WARNINGS AND PRECAUTIONS FOR THE USE OF THE IQ TM Intelligent Driver

Transcription

1 Tradeport Drive Jacksonville, FL Revision: A Tel FAX Date: 4/2013 WARNINGS AND PRECAUTIONS FOR THE USE OF THE IQ TM Intelligent Driver ATTENTION OPERATING SURGEON DESCRIPTION Biomet Microfixation manufactures and distributes a variety of instruments to aid in the implantation of internal fixation devices. The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for two functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium fixation screws. The device only operates in the forward direction. The IQ Intelligent Driver is indicated to aid in the implantation of screws (drilling holes and inserting screws). DIRECTIONS FOR USE Maximum value and dependable service may be obtained from your Biomet Microfixation IQ Driver by becoming familiar with the provided maintenance and operation instructions. Please note that these instructions may be different from other manufacturer s drivers. CLEANING AND STERILIZATION OF DRIVER This driver must be cleaned and sterilized after every patient using the following guidelines: Battery must be removed from the handpiece before cleaning and sterilizing Hand wash only Do not exceed 275 degrees F (135 degrees C). Do not submerge in any solution. Do not use ultrasonic cleaners. Do not use surface disinfectants. 1. Ensure that the driver blade/drill has been removed. 2. Remove the battery from the driver and discard. The battery packs are single use and must be removed prior to cleaning and sterilization or damage to the unit may occur. 3. Carefully inspect all devices for flaws or damage prior to sterilization. Devices with flaws or damage should be returned to Biomet Microfixation. 4. Clean the exterior of the driver with a damp towelette to remove any debris. All soiled surfaces should be washed with a neutral (7.0) ph detergent. Use a soft nylon brush to remove any visible debris. Do not submerge driver. 5. Thoroughly rinse the driver with distilled or soft tap water. 6. Sterilization Method*: Pre-Vacuum Steam Autoclave (wrapped): (1) Place driver in the supplied tray. (2) Wrap tray with a Sterilization wrap. (3) Temperature: 270 o (132 o C) (4) Dwell Time: 4 minutes (5) Wrapped Drying Time: 30 minutes minimum (6) Remove from the autoclave immediately after the cycle is complete, and allow the driver to cool for at least 1 hour. STERRAD (Do NOT sterilize any implants AND instrumentation in any STERRAD system) (1) All items including trays must be cleaned, rinsed, and thoroughly dried before loading into the sterilizer. Warning: Failure to ensure that the devices are completely dry before they are processed may result in residual hydrogen peroxide being present on the outer surface of the load. This may cause contact burns when the surface of the load is handled. (2) Carefully inspect all devices for cleanliness and dryness prior to preparing for sterilization. If visible soil is present, the item must be re-cleaned and dried prior to sterilization. If moisture is present, dry the item thoroughly prior to sterilization. (3) Place driver in the supplied tray. (4) Wrap tray in STERRAD compatible wrap. (5) See table below for validated STERRAD systems and the corresponding recommended cycles: Warning: Loads containing moisture may result in either NON-STERILE device or cycle cancellation. Wear chemical resistant gloves when handling items from any load containing moisture. STERRAD System Cycle (US) Cycle (OUS) Cycle Times STERRAD Minutes STERRAD Short 75 Minutes STERRAD 100S - Short 55 Minutes STERRAD NX Standard Standard 28 Minutes STERRAD 100NX Standard Standard 47 Minutes Please refer to the STERRAD Systems User s Guide for general processing instructions, including proper cleaning and drying, and packaging information prior to reprocessing any device in a STERRAD System. Note: After repeated STERRAD Sterilizations, slight discoloration may occur. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. ing should be conducted in the health care facility to assure that conditions essential to sterilization can be achieved. Since Biomet Microfixation is not familiar with individual hospital handling methods and bioburden, Biomet Microfixation cannot assume responsibility for sterility even though the guideline is followed. Failure to follow these precautionary measures may cause driver failure, or patient injury, and may void warranty. Failure to follow proper infection control guidelines, manufacturing guidelines, or both when disposing of accessory items or cleaning materials may result in hazard to environment. Consult with local authorities for the proper manner of disposal of this device when it is no longer repairable or has otherwise reached the end of its service life. Failure to dispose of this device in the proper manner may result in hazard to the environment. BATTERY REQUIREMENTS This driver uses one battery pack (P/N ) which is solely supplied by Biomet Microfixation. ACCESSORIES The following accessories can be used in conjunction with the IQ device.

