MaxDriver 2.0 Instructions for Use Rev B

WARNING:

CAUTION:

No field‐modification of the MaxDriver 2.0 may be safely performed. There are no user serviceable components in this device. The MaxDriver 2.0 must be returned to KLS Martin L.P. for repair or service. Correct care, handling, and maintenance procedures must be maintained to ensure proper function. Foreign substances entering the device or physical damage may affect its functionality. Prior to use, inspect for proper function. If the device shows visible signs of damage or fails to operate properly, discontinue use immediately. Devices that have experienced extensive use or excessive damage may be susceptible to failure.

DRIVER BIT INSTALLATION AND REMOVAL To install a KLS Martin L.P. driver bit, pull the chuck sleeve (nose cone) proximally and hold in that position while inserting the driver bit into the collet shaft. Slowly rotate the driver bit as necessary while pushing it into the collet shaft until it drops and seats into the internal hex interface. Release the chuck sleeve, allowing it to spring forward to the locked position. Pull on the driver bit to ensure it is locked into the collet. To remove the driver bit, pull the chuck sleeve proximally and hold in that position while removing the driver bit from the collet shaft. Release the chuck sleeve, allowing it to spring forward to the locked position. CAUTION:

Prior to use always ensure that the KLS Martin L.P. driver bit is properly seated and locked into the collet by visually confirming that the chuck sleeve (nose cone) is in the forward position, and firmly pulling on the driver bit.

BATTERY INSTALLATION, SELF‐DIAGNOSTICS CHECK, AND BATTERY REMOVAL To install a Battery Pack KLS‐BP2‐001, orient the battery such that the metal contacts on the battery pack visually align with the contacts inside of the proximal end of the MaxDriver 2.0 housing. Firmly slide the battery pack into the MaxDriver 2.0 until the latch on the bottom of the battery pack locks the battery pack securely in place. Gently pull on the battery to confirm that it is locked in place. The MaxDriver 2.0 will initiate a 2 second self‐diagnostics check upon button press. Upon successful completion of the self‐diagnostics check, the MaxDriver 2.0 is ready to use. If the self‐diagnostics check is not successfully completed the driver will render itself inoperable and the buttons will light up red. The user should consult the troubleshooting section of this document. WARNING:

The MaxDriver 2.0 operates only with the Battery Pack KLS‐BP2‐001. Do not attempt to use another power source with this device. Use of a power source other than the Battery Pack

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KLS‐BP2‐001 may present a risk of fire, explosion, or other damage, and should therefore never be attempted.

DEVICE OPERATION The driver may be operated by one of the three push‐button motion switches and one push‐button mode switch. The high‐speed forward (HI‐FWD) button provides clockwise rotation to drive a screw into bone at a speed of approximately 2200RPM. The low‐speed forward (LO‐FWD) button provides clockwise rotation to drive a screw into bone at a speed of approximately 600RPM. The reverse (REV) button provides counter‐clockwise rotation to remove a screw from bone at a speed of approximately 450RPM. The Mode button will be used to alternate between Adaptive Torque Limiting (ATL) and Non‐Torque Limiting (NTL)/Drill mode for the high‐speed forward (HI‐FWD) and low‐speed forward (LO‐FWD) buttons. The HI‐FWD, LO‐FWD, and MODE button will light up green when in ATL mode. The HI‐FWD, LO‐FWD, and MODE button will light up blue when in NTL/Drill mode. The driver will continue to operate until the button is released by the user (HI‐FWD, LO‐FWD, & REV) in NTL/Drill mode only. The driver will stop operating when the screw has been fully seated when the forward motion buttons (HI‐FWD, LO‐FWD) are used in ATL mode only. There are no parts that are to be serviced or maintained while in use with a patient. The battery may need to be replaced if it becomes depleted during use of the device. See Troubleshooting section for more information.

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USE ENVIRONMENT AND USER QUALIFICATIONS The MaxDriver 2.0 is to be used by a qualified surgeon within the sterile field of a typical operating room environment. The driver may be operated in any orientation as required by the user, depending on the circumstances of the surgery being performed. Federal law (USA) restricts this device to sale by or on the order of a physician. ACCESSORIES Battery Pack KLS‐BP2‐001; KLS E‐Coupling Adapter PDEC‐1000‐3 Pro‐Dex P/N 9806 Rev. B: 06/15/2022

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Cleaning & Sterilization Instructions for the MaxDriver 2.0 CAUTION:

Clean and sterilize the MaxDriver 2.0 within the guidelines prescribed in this IFU. The device has not been designed or tested for cleaning using any other method, therefore successful cleaning or sterilization by any other method cannot be guaranteed, and such processing may damage the device and void the warranty.  Do not use abrasive cleaners on the MaxDriver 2.0.  Do not ultrasonically clean the MaxDriver 2.0.  Do not immerse the MaxDriver 2.0 in any fluid.  Failure to follow proper infection control guidelines may result in patient or user infection.

