Depuy Synthes ATP/Lateral Discectomy Surgical Instrumentation System Instructions

Part List Catalog Number 287301001 287301010 287301020 287301030 287301040 289215233 289215236 289215241 287303116 287303206 287304400 287304401 287304402 287352240 287352440 287353201 287353202 287353203 287353204 287353206 287353207 287353212 287353213 287353216 287353217 287353401 287353402 287353403 287353404 287353406 287353407 287353416 287353417 287353601 287353602 287353603 287353604 287353606 287353607 287353612 287353613 287353614 287353616 287353617 287354401 287354411 287354412 287354421 287354422 287354431 287354441 287354442 287354451 287354453 287354454 287354455 287354456 287354471 287354472 287354481 287354484 287354485 287354601

RD_IFU-18002E-01 Rev. C

Description

ATP LAT DISCECTOMY LID ATP LAT DISCECTOMY CASE 1 ATP LAT DISCECTOMY CASE 2 ATP ANGLED INSTRUMENTS CASE ATP LAT DISCECTOMY AUX CASE TRAY FOR RONGEURS TRAY F/STRAIGHT/SGL BEND INSTR TRAY F/DINGO/DBL BEND INSTR LAT SPREADER 16x5MM LAT 6MM ANGLED SPREADER LAT 4MM ATP RASP LATERAL 4MM STRAIGHT RASP LATERAL 4MM ANGLED RASP LAT 2MM 40 DEG KERRISON RONGUER LAT 4MM 40 DEG KERRISON RONGUER LAT 2MM STRAIGHT PITUITARY LAT 2MM ANGLED PITUITARY RIGHT LAT 2MM ANGLED PITUITARY LEFT LAT 2MM UP-ANGLED PITUITARY LAT 2MM ANGLED UP-ANGLED PITUITARY RIGHT LAT 2MM ANGLED UP-ANGLED PITUITARY LEFT LAT 2MM ANGLED PITUITARY RIGHT LAT 2MM ANGLED PITUITARY LEFT LAT 2MM ANG UP-ANG PITUITARY R LAT 2MM ANG UP-ANG PITUITARY L LAT 4MM STRAIGHT PITUITARY LAT 4MM ANGLED PITUITARY RIGHT LAT 4MM ANGLED PITUITARY LEFT LAT 4MM UP-ANGLED PITUITARY LAT 4MM ANGLED UP-ANGLED PITUITARY RIGHT LAT 4MM ANGLED UP-ANGLED PITUITARY LEFT LAT 4MM ANG UP-ANG PITUITARY R LAT 4MM ANG UP-ANG PITUITARY L LAT 6MM STRAIGHT PITUITARY LAT 6MM ANGLED PITUITARY, RIGHT LAT 6MM ANGLED PITUITARY, LEFT LAT 6MM UP-ANGLED PITUITARY LAT 6MM ANGLED UP-ANGLED PITUITARY, RIGHT LAT 6MM ANGLED UP-ANGLED PITUITARY, LEFT LAT 6MM ANGLED PITUITARY RIGHT LAT 6MM ANGLED PITUITARY, LEFT LAT 6MM UP-ANGLED PITUITARY LAT 6MM ANG UP-ANG PITUITARY R LAT 6MM ANG UP-ANG PITUITARY L LAT 4MM STRAIGHT CURETTE LAT 4MM ANGLED CURETTE, RIGHT LAT 4MM ANGLED CURETTE, LEFT LAT 4MM ATP CUP CURETTE, CRAN LAT 4MM ATP CUP CURETTE, CAUD LAT 4MM UP-BITING CURETTE LAT 4MM ANGLED UP-BITING CURETTE, RIGHT LAT 4MM ANGLED UP-BITING CURETTE, LEFT LAT 4MM UP-BITING ATP CURETTE LAT 4MM DOWN-BITING CURETTE LAT 4MM ANGLED DOWN-BITING CURETTE, RIGHT LAT 4MM ANGLED DOWN-BITING CURETTE, LEFT LAT 4MM DOWN-BITING ATP CURETTE LAT 4MM PUSH-PULL ATP CURETTE, CRAN LAT 4MM PUSH-PULL ATP CURETTE, CAUD LATERAL 4MM STRAIGHT PUSH-PULL CURETTE LATERAL 4MM ANGLED PUSH-PULL CURETTE, RIGHT LATERAL 4MM ANGLED PUSH-PULL CURETTE, LEFT LAT 6MM STRAIGHT CURETTE

