INSTRUCTIONS FOR USE (IFU)

Transcription

1 !! INSTRUCTIONS FOR USE (IFU) ME1000 SURGICAL IMPACTOR Rx ONLY English (EN)! 1 English

2 TABLE OF CONTENTS INTRODUCTION... 2 GENERAL PRODUCT INFORMATION... 4 HOW SUPPLIED... 4 DEVICE DESCRIPTION... 4 INTENDED USE... 4 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS... 4 SYMBOLS GLOSSARY... 5 SIGNAL WORDS... 6 GENERAL SAFETY INFORMATION... 9 PRODUCT FEATURES AND SPECIFICATIONS ENVIRONMENTAL CONDITIONS OPERATING INSTRUCTIONS SAFETY INSTRUCTIONS BATTERY PACK ATTACHMENT & REMOVAL ADAPTER ATTACHMENT & REMOVAL IMPACT MODE FORWARD AND REVERSE OPERATION 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 ELECTROMAGNETIC COMPATIBILITY INTRODUCTION! 2 English

3 These Instructions for Use is recommended for safe, effective and compliant operation, processing and care for the ME1000 Surgical Impactor. 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 Surgical Impactor is provided non-sterile. The Surgical Impactor 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 Surgical Impactor or any of its parts are damaged or missing, please contact your MED Sales Representative for assistance. DEVICE DESCRIPTION The ME1000 Surgical Impactor is a battery-powered impaction tool which provides power to designated surgical instruments and devices through the ME1000 Adapters. INTENDED USE The ME1000 Surgical Impactor is intended for use in delivering power to surgical instruments to impact hard tissue or bone during surgical procedures, and in the placement and removal of implants, cups, nails, wires, pins and other devices, including acetabular cups and acetabular cup liners. The Surgical Impactor is intended for patient use ONLY after careful consideration of the Instructions for Use. It is designed for use by physicians and trained medical personnel ONLY. Use the ME1000 Surgical Impactor ONLY with the ME1000 Adapters and MB1000 Battery Pack as shown below. BATTERY PACK MB1000 BATTERY PACK ADAPTERS ONLY ME1000 Adapters designated for use with ME1000 Surgical Impactor may be used. For use limitations, instructions and ordering information, reference the ME1000 Adapter Instructions for Use and/or contact your MED Sales Representative or MED for additional support. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS The surgeon must evaluate if the ME1000 Surgical Impactor and its accessories, referred to henceforth as (ME1000 Impact System) are appropriate for the intended procedure, based on the designed capabilities of the ME1000 Impact System with regards to bone density, bone strength, bone size, surgical approach and anatomical situation. Additionally, the manufacturer s contraindications and use considerations for the surgical instrument or device which MED has designated for use with the ME1000 Impact System, must be fully understood and considered prior to use. The MED designated surgical instruments and devices for use with the ME1000 Impact System are identified in the ME1000 Adapter Instructions for Use. Contact your MED Sales Representative or MED for additional support. The warnings and cautions contained within these Instructions for Use relate to the operation, processing and care of the ME1000 Surgical Impactor in addition to its use with the MB1000 Battery Pack and ME1000 Adapters.! 4 English

5 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.! 5 English

6 !!!!!!!!!!!!!!!!!!! SYMBOL DEFINITION Caution PPE (Personal Protective Equipment) Consult Instructions for Use Device is classified as type B against electrical shock and leakage current. SYMBOL Battery Charger meets CEC efficiency requirements. DEFINITION Combined Canada/U.S. UL listing mark. Manufacturer Temperature Limitation Combined Canada/U.S. UL classification mark. Direct Current Humidity Limitation W Alternating Current Watts Atmospheric Pressure Limitation V Hz Volt Hertz Date of Manufacture db Ah Decibel Ampere-hour SYMBOL Catalog number DEFINITION Serial Number Wh Watt-hour This device should be disposed of in accordance with environmental protection requirements. Rx ONLY Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. BFP Back Feed Protection Lock/Unlock Non-sterile Class 2 Battery Charger Classified as a Class 2 power supply 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 Surgical Impactor, 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 Surgical Impactor with other MED compatible products, READ and UNDERSTAND the Instructions for Use provided with each product 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 Surgical Impactor. The use of other packaging may lead to extended cleaning times, inadequate sterilization and product damage. The Surgical Impactor 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 Surgical Impactor 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 the Surgical Impactor if it has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. DO NOT operate or store the Surgical Impactor where flammable or explosive vapors and/or gasses may be present. ONLY use the Surgical Impactor with the MB1000 Battery Pack and ME1000 Adapters 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 Surgical Impactor. 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 Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. DO NOT expose the Surgical Impactor to conditions in excess of the limitations indicated in the ENVIRONMENTAL CONDITIONS section of these Instructions for Use. NOTES: The Surgical Impactor is classified as type BF applied part against electrical shock and leakage current. The Surgical Impactor is suitable for use on patients in accordance with UL For important information regarding electromagnetic compatibility (EMC), reference the ELECTROMAGNETIC COMPATIBLITY section within these Instructions for Use.! 9 English

