Users Manual

FCC ID: Q9R-5400

Users Manual

Download: PDF
FCCID_472344

IMPORTANT INFORMATION: File in your maintenance records Consolidated Operating Room Equipment (CORE) Powered Instrument Driver REF 5400-50 Instructions For Use •••••••••••••••••••••• US Patents: ??? and other patents pending. Software Version F T 4.x 4100 E. Milham Kalamazoo, Michigan D RA (USA) 49001 1-269-323-7700 1-800-253-3210 5400-050-700 Rev- 10/04

Table of Contents Important Information ....................................................................................................................................................................................... 3 Compliance Statements ................................................................................................................................................................................... 3 Software License Notice .................................................................................................................................................................................. 4 Limited Warranty .............................................................................................................................................................................................. 4 User/Patient Safety .......................................................................................................................................................................................... 5 Indications For Use .......................................................................................................................................................................................... 5 Contraindications ............................................................................................................................................................................................. 5 System Overview ............................................................................................................................................................................................. 6 System Block Diagram .................................................................................................................................................................................... 6 Hardware Features .......................................................................................................................................................................................... 7 Accessories ..................................................................................................................................................................................................... 7 Operating Instructions ...................................................................................................................................................................................... 8 Interconnect Diagram .................................................................................................................................................................................. 8 To Connect the Components: ...................................................................................................................................................................... 9 Button Definitions ...................................................................................................................................................................................... 10 Software Menu Map ................................................................................................................................................................................... 12 To Power Up: ............................................................................................................................................................................................. 13 To View Options: ........................................................................................................................................................................................ 14 To Adjust Handpiece Speed (or Power): ................................................................................................................................................ 15 To Select Handpiece Direction and Mode: ............................................................................................................................................ 15 To Adjust Options: .................................................................................................................................................................................. 16 To Program Footswitch Options: ....................................................................................................................................................... 17 To Set Handpiece Options: ................................................................................................................................................................ 19 To Select a User Preference Favorite: .................................................................................................................................................. 20 To Replace a User Preference Favorite ............................................................................................................................................ 20 To Adjust Irrigation Pump Settings: ....................................................................................................................................................... 21 To Adjust the Console Settings: - Standard and Advance User Mode .................................................................................................. 21 To Manage User Preference Files: - Advance User Mode Only ....................................................................................................... 23 To Access Help: ..................................................................................................................................................................................... 27 Troubleshooting Guidelines ........................................................................................................................................................................... 28 Periodic Maintenance .................................................................................................................................................................................... 28 Storage and Handling .................................................................................................................................................................................... 28 Cleaning and Sterilization Recommendations ............................................................................................................................................... 28 Error Messages ............................................................................................................................................................................................. 29 Messages ................................................................................................................................................................................................... 30 Specifications ................................................................................................................................................................................................. 31 F T D © 2003, 2004 Stryker Corporation RA 2

Important Information WARNING - CAUTION - NOTE Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed. WARNING: The personal safety of the patient and user may be involved. Disregarding this information could result in injury to the patient and/or user. CAUTION: These instructions point out special service procedures or precautions that must be followed to avoid damaging the instrument. NOTE: This provides special information to make maintenance easier or important instructions clearer. An exclamation point within a triangle displayed on the product is intended to alert the user to the presence of important operating and maintenance instructions in this manual. Compliance Statements Federal Communications Commission (FCC) Industry Canada (IC) FCC ID: Q9R-5400 IC: 4919A-5400 This device complies with Part 15 of the FCC rules. Operation is The term "IC:" before the radio certification number only signifies subject to the following two conditions: (1) this device may not that Industry Canada technical specifications were met. cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: FCC regulations provide that changes or modifications not expressly approved by Stryker Instruments could void your authority to operate this equipment. F T D RA 3

