INSTRUCTIONS FOR USE (IFU)

Transcription

1 ! INSTRUCTIONS FOR USE (IFU) ME1000 BROACH ADAPTERS Dual Offset Left Broach Adapter Straight Broach Adapter Dual Offset Right Broach Adapter Rx ONLY English (EN) TABLE OF CONTENTS! 1 English

2 INTRODUCTION... 2 GENERAL PRODUCT INFORMATION... 4 HOW SUPPLIED... 4 DEVICE DESCRIPTION... 4 INTENDED USE... 4 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS... 5 SYMBOLS GLOSSARY... 6 SIGNAL WORDS... 6 GENERAL SAFETY INFORMATION... 9 PRODUCT FEATURES AND SPECIFICATIONS ENVIRONMENTAL CONDITIONS OPERATING INSTRUCTIONS SAFETY INSTRUCTIONS BROACH ATTACHMENT & REMOVAL CLEANING SAFETY INSTRUCTIONS POINT OF USE INSTRUCTIONS CONTAINMENT INSTRUCTIONS PREPARATION FOR CLEANING INSTRUCTIONS MANUAL CLEANING INSTRUCTIONS LUBRICATION SAFETY INSTRUCTIONS LUBRICATION INSTRUCTIONS INSPECTION AND FUNCTIONAL TESTING SAFETY INSTRUCTIONS INSPECTION INSTRUCTIONS FUNCTIONAL TESTING INSTRUCTIONS PACKAGING SAFETY INSTRUCTIONS PACKAGING METHODS PACKAGING INSTRUCTIONS STERILIZATION SAFETY INSTRUCTIONS STERILIZATION INSTRUCTIONS STORAGE AND HANDLING SAFETY INSTRUCTIONS STORAGE INSTRUCTIONS TROUBLESHOOTING MAINTENANCE AND REPAIR DISPOSAL AND RECYCLING ORDERING INFORMATION INTRODUCTION These Instructions for Use is recommended for safe, effective and compliant operation, processing and care for the ME1000 Broach Adapters.! 2 English

3 These Instructions for Use is intended for in-service trainers, biomedical equipment technicians, and central supply/sterile processing technicians. Keep and consult these Instructions for Use during the life of the product. NOTES: Medical Enterprises Distribution is referred to as MED in these Instructions for Use. The ME1000 Surgical Impactor and its accessories are referred to as the ME1000 Impact System in these Instructions for Use.! 3 English

4 GENERAL PRODUCT INFORMATION HOW SUPPLIED The ME1000 Broach Adapters are provided non-sterile. The Broach Adapters must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use. Protective covers and films must be completely removed before processing. NOTE: If the Broach Adapter or any of its parts are damaged or missing, please contact your MED Sales Representative for assistance. DEVICE DESCRIPTION ME1000 Adapters are accessories to the ME1000 Impact System which provide a mechanical connection between designated surgical instruments and the ME1000 Surgical Impactor. The ME1000 Broach Adapters are designed and designated for use ONLY with specific DePuy Synthes Hip System Instruments as indicated in the INTENDED USE section of these Instructions for Use. INTENDED USE The ME1000 Broach Adapters are accessories for the ME1000 Surgical Impactor and are used for connecting surgical instruments and devices to the ME1000 Surgical Impactor. The Broach Adapters are intended for patient use ONLY after careful consideration of the Instructions for Use. They are designed for use by physicians and trained medical personnel ONLY. Use the ME1000 Broach Adapters ONLY with the ME1000 Surgical Impactor and the designated DePuy Synthes Hip System Surgical Instruments shown below. SURGICAL IMPACTOR ME1000 SURGICAL IMPACTOR DePuy Synthes SUMMIT Tapered Hip System Surgical Instruments Catalog Number Item Description Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size 10! 4 English

5 DePuy Synthes TRI-LOCK Bone Preservation System Surgical Instruments Catalog Number Item Description Broach Size Starter Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Broach Size Modular Box Osteotome DePuy Synthes CORAIL AMT Hip System Surgical Instruments Catalog Number Item Description L20408 Broach Size 8 L20409 Broach Size 9 L20410 Broach Size 10 L20411 Broach Size 11 L20412 Broach Size 12 L20413 Broach Size 13 L20414 Broach Size 14 L20415 Broach Size 15 L20416 Broach Size 16 L20418 Broach Size 18 L20420 Broach Size 20 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS The warnings and cautions contained within these Instructions for Use relate to the operation, processing and care of the ME1000 Broach Adapters. For additional Warnings, Cautions and contraindications that relate to ME1000 Broach Adapter use with the ME1000 Impact System, reference the ME1000 Surgical Impactor Instructions for Use.! 5 English

6 !!!!!!!!!!!!!!!!!!! SYMBOLS GLOSSARY The following symbols located on the ME1000 Surgical Impactor and its accessories (ME1000 Impact System) and/or labeling are provided and defined in this section. It is recommended that each are studied and understood for proper interpretation. SYMBOL DEFINITION Non-sterile Caution Consult Instructions for Use Class 2 Battery Charger Classified as a Class 2 power supply Device is classified as type B against electrical shock and leakage current. Manufacturer PPE (Personal Protective Equipment) Battery Charger meets CEC efficiency requirements. Temperature Limitation Humidity Limitation Atmospheric Pressure Limitation SYMBOL DEFINITION Combined Canada/U.S. UL listing mark. Combined Canada/U.S. UL classification mark. Direct Current Date of Manufacture Alternating Current Catalog number W V Watts Volt SYMBOL DEFINITION Hz Hertz Serial Number db Ah Decibel Ampere-hour Rx ONLY Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Wh Watt-hour This device should be disposed of in accordance with environmental protection requirements. Lock/Unlock BFP Back Feed Protection SIGNAL WORDS! 6 English