10 ! PRODUCT FEATURES PRODUCT FEATURES AND SPECIFICATIONS The safe use of the Surgical Impactor 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. DETENT REGION: Mechanical interface allowing proper connection of the ME1000 Adapters to the ME1000 Surgical Impactor ANVIL: Transmits impact energy from the internal impact mechanism to the Locking Collar. LOCKING COLLAR: Rotary mechanism allowing locked and unlocked connection of Adapters which are properly inserted into the Detent Region. TRIGGER: Spring loaded, momentary switch which initiates impact cycling when fully depressed. BATTERY PACK PORT: The Mechanical interface for the MB1000 Battery Pack. The Battery Pack Port is designed to mate with the Battery Pack Raised Rib to enable the Battery Pack Terminals to electrically connect to the Surgical Impactor. BATTERY PACK LATCH: Secures the MB1000 Battery Pack to the ME1000 Surgical Impactor. The Battery Pack Latch must be in the fully opened position to insert a Battery Pack. The Battery Pack Latch is shown in the fully closed position in the image below. GLAMOR CAP: Covers and protects the Anvil while providing pinch point protection between the Locking Collar and the ME1000 Surgical Impactor housing. PRODUCT SPECIFICATIONS Fig. 1! 10 English

11 Motion... Linear Direction Modes... Forward, Backward Impact frequency Hz Switch Type... Momentary Switch Weight (Surgical Impactor Only) lb. (2.2 kg) Dimensions in. L x 3.5 in. W x 8.5 in. H (36.2 cm L x 8.9 cm W x 21.6 cm H) Degree of protection against electrical shock... BF Degree of protection against water penetration... IPX5 Duty Cycle...5 Seconds On/10 Seconds Off* Operating voltage V DC *Thermal limitations: If the Surgical Impactor stops functioning or only allows single impact mode operation after extended use, allow the MB1000 Battery Pack to cool to room temperature before resuming operation. PRODUCT IDENTIFICATION AND SAFETY INFORMATION The product label is located on the side of the Surgical Impactor and contains product identification and safety information. Reference this label for product name, catalog number and serial number. Important safety information and operation ratings are also included on this label. ENVIRONMENTAL CONDITIONS USE TRANSPORTATION* STORAGE Temperature 30 C 86 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 Surgical Impactor 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 Surgical Impactor to cool for at least 1 hour before use. When handling the Surgical Impactor, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. The user should ALWAYS use hearing protection when operating the Surgical Impactor. DO NOT operate or store the Surgical Impactor where flammable or explosive vapors and/or gasses may be present. ONLY use the Surgical Impactor for its intended use. To avoid unintended operation, DO NOT place the Surgical Impactor in a magnetic environment. MED recommends an alternative manual system to be readily available during each use of this product in the unlikely event that technical problems occur. Normally, one fully charged MB1000 Battery Pack has sufficient capacity for an entire operation. As a precaution, it is recommended that a second fully charged and sterilized MB1000 Battery Pack is readily available for use so that it can be quickly exchanged under sterile conditions during the surgical procedure, if necessary. To prevent unintended operation, ONLY attach the MB1000 Battery Pack when ready to use Surgical Impactor. Before use, check for misalignment or binding of moving parts, breakage of parts, or any other condition that may affect the Surgical Impactor s operation. Reference the INSPECTION AND FUNCTIONAL TESTING section of these Instructions for Use. MED recommends using MB1000 Battery Packs that have been charged within the last 30 days. DO NOT use or process a ME1000 Surgical Impactor 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 the Surgical Impactor if it has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. Due to vibration of the Surgical Impactor, DO NOT use for more than 3 hours in a 24-hour period. Avoid unintended contact with Trigger when handling the Surgical Impactor with an attached MB1000 Battery Pack. DO NOT use the Surgical Impactor if the Trigger does not turn it on and off. If the Surgical Impactor cannot be controlled with the Trigger, it is dangerous and must be replaced. Contact your MED Sales Representative for disposition and replacement. If the Surgical Impactor continues to operate after the Trigger is released, remove it from the use area, then with assistance, remove the MB1000 Battery Pack. ONLY use the Surgical Impactor with the MB1000 Battery Pack and ME1000 Adapters 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 Locking Collar and Battery Pack Latch are in the locked and/or fully closed position and secured within the Surgical Impactor. If the ME1000 Adapter has a locking mechanism, ALWAYS ensure it is in the locked position and its attachment is secured within the ME1000 Adapter. Unsecured attachments during use may lead to injury. DO NOT use a ME1000 Adapter if it does not have a secure connection to the ME1000 Surgical Impactor. Proper fit of the Adapter with the ME1000 Surgical Impactor is required for proper function. DO NOT use a MB1000 Battery Pack if it does not have a secure connection to the ME1000 Surgical Impactor. When in use, ensure sterile Surgical Impactor components and accessory attachments do not come in contact with non-sterile surfaces outside of the sterile field. DO NOT place hands near moving components during use. During a procedure or reprocessing, ALWAYS place the Surgical Impactor on its side when not being handled to avoid the risk of dropping the device. ALWAYS remove the MB1000 Battery Pack from the 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 prevent damage to the Surgical Impactor and unexpected interruptions in use, ALWAYS follow the duty cycle when using this product. Reference the PRODUCT FEATURES AND SPECIFICATIONS section of these Instructions for Use. A defective Surgical Impactor may not be reused. Reusing a defective Surgical Impactor may lead to injury. Contact your MED Sales Representative for disposition and replacement. DO NOT modify or disassemble the Surgical Impactor. Modification or disassembly is considered misuse and could result in injury.! 12 English