Software License Notice The Stryker CORE Powered Instrument Driver (console) contains software that is installed by Stryker Corporation (“Stryker”). Stryker owns this software and is licensing it to you, the original CORE Console customer, subject to the following terms and conditions. Stryker hereby grants you a nonexclusive, nontransferable License to use the software to operate the CORE Console for your own use and to perform maintenance thereon. You hereby agree that you will not copy, alter, modify, translate, disassemble, decompile, reverse engineer, create derivative works of, distribute, sub-license, sell, lease, lend, or otherwise transfer all or any portion of this software, in either original or modified form, except as specifically authorized under this License Agreement. In addition, you agree that you will not use this software in any product other than the Stryker product in which the software was initially installed by Stryker. EXCEPT FOR ANY WARRANTIES THAT MAY BE EXPRESSLY PROVIDED IN THE STRYKER PRODUCT LITERATURE ACCOMPANYING YOUR CORE CONSOLE OR SOFTWARE, THIS SOFTWARE AND DOCUMENTATION IS PROVIDED “AS IS,” AND STRYKER MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. STRYKER WILL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING OUT OF ANY USE OF THE SOFTWARE OR DOCUMENTATION. By using this software, you acknowledge and agree that you have read, understood, and agree to be bound by these terms and conditions. Limited Warranty In the USA only, products of Stryker Instruments are warranted to the original purchaser for a period of one year from the date of purchase, with exceptions noted below. Products are warranted to be free from defects in material and workmanship. Abnormal wear and tear or damage caused by misuse or by failure to perform normal and routine maintenance as set out in the Maintenance Manual or Operating Instructions, or as demonstrated by an authorized Stryker Instruments representative, is not covered by the warranty. Any effort at field repair or adjustment may invalidate your warranty. Using any accessory that is not a Stryker product will invalidate your warranty. The warranty extends to all purchasers and is limited to the repair or replacement of the product without charge when returned prepaid to Stryker Instruments. There are no other expressed warranties. This warranty gives you specific legal rights and you may have other rights, which vary by state and municipality. For selected products. • Universal Handswitch is warranted for a period of 6 months from date of invoice. • Handpiece cords are warranted for a period of 6 months from date of invoice. • Cutting accessories are not warranted. F T D RA 4

User/Patient Safety WARNINGS: • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay special attention to the important User/Patient Safety information provided in the instruction booklets. Familiarization with the system prior to use is important. Failure to comply may result in patient and/or operating room staff injury or damage to components. • The surgeon performing any procedure is responsible to determine the appropriateness of this instrument and the specific technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique. • Clean and sterilize components before first and every use. See the CORE Cleaning, Maintenance and Sterilization Recommendations for specific details. • DO NOT use this equipment in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. • Prior to each use, operate system components and inspect for damage. DO NOT use if damage is apparent. • Use only Stryker approved accessories. Other accessories may not properly interface with the console. Contact your Stryker sales representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient and/or operating room staff injury. • All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment. Failure to comply may result in patient and/or operating room staff injury. • Always use the appropriate accessory combination with a handpiece. Contact your Stryker sales representative for a complete list of accessories. Failure to comply may result in patient and/or operating room staff injury. • DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating. Failure to comply may result in operating room staff injury. • DO NOT modify the ground connection of the console power cord. Failure to comply may result in patient and/or operating room staff injury. • DO NOT place a handpiece on a patient. Failure to comply may result in patient injury, for example burns or damage to tissue. • DO NOT place a handpiece on or near a magnetic pad or tray. A magnetic field can simulate the output of a handswitch or footswitch and may cause the handpiece to operate inadvertently. Failure to comply may result in patient and/or operating room staff injury. • DO NOT perform footswitch mapping (assign a handpiece port to a footswitch port) while operating a handpiece. Failure to comply may result in patient and/or operating room staff injury. • Operating a handpiece in the Window Jog mode may increase the temperature of the handpiece. If a handpiece overheats, the console automatically shuts off the handpiece. (The audible alarm does not warn the user if this event occurs.) Monitor the operating time of the handpiece to prevent overheating. Failure to comply may result in patient and/or operating room staff injury. • Use safety glasses. Failure to comply may result in operating room staff injury. NOTE: If the console screen is touched in two places simultaneously, unintended button activation may result. Indications For Use The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of teeth, bone, bone cement, and other bone-related tissue in a variety of surgical procedures, including but not limited to Neuro, ENT, Dental and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. Contraindications None. F T D RA 5

System Overview The Stryker CORE Powered Instrument Driver (console) provides an integrated, centrally controlled environment that promotes safe and economical surgical practice. The console’s software provides control over system components including the console, the graphical user interface (GUI), the irrigation pump, and the connected handpieces and footswitches. The software’s file management capability allows you to save and store user preference settings and have convenient access to a favorites list of the most frequently used files to improve efficiency. The color display, with its touch sensitive screen, provides an intuitive graphical user interface that allows you to view multiple system components and set their parameters with the touch of a finger. Changes may be made rapidly, with little to no interruption during surgery. Multiple handpieces and footswitches may be connected and operated simultaneously from a single console. The console provides a common interface for both micro and heavy-duty handpieces. Because options vary among different handpieces, the console will only display those options that are related to the connected handpiece. Various cutting accessories and irrigation cassettes used with the system are also recognized and identified on the console screen by means of a wireless tag technology. The console’s enhanced serial interface provides a serial communications channel between the console and other devices. This feature allows the transfer of data and control information, like run-time data and software upgrades over a computer network. An integral irrigation pump system reliably supplies coolant/irrigation to the cutting site with adjustable flow rates. Console settings, like display brightness and speaker volume, may be easily adjusted. The on board speaker provides audible feedback during operation and configuration. The console accepts either 115 VAC or 230 VAC input and has the capability to power heavy-duty handpieces. System Block Diagram 115 or 230 VAC Facility Power Other Devices Enhanced Serial Interface via Computer Network Handpiece 1 Main Processor Handpiece Control Handpiece 2 CORE Console Handpiece 3 Footswitch 1 Footswitch and Irrigation Pump Control Footswitch 2 Touch Color Sensitive Speaker Display Screen Irrigation Pump Finger/Stylus Graphical/ Irrigation Pump Input Audio Output Cassette F T D RA 6

