Manual

FCC ID: Q9R-5100

Users Manual

Download: PDF
FCCID_344279

IMPORTANT INFORMATION: File this in your TPS records Total Performance System Consoles REF 5100-1 Console REF 5100-50 Irrigation Console Hermes READY™ REF 5100-201 Console REF 5100-250 Irrigation Console 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 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 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-800-253-3210 1-269-323-7700 6/03 5100-001-709 Rev-A 1

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 Corpora- tion 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. 3 © 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 Recom- mendations 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. 4

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 ! Excessive pressure, such as bending or prying, may flammable anesthetic mixture with air or with oxygen or cause accessory to bend or break and cause tissue nitrous oxide. damage to patient and/or operating room staff. ! The Stryker Total Performance System is designed to ! Heavy sideloads and/or long operating periods be used by persons familiar with surgical procedures. occasionally will cause overheating of the distal tip and Misuse may cause injury to both patient and system the body of handpieces to the point where the hand- components. Prior to each use, system components piece is uncomfortable to hold or causes injury to the should be inspected for damage. DO NOT use if patient. damage is apparent. ! If the recommended duty cycle is not followed, the ! Use only Stryker TPS components and accessories handpiece may overheat and cause injury to patient unless otherwise specified. and/or operating room staff. See the Duty Cycle information supplied with each handpiece. ! 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 ! Use of safety glasses by user and operating room staff operated at a high speed, it is possible that the bur will is recommended to prevent eye injuries. 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 HANDPIECE SAFETY broken piece would be ejected at a high velocity ! Read this booklet and the information supplied endangering the patient and/or operating room staff. It with your TPS components. Component instruc- is therefore recommended that safety glasses be used. tions provide specific safety information. Refer to the instructions supplied with Stryker Endoscopy ! Excessive pressure, such as bending and prying with handpieces when using those handpieces in blade, may cause the blade to bend or fracture and conjunction with the TPS console. 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 ! Stryker handpieces which fail due to long life and/or device in the SAFE position when not in use. IMPOR- nose bearing failure may allow foreign matter to TANT: Be aware that the TPS footswitch will override migrate or emit from the distal tip of the handpiece. the Universal Handswitch SAFE setting. Fluid may leak into the surgical site, such that mea- sures may be required, per the physician's discretion, ! Always use the appropriate accessory combination with to protect the patient from infection. a handpiece. Contact your Stryker sales representative for a complete list of accessories. Failure to comply ! Never rest handpiece on the patient. Improper may result in patient and/or operating room staff injury. handling of a handpiece could result in damage or burns to tissue. ! Please note the handpiece starts with rapid accelera- tion 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 Univer- ! During initial use of your TPS handpieces, monitor the sal Handswitch and may cause the handpieces to run heat response in relation to the type of surgical inadvertently. procedure being performed. Frequently check the distal tip and body until you are familiar with its ! DO NOT modify any bur to fit the handpieces. Use temperature rise characteristics. Failure to pay close only Stryker approved burs. Other burs may not fit attention to handpiece temperature may cause burn properly in the handpiece. During use they may come injury to patient. 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. 5

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 272-704- 100 and 12K Hand Controlled Shaver REF 272-704-500. Symbol Definition Power ON TPS Handpiece Power OFF TPS Irrigation Console Footswitch Stryker Connector 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 Connection Detail Part 6

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 Hermes READY™ TPS Consoles to the information supplied with the component. 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 2. Plug the console's power cord into the recessed power socket on the back of affect the normal function of the console. the console. At any time, console functions may be selected from the control screen or by 3. Plug the other end of the power cord into a hospital-grade wall outlet. using a control accessory such as a TPS footswitch. 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 WARNINGS: various components as they are plugged in. ! Only the Hermes Operating Room 5. If using a Footswitch, plug the footswitch cable into the console port marked Control Center is approved for use FOOTSWITCH. Align orientation marks and gently push connectors together. with the TPS console. Do not plug any other device into the Hermes CAUTION: All TPS Cords have push/pull connectors. Do not thread or twist for console port. Use of other devices insertion or removal. may damage the console. 6. Plug the handpiece cord(s) into the console port(s) identified for the hand- ! It is important to read and understand piece. Align connector orientation marks and gently push connectors together. NOTE: Ports marked TPS1 and TPS2 are for Stryker TPS handpieces only. the Hermes Operating Room Control The port marked ENDO is intended for the following list of Stryker Endoscopy Center instructions; the use of the handpieces: SE5 Handpiece REF 272-704-100, SE5 Hand-controlled REF 272- TPS console with the Hermes 704; QuadraCut Shaver REF 275-701; QuadraCut Bone Plug REF 275-705; and Operating Room Control Center is QuadraCut small Joint REF 275-601. explained in those instructions. NOTE: If using a TPS Universal Handswitch, attach it to the handpiece before you plug the cord into the handpiece. ! Stryker recommends attaching an alternate control accessory 7. Plug the other end of the handpiece cord(s) into the handpiece(s). (footswitch) to the console in the event the Hermes System fails during 8. Attach cutting accessories to handpieces. Instructions supplied with each surgery. handpiece or attachment provide details for cutting accessory assembly. NOTE: The port labeled DATA PORT is WARNING: Use only Stryker approved cutting accessories. intended for the manufacturer's use only. 9. If using an Irrigation Console REF 5100-50 or 5100-250, assemble Irrigation If you have questions about using the Pole REF 5100-50-28 to the console as shown. Hang irrigation bag from pole. Hermes System with the TPS console, Install irrigation cassette into the pump. Attach irrigation clips to handpieces and contact your Stryker Endoscopy connect tubing. representative or call Stryker Endoscopy Customer Service at 1-800-624-4422. Continue to the next step if using a Hermes READY™ TPS Console and Hermes Outside the US, contact the nearest Operating Room Control Center. Stryker subsidiary. 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. 7

