MatrixPRO Driver Instructions for Use

MatrixPRO™ Driver Instructions for Use 1) The following apply for CMF Applications, Insert Screwdriver Blade. For Spinal applications, refer to EXPEDIUM Verse Power Surgical technique guide: The collet has been designed to interface only with the DePuy Synthes MatrixNEURO Screwdriver Blades and Low Profile Neuro Screwdriver Blades. Do not attempt to use other screwdriver blades with this device. To install a screwdriver blade, pull the collet grip (nose cone) back and hold in that position while inserting the screwdriver blade into the collet shaft. Slowly rotate the screwdriver blade as necessary while pushing it into the collet shaft until it drops and seats into the internal hex interface. Release the collet grip to allow it to spring forward to the locked position. Pull on the screwdriver blade to ensure it is locked into the collet. Warning: Failure to insert the screwdriver blade properly may cause personal injury, damage to the device, and may void the warranty. Prior to use always ensure that the screwdriver blade is properly seated and locked into the collet by visually confirming that the collet grip (nose cone) is in the forward position, and giving the screwdriver blade a firm pull. Note: Only MatrixNEURO Screwdriver Blades (03.503.016 & 03.503.017) and Low Profile Neuro Screwdriver Blades (313.931 & 313.932) can be used. 2) Battery Installation, Self-Diagnostics Check: Orient the black arrow on the battery with the white arrow on the driver. Firmly insert the battery onto the battery mount ring until the tabs “click” and lock the battery securely in place. Gently pull on the battery to confirm that it is locked in place. After battery insertion, the hand piece will be ready for use. To operate, press either the Forward or Reverse buttons and hold for at least 1 second. The buttons will illuminate and the hand piece will do an internal self-check of the electronics, buttons and motor. If the system passes the internal checks, the inserted screwdriver blade will rotate in the direction as determined by the selected button (forward or reverse). Should any of the internal checks fail, the lights will flash indicating an internal failure. Replace the battery with a fresh, unused one and repeat the operation. If the lights flash again, return the hand piece for repair or replacement. Precaution: If the lights under the button pad begin to flash, this indicates that the device has failed the self-diagnostics check and it will not function properly. Do not attempt to use it. Warning: The MatrixPRO Driver has been designed and tested to operate only with the MatrixPRO Driver Battery-Sterile. Do not attempt to use another power source with this device. Use of a power source other than the MatrixPRO Driver BatterySterile may present a risk of fire, explosion, or other damage, and should therefore never be attempted. 3) Load Screw: Select the appropriate length Self-Drilling screw (3 mm & 4 mm lengths) and align the screwdriver blade with the screw head recess and push down to engage the screw head. 4) Insert Screw: Cranial Bone: Position the tip of the screw on the bone in desired location and hold down the forward button (do not remove finger from button) and drive the screw until it stops. Once the screw is seated, remove your finger from the button and gently rock the hand piece once from side to side to release the screwdriver blade from the screw head. DePuy Synthes PEEK Patient Specific Implant (PSI): Only 4mm long screws can be inserted into PEEK PSI using the MatrixPRO Driver. Prepare the screw hole by predrilling a Ø1.1mm hole, 4mm deep into the PEEK PSI away from the surgical site. Position the screw in the prepared hole and hold down the forward button (do not remove finger from button) and drive the screw until it stops. Once the screw is seated, remove your finger from the button and gently rock the hand piece once from side to side to release the screwdriver blade from the screw head.