Hardware Features Footswitch Connection Handpiece Connec- Color Touch Screen Area; allows you to tion Area; allows you Display Area; allows connect two to connect three you to view and make footswitches simulta- handpieces simulta- handpiece settings using neously. neously. its touch screen capability Irrigation Pump Cassette; install the irrigation cassette here if you use the irrigation pump (optional). Power Switch; press to turn console power ON and OFF. Speaker; provides audible sounds and alarms (located inside Irrigation Bag Pole console). Mounting Bracket; connect the pole here if you use the irrigation pump (optional). Enhanced Serial Interface Connectors; three Power Receptacle; connect the communication ports allow you to transfer data and control console to facility power using the information, including software upgrades. console power cord. The console will accept 115 or 230 V facility power. Accessories WARNING: Use only Stryker approved accessories. Other accessories may not properly interface with the CORE Console. Contact your Stryker sales representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient and/or operating room staff injury. Description REF Power Cord ................................................................................................................................................................................. 0996-851-010 Cable; push-pull type connector with alignment markings and keyed connectors .................................................................. 5100-004-000 Footswitch .................................................................................................................................................................................. 5100-008-000 Disposable Irrigation Cassette ................................................................................................................................................... 5400-050-001 F T D RA 7

Operating Instructions Interconnect Diagram The interconnect diagram provides the connection sequence of CORE system components. The diagram's numbered callouts correspond to the numbered instructions on the next page. See the instructions for use supplied with each component for specific connection information. Symbol Definitions On/Off (push-push) Footswitch Handpiece Irrigation Type BF Applied Part F T D RA 8

To Connect the Components: NOTE: Refer to the Interconnect Diagram while performing the instructions below. See the instructions for use supplied with each component for specific connection information. 1. Place the console on a sturdy, flat surface near a hospital grade outlet. 2. Install the power cord plug into the power receptacle. Pull the bracket over the plug to secure it within the power receptacle. 3. Install the other end of the power cord into a hospital-grade wall outlet. 4. Press the power switch to turn the console on. See To Power Up and To Adjust Options sections for more information. NOTES: • The universal power supply will automatically adjust to match the voltage and frequency of the facility power. • As you connect components to the console, the console’s screen will change to reflect the various components that are connected. CAUTIONS: • DO NOT thread or twist the push/pull connectors on the cords during installation or removal. • When connecting or disconnecting a cable(s) to the front of the console, always hold the cable by its connector (the plug, not the cord). Failure to comply may result in damage to the cable or console. • Cables that are connected to the front of the console have keyed, push-pull type connectors that lock into place. DO NOT force a connector into a console port. Each connector and port has an alignment mark to indicate proper cable orientation. 5. If using a footswitch, plug the footswitch cable into the console port marked with a FOOTSWITCH PORT symbol. Align the marks and gently push the connectors together. Two footswitches may be connected to the console. 6. Plug the handpiece cord(s) into the console port(s) marked with a HANDPIECE PORT symbol. Align the marks and gently push the connectors together. Three handpieces may be connected to the console and operated simultaneously. NOTE: If using a CORE Universal Handswitch, attach it to the handpiece before you plug the cord into the handpiece. 7. Plug the other end of the handpiece cord(s) into the handpiece(s). See instructions for use supplied with each handpiece for connection information. WARNING: Use only Stryker approved cutting accessories. 8. Attach the cutting accessory to the handpieces. See the instructions for use supplied with each handpiece or attachment for cutting accessory installation information. NOTE: If using the console irrigation pump (optional), install the Irrigation Pole REF 5100-50-28 (optional, may use equivalent irrigation pole) to the mounting bracket on the back of the console. Hang the irrigation bag from the pole. 9. If required, install the irrigation cassette into the console port marked with a IRRIGATION PUMP CASSETTE symbol. 10. If required, connect the irrigation tubing to the irrigation bag. 11. If required, attach the irrigation clips to the handpiece(s) and connect the tubing. Connect the irrigation tubing to the handpiece. See the instructions for use supplied with each handpiece for connection information. 12. Test all the CORE system components to ensure that they are performing properly before surgery. Refer to the Button Definitions and Software Menu Map sections when using the graphical user interface. F T D RA 9

