Stryker Instruments 5100 TPS Console and TPS Irrigation Console RFID User Manual 5100 001 709 pmd 334
Stryker Instruments TPS Console and TPS Irrigation Console RFID 5100 001 709 pmd 334
Manual
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 344279 |
| Application ID | XtXGdqyMcgdP9JXVt30ogg== |
| Document Description | Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 19.57kB (244673 bits) |
| Date Submitted | 2003-07-30 00:00:00 |
| Date Available | 2003-07-30 00:00:00 |
| Creation Date | 2003-07-07 15:01:32 |
| Producing Software | Acrobat Distiller 5.0 (Windows) |
| Document Lastmod | 2003-07-07 15:01:35 |
| Document Title | 5100-001-709.pmd.334 |
| Document Creator | Adobe PageMaker 7.0 |
| Document Author: | akline |
IMPORTANT INFORMATION: File this in your TPS records Total Performance System Consoles 5100-1 Console REF 5100-50 Irrigation Console REF Hermes READY™ 5100-201 Console REF 5100-250 Irrigation Console REF User's Guide •••••••••••••••••••••• Includes setup, safety, repair, and warranty information for the Stryker Total Performance System. For answers to questions about other equipment, see the information supplied with that equipment. Version 4.0 6/03 US Patents D398,598; D415,134; 5,543,695; 5,689,159; 6,017,354; 6,025,683; 6,045,564; 6,329,778 and other patents pending 5100-001-709 Rev-A 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-800-253-3210 1-269-323-7700 2 Contents Software License Notice .................................................................................... 3 Where to Find Answers ...................................................................................... 4 Warning, Caution, Note Defined ........................................................................ 4 Important Safety Instructions ............................................................................ 5 System Overview Symbol Definition ................................................................................................ 6 Operating Instructions Connecting the Equipment Hermes READY™ TPS Consoles ....................................................................... 7 The Control Screen TPS Start-Up Screen No Handpiece Detected Screen ......................................................................... 8 Functions of the Control Screen Elements of the Control Screen ......................................................................... 9 Select Your System Settings Standard Features ............................................................................................. 10 Quick Reference Guide (Icon Definition) .......................................................... 11 Handpiece Screens Saw Handpiece Screen (TPS Oscillating and Sagittal Saws) ........................... 12 Rotary Handpiece Screen (TPS Universal and MicroDrills & TPS MicroDriver) ........................................... 13 Stryker Endoscopy and Leibinger Handpiece Screen (SE5 hand-controlled Endo Shaver, QuadraCut Shaver, QuadraCut Bone Plug, and QuadraCut Small Joint, Hummer 4, Formula, 6K Micro, 12K Micro) ........... 14 Other Screens Main Option Screen .......................................................................................... 15 System Information Screen .............................................................................. 16 Handpiece Adjustment Screen ........................................................................ 17 Console Adjustment Screen ............................................................................ 18 Footswitch Adjustment Screen ........................................................................ 19 Footswitch Button Mapping Screen ................................................................ 20 Handpiece Button Mapping Screen ................................................................. 21 Surgeon Preference Screen ............................................................................. 22 Messages and Error Messages ....................................................................... 23 Specifications .................................................................................................... 24 Federal Communications Commission Compliance Statement ................... 24 Repair/Loaner Program Limited Warranty ............................................................................................... 25 Stryker International Subsidiaries ................................................................... 26 Software License Notice Stryker® TPS™ Surgical Tool System products contain software that is installed in the products by Stryker Corporation. Stryker Corporation owns this software; this software is never sold. Each sale of a software containing product is not a sale of such software; it includes only a license to use the software in the product in which the software was initially installed. Any license granted by Stryker Corporation to use the software contained in its; products does not give the licensee the right to copy, alter, disassemble, reverse engineer, create derivative works of such software or to use such software in either original or modified form in any product other than the Stryker Corporation product in which the software was initially installed by Stryker Corporation. © 2003, Stryker Corporation Where to Find Answers When you have questions about your Stryker TPS products, there are several places to find the answers. In this book Use this book to set up your system and select console options. This book also contains information on system safety, repair, and component warranty. ............................................................................................................................................ In TPS component instructions For answers to questions about any TPS handpiece, attachment, or component , see the information supplied with that component. A copy of TPS Cleaning, Maintenance and Sterilization Recommendations is also supplied with each component. ............................................................................................................................................ From your Stryker Sales Representative If you can't find an answer in any of the materials provided or you have questions about other Stryker Instruments products, call your Stryker Sales Representative. ............................................................................................................................................ From Stryker Customer Service Please contact our Customer Service Department to order product information literature, a cutting accessories guide, additional TPS maintenance manuals, and component instructions by dialing 1-800-253-3210. Outside the U.S.A., contact your nearest Stryker subsidiary. ............................................................................................................................................ See the TPS Cleaning, Maintenance, and Sterilization Recommendations booklet for care information. Warning • Caution • Note This symbol is used to alert the reader to important safety and precautionary information. When displayed on the actual device, it refers the user to accompanying documents. Please read this manual and follow all instructions carefully. The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed. WARNING: The personal safety of the patient and/or user may be involved. Disregarding this information could result in injury to the patient and/or operating room staff. 