Tornado Micro II Instructions for Use

ENGLISH Tornado Micro II

DESCRIPTION The Tornado Micro II handpiece is an accessory device to the FMS VUE™ systems (FMS VUE and FMS VUE II). The handpiece consists of a locking and rotating device for holding shavers and burrs, and includes (for REF. 283812 only) three buttons for controlling shaver or burr rotation direction and BLOODSTOP™ functions (Figure 1). A foot pedal also may be used to control shaver or burr rotation direction. The device provides suction through a suction port when connected to the FMS VUE/FMS VUE II pump or wall suction.

2c

2a

2

4

5 2b

1

3

7

10

8

9

6

Figure 1. Tornado Micro II handpiece components

2

PART

FUNCTION

1

Locking ring

Holds shaver or burr in place.

2

Suction lever

Controls suction through the suction port.

2a

BLOODSTOP button

Activates the BLOODSTOP mode.

2b

Handpiece rotation mode button

Press to change from forward to reverse to oscillate mode.

2c

ON/OFF button

Turns the handpiece on and off.

3

Serial number

Handpiece Identification.

4

Suction port

Connects to the FMS tubing.

5

Alignment slots

Aligns shaver or burr face up or face down.

6

Protective cap

Covers the connector during cleaning.

7

Connector alignment arrow

Aligns with the red dot on the FMS connection port to indicate proper connector alignment.

8

Handpiece cable connector

Connects to FMS connection port.

9

FMS connection port

Connection port for handpiece or FMS CONNECT Interface Cable.

10

Cable

3m cable that connects handpiece to the pump.

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

INDICATION FOR USE The Tornado Micro II handpiece is an accessory to the FMS VUE/FMS VUE II Fluid Management and Tissue Debridement Systems. The FMS VUE/FMS VUE II Fluid Management and Tissue Debridement Systems are 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 Tornado Micro II handpiece with systems other than the FMS VUE/FMS VUE II.

WARNINGS • This equipment may be operated only by personnel trained in arthroscopy. The personnel must also 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 to IEC 60601-1-2: 2014 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 Synthes Customer Service at +1‑(800)‑382‑4682 in the United States or contact your DePuy Synthes sales representative. Outside of the United States, contact your local affiliate. • Disconnect the device from the pump when cleaning or inspecting. • Do not insert anything other than approved DePuy Mitek shavers and burrs into the distal end of the handpiece. • For patients with, or suspected with, Creutzfeldt-Jakob disease (CJD), variant CJD or other transmissible spongiform encephalopathy (TSE) and related infections, it is recommended to treat the patient using single-use instruments. Safely dispose of all devices used in accordance with local procedures and guidelines. • Failure to follow the Cleaning and Sterilization instructions may result in an infection.

3

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/FMS VUE II System accessories before use. Your sales representative can advise which accessories are used with these systems. • Blade/burr should be fully inserted and correctly assembled into the device to prevent soft tissue irritation. • Failure to follow the Specifications section for using the device may result in burns due to the device overheating. • A delay to the surgical procedure may occur due to mechanical and/or electrical failures while using the device. Refer to the Maintenance section for indications that the device needs service.

ADVERSE REACTIONS The following list of adverse effects may be associated with the use of this device: • Electrical Shock; • Infection; • Soft Tissue Irritation; • Burns (device overheating); • Surgical Delay;

INSTRUCTIONS FOR USE Default Button control mode To…

Press…

System Response

Start/Stop shaver & burr rotation

Starts and stops shaver & burr rotation.

Change shaver & burr rotation direction (Forward or Oscillate)

MODE button switches between oscillate and forward

Reverse shaver & burr rotation

Reverses shaver & burr rotation direction

Start BLOODSTOP mode

BLOODSTOP Mode is enabled

Activate/deactivate override feature when the Foot Pedal is connected to the pump

MODE and ON/OFF buttons are Activate/deactivate on handpiece when the Foot Pedal is connected to the pump

Activate/deactivate Default Button Control mode to Dedicated button control mode (Only for FMS II)

ON/OFF button becomes a dedicated Oscillate button. MODE button becomes a dedicated forward button