Pro-Dex P/N 9170_EN Rev. F: 03/26/18

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MatrixPRO™ Driver Instructions for Use Precautions: • If the screw does not fully seat, complete screw insertion by hand. • DO NOT re-engage the screwdriver on a screw that has not fully seated. • DO NOT press the forward button a second time after the screw is fully seated, as this may cause the screw to strip. • The MatrixPRO Driver is not indicated for use with 5mm long MatrixNEURO Self-Drilling Screws and Low Profile Neuro Self-Drilling Screws as they may be difficult to remove. • Do not use the MatrixPRO Driver to Insert a MatrixNEURO Self-Drilling 3mm screw into a MaxtrixNEURO Contourable Mesh 0.6 mm Rigid (Pink). Note: The average no-load forward speed is 2,000 RPM. 5) Remove Screw (if necessary): Reengage the screwdriver blade with the screw head recess and push the reverse button. Notes: • If the screw does not reverse, help initiate screw removal by holding the reverse button and rotating your wrist ¼ turn counter clockwise at the same time (repeat if necessary). • The average no-load reverse speed is 275 RPM. 6) After Use, Remove Battery and Screwdriver Blade: To remove the battery, press the movable latches on the battery together and pull the battery from the hand piece. To remove the screwdriver blade pull the collet grip back and hold in that position while removing the screwdriver blade from the collet shaft. Release the collet grip and allow it to again spring forward to the locked position. Use Environment and User Qualifications: The MatrixPRO Driver is to be used by a trained and qualified surgeon indoors within the sterile field of a typical operating room environment. The MatrixPRO Driver may be operated in any orientation as required by the user, depending on the circumstances of the surgery being performed. CLEANING & STERILIZATION INSTRUCTIONS: Precautions: • Do not use abrasive cleaners on the MatrixPRO Driver. • Do not immerse/submerge the MatrixPRO Driver in any liquid • Do not ultrasonically clean the MatrixPRO Driver • Failure to follow proper infection control guidelines may result in patient or user infection • Clean the MatrixPRO Driver within the guidelines prescribed in this IFU. The device has not been designed or tested for cleaning using any other method, therefore successful cleaning cannot be guaranteed with such processing and may damage the device and void the warranty. The MatrixPRO Driver Hand Piece (05.000.020) must be cleaned and sterilized after every patient use according to the following guidelines: • Important: Ensure the battery has been removed. • Ensure the screwdriver blade has been removed. • The device should be cleaned within 30 minutes after use, preferably immediately after use, to minimize debris drying & caking on the device. • Rinse the device with warm distilled or warm soft tap water. Gently scrub the device in multiple directions with a clean soft nylon brush or a clean, soft, lint-free cloth until all visible debris has been removed. Complete the device cleaning per either the Manual Cleaning Method or the Mechanical Cleaning Method as outlined below.

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MatrixPRO™ Driver Instructions for Use Manual Cleaning Method: • Clean the device using an enzymatic detergent with a neutral pH (7.0 to 9.0). Gently scrub the entire outer surface area of the device in multiple directions for a minimum of 3 minutes using a clean soft nylon brush. Pay particular attention to seams and areas where debris is visibly noticeable. Detergent may be applied using a plunger syringe to flush heavily soiled areas. • Thoroughly rinse the device with warm de-ionized (DI) or purified (PURW) water for a minimum of 2 minutes. Visually inspect for debris and repeat the scrubbing step until all visible soils are removed. • Dry the device using a clean, soft, lint-free cloth or clean compressed air. Mechanical Cleaning Method: • Mechanical Cleaning may be performed with the MatrixPRO Driver either inside the MatrixPRO Driver Graphic Case (60.000.010) or out of the MatrixPRO Driver Graphic Case. • A Neutralize cycle may be performed as required after the wash cycle(s). Cycle Time Water/Temperature Comments (minutes) Fill and Pre-Wash 1 3 Cold tap water, 10°C - 24°C (50°F - 75°F) Tec Wash III or equivalent Pre-Wash 2 5 Hot tap water, 55°C (131°F) (pH 7.0 – 9.0) Tec Wash III equivalent Wash 10 Hot tap water, 60°C (140°F) (pH 7.0 – 9.0) Rinse 1 De-ionized water, 10°C - 24°C (50°F - 75°F) Final Rinse 10 De-ionized water, 93°C (199.4°F) Sterilizing the MatrixPRO Driver: • Sterilization to be performed with the MatrixPRO Driver inside the MatrixPRO Driver Graphic Case (60.000.010). • Sterilization to be performed with devices wrapped. Cycle Type

Minimum Sterilization Exposure Time (minutes)

Pre-Vacuum

4

Pre-Vacuum

3

TROUBLESHOOTING: Issue Button pad fails to light after button is pressed.

Self-diagnostics check does not complete within 5 seconds as indicated by lights on continuously.

Self-diagnostics check fails (indicated by fast flashing lights under button pad).

Minimum Sterilization Exposure Temperature

132°C (270°F)

134°C (273°F) EU

Minimum Dry Time (minutes) 40 minute minimum dry time, 15 minute open-door time, and 30 minute cool-down time. 30 minute dry time.

Potential Remedy • Remove battery and re-insert. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons. • If issue persists replace battery with a new (unused) battery and again allow selfdiagnostics check to successfully complete. • If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Remove battery and re-insert. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons. • If issue persists replace battery with a new (unused) battery and again allow selfdiagnostics check to successfully complete. • If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Remove battery and replace with a new (unused) battery. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons.

Pro-Dex P/N 9170_EN Rev. F: 03/26/18

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MatrixPRO™ Driver Instructions for Use

Driver will not turn on.

Driver is sluggish.

Screws do not fully seat. (Complete the screw insertion process manually for all screws that did not fully seat. Do not re-engage screwdriver on a screw that has not fully seated.) Screwdriver blade falls out of collet, or freely spins independently of collet shaft.