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 more clear. IMPORTANT SAFETY INSTRUCTIONS WARNING: The personal safety of the patient and/or user may be involved. Disregarding this information could result in injury to the patient and/or operating room staff. Read and understand the following warnings. SYSTEM SAFETY ! DO NOT modify ground of power cord. ! Burs and blades are intended for single use only. ! Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. ! Excessive pressure, such as bending or prying, may cause accessory to bend or break and cause tissue damage to patient and/or operating room staff. ! The Stryker Total Performance System is designed to be used by persons familiar with surgical procedures. Misuse may cause injury to both patient and system components. Prior to each use, system components should be inspected for damage. DO NOT use if damage is apparent. ! Heavy sideloads and/or long operating periods occasionally will cause overheating of the distal tip and the body of handpieces to the point where the handpiece is uncomfortable to hold or causes injury to the patient. ! If the recommended duty cycle is not followed, the handpiece may overheat and cause injury to patient and/or operating room staff. See the Duty Cycle information supplied with each handpiece. ! Use only Stryker TPS components and accessories unless otherwise specified. ! Clean and sterilize handpieces and accessories before first and every use. ! Excessive pressure, such as bending and/or prying with a bur, may cause the bur to bend or fracture. If operated at a high speed, it is possible that the bur will bend yet further. This could result in damage to tissue in the surgical site, handpiece vibration that causes lost tactile control, or breakage of the bur such that the broken piece would be ejected at a high velocity endangering the patient and/or operating room staff. It is therefore recommended that safety glasses be used. ! Use of safety glasses by user and operating room staff is recommended to prevent eye injuries. HANDPIECE SAFETY ! Read this booklet and the information supplied with your TPS components. Component instructions provide specific safety information. Refer to the instructions supplied with Stryker Endoscopy handpieces when using those handpieces in conjunction with the TPS console. ! Excessive pressure, such as bending and prying with blade, may cause the blade to bend or fracture and could result in damage to tissue in the surgical site and/or loss of tactile control. ! DO NOT attempt to change a saw, bur, or drill while handpiece is running. ! If using a device with a safety lock, such as a MicroDriver or Universal Handswitch, always place that device in the SAFE position when not in use. IMPORTANT: Be aware that the TPS footswitch will override the Universal Handswitch SAFE setting. ! Stryker handpieces which fail due to long life and/or nose bearing failure may allow foreign matter to migrate or emit from the distal tip of the handpiece. Fluid may leak into the surgical site, such that measures may be required, per the physician's discretion, to protect the patient from infection. ! 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. ! Never rest handpiece on the patient. Improper handling of a handpiece could result in damage or burns to tissue. ! Please note the handpiece starts with rapid acceleration when the footswitch or handswitch is activated. ! Do not place a TPS handpiece near or on a magnetic pad or tray. The magnetic field can simulate a Universal Handswitch and may cause the handpieces to run inadvertently. ! During initial use of your TPS handpieces, monitor the heat response in relation to the type of surgical procedure being performed. Frequently check the distal tip and body until you are familiar with its temperature rise characteristics. Failure to pay close attention to handpiece temperature may cause burn injury to patient. ! DO NOT modify any bur to fit the handpieces. Use only Stryker approved burs. Other burs may not fit properly in the handpiece. During use they may come out of the handpiece or bend which would result in damage to tissue in the surgical site due to loss of control of the bur. System Overview The Stryker Total Performance System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also used for the placement or cutting of screws, wires, pins, and other fixation devices as it can be used to cut metal. TPS console powers multiple handpieces while allowing the user to program a number of customized settings. Hermes READY™ TPS Consoles are designed to interface with Computer Motion's Hermes Operating Room Control Center. The Hermes system allows voice control and pendant setting adjustment of the SE5 Hand Controlled Shaver REF 272-704100 and 12K Hand Controlled Shaver REF 272-704-500. Symbol Definition Power ON Power OFF TPS Handpiece TPS Irrigation Console Footswitch Connector Stryker Endoscopy Handpiece ENDO Endoscopy Handpiece Port TPS Handpiece with Universal Handswitch TPS1 TPS Handpiece Port 1 Handpiece Cords TPS2 TPS Handpiece Port 2 TPS Footswitch Type B Applied Part Type BF Applied Part Connection Detail Operating Instructions WARNINGS: Before using this system read and understand the information in this manual and the instructions supplied with each TPS component and Stryker Endoscopy handpieces. Pay close attention to the User/Patient Safety Information. Familiarization with the Total Performance System prior to use is important. If you have any questions, contact your Stryker Instruments representative or Stryker Customer Service at 1-800-253-3210. Prior to use, system components should be operated and inspected for any damage. DO NOT use if damage is apparent. Connecting the Equipment This is a system overview. For specific instructions on each TPS component, refer to the information supplied with the component. Hermes READY™ TPS Consoles REF 5100-201 and 5100-250 1. Place your console on a sturdy, flat surface near a hospital grade outlet. A Hermes-Interface cable links the two systems. Linking the system does not affect the normal function of the console. At any time, console functions may be selected from the control screen or by using a control accessory such as a TPS footswitch. 