UDI

00190776152017 00190776151973 00190776151980 00190776151997 00190776152000 00190776155384 00190776155391 00190776155407 00190776152123 00190776152918 00190776152369 00190776152208 00190776152352 00190776152031 00190776152048 00190776152079 00190776152390 00190776152406 00190776152109 00190776152703 00190776152710 00190776151140 00190776151164 00190776151195 00190776151225 00190776152086 00190776152291 00190776152307 00190776152116 00190776152413 00190776152420 00190776151188 00190776151218 00190776152093 00190776152673 00190776152680 00190776152697 00190776152727 00190776152734 00190776151157 00190776151171 00190776151249 00190776151201 00190776151232 00190776152161 00190776152314 00190776152321 00190776152437 00190776152444 00190776152185 00190776152451 00190776152468 00190776152819 00190776152475 00190776152833 00190776152840 00190776152871 00190776152499 00190776152505 00190776152192 00190776152338 00190776152345 00190776152178

Languages and Part Lists

Catalog Number 287354611 287354612 287354621 287354622 287354631 287354641 287354642 287354651 287354653 287354654 287354655 287354656 287354861 287354862 287361101 287361102 287361103 287361200 287361201 287361202 287361203 287361300 287361301 287362100 287362101 287362102 287362150 287362152 287363104 287363106 287363108 287363114 287363116 287363118 287363134 287363136 287363138 287363144 287363146 287363148 287363204 287363206 287363208 287363214 287363216 287363218

RD_IFU-18002E-01 Rev. C

Description

LAT 6MM ANGLED CURETTE, RIGHT LAT 6MM ANGLED CURETTE, LEFT LAT 6M ATP CUP CURETTE, CRAN LAT 6MM ATP CUP CURETTE, CAUD LAT 6MM UP-BITING CURETTE LAT 6MM ANGLED UP-BITING CURETTE, RIGHT LAT 6MM ANGLED UP-BITING CURETTE, LEFT LAT 6MM UP-BITING ATP CURETTE LAT 6MM DOWN-BITING CURETTE LAT 6MM ANGLED DOWN-BITING CURETTE, RIGHT LAT 6MM ANGLED DOWN-BITING CURETTE, LEFT LAT 6MM DOWN-BITING ATP CURETTE LAT 8MM ANGLED RING CURETTE LAT 8MM ANGLED RING CURETTE, FLAT LAT COBB ELEVATOR 12.7MM LAT COBB ELEVATOR 20MM LAT COBB ELEVATOR 12.7MM ANGLED TIP LAT ANGLED COBB ELEVATOR 12.7MM, RIGHT LAT ANGLED COBB ELEVATOR 12.7MM, LEFT LAT 20MM ANGLED COBB ELEVATOR, RIGHT LAT 20MM ANGLED COBB ELEVATOR, LEFT LAT COBB ELEVATOR 12° ATP 12.7MM, RIGHT LAT COBB ELEVATOR 12° ATP 12.7MM, LEFT LAT 10MM STRAIGHT OSTEOTOME LAT 10MM ANGLED OSTEOTOME LAT 10MM STRAIGHT ATP OSTEOTOME (DINGO) LAT 15MM STRAIGHT OSTEOTOME LAT 15MM STRAIGHT ATP OSTEOTOME (DINGO) LAT 4MM x 18MM BOX CUTTER LAT 6MM x 18MM BOX CUTTER LAT 8MM x 18MM BOX CUTTER LAT 4MM x 18MM BOX CUTTER, ANGLED LAT 6MM x 18MM BOX CUTTER, ANGLED LAT 8MM x 18MM BOX CUTTER, ANGLED LAT 4MM x 18MM ATP BOX CUTTER LAT 6MM x 18MM ATP BOX CUTTER LAT 8MM x 18MM ATP BOX CUTTER LAT 4MM x 18MM ATP BOX CUTTER (DINGO) LAT 6MM x 18MM ATP BOX CUTTER (DINGO) LAT 8MM x 18MM ATP BOX CUTTER (DINGO) LAT 4MM x 23MM BOX CUTTER LAT 6MM x 23MM BOX CUTTER LAT 8MM x 23MM BOX CUTTER LAT 4MM x 23MM BOX CUTTER, ANGLED LAT 6MM x 23MM BOX CUTTER, ANGLED LAT 8MM x 23MM BOX CUTTER, ANGLED

