Tecomet / DePuy Synthes Cases and Trays Instructions for Use and Reprocessing

English - EN

Instructions For Use and Reprocessing For Tecomet/DePuy Synthes Cases & Trays Intended Use The Cases are intended for the protection, organization, and delivery to the surgical field of the DePuy Synthes Instruments. The cases are not intended to maintain sterility by itself. They are designed to facilitate the sterilization process when used with an approved sterilization wrap or rigid sterilization container. Wrapping material is designed to allow air removal, steam penetration/evacuation (drying) and to maintain the sterility of the internal components. Indications For Use The cases are indicated for use to protect, organize, transport, and facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap and following the specified IFU, the sterility of the enclosed medical device is maintained provided the sterilized instruments are properly housed and sterility maintenance is performed per ANSI ST79.

Intended Patient Population No intended patient population. The cases are intended to protect, organize, transport, and facilitate the sterilization of DePuy Synthes Instruments. Intended User The cases are intended to be used by qualified health care professionals e.g., surgeons, physicians, operating room staff, and individuals involved in preparation of the surgical device.

Expected Clinical Benefits The cases protect, organize, transport, and facilitate the sterilization DePuy Synthes Instruments. Performance Characteristics The cases protect, organize, transport, and facilitate the sterilization DePuy Synthes Instruments. The cases performance and safety are established, and it represent the current state of the art when used as intended. Adverse Events & Complications All surgical operations carry risk. The following are frequently encountered adverse events and complications related to having a surgical procedure in general: • Delay to surgery caused by missing, damaged or worn instruments. • Tissue injury and additional bone removal due to blunt, damaged or incorrectly positioned instruments. • Infection and toxicity due to improper processing.

Adverse events to user: • Cuts, abrasions, contusions or other tissue injury caused by burrs, sharp edges, impaction, vibration or jamming of instruments. Adverse Events & Complications – Reporting of Serious Incidents

Serious Incident Reporting (EU) Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: • The death of a patient, user, or other person,

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• The temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, • A serious public health threat. Materials & Restricted Substances For indication that the device contains a restricted substance or material of animal origin see product label.

Combination of Medical Devices The cases are designed to protect, organize, transport, and facilitate the sterilization of the DePuy Synthes Instruments. The cases are not to be used in combination with devices provided by other manufacturers. Tecomet assumes no liability in such instances. Disposal

• At the end of the device’s life safely dispose of the device in accordance with local procedures and guidelines. • Any device that has been contaminated with potentially infectious substances of human origin (such as bodily fluids) should be handled according to hospital protocol for infectious medical waste. Any disposable or defective device that contains sharp edges should be discarded according to hospital protocol in the appropriate sharps container. Warnings

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U.S Federal law restricts this device to sale by or on the order of a physician.

• The cases are provided NON-STERILE and must be cleaned and sterilized according to these instructions prior to each use. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated cases. • Saline and cleaning/disinfection agents containing aldehyde, chloride, active chlorine, bromine, bromide, iodine or iodide are corrosive and should not be used. • Do not allow biologic soil to dry on contaminated devices. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluids and tissue debris to dry on used cases. • Metal brushes and scouring pads MUST NOT be used during manual cleaning. These materials will damage the surface and finish of the cases. Use only soft bristle nylon brushes with different shapes, lengths and sizes to aid with manual cleaning. • Use of hard water should be avoided. Softened tap water may be used for most rinsing however purified water should be used for final rinsing to prevent mineral deposits. • The cases have NOT been validated for ETO sterilization of devices. NON STERILE

Cleaning

• Both physical and chemical (detergent) processes may be necessary to clean soiled items. • Chemical (detergent) cleansers alone cannot remove all soil and debris; therefore, a careful manual cleaning of each item with a soft sponge or cloth is essential for maximum decontamination. • For difficult areas, a clean soft bristled brush is recommended. • Once the items have been cleaned, they should be thoroughly rinsed with clean water to remove any detergent or chemical residue before sterilization. • Tecomet recommends the use of mild enzymatic detergent with near neutral pH. • Do not use solvents, abrasive cleaners, metal brushes, or abrasive pads. • Follow instrument manufacturer’s instructions for use for cleaning the instruments. 2