2. Plug the console's power cord into the recessed power socket on the back of the console. 3. Plug the other end of the power cord into a hospital-grade wall outlet. 4. Turn on the console. The on/off switch is located on the front of the console. NOTE: As you set up the system, the console's screen will change to indicate the various components as they are plugged in. 5. If using a Footswitch, plug the footswitch cable into the console port marked FOOTSWITCH. Align orientation marks and gently push connectors together. WARNINGS: Only the Hermes Operating Room Control Center is approved for use with the TPS console. Do not plug any other device into the Hermes console port. Use of other devices may damage the console. It is important to read and understand the Hermes Operating Room Control Center instructions; the use of the TPS console with the Hermes Operating Room Control Center is explained in those instructions. Stryker recommends attaching an alternate control accessory (footswitch) to the console in the event the Hermes System fails during surgery. CAUTION: All TPS Cords have push/pull connectors. Do not thread or twist for insertion or removal. 6. Plug the handpiece cord(s) into the console port(s) identified for the handpiece. Align connector orientation marks and gently push connectors together. NOTE: Ports marked TPS1 and TPS2 are for Stryker TPS handpieces only. The port marked ENDO is intended for the following list of Stryker Endoscopy handpieces: SE5 Handpiece REF 272-704-100, SE5 Hand-controlled REF 272704; QuadraCut Shaver REF 275-701; QuadraCut Bone Plug REF 275-705; and QuadraCut small Joint REF 275-601. NOTE: If using a TPS 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). 8. Attach cutting accessories to handpieces. Instructions supplied with each handpiece or attachment provide details for cutting accessory assembly. WARNING: Use only Stryker approved cutting accessories. 9. If using an Irrigation Console REF 5100-50 or 5100-250, assemble Irrigation Pole REF 5100-50-28 to the console as shown. Hang irrigation bag from pole. Install irrigation cassette into the pump. Attach irrigation clips to handpieces and connect tubing. Continue to the next step if using a Hermes READY™ TPS Console and Hermes Operating Room Control Center. CAUTION: Use only the Hermes-Interface cable provided by Stryker Endoscopy. 10. Connect the TPS console to the Hermes controller using a Hermes-Interface cable into the port labeled Hermes on the back of the console. Plug the other end into any available device port on the rear panel of the Hermes controller. 11. Power up both systems and test the devices to ensure they are performing properly prior to surgery. NOTE: The port labeled DATA PORT is intended for the manufacturer's use only. If you have questions about using the Hermes System with the TPS console, contact your Stryker Endoscopy representative or call Stryker Endoscopy Customer Service at 1-800-624-4422. Outside the US, contact the nearest Stryker subsidiary. The Control Screen TPS Start-Up Screen This display appears on the screen every time the console is turned on. This display remains on the screen until a cord is plugged into one of the TPS handpiece ports or the OPT button is depressed. If a handpiece cord is plugged into a handpiece port when the console is turned on, this display shows momentarily before changing to either a no handpiece detected screen or to the screen of the selected handpiece. No Handpiece Detected Screen This image indicates that no handpiece is attached to the cord plugged into the selected port. The screen will change to the handpiece screen when the missing handpiece is connected to the cord. NOTE: This screen will also appear if the console is unable to recognize the handpiece. This could be caused by a handpiece that is not compatible with the TPS console, or a faulty or damaged handpiece or cord. This example shows that no handpiece is attached to the cord plugged into the TPS2 port. Functions of the Control Screen The TPS console allows the user to select functions and settings such as handpiece selection, speed, and direction. Designed to be easy to use and understand, the touch sensitive control screen allows you to set the system controls with the touch of a finger. Interactive icons on the control panel represent system components and functions. The control screen also provides important monitoring information for the selected handpiece. Surgeon preference indicator Handpiece identification Attachment/ Blade identification Handpiece power Indicator ramp Handpiece speed TPS handpiece select buttons Select system options screen Endo handpiece select button Footswitch indicator and options Elements of the Control Screen Handpiece identification displays the name of the active handpiece. NOTE: Handpieces can be plugged into each of the console's handpiece ports, but only one can be selected at a time. Control screen visually presents options which can be set for the selected handpiece. Icons represent elements of your TPS system. Icons are functional buttons. Each function may be selected by pressing the screen where the button is displayed. When you touch an icon, the icon appears to be pressed down and the graphic symbol highlights to indicate that it is activated. (See Icon Definition). NOTE: When *CUSTOM* is displayed at the top of the screen, the console's default settings are selected from Surgeon Preferences. The console is able to capture the preferred settings for several different users. When this feature is activated, the preferred settings act as default settings. See Surgeon Preference for further details. NOTE: An audible signal indicates interface with icons. Handpiece speed information displays the default speed for each handpiece until you reset speed settings. 