Button Definitions Button Name Definitions Button Name Definitions HOME View and adjust handpieces OSCILLATE Set default mode of and system settings handpiece to oscillate HELP Access task-oriented HELP FORWARD Set default mode of related to screen and handpiece to rotate in the button functionality forward (clockwise) direction REVERSE Set default mode of BACK Return to the previous handpiece to rotate in the screen reverse (counterclockwise) direction LOW Set default mode of handpiece to operate in the UP Scroll up low rpm range mode HIGH Set default mode of handpiece to operate in the INCREASE Increase the value of a high rpm range mode setting ADJUST Adjust handpiece, footswitch OPTIONS and console options DOWN Scroll down FIXED SPEED Set the default run mode of the handpiece speed to DECREASE Decrease the value of a operate at the set speed only setting VARIABLE Set the default run mode of SPEED the handpiece speed to OK Accept inputs, changes or respond to the degree of selections and return to pressure applied to the previous screen handswitch or footswitch ONE TOUCH Set the default run mode of the handpiece activation to ESC Close a pop up or screen respond to one touch of a without accepting inputs, handswitch or footswitch changes or selections and return to previous screen PROGRAM Program the footswitch FOOTSWITCH pedals and pads based on the handpiece capabilities FACTORY Apply original factory DEFAULT default settings ASSIGN Assign a specific footswitch FOOTSWITCH port to a specific handpiece TO port HANDPIECE F T D RA 10

Button Definitions (cont'd) Button Name Definitions Button Name Definitions SET Select specific handpiece EDIT Change user preference file HANDPIECE options and assign them to SETTINGS settings OPTIONS a particular handpiece button MANAGE Create and modify user SAVE Save current console USER preference folders and CURRENT settings as a new user PREFERENCES files SETTINGS preference file NAVIGATE UP Navigate one directory ADJUST Adjust console options in the ONE LEVEL level up CONSOLE standard or advanced mode OPTIONS DELETE Delete a folder or file ADJUST Adjust console volume, VOLUME brightness and contrast AND SCREEN CREATE FILE Create a new user ACCESS Access user preference preference file ADVANCED options MODE COPY Copy a user preference SELECT Select one of five favorite file or folder USER user preference files as the PREFERENCE console default FAVORITE CREATE Create a new user SWAP USER Replace one of the five FOLDER preference folder PREFERENCE favorite user preference files FAVORITE with another preference file OPEN AND Open a user preference ADJUST Apply an irrigation flow rate MODIFY folder and modify the IRRIGATION to a handpiece cutting file(s) as required PUMP accessory SETTINGS FLUSH Provide a continuous ADD Add a handpiece to a user TUBING SET irrigation flow rate to flush HANDPIECE preference file the tubing set AUTO Prime the tubing set from the SAVE Save changes to the PRIME pump head to the irrigation CHANGES handpiece settings of a TUBING SET tip clip user preference file VIEW/EDIT View and edit the user SETTINGS preference file settings of a selected handpiece UNDO Undo the last changes F T RA CHANGES made D 11

Software Menu Map The software menu map is a visual representation of the menu structure and its hierarchy. The map also provides the sequence of screen information provided in this manual, top down and left to right. The icons used in this map are the same icons used on buttons in the software and are also used with the header information in this manual. Home Screen Select User Adjust Speed/ Adjust Irrigation Adjust Console Adjust Options Preference Access Help Power Pump Settings Options Favorite Swap User Select Adjust Audio Preference Direction/Mode Video Controls Favorite Program Access Footswitch Advance User Options Mode Manage User Assign Create New Preferences Footswitch Folder(s) Folders Manage User Set Handpiece Create New Preference Options File(s) Files Modify File Add Handpiece Edit Settings F T D RA 12

To Power Up: Power Up Screen This screen is momentarily displayed while the console powers up. Note the software version is displayed in the lower right corner of the screen. Plug in Handpiece Cable Screen If no handpieces or cords are connected to the console during initial power up, the following screen will appear: If the Adjust Options button is pressed before any cords or handpieces are connected, the following screen will appear. At this time, console options that are not handpiece specific may be set up before the sterile handpieces are brought into the operating room and plugged into the console. Adjust Options The subdued portions of these screens will become available once a handpiece is plugged into the console. These screens do not depend on whether a footswitch is plugged into the console. F T D RA 13

To View Options: HOME screen The HOME screen is where most user interaction will take place. Up to three handpieces may be displayed on the screen simultaneously. When the console is initially turned on, the console settings are factory default settings until a user preference file is selected or the settings are manually modified. Handpiece Operating Area View User Preference File Name View and modify key View name of file that contains handpiece settings. handpiece settings for a specific procedure, for example, ACL surgery. Console Operating Area Access key console functions. Attached Handpieces Three handpieces may be attached to the console and two may be operated simulta- neously. View Handpiece Name View Cutting Accessory or View name of active Attachment Name handpiece. Three View cutting accessory or handpieces may be attachment name if the connected and handpiece, accessory and/or displayed. Two attachment have recognition powered handpieces may capability. View Option Settings be operated from the same View option settings such as irrigation, console, simultaneously. footswitch control, and fixed or variable RPM. All of these settings may be modified. F T D RA 14