UDI

00190776152741 00190776152758 00190776152765 00190776152772 00190776152789 00190776152796 00190776152802 00190776152826 00190776152482 00190776152857 00190776152864 00190776152888 00190776152895 00190776152901 00190776152055 00190776152062 00190776152550 00190776152215 00190776152222 00190776152239 00190776152246 00190776152253 00190776152260 00190776152024 00190776152529 00190776152536 00190776152512 00190776152543 00190776152130 00190776152147 00190776152154 00190776152277 00190776152376 00190776152383 00190776152284 00190776152628 00190776152635 00190776152642 00190776152659 00190776152666 00190776152567 00190776152574 00190776152581 00190776152598 00190776152604 00190776152611

Languages and Part Lists

English EN Depuy Synthes ATP/Lateral Discectomy Surgical Instrumentation System Instructions 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. Instrument case and trays may consist of different materials including stainless steels, aluminum and silicone mats. 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. WARNINGS

• • • • • • • • • •

To prevent damage to soft tissue or vascular structures, use the instruments carefully under fluoroscopy when crossing the disc space to release the contralateral annulus. 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. 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. 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. Wash the instrument case and trays with an aluminum safe, neutral pH detergent to avoid faded surface colors and deterioration of anodized surfaces. 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 deviation by the reprocessor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences.

RD_IFU-18002E-01 Rev. C

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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 (Sonicator) Automated Washer

POINT-OF-USE AND CONTAINMENT 1) 2)

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. Follow universal precautions and contain devices in closed or covered containers for transport to central supply.

MANUAL CLEANING 3)

Disassemble all rongeurs identified for disassembly according to these instructions: **** Careful handling of the device in the disassembled condition is critical to avoid instrument damage.**** a.

Rongeur Disassembly: The ATP / Lateral Discectomy Surgical instrument set includes versions of the Kerrison and Pituitary rongeurs that can be disassembled to aid in reprocessing cleaning. The grey clip on the handle indicates the rongeur is a version that can be disassembled for cleaning. There may be rongeurs in the set that are not designed to be disassembled during cleaning, these rongeurs do not have the grey clips. Kerrison Rongeur

Pituitary Rongeur

Note Arrows etched on part do not align when in the assembled and handle open state.

To disassemble the rongeurs, follow the etched instructions on instrument: 1. Squeeze the rongeur handles 2. Pull grey clip out and then turn the clip clockwise. 3. The rongeur top slide will then disassemble.

RD_IFU-18002E-01 Rev. C

English

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Kerrison Rongeur

Pituitary Rongeur

Note Arrows align when the grey clip is turned and the rongeur can be disassembled

The rongeurs disassemble differently depending on type. See below for how each type opens – the slide will remain attached to the rongeur body the instrument opens but the slide remains attached so that it is not lost during cleaning. The open position allows for flushing and rinsing between the slide and the bottom jaw of the rongeur. Kerrison Rongeur Pituitary Rongeur Note Disassembled device

Handle the instruments carefully when in the disassembled (open) state to avoid damage to the instruments.

N/A

RD_IFU-18002E-01 Rev. C

English

For Kerrison Rongeurs ONLY: Top slide can be removed completely if necessary. When rotating a small resistance or “click” will be felt when disassembly occurs

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N/A

b.