CAUTION: Do not expose the MaxDriver 2.0 to any environment exceeding 135°C (275°F). The MaxDriver 2.0 must be cleaned and sterilized after every patient use according to the following guidelines:  Ensure that the KLS Martin L.P. driver bit has been removed.  Ensure that the battery has been removed.  The device should be cleaned within 30 minutes after use, preferably immediately, to minimize drying and caking of debris onto the device.  Rinse the device with warm distilled or 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. Manual Cleaning Method  Clean the device using a neutral cleanser (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. Where necessary, use a plunger syringe to flush heavily soiled areas.  Thoroughly rinse the device with warm distilled or warm soft tap water for a minimum of 2 minutes.  Visually inspect for debris and repeat scrubbing step until all visible soil is removed.  Wipe down device using fresh clean, soft non‐shedding sponge and neutral cleaner or detergent (pH 7.0‐ 9.0).  Rinse device with warm distilled or warm soft tap water.  Dry the device using a clean soft lint‐free cloth. Mechanical Cleaning Method  Mechanical Cleaning may be performed with the MaxDriver 2.0 inside the sterilization case, CTM‐1901 with CTM‐1901‐105 lid or the CTM‐1902 with CTM‐1902‐105 lid.  A neutralize cycle may be performed after the wash cycle(s). Cycle

Water/Temperature

Comments

Fill and Pre‐Wash 1

Time (minutes) 3

Cold tap water, 10°C ‐ 24°C (50°F ‐ 75°F)

Pre‐Wash 2

5

Hot tap water, 55°C (131°F)

Wash

10

Hot tap water, 60°C (140°F)

Rinse Dry Time

1 20

De‐ionized water, 43°C (109.4°F) 90°C (194°F)

‐ Tec Wash III or equivalent (pH 7.0 – 9.5) Tec Wash III equivalent (pH 7.0 – 9.5) ‐ ‐

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 

Sterilization to be performed with devices using the MaxDriver 2.0 sterilization case, CTM‐1901 with CTM‐1901‐105 lid or the CTM‐1902 with CTM‐1902‐105 lid. Loaded Sterilization case to sterilize individually wrapped in two layers of 1‐ply polypropylene wrap (Kimguard KC600‐510(K) K082554) using sequential envelope folding techniques or equivalent.

Cycle Type Pre‐Vacuum Pre‐Vacuum

Minimum Sterilization Exposure Time (minutes) 4 3

TROUBLESHOOTING: Issue

Driver will not turn on.

Driver is sluggish.

Minimum Sterilization Exposure Temperature

Minimum Dry Time (minutes)

132°C (270°F) 134°C (273°F)

30 30

Potential Remedy  Confirm battery pack is fully inserted into MaxDriver 2.0. If issue persists, remove battery and re‐insert.  If issue persists, remove battery and replace with an unused battery. Push any motion button for two (2) seconds to initiate the self‐diagnostics check.  If issue persists do not use driver – return driver to KLS Martin L.P. for repair or replacement.  Remove battery and replace with an unused battery.  If issue persists do not use driver – return driver to KLS Martin L.P. for repair or replacement.

Screws do not fully seat. (Complete the screw insertion process manually for all screws that did not fully seat. Do not use the MaxDriver 2.0 to resume insertion of a screw that has not fully seated).

 Remove battery and replace with an unused battery.  If issue persists do not use driver – return driver to KLS Martin L.P. for repair or replacement.

Driver bit falls out of collet or rotates independent of collet shaft rotation.

 Inspect driver bit to confirm that it is a KLS Martin L.P. driver bit or ULP driver bit. If so, re‐insert driver bit per directions in this IFU.  Be sure that chuck sleeve (nose cone) springs back to the forward position.  Confirm driver bit is seated and locked by visually confirming that the chuck sleeve (nose cone) is in the forward position, and firmly pulling on the driver bit.  If issue persists do not use driver – return driver to KLS Martin L.P. for repair or replacement.

If a problem arises that is not covered in the TROUBLESHOOTING section above, you may contact KLS Martin L.P. at (800) 625‐1557 for assistance. In order to initiate return of an item, please contact KLS Martin L.P. Customer Service at 1‐800‐625‐1557 to obtain a Return Material Authorization (RMA) number. Return Address:

KLS Martin L.P. 11201 Saint John’s Industrial Pkwy. South Jacksonville, FL 32246

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SYMBOLS

V

Consult instructions for use

Caution

Manufacturer/Date of Manufacture

Do Not Immerse

Type B applied equipment

Autoclave

Volts

DC

Direct Current

Catalogue Number

Batch Code

Serial Number

Quantity

Temperature Range for Shipping and Storage

Humidity Range for Shipping and Storage

Pressure Range for Shipping and Storage

Keep Dry

Model Number

Fragile

Federal Law (U.S.A) restricts this device to sale by or on the order of a physician