To Adjust Handpiece Speed (or Power): From the HOME screen, touch the plus and minus buttons to adjust the handpiece speed or power set point in rpms or percentage of power. NOTE: When you install a cutting accessory with cutter recognition capability, the system will automatically override the selected speed setting in each mode to the speed settings that are appropriate for the installed cutting accessory. While the handpiece is running, the display shows the actual handpiece speed. If the handpiece is not running, the default or selected speed is displayed. The default speed is displayed for each handpiece until you adjust the speed set point based on the handpiece capability. Touch the adjustment buttons (or slider bar that becomes visible when touching the speed value) to increase or decrease the speed (power) set point. To Select Handpiece Direction and Mode: From the HOME screen, touch the Select Direction/Mode button to adjust the handpiece direction and mode. FORWARD: Touch to cause REVERSE: Touch to cause the OSC: Touch to cause the the handpiece cutting handpiece cutting accessory to handpiece cutting accessory to rotate in the rotate in the reverse accessory to oscillate. forward (clockwise) direction. (counterclockwise) direction. Direction Options Select the direction of the cutting accessory Mode Options Select the mode of handpiece operation LOW: Touch to cause the HIGH: Touch to cause the handpiece to operate in the handpiece to operate in low rpm range mode. the high rpm range mode. NOTE: The available handpiece options, including handpiece direction and mode, will depend on the type of handpiece that is identified F T at the top of the screen. D RA 15

To Adjust Options: From the HOME screen, touch the Adjust Options button to adjust the handpiece and footswitch options. The available handpiece options will depend on the type of handpiece that is identified at the top of the screen. Adjust Acceleration Select Run Mode • Touch the plus and minus buttons or slider bar to adjust the • FIXED: handpiece speed runs at the maximum setting percent of acceleration [0 to 100%]. only. Varying pressure on the footswitch or handswitch • At 100%, the handpiece speed accelerates quickly. will not vary the handpiece speed. Acceleration slows as the setting approaches zero percent. • VARIABLE: handpiece speed responds to the degree of pressure applied to the footswitch or handswitch. • ONE TOUCH: Handpiece activation responds to one touch of a trigger device Adjust Braking (footswitch, handswitch) and • Touch the plus continues to run when the and minus buttons trigger device is released. or slider bar to Handpiece is deactivated by adjust the percent touching any trigger device. of braking [0 to In this mode, the handpiece 100%]. operates at constant set- • At 100%, the point speed/power level. handpiece stops abruptly. The amount of deceleration decreases as the setting approaches zero percent. Adjust Oscillate Turns • Touch the plus and minus buttons to select the number of turns per direction when running a handpiece in the oscillate mode. F T D RA 16

To Program Footswitch Options: From the Adjust Options screen, touch the Program Footswitch button to program the footswitch pedals and pads based on the capabilities of the connected handpiece. Two footswitches may be connected to and simultaneously operated from the same console. However, two footswitches cannot be used to control the same handpiece at the same time. View Handpiece Port Indicates the handpiece port that the footswitch is programmed for. Touch the arrow buttons to scroll through the footswitch options. The available options are handpiece specific. Touch the OK button to select the option. Assign Specific Option Select a footswitch pedal or pad [A, B, I, II or III] button and assign a specific option. • LOW: pressure on the footswitch pad will cause the handpiece to operate in the low speed range or mode. • SPEED INCREMENT: pressure on the footswitch pad will increment the set point speed. • SPEED DECREMENT: pressure on the footswitch pad will decrement the set point speed. • IRRIGATION INCREMENT: pressure on the footswitch will increment the pump flow set point and increase irrigation to the handpiece cutting accessory. • IRRIGATION DECREMENT: pressure on the footswitch will decrement the pump flow set point and decrease irrigation to the handpiece cutting accessory. • IRRIGATION ON/OFF: pressure on the footswitch will toggle the irrigation pump on and off. If pressed and held, the Based on handpiece capabilities, options may include: irrigation pump can be turned on without running the • FORWARD: pressure on the pad or pedal will cause the handpiece. Once started, the irrigation pump can be stopped handpiece to rotate in the forward (clockwise) direction. by pressing the pad again or by starting the handpiece. • REVERSE: pressure on the pad or pedal will cause the • PUMP FLUSH: pressure on the footswitch will turn the handpiece to rotate in the reverse (counterclockwise) direction. irrigation pump on at the flush rate. Once started the irrigation • +OSC TURNS: pressure on the footswitch pad will cause the pump may be stopped by pressing the pad again or by starting handpiece to oscillate; increase number of turns. the handpiece. • -OSC TURNS: pressure on the footswitch pad will cause the • CHANGE PORT: pressure on the footswitch pad will change handpiece to oscillate; decrease number of turns. the footswitch assignment to another active handpiece. • ON: pressure on the footswitch pad or pedal will make the port • ONE TOUCH: acting like an on/off toggle, tap the footswitch active, for example it will provide input to the assigned pad to operate the handpiece at the maximum speed. Tap the handpiece. footswitch pad again to stop the operation. • OFF: pressure on the footswitch pad or pedal will make the • VARIABLE: varying pressure on the footswitch pad will cause port inactive, for example it will not provide input to the the handpiece speed to vary. assigned handpiece. • FIXED: pressure on the footswitch pad will cause the • HIGH: pressure on the footswitch pad will cause the handpiece handpiece to operate at a constant speed as set on the HOME to operate in the high-speed range or mode. screen. F T D RA 17