4

Dedicated button control mode (Only for FMS VUE II) To…

Press…

System Response

Activate/deactivate Oscillate function

Starts and stops Oscillate

Activate/deactivate Forward/Reverse

Starts and stops Forward/Reverse

Change direction between Reverse/Forward

Changes rotation direction

Start BLOODSTOP mode

BLOODSTOP Mode is enabled

Activate/deactivate override feature when the Foot Pedal is connected to the pump

MODE and ON/OFF buttons are Activate/deactivate on handpiece when the Foot Pedal is connected to the pump

Activate/deactivate Dedicated button control mode to Default Button Control mode

ON/OFF and MODE buttons revert back to default

Handpiece To…

Move…

System Response

Increase/turn on suction

Suction is turned on or increased

Reduce/stop suction

Suction is turned off or decreased

To…

Unscrew…

Remove protective cap at end of cable

5

To…

Align and press…

Attach Handpiece Cable Connecter to the FMS connection port using Connector alignment arrow

Attach FMS tubing to Suction port

BLOODSTOP Feature The BLOODSTOP feature provides for a timed (2 minute) cycle of increased flow and pressure to stop bleeding and clear the field of view. Once the cycle is complete, the FMS VUE/FMS VUE II will return to its original settings. When the BLOODSTOP feature is activated, the pump will have flashing brackets in the pump pressure display (Figure 2).

Figure 2. Flashing brackets in the pump pressure display on FMS VUE/FMS VUE II

Dedicated button control mode (Only for FMS VUE II) A configuration for your controls that consists of a dedicated oscillate and forward/reverse button. The controls will return to default button control mode every time the handpiece is reconnected to the pump or when the pump is re-started.

Inserting and Removing Shavers & Burrs To insert shavers and burrs into the handpiece, align the shaver/burr’s locking pin with the handpiece alignment slot (face up or face down, depending on user preference) (Figure 3) and push in until an audible “click” is heard. To remove the shaver/burr, use your thumb to rotate the locking ring to the left, then pull out shaver/burr (Figure 4).

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2.

1.

Figure 4. Rotate locking ring left and pull

Figure 3. Handpiece alignment slots

Handpiece Controls when Foot Pedal is Connected When the foot pedal is connected to the pump, the handpiece MODE button and the ON/OFF button are automatically deactivated, but the BLOODSTOP button remains functional. The Override feature allows both foot pedal and handpiece controls when pressing (BLOODSTOP Feature) and (ON/OFF) buttons for 2 seconds simultaneously (Figure 5a). A visual display indicates handpiece control is activated when Foot Pedal is connected (Figure 5b).

Figure 5a. To override feature press (BLOODSTOP Feature) and (ON/OFF) buttons.

Figure 5b. Hand Control de-activated (left) Hand Control activated (right). Refer to the following manuals for instructions for using the handpiece with the FMS VUE/FMS VUE II system: • FMS VUE Operator’s Manual (Ref. IFU-110665) • FMS VUE II Operator’s Manual (Ref. IFU-115810)

HANDPIECE CLEANING AND STERILIZATION The Tornado Micro II handpiece shall be cleaned using either the Manual or the Automated instructions and sterilized before the first use and in-between uses. Clean instruments as soon as possible after use. If cleaning must be delayed, immerse instruments in a compatible detergent solution, spray with an instrument pre-soak solution, or cover instruments with a towel moistened with purified water to prevent drying and encrustation of surgical soil. Cleaning agents with a used dilution pH of within 7 – 9 are recommended. Highly alkaline conditions (pH>10) can damage components/ devices, such as aluminum materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products). Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes. Carefully inspect instruments between uses to verify proper functioning. Return damaged instruments to a DePuy Synthes sales representative. These reprocessing instructions have been validated as being capable of preparing reusable DePuy Orthopaedics, Inc. and DePuy International Ltd. instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences.

7

Automated Cleaning 1. SCREW the protective cap securely onto the shaver handpiece connector (Figure 6).