Packaging for Sterilization • Reference Case markings for placing the cleaned instruments to their respective locations. • Always inspect instruments and case for cleanliness and damage before use. Make sure all latches and handles are secure and in working order. Do not overload cases. • Tecomet recommends that the cases and trays be wrapped according to the sterilization wrap manufacturer’s instructions prior to sterilization to maintain sterility of internal components/ items and for proper aseptic presentation to the surgical field. • Always follow instrument manufacturer instructions if their sterilization or drying recommendations exceed these guidelines. Sterilization

• Moist heat/steam sterilization is the recommended method for the device. • Use of an approved chemical indicator (class 5) or chemical emulator (class 6) within each sterilization load is recommended. • Always consult and follow the sterilizer manufacturer instructions for load configuration and equipment operation. Sterilizing equipment should have demonstrated efficacy (e.g., FDA clearance, EN 13060 or EN 285 compliance,). Additionally, the manufacturer’s recommendations for installation, validation, and maintenance should be followed. • Validated exposure times and temperatures to achieve a 10-6 sterility assurance level (SAL) are listed in the following table. Cycle Type

Temperature

Exposure Time

Dry Time

Cool-Down Time*

United States Recommended Parameters Pre-vacuum / 132°C / 270°F Vacuum Pulse Cycle Type

Temperature

4 minutes

Exposure Time

30 minutes

Dry Time

30 minutes

Cool-Down Time*

European Recommended Parameters Pre-vacuum/ 134°C / 273°F Vacuum Pulse

3 minutes

30 minutes

30 minutes

*Allow the wrapped device to cool outside of the autoclave for 30 minutes prior to use. A 30-minute minimum cooling time is recommended after drying but longer times may be necessary because of load configuration, ambient temperature and humidity, device design and packaging used.

Notice 1. DO NOT load cases into sterilizer on sides or upside down with lid side on shelf or cart. Load cases on cart or shelf so that the lid is always facing upwards. This will allow for proper drying. 2. DO NOT STACK cases or trays in an autoclave chamber.

3. After the autoclave door is opened, all cases must be allowed to cool thoroughly. Place cases on rack or shelf with linen cover until cooling is complete. The potential for condensation may increase if the case is not allowed to cool properly. 4. If condensation is observed, check to ensure steps 1, 2, and 3 were followed. In addition, verify that the steam, which is being used for sterilization processing, has a quality of more than 97% per ANSI/AAMI ST79. Also confirm that the sterilizers have been inspected for routine maintenance in accordance with manufacturer recommendations.

5. Silicone mat accessories should be placed in alignment with the perforations in the case or tray so that the sterilant pathways are not obstructed.

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The following table provides guidance on maximum loads. Do not overload cases, and always follow AAMI, OSHA and hospital standards for maximum loading. Tray Size

Maximum Total Weight

Small (~ 4 x 8 x 1 in.)

1 lb. (0.45 kg)

½ Size Case (~ 7 x 7 x 4 in.)

8 lb. (3.6 kg)

Tray (~ 8 x 17 x 1 in.)

¾ Size Case (~ 7 x 12 x 4 in.)

Full Size Case (~ 9 x 19 x 4 in.)

2 lb. (0.91 kg) 13 lb. (5.9 kg)

22 lb. (10.0 kg)

Symbols Used on Labeling: Caution

Non-Sterile

NON STERILE

U.S Federal law restricts this device to sale by or on the order of a physician CE Mark EC

REP

Authorized Representative in the European Community Manufacturer

Date of Manufacture REF

Lot Number



Consult Instructions for Use

Catalog Number Medical Device Packaging Unit

Country of Manufacture CH REP

Distributor

Swiss Authorized Representative1 Importer

Unique Device Identifier

Refer to the labeling for Swiss Authorized Representative

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Manufactured by: Legal Name: Symmetry Medical Manufacturing, Inc. 253 Abby Road Manchester, NH 03103 USA Phone: +1 603 647 7822 www.tecomet.com CH REP

MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland

7079 Rev A (11/28/2022)

EC REP European Representative: Symmetry Medical Polyvac S.A.S Parc d’Activités du Moulin 139, Avenue Clément Ader Wambrechies 59118 France Phone: +33 3 28 09 94 54