To Program Footswitch Options: WARNING: DO NOT perform footswitch mapping (assign a handpiece port to a footswitch port) while operating a handpiece. Failure to comply may result in patient and/or operating room staff injury. Assign Handpiece Port to a Footswitch Port The Assign Handpiece to Footswitch screen will appear automatically when connecting two footswitches and two or more handpieces to the console. Access the Assign Handpiece to Footswitch screen manually as follows: 1. From HOME screen, press Adjust Options button 2. From Adjust Options screen, press Program Footswitch button 3. From Program Footswitch screen, press Assign Handpiece to Footswitch button The color options above indicate the default setting for two connected footswitches and three connected handpieces. Touch the handpiece name button to toggle through the four color options. Each color indicates a footswitch to handpiece port assignment as described below: Green indicates the top (green) footswitch port is assigned to the handpiece port. Yellow indicates the bottom (yellow) footswitch port is assigned to the handpiece port. Green/Yellow combination indicates both footswitch ports are assigned to the handpiece port. Gray indicates no footswitch port is assigned to the handpiece port. Color icon indicates which handpiece will be operated when the associated footswitch is actuated. F T D RA 18

To Set Handpiece Options: WARNING: Read and understand the appropriate Stryker handpiece instructions for use. From the Adjust Options screen, touch the Set Handpiece Options button to select specific handpiece options and assign them to a particular handpiece button. Options are handpiece dependent and may not be available if the handpiece does not support them. Handpiece attachments may also be selected, if supported. If selected, the console will display the correct attachment information and set maximum speed values for the handpiece. Select Handpiece Attachment Select specific attachment based on the handpiece capability. Touch arrows to scroll through and highlight a handpiece attachment. Program Handpiece Buttons • Touch numbered button to assign an option. • Select specific options and assign them to a particular handpiece button based on handpiece capability. Based on handpiece capabilities, options may include: • FORWARD: option will rotate cutting accessory in the forward (clockwise) direction. • REVERSE: option will rotate cutting accessory in the reverse (counterclockwise) direction. • +OSC TURNS: option will increase the number of oscillate turns. • -OSC TURNS: option will decrease the number of oscillate turns. • HIGH: option will operate handpiece in the high-speed mode. • LOW: option will operate handpiece in the low speed mode. • CHANGE PORT: option will change the button assignment to another active handpiece. • +IRRIGATION: option will increase irrigation to the handpiece cutting accessory. • -IRRIGATION: option will decrease irrigation to the handpiece cutting accessory. • WINDOW JOG TRIGGER: option will rotate the cutting accessory at a very low speed to position the cutting edge within the cutting window. F T D RA 19

To Select a User Preference Favorite: From the HOME screen, touch the Select a User Preference Favorite button to select a favorite user preference file or replace an existing one. Five favorite files are available. Each file contains specific handpiece(s) settings for a particular procedure. Touch to select one of the five favorite user preference files. To Replace a User Preference Favorite From the Select a User Preference Favorite pop up, make a file selection via the arrow buttons and OK button, then touch the Swap button to replace an existing favorite file. Touch arrow buttons to scroll through the list and highlight one of the preference files. Touch OK button to replace one of the favorite preference files. F T D RA 20