For Kerrison Rongeurs ONLY: If top slide was completely removed; reattach proximal end of top slide to slot on trigger mechanism, a click will be felt when it is seated in position

Rongeur Assembly: To re-assemble the rongeurs, (rongeurs are to be re-assembled prior to sterilization). 1. If top slide was completely removed; re-attach promial end of top slide to slot on trigger mechanism, a click will be felt when it is seated in position. 2. Close the slide, taking caution to carefully realign the slide with the bottom jaw of the rongeur 3. Squeeze handles to engage top slide with bottom slide 4. Turn the grey clip counter clockwise until clip is locked into place. 5. Squeeze the rongeur handle to ensure complete assembly and correct function of the instrument.

4)

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. 5) 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. 6) 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. 7) 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. 8) 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. 9) 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. 10) 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. 11) Dry the device using an absorbent cloth. Dry any internal areas with filtered, compressed air.

RD_IFU-18002E-01 Rev. C

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12) Visually inspect the device for soil including all actuating mechanisms, cracks, crevices, and lumens. If not visibly clean, repeat steps 4-12. 13) Submerge device in 2-3% hydrogen peroxide. The appearance of bubbles confirms the presence of hemoglobin. Repeat steps 4-13 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 1-8. Steps 9-13are optional but advised. 14) Transfer the devices to an automatic washer/disinfector for processing per the below minimum parameters. Phase Pre-wash 1 Enzyme Wash Wash 1 Rinse 1 Purified Water Rinse Drying

Time (minutes) 02:00 02:00 02:00 02:00 02:00 15:00

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

15) Dry excess moisture using an absorbent cloth. Dry any internal areas with filtered, compressed air. 16) Visually inspect the device for soil including all actuating mechanisms, cracks, crevices and lumens. If not visibly clean, repeat steps 4-8, 14-16. 17) Submerge device in 2-3% hydrogen peroxide. The appearance of bubbles confirms the presence of hemoglobin. Repeat steps 4-8, 14-17 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. Load the devices in the washer-disinfector according to the manufacturer’s instructions, ensuring that the devices and lumens can drain freely. The following automated cycles are examples of validated cycles: Recirculation Time (min.) 1 5

Phase Thermal Disinfection Thermal Disinfection

Water Temperature >90°C (194°F) >90°C (194°F)

Water Type RI/DO Water RI/DO Water

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.

Sterilization Wraps: Cycle Type Prevacuum

Temperature 132°C (270°F)

RD_IFU-18002E-01 Rev. C

Exposure Time 4 minutes

English

Pulses 4

Drying Time 45 minutes

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Prevacuum • •

•

•

134°C (273°F)

3 minutes

4

45 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/wrap or the tape used to secure it may compromise the sterility of the processed loads or be indicative of a sterilization process failure. Visually check outside wrap for dryness. If there are water droplets for visible moisture observed the pack or instrument tray is considered unacceptable. Repackaging and re-sterilize the 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 •

Notice to Patient and User: Any serious incident that has occurred in relation to the medical devices should be reported to the manufacturer and the competent authority of the EU Member State in which the user and/or patient is established. Manufactured by: Avalign Technologies 8727 Clinton Park Drive Fort Wayne, IN 46825 1-877-289-1096 www.avalign.com [email protected]

Authorized Representative Instruments: Instrumed GmbH (dba Avalign German Specialty Instruments) 78 532 Tuttlingen, Unter Buchsteig 3 Germany Phone: +49 7462 200 49 0

Authorized Representative Case and Tray: Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

RD_IFU-18002E-01 Rev. C

English

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Distributed in US by: DePuy Synthes Sales Inc. (DSSI) 325 Paramount Drive Raynham, MA 02767 USA www.depuysynthes.com Distributed outside US by: Medos International Sarl Chemin-Blanc 38 CH-2400 LeLocle Switzerland Symbol

Title

Symbol

Title and Translations

Manufacturer & Date of Manufacture

Caution

Lot Number / Batch Code

Non-Sterile

Catalogue Number

Federal Law (USA) restricts this device to sale by or on the order of a physician

Consult Instructions for Use

Medical Device

Authorized Representative in the European Community

RD_IFU-18002E-01 Rev. C

English

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