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. NOTE: Buttons such as the adjust arrows or OPT button which are temporary toggles or adjustment buttons only highlight while depressed. NOTE: Buttons with a white background are toggle buttons. NOTE: Incremental information displayed on the control screen is accurate within +/-1%. NOTE: Options vary among different handpieces. The console will only display the options available for a given handpiece. Select Your System Settings Standard Features NOTE: When the console is turned on, its default setting is factory default unless a Surgeon Preference setting is selected as the start up default. See Surgeon Preference for further details. Main Option Icon The option icon appears on all handpiece screens and allows access to the MAIN OPTION screen. See MAIN OPTION SCREEN for further details. 1. Handpiece select buttons enable you to activate the handpiece plugged into one of the three ports on the front of the console. To display the control screen for the handpiece plugged into the TPS1 port, touch the corresponding handpiece select icon. The icon highlights and appears pressed down. NOTE: Selecting a handpiece icon activates the corresponding handpiece and displays its specific control screen. Footswitch Icon 2. Change the maximum handpiece speed. Press the adjustment arrows to change the handpiece speed setting incrementally until the desired speed is reached. The footswitch icon only appears when a footswitch is plugged into the console. If using a footswitch with these graphics, pedal functions can be reprogrammed. See Footswitch Adjustments and Footswitch Button Mapping. • Saws - The set point is displayed as a percentage of maximum power and vertical line on the speed ramp. During handpiece operation, the percentage reading and speed ramp displays the power level. • Rotary handpieces - The speed set point is displayed. During handpiece operation, the current speed is displayed. A footswitch with these graphics cannot be reprogrammed. 3. Select various settings as desired. Refer to the control screens on the following pages for details for each handpiece. Handpiece Irrigation 4. Select the OPT icon to access the MAIN OPTION screen. This screen allows access to general console and user settings as well as direct access to each handpiece option screen. Irrigation functions pertain only to consoles with the builtin irrigation pump REF 5100-50 and 5100-250. Press the icon to start irrigation flow while the handpiece is running. NOTE: The screen returns to the active handpiece adjustments screen when the handpiece name is touched. If irrigation is desired while the handpiece is stopped, press and hold the icon until the pump is activated. The pump can be turned off by touching the icon again. 5. Touch the EXIT icon to return to the active handpiece control screen. Irrigation flow rate can be adjusted from the HANDPIECE screen or the HANDPIECE ADJUSTMENTS screen. From the HANDPIECE screen, toggle the SPEED icon to WATER before using the arrows to adjust flow rate. -ORFrom the HANDPIECE ADJUSTMENTS screen, select the WATER icon and use the arrows to adjust flow rate. Flow rate diminishes as the setting approaches zero. NOTE: Flow rate may vary among handpiece models. The pump can also be turned on and off with the footswitch. 10 Quick Reference Guide Icon Definition Handpiece Select This type of icon appears when a cord (without a handpiece) is plugged into the corresponding Endo, TPS1 or TPS2 port. Footswitch Icon: Appears when a footswitch is connected to the console. Also gives access to footswitch adjustments screen. It appears depressed when selected. Adjustment Arrows: Use in conjunction with other options to set handpiece The handpiece graphic appears speed or power, braking, acceleration, when a handpiece is attached irrigation flow, screen contrast etc. to the corresponding cord. Increase The handpiece graphic highlights and the icon appears depressed when selected. Decrease High: Enables handpiece to operate in a high speed mode. Low: Enables handpiece to operate in a low speed mode. Toggle Buttons NOTE: For easy identification, only toggle buttons have a white background. Speed: Use with the increase and decrease icons to adjust rotary handpiece speed. Water: Use with the increase and decrease icons to adjust irrigation flow. System Options Options: Gives access to handpiece adjustments, system information, console adjustments and user preference. Power: Use with the increase and decrease icons to adjust saw power. Forward (clockwise) Variable: Handpiece speed responds to varying degrees of pressure on the footswitch or handswitch. Exit: Returns to previous screen. Reverse (counterclockwise) Nonvariable: Handpiece operates at constant set-point speed/power level. Information: Displays system information screen. Oscillate Handpiece option: Accesses corresponding handpiece adjustment screens. Console: Gives access to console adjustment screen. Direction Arrows: Sets handpiece mode. Irrigation: Activates or deactivates handpiece irrigation. One touch: Handpiece is activated by one touch of a trigger device and continues to run when the trigger device is released. Handpiece is deactivated by touching any trigger device. In this mode, the handpiece operates at constant set-point speed/power level. Allows access to the surgeon Advanced: - Accesses the advanced footswitch mapping screen. Button: Access button mapping screen. NOTE: TPS Console models REF 5100-1 and 5100-201 do not display options related to handpiece irrigation. 11 Return to full screen: Return from Big to full handpiece screen. Saw Handpiece Screen TPS Oscillating and Sagittal Saws POWER/WATER ADJUSTMENT The power icon functions as a toggle switch for power and water settings. Power and irrigation adjustments are made using the adjustment arrows. As the power setting is reduced from 100%, a vertical bar displays to correspond to the lower selected maximum power. This screen appears when a TPS saw is selected at the TPS1 port with the maximum power set at 100%. ENDO, TPS2 and the footswitch icons indicate other instruments are plugged into the console. The irrigation setting is not displayed on this screen. However, it can be seen on the Handpiece Adjustments screen. METHOD OF OPERATION Saws can be operated with the TPS Universal Handswitch or TPS Footswitch. Handswitch Handpiece selection can be made by depressing the handswitch once. The handpiece select icon changes to indicate the active handpiece. Depress the handswitch again to run the handpiece. Handpiece runs from start-up to the maximum selected speed. Footswitch Handpiece runs from start-up to the maximum selected speed with either the forward or reverse pedal. 