13 DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Surgical Impactor 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 Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. ALWAYS follow the recommended operating conditions when using the Surgical Impactor. Reference the ENVIRONMENTAL CONDITIONS section of these Instructions for Use. DO NOT strike the Surgical Impactor with a mallet or any other instrument. DO NOT unnecessarily operate the Surgical Impactor without being in contact with an impact surface. NOTES: The user of the Surgical Impactor is responsible for their proper use during surgery. The Surgical Impactor is intended for patient use ONLY after careful consideration of the Instructions for Use. The Surgical Impactor is designed for use by physicians and trained medical personnel ONLY.! 13 English

14 BATTERY PACK ATTACHMENT & REMOVAL Attaching a MB1000 Battery Pack: See Figures 2-3 WARNING: ALWAYS remove the MB1000 Battery Pack from the 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. 3.Lower the Battery Pack Latch into the fully closed position when the MB1000 Battery Pack is not attached to prevent damage to the Battery Pack Latch. NOTE: The Surgical Impactor is operational at the point of attachment with a charged MB1000 Battery Pack. 1.If any ME1000 Adapters are connected to the Surgical Impactor, fully extend the Anvil by pulling the Adapter straight out with one hand while holding the Surgical Impactor with the other. 2.Lift the Battery Pack Latch to the fully open position. 3.Align the MB1000 Battery Pack Raised Ribs with the Grooves in the Battery Pack Port and slide the MB1000 Battery Pack into place. 4.Lower the Battery Pack latch until it engages into the fully closed position. 5.While holding the Surgical Impactor with one hand, pull the MB1000 Battery Pack forward and backward to verify a secure, locked connection. Fig. 2 REMOVE Removing a MB1000 Battery Pack: See Figure 4 1.Lift the Battery Pack Latch to the fully open position. 2.Remove the MB1000 Battery Pack by sliding the MB1000 Battery Pack straight out of the Battery Pack Port. Fig. 3! 14 English

15 ADAPTER ATTACHMENT & REMOVAL Fig. 4 ME1000 Adapters are available to connect designated surgical instruments and devices to the Surgical Impactor. The Instructions for Use provided with each ME1000 Adapter indicates the surgical instruments and devices designated for use. Attaching a ME1000 Adapter: See Figures 5-7 WARNING: ALWAYS remove the MB1000 Battery Pack from the 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 Surgical Impactor. 2.Rotate the Locking Collar to the unlocked position by aligning the arrow symbol on the Locking Collar with the unlock symbol on the Glamor Cap. 3.Insert the ME1000 Adapter into the Detent Region of the Locking Collar until it is fully seated. 4.Rotate the Locking Collar to the locked position by aligning the arrow symbol on the Locking Collar with the lock symbol on the Glamor Cap. Fig. 5 NOTE: The Locking Collar is designed to allow the ME1000 Adapter to be inserted in 90 increments. 5.While holding the Surgical Impactor with one hand, pull the ME1000 Adapter forward and backward to verify a secure, locked connection. Fig. 6 6.Finish by pulling the ME1000 Adapter so that the Anvil is in the fully extended position.! 15 English Fig. 7