To Adjust Irrigation Pump Settings: NOTE: If using the irrigation pump, assemble the irrigation pole to the mounting bracket located on the back of the console. Hang the irrigation bag from the pole. Install the irrigation cassette into the console pump. Attach the irrigation clips onto the handpiece and connect the tubing. From the HOME screen, touch the Adjust Irrigation Pump Settings button to apply an irrigation flow rate to a handpiece cutting accessory. AUTO PRIME and FLUSH options are also provided. Adjust Irrigation AUTO PRIME % Setting Tubing Set • Touch the slide • Touch to activate bar or plus, the priming minus buttons to sequence of the adjust the flow installed irrigation rate percentage cassette. of irrigation [1 to • The tubing will be 100% or OFF] to primed from the the cutting pump head to the accessory of the irrigation tip clip handpiece. within 20 seconds. • At 100%, • The button will irrigation to the remain depressed handpiece is set during the timed to maximum operation. flow rate. The rate decreases as the setting approaches FLUSH Tubing Set - Touch and zero. hold to provide a continuous flow rate of 300 ml/min with no irrigation Select Handpiece clip and a minimum pressure of 30 • Touch one or all of the handpiece buttons to allow activation of the irrigation psi when the tubing is blocked. pump. If no buttons are selected, the pump will not operate. • Activation will apply an irrigation flow rate to the handpiece cutting accessory. • The flow rate will depend on the type of handpiece. • Activating a handpiece will gain control of the console irrigation. While the first activated handpiece is running, activating a second or third handpiece will not change pump flow, but may reduce irrigation to the first handpiece if a Y-splitter is used. To gain control of console irrigation using a second or third handpiece, activate the second or third handpiece while the first handpiece is not running. To Adjust the Console Settings: - Standard and Advance User Mode From the Adjust Options screen, touch the Adjust Console Options button to adjust the volume, brightness and contrast. Adjust Audio/Video Controls - Standard Mode Adjust Volume Adjust the percent of console volume [0 to 100%] by touching the slide bar or the plus, minus buttons Adjust Brightness Adjust the percent of console display brightness [0 to 100%] using the slide bar or the plus, minus buttons Adjust Contrast Adjust the percent of console display contrast [0 to 100%] using the slide bar or the plus, minus buttons F T D RA 21

To Adjust the Console Settings: - Standard and Advance User Mode Access Advance User Mode From the Adjust Console Options screen, touch the ADV button to gain access to the Advance User Mode and the User Preference file management system. A pop up will appear to confirm your request. Once confirmed, the Manage User Preference button will appear. Return to Standard User Mode After managing user preference files in the advance user mode, touch the ADV button to return to the standard user mode. F T D RA 22

To Manage User Preference Folders: - Advance User Mode Only NOTE: You must be in the Advance User Mode to manage user preferences. See To Adjust Console Options section for details. From the Adjust Console Options screen, touch the Manage User Preferences button to create and modify user preference folders and files. Each folder may contain multiple files and each file may contain the settings for multiple handpieces used for a specific procedure and/or physician. View Address Bar Open Folder View the directory file path (folder/file Touch arrow buttons to scroll through and highlight a folder. name) to help with navigation. Touch folder button to access files within a folder. Manage user preferences MAIN ENT DR. CARRY ORAL Create New Folder Touch to create a new folder. GEN LAPARASCOPY ? ESC To Manage User Preference Files: - Advance User Mode Only Open File Touch arrow buttons to scroll through and highlight a file. Touch Modify button to open and modify a file. Create New File Touch to create a new file. F T D RA 23

To Manage User Preference Folders and Files: - Advance User Mode Only Create a New Folder or File From the Manage User Preferences screen (folder or file screen), touch the Create New Folder or File button to create a new preference folder or file using a keyboard screen. Enter a Folder or File Name Touch key buttons to enter a folder or file name. Shift Lock/Unlock Touch to enter symbols or numbers. Use Backspace Touch to delete keystrokes. F T D RA 24

To Manage User Preference Folders and Files: - Advance User Mode Only Modify File View and Edit Settings Touch the ADD Handpiece button to add a handpiece to the file. Once handpieces are added to a file, touch the arrow buttons to scroll through and highlight a handpiece. Touch the magnifying glass button to create or edit handpiece settings. Add Handpiece Touch to add a handpiece to the preference file. Add a Handpiece From the Modify File screen, touch the Add Handpiece button to add a handpiece to the preference file from a list of available handpieces. View and Add a Handpiece Touch arrow buttons to scroll through and highlight a handpiece. Touch the ADD button to add a handpiece to the user preference file. F T D RA 25

To Manage User Preference Folders and Files: - Advance User Mode Only View and Edit Settings From the Modify File screen, touch the View and Edit (magnifying glass) button to view and edit the preference settings of a selected handpiece within a user preference file. View and Edit Settings Touch arrow buttons to scroll through and highlight a handpiece setting. Touch EDIT button to change the setting. Edit Settings From the Edit screen, touch the EDIT button to modify the setting within the user preference file only (console defaults remain unchanged). Notice that the user preference Edit screen below (typical example) has a light blue background color to differentiate it from a console default Edit screen (dark blue). F T D RA 26

To Access Help: From most screens or pop ups, touch the Help button to obtain specific screen and button information. Each Help screen is divided into two columns. The right column contains a summary of the screen's overall function. The left column provides a list of all the screen buttons and their function. Select Help Topic Screen View Help Topics - Touch the arrow buttons to scroll through and view help topic information. F T D RA 27