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 at- tached 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. 8

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 Handpiece power indicator Indicator ramp Attachment/ Handpiece Blade Handpiece identification identification speed TPS handpiece select buttons Endo handpiece Select system Footswitch select button options screen indicator and options Elements of the Control Screen Control screen visually presents options which can be set Handpiece identification displays the name of the active for the selected handpiece. handpiece. NOTE: Handpieces can be plugged into each of the console's handpiece ports, but only one can be Icons represent elements of your TPS system. Icons are selected at a time. functional buttons. Each function may be selected by pressing the screen where the button is displayed. When NOTE: When *CUSTOM* is displayed at the top of the you touch an icon, the icon appears to be pressed down screen, the console's default settings are selected from and the graphic symbol highlights to indicate that it is Surgeon Preferences. The console is able to capture the activated. (See Icon Definition). preferred settings for several different users. When this feature is activated, the preferred settings act as default NOTE: An audible signal indicates interface with icons. settings. See Surgeon Preference for further details. NOTE: Buttons such as the adjust arrows or OPT button Handpiece speed information displays the default speed which are temporary toggles or adjustment buttons only for each handpiece until you reset speed settings. highlight while depressed. While the handpiece is running, the display shows the actual handpiece speed. If the handpiece is not running NOTE: Buttons with a white background are toggle buttons. the default or selected speed is displayed. NOTE: Incremental information displayed on the control NOTE: Options vary among different handpieces. The screen is accurate within +/-1%. console will only display the options available for a given handpiece. 9

Select Your System Settings Standard Features NOTE: When the console is turned on, its default setting is factory default unless a Surgeon Preference Main Option Icon setting is selected as the start up default. See Surgeon Preference for further details. The option icon appears on all handpiece screens 1. Handpiece select buttons enable you to activate the and allows access to the MAIN OPTION screen. handpiece plugged into one of the three ports on the See MAIN OPTION SCREEN for further details. 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 The footswitch icon only appears when a adjustment arrows to change the handpiece speed footswitch is plugged into the console. setting incrementally until the desired speed is reached. If using a footswitch with these graph- • Saws - The set point is displayed as a percentage of ics, pedal functions can be repro- maximum power and vertical line on the speed ramp. grammed. See Footswitch Adjustments During handpiece operation, the percentage reading and Footswitch Button Mapping. and speed ramp displays the power level. • Rotary handpieces - The speed set point is displayed. A footswitch with these graphics During handpiece operation, the current speed is cannot be reprogrammed. displayed. 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 Irrigation functions pertain only to consoles with the built- and user settings as well as direct access to each in irrigation pump REF 5100-50 and 5100-250. handpiece option screen. Press the icon to start irrigation flow while the NOTE: The screen returns to the active handpiece handpiece is running. 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 5. Touch the EXIT icon to return to the active hand- be turned off by touching the icon again. piece 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. -OR- From the HANDPIECE ADJUSTMENTS screen, select the WATER icon and use the arrows to adjust flow rate. Flow rate diminishes as the set- ting 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 Footswitch Icon: Appears High: Enables handpiece to a cord (without a handpiece) is when a footswitch is connected operate in a high speed mode. plugged into the corresponding to the console. Also gives Endo, TPS1 or TPS2 port. access to footswitch adjust- ments screen. Low: Enables handpiece to It appears depressed when operate in a low speed mode. selected. Adjustment Arrows: Use in conjunction with other options to set handpiece The handpiece graphic appears speed or power, braking, acceleration, Toggle Buttons when a handpiece is attached irrigation flow, screen contrast etc. NOTE: For easy identification, only toggle to the corresponding cord. buttons have a white background. Increase The handpiece graphic Speed: Use with the increase highlights and the icon appears and decrease icons to adjust depressed when selected. rotary handpiece speed. Decrease Water: Use with the increase and decrease icons to adjust irrigation flow. System Options Options: Gives access to Power: Use with the increase handpiece adjustments, and decrease icons to adjust system information, console saw power. adjustments and user preference. Direction Arrows: Sets handpiece Variable: Handpiece speed mode. responds to varying degrees of Handpiece option: pressure on the footswitch or Accesses corre- Forward (clockwise) handswitch. sponding handpiece adjustment screens. Nonvariable: Handpiece Reverse (counterclock- operates at constant set-point Exit: Returns to previous wise) speed/power level. screen. One touch: Handpiece is Oscillate activated by one touch of a Information: Displays system trigger device and continues to information screen. run when the trigger device is released. Handpiece is deactivated by touching any Console: Gives access to