7 The following statements are located on the ME1000 Surgical Impactor and its accessories (ME1000 Impact System) and/or labeling and are intended to explain the levels of risk associated with those products. STATEMENT NOTE MEANING Identifies a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare worker injury. Identifies a product reliability issue. ALWAYS comply with this information to prevent product damage. Supplements and/or clarifies procedural information.! Date Printed: REV A 7 English

8 ! Date Printed: REV A 8 English

9 GENERAL SAFETY INFORMATION SAFETY INSTRUCTIONS WARNINGS: Before using the Broach Adapters, READ and UNDERSTAND all instructions contained in these Instructions for Use. Pay particular attention to safety information. Failure to comply with these Instructions for Use may result in injury. Before using the Broach Adapters with other MED compatible products, READ and UNDERSTAND the Instructions for Use provided with each products to be used. Pay particular attention to safety information. Failure to comply with those instructions may result in injury. Unless otherwise indicated, ONLY use the recommended packaging as indicated in the PACKAGING section of these Instructions for Use for the storage, sterilization and transportation of the Broach Adapters. The use of other packaging may lead to extended cleaning times, inadequate sterilization and product damage. The Broach Adapters must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. DO NOT use a Broach Adapter that has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. ONLY use the Broach Adapter with the ME1000 Surgical Impactor and the designated Surgical Instruments indicated in the INTENDED USE section of these Instructions for Use. Use with other equipment may result in injury and or product damage. DO NOT modify or disassemble the Broach Adapters. Modification or disassembly is considered misuse and could result in injury. CALIFORNIA PROPOSITION 65 WARNING: This product may contain chemicals, including lead, known to the State of California to cause cancer, birth defects or other reproductive harm. Wash hands after handling. CAUTIONS: ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. DO NOT expose the Broach Adapters to conditions in excess of the limitations indicated in the ENVIRONMENTAL CONDITIONS section of these Instructions for Use.! 9 English

10 PRODUCT FEATURES PRODUCT FEATURES AND SPECIFICATIONS The safe use of the Broach Adapters requires an understanding of the information in these Instructions for Use as well as knowledge of the procedure to be performed. Before use of this product, familiarize yourself with all operating features and safety instructions. LOCKING LATCH: Secures the Broach to the ME1000 Broach Adapter. The latch must be in the fully opened position to insert or remove a Broach. LOCKING LATCH CLIP: Maintains the Locking Latch in the fully closed position during use. LOCATOR: Mating feature for the Broach Pin allowing proper connection of the Broach to the ME1000 Broach Adapter. CLOVERLEAF FITTING: Mechanical interface allowing proper connection to the ME1000 Surgical Impactor. GUIDE PIN: Aligns with Locator opening of the Broach allowing proper Broach connection with the ME1000 Broach Adapter. LINKAGE: Hinged mechanism allowing Locking Latch function. See figure 39. Fig. 1 Fig. 2 Fig. 3 Dual Offset Left Broach Adapter Straight Broach Adapter Dual Offset Right Broach Adapter ! 10 English

11 PRODUCT SPECIFICATIONS Straight Broach Adapter: Weight lbs. (0.3 kg) Length in. (15.4 cm) Dual Offset Right Broach Adapter: Weight lbs. (0.7 kg) Length in. (22.2 cm) Dual Offset Left Broach Adapter: Weight lbs. (0.7 kg) Length in. (22.2 cm) PRODUCT IDENTIFICATION AND SAFETY INFORMATION The product label is located on the side of each Broach Adapter and contains product identification. Reference this label for product name, catalog number and serial number. ENVIRONMENTAL CONDITIONS USE TRANSPORTATION* STORAGE Temperature 40 C 104 F 60 C 140 F for max. 72 h 40 C 104 F 10 C 50 F 29 C 20 F 10 C 50 F Relative Humidity 90% 90% 90% 30% 10% 30% Atmospheric Pressure 1000 hpa 1000 hpa 1000 hpa 811 hpa 811 hpa 811 hpa Altitude ft ft. * Transportation conditions were tested according to ASTM D ! 11 English

