Tecomet
Bridgeback Easy Clean Acetabular Reamer Driver
ACETABULAR REAMER DRIVER INSTRUMENTS (BRIDGEBACK) Instructions for Use and Reprocessing
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IMPORTANT INFORMATION - PLEASE READ BEFORE USE INFORMATIONS IMPORTANTES - À LIRE AVANT UTILISATION INFORMAZIONI IMPORTANTI - LEGGERE PRIMA DELL’USO WICHTIGE INFORMATIONEN - VOR GEBRAUCH BITTE LESEN INFORMACIÓN IMPORTANTE - LÉALA ANTES DE UTILIZAR ESTE PRODUCTO 重要な情報 - 使用前にお読みください ВАЖНА ИНФОРМАЦИЯ - МОЛЯ, ПРОЧЕТЕТЕ ПРЕДИ УПОТРЕБА VAŽNE INFORMACIJE - PROČITATI PRIJE UPORABE DŮLEŽITÉ INFORMACE - PŘEČTĚTE SI PŘED POUŽITÍM VIGTIGE OPLYSNINGER - SKAL LÆSES INDEN BRUG BELANGRIJKE INFORMATIE - VOOR GEBRUIK DOORLEZEN OLULINE TEAVE - PALUN LUGEGE ENNE KASUTAMIST TÄRKEITÄ TIETOJA - LUETTAVA ENNEN KÄYTTÖÄ ΣΗΜΑΝΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ - ΠΑΡΑΚΑΛΟΥΜΕ ΔΙΑΒΑΣΤΕ ΠΡΙΝ ΑΠΟ ΤΗ ΧΡΗΣΗ FONTOS TUDNIVALÓK - HASZNÁLAT ELŐTT OLVASSA EL SVARĪGA INFORMĀCIJA - LŪDZU, IZLASIET PIRMS LIETOŠANAS SVARBI INFORMACIJA - PERSKAITYKITE PRIEŠ NAUDODAMI VIKTIG INFORMASJON - LES FØR BRUK WAŻNE INFORMACJE - NALEŻY PRZECZYTAĆ PRZED UŻYCIEM INFORMAÇÕES IMPORTANTES - LER ANTES DE UTILIZAR INFORMAȚII IMPORTANTE - VĂ RUGĂM SĂ LE CITIȚI ÎNAINTEA UTILIZĂRII DÔLEŽITÉ INFORMÁCIE - PREČÍTAJTE SI ICH PRED POUŽITÍM POMEMBNE INFORMACIJE - PREBERITE PRED UPORABO VIKTIG INFORMATION - LÄS FÖRE ANVÄNDNING ÖNEMLİ BİLGİ - LÜTFEN KULLANMADAN ÖNCE OKUYUN
7025-99 Rev D (10/06/2021)
Contents (English - EN) English - EN
INSTRUCTIONS FOR USE AND REPROCESSING FOR THE ACETABULAR REAMER DRIVER INSTRUMENTS (BRIDGEBACK) These instructions are in accordance with ISO 17664 and AAMI ST81. They apply to the Bridgeback Acetabular Reamer Driver Instruments (provided as non-sterile) supplied by Tecomet intended for reprocessing in a health care facility setting. All Tecomet instruments and accessories may be safely and effectively reprocessed using the manual or combination manual/automated cleaning instructions and sterilization parameters provided in this document UNLESS otherwise noted in instructions and accompanying a specific instrument. In countries where reprocessing requirements are more stringent than those provided in this document, it is the responsibility of the user/processor to comply with those prevailing laws and ordinances. These reprocessing instructions have been validated as being capable of preparing reusable Tecomet instruments and accessories for surgical use. It is the responsibility of the user/ hospital/health care provider to ensure that reprocessing is performed using the appropriate equipment, materials and that personnel have been adequately trained in order to achieve the desired result; this normally requires that equipment and processes are validated and routinely monitored. Any deviation by the user/hospital/health care provider from these instructions should be evaluated for effectiveness to avoid potential adverse consequences.
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DESCRIPTION The Tecomet Acetabular Reamer Driver Instruments (Bridgeback) are reusable devices designed to help the surgeon prepare the patient’s acetabulum to receive an implant during total hip arthroplasty (THA). An acetabular reamer is attached to the distal end of the reamer driver which then provides a means to transfer rotational force applied either manually or with a powered driver at the proximal end. Tissue Protectors are used to cover the rotating shaft of the Acetabular Reamer Driver and provide a means to support the shaft during use while preventing tissue from getting caught or wound on the shaft. INTENDED USE The Acetabular Reamer Driver Instruments (Bridgeback) are intended for use during Total Hip Arthroplasty (THA) prescribed to treat various diseases of the hip joint. The instrument provides a means for holding and driving an acetabular reamer during preparation of the acetabulum to receive an implant. The device may be operated manually or by means of a powered surgical driver. WARNINGS AND PRECAUTIONS
Warnings • All instruments and accessories are provided NON-STERILE and must be properly cleaned and sterilized prior to each use.