12 Rotary Handpiece Screen SPEED/WATER ADJUSTMENT The speed icon functions as a toggle switch for speed and water settings. Speed and irrigation adjustments are made using the adjustment arrows. DIRECTION OPTIONS FORWARD Clockwise REVERSE Counterclockwise This screen appears when a TPS rotary handpiece is selected. The TPS Universal Drill is plugged into the TPS2 port and the speed is set at 75,000 RPM. ENDO, TPS1 and the footswitch icons indicate that other instruments are plugged into the console. TPS Universal and Micro Drills OSCILLATE TPS MicroDriver and Universal Driver METHOD OF OPERATION The Universal Drill can be operated with the TPS Universal Handswitch or TPS Footswitch. Handswitch Handpiece selection can be made by depressing the handswitch once. The handpiece select icon changes to indicate the active handpiece. Depress the handswitch again to run the handpiece. Handpiece runs from start-up to the maximum selected speed. Speed and cutting direction corresponds to what is selected on the screen. METHOD OF OPERATION The TPS MicroDriver can be operated with its builtin trigger and rotary control switch or with the TPS Footswitch. NOTE: The handpiece will not run when the rotary switch is in the SAFE position. Trigger The built-in speed control trigger(s) runs the handpiece from start-up to the maximum selected speed. Footswitch Handpiece runs from start-up to the maximum selected speed. Handpiece direction is controlled by selecting the forward or reverse pedals. The direction icon on the screen changes when the corresponding footswitch pedal is depressed. MicroDriver only: Select cutting direction with the rotary switch on the handpiece. Direction icon will highlight to match the rotary switch position. Universal Driver only: Select cutting direction by depressing either the forward trigger or the reverse trigger. Squeezing both triggers simultaneously runs the handpiece in the oscillate mode. The oscillate icon will become highlighted. Footswitch Handpiece runs from start-up to the maximum selected speed. The direction icon on the screen changes when the corresponding footswitch pedal is depressed. Footswitch operation overrides handpiece settings. Example: If the footswitch reverse pedal is depressed while the handpiece rotary switch is set in forward, the handpiece operates in the reverse direction and the reverse icon highlights. However, after the pedal is released, the direction icon will revert to the direction set on the rotary switch. 13 The Stryker Endoscopy and Leibinger Handpiece Screen Depress the mode icon and set the maximum speed using the adjustment arrows. Speed settings are individually selected for each mode. Default speed settings and incremental steps are specific to each handpiece. MODES Operation in high speed mode. Operation in oscillate mode. The oscillate mode is selected and Set Speed is set at 1,800 RPM. Operation in low speed mode. TPS1, TPS2 and the footswitch icons indicate that other instruments are plugged into the console. WARNING: Read and understand the Stryker Endoscopy handpiece instructions. If instructions were not supplied with your handpiece, refer to the appropriate Stryker Endoscopy Operating and Maintenance Manual listed below. Handpiece 272-704 275-701 275-705 275-601 290-601 Manual 1000-400-120 1000-400-034 1000-400-034 1000-400-034 1000-400-288 IMPORTANT INFORMATION The hand-controlled Endo Shaver can be controlled by the footswitch or by the handcontrol buttons built into the handpiece. 14 Main Option Screen Select the OPT icon to access the MAIN OPTION screen. This screen allows direct access to the handpieces attached to the console, console and user settings, and system information. OPTION 1, 2, and E icons appear only when handpieces are plugged into the corresponding console ports. A handpiece must be plugged in to program its settings. To go to the HANDPIECE ADJUSTMENT screen, touch the option button that corresponds to the desired handpiece. Refer to HANDPIECE ADJUSTMENT. The MAIN OPTION screen also gives DIRECT access to: Refer to SURGEON PREFERENCE. Refer to CONSOLE ADJUSTMENT. Refer to SYSTEM INFORMATION. EXIT: Return to handpiece screen. 15 System Information Screen Selecting the INFO icon from the MAIN OPTION menu displays the part numbers and revision levels of the configured system components. This information is used as a diagnostic aid only. Return to the MAIN OPTION screen. 16 Handpiece Adjustment Screen Select a Handpiece Option icon from the MAIN OPTION screen to access this screen. ATTACHMENT: Use the arrow icon on the left to scroll through the list of attachments. Select the attachment that is assembled to the handpiece by stopping on it. NOTE: For quick access to this screen, touch the handpiece title displayed at the top of any handpiece screen. And return to the handpiece screen by touching the handpiece title displayed on this screen. Selecting the proper attachment will optimize the performance of the handpiece for the attachment and display the appropriate speed scale on the handpiece screen. Depending on the type of handpiece, one or more of the following options will be available. RUN MODE: Use the RUN MODE toggle button to scroll through the options and stop on the desired setting. Select BRAKE, ACCEL, TURNS, WATER or AUX then press the arrow icons to change the setting. Variable: Handpiece speed responds to the degree of pressure applied to the handswitch. Brake: At 100%, the handpiece stops abruptly. Deceleration slows as the setting nears zero. Nonvariable: Handpiece speed runs at the maximum setting only. Varying pressure on the handswitch does not vary the handpiece speed. Accelerate: At 100%, handpiece speed accelerates quickly. Acceleration slows as the setting approaches zero. Turns: Use to set the number of turns per direction when running a handpiece in the oscillate mode. The minimum setting will set the oscillate function to operate in a TIMEBASED mode where the number of turns are based on the speed of the handpiece. One touch: Toggle the handpiece on and off with a single touch of a trigger device. The trigger device can be the handswitch or handpiece trigger buttons. BUTTON: See Handpiece Button Mapping. Water: At 100%, irrigation volume is greatest. Volume decreases as the setting approaches zero. FOOTSWITCH: Activates FOOTSWITCH ADJUSTMENTS. See Footswitch Adjustments. 