Troubleshooting Guidelines* Problem Action Sporadic electrical interference is Turn off all electrical equipment not in experienced. use in the operating room. Relocate electrical equipment; increase spatial distance. Plug the console and other operating room equipment into different outlets. *The CORE Console is not field repairable. In case of operating difficulties, return this product to Stryker Instruments for repair. For more information, contact your Stryker sales representative or Customer Service at 1-800-253-3210. Periodic Maintenance Interval Activity Prior to Use. Inspect console for damage or signs of wear. DO NOT use if damage is apparent. Storage and Handling To ensure the longevity, performance, and safety of this equipment, package in original package materials when storing or transporting. Cleaning and Sterilization Recommendations WARNINGS: • Clean and sterilize handpieces before first and every use. • Cutting accessories are single use only. Sterile only if package is unopened and undamaged. DO NOT resterilize or reuse. CORE Console, Power Cord, Cable(s) and Footswitch Cleaning Instructions CAUTIONS: • DO NOT sterilize the CORE Console or power cord. • DO NOT allow moisture in any CORE Console opening, or power cord, handpiece cable and footswitch electrical connection. • DO NOT use an aerosol spray directly on the CORE Console display. 1. Lightly wipe the CORE Console, cord, handpiece cable and footswitch surfaces with a soft cloth dampened with a non-abrasive, hospital disinfectant or mild detergent and water. 2. Apply glass cleaner to a soft cloth and wipe the CORE Console display. F T D RA 28

Error Messages* Message Action to Take Error xxx. Console hardware fault is Contact your Stryker service representative. Turn the console off and on detected. again. If the problem persists, return the console to Stryker for repair. Error xxx. Footswitch fault is detected; Contact your Stryker service representative. Unplug the footswitch from the the right pedal is disabled. console and plug it into the console again. If the problem persists, return the footswitch to Stryker for repair. Error xxx. Footswitch fault detected, left Contact your Stryker service representative. Unplug the footswitch from the pedal is disabled. console and plug it into the console again. If the problem persists, return the footswitch to Stryker for repair. Error xxx. Footswitch is not detected or Contact your Stryker service representative. Unplug the footswitch from the fails to be recognized by the console. console and plug it into the console again. If the problem persists, return the footswitch to Stryker for repair. Error xxx. Handpiece fault is detected, Contact your Stryker service representative. Unplug the cord from handpiece trigger is disabled. handpiece and plug the cord into the handpiece again. If the problem persists, return the handpiece to Stryker for repair. Error xxx. Handpiece is not detected or Contact your Stryker service representative. Unplug handpiece from fails to be recognized by the console. console and plug in again. If problem persists, return handpiece Stryker for repair. Error xxx. Handpiece requires Contact your Stryker service representative. additional console hardware. Error xxx. Cutting accessory requires See the instructions for use supplied with the cutting accessory. additional console hardware. * For more information, contact your Stryker sales representative or Customer Service at 1-800-253-3210. To Be Determined F T D RA 29

Messages* Message If You Select OK to a Question Delete all the surgeon’s user preferences? The surgeon ID and all user preferences will be deleted. Change the name of all the surgeon’s user preferences? User preferences listed under the surgeon will be moved under the current surgeon’s name. Identical record found. Maximum number of records exceeded. Please delete inactive records. Initializing console hardware. Please wait. To Be Determined Handpiece has reached recommended service interval. Please return for service at earliest convenience. Handpiece does not support the selected preference. Default handpiece setting will be used. Handpiece temperature has exceeded its nominal operating range and may cause burning. Handpiece temperature has exceeded its operating range. Allow to cool before restarting. Procedure name unspecified. DO NOT allow the handpiece speed to exceed specified attachment limitations. Failure to comply may result in user and/or patient injury. Cutter/bur is not compatible with the current handpiece. Cutter/bur has exceeded its life. Please replace with a new cutter/bur. F T D RA 30

Specifications* Model: REF 5400-50 CORE Console Size: 12.5 in. [317.5 mm] width 5 in. [127 mm] height 17 in. [431.8 mm] depth Weight: <20 lbs. [ 9.1 kg] Equipment Type: Class I, Type BF Applied Part Power Supply: Input voltage: 120V, 60Hz, 6.0A Output voltage: 40V + 0.25 V Output power: 200 W continuous, 400 W peak Enclosure Protection: IPXO Ordinary Equipment Protective Earth Ground: Duty Cycle: Peak power - 10 A, 400 W 50% duty cycle for 10 seconds Sustained power - 5 A, 100% duty cycle for three minutes continuous Display/Color Touch Screen: Wide 65° minimum viewing angle; 6.5 inch diagonal active LCD; resolution 800 (horizontal) x 480 (vertical); 16:9 aspect ratio; 16-bit color; dimensions 3.19 in. [81.0 mm] height 5.67 in. [144.0 mm] width Volume Adjustment: 0 dBA to 81 dBA Environmental Conditions: Operation Storage and Transportation Temperature: Relative Humidity: Atmospheric Pressure: *Specifications listed are approximate and may vary slightly from unit to unit or by power supply fluctuations. F T D RA 31

4100 E. Milham F T RA Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 D


Document Created: 2004-09-20 16:50:07
Document Modified: 2004-09-20 16:50:07
© 2024 FCC.report
This site is not affiliated with or endorsed by the FCC