary

00190776141561

English EN Disc Preparation Surgical Instruments Instructions for Use INTENDED USE •

The Disc Preparation Surgical Instruments are intended to offer a comprehensive set of surgical instruments to prepare the intervertebral disc space for interbody spinal fusion.

INTENDED USER PROFILE • •

Surgical procedures should be performed only by persons having adequate training and familiarity with surgical techniques. Consult medical literature relative to techniques, complications and hazards prior to performance of any surgical procedure. Before using the product, all instructions regarding its safety features must be read carefully.

DEVICE DESCRIPTION • • • • •

Surgical instruments comprising fixed assemblies, simple hinged instruments and simple assemblies generally composed of medical grade stainless steels, titanium, aluminum and silicone rubber. Devices are supplied NON-STERILE and must be inspected, cleaned and sterilized before each use. Devices are critical and require terminal sterilization. Devices are not implantable. Frazier Suction Tubes interface with standard surgical tubing sizes over the barbed fitting: 6mm, ¼” (6.35mm), 7mm, 9/32” (7.14mm), 5/16” (7.94mm), and 8mm.

WARNINGS

• • • • • • • • • • •

Avalign recommends thorough manual and automated cleaning of medical devices prior to sterilization. Automated methods alone may not adequately clean devices. Devices should be reprocessed as soon as possible following use. Instruments must be cleaned separately from cases and trays. For the Frazier Suction Tubes, disassemble and remove stylet before cleaning. All cleaning agent solutions should be replaced frequently before becoming heavily soiled. Prior to cleaning, sterilization and use, remove all protective caps carefully. All instruments should be inspected to ensure proper function and condition. Do not use instruments if they do not perform satisfactorily. The sterilization methods described have been validated with the devices in predetermined placement locations per the case and tray designs. Areas intended for specific devices shall contain only those devices. Proper installation and maintenance instructions for interfacing suction equipment should be followed to achieve desired vacuum pressure and flow rate. If vacuum pressure or flow rate are diminished, verify tubing is installed over at least one of the suction instrument’s barbed connection features. Utilize stylet to remove any material lodged in the suction cannula. Risk of damage – The surgical instruments are precision devices. Careful handling is important for the accurate functioning of the devices. Improper external handling can cause the devices to malfunction. Use caution when handling sharp instruments to avoid injury. If a device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination.

CAUTION

Federal U.S. Law restricts this device to sale, distribution, and use, by, or on order of a physician. LIMITATIONS ON REPROCESSING Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. DISCLAIMER It is the responsibility of the reprocessor to ensure reprocessing is performed using equipment, materials and personnel in the reprocessing facility and achieves the desired result. This requires validation and routine monitoring of the process. Any

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deviation by the reprocessor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences.

Reprocessing Instructions TOOLS AND ACCESSORIES Water Cleaning Agents Accessories

Equipment

Cold Tap Water (< 20°C / 68°F) Warm Water (38°- 49°C / 100°- 120°F) Hot Tap Water (> 40°C / 104°F) Deionized (DI) or Reverse Osmosis (RO) Water (ambient) Neutral Enzymatic Detergent pH 6.0-8.0 i.e. MetriZyme, EndoZime, Enzol Assorted Sizes of Brushes and/or Pipe Cleaners with Nylon Bristles Sterile Syringes or equivalent Absorbent, Low Lint Disposable Cloths or equivalent Soaking Pans Medical Compressed Air Ultrasonic Cleaner Automated Washer

POINT-OF-USE AND CONTAINMENT 1) 2) 3)

Follow health care facility point of use practices. Keep devices moist after use to prevent soil from drying and remove excess soil and debris from all lumens, surfaces, crevices, sliding mechanisms, hinged joints, and all other hard-to-clean design features. Suction or flush lumens with a cleaning solution immediately after use. Follow universal precautions and contain devices in closed or covered containers for transport to central supply.