12 OPERATING INSTRUCTIONS SAFETY INSTRUCTIONS WARNINGS: The Broach Adapter must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. Following sterilization, allow the Broach Adapters to cool for at least 1 hour before use. When handling the Broach Adapters, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. ONLY use the Broach Adapter for its intended use. ALWAYS follow the recommended operating conditions when using the Broach Adapters. Reference the ENVIRONMENTAL CONDITIONS section of these Instructions for Use. MED recommends an alternative manual system to be readily available during each use of the ME1000 Surgical Impactor and its accessory devices in the unlikely event that technical problems occur. Before use, check for misalignment or binding of moving parts, breakage of parts, or any other condition that may affect Broach Adapters operation. Reference the INSPECTION AND FUNCTIONAL TESTING section of these Instructions for Use. DO NOT use the Broach Adapter if it does not have a secure connection to the Broach. Proper fit of the Broach with the Broach Adapter is required for proper function. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. DO NOT use a Broach Adapter that has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. ONLY use the Broach Adapter with the ME1000 Surgical Impactor and the designated Surgical Instruments indicated in the INTENDED USE section of these Instructions for Use. Use with other equipment may result in injury and or product damage. Before use, ALWAYS ensure that the Broach Adapter is secured within the ME1000 Surgical Impactor, the Locking Latch is in the locked and/or fully closed position and the Broach is secured within the Broach Adapter. Unsecured attachments during use may lead to injury. ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. To avoid injury, refer to the Instructions for Use provided by the device Manufacturer for safe and proper handling and use of Surgical Instruments. A defective Broach Adapter may not be reused. Reusing a defective Broach Adapter may lead to injury. Contact your MED Sales Representative for disposition and replacement. DO NOT modify or disassemble the Broach Adapters. Modification or disassembly is considered misuse and could result in injury. DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Broach Adapters unless otherwise specified. These chemicals can lead to inadequate sterilization and/or damage, weaken or destroy device parts that may result in injury. CAUTIONS: ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. DO NOT strike the Broach Adapter with a mallet or any other instrument. NOTES: The user of the Broach Adapters is responsible for their proper use during surgery. The Broach Adapters are intended for patient use ONLY after careful consideration of the Instructions for Use. The Broach Adapters are designed for use by physicians and trained medical personnel ONLY.! 12 English

13 BROACH ATTACHMENT & REMOVAL Broach Adapters are available to connect designated surgical instruments and devices to the ME1000 Surgical Impactor. The Instructions for Use provided with each Broach Adapter indicates the surgical instruments and devices designated for use. Attaching a Broach: See Figure 4 WARNING: ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. 1.Remove the MB1000 Battery Pack from the ME1000 Surgical Impactor, if attached. 2.Raise and hold the Locking Latch in the fully open position. 3.Insert the Broach Pin into the Broach Adapter Locator while also aligning the Broach Adapter Guide Pin with the Locator opening on the Broach. The Guide Pins are intended to seat fully into the Locator openings of each part. Fig. 4 4.Lower the Locking Latch to the fully closed position. Removing a Broach: See Figure 5 WARNING: ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. 1.Remove the MB1000 Battery Pack from the ME1000 Surgical Impactor, if attached. 2.Raise and hold the Locking Latch in the fully open position. 3.Remove the Broach by pulling it straight out of the Broach Adapter. Fig. 5 ME1000 Surgical Impactor Attachment and Removal: Reference the OPERATING INSTRUCTIONS section of the ME10000 Surgical Impactor Instructions for Use for properly attaching and removing the Broach Adapter from the ME1000 Surgical Impactor.! 13 English

14 CLEANING SAFETY INSTRUCTIONS WARNINGS: The Broach Adapter must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. Failure to properly clean instruments prior to sterilization may lead to inadequate sterilization. Surgical instruments are used with or on patients who may harbor both recognized and unrecognized infections. To prevent the spread of infection, all reusable instruments must be thoroughly cleaned and sterilized prior to initial use and after each patient use. Instruments may have sharp edges or features. Users and reprocessors must be cautious when handling instruments. ONLY the manual cleaning method as indicated in these Instructions for Use is recommended for cleaning the Broach Adapters. Other cleaning methods were not validated and may lead to inadequate cleaning, sterilization and product damage. ONLY individuals trained and experienced in the processing of reusable medical devices should clean the Broach Adapters. Brushes and other cleaning tools should either be single-use disposable items or, if reusable, decontaminated at least daily. Contaminants could otherwise be transferred from one device to the next during cleaning and pose health risks to healthcare workers. MED recommends the Broach Adapters to be cleaned using fresh detergent solution. ALWAYS make sure detergent solution is completely rinsed from Broach Adapters before drying the devices. DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Broach Adapters unless otherwise specified. These chemicals can lead to inadequate sterilization and/or damage, weaken or destroy device parts that may result in injury. ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. To avoid injury, refer to the Instructions for Use provided by the device Manufacturer for safe and proper handling and use of Surgical Instruments. When handling the Broach Adapters, ALWAYS use personal protective! 14 English equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. CAUTIONS: To avoid physical damage with other equipment, ONLY transport the Broach Adapters in their recommended packaging. Reference the PACKAGING section of these Instructions for Use. DO NOT allow soil to dry on the Broach Adapters. Maintain moisture on the devices as indicated in these Instructions for Use to prevent drying and facilitate cleaning. DO NOT use pressurized water as this may cause damage to the Broach Adapters. DO NOT use ultrasonic equipment to clean the Broach Adapters. Detergents with a ph of are recommended. Higher or lower ph values can cause damage to Broach Adapter materials. ALWAYS prepare the detergent solution per the detergent manufacturer s Instructions for Use. ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. DO NOT use sharp, hard, abrasive, pointed or metal cleaning aids (e.g. pipe cleaning, wire brushes, etc.) to clean the Broach Adapters. NOTES: The cleaning and sterilization instructions provided in these Instructions for Use were validated as being capable of preparing this product for use. It is the responsibility of the health care facility to ensure that reprocessing is performed using the appropriate equipment and materials, and that designated personnel have been adequately trained in order to achieve the proper result. ALWAYS verify the cleaning and sterilization processes using your actual equipment and designated personnel to ensure proper results are achieved. The cleaning instructions in these Instructions for Use apply ONLY to the ME1000 Broach Adapters. Repeated processing according to these Instructions for Use has minimal effect on and should not compromise the performance of the Broach Adapters. End of life is normally determined by wear and damage due to use. MED used the following cleaning agents during validation of the manual cleaning instructions. These cleaning agents