17 Console Adjustment Screen Select the CONSOLE ADJUSTMENTS icon from the MAIN OPTION screen to access this screen. Select CONTRAST, BRIGHTNESS or VOLUME then press the arrow icons to change the setting. Contrast: Screen contrast lightens at higher settings. The chosen setting remains until reset. Brightness: Screen brightness intensifies at higher settings. Volume: The audible signal is louder at higher settings. Use the BIG SCREEN toggle button to select one of the following options. Automatic: A big screen is displayed while the handpiece is running and automatically returns to the full screen when handpiece stops. On: The big screen is continuously displayed. It can be temporarily switched back to the full screen by touching the Full Screen icon which appears in the lower right corner of each handpiece screen. See example of screens below. Off: The big screen option is turned off. Only a full screen is displayed. Example of full screen. 18 Example of big screen. Footswitch Adjustment Screen This screen appears only when using a TPS Footswitch that is Revision 3 or newer. See Standard Features. NOTE: The Footswitch revision is displayed on the SYSTEM INFORMATION screen. Access this screen by selecting the Footswitch icon on the HANDPIECE CONTROL SCREEN or HANDPIECE ADJUSTMENTS screen. NOTE: These footswitch settings function only for the handpiece for which they were selected. The handpiece is identified at the top of the screen. From this screen, the default functions of footswitch pads A and B can be reprogrammed to accommodate the surgeon's preferences. The left and right toggle icons correspond respectively to footswitch pads A and B. Press each icon to scroll through the following function options and stop on the desired setting. Off: Pedal is turned off. Default: Footswitch defaults to the settings selected on the handpiece screen. Forward: Pedal setting default is overridden. Pedal will provide handpiece rotation in the forward (clockwise) direction. Reverse: Pedal setting default is overridden. Pedal will provide handpiece rotation in the reverse (counterclockwise) direction. Advanced: Use to access the Footswitch Button Mapping screen. It will allow you to reprogram all the footswitch pedals. Return: Return to the previous screen. 19 Footswitch Button Mapping Screen Access this screen by selecting the ADVANCED icon on the FOOTSWITCH ADJUSTMENTS screen. The default functions of each footswitch pedal and button can be reprogrammed to accommodate the surgeon's preferences. Depending on the type of handpiece displayed at the top of the screen, one or more of the following options will be available on this screen. The DIRECTION, OP MODE, and RUN MODE icons correspond respectively to the two largest footswitch pedals. Press each icon to scroll through the following function options. And stop on the desired function setting. DIRECTION Pedal is turned off. BUTTON FUNCTION Footswitch defaults to the settings selected on the handpiece screen. The I, II, and III icons correspond to the three small pads across the top of the footswitch. Forward: Pedal setting default is overridden. Pedal will provide handpiece rotation in the forward (clockwise) direction. Button Function displays the active function of the corresponding button. Use the arrow icons to scroll through the functions and stop on the desired setting. Reverse: Pedal setting default is overridden. Pedal will provide handpiece rotation in the reverse (counterclockwise) direction. See Button Functions listed on next page. OP MODE Footswitch defaults to the settings selected on the handpiece screen. Handpiece operates in the high speed range. Reset all: Press to return all pedals and buttons back to their default setting. Handpiece operates in the low speed range. Handpiece operates in oscillate mode. Reset: Press to return the selected footswitch button back to its default setting. RUN MODE Footswitch defaults to the settings selected on the handpiece adjust screen. Variable: Variable speed control. Speed responds to varying degrees of pressure on the footswitch. Nonvariable: Handpiece operates at a constant speed level determined by the maximum speed selected from the handpiece screen. One touch: The one touch function is similar to an on/off toggle. Tap the footswitch to operate the handpiece at the maximum speed selected from the handpiece screen. Tap any trigger device again to stop operation. 20 Handpiece Button Mapping Screen Access this screen from the Handpiece Adjustment screen. Use it to change handpiece button functions. Depending on the features of the handpiece, as many as five buttons can be reprogrammed. Identify corresponding button numbers by pressing the buttons on the handpiece. When the handpiece button is selected, the corresponding function is displayed on the screen. Use the arrow icons to scroll through the function options. Stop on the desired option. See the list below for a description of the options. NOTE: Available options are handpiece specific. BUTTON FUNCTIONS Reset: Select to return a single button to its default function. Reset all: Select to return all buttons to their default functions. Return: Return to previous screen. Button Functions List Description Button Function Description Main trigger Starts handpiece in default direction and mode. Osc <> High/low Toggles the run mode between oscillate and high or low. FWD trigger Starts handpiece in forward direction in default mode. High <> Low Toggles the run mode between high and low. REV trigger Starts handpiece in reverse direction in default mode. OSC trigger Starts handpiece in oscillate mode. Button Function Forward <> Reverse Toggles the running direction. Change port Speed increment Increments the set point speed. Speed decrement Decrements the set point speed. Water increment Increments the pump flow set point. Water decrement Decrements the pump flow set point. Water on/off Changes the active handpiece port. Change attachment Scrolls through the attachment list for the selected handpiece. Pump flush Make port active Toggles the pump on/off button. If pressed and held, the pump can be turned on without running the handpiece. Once started, the pump can be stopped by pressing the button again or by starting the handpiece. 21 Turns the pump on at the flush rate. Once started the pump can be stopped by pressing the button again or by starting the handpiece. Makes the selected handpiece active. Surgeon Preference Screen Access the SURGEON PREFERENCE screen from the MAIN OPTIONS screen. The console is able to capture and store the preferred settings of different surgeon's. There are three options: • Factory default settings • Settings saved by a previous surgeon • Collection and storage of new settings Using factory settings 1. Use the arrows to obtain "Stryker" and "Factory Default." NOTE: The EDIT, DELETE and padlock icons do not function while factory default settings are selected. Using the settings saved by a previous user 1. Use the arrows to select the surgeon and procedure. 