2 IQ Driver Battery (P/N ) IQ Drills IQ 1.5mm blade for the insertion of titanium screws OPERATION STERILE BATTERY INSTALLATION AND REMOVAL Insert the battery pack into the driver. Make sure the battery connection on the pack is aligned with the battery connection in the driver. The blue LED lights on the push button will illuminate when the battery pack is properly engaged in the device. To remove the battery, depress the tabs on the sides of the battery pack and pull the battery out. Discard the battery. Do not use excessive force when inserting the IQ battery into the device. If the battery does not insert easily into the device, remove it and re-insert the battery. Failure to properly insert the battery into the device can result in damage to the driver and/or the battery. DRIVER BLADE OR DRILL INSTALLATION AND REMOVAL The IQ Driver is designed to accept only Biomet Microfixation IQ driver blades and drills. Do not attempt to use any other tools in this driver. To install a blade or drill: 1) Push the collet forward and insert the blade/drill into the collet by aligning the wings on the blade/drill with the slots on the driver. 2) While holding the collet in the forward position, apply a slight inward pressure to the blade/drill and rotate the blade/drill clockwise until the etched lines on the blade/drill are aligned with the etched lines on the collet. 3) Release the collet 4) Give a firm pull on the blade/drill to ensure it is properly engaged. To remove a blade or drill: 1) Push the collet forward and hold while rotating the blade/drill counter-clockwise until the wings become aligned with the slots in the driver. 2) Pull the blade/drill straight out. The IQ driver has bit sensing software integrated into the device to decipher whether a drill bit or titanium screw blade is properly inserted into the collet. The device requires 3 seconds to recognize the blade/drill that has been inserted before it will be ready to fire. The driver has one push button switch to activate the device. Always ensure that the driver blade/drill is properly inserted into the collet by giving it a firm pull before use. Failure to properly insert a driver bit may result in injury to the patient, the user, or third party, damage to the driver, and may void the warranty. DRILL MODE The IQ driver will drill pilot holes using drills available from Biomet Microfixation that are intended to be used with the IQ driver. Once a drill bit is properly inserted into the collet, the IQ device is activated and can be fired by pushing and holding the button. When the button is depressed, the drill will rotate in the clockwise rotation at a speed of approximately 10,000 RPM. Utilizing a peck drill technique will help to ensure the device performs as intended. The device is designed to temporarily shut down after it has been running for 5 seconds of constant use to avoid overheating. The IQ Device is active when a drill bit is properly inserted into the collet. Take precautions when handling the device as accidental activation of the button may result in injury to the patient, the user, or third party. If the device shuts down after the 5 second interval while the bit is still engaged in the bone, re-activate the device to facilitate removing the drill from the bone Titanium Screw Mode The IQ driver drives 1.5 X 4mm titanium cross-drive self-drilling screws available from Biomet Microfixation. The device has a two-step activation mechanism to activate such that the device will not fire unless the device is plunged fully. Once a screw blade is properly inserted into the collet follow the instructions below to drive a titanium screw: 1) Load screw onto blade (Note: ensure finger is not located on button to prevent device activation during screw loading, and ensure screw is loaded adequately onto the blade). 2) Contour plate to bone and hold plate securely to the bone with free-hand or plate holding wand. 3) Place screw tip into the center of the plate hole and hold the device perpendicular to the bone for optimum performance 4) Plunge (pre-load) the device fully (tactile feel that the device can t be plunged downward any further). 5) Engage the button to activate (the button is not required to be held down during the full cycle). The internal software in the device is designed to control the motor to prevent excessive torque and ensure the screw seats successfully. 6) Once the screw is fully seated, the blade should be rocked off to disengage from the screw head. If a screw is driven and not seated fully, a hand-held driver and blade can be used to engage the screw and seat it completely. If the device is fired while loading a screw from the screw dial, the screw should be discarded and not implanted. The driver automatically stops when a screw is seated onto a plate. Intraoperative fracture or stripping of screws can occur if additional activations of the device are reapplied. The IQ Device is not recommended for inserting Titanium screws into HTR implant material. WARNINGS The IQ Driver should only be used for the applications listed in the operation section. Use of the device with other systems or lengths of screws can involve incalculable risks for the implant and the driver, thereby potentially endangering the patient, user, or third party. Correct care, handling and maintenance procedures must be maintained to assure proper function. Prior to use, inspect device. If the instrument shows visible signs of damage, the exterior coating shows any sign of degradation or if the device fails to operate properly, discontinue its use immediately and return to the manufacturer. Instruments, which have experienced extensive use or excessive force, may be susceptible to failure. There are no user serviceable components of the IQ device. It must be returned to the manufacturer for repair or service. Care must be taken to avoid over tightening of screws. Intraoperative fracture or stripping of screws can occur if additional activations are applied while seating the screws, or additional torque is provided to the screw using a hand-held driver. While the IQ Driver is expected to aid surgeons in implant insertion, surgeons must also use their judgment to determine if the plunge force of the device exceeds what is acceptable for a certain application. This instrument should only be used for its intended purpose. Correct handling and maintenance of the IQ Driver is important. Substances entering the driver or physical damage to the driver may affect its function. Federal law (USA) restricts this device to sale by or on the order of a physician. Operating Surgeons and all personnel involved with handling these products are responsible for attaining appropriate education and training within the scope of the activities with which they are involved in the handling and use of this product. This equipment contains electronic and ferrous components whose operation can be affected by intense electromagnetic fields. Do not operate the IQ Driver in an MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or shortwave therapy equipment. Electromagnetic interference could disrupt the operation of the IQ Driver. This equipment is specified for use only in shielded location.