Figure 6. Screw the protective cap on. 2. Pre-clean through rinsing in cold tap water for a minimum of 1 minute. While rinsing, actuate all moving parts at least five (5) times and use a soft bristle brush to clean all surfaces. Rinse the suction port with the suction lever in open position. Moveable parts: • The Locking Ring: (Inner and Outer parts) Open and close the locking system to ensure that it is free of foreign bodies. (Figure 7)

Figure 7. Locking ring • The Suction Port: Pass running water through the suction port, with the suction lever switch in the fully open position. (Figure 8)

Figure 8. Suction port • The Suction Lever: Open and close the suction lever several times. Rinse the inner and outer parts thoroughly. (Figure 9)

Figure 9. Suction lever 3. Leave the suction lever in the open «MAX» position (Figure 10). Soak soiled instruments per manufacturer’s instructions (minimum of 5 minutes) in the solution. Immerse the instrument in the neutral pH cleaning (pH 7-9, which may or may not contain enzymes) solution to avoid aerosol generation. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hardto-reach areas, textured surfaces, or crevices. While soaking, use a soft-bristled, tight-fitting lumen brush to brush both the distal and proximal ends of device’s lumen for 1 minute. Flush all lumens with the detergent solution for a minimum of 1 minute.

Figure 10. Suction lever in open position. 4. Check for remaining debris and remove as needed. 5. Ultrasonically clean for a minimum of 4 minutes in a second soaking bath using a pH-neutral detergent prepared in accordance with the manufacturer’s instructions. While submerged, use a syringe to flush all lumens and articulating areas. 6. Rinse the device components with warm tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone. Include actuation of all moving parts and rinse the suction lumen with the lever in the open position.

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7. Confirm the protective cap is securely screwed onto the shaver handpiece connector. 8. Load the device components so that the lumens can drain. 9. Automated cleaning can be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and -2. The following automated cycle is an example of a validated cycle: Phase

Recirculation Time (Minimum)

Water Temp (Set point)

Detergent Type

Pre-Wash

2:00

Cold Tap Water

N/A

Enzyme wash

1:00

Hot Tap water

Enzymatic Cleaner

Wash

3:00

60°C

Neutral pH Detergent

Rinse

1:00

Hot Tap water

N/A

Rinse

0:20

Ambient

DI or PUR**

Thermal Disinfection *

1:00

>90°C

N/A

Dry

7:00

66°C

N/A

*A minimum A0 of 600 is recommended in accordance to ISO 15883-1 and -2. Higher levels of A0 can be achieved by increasing the exposure time and temperature (e.g., A0 of 3000 at >90°C for 5 min, in accordance with local requirements. **DI/ PURW/ Critical water (high purity water generated by processes such as RO, deionization or distillation)

Manual Cleaning 1. SCREW the protective cap securely onto the shaver handpiece connector. (Figure 11)

Figure 11. Screw the protective cap on. 2. Leave the suction lever in the open «MAX» position. (Figure 12)

Figure 12. Suction lever in open position. 3. Pre-clean through rinsing in cold tap water for a minimum of 1 minute. While rinsing, actuate all moving parts at least five (5) times and use a soft bristle brush to clean all surfaces. Rinse the suction port with the suction lever in open position. 4. Carry out a first soaking bath in a pH-neutral detergent solution (pH 7-9, which may or may not contain enzymes) for a minimum of 5 minutes. Soak soiled instruments per manufacturer’s instructions (minimum of 5 minutes) in the pH-neutral solution. Immerse the instrument in the cleaning solution to avoid aerosol generation. 5. Carry out brushing with a swab-type brush on all surfaces, paying particular attention to lumens, holes and spring loaded retractable features. Actuate moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features. While soaking, use a soft-bristled, tight-fitting lumen brush to brush both the distal and proximal ends of device’s lumen for 1 minute. Flush all lumens with the detergent solution for a minimum of 1 minute.