16 Removing a ME1000 Adapter: See Figures 8-9 WARNING: ALWAYS remove the MB1000 Battery Pack from the 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 Surgical Impactor. Fig. 8 2.Rotate the Locking Collar to the unlocked position by aligning the arrow symbol on the Locking Collar with the Unlock Symbol on the Glamor Cap. 3.Remove the ME1000 Adapter by pulling it straight out of the Locking Collar. Fig. 9! 16 English

17 IMPACT MODE The Surgical Impactor delivers power in single impact mode and continuous impact cycle mode. The impact mode is controlled by depressing the Trigger. The Trigger function is described in further detail below. NOTE: During use, observe the listed duty cycle of 5 seconds of use, followed by a 10 second rest for up to 8 cycles. Once 8 cycles are complete, allow the Surgical Impactor to cool for a minimum of 4 minutes before continued use. Single Impact Cycle Mode: 1.Depress and immediately release the Trigger. 2.The Surgical Impactor will deliver 1 impact. Continuous Impact Cycle Mode: 1.Depress and hold the Trigger. 2.The Surgical Impactor will deliver 1 impact, followed by a millisecond delay. 3.Continuous impact cycling will begin following the delay. FORWARD OPERATION 4.Release the Trigger to end impacting. FORWARD AND REVERSE OPERATION The direction of the Surgical Impactor s linear motion is selected by the operator by pushing forward or pulling backward on the Surgical Impactor. Forward Operation: See Figure 10 1.Pushing forward with the Surgical Impactor while depressing the Trigger delivers forward linear motion. Reverse Operation: See Figure 11 1.Pulling backward on the Surgical Impactor while depressing the Trigger delivers backward linear motion. REVERSE OPERATION Fig. 10! 17 English

18 Fig. 11! 18 English

19 CLEANING SAFETY INSTRUCTIONS WARNINGS: The Surgical Impactor 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 Surgical Impactor. Other cleaning methods have not been 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 Surgical Impactor. 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 Surgical Impactor to be cleaned using fresh detergent solution. ALWAYS make sure the detergent solution is completely rinsed from the Surgical Impactor before drying the device. DO NOT allow petroleum-based products, penetrating oils, solvents, lubricants or other chemicals to come in contact with the Surgical Impactor unless otherwise specified. These chemicals can lead to inadequate sterilization and/or damage, weaken or destroy device parts that may result in injury. DO NOT use or process a ME1000 Surgical Impactor 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 remove the MB1000 Battery Pack from the 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. When handling the Surgical Impactor, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. CAUTIONS: To avoid physical damage with other equipment, ONLY transport the Surgical Impactor in its recommended packaging. Reference the PACKAGING section of these Instructions for Use. DO NOT allow soil to dry on the Surgical Impactor. Maintain moisture on the device 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 Surgical Impactor. DO NOT use automated or ultrasonic equipment to clean the Surgical Impactor. DO NOT immerse the Surgical Impactor or allow liquid to soak into its terminals or openings. During cleaning, the product may be placed under running water to thoroughly rinse all surfaces. Detergents with a ph of are recommended. Higher or lower ph values can cause damage to the Surgical Impactor materials. ALWAYS prepare the detergent solution per the detergent manufacturer s Instructions for Use. ALWAYS handle the Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. During a procedure or reprocessing, ALWAYS place the Surgical Impactor on its side when not being handled to avoid the risk of dropping the device. DO NOT bend the Surgical Impactor terminals during cleaning. DO NOT use sharp, hard, abrasive, pointed or metal cleaning aids (e.g. pipe cleaning, wire brushes, etc.) to clean the Surgical Impactor.! 19 English 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

20 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. DO NOT use tools to remove ME1000 Surgical Impactor accessory attachments or to operate ME1000 Impact System movable part (e.g. locks, latches, etc.) The cleaning instructions in these Instructions for Use apply ONLY to the ME1000 Surgical Impactor. Repeated processing according to these Instructions for Use has minimal effect on and should not compromise the performance of the ME1000 Surgical Impactor. 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 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 Surgical Impactor will be in contact with the following product materials: Stainless steel, Aluminum, Gold, Plastic, Rubber, and Silver/Tin! 20 English

21 POINT OF USE INSTRUCTIONS Recommended Point of Use Supplies for Surgical Impactor: Soft lint-free cloth Tap water Point of Use Steps for Surgical Impactor: See Figures WARNING: ALWAYS remove the MB1000 Battery Pack from the 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. NOTE: Reference the OPERATING INSTRUCTIONS section of these Instructions for Use for properly removing the MB1000 Battery Pack and ME1000 Adapters from the Surgical Impactor. 1.Remove the MB1000 Battery Pack from the Surgical Impactor. Fig Remove the ME1000 Adapter from the Surgical Impactor. Fig Position all Surgical Impactor movable parts for cleaning access. Raise the Battery Pack Latch to the fully open position. Fully extend the Anvil. Place the Locking Collar in the locked Position to expose the Lubrication Openings. Fig. 14! 21 English