MANUAL CLEANING 4) 5)

Disassemble all devices as warranted per manufacturer’s instructions. Rinse devices under cold running tap water for a minimum of 3 minutes while wiping off residual soil or debris. Actuate moveable mechanisms and flush all lumens, cracks and/or crevices while rinsing. 6) Prepare an enzymatic cleaning solution per manufacturer’s instructions including dilution/concentration, water quality and temperature. Immerse devices and soak for a minimum of 10 minutes. While in the solution, use a soft, bristle brush to remove all traces of blood and debris from the device, paying close attention to threads, crevices, seams, and any hard to reach areas. a. If the device has sliding mechanisms or hinged joints, actuate the device while scrubbing to remove trapped soil. b. If the device contains a lumen, use a tight-fitting nylon brush or pipe cleaner while pushing in and out with a twisting motion to facilitate removal of debris; ensure the full diameter and depth of the lumen is accessed. Flush the lumen, three times minimum, with a syringe containing a minimum solution of 60mL. 7) Remove devices and rinse/agitate in cold tap water for a minimum of 3 minutes. Actuate moveable mechanisms and flush all lumens, cracks and/or crevices while rinsing. 8) Prepare a neutral detergent cleaning solution per manufacturer’s instructions including dilution/concentration, water quality and temperature. Immerse devices and soak for a minimum of 5 minutes. While in the solution, use a soft, bristle brush to remove all traces of blood and debris from the device, paying close attention to threads, crevices, seams, and any hard to reach areas. a. If the device has sliding mechanisms or hinged joints, actuate the device while scrubbing to remove trapped soil. b. If the device contains a lumen, use a tight-fitting nylon brush or pipe cleaner while pushing in and out with a twisting motion to facilitate removal of debris; ensure the full diameter and depth of the lumen is accessed. Flush the lumen, three times minimum, with a syringe containing a minimum solution of 60mL. 9) Remove devices and rinse/agitate in cold tap water for a minimum of 3 minutes. Actuate moveable mechanisms and flush all lumens, cracks and/or crevices while rinsing. 10) Prepare an enzymatic cleaning solution using hot water per manufacturer’s recommendations in an ultrasonic unit. Sonicate the devices for a minimum of 15 minutes using a minimum frequency of 40 kHz. It is recommended to use an ultrasonic unit with flushing attachments. Devices with lumens should be flushed with cleaning solution under the surface of the solution to ensure adequate perfusion of channels. 11) Remove devices and rinse/agitate in ambient DI/RO water for a minimum of 4 minutes. Actuate moveable mechanisms and flush all lumens, cracks and/or crevices while rinsing. Flush internal lumens a minimum of 3 times with RO/DI water (minimum of 15mL) using an appropriately sized syringe. If available, use flush ports for flushing. 12) Dry the device using an absorbent cloth. Dry any internal areas with filtered, compressed air.

RD_IFU-0007 Rev. C

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13) Visually inspect the device for soil under magnification including all actuating mechanisms, cracks, crevices, and lumens. If not visibly clean, repeat steps 4-13. 14) Submerge device in 2-3% hydrogen peroxide. The appearance of bubbles confirms the presence of hemoglobin. Repeat steps 5-14 if bubbles appear. Adequately rinse device with DI/RO water. AUTOMATED CLEANING Note: All devices must be manually pre-cleaned prior to any automated cleaning process, follow steps 1-9. Steps 10-14 are optional but advised. 15) Transfer the devices to an automatic washer/disinfector for processing per the below minimum parameters. Time (minutes) 02:00 02:00 02:00 02:00 02:00 15:00

Phase Pre-wash 1 Enzyme Wash Wash 1 Rinse 1 Purified Water Rinse Drying

Temperature

Detergent Type & Concentration

Cold Tap Water Hot Tap Water 63°C / 146°F Hot Tap Water 146°F / 63°C 194°F / 90°C

N/A Enzyme Detergent Neutral Detergent N/A N/A N/A

16) Dry excess moisture using an absorbent cloth. Dry any internal areas with filtered, compressed air. 17) Visually inspect the device for soil under magnification including all actuating mechanisms, cracks, crevices and lumens. If not visibly clean, repeat steps 4-9, 15-17. 18) Submerge device in 2-3% hydrogen peroxide. The appearance of bubbles confirms the presence of hemoglobin. Repeat steps 5-9, 15-18 if bubbles appear. Adequately rinse device with DI/RO water. DISINFECTION • •

Devices must be terminally sterilized (See § Sterilization). Avalign instruments are compatible with washer/disinfector time-temperature profiles for thermal disinfection per ISO 15883.