NON STERILE
READ THESE INSTRUCTIONS COMPLETELY BEFORE USING THE DEVICES • The Tissue Protector must be disassembled from the Acetabular Reamer Driver before cleaning and sterilization. • Ensure that the spring is retained on the shaft of the Acetabular Reamer Driver before assembling the Tissue Protector to the Acetabular Reamer Driver. See Figure 2 for details. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated instruments. • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of the devices. • Never use metal brushes or steel wool for cleaning. 2
PRECAUTIONS .S Federal law restricts this device to sale by or on the order U of a physician. • The instruments should be inspected for damage, especially at the quick connection, the spring, and the release button prior to each use. Instruments that show signs of damage should not be used. • As with any surgical instrument careful attention should be exercised to ensure that excessive force is not placed on the instrument during use. Excessive force can result in instrument failure. • Careful attention must be paid to asepsis and avoidance of anatomical hazards.
LIMITATION OF REPROCESSING End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended use or misuse and not reprocessing.
CLEANING • Tecomet recommends that the instruments be cleaned as soon as possible after each surgical procedure in order to limit the drying time of residue biologic soil left on the instruments. • Water quality used for diluting cleaning agents and for rinsing instruments should be carefully considered. Use of distilled water for cleaning and distilled or sterile water for rinsing is recommended. Avoid using hot water as this will coagulate and harden protein based soil. • Cleaning agents and disinfectants must be prepared according to the recommendations of their manufacturer. Only use cleaning agents and disinfectants that have a nearly neutral pH and are approved for use on surgical instruments. POINT OF USE PRE-CLEANING • Remove excess biologic soil and tissue from instruments using disposable wipes. • As soon as possible after use, set instruments in a basin of distilled water or in a tray covered with damp towels.
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A. MANUAL CLEANING FOR THE ACETABULAR REAMER DRIVER INSTRUMENTS (BRIDGEBACK) 1. P repare a solution of proteolytic enzymatic detergent according to the manufacturer’s recommendations. 2. Before cleaning, disassemble all components. a. R emove the Tissue Protector by depressing the release button and sliding the Tissue Protector proximally as shown in Figure 1. The spring and thumb trigger must remain on the Acetabular Reamer Driver shaft. Figure 1: Disassembly of Tissue Protector RELEASE BUTTON TISSUE PROTECTOR
THUMB TRIGGER
SPRING
3. I mmerse instruments and soak for the time recommended by the detergent manufacturer. Actuate all moving parts while immersed in detergent solution. 4. U se a soft bristle cleaning brush and scrub the instruments until all visible contamination has been removed. Scrub the device below the surface of the cleaning solution to prevent aerosolization of contaminants. Pay particular attention to the features of each device that will pose a challenge to effective cleaning; e.g. moving parts. 5. A ctuate and maneuver all moving parts of the device during cleaning to ensure complete exposure of the cleaning solution to all surfaces. Refer to Figure 1 while performing the following manipulations: a. Depress release button multiple times while cleaning.
b. Move the spring and thumb trigger along the driver shaft while scrubbing the distal tip of the Acetabular Reamer Driver. Be careful not to dislodge or remove the spring from the driver shaft while cleaning.
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c. S crub the inside diameter of the Tissue Protector by passing a snug fitting pipe cleaner/brush through the tube three (3) times.
6. R inse thoroughly with distilled or sterile water until all traces of cleaning solution are removed. Maneuver all moving parts while rinsing. Flush the inside diameter of the Tissue Protector tube using a large syringe. 7. P repare an ultrasonic bath with a cleaning solution at the concentration and temperature recommended by the detergent manufacturer. 8. S ubmerge the instruments and activate the bath for a minimum of 10 minutes. A frequency of 25 – 50 kHz is recommended. 9. R emove and rinse the instruments in distilled or sterile water for at least one (1) minute or until all traces of cleaning solution are removed. Maneuver all moving parts while rinsing. Flush the inside diameter of the Tissue Protector tube using a large syringe. 10.Visually inspect the instruments for visible soil and repeat these cleaning steps if remaining soil is observed. 11.Dry the instruments with clean, lint-free wipes in preparation for sterilization. Use clean pressurized air to remove moisture from hard to reach areas.