22 4.Wipe the surfaces of the Surgical Impactor using a clean soft lint-free cloth dampened with clean tap water to remove gross soil and debris. CONTAINMENT INSTRUCTIONS Fig. 15 Recommended Containment Supplies & Devices for Surgical Impactor: 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 Containment Steps for Surgical Impactor: See Figures Load the Surgical Impactor into its designated place in the MediTray Insert Basket. Place the Anvil in the fully extended position and the Battery Pack Latch in the fully open position. Rotate the Locking Collar to the locked Position to expose the Lubrication Openings. Position the Surgical Impactor in the MediTray Insert Basket with the catalog number facing up. Fig Place the loaded MediTray Insert Basket into the SteriTite Container. Fig. 17! 22 English

23 3.Cover the Surgical Impactor and ME1000 Broach Adapters with clean soft lint-free towels dampened with clean tap water to prevent drying of soil and debris on the device prior to cleaning. Fig Place the SteriTite Container Lid over the SteriTite Container and latch securely for transport. 5.It is recommended that the Surgical Impactor is reprocessed as soon as is reasonably practical following each use. Fig. 18 PREPARATION FOR CLEANING INSTRUCTIONS! 23 English

24 Preparation for Cleaning Steps for Surgical Impactor: See Figures WARNING: ALWAYS remove the MB1000 Battery Pack from the 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 these Instructions for Use for properly removing the MB1000 Battery Pack and ME1000 Adapters from the Surgical Impactor and for further instruction on Battery Pack Latch and Locking Collar operation. 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 the Surgical Impactor from the MediTray Insert Basket. Fig Ensure all attachments are removed from the Surgical Impactor. If the MB1000 Battery Pack is connected to the Surgical Impactor, remove the MB1000 Battery Pack first before removing any other attachments. Remove the ME1000 Adapter from the Surgical Impactor if attached. Fig. 21 Fig. 22! 24 English

25 4.Position all Surgical Impactor movable parts for cleaning access. Raise the Battery Pack Latch to the fully open position. Fully extend the Anvil. Rotate the Locking Collar to the locked position to expose the Lubrication Openings Fig. 23 MANUAL CLEANING INSTRUCTIONS Recommended Manual Cleaning Supplies for Surgical Impactor: 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) Fig. 24 Manual Cleaning Steps for Surgical Impactor: See Figures CAUTION: To prevent extended drain times and product damage, DO NOT hold the Battery Pack Port under running water while rinsing, position at an angle to prevent water from entering the Surgical Impactor. 1.Rinse gross soil from all Surgical Impactor surfaces, including Battery Pack Port Terminals, for at least three (3) minutes under cool running tap water. Manipulate the Trigger, Locking Collar and Battery Pack Latch 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 device. Fig Prepare a fresh batch of ph neutral enzymatic detergent solution according to the detergent manufacturer s written instructions.! 25 English

26 3.Using a soft bristled nylon brush wetted with detergent solution, remove any visible soil from the Surgical Impactor by scrubbing all device surfaces with detergent solution for at least five (5) minutes. Manipulate the Trigger, Locking Collar and Battery Pack Latch to scrub hidden surfaces. Scrub all surfaces behind the Locking Collar and inside the Battery Pack Port, including Battery Pack Port Terminals. Scrub the inside of the Locking Collar Opening using an appropriate brush, ensuring the inner walls and the full depth of the Opening are reached. Place the Locking Collar in the Locked Position to access the Lubrication Openings between the Locking Collar Teeth. Flush the inside of each Lubrication Opening using a syringe filled with detergent solution for a minimum of three (3) times. Use a syringe filled with detergent solution to flush any other areas they may be shielded from brushing, ensuring detergent solution contacts all device surfaces. Fig. 26 Fig. 27 Fig. 28! 26 English

27 CAUTION: To prevent extended drain times and product damage, DO NOT hold the Battery Pack Port under running water while rinsing, position at an angle to prevent water from entering the Surgical Impactor. Fig. 30 Fig Rinse all Surgical Impactor surfaces thoroughly under lukewarm running tap water for at least two (2) minutes to remove all traces of detergent solution. Manipulate the Trigger, Locking Collar and Battery Pack Latch under running water to rinse hidden surfaces. Place the Locking Collar in the locked position to access the Lubrication Openings between the Locking Collar Teeth. Flush the inside of each Lubrication Opening using a syringe filled with tap water for a minimum of three (3) times. Use a syringe filled with tap water to flush any other hard-to-reach areas.! 27 English