15 are not listed in preference to other available cleaning agents which may perform satisfactorily. Type: Neutral ph Enzymatic Detergent Product Name: EmPower Dual Enzymatic Detergent Product Catalog Number: Detergents used on the ME1000 Broach Adapters will be in contact with the following product materials: Stainless steel. DO NOT use tools to remove ME1000 Surgical Impactor accessory attachments or to operate ME1000 Impact System movable part (e.g. locks, latches, etc.)! 15 English

16 POINT OF USE INSTRUCTIONS Recommended Point of Use Supplies for Broach Adapters: Soft lint-free cloth Tap water Point of Use Steps for Broach Adapters: See Figures 6-11 WARNING: ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. NOTES: Reference the OPERATING INSTRUCTIONS section of the ME1000 Surgical Impactor Instructions for Use for properly removing the MB1000 Battery Pack and Broach Adapters from the ME1000 Surgical Impactor. Reference the OPERATING INSTRUCTIONS of these Instructions for Use for properly removing the Broach from the Broach Adapter. 1.Remove the MB1000 Battery Pack from the ME1000 Surgical Impactor. Fig. 6 2.Remove the Broach Adapter from the ME1000 Surgical Impactor. Fig. 7 3.Remove Broaches from the Broach Adapters if attached. Fig. 8! 16 English

17 4.Position all Broach Adapter movable parts for cleaning access. Raise the Locking Latch to the fully open position. 5.Wipe the surfaces of each Broach Adapter using a clean soft lint-free cloth dampened with clean tap water to remove gross soil and debris. Fig. 9 6.Flush the cannulations in Right and Left Offset Broach Adapters using a syringe filled with clean tap water. Fig. 10 Fig. 11! 17 English

18 CONTAINMENT INSTRUCTIONS Recommended Containment Supplies & Devices for Broach Adapters: Soft lint-free towels Tap water Case Medical SteriTite Full Size Sealed Container w/ Lid w/etched MED Logo Case Medical MediTray Full Size Insert Basket Preconfigured for MED Fig. 12 Containment Steps for Broach Adapter: See Figures Load each Broach Adapter into its designated place in the MediTray Insert Basket. Place Locking Latches in the closed position prior to loading. Position the Broach Adapter in the MediTray Insert Basket with the catalog number facing up. Fig Place the loaded MediTray Insert Basket into the SteriTite Container.! 18 English

19 3.Cover Broach Adapters and ME1000 Surgical Impactor with clean soft lint-free towels dampened with clean tap water to prevent drying of soil and debris on the device prior to cleaning. 4.Place the SteriTite Container Lid over the SteriTite Container and latch securely for transport. Fig It is recommended that the Broach Adapters are reprocessed as soon as is reasonably practical following each use. Fig. 14! 19 English

20 PREPARATION FOR CLEANING INSTRUCTIONS Preparation for Cleaning Steps for Broach Adapters: See Figures WARNING: ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. NOTES: Reference the OPERATING INSTRUCTIONS section of the ME1000 Surgical Impactor Instructions for Use for properly removing the MB1000 Battery Pack and ME1000 Adapters from the ME1000 Surgical Impactor. Reference the OPERATING INSTRUCTIONS of these Instructions for Use for properly removing the Broach from the Broach Adapter. Reference the SteriTite Instructions for Use for properly reprocessing the SteriTite Container and MediTray Insert Basket. 1.Remove the Lid from the SteriTite Container. 2.Remove Broach Adapters from the MediTray Insert Basket. Fig Ensure all attachments are removed from the Broach Adapter. If the Broach Adapter is attached to a ME1000 Surgical Impactor with a connected MB1000 Battery Pack, remove the Battery Pack first before removing any other attachments. Fig. 17! 20 English Fig. 18

21 4.Position all Broach Adapter movable parts for cleaning access. Raise the Locking Latch to the fully open position. Fig. 19 MANUAL CLEANING INSTRUCTIONS Recommended Manual Cleaning Supplies for Broach Adapters: ph Neutral Enzymatic Detergent Soft lint-free cloth Various sized soft bristle nylon brushes Syringe Tap Water De-ionized (DI) water Filtered pressurized compressed air (20 psi) Manual Cleaning Steps for Broach Adapters: See Figures Rinse gross soil from all surfaces of each Broach Adapter for at least three (3) minutes under cool running tap water. Manipulate the Locking Latch of each Broach Adapter under running water to rinse hidden surfaces. Use a clean soft lint-free cloth, soft bristle nylon brush and/or syringe filled with tap water to assist in removing gross soil from each device. Fig Prepare a fresh batch of ph neutral enzymatic detergent solution according to the detergent manufacturer s written instructions.! 21 English

