Cadence Total Ankle System Non-Sterile Device Reprocessing, Instructions for Use

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Caution: Federal (US) law restricts this device to sale by or on the order of a physician.

EN - ENGLISH

Integra® Cadence® Total Ankle System Non-Sterile Device Reprocessing, Instructions For Use DESCRIPTION AND INTENDED USE Integra LifeSciences Corporation reusable surgical device sets consist of various configurations of orthopedic devices in cases or trays. The sets are constructed from durable metal and/or plastic materials. The reusable and single use surgical devices are intended for use in orthopedic surgical procedures according to the Instructions for Use and Surgical techniques that accompany Integra® implants. Reusable devices are to be cleaned, inspected, and sterilized between uses.

INSPECTION BEFORE USE Reusable Devices can be used indefinitely if not damaged or worn. Device systems should be cleaned and then inspected between uses. DO NOT use broken or damaged devices. Contact Integra for repair or replacement of damaged items. If damage or malfunction is detected, the device should not be used. Disposable Devices should be disposed of according to hospital procedure and any applicable laws. Do not reuse disposable devices. Warnings and Precautions (All Instruments): • Inspect instruments for proper operation before use. • Never use bent or damaged instrument. • Ensure proper assembly of instrument before activation. • Eye protection for operating room personnel is recommended during use. • Protect patient tissue at all times. Warnings and Precautions (Single Use Instruments): • Do not re-sharpen instruments. • Instruments should not be used with speeds exceeding the instrument manufacturer’s specifications. • Be cautious of pins loosening or backing out while performing sawing steps. • Any disposable instrument, once used, should be discarded according to hospital policy. • Do not reuse single use instruments, reuse of disposable instruments may result in damage to single use or reusable instruments.

PREPARATION/GENERAL GUIDANCE FOR CLEANING Verify that all instruments required for use are present in the case. It is not recommended to use chloride containing cleaning solutions since its use has been linked to corrosion of metallic instruments, especially stainless steel. Please also note the following: • Disinfect and clean devices immediately after use in order to avoid device encrustations. • Solutions used for cleaning must always be prepared in accordance with the m  anufacturer’s instructions. • Never use metal brushes or metal sponges for manual cleaning. • Use a suitably sized non-metallic bristle brush for cleaning lumens, cannulations, blind holes, and cavities, making sure that every part of the inner surface can be properly accessed. • Clean jointed instruments in closed as well as open positions. • Disassemble instruments as far as possible before cleaning. • Be sure to arrange the items so that the water can easily flow out of cannulations, blind holes, and cavities. • For instruments with long or narrow lumens, standard processing should be used only if the disinfectant can flow easily through the lumens and safe rinsing is guaranteed. • The cases/trays used for cleaning must always be loaded correctly to ensure proper cleaning. • After cleaning, check instruments for cleanliness (visible dirt). This especially applies to cannulated instruments or those with blind holes and crevices. • To ensure proper instrument functioning, verify that all movable parts have been thoroughly cleaned. • Pay special attention to slots, ratchets, joints and box locks, narrow lumens, blind holes, and other areas that are hard to access. • Deionized or distilled water should be used for the final rinse.

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EN – ENGLISH

MANUAL CLEANING INSTRUCTIONS The following steps should be completed in sequence. Please note that all instructions provided are as validated by Integra LifeSciences. Depending upon the detergent selection, minimum processing times and temperature settings may need to be adjusted for optimal processing: a) Prepare a neutral pH enzymatic detergent as per the manufacturer’s recommendation (e.g. Enzol® prepared at 1 oz. per gallon of lukewarm deionized water). b) Disassemble instruments to lowest level. c) Rinse devices under lukewarm running water to remove all gross soil. Use a soft bristled brush to aid in the brushing. Agitate the instruments under the running water. Agitation includes actuating all movable parts such as opening and closing hinges and moving the instruments around under the running water. Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of instruments. Use a syringe to flush any lumens. d) Fully immerse each device in the prepared detergent and allow it to soak for a minimum of two minutes. e) After soaking the devices, and while still immersed, use a syringe to flush all hard to reach areas/lumens with the prepared detergent. Use a pipe cleaner brush to clean all hard to reach areas and/or lumens of each article. Use a soft bristle brush and circular strokes to remove any visible soil. Pay particular attention to all the areas where the soil could be imbedded (i.e. grooves, crevices, lumens, blind holes). Bend flexible components to their maximum amount in all orientations during this step. Note: Cleaning is performed under the surface of the prepared detergent solution to limit aerosolization of the cleaning fluid and soil, as well as for worker and environmental safety. f) Use a syringe to flush lumens and a pipe cleaner to clean lumens and holes. g) Remove articles from the detergent, and rinse devices under running lukewarm water for a minimum of one and a half (1.5) minutes to remove any detergent residuals. In accordance with Step C, agitate the devices under the running water, being sure to actuate all movable parts, and using a soft bristled brush for internal and exterior device surfaces. Use a syringe to flush all hard to reach areas and/or lumens with water. h) Prepare a neutral pH enzymatic detergent (eg. Enzol) in a sonicator, as per the manufacturer’s recommendation using lukewarm water. Fully immerse the devices in the detergent. Flush the articles with a syringe and actuate to ensure no air bubbles are trapped within the device. Bend flexible components to their maximum amount in all orientations during this step. Sonicate for 10 minutes. i) After sonication, remove articles from the detergent and rinse the devices with running lukewarm water (use the highest grade of water available, distilled or deionized water is recommended) for three (3) minutes. Agitate the devices under the running water, being sure to actuate all movable parts. Use a clean soft bristled brush and/or pipe cleaner to aid in the rinse of internal and exterior device surfaces. Use a syringe to flush all lumens and hard to reach areas within the device. j) Dry the devices using filtered pressurized air and visually examine to determine if all adherent visible soil has been removed. k) Repeat the above cleaning procedure, if visible debris is detected.