• If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Confirm that self-diagnostics check has successfully completed as indicated by a steady light under the button pad. • If issue persists remove battery and replace with a new (unused) battery. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons. • If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Remove battery and replace with a new (unused) battery. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons. • If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Remove battery and replace with a new (unused) battery. Allow self-diagnostics check to successfully complete as indicated by a steady light beneath the buttons. • If issue persists do not use MatrixPRO Driver – return driver to DePuy Synthes for repair or replacement. • Remove screwdriver blade and re-insert per directions in this IFU. • Be sure that collet grip (nose cone) springs back to the forward position. • Confirm screwdriver blade is seated and locked by visually confirming that the collet grip (nose cone) is in the forward position, and giving the screwdriver blade a firm pull.

SYMBOLS:

V

Battery/Driver Alignment Arrow

Do not immerse

Forward button

Caution

Reverse button

Type B applied equipment

Manufacturer/Date of Manufacture

Consult instructions for use

Serial Number

Autoclave

Volts

DC

Direct Current

Catalogue Number

Batch Code

Temperature Range for Shipping and Storage

Quantity

Pressure Range for Shipping and Storage

Humidity Range for Shipping and Storage

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MatrixPRO™ Driver Instructions for Use Medical Equipment ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) CAN/CSA c22.2 No. 60601-1 (2008)

Keep Dry

Conforms to European Medical Device Directive Underwriters Laboratories for Canada and United States With respect to electrical shock, fire and mechanical hazards only, in accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)/CAN/CSA c22.2 No. 60601-1 (2008)

TECHNICAL SPECIFICATIONS: Product Number: 05.000.020 Classification: complies with ANSI/AAMI 60601-1:2005(R) 2012/A1:2012, CSA C22.2 NO 60601-1:14, IEC 60601-1:2005+AMD1:2012 Voltage: 8.0 VDC Mode of operation: Non-continuous – S3 20% (1 second on, 4 seconds off) Protection against harmful ingress of water: Ordinary – IPXO Operating conditions: 50°F to 95°F (10°C to 35°C): 20% to 75% Relative Humidity non-condensing, 70 kPa to 106 kPa, indoor use only Operating altitude: 3000m max Shipping and storage conditions: -4°F to 140°F (-20°C to 60°C): 5% to 95% Relative Humidity non-condensing, 47 kPa to 106 kPa, indoor use only. Note: This device complies with IEC 60601-1 regulations (listed above) regarding the emissions of and effect to this device of electromagnetic interference. These specifications provide reasonable assurance that use of this device will not affect and will not be affected by the operation of other electronic devices that may be nearby. ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION WARNING: Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility (EMC) information provided in the accompanying documents. WARNING: Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. WARNING: The Medical Equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it is used. NOTE: The EMC tables and other guidelines that are included in this IFU provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment or Systems or non-medical electrical equipment. EMC Table 1 (IEC 60601-1-2, Ed 3) Guidance and manufacturer’s declaration - electromagnetic emissions The SYN-1000 series is intended for use in the electromagnetic environment specified below. The customer or the user of the SYN-1000 series should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions Group 1 CISPR 11

Pro-Dex P/N 9170_EN Rev. F: 03/26/18

The SYN-1000 series uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

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MatrixPRO™ Driver Instructions for Use RF Emissions Class B CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

The SYN-1000 series is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies building used for domestic purposes.

Not Applicable Not Applicable

EMC Table 2 (IEC 60601-1-2, Ed 3) Guidance and manufacturer’s declaration – electromagnetic immunity The SYN-1000 series is intended for use in the electromagnet environment specified below. The customer or the end user of the SYN-1000 series should assure that it is used in such an environment. IEC 60601 Electromagnetic environment Immunity test Compliance level Test level guidance Electromagnetic +6 kV contact +6 kV contact Floors should be wood, concrete or discharge (ESD) +8 kV air +8 kV air ceramic tile. If floors are covered IEC 61000-4-2 with synthetic material, the relative humidity should be at least 30 %. Electrical fast +2 kV for power supply Not Applicable Mains power quality should be transient/burst lines that of a typical commercial or IEC 61000-4-4 +1 kV for input/output hospital environment. lines Surge +1 kV differential mode Not Applicable Mains power quality should be IEC 61000-4-5 +2 kV common mode that of a typical commercial or hospital environment. Voltage dips, short <5 % UT Not Applicable Mains power quality should be interruptions and (>95 % dip in UT) that of a typical commercial or voltage variations for 0.5 cycle hospital environment. If the user on power supply 40 % UT of the SYN-1000 series requires input lines (60 % dip in UT) continued operation during power IEC 61000-4-11 for 5 cycles mains interruptions, it is 70 % UT recommended that the SYN-1000 (30 % dip in UT) series be powered from an for 25 cycles uninterruptible power supply or a <5 % UT battery. (>95 % dip in UT) for 5 sec Power frequency 3 A/m 3 A/m Power frequency magnetic fields (50/60 Hz) magnetic should be at levels characteristic of field a typical location in a typical IEC 61000-4-8 commercial or hospital environment.