2. Select LOAD. Screen returns to the MAIN OPTION screen. 3. Proceed with surgery. This is the key pad screen used to enter the doctor's name and name of procedure. Padlock opened to gather preferences. Collect and store preferred settings 1. Select NEW. The editor screen will appear with the selected surgeon's name. 2. To create a new procedure under this surgeons name, select ENTER. Or if you wish to collect and store settings under a new surgeon name, use the key pad to delete (DEL) the existing name then key-in the new name. Upon completion, select ENTER. 3. Use the key pad to enter the procedure name. 4. Upon completion, select ENTER. The screen returns to the SURGEON PREFERENCE screen. 5. Toggle padlock icon so that the padlock appears open. 6. Select LOAD. 7. Configure system settings. 8. Upon completion, return to the SURGEON PREFERENCE screen. 9. Toggle the padlock icon so that the padlock appears locked. NOTE: If the padlock icon remains in the unlocked position, the selected settings will be continuously updated with current settings. Select to add a surgeon name. Padlock closed to store preferences. Select to change the doctor name and/or procedure. NOTE: Toggle the UPPER/LOWERCASE pad on the editor screen to select letter case. Delete: Select to delete the currently displayed file. Select and use with the open padlock to gather (load) new preference settings. Default: Using the arrows, scroll the SURGEON PREFERENCE screen to the desired surgeon and procedure settings before activating DEFLT. This selection becomes the default power on setting for the system until a different selection is made. 22 Messages Message If you select OK to this question: Delete all the surgeon's procedures? The surgeon ID and all procedures will be deleted. Change the name of all the surgeon's procedures? Procedures 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. 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. Ensure handpiece speed does not exceed specified attachment limitations. Failure to do so may result in user and/or patient injury. Error Messages Message Error 001. Console hardware fault detected. Action to Take Return console to Stryker for repair. Error 002. Console hardware fault detected. Contact your Stryker service representative. Turn unit off and on again. If problem persists, return console to Stryker for repair. Error 003. Console hardware fault detected. Contact your Stryker service representative. Turn console off and on again. If problem persists, return console to Stryker for repair. Error 004. Footswitch fault detected, right pedal will be disabled. Contact your Stryker service representative. Unplug Footswitch from console and plug in again. If problem persists, return footswitch to Stryker for repair. Error 005. Footswitch fault detected, left pedal will be disabled. Contact your Stryker service representative. Unplug Footswitch from console and plug in again. If problem persists return footswitch to Stryker for repair. Error 006. Footswitch unreadable. Contact your Stryker service representative. Unplug Footswitch from console and plug in again. If problem persists, return footswitch to Stryker for repair. Error 007. Handpiece fault detected, handpiece triggers will be disabled. Contact your Stryker service representative. Unplug cord from handpiece and plug in again. If problem persists, return handpiece to Stryker for repair. Error 008. Handpiece unreadable. Contact your Stryker service representative. Unplug handpiece from console and plug in again. If problem persists, return handpiece Stryker for repair. Error 009. Handpiece requires additional console hardware. Contact your Stryker service representative. Call your Stryker Instruments sales representative. Error 010 Handpiece requires additional console hardware. Contact your Stryker service representative. Call your Stryker Instruments sales representative. Error 011 Handpiece requires additional console hardware. Contact your Stryker service representative. Call your Stryker Instruments sales representative. The Total Performance System is not field repairable. In case of operating difficulties, Stryker products must be returned for maintenance or repair. 23 Specifications Models: 5100-1 TPS Console 5100-50 TPS Irrigation Console Size: Class I 11.8 in. [299 mm] width 7.0 in. [179 mm] height 9.0 in. [229 mm] depth 12.2 in. [310 mm] depth (units with irrigation pump) Weight: 9 lbs. [4.1 Kg] 14.1 lbs. [6.4 Kg] (units with irrigation pump) Models: 5100-201 TPS Hermes READY™ Console 5100-250 TPS Hermes READY™ Irrigation Console PORT TYPE Endo TPS1 BF TPS2 BF SYMBOL IPX0 Ordinary Equipment Protective Earth Ground Size: 11.8 in. [299 mm] width 7.0 in. [179 mm] height 9.4 in. [240 mm] depth 12.7 in. [322 mm] depth (units with irrigation pump) Duty Cycle: Continuous operation with intermittent loading Refer to cycle times defined in the TPS handpiece instructions. Weight: 9 lbs. [4.1 Kg] 14.1 lbs. [6.4 Kg] (units with irrigation pump) Electrical: 100-120VAC, 50-60Hz 6.0A Approval: CSA International • UL 2601-1 • CAN/CSA-C22.2 No. 601.1 M90 • IEC 60601-1 Handling your console and equipment Environmental Conditions • When setting up your console, place on a sturdy, flat surface, and carefully follow all setup instructions. These conditions apply to all components of the TPS system unless otherwise specified in the information supplied with that device. • When connecting or disconnecting a cable, always hold the cable by its connector (the plug, not the cord). Environmental Conditions: • Never force a connector into a port. If the connector and port do not join with reasonable ease, they probably don't match. Make sure that the connector matches the port and that you have positioned the connector correctly in relation to the port. Operation Storage and Transportation Temperature: Relative humidity: • To ensure the longevity, performance, and safety of this equipment, package in original package materials when storing or transporting. Atmospheric Pressure: If the console experiences sporadic electrical interference: • Turn off all electrical equipment not in use in the operating room. • Relocate electrical equipment; increase spacial distance. Specifications listed are approximate and may vary slightly from unit to unit or by power supply fluctuations. • Plug the TPS console and other operating room equipment into different outlets. Federal Communications Commission Compliance Statement (US only.) FCC ID: Q9R-5100 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note that FCC regulations provide that changes or modifications not expressly approved by Stryker Instruments could void your authority to operate this equipment. 