28 5.Visually inspect all Surgical Impactor surfaces for any remaining soil. Manipulate the Trigger, Locking Collar and Battery Pack Latch to inspect hidden surfaces. Inspect all surfaces behind the Locking Collar and inside the Battery Pack Port. Pay close attention to crevices, grooves, and any hard-to-reach areas. If soil is observed, repeat steps 1-5 using a fresh batch of detergent solution. Fig. 31 CAUTION: To prevent extended drain times and product damage, DO NOT hold the Battery Pack Port under running water while rinsing, position at an angle to prevent water from entering the Surgical Impactor. NOTE: Deionized (DI) water is recommended for the final rinse of the Surgical Impactor. Mineral residues from hard water can stain the product and/or prevent effective cleaning. Fig. 32 DE-IONIZED (DI) WATER RINSE 6.Rinse all Surgical Impactor surfaces thoroughly under de-ionized (DI) water for at least two (2) minutes. Manipulate the Trigger, Battery Pack Latch and Locking Collar under running water to rinse hidden surfaces. Place the Locking Collar in the locked position to access the Lubrication Openings between the Locking Collar Teeth. Flush the inside of each Lubrication Opening using a syringe filled with de-ionized (DI) water for a minimum of three (3) times. Use a syringe filled with de-ionized (DI) water to flush any other hard-to-reach areas.! 28 English Fig. 33 X

29 7.With the Locking Collar in the in the locked position, the Anvil Shaft fully extended and the Battery Pack Latch open, position the Surgical Impactor at a decline on a clean absorbent lintfree cloth with the Locking Collar pointed down. Allow the Surgical Impactor to drain for at least two (2) minutes. Fig Dry all Surgical Impactor surfaces using a clean soft lint-free cloth or filtered pressurized compressed air. Manipulate the Trigger, Battery Pack Latch and Locking Collar to dry hidden surfaces. Pay close attention to crevices, grooves, and openings where moisture can accumulate. Fig. 34! 29 English

30 LUBRICATION Fig. 36! 30 English

31 The Surgical Impactor 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 Surgical Impactor, 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 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 Surgical Impactor. Modification or disassembly is considered misuse and could result in injury. ONLY use STERILIT I DRIP LUBRICATOR (REF. JG598) to lubricate the ME1000 Surgical Impactor 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 Surgical Impactor 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 indicted 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 Surgical Impactor 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. ONLY individuals trained and experienced in the maintenance of reusable medical devices should lubricate the Surgical Impactor. CAUTIONS: ALWAYS handle the Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. During a procedure or reprocessing, ALWAYS place the Surgical Impactor on its side when not being handled to avoid the risk of dropping the device. DO NOT strike the Surgical Impactor with a mallet or any other instrument.! 31 English

32 LUBRICATION INSTRUCTIONS Lubricate the Surgical Impactor 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 Surgical Impactor components are detailed in the instructions that follow. Reference the SURGICAL IMPACTOR 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 Surgical Impactor: STERILIT I DRIP LUBRICATOR REF: JG598 Soft lint-free cloth Lint-free absorbent cloth WARNING: ALWAYS remove the MB1000 Battery Pack from the 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 containing a numerical value is provided to show the recommended number of lubrication droplets for each component. See Figure 37 Remove all attachments from the Surgical Impactor prior to lubrication. Fig. 37 Anvil: See Figure 38 1.Fully extend the Anvil by pulling the Locking Collar straight out with one hand while holding the Surgical Impactor with the other hand. If the Anvil is difficult to extend, attach a ME1000 Adapter to the Surgical Impactor to extend the Anvil as indicated in the Anvil OPERATING INSTRUCTIONS section of these Instructions for Use. 2.Put 4 drops of lubricant evenly spaced around the base of the Anvil Shaft. 3.Retract and extend the Anvil Shaft several times to spread lubricant by pushing the Locking Collar inward and pulling it outward. Fig Wipe off excess lubricant from the Glamor Cap and Locking Collar using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Locking Collar Lubrication Openings: See Figure 39! 32 English

33 1.Place the Locking Collar in the locked position to access Lubrication Openings between Locking Collar Teeth. 2.Put 1 drop of lubricant in each Lubrication Opening. Rotate the Locking Collar to the locked and unlocked position several times to spread lubricant. Locking Collar Lubrication Openings Fig. 39 Detent Region: See Figures Put 2 drops of lubricant on the inner wall inside the Detent Region. 2.Spread the lubricant evenly along the surface using the lubricant applicator tip in a circular action. Detent Region Fig Drain any excess lubricant from the Locking Collar by holding the Surgical Impactor vertically with the Locking Collar pointed down on a clean absorbent cloth for 2 minutes. 4.Wipe off excess lubricant from the Locking Collar using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Fig. 41! 33 English