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Moveable parts • The Locking Ring: Open and close the locking ring to ensure that it is free of foreign bodies (Inner and Outer parts). (Figure 13)

Figure 13. Locking ring • The Suction Port: Pass running water through the suction port, with the suction lever switch in the fully open position. (Figure 14)

Figure 14. Suction port • The Suction Lever: Open and close the suction lever several times. Irrigate the inner and outer parts thoroughly. (Figure 15)

Figure 15. Suction lever 6. Check for remaining debris and remove as needed. 7. Ultrasonically clean for a minimum of 10 minutes in a second soaking bath using a pH-neutral detergent prepared in accordance with the manufacturer’s instructions. While submerged, use a syringe to flush all lumens and articulating areas. 8. Remove the devices and rinse under running ambient (≤40°C) tap water for a minimum of 1 minute. While rinsing, actuate all moving parts at least five (5) times and rinse the suction port with the suction lever in the open position. 9. Submerge each device in PURW/ Critical water for a minimum of 30 seconds with actuation of all moving parts and flushing of the suction lumen. PURW/ Critical water is high purity water generated by processes such as RO, deionization or distillation. 10. Dry using clean lint-free cloths and/or with filtered pressurized air at less than 100°C or 212°F for a minimum of 30 seconds. CAUTION: Do not direct air into the shaver/burr 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 Package trays/instruments with a barrier wrap material in accordance with local procedures, using standardized wrapping techniques such as those described in ANSI/AAMI ST79. In the United States, use an FDA-cleared sterilization wrap. Sterilize in a validated sterilizer according to the guidelines below: • Steam (moist heat) sterilization is recommended in an approved, pre-vacuum (force air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285 or ANSI/AAMI ST8. Ensure that the steam sterilizer cycle is chosen that is designed to remove air from porous loads and/or devices with lumens in accordance to manufacturer’s instructions. • Effective steam sterilization can be achieved using the following cycles: Cycle Type

Minimum Exposure Time

Minimum Sterilization Temperature

Minimum Drying Time

Pre-vacuum

4 minutes

132°C (270°F)

30 minutes

Pre-vacuum (outside of US)

3 minutes

134°C (273°F)

30 minutes

The total combined sterilization tray system should not exceed 22 lbs. (weight limit). Do not stack tray systems for sterilization.

Additional Information: • Cleaning Agent Information: DePuy Orthopaedics, Inc. used the following cleaning agents during validation of these reprocessing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily: Valsure® and Enzol®. • The cleaning and sterilization information is provided in accordance with ANSI/AAMI ST81 and EN ISO 17664. 10

MAINTENANCE Inspect equipment and cables periodically for wear. Return to DePuy Mitek Repair Service if you notice damage to the handpiece or its components. Contact Customer Service at 1-800-382-4682 for service requests. Outside of the United States, contact your local affiliate. The device is designed to be free from defects in material and workmanship for the warranty period. During the lifetime of the device, it is intended to be regularly inspected for damage or degradation signs prior to use as indicated throughout the instructions for use. The following should be considered as indications that the device requires repairs or has reached the end of life: • Damaged connectors and/or mechanical connection points; • Loss of functionality (inability to connect/disconnect) with ancillary devices; • Compromised sealing integrity; • Broken or damaged controls; • Damage to surfaces and/or corners indicating the device was dropped; • Degraded physical labeling; • Error messages related to fatal conditions; • Issues related to loss of functionality such as: • Loss of power; • Degraded performance; • Significant change in torque/force to actuate mechanical controls; DePuy Synthes offers Service and Replacement Programs for its products to minimize downtime in your operating room. Contact your DePuy Synthes representative or DePuy Synthes Customer Service for specific Service and Replacement programs available for your product.

SPECIFICATIONS Recommended Handpiece Utilization Cycle: 1 minute every 6 minutes

RoHS Compliance The product is in compliance with the European Union’s RoHS legislation Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of hazardous substances in electrical and electronic equipment.

Packaging All the packaging materials used for theTornado Micro II packaging assembly are recyclable. Please recycle per your standard local procedures.

ESPAÑOL Tornado Micro II DESCRIPCIÓN La pieza de mano Tornado Micro II es un accesorio para los sistemas FMS VUE™ (FMS VUE y FMS VUE II). La pieza de mano consta de un dispositivo giratorio con bloqueo para sostener los rasuradores y las fresas, y (solo para REF. 283812) de tres botones para controlar la dirección de rotación del rasurador y de las fresas y las funciones de BLOODSTOP™ (figura 1). El pedal también se puede utilizar para controlar la dirección de rotación del rasurador y la fresa. El dispositivo proporciona succión a través de un puerto de succión cuando se conecta a las bombas FMS VUE/FMS VUE II o a la succión de pared.