24 Repair and Loaner Program This service is available in the United States only. Outside the U.S.A., contact your Stryker sales representative or your nearest subsidiary listed on the last page. On request, Stryker Instruments will provide a loaner unit for your use while repairs are being made. Please clean and sterilize all potentially contaminated products being sent in for repair, credit, or return of a loaner unit. The policy of Stryker Instruments is not to accept or process potentially contaminated products which do not meet this requirement. Also, please be aware that it is unlawful to transport bio-contaminated products through interstate commerce which are not properly packaged and labeled as such. 1. Contact Stryker Customer Service at 1-800-253-3210 to request a loaner. Provide a name and address for shipping. Every effort will be made to send a loaner unit immediately. 2. Send the inoperative unit to Stryker with a purchase order number of authorization for repair. The order should explain the nature of the difficulty. Also, provide a name and address for shipping the repaired instruments. Return the inoperative unit to: Stryker Instruments Repair Department 4100 E. Milham Kalamazoo, Michigan, 49001. 3. The repaired unit will be shipped back and the repair invoice will follow under separate cover. Under most conditions, repair turnaround time will be approximately 2-3 weeks. 4. As soon as your repaired unit is returned, return the loaner to Stryker Instruments. Limited Warranty For all TPS products unless otherwise specified. In the U.S.A. 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. 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. 25 Stryker International Subsidiaries Stryker SA European Headquarters Cite-Centre, Grand-Rue 92 CH-1820 Montreux, Switzerland Stryker BV Postbus 8747 5605 LS Eindhoven The Netherlands Stryker Corp.- U.K.Branch Medway House 5000 Newbury Business Park London Road, Newbury Berkshire, U.K. RG14 2ST Stryker Deutschland GmbH Gewerbeallee 18 D-45478 Mulheim an der Ruhr Germany Stryker Polska Sp. Zo.o ul. Kolejowa 10/21 01-217 Warsawa, Poland Stryker Far East Inc., Taiwan 5F-1, 23 Pa-Te Road Section 1, Taipei, Taiwan ROC Phone: 44-163-52-62400 Fax: 44-163-55-80300 Stryker Korea 11F, Dongsung B/D, 158-24 Samsung-dong, Kangman-ku, Seoul 135-090, Korea Phone: 82-2-565-7303 Fax: 82-2-552-4156 Stryker Malaysia No 55, Lorung Rahim Kajai 13 Taman Tun Dr. Ismail 6000 Kuala Lumpur, Malaysia Phone: 603-715-3650 Fax: 603-715-5228 Phone: 49-20899-9060 Fax: 49-208999-0666 Stryker France SARL BP 50040-95946 Roissy CDG France Phone: 33-1-48-17-50-00 Fax: 33-1-48632175 Stryker Italy SrL Via Ghisalba, 158 00188 Rome Italy Phone: 7-095-917 3484 Fax: 7-095-97 3484 Stryker Far East Inc., India 1st floor 94 Uday Park New Delhi 110 049 India Stryker Korea Limited Room 1407, Guhsung Bldg. 541, Dohwa-Dong, Mapo-Ku Seoul, Korea Phone: 39-06-330541 Fax: 39-06-33625826 Stryker C.I.S. Pokerovka Str 42/5 3rd Floor 103062 Moscow, Russia Stryker Beijing Liaison Office Room 2037, Xiyuan Hotel Beijing, China Nippon Stryker K.K. 4-7 Awajimachi Nichome, Chuo-ku Osaka 541-0047, Japan Phone: 351-1-839 49 10 Fax: 351-1-839 49 19 Phone: 27-11-888-4841 Fax: 27-11-782-4080 Stryker Australia Pty. Ltd. Unit 20/39 Herbert St. St. Leonards NSW 2065 PO Box 50 Australia Stryker Middle East-Africa PO Box 26589 Abu Dhabi, UAE Phone: 34-1323-1731 Fax: 34-1315-2782 Stryker South Africa 195 DF Malan Drive 2195 Northcliff Johannesburg, South Africa Stryker China, Limited 10/F., Sungib Industrial Centre 53 Wong Chuk Hang Road Aberdeen, Hong Kong Stryker Singapore Ltd. 70 Bendemeer Road #03-02 Hiap Juat House Singapore 339940 Phone: 48-22-631-20-13 Fax: 48-22-631-20-15 Phone: 358-9-477-3400 Fax: 011-358-9-477-3344 Stryker Portugal, Produtos Medicos, Lda. Avenida Marechal Gomes da Costa, 35 1 800-255 Lisbon Portugal Phone: 65-287-8851 65-287-8353 Fax: 65-382-3920 Phone: 31-40-292-2522 Fax: 31-40-292-2555 Stryker Finland Nuijamiestentie 5B, Fin-00400 Helsinki, Finland Dimso Iberica SA Calle Puente Cesures 1 Bajos 28020 Madrid Stryker Far East Inc., Singapore Block 204, #04-103 Hougang Street 21 Singapore 1953 Phone: 41-21-963-87-01 Fax: 41-21-963-87-00 Phone: 852-814-7463 FAX: 852-873-0210 Phone: 61-29-439-5100 Fax: 61-29-439-6400 Phone: 86-1-831-3388 Extension: 2037 Fax: 86-1-831-4577 Extension: 2037 Phone: 91-11-686-25677 Fax: 91-11-651-5496 26 Phone: 886-2-2322-2895 Fax: 886-2-2357-8543 Phone: 65-293-0119 Fax: 65-293-7028 Phone: 971-2-312-145 Fax: 971-2-313-698 Phone: 81-6-6203-2060 Fax: 81-6-6202-3548 Phone: 82-2-718-2972 Fax: 82-2-718-2974 Stryker Americas-Middle East 2725 Fairfield Road Kalamazoo, Michigan 49002 USA Mailing Address: P.O. Box 4085 Kalamazoo, Michigan 49003-4085 USA Phone: 269-385-2600 800-726-2725 Fax: 269-385-1062 Stryker Chile SRL Avenida Nueve Tajamar 481 Torre Norte Piso 8 Oficina 805 Santiago, Chile Phone:562-244-3600 Fax: 562-244-3696 Stryker Latin America Plaza Royale, Suite 304 15600 NW 67th Ave Miami Lakes, FL 33014 Phone: 305-821-1888 Fax: 305-826-0067 Stryker Mexico, S.A. de C.V. Montecito No. 38 Piso 12 Oficina 31, Col. Napoles Mexico D.F. 03810 Phone: 525-488-0890 Fax: 525-488-0891 Stryker Canada - Toronto 3375 North Service Road Unit C-9 Burlington, Ontario Canada L7N3G2 Phone: 905-332-3235 Fax: 905-332-7674 Stryker Canada - Montreal 72 3rd Avenue North Roxboro, Quebec Canada H8Y 2L9 Phone: 514-685-4024 Fax: 514-685-4024 27 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-800-253-321 1-269-323-7700 28
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.2 Linearized : No Encryption : Standard V1.2 (40-bit) User Access : Print, Modify, Copy, Annotate, Fill forms, Extract, Assemble, Print high-res Create Date : 2003:07:07 15:01:32-04:00 Modify Date : 2003:07:07 15:01:35-03:00 Subject : 5100-001-709.pmd.334 Page Count : 28 Creation Date : 2003:07:07 19:01:32Z Mod Date : 2003:07:07 19:01:32Z Producer : Acrobat Distiller 5.0 (Windows) Author : akline Keywords : Metadata Date : 2003:07:07 19:01:32Z Creator : akline Title : 5100-001-709.pmd.334 Description : 5100-001-709.pmd.334EXIF Metadata provided by EXIF.tools