34 Trigger Shaft: See Figure 42 1.Position the Surgical Impactor horizontally with the product label side up. 2.Put 1 drop of lubricant on the Trigger Shaft. 3.Depress and release the Trigger several times to spread lubricant. 4.Wipe off excess lubricant from the Trigger housing using a clean soft lint-free cloth. 5.Avoid wiping intended lubrication areas. Trigger Shaft Fig. 42 Battery Pack Latch Hinges: See Figure 43 1.Place the Battery Pack Latch in the locked positon. 2.Put 1 drop of lubricant on each Battery Pack Latch Hinge Pin. 3.Raise and lower the Battery Pack Latch several times to spread lubricant. 4.Wipe off excess lubricant from the Battery Pack Latch using a clean soft lint-free cloth. Avoid wiping intended lubrication areas. Battery Pack Latch Hinges Fig. 43! 34 English

35 Surgical Impactor Component Lubrication Sites: Locking Collar Lubrication Openings Detent Region Battery Pack Latch Hinges Anvil Trigger Shaft Fig. 44! 35 English

36 SAFETY INSTRUCTIONS INSPECTION AND FUNCTIONAL TESTING WARNINGS: The Surgical Impactor 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 Surgical Impactor, ALWAYS use personal protective equipment (PPE) including safety goggles as recommended by the healthcare facility guidelines and cleaning agent SDS. The user should ALWAYS use hearing protection when operating the Surgical Impactor. DO NOT operate or store the Surgical Impactor where flammable or explosive vapors and/or gasses may be present. ONLY use the Surgical Impactor for its intended use. To prevent unintended operation, ONLY attach the MB1000 Battery Pack when ready to use Surgical Impactor. To avoid unintended operation, DO NOT place the Surgical Impactor in a magnetic environment. Before use, check for misalignment or binding of moving parts, breakage of parts, or any other condition that may affect the Surgical Impactor s operation. Reference the INSPECTION AND FUNCTIONAL TESTING section of these Instructions for Use. DO NOT use or process a ME1000 Surgical Impactor 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 the Surgical Impactor if it has been dropped and appears damaged or is not functioning properly. Contact your MED Sales Representative for disposition and replacement. Avoid unintended contact with Trigger when handling the Surgical Impactor with an attached MB1000 Battery Pack. DO NOT use the Surgical Impactor if the Trigger does not turn it on and off. If the Surgical Impactor cannot be controlled with the Trigger, it is dangerous and must be replaced. Contact your MED Sales Representative for disposition and replacement. If the Surgical Impactor continues to operate after the Trigger is released, remove it from the use area, then with assistance, remove the MB1000 Battery Pack. ONLY use the Surgical Impactor with the MB1000 Battery Pack and ME1000 Adapters indicated in the INTENDED USE section of these Instructions for Use. Use with other equipment may result in injury and/or product damage. Due to vibration of the Surgical Impactor, DO NOT use for more than 3 hours in a 24-hour period. Before use, ALWAYS ensure that the Locking Collar and Battery Pack Latch are in the locked and/or fully closed position and secured within the Surgical Impactor. If the ME1000 Adapter has a locking mechanism, ALWAYS ensure it is in the locked position and its attachment is secured within the ME1000 Adapter. Unsecured attachments during use may lead to injury. DO NOT use a ME1000 Adapter if it does not have a secure connection to the ME1000 Surgical Impactor. Proper fit of the Adapter with the ME1000 Surgical Impactor is required for proper function. DO NOT use a MB1000 Battery Pack if it does not have a secure connection to the ME1000 Surgical Impactor. DO NOT place hands near moving components during use. ALWAYS remove the MB1000 Battery Pack from the 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 prevent damage to the Surgical Impactor and unexpected interruptions in use, ALWAYS follow the duty cycle when using this product. Reference the PRODUCT FEATURES AND SPECIFICATIONS section of these Instructions for Use. A defective Surgical Impactor may not be reused. Reusing a defective Surgical Impactor may lead to injury. Contact your MED Sales Representative for disposition and replacement. DO NOT modify or disassemble the Surgical Impactor. 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 Surgical Impactor 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 inspection and 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 Surgical Impactor. CAUTIONS: ALWAYS handle the Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. During a procedure or reprocessing, ALWAYS place the Surgical Impactor on its side when not being handled to avoid the risk of dropping the device.! 36 English

37 DO NOT strike the Surgical Impactor with a mallet or any other instrument. DO NOT unnecessarily operate the Surgical Impactor without being in contact with an impact surface. ALWAYS follow the recommended operating conditions when using the Surgical Impactor. Reference the ENVIRONMENTAL CONDITIONS section of these Instructions for Use. NOTE: The routine inspection and functional testing as indicated in the following instructions, are the best methods for determining the life span of the Surgical Impactor.! 37 English