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for FMS VUE™/FMS VUE™ II Fluid Management and Tissue Debridement Systems REF. 283712 and 283812

P/N: 116775 Rev: A Issued 10/2019 © DePuy Synthes 2019. All rights reserved.

ENGLISH Tornado Micro II

DESCRIPTION The Tornado Micro II handpiece is an accessory device to the FMS VUE™ systems (FMS VUE and FMS VUE II). The handpiece consists of a locking and rotating device for holding shavers and burrs, and includes (for REF. 283812 only) three buttons for controlling shaver or burr rotation direction and BLOODSTOP™ functions (Figure 1). A foot pedal also may be used to control shaver or burr rotation direction. The device provides suction through a suction port when connected to the FMS VUE/FMS VUE II pump or wall suction.

2c

2a

2

4

5 2b

1

3

7

10

8

9

6

Figure 1. Tornado Micro II handpiece components

2

PART

FUNCTION

1

Locking ring

Holds shaver or burr in place.

2

Suction lever

Controls suction through the suction port.

2a

BLOODSTOP button

Activates the BLOODSTOP mode.

2b

Handpiece rotation mode button

Press to change from forward to reverse to oscillate mode.

2c

ON/OFF button

Turns the handpiece on and off.

3

Serial number

Handpiece Identification.

4

Suction port

Connects to the FMS tubing.

5

Alignment slots

Aligns shaver or burr face up or face down.

6

Protective cap

Covers the connector during cleaning.

7

Connector alignment arrow

Aligns with the red dot on the FMS connection port to indicate proper connector alignment.

8

Handpiece cable connector

Connects to FMS connection port.

9

FMS connection port

Connection port for handpiece or FMS CONNECT Interface Cable.

10

Cable

3m cable that connects handpiece to the pump.

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

INDICATION FOR USE The Tornado Micro II handpiece is an accessory to the FMS VUE/FMS VUE II Fluid Management and Tissue Debridement Systems. The FMS VUE/FMS VUE II Fluid Management and Tissue Debridement Systems are 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 Tornado Micro II handpiece with systems other than the FMS VUE/FMS VUE II.

WARNINGS • This equipment may be operated only by personnel trained in arthroscopy. The personnel must also 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 to IEC 60601-1-2: 2014 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 Synthes Customer Service at +1‑(800)‑382‑4682 in the United States or contact your DePuy Synthes sales representative. Outside of the United States, contact your local affiliate. • Disconnect the device from the pump when cleaning or inspecting. • Do not insert anything other than approved DePuy Mitek shavers and burrs into the distal end of the handpiece. • For patients with, or suspected with, Creutzfeldt-Jakob disease (CJD), variant CJD or other transmissible spongiform encephalopathy (TSE) and related infections, it is recommended to treat the patient using single-use instruments. Safely dispose of all devices used in accordance with local procedures and guidelines. • Failure to follow the Cleaning and Sterilization instructions may result in an infection.

3

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/FMS VUE II System accessories before use. Your sales representative can advise which accessories are used with these systems. • Blade/burr should be fully inserted and correctly assembled into the device to prevent soft tissue irritation. • Failure to follow the Specifications section for using the device may result in burns due to the device overheating. • A delay to the surgical procedure may occur due to mechanical and/or electrical failures while using the device. Refer to the Maintenance section for indications that the device needs service.

ADVERSE REACTIONS The following list of adverse effects may be associated with the use of this device: • Electrical Shock; • Infection; • Soft Tissue Irritation; • Burns (device overheating); • Surgical Delay;

INSTRUCTIONS FOR USE Default Button control mode To…

Press…

System Response

Start/Stop shaver & burr rotation

Starts and stops shaver & burr rotation.