INSPECTION AND FUNCTIONAL TESTING • • • •

Visually inspect devices for damage or wear, including sharp edges. Instruments with broken, cracked, chipped or worn features, should not be used, but should be replaced immediately. Verify device interfaces (junctions and threads) continue to function as intended without complications. Check for smooth movement of hinges. Locking mechanisms should be free of nicks. Lubricate before autoclaving with Instra-Lube, or a steam permeable instrument lubricant.

PACKAGING • • • •

Only FDA cleared sterilization packaging materials should be used by the end user when packaging the devices. The end user should consult ANSI/AAMI ST79 or ISO 17665-1 for additional information on steam sterilization. Sterilization Wrap o Cases may be wrapped in a standard, medical grade sterilization wrap using the AAMI double wrap method or equivalent. Rigid Sterilization Container o For information regarding rigid sterilization containers, please refer to appropriate instructions for use provided by the container manufacturer or contact the manufacturer directly for guidance.

STERILIZATION Sterilize with steam. The following are minimum cycles required for steam sterilization of Avalign devices:

1.

US Sterilization Wraps: Cycle Type Prevacuum Gravity Displacement

2.

Exposure Time 4 minutes 15 minutes

Pulses 3 -

Drying Time 30 minutes 30 minutes

Temperature 134°C (273°F)

Exposure Time 3 minutes

Pulses 3

Drying Time 30 minutes

Temperature 132°C (270°F)

Exposure Time 4 minutes

Pulses 3

Drying Time 30 minutes

OUS Sterilization Wraps: Cycle Type Prevacuum

3.

Temperature 132°C (270°F) 132°C (270°F)

US Rigid Containers: Cycle Type Prevacuum

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4.

OUS Rigid Containers: Cycle Type Prevacuum

• •

•

•

Temperature 134°C (273°F)

Exposure Time 3 minutes

Pulses 3

Drying Time 30 minutes

The operating instructions and guidelines for maximum load configuration of the sterilizer manufacturer should be followed explicitly. The sterilizer must be properly installed, maintained, and calibrated. Time and temperature parameters required for sterilization vary according to type of sterilizer, cycle design, and packaging material. It is critical that process parameters be validated for each facility’s individual type of sterilization equipment and product load configuration. A facility may choose to use different steam sterilization cycles other than the cycle suggested if the facility has properly validated the cycle to ensure adequate steam penetration and contact with the devices for sterilization. Note: rigid sterilization containers cannot be used in gravity steam cycles. Water droplets and visible signs of moisture on sterile packaging or the tape used to secure it, may compromise sterility of processed loads or be indicative of a sterilization process failure. Visually check outside wrapper for dryness. If there are water droplets or visible moisture on the exterior of the package or on the tape used to secure it, the pack or instrument tray is considered unacceptable. Repackage and re-sterilize sterilization packages with visible signs of moisture.

STORAGE • •

After sterilization, instruments should remain in sterilization packaging and be stored in a clean, dry cabinet or storage case. Care should be taken when handling devices to avoid damaging the sterile barrier.

MAINTENANCE • •

Attention: Apply lubricant only on the connecting elements (locking mechanism) and moving parts. Discard damaged, worn or non-functional devices.

WARRANTY • •

All products are guaranteed to be free from defects in material and workmanship at the time of shipping. Avalign instruments are reusable and meet AAMI standards for sterilization. All our products are designed and manufactured to meet the highest quality standards. We cannot accept liability for failure of products which have been modified in any way from their original design.

CONTACT Manufactured by: Avalign Technologies 8727 Clinton Park Drive Fort Wayne, IN 46825 1-877-289-1096 www.avalign.com [email protected] Authorized Representative: Instrumed GmbH (dba Avalign German Specialty Instruments) 78 532 Tuttlingen, Unter Buchsteig 3 Germany Phone: +49 7462 200 49 0

2797

___________________________________ CE mark is valid if printed on product label.

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