38 INSPECTION INSTRUCTIONS Inspection Steps for Surgical Impactor: WARNING: ALWAYS remove the MB1000 Battery Pack from the 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.Visually inspect cleaned Surgical Impactor 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 Surgical Impactor with damage or wear to be reused. 3.If no damage or wear is detected, immediately proceed to the following functional testing instructions. FUNCTIONAL TESTING INSTRUCTIONS Insertion / Removal of Attachments and Movable Parts: See Figures NOTE: Reference the OPERATING INSTRUCTIONS section of these Instructions for Use for insertion/ Removal of attachments and Surgical Impactor Operation assistance while performing the following functional tests. Verify the following criteria while performing the functional tests indicated below. Locking Collar and Battery Pack Latch movement is smooth and without blockage. Trigger depression and release is smooth and without blockage. Insertion and removal of ME1000 Adapter and MB1000 Battery Pack is smooth and without blockage.! 38 English ME1000 Adapter Attachment: See Figures 45-48

39 1.Remove the MB1000 Battery Pack from the Surgical Impactor if attached. Fig Insert a ME1000 Adapter into the Locking Collar and rotate the Locking Collar to the Locked position. Fig While holding the Surgical Impactor with one hand, pull the ME1000 Adapter forward and backward to verify a secure, locked connection. Fig Rotate the Locking Collar to the unlocked position and remove the ME1000 Adapter. MB1000 Battery Pack Attachment and Surgical Impactor Operation: See Figures Fig Remove ME1000 Adapter from Surgical Impactor if attached.! 39 English

40 2.Insert a fully charged MB1000 Battery Pack into Battery Pack Port and lower the Battery Pack Latch to the fully closed position. Fig. 49 Fig While holding the Surgical Impactor with one hand, pull the MB1000 Battery Pack forward and backward to verify a secure, locked connection. Fig. 51! 40 English

41 4. Aim the Surgical Impactor towards the floor, taking care to avoid aiming the Surgical Impactor at anyone. 5.Depress the trigger for 1-2 seconds to operate the Surgical Impactor. DO NOT depress for a longer period since the Surgical Impactor is designed to operate against an impact surface. 6.If the Surgical Impactor does not perform one or more impact cycles, reference the TROUBLESHOOTING section of these Instructions for Use. If the Surgical Impactor continues to not operate properly contact your MED Sales Representative for disposition and replacement. Fig. 52 Fig Remove the MB1000 Battery Pack from the Surgical Impactor after functional testing is complete. 8.Remove the ME1000 Adapter from the Surgical Impactor after the MB1000 Battery Pack has been removed.! 41 English

42 ! 42 English Fig. 54

43 SAFETY INSTRUCTIONS WARNINGS: When handling the Surgical Impactor, 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 Surgical Impactor. The use of other packaging may lead to extended cleaning times, inadequate sterilization and product damage. ALWAYS make sure the Surgical Impactor has been properly cleaned, lubricated, inspected, functional tested and is completely dry prior to sterile packaging. DO NOT use or process a ME1000 Surgical Impactor 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 Surgical Impactor. The use of a MediTray Lid with the ME1000 Surgical Impactor 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 Surgical Impactor with care to prevent product damage. DO NOT drop the Surgical Impactor. During a procedure or reprocessing, ALWAYS place the Surgical Impactor on its side when not being handled to avoid the risk of dropping the device. NOTES: The validated sterilization instructions provided in these Instructions for Use are ONLY applicable to the product configurations and packaging methods 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. PACKAGING METHODS! 43 English

44 The packaging method recommended for the sterilization, sterile storage and transport of the ME1000 Surgical Impactor 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 56,57 For non-sterile storage of the Surgical Impactor, 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 Surgical Impactor: See Figures WARNINGS: ALWAYS make sure the Surgical Impactor has been properly cleaned, lubricated, inspected, functional tested and is 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 Surgical Impactor into its designated place in the MediTray Insert Basket. Prior to loading, place the Anvil in the fully extended position and the Battery Pack Latch in the fully open position. Place the Locking Collar in the Locked Position. Position the Surgical Impactor in the MediTray Insert Basket with the catalog number facing up. Fig. 55! 44 English

45 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. 57 Table 1: Load Plan for MediTray Full Size Insert Basket Preconfigured for MED! 45 English

46 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 Straight Broach Adapter ME1000 Dual Offset Left Broach Adapter ME1000 Surgical Impactor ME1000 Dual Offset Right Broach Adapter Fig. 58 Table 2: 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)! 46 English