22 3.Using a soft bristled nylon brush and while devices are submerged in detergent solution, remove any visible soil from each Broach Adapter by thoroughly scrubbing all surfaces of each device with detergent solution for at least five (5) minutes. Manipulate the Locking Latch of each device when brushing the Linkage and to access hidden surfaces. Use a syringe filled with enzymatic detergent solution to thoroughly flush all cannulations in the Dual Offset Right and Left Broach Adapters for a minimum of three (3) times. Use a syringe filled with enzymatic detergent solution to flush any other areas that may be shielded from brushing. CLEAN WHILE FULLY SUBMERGED Fig. 21 Fig. 22 CLEAN WHILE FULLY SUBMERGED FULLY SUBMERGED Fig. 23 MANIPULATE MOVABLE PARTS WHILE SUBMERGED Fig. 24! 22 English

23 4.Rinse all surfaces of each Broach Adapter thoroughly under lukewarm running tap water for at least two (2) minutes to remove all traces of detergent solution. Manipulate the Locking Latch of each device under running water to rinse hidden surfaces. Use a syringe filled with tap water to thoroughly flush all cannulations in the Dual Offset Right and Left Broach Adapters for a minimum of three (3) times. Use a syringe filled with tap water to flush any other hard-to-reach areas. Fig. 25 Fig Visually inspect all surfaces of each Broach Adapter for remaining soil. Manipulate the Locking Latch of each device when inspecting the Linkage and Locator to inspect hidden surfaces. Pay close attention to crevices, cannulations and any hard-to-reach areas. If soil is observed, repeat steps 1-5 using a fresh batch of detergent solution. Fig. 27! 23 English

24 NOTE: Deionized (DI) water is recommended for the final rinse of the Broach Adapters. Mineral residues from hard water can stain the product and/or prevent effective cleaning 6. Rinse all surfaces of each Broach Adapter thoroughly under de-ionized (DI) water for at least two (2) minutes. Manipulate the Locking Latch of each device under running water to rinse hidden surfaces. Use a syringe filled with de-ionized (DI) water to thoroughly flush all cannulations in the Dual Offset Right and Left Broach Adapters for a minimum of three (3) times. Use a syringe filled with de-ionized (DI) water to flush any other hard-to-reach areas. 8.Dry each Broach Adapter using a clean soft lintfree cloth or filtered pressurized compressed air. Manipulate the Locking Latch of each device to dry hidden surfaces. Pay close attention to crevices, cannulations and openings where moisture can accumulate. DE-IONIZED (DI) WATER RINSE Fig Position each Broach Adapter horizontally on a clean lint-free absorbent cloth with the Locking Latch facing up. Allow each Broach Adapter to drain for at least two (2) Minutes. Fig. 29 Fig. 30! 24 English Fig. 31

25 LUBRICATION SAFETY INSTRUCTIONS WARNINGS: The Broach Adapters must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. When handling the Broach Adapters, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. DO NOT modify or disassemble the Broach Adapters. Modification or disassembly is considered misuse and could result in injury. ONLY use STERILIT I DRIP LUBRICATOR (REF:. JG598) to lubricate the ME1000 Broach Adapters following cleaning as indicated in these Instructions for Use. DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Broach Adapters unless otherwise specified. These chemicals can lead to inadequate sterilization and/or damage, weaken or destroy device parts that may result in injury. After each cleaning and prior to sterilization, ALWAYS perform the lubrication instructions as indicated in these Instructions for Use. Failing to follow these instructions will lead to damage and malfunction, increasing the risk of injury. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. DO NOT strike the Broach Adapter with a mallet or any other instrument. ONLY individuals trained and experienced in the maintenance of reusable medical devices should lubricate the Broach Adapters. CAUTIONS:! 25 English

26 LUBRICATION INSTRUCTIONS Lubricate each Broach Adapter following the completion of every cleaning and prior to sterilization using STERILIT I Drip Lubricator. Follow the lubricant manufacturer s Instructions for Use (i.e. concentration/dilution and shelf life). Lubrication steps for individual Broach Adapter components are detailed in the instructions that follow. Reference the BROACH ADAPTER COMPONENT LUBRICATION SITES provided in these instructions for use for assistance in locating each component indicated in the lubrication instructions. See Figures Recommended Lubrication Supplies for Broach Adapters: STERILIT I DRIP LUBRICATOR REF: JG598 Soft lint-free cloth Lint-free absorbent cloth WARNING: ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. NOTES: A droplet symbol containing a numerical value is provided to show the recommended number of lubrication droplets for each component. See Figure 32 ALWAYS remove the Broach and the ME1000 Surgical Impactor from the Broach Adapter prior to lubrication. Fig. 32! 26 English

27 Linkage: See Figures Hold the Broach Adapter horizontally with the Locking Latch fully open and facing down to expose the underside of the Broach Adapter. 2.Put one drop of lubricant on the Linkage joint of each Broach Adapter. The Straight Broach Adapter has 2 Linkage joints. The Dual Offset Left and Right Broach Adapters have 3 Linkage Joints. 3.Raise and lower the Locking Latch several times to spread lubricant. Fig Wipe off excess lubricant from Broach Adapter housing using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Fig. 34 Fig. 35! 27 English