B. AUTOMATIC CLEANING FOR THE ACETABULAR REAMER DRIVER INSTRUMENTS (BRIDGEBACK) 1. P repare a solution of proteolytic enzymatic detergent according to the manufacturer’s recommendations. 2. Before cleaning, disassemble all components. a. Remove the Tissue Protector by depressing the release button and sliding the Tissue Protector proximally as shown in Figure 1 above. The spring and thumb trigger must remain on the Acetabular Reamer Driver shaft. 3. I mmerse instruments and soak for the time recommended by the detergent manufacturer. Actuate all moving parts while immersed in detergent solution. 4. U se a soft bristle cleaning brush and scrub the instruments until all visible contamination has been removed. Scrub the device below the surface of the cleaning solution to prevent aerosolization of contaminants. Pay particular attention to the features of each device that will pose a challenge to effective cleaning; e.g. moving parts. 5
5. A ctuate and maneuver all moving parts of the device during cleaning to ensure complete exposure of the cleaning solution to all surfaces. Refer to Figure 1 while performing the following manipulations: a. Depress release button multiple times while cleaning. b. Move the spring and thumb trigger along the driver shaft while scrubbing the distal tip of the Acetabular Reamer Driver. Be careful not to dislodge or remove the spring from the driver shaft while cleaning. c. S crub the inside diameter of the Tissue Protector by passing a snug fitting pipe cleaner/brush through the tube three (3) times. 6. Rinse thoroughly with distilled or sterile water until all traces of cleaning solution are removed. Maneuver all moving parts while rinsing. Flush the inside diameter of the Tissue Protector tube using a large syringe. 7. Load instruments in an automated washer-disinfector in a manner that maximizes exposure of the instrument surfaces. 8. Operate the washer-disinfector according to the manufacturer’s instructions to ensure all cycle parameters (i.e. time, temperature) are followed. 9. Remove instruments and check for remaining soil or wetness. If soil remnants are observed repeat the automated cleaning cycle. If remaining wetness is observed, dry the instruments with clean, lint-free wipes in preparation for sterilization.
STERILIZATION Moist heat/steam sterilization is the preferred and recommended method for the Acetabular Reamer Driver Instruments. • Instruments must be properly cleaned before sterilization. • Instruments should be disassembled before sterilization (see cleaning instructions for details on disassembly). ○ Remove the Tissue Protector by depressing the release button and sliding the Tissue Protector proximally as shown above in Figure 1. ○ Ensure that the spring is still retained on the shaft of the Acetabular Reamer Driver. ○ Use only approved sterilization wraps or pouches when processing single devices.
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• The Tissue Protector should not be assembled onto the Acetabular Reamer Driver for sterilization. ○ If a sterilization case is used, the Tissue Protector should have its own space in the sterilization case. If the device is sterilized as part of an instrument set in a rigid container then it is the responsibility of the health care facility to ensure that the minimum recommended sterilization parameters are achieved since changes in instrument load size may affect sterilization efficacy. Cycle Type
Temperature
Exposure Time
United States Recommended Parameters Pre-vacuum / Vacuum Pulse
132°C / 270°F
Exposure Time
Pre-vacuum/ Vacuum Pulse
134°C / 273°F
3 minutes
Cycle Type
Temperature
European Recommended Parameters
4 minutes
ASSEMBLY PRIOR TO USE Prior to use, ensure that the device is appropriately assembled. • Ensure that the correct length Tissue Protector is utilized with the appropriate Acetabular Reamer Driver. ○ Check that the etch description on the Tissue Protector matches the etched description on the Acetabular Reamer Driver. • The spring must be present and functional. • The stepped end of the Tissue Protector must go on the Acetabular Reamer Driver first (see Figure 2). Depress the release button and slide the Tissue Protector over it. Ensure that the thumb trigger engages the Bridgeback reamer connection as shown in Figure 2. • Assess fit of the Tissue Protector. ○ There should not be a lot of excess space between the Tissue Protector and the release button. ○ If you believe there is excess space, remove the Tissue Protector and ensure that the etched length (Standard or Extended) on the Acetabular Reamer Driver match the length on the Tissue Protector
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Figure 2: Assembly of the Tissue Protector onto the Acetabular Reamer Driver
RELEASE BUTTON TISSUE PROTECTOR SPRING
SPRING
FOR SINGLE STEP TISSUE PROTECTOR, THE STEPPED END NEEDS TO BE ASSEMBLED FIRST
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SYMBOLS THAT MAY BE USED ON LABELING U.S Federal law restricts this device to sale by or on the order of a physician. REF
2797
Manufacturer
Catalog Number
CE Mark with Notified Body Number Caution
Consult Instructions for Use NON STERILE
EC
REP
Lot Number Non-Sterile
European Representative Date of Manufacture Medical Device
Packaging Unit
Country of Manufacture Distributor
ADDITIONAL LABELING: “REMOVE FOR CLEANING & STERILIZATION”
Device should be disassembled prior to cleaning and sterilization. 9
Manufactured by:
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 EC
2797
REP
Legal Name: Symmetry Medical Manufacturing Inc. 486 West 350 North Warsaw, IN 46582 USA Phone: +1 574 267 8700 www.tecomet.com 7025-99 Rev D (10/06/2021)