Change shaver & burr rotation direction (Forward or Oscillate)

MODE button switches between oscillate and forward

Reverse shaver & burr rotation

Reverses shaver & burr rotation direction

Start BLOODSTOP mode

BLOODSTOP Mode is enabled

Activate/deactivate override feature when the Foot Pedal is connected to the pump

MODE and ON/OFF buttons are Activate/deactivate on handpiece when the Foot Pedal is connected to the pump

Activate/deactivate Default Button Control mode to Dedicated button control mode (Only for FMS II)

ON/OFF button becomes a dedicated Oscillate button. MODE button becomes a dedicated forward button

4

Dedicated button control mode (Only for FMS VUE II) To…

Press…

System Response

Activate/deactivate Oscillate function

Starts and stops Oscillate

Activate/deactivate Forward/Reverse

Starts and stops Forward/Reverse

Change direction between Reverse/Forward

Changes rotation direction

Start BLOODSTOP mode

BLOODSTOP Mode is enabled

Activate/deactivate override feature when the Foot Pedal is connected to the pump

MODE and ON/OFF buttons are Activate/deactivate on handpiece when the Foot Pedal is connected to the pump

Activate/deactivate Dedicated button control mode to Default Button Control mode

ON/OFF and MODE buttons revert back to default

Handpiece To…

Move…

System Response

Increase/turn on suction

Suction is turned on or increased

Reduce/stop suction

Suction is turned off or decreased

To…

Unscrew…

Remove protective cap at end of cable

5

To…

Align and press…

Attach Handpiece Cable Connecter to the FMS connection port using Connector alignment arrow

Attach FMS tubing to Suction port

BLOODSTOP Feature The BLOODSTOP feature provides for a timed (2 minute) cycle of increased flow and pressure to stop bleeding and clear the field of view. Once the cycle is complete, the FMS VUE/FMS VUE II will return to its original settings. When the BLOODSTOP feature is activated, the pump will have flashing brackets in the pump pressure display (Figure 2).

Figure 2. Flashing brackets in the pump pressure display on FMS VUE/FMS VUE II

Dedicated button control mode (Only for FMS VUE II) A configuration for your controls that consists of a dedicated oscillate and forward/reverse button. The controls will return to default button control mode every time the handpiece is reconnected to the pump or when the pump is re-started.

Inserting and Removing Shavers & Burrs To insert shavers and burrs into the handpiece, align the shaver/burr’s locking pin with the handpiece alignment slot (face up or face down, depending on user preference) (Figure 3) and push in until an audible “click” is heard. To remove the shaver/burr, use your thumb to rotate the locking ring to the left, then pull out shaver/burr (Figure 4).

6

2.

1.

Figure 4. Rotate locking ring left and pull

Figure 3. Handpiece alignment slots

Handpiece Controls when Foot Pedal is Connected When the foot pedal is connected to the pump, the handpiece MODE button and the ON/OFF button are automatically deactivated, but the BLOODSTOP button remains functional. The Override feature allows both foot pedal and handpiece controls when pressing (BLOODSTOP Feature) and (ON/OFF) buttons for 2 seconds simultaneously (Figure 5a). A visual display indicates handpiece control is activated when Foot Pedal is connected (Figure 5b).

Figure 5a. To override feature press (BLOODSTOP Feature) and (ON/OFF) buttons.

Figure 5b. Hand Control de-activated (left) Hand Control activated (right). Refer to the following manuals for instructions for using the handpiece with the FMS VUE/FMS VUE II system: • FMS VUE Operator’s Manual (Ref. IFU-110665) • FMS VUE II Operator’s Manual (Ref. IFU-115810)

HANDPIECE CLEANING AND STERILIZATION The Tornado Micro II handpiece shall be cleaned using either the Manual or the Automated instructions and sterilized before the first use and in-between uses. Clean instruments as soon as possible after use. If cleaning must be delayed, immerse instruments in a compatible detergent solution, spray with an instrument pre-soak solution, or cover instruments with a towel moistened with purified water to prevent drying and encrustation of surgical soil. Cleaning agents with a used dilution pH of within 7 – 9 are recommended. Highly alkaline conditions (pH>10) can damage components/ devices, such as aluminum materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products). Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes. Carefully inspect instruments between uses to verify proper functioning. Return damaged instruments to a DePuy Synthes sales representative. These reprocessing instructions have been validated as being capable of preparing reusable DePuy Orthopaedics, Inc. and DePuy International Ltd. instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences.

