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 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 D 5400-050-700 Rev- F RA T 4.
Table of Contents Important Information ....................................................................................................................................................................................... 3 Compliance Statements ................................................................................................................................................................................... 3 Software License Notice ..........................................................
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.
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.
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.
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.
Hardware Features Color Touch Screen Display Area; allows you to view and make handpiece settings using its touch screen capability Footswitch Connection Area; allows you to connect two footswitches simultaneously. Handpiece Connection Area; allows you to connect three handpieces simultaneously. 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.
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.
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. 2. 3. 4. Place the console on a sturdy, flat surface near a hospital grade outlet. Install the power cord plug into the power receptacle. Pull the bracket over the plug to secure it within the power receptacle. Install the other end of the power cord into a hospital-grade wall outlet.
Button Definitions Button Button Name Definitions View and adjust handpieces and system settings OSCILLATE Set default mode of handpiece to oscillate HELP Access task-oriented HELP related to screen and button functionality FORWARD Set default mode of handpiece to rotate in the forward (clockwise) direction REVERSE BACK Return to the previous screen Set default mode of handpiece to rotate in the reverse (counterclockwise) direction LOW Set default mode of handpiece to operate in the low rpm r
Button Definitions (cont'd) Button Name Definitions SET HANDPIECE OPTIONS Button Name Definitions Select specific handpiece options and assign them to a particular handpiece button EDIT SETTINGS Change user preference file settings MANAGE USER PREFERENCES Create and modify user preference folders and files SAVE CURRENT SETTINGS Save current console settings as a new user preference file NAVIGATE UP ONE LEVEL Navigate one directory level up ADJUST CONSOLE OPTIONS Adjust console options in th
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.
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.
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 and modify key handpiece settings.
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.
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. Select Run Mode • FIXED: handpiece speed runs at the maximum setting only. Varying pressure on the footswitch or handswitch will not vary the handpiece speed. • VARIABLE: handpiece speed responds to the degree of pressure applied to the footswitch or handswitch.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
Troubleshooting Guidelines* Problem Action Sporadic electrical interference is experienced. Turn off all electrical equipment not in 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.
Error Messages* Message Action to Take Error xxx. Console hardware fault is detected. Contact your Stryker service representative. Turn the console off and on again. If the problem persists, return the console to Stryker for repair. Error xxx. Footswitch fault is detected; the right pedal is disabled. Contact your Stryker service representative. Unplug the footswitch from the console and plug it into the console again. If the problem persists, return the footswitch to Stryker for repair. Error xxx.
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. To Be Determined Initializing console hardware. Please wait. Handpiece has reached recommended service interval.
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.
4100 E.