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MatrixPRO™ Driver Instructions for Use EMC Table 4 (IEC 60601-1-2, Ed 3) Guidance and manufacturer’s declaration - electromagnetic immunity The SYN-1000 series is intended for use in the electromagnetic environment specified below. The customer or the user of the SYN-1000 series should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - guidance Test level Level Portable and mobile RF communications equipment should be used no closer to any part of the SYN-1000 series including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Not Applicable Conducted RF

3 Vrms

IEC 61000-4-6

150kHz to 80 MHz

Radiated RF

3V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

Not Applicable

d = 1.2 P 80 MHz to 800 MHz 3 V/m d = 2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SYN-1000 series is used exceeds the applicable RF compliance level above, the SYN-1000 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SYN-1000 series. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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MatrixPRO™ Driver Instructions for Use EMC Table 6 (IEC 60601-1-2, Ed 3) Recommended separation distance between Portable and mobile RF communications equipment and the SYN-1000 series The SYN-1000 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SYN-1000 series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SYN-1000 series as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz Rated maximum output power of transmitter W

 3.5  d  P  v1 

 3.5  d  P  E1 

800 MHz to 2.5 GHz

7 d  P  E1  0.01

0.12

0.12

0.23

0.1

0.34

0.34

0.74

1

1.7

1.7

2.3

10

3.7

3.7

7.4

100

11.7

11.7

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Product Warranty: Subject to a limited warranty. The warranty applies only if the product has been maintained per these instructions. The warranty will not apply if the product has been subject to misuse or abuse. Sole liability under this warranty is limited to the repair or replacement, at our option, of the product. No other warranties are expressed or implied. The product must be returned to DePuy Synthes with proof of purchase (copy of dealer invoice) and transportation prepaid. Pro-Dex Inc., as the manufacturer and DePuy Synthes, as distributor, do not assume any liability for direct or consequential damage resulting from improper use or handling, in particular as a result of failure to comply with the operating instructions or as a result of incorrect care or maintenance.

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MatrixPRO™ Driver Instructions for Use Precautions: • Correct care, handling, and maintenance procedures must be maintained to ensure proper function. Prior to use, inspect for proper function. If the device shows visible signs of damage, foreign substances, or fails to operate properly, discontinue use immediately. Devices that have experienced extensive use or excessive damage may be susceptible to failure. • If the screw does not fully seat, complete screw insertion by hand. • DO NOT re-engage the screwdriver on a screw that has not fully seated. • DO NOT press the forward button a second time after the screw is fully seated, as this may cause the screw to strip. • The MatrixPRO Driver is not indicated for use with 5mm long MatrixNEURO Self-Drilling Screws and Low Profile Neuro Self-Drilling Screws as they may be difficult to remove. • No field-modification of the MatrixPRO Driver may safely be performed. There are no user serviceable components in this device. The MatrixPRO Driver must be returned to the DePuy Synthes for repair or service. • Clean the MatrixPRO Driver within the guidelines prescribed in this IFU. The device has not been designed or tested for cleaning using any other method, therefore successful cleaning cannot be guaranteed with such processing and may damage the device and void the warranty. • Do not expose the MatrixPRO Driver to any environment that exceeds 135°C (275°F) • Do not use abrasive cleaners on the MatrixPRO Driver • Do not submerge the MatrixPRO Driver in any liquid • Do not ultrasonically clean the MatrixPRO Driver • Do not thermally clean or disinfect the MatrixPRO Driver • Do not use the MatrixPRO Driver to Insert a MatrixNEURO Self-Drilling 3mm screw into a MatrixNEURO Contour Mesh 0.6mm Rigid (Pink) • Failure to follow proper infection control guidelines may result in a hazard of infection to patient or user • Consult with local authorities for the proper manner of disposal of this device Federal law (USA) restricts this device to sale by or on the order of a physician. Distributed by DePuy Synthes

Manufactured by Pro-Dex

Authorized Representative:

Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 Telephone: (719) 481-5300 To order: (800) 523-0322 Fax: (800) 796-8437 Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Telephone: +41 61 965 61 11 Fax: +41 61 965 66 00 www.depuysynthes.com

Pro-Dex, Inc. 2361 McGaw Ave. Irvine, CA 92614 Telephone: (800) 562 6204 Fax: (949) 769-3281

European Complaince Services Greyfriars Court Paradise Square Oxford, OX11BE, UK +44(0)1793 784 113

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