3 This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in IEC for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual. TROUBLESHOOTING Driver will not activate Blade/drill falls out. Driver fires inadvertently Driver fires intermittently or incorrectly Driver bogs down during drilling Driver will not activate. Ensure the device is given 3 seconds to recognize the blade/drill after inserted into collet. Battery may be loose. Make sure battery is pushed in all the way and the button is lit. Battery drained. Always use a fresh battery. Driver blade/drill not properly inserted. Pull on bit to be certain it is secure or remove bit and re-engage bit into collet. Driver blade/drill inserted prior to the battery. Remove the blade/drill and ensure the device is given 3 seconds to reset and then re-insert the blade/drill and given another 3 seconds to recognize the blade/drill after inserted into the collet. Blade/drill not properly inserted. Pull on bit to be certain it is secure. Ensure finger is not placed on button during drill mode, or when inserting a blade/drill into the collet. If device fires without finger on button, discontinue use and contact the manufacturer. Remove the battery and remove the blade/drill engaged in collet. Reinsert the battery and blade/drill. If problem persists, discontinue use and contact Biomet Microfixation. Remove the battery and remove the blade/drill engaged in collet. Reinsert the battery and blade/drill. If problem persists, discontinue use and contact Biomet Microfixation. Replace battery and/or replace drill bit. If problem persists, discontinue use and contact manufacturer. Utilize a peck drilling technique. If problem persists, discontinue use and contact manufacturer. Titanium screw doesn t seat fully Titanium screw strips out the bone Blade strips titanium screw head Ensure the plate is contoured to the bone, the screw is centered in the plate hole and the screw is axial to the blade during insertion for optimal performance. Ensure a new battery was used at the beginning of the case. For less dense bone, manually insert screws. Ensure the screw is loaded onto the blade with proper alignment and retention. Ensure the screw is axial to the blade during insertion. MAINTENANCE The driver requires no regular maintenance. TECHNICAL SPECIFICATIONS Product Number: Classification: Internally powered, Type B applied part Rated battery Voltage: Input ratings: A Mode of operation: Intermittent 25% On time Suitability for use with flammable anesthetics: Equipment not suitable for use in presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Shipping and storage conditions: F (5 50 C): 20 95% Relative Humidity (RH) Guidance and manufacturer's declaration- electromagnetic emissions Emissions RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Not applicable Electromagnetic environment- guidance The IQ Intelligent driver 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. The IQ Intelligent driver is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

4 3 Table 1: Guidance and Manufacturer s Declaration-electromagnetic Emissions The manufacturer recommends usage of the IQ driver within domestic establishments specific to a hospital operating room. Guidance and manufacturer's declaration- electromagnetic immunity IEC test level Electromagnetic environmentguidance Electrosta tic ± 6 kv discharge ± 6 kv contact contact (ESD) IEC ± 8 kv air ± 8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Table 2: Guidance and Manufacturer s Declaration- Electromagnetic Guidance and manufacturer's declaration- electromagnetic immunity IEC test level Electromagnetic environment- guidance Recommended separation distance d= 1.17 P 80 MHz to 800 MHz d=2.33 P 800 MHz to 1.5 GHz Radiated RF IEC V/m 80 MHz to 2.5 GHz 3 V/m 80 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic survey, a should be less than the compliance level in each frequency range. b 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 might 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 transmiters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the IQ Intelligent driver is used exceeds the applicable RF compliance level abone, the IQ Intelligent driver should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the IQ Intelligent driver. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than [V 1] V/m. Table 3: Guidance and Manufacturer s Declaration- Electromagnetic PRODUCT WARRANTY The Biomet Microfixation IQ Intelligent Driver is warranted to be free from defects in material and workmanship for a period of one (1) year from date of purchase. This 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 defective product. No other warranties are expressed or implied. Any defective product must be returned to the address below with proof of purchase (copy of dealer invoice) and transportation prepaid. IQ is a trademark of Biomet, patent pending. Biomet and all other trademarks herein are the property of Biomet, Inc. or its subsidiaries. Authorized Representative in EC: European Sales Headquarters: Biomet UK, Ltd. Biomet Microfixation Europe Waterton Industrial Estates, Toermalijnring LC Bridgend, South Wales 3316 LC Dordrechtv CF31 3XA, U.K. Netherlands Phone: (+44) Phone: (+31)

5 Fax: (+44) Fax: (+31)