AUTOMATED CLEANING PROCEDURE The following steps should be completed in sequence: a) Prepare an enzymatic detergent using lukewarm deionized water as per the manufacturer’s recommendation. b) Fully immerse the devices and allow to soak for a minimum of two (2) minutes. c) Following the soak time, flush any lumens of the device using a syringe. d) Rinse the devices under lukewarm running deionized water for a minimum of one (1) minute, while agitating the devices. Agitation includes actuating all movable parts, such as opening and closing hinges and moving the devices around under the running water. e) Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of device components. Use a syringe to flush any lumens. f) Place the devices back into the designated locations of the case/tray, and load the case/tray set into an automated washer (Steris 444 or equivalent). g) The washer cycle parameters are as follows:

Phase

Recirculation Time (Min.)

Water Temperature

Detergent

Pre-Wash

02:00

Cold Water

N/A

Enzyme Wash

01:00

Hot Water

Enzymatic Cleaner

Wash

02:00

60°C

Neutral Detergent

Rinse

10:00

Hot Water*

N/A

*Note: The highest grade of water available should be used during the final rinse cycle, distilled or deionized water is recommended. h) After washing, dry the devices using a clean lint free cloth and visually examine to determine if all adherent visible soil has been removed. i) Repeat the cleaning procedure if visible debris is detected.

INSPECTION AFTER CLEANING Following cleaning, the instruments must be macroscopically clean, i.e. free from visible dirt or deposits. All movable parts, working tips and blades (scissors) should be inspected with particular care.

STERILIZATION Integra LifeSciences Corporation has completed sterilization validations for our instrument sets. The validation protocols were performed in accordance with AAMI ST79:2006 Steam Sterilization and Sterility Assurance in Health Care and AAMI ST77-2006 Containment Devices for Reusable Medical Device Sterilization All testing was done using the overkill approach with Geobacillus stearothermophilus spores. The results confirmed 106 Sterility Assurance Level (SAL) for the sets when using the recommended cycles. In accordance with our validation results, the following cycles are recommended for wrapped goods utilizing FDA-cleared sterilization wrap:

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EN – ENGLISH Recommended Sterilization Parameters Device Set System

Pre-vacuum

Gravity

Pre-vacuum1

Pre-vacuum1

132°C/4 Min.

132°C/15 Min.

134°C/3 Min.

134°C/18 Min.

Dry Time Requirements (minutes)

1

Case for Resection Instruments

30

30

30

30

Case for Trials, Insertion and Removal Instruments

30

30

30

30

Case, Flat Cut Instruments

30

30

30

30

Case, Flat Cut Instruments, Alternate

30

30

30

30

134°C setting is for use outside the USA only.

PRODUCT INFORMATION DISCLOSURE INTEGRA HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THIS PRODUCT. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCT.

SYMBOLS USED ON LABELING Symbol

NON STERILE

EC REP

Title of Symbol

Meaning of Symbol

Standard

Reference Number

Do not re-use

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied

5.4.2

Consult Instructions for use

Indicates the need for the user to consult the instructions for use.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied

5.4.3

Date of Manufacture (YYYY-MM-DD)

Indicates the date when the medical device was manufactured.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

5.1.3

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

5.1.1

Prescription Use Only

Caution: Federal (US) law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner.

Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements, dated January 21, 2000

N/A

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied

5.1.6

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

5.1.5

Quantity

To indicate the number of devices per package

Proprietary

N/A

Non-sterile

Indicates a medical device that has not been subjected to a sterilization process.

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

5.2.7

Authorized Representative in the European Community

Indicates the authorized representative in the European Community

ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

5.1.2

CE Mark

Product complies with the requirements of directive 93/42/EEC

93/42/EEC

N/A

Medical Device

Indicates that the product is classified as a medical device per Regulation (EU) 2017/745

N/A

N/A

Stainless steel

To indicate the material of the device is stainless steel

N/A

N/A

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EN – ENGLISH

2797

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, TX 78758 USA Phone: 1(800) 654-2873 Fax: 1(888) 980-7742 integralife.com ■

Integra LifeSciences Services (France) Immeuble Séquoia 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, France Voice: +33 (0) 4 37 47 59 10

Made in the U.S.A.

Cadence, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Enzol is a trademark of Johnson & Johnson. ©2020 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. LC-04-1020-0006 Rev H 2020-07 0430310-10

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2797

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, TX 78758 USA Phone: 1(800) 654-2873 Fax: 1(888) 980-7742 integralife.com ■

Integra LifeSciences Services (France) Immeuble Séquoia 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, France Voice: +33 (0) 4 37 47 59 10

Made in the U.S.A.

Cadence, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Enzol is a trademark of Johnson & Johnson. ©2020 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. LC-04-1020-0006 Rev H 2020-07 0430310-10