7

Automated Cleaning 1. SCREW the protective cap securely onto the shaver handpiece connector (Figure 6).

Figure 6. Screw the protective cap on. 2. Pre-clean through rinsing in cold tap water for a minimum of 1 minute. While rinsing, actuate all moving parts at least five (5) times and use a soft bristle brush to clean all surfaces. Rinse the suction port with the suction lever in open position. Moveable parts: • The Locking Ring: (Inner and Outer parts) Open and close the locking system to ensure that it is free of foreign bodies. (Figure 7)

Figure 7. Locking ring • The Suction Port: Pass running water through the suction port, with the suction lever switch in the fully open position. (Figure 8)

Figure 8. Suction port • The Suction Lever: Open and close the suction lever several times. Rinse the inner and outer parts thoroughly. (Figure 9)

Figure 9. Suction lever 3. Leave the suction lever in the open «MAX» position (Figure 10). Soak soiled instruments per manufacturer’s instructions (minimum of 5 minutes) in the solution. Immerse the instrument in the neutral pH cleaning (pH 7-9, which may or may not contain enzymes) solution to avoid aerosol generation. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hardto-reach areas, textured surfaces, or crevices. While soaking, use a soft-bristled, tight-fitting lumen brush to brush both the distal and proximal ends of device’s lumen for 1 minute. Flush all lumens with the detergent solution for a minimum of 1 minute.

Figure 10. Suction lever in open position. 4. Check for remaining debris and remove as needed. 5. Ultrasonically clean for a minimum of 4 minutes in a second soaking bath using a pH-neutral detergent prepared in accordance with the manufacturer’s instructions. While submerged, use a syringe to flush all lumens and articulating areas. 6. Rinse the device components with warm tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone. Include actuation of all moving parts and rinse the suction lumen with the lever in the open position.

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7. Confirm the protective cap is securely screwed onto the shaver handpiece connector. 8. Load the device components so that the lumens can drain. 9. Automated cleaning can be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and -2. The following automated cycle is an example of a validated cycle: Phase

Recirculation Time (Minimum)

Water Temp (Set point)

Detergent Type

Pre-Wash

2:00

Cold Tap Water

N/A

Enzyme wash

1:00

Hot Tap water

Enzymatic Cleaner

Wash

3:00

60°C

Neutral pH Detergent

Rinse

1:00

Hot Tap water

N/A

Rinse

0:20

Ambient

DI or PUR**

Thermal Disinfection *

1:00

>90°C

N/A

Dry

7:00

66°C

N/A

*A minimum A0 of 600 is recommended in accordance to ISO 15883-1 and -2. Higher levels of A0 can be achieved by increasing the exposure time and temperature (e.g., A0 of 3000 at >90°C for 5 min, in accordance with local requirements. **DI/ PURW/ Critical water (high purity water generated by processes such as RO, deionization or distillation)

Manual Cleaning 1. SCREW the protective cap securely onto the shaver handpiece connector. (Figure 11)

Figure 11. Screw the protective cap on. 2. Leave the suction lever in the open «MAX» position. (Figure 12)

Figure 12. Suction lever in open position. 3. Pre-clean through rinsing in cold tap water for a minimum of 1 minute. While rinsing, actuate all moving parts at least five (5) times and use a soft bristle brush to clean all surfaces. Rinse the suction port with the suction lever in open position. 4. Carry out a first soaking bath in a pH-neutral detergent solution (pH 7-9, which may or may not contain enzymes) for a minimum of 5 minutes. Soak soiled instruments per manufacturer’s instructions (minimum of 5 minutes) in the pH-neutral solution. Immerse the instrument in the cleaning solution to avoid aerosol generation. 5. Carry out brushing with a swab-type brush on all surfaces, paying particular attention to lumens, holes and spring loaded retractable features. Actuate moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features. While soaking, use a soft-bristled, tight-fitting lumen brush to brush both the distal and proximal ends of device’s lumen for 1 minute. Flush all lumens with the detergent solution for a minimum of 1 minute.

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