Pro-Dex MaxDriver KLS-SD-1000 Intsructions for Use Rev B

CAUTION:

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 MaxDrive driver bit, pull the collet grip (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 collet grip, 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 collet grip proximally and hold in that position while removing the driver bit from the collet shaft. Release the collet grip, allowing it to spring forward to the locked position. CAUTION:

Prior to use always ensure that the KLS Martin MaxDrive driver bit is properly seated and locked into the collet by visually confirming that the collet grip (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-BP-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 housing, and the spring tab on the battery pack visually aligns with the slot on the bottom side of the driver. Firmly insert the battery pack into the MaxDriver until the spring tab on 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 will initiate a self-diagnostics check, once one of the buttons in depressed, which will take no more than two (2) seconds to complete. Upon successful completion of the self-diagnostics check, the P/N 9169 Rev B Page 2 of 7

MaxDriver is ready to use. If the self-diagnostics check is not successfully completed then the driver will render itself inoperable, and the user should refer to the Troubleshooting section of this IFU. WARNING:

The MaxDriver operates only with the Battery Pack KLS-BP-001. Do not attempt to use another power source with this device. Use of a power source other than the Battery Pack KLS-BP-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 switches. The high-speed forward (HI-FWD) button provides clockwise rotation to drive a screw into bone at a speed of approximately 3600RPM. 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. P/N 9169 Rev B Page 3 of 7

The driver will continue to operate until either; • the torque-limiting feature shuts off the motor (HI-FWD & LO-FWD), or • the button is released by the user (HI-FWD, LO-FWD, & REV) 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 the devices use. See Troubleshooting section for more information. USE ENVIRONMENT AND USER QUALIFICATIONS The MaxDriver is to be used by a trained and 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-BP-001 Cleaning & Sterilization Instructions for the MaxDriver CAUTION:

Clean and sterilize the MaxDriver within the guidelines prescribed in this IFU. The device has not been designed or tested for cleaning using any other method, therefore successful cleaning 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. • Do not ultrasonically clean the MaxDriver. • Do not immerse the MaxDriver in any fluid.

CAUTION:

Do not expose the MaxDriver to any environment exceeding 135°C (275°F).

The MaxDriver must be cleaned and sterilized after every patient use according to the following guidelines: • Ensure that the KLS Martin driver bit has been removed. • Ensure that the battery has been removed. CLEAN: • The device should be cleaned immediately or within 30 minutes after use, 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. • Clean the device using a neutral cleanser (pH 7.0 to 8.0). 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 paying 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. • Repeat steps 2-4 until visible soil is removed. • Wipe down device using fresh clean soft non-shedding sponge and neutral cleaner or detergent (pH 7.08.0). • Rinse device with warm distilled or warm soft tap water. Repeat steps 6-7 until visible debris is removed. P/N 9169 Rev B Page 4 of 7

•

Dry the device using a clean soft lint-free cloth or clean dry compressed air.

STERILIZE: • Sterilization to be performed with devices using the KLS-MDTRAY-001 sterilization case. • Loaded Sterilization case to sterilized individually wrapped in two layers of 1-ply polypropylene wrap (Kimguard KC600-510(K) K082554) using sequential envelope folding techniques.

Cycle Type Pre-Vacuum

Minimum Sterilization Exposure Time (minutes) 4

TROUBLESHOOTING Issue

Driver will not turn on.

Driver is sluggish.

Minimum Sterilization Exposure Temperature

Minimum Dry Time (minutes)

132°C (270°F)

30

Potential Remedy • Confirm battery pack is fully inserted into MaxDriver. If issue persists, remove battery and re-insert. • If issue persists, remove battery and replace with an unused battery. Push any button for two (2) seconds to initiate the selfdiagnostics check. • If issue persists do not use driver – return driver to KLS Martin for repair or replacement. • Remove battery and replace with an unused battery. • If issue persists do not use driver – return driver to KLS Martin 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 Max Driver 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 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 MaxDrive or ULP driver bit. If so, re-insert driver bit per directions in this IFU. • Be sure that collet grip (nose cone) springs back to the forward position. • Confirm driver bit is seated and locked by visually confirming that the collet grip (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 for repair or replacement.

If a problem arises that is not covered in the TROUBLESHOOTING section above, you may contact KLS Martin at (800) 625-1557 for assistance. In order to initiate return of an item, please contact KLS Martin 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 P/N 9169 Rev B Page 5 of 7

SYMBOLS Consult instructions for use

Conforms to European Medical Device Directive

Caution

Authorized representative in the European community ]

V

Manufacturer/Date of Manufacture

Date of Manufacture

Use by

Do not use if package is damaged

Volts

DC

Direct Current

Catalogue Number

Batch Code

Sterilized using irradiation

Quantity

Temperature Range for Shipping and Storage

Humidity Range for Shipping and Storage

Pressure Range for Shipping and Storage

Keep Dry

Do NOT Reuse

Do NOT Autoclave

Separate collection

Do NOT incinerate

Fragile

TECHNICAL SPECIFICATIONS Product Number: KLS-SD-1000 Classification: complies with IEC 60601-1:2006 Voltage: 16.0 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 Expected Service Life: 150 product cycles including cleaning, sterilization and surgical use.

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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.

PRODUCT WARRANTY The KLS-SD-1000 is warranted to be free from defects in material and workmanship for a period of one (1) year. The KLS-BP-001 is warranted to be free from defect in material and workmanship for a period consistent with the Expiration Date on the product packaging. 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 Pro-Dex, Inc. 2361 McGaw Ave. Irvine, CA 92614 (800) 562-6204

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