Micro Handpiece for FMS VUE Fluid Management and Tissue Debridement Systems

ENGLISH MICRO HANDPIECE Some products may not be licensed in all jurisdictions.

DESCRIPTION The Micro Handpiece is an accessory device to the FMS VUE™ system. The handpiece consists of a locking and rotating device for holding burrs and blades, and three buttons for controlling shaver rotation direction and BLOODSTOP™ functions (Figure 1). The device provides suction through a suction port when connected to the FMS VUE pump or wall suction. 2b 1

2a

2c

2

3

4

7

5 8

5 6

Figure 1. Micro Handpiece Components PART

FUNCTION

1

Blade locking ring

Holds blade or burr in place

2

Suction

Controls suction through the suction port.

2a

BLOODSTOP

Activates the BLOODSTOP mode.

2b

Shaver rotation mode button

Press to change from forward to reverse to oscillate mode.

2c

ON/OFF button

Turns the shaver on and off

3

Serial number

4

Suction port

The suction tubing is connected to the suction port

5

Blade alignment slots

Aligns blade face up or face down

6

Protective cap

Covers the connector during cleaning

7

Connector sleeve

Pull on sleeve to remove the cable from the control unit.

8

Connector alignment dot

Matches with the dot on the control unit to indicate proper connector alignment.

INTENDED USE The FMS Micro Handpiece is intended for use with the FMS systems in a surgical setting by personnel trained in arthroscopy. 2

INDICATION FOR USE The Micro Handpiece is an accessory to the FMS VUE Fluid Management and Tissue Debridement System. The FMS VUE Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

CONTRAINDICATIONS Do not use the Micro Handpiece with systems other than the FMS VUE.

WARNINGS • This equipment may be operated only by arthroscopic surgeons. The surgeon using this device must be trained in arthroscopic surgical procedures, be aware of the risks associated with those procedures, and have current knowledge of technological advances in surgical products and techniques. • Prior to use, check the system components for damage. Check the cable integrity carefully. If there are signs of damage, do not use. • Failure to follow all applicable instructions may result in serious surgical consequences to the patient. • Do not wrap handpiece cable around metal objects. Wrapping cables around metal objects may induce currents that could lead to electric shock, fire and/or injury to patient or surgical personnel. • This device has been tested and found in compliance with limits of medical devices according IEC 60601-1-2 2007 standard. These limits are designed to provide reasonable protection in a typical medical installation, against harmful interference when devices are located in close proximity. If the pump is causing harmful interference with other devices, turn the main power off, then on again to determine if it is causing the interference, relocate the system or separate it from other devices. If you cannot resolve the problem contact DePuy Customer Service at 1-800-382-4682. In the European Union, contact your local affiliate. • Disconnect the device from the pump when cleaning or inspecting. • Do not insert anything other than approved DePuy Mitek burrs and blades into the distal end of the handpiece.

PRECAUTIONS • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • Read the instructions, cautions, and warnings provided with all FMS VUE System accessories before use. Your sales representative can advise which accessories are used with these systems.

INSTRUCTIONS FOR USE Refer to the following manual for instructions for using the handpiece with the FMS VUE system: • FMS VUE Operator’s Manual (Ref. IFU-110665)

HANDPIECE CLEANING AND STERILIZATION CAUTION: T  hese guidelines do not guarantee that the device is sterile after the procedure. The institution is responsible for sterility assurance validation.

Automated Cleaning Clean and sterilize before and after each use: 1. Place the protective cap securely onto the shaver handpiece connector. 2. Leave the suction toggle in the open «MAX» position. Soak soiled instruments per manufacturer’s instructions (minimum of 15 minutes) in the enzymatic solution. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hard-to-reach areas, textured surfaces, or crevices. Rinse the instrument thoroughly with warm tap water. 3. Carry out five (5) to and fro motions with a swab-type brush on all surfaces, paying particular attention to lumens, holes and spring loaded retractable features. Immerse the instrument in the neutral pH cleaning solution to avoid aerosol generation. Actuate moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features. 4. Actuate and/or retract moveable parts while rinsing: The Locking System: (Inner and Outer parts) Open and close the locking system to ensure that it is free of foreign bodies. The Suction Port: Pass running water through the suction port, with the suction toggle switch in the fully open position. The Suction Toggle: Open and close the suction toggle several times. Rinse the inner and outer parts thoroughly. 5. Check for remaining debris and remove as needed. 6. Carry out a second soaking bath in a pH-neutral detergent prepared in accordance with the manufacturer’s instructions for a minimum of 15 minutes in an ultrasound bath. 7. Rinse with deionized water for 30 seconds. 3

8. Dry the instrument immediately after final rinse. 9. Confirm the protective cap is securely on the shaver handpiece connector. 10. Clean in a validated washer disinfector using the “INSTRUMENTS” cycle and a pH-neutral cleaning agent intended for use in automated cleaning. Effective cleaning can be achieved using the following parameters: a. Pre-wash at ambient temperature for a minimum time of 4 min. b. Enzyme washes with enzymatic cleaning agent for a minimum time of 4 min. c. Wash at a minimum temperature of 60°C with a pH neutral cleaning agent for a minimum time of 3 min. d. Rinse with hot water for a minimum time of 20 seconds. e. Dry at a minimum temperature of 95°C for a minimum time of 5 min.

Manual Cleaning 1. Place the protective cap securely onto the shaver handpiece connector. 2. Leave the suction toggle in the open «MAX» position. 3. Carry out a first soaking bath in a pH-neutral detergent solution for a minimum of 15 minutes. 4. Carry out five (5) to and fro motions with a swab-type brush on all surfaces, paying particular attention to lumens, holes and spring loaded retractable features. Immerse the instrument in the neutral pH cleaning solution to avoid aerosol generation. Actuate moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features. • The Locking System: Open and close the locking system to ensure that it is free of foreign bodies (Inner and Outer parts). • The Suction Port: Pass running water through the suction port, with the suction toggle switch in the fully open position. • The Suction Toggle: Open and close the suction toggle several times. Irrigate the inner and outer parts thoroughly. 5. Check for remaining debris and remove as needed. 6. Ultrasonically clean for a minimum of 15 minutes in a second soaking bath using a pH-neutral detergent prepared in accordance with the manufacturer’s instructions. 7. While actuating moving parts, rinse all areas of the device with deionized water for 30 seconds. 8. Dry with medical air at less than 100°C or 212°F for 30 seconds. CAUTION: Do not direct air into the blade seal.

Inspection after Cleaning 1. Inspect before sterilization or storage to ensure the complete removal of soil from surfaces and holes. 2. If soil is still present, re-clean.

Sterilization Use a validated, properly maintained and calibrated steam sterilizer. Effective steam sterilization can be achieved using the following cycles: Pre-vacuum cycle of 132°C for 4 minutes

MAINTENANCE Inspect equipment and cables periodically for wear. Return to DePuy Mitek Repair Service if you notice damage to the handpiece or its components.

STORAGE Store in a cool dry area (below 26°C, 80°F). Sterile product, once opened, should be used in surgery or discarded. Never return to storage.

SPECIFICATIONS Recommended Handpiece Utilization Cycle: 1 minute every 6 minutes

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