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. 60601‐1:14

TECHNICAL SPECIFICATIONS Product Number: KLS‐SD‐2000 Model Number: MaxDriver 2.0 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): 20% to 95% Relative Humidity non‐condensing, 50 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. Pro‐Dex P/N 9806 Rev. B: 06/15/2022

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WARNING: The KLS‐SD‐2000 is intended for use in a hospital operating room. Device not intended to be used in the presence of active HF SURGICAL 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. WARNING: Use of accessories, transducers and cables other than those specified by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING: Portable RF Communications Equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the KLS‐SD‐2000, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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 4) Guidance and manufacturer’s declaration ‐ electromagnetic emissions The KLS‐SD‐2000 series is intended for use in the electromagnetic environment specified below. The customer or the user of the KLS‐SD‐2000 series should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions The KLS‐SD‐2000 series uses RF energy only for its internal (CISPR 11) Group 1 function. Therefore, its RF emissions are very low and are not likely (EN 55011) to cause any interference in nearby electronic equipment. The KLS‐SD‐2000 series is suitable for use in all establishments RF Emissions Class B other than domestic and those directly connected to the public (CISPR 11) low‐voltage power supply network that supplies building used for (EN 55011) domestic purposes. Harmonic emissions IEC 61000‐3‐2 Not Applicable Voltage Not Applicable fluctuations/flicker emissions IEC 61000‐3‐3 EMC Table 2 (IEC 60601‐1‐2, Ed 4) Guidance and manufacturer’s declaration – electromagnetic immunity The KLS‐SD‐2000 series is intended for use in the electromagnet environment specified below. The customer or the end user of the KLS‐SD‐2000 series should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment ‐ Immunity test Test level level guidance ±8kV contact Floors should be wood, concrete or ±8kV contact Electromagnetic discharge ±2 kV, ±4 kV, ceramic tile. If floors are covered with ±2 kV, ±4 kV, ±8kV (ESD) synthetic material, the relative humidity ±8kV and and ±15 kV air EN 61000‐4‐2 ±15 kV air IEC 61000‐4‐2 should be at least 30 %. Electrical fast transient/burst +2 kV for power Not EN 61000‐4‐4 Applicable1,3 supply lines IEC 61000‐4‐4 +1 kV for input/output lines +2 kV differential Surge Not EN 61000‐4‐5 Applicable3 mode IEC 61000‐4‐5 +1 kV common mode Pro‐Dex P/N 9806 Rev. B: 06/15/2022

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Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000‐4‐11 IEC 61000‐4‐11

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec 30 A/m RMS @ 50 & 60Hz

Not Applicable3

30 A/m RMS Power frequency magnetic fields should Power frequency (50/60 Hz) @ 50 & 60Hz be at levels characteristic of a typical magnetic field location in a typical commercial or EN 61000‐4‐8 hospital environment. IEC 61000‐4‐8 Notes: 1The KLS‐SD‐2000 does not contain any interconnection cables. 2 The KLS‐SD‐2000 does not contain any magnetically sensitive devices. 3 The KLS‐SD‐2000 is powered by a non‐rechargeable 8VDC Lithium‐Ion or Lithium Metal battery. EMC Table 4 (IEC 60601‐1‐2, Ed 4) Guidance and manufacturer’s declaration ‐ electromagnetic immunity The KLS‐SD‐2000 series is intended for use in the electromagnetic environment specified below. The customer or the user of the KLS‐SD‐2000 series should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment ‐ guidance test Test level Level

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Portable and mobile RF communications equipment should be used no closer to any part of the KLS‐SD‐2000 series including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF

3 Vrms

IEC 61000‐4‐6

150kHz to 80 MHz

Radiated RF

3V/m

IEC 61000‐4‐3

80 MHz to 2.7 GHz in 1% increments 80% Sinusoidal AM at 1000 Hz, 1 second dwell time

Not Applicable

Not Applicable

3 V/m

d = 1.2 P 80 MHz to 800 MHz 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 KLS‐SD‐2000 series is used exceeds the applicable RF compliance level above, the KLS‐SD‐2000 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the KLS‐SD‐2000 series. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. EMC Table 6 (IEC 60601‐1‐2, Ed 4) Recommended separation distance between portable and mobile RF communications equipment and the KLS‐ SD‐2000 series

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The KLS‐SD‐2000 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KLS‐SD‐2000 series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KLS‐SD‐2000 series as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 80 MHz to 800 MHz 800 MHz to 2.5 GHz 150 kHz to 80 MHz

 3.5  d   P  v1 

 3.5  d   P  E1 

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 The KLS‐SD‐2000 is warranted to be free from defects in material and workmanship for a period of eighteen (18) months. This warranty applies only if the product(s) has been maintained per these instructions. The warranty will not apply if the product(s) 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 the address below with proof of purchase (copy of dealer invoice) and transportation prepaid. Pro‐Dex Inc., as the company marketing these products, does 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. Distributed by KLS Martin L.P. KLS Martin L.P. 11201 Saint John’s Industrial Pkwy. South Jacksonville, FL 32246 (800) 625‐1557

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

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