28 Locator: See Figure 36 1.Put one drop of lubricant on the inner wall of the Locator opening for each Broach Adapter. 2.Spread lubricant evenly along the surface using the lubricant applicator tip in a circular action. 3.Wipe off excess lubricant from Broach Adapter housing using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Fig. 37 STRAIGHT BROACH ADAPTER Locking Latch Hinge: See Figures Raise the Locking Latch to its fully open position. 2.Put one drop of lubricant in the Locking Latch joint located between the Locking Latch and the Broach Adapter housing. 3.Raise and lower the Locking Latch several times to spread the lubricant. 4.Wipe off excess lubricant from Broach Adapter housing using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Fig. 38 Fig. 36 DUAL OFFSET LEFT AND RIGHT BROACH ADAPTER! 28 English

29 Broach Adapter Component Lubrication Sites: ME1000 DUAL OFFSET LEFT AND RIGHT BROACH ADAPTER Locator Locking Latch Hinge Linkage Locking Latch Hinge Linkage Locator ME1000 STRAIGHT BROACH ADAPTER Fig. 39! 29 English

30 SAFETY INSTRUCTIONS INSPECTION AND FUNCTIONAL TESTING WARNINGS: The Broach Adapter must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. When handling the Broach Adapters, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. To avoid injury, refer to the Instructions for Use provided by the device Manufacturer for safe and proper handling and use of Surgical Instruments. ONLY use the Broach Adapter for its intended use. Before use, check for misalignment or binding of moving parts, breakage of parts, or any other condition that may affect Broach Adapter operation. Reference the INSPECTION AND FUNCTIONAL TESTING section of these Instructions for Use. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. DO NOT use a Broach Adapter that has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. DO NOT use the Broach Adapter if it does not have a secure connection to the Broach. Proper fit of the Broach with the Broach Adapter is required for proper function. ONLY use the Broach Adapter with the ME1000 Surgical Impactor and the designated Surgical Instruments indicated in the INTENDED USE section of these Instructions for Use. Use with other equipment may result in injury and or product damage. Before use, ALWAYS ensure that the Broach Adapter is secured within the ME1000 Surgical Impactor, the Locking Latch is in the locked and/or fully closed position and the Broach is secured within the Broach Adapter. Unsecured attachments during use may lead to injury. ALWAYS remove the MB1000 Battery Pack from the ME1000 Surgical Impactor before attaching or removing ME1000 Adapters (including surgical instruments and devices designated for use with the Adapters), processing, lubricating and/or performing inspection. Removing the MB1000 Battery Pack will prevent unexpected operation that could cause injury. A defective Broach Adapter may not be reused. Reusing a defective Broach Adapter may lead to injury. Contact your MED Sales Representative for disposition and replacement. DO NOT modify or disassemble the Broach Adapters. Modification or disassembly is considered misuse and could result in injury. DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Broach Adapters unless otherwise specified. These chemicals can lead to inadequate sterilization and/or damage, weaken or destroy device parts that may result in injury. Following lubrication and prior to sterilization, ALWAYS perform the functional testing instructions as indicated in these Instructions for Use. Failing to follow these instructions will lead to damage and malfunction, increasing the risk of injury. ONLY individuals trained and experienced in the maintenance of reusable medical devices should inspect and test the Broach Adapters. CAUTIONS: ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. ALWAYS follow the recommended operating conditions when using the Broach Adapters. Reference the ENVIRONMENTAL CONDITIONS section of these Instructions for Use. DO NOT strike the Broach Adapter with a mallet or any other instrument. NOTE: The routine inspection and functional testing as indicated in the following instructions, are the best methods for determining the life span of the Broach Adapters. INSPECTION INSTRUCTIONS Inspection Steps for Broach Adapters:! 30 English

31 1.Visually inspect each cleaned Broach Adapter for damage and wear. Reference the following bulleted examples: Damage: (e.g. cracked, dented or separated housing, physical imperfections that can cause damage or injury, etc.) Wear: (e.g. corrosion, removed or illegible part numbers, symbols and markings, etc.) 2.If damage or wear is detected, contact your MED Sales Representative for disposition and replacement. DO NOT sterilize, or allow a ME1000 Broach Adapter with damage or wear to be reused. 4.If no damage or wear is detected, immediately proceed to the following functional testing instructions. Recommended Functional Testing Supplies for Broach Adapters: Lint-free Surgical Towel FUNCTIONAL TESTING INSTRUCTIONS Insertion / Removal of Attachments and Movable Parts: See Figures Verify the following criteria for all Inspected Broach Adapters while performing the functional tests indicated below. Locking Latch movement is smooth and without blockage. Insertion and removal of surgical instrument from each Broach Adapter is smooth and without blockage. ME1000 Surgical Impactor Insertion and removal of each Broach Adapter is smooth and without Blockage. Broach Attachment: See Figures Raise and hold the Locking Latch of a cleaned, lubricated and inspected Broach Adapter in the fully open position. Fig. 40! 31 English

32 2.Using a clean lint free surgical towel, cover the cutting surface of a cleaned Broach that is designated for use with the ME1000 Broach Adapters. 3.Insert the Broach into the Broach Adapter and lower the Locking Latch to the fully closed position. Fig While holding the Broach Adapter with one hand and while placing the other hand around the cloth covered Broach, Pull the Broach forward and backward to verify a secure, locked connection while also verifying the Locking Latch remains closed. Fig Raise and hold the Locking Latch in the fully open position and remove the Broach. 6.Repeat steps 1-6 for all remaining Broach Adapters, ensuring all Broach Adapters are functional tested with an appropriate Broach prior to sterilization. Fig. 43! 32 English

33 Broach Adapter Attachment: See Figures NOTE: Reference the OPERATING INSTRUCTIONS section of the ME1000 Surgical Impactor Instructions for Use for properly attaching and removing the Broach Adapter from the ME1000 Surgical Impactor. 5.Remove the MB1000 Battery Pack from the ME1000 Surgical Impactor, if attached. Fig Insert a cleaned, lubricated and inspected Broach Adapter into the Locking Collar of a cleaned, lubricated and inspected ME1000 Surgical Impactor and rotate the Locking Collar to the Locked position. Fig While holding the ME1000 Surgical Impactor with one hand, pull the Broach Adapter forward and backward to verify a secure, locked connection. Fig Rotate the ME1000 Surgical Impactor Locking Collar to the unlocked position and remove the Broach Adapter. 9.Repeat steps 1-3 for all remaining cleaned and lubricated Broach Adapters, ensuring all Broach Adapters are functional tested with the ME1000 Surgical Impactor prior to sterilization. Fig. 47! 33 English

34 PACKAGING SAFETY INSTRUCTIONS WARNINGS: When handling the Broach Adapters, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. Unless otherwise indicated, ONLY use the recommended packaging as indicated in the PACKAGING section of these Instructions for Use for the storage, sterilization and transportation of the Broach Adapters. The use of other packaging may lead to extended cleaning times, inadequate sterilization and product damage. ALWAYS make sure the Broach Adapters have been properly cleaned, lubricated, inspected, functional tested and are completely dry prior to sterile packaging. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. DO NOT use a Lid on the MediTray Insert Basket for packaging the ME1000 Broach Adapters. The use of a MediTray Lid for ME1000 Surgical Impactor sterilization is not recommended and may lead to inadequate sterilization of the device. ONLY Trays and Containers manufactured for or Distributed by MED should contain MED products as indicated by MED. Use of other containment devices are not recommended and may lead to extended cleaning times, inadequate sterilization and product damage. For Preconfigured Tray, Basket and Container layouts, areas designated for specific devices shall ONLY contain those devices and in the configuration specified by MED. DO NOT add devices to a preconfigured Tray, Basket or Container in excess of its defined device configuration. Overcrowding and/or incorrect loading can result in product damage and impact the effectiveness of sterilization. ONLY load the devices indicated in the TABLE 1 PACKAGING section of these Instructions for Use into the MediTray Insert Basket Preconfigured for MED. CAUTION: ALWAYS handle the Broach Adapter with care to prevent product damage. DO NOT drop the Broach Adapter. NOTES: The validated sterilization instructions provided in these Instructions for Use are ONLY applicable to the product configurations and packaging methods as indicated in the PACKAGING section of these Instructions for Use. Reference the SteriTite Instructions for Use for the recommended use of disposable sterilization accessories. (i.e. Chemical Indicators, Load Cards, Tamper Evident Seals, etc.) with the MediTray Insert Basket and the SteriTite Container.! 34 English

35 PACKAGING METHODS The packaging method recommended for the sterilization, sterile storage and transport of the ME1000 Broach Adapters is described below and specified in the PACKAGING INSTRUCTIONS section of these Instructions for Use. No other packaging method is recommended for use with this product. Packaging Method: SteriTite Container w/meditray : SteriTite Full Size Sealed Container w/lid and w/etched MED Logo with enclosed MediTray Full Size Insert Basket Preconfigured for MED. See Figures For non-sterile storage of the Broach Adapters, ONLY use the SteriTite Container w/meditray packaging method or if in good condition, the original product packaging. Contact your MED Sales Representative if replacement product packaging is needed. PACKAGING INSTRUCTIONS Recommended Packaging for Surgical Impactor: Case Medical SteriTite Full Size Sealed Container w/lid w/etched MED Logo REF: SC06FG Case Medical SteriTite Disposable Filters Cellulosic 7.5" Dia. 1000/pk. (For use with REF: SC06FG SteriTite Full Size Sealed Container) REF: SCF01 Case Medical MediTray Full Size Insert Basket Preconfigured for MED REF: BSKF06 Packaging Steps for Broach Adapters: See Figures WARNINGS: ALWAYS make sure the Broach Adapters have been properly cleaned, lubricated, inspected, functional tested and are completely dry prior to sterile packaging. ONLY load the devices indicated in the TABLE 1 PACKAGING section of these Instructions for Use into the MediTray Insert Basket Preconfigured for MED. NOTE: Reference the SteriTite Instructions for Use for the recommended use of disposable sterilization accessories. (i.e. Chemical Indicators, Load Cards, Tamper Evident Seals, etc.) with the MediTray Insert Basket and the SteriTite Container. 1.Load clean, lubricated and dry Broach Adapters into their designated place in the MediTray Insert Basket. Place Locking Latches in the closed position prior to loading. Position the Broach Adapter in the MediTray Insert Basket with the catalog number facing up. Fig. 48! 35 English

36 2.Place the loaded MediTray Insert Basket into the SteriTite Container. SteriTite Sterilization Container Base and Loaded MediTray Insert Basket BSKF06 MediTray Full Size Insert Basket Preconfigured for MED SC06FG SteriTite Full Size Sealed Container Base w/etched MED Logo Fig Place SteriTite Filters into the filter housings on the SteriTite Container Lid as indicated in the Case Medical SteriTite Instructions for Use. 4.Place the SteriTite Container lid over the SteriTite Container and latch securely.. SteriTite Sterilization Container Base, Lid and enclosed MediTray Insert Basket SteriTite Full Size Container Lid for SC06FG w/etched MED Logo BSKF06 MediTray Full Size Insert Basket Preconfigured for MED SC06FG SteriTite Full Size Sealed Container Base w/etched MED Logo Fig. 50! 36 English

37 Table 1: Load Plan for MediTray Full Size Insert Basket Preconfigured for MED REF Product Description QTY ME1000 SURGICAL IMPACTOR ME1000 STRAIGHT BROACH ADAPTER ME1000 DUAL OFFSET LEFT BROACH ADAPTER ME1000 DUAL OFFSET RIGHT BROACH ADAPTER 1 LOADED BSKF06 MEDITRAY INSERT BASKET PRECONFIGURED FOR MED ME1000 Surgical Impactor ME1000 Straight Broach Adapter ME1000 Dual Offset Left Broach Adapter ME1000 Dual Offset Right Broach Adapter Fig. 51 Table 2: Load Dimensions for SteriTite Container and MediTray Insert Basket REF Product Description Dimensions SC06FG BSKF06 STERITITE FULL SIZE SEALED CONTAINER W/LID W/ETCHED MED LOGO MEDITRAY FULL SIZE INSERT BASKET PRECONFIGURED FOR MED 23.5 x 11 x 6 (59.7 x 28 x 15.24cm) 21.3" x 9.7" x 6.0" (54.1 x 24.6 x 15.2cm)! 37 English

38 STERILIZATION SAFETY INSTRUCTIONS WARNINGS: When handling the Broach Adapters, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. The Broach Adapters must be cleaned, lubricated, inspected, functional tested and sterilized prior to first use and after every subsequent use as indicated in these Instructions for Use. Protective covers and films must be completely removed before reprocessing. ONLY individuals trained and experienced in the processing of reusable medical devices should sterilize the Broach Adapters. DO NOT use or process a ME1000 Broach Adapter for use if damage, wear, corrosion or missing parts are apparent or the inspection criteria are not met. Contact your MED Sales Representative for disposition and replacement. ALWAYS make sure the Broach Adapters have been properly cleaned, lubricated, inspected, functional tested and are completely dry prior to sterilization. DO NOT use a Lid on the MediTray Insert Basket for packaging the ME1000 Broach Adapters. The use of a MediTray Lid for ME1000 Surgical Impactor sterilization is not recommended and may lead to inadequate sterilization of the device. Autoclave design and performance can affect the sterilization process. ALWAYS verify the process using your actual equipment and designated personnel. ONLY use the recommended sterilization methods as indicated in these Instructions for Use. Using other sterilization methods may lead to inadequate sterilization and/or product damage. ALWAYS Follow the recommended dry times to prevent moisture accumulation. Moisture may prevent proper sterilization and/or damage the Broach Adapters. Following sterilization, allow Broach Adapters to cool for at least 1 hour before use. CAUTIONS: DO NOT dry Broach Adapters in an oven. ONLY compressed air and/or clean soft lint-free cloth are recommended for drying this product. Residual moisture from cleaning may lead to product damage. DO NOT expose Broach Adapters to conditions in excess of the Sterilization Exposure Time and Temperature indicated in these Instructions for Use. Exceeding recommended steam sterilization exposure times or temperatures for Broach Adapters may reduce product life, affect performance and/or damage the product. MED does not recommend immediate-use steam sterilization for Broach Adapters. NOTES: The cleaning and sterilization instructions provided in these Instructions for Use were validated as being capable of preparing this product for use. It is the responsibility of the health care facility to ensure that reprocessing is performed using the appropriate equipment and materials, and that designated personnel have been adequately trained in order to achieve the proper result. ALWAYS verify the cleaning and sterilization processes using your actual equipment and designated personnel to ensure proper results are achieved. The final responsibility for verification of sterilization techniques lies directly with the healthcare facility. To ensure the efficacy of health care facility processing, all cycles and methods should be verified for different sterilization chambers, packaging methods, and/or various loading configurations. Under certain classifications of risk, the World Health Organization (WHO), or local regulatory authorities recommend special CJD (Creutzfeldt-Jakob Disease) inactivation processing procedures. Consult WHO and local regulations for further information. The sterilization instructions provided in these Instructions for Use apply ONLY to the ME1000 Broach Adapters. Repeated processing according to these Instructions for Use has minimal effect on and should not compromise the performance of the Broach Adapters. End of life is normally determined by wear and damage due to use. STERILIZATION INSTRUCTIONS Sterilization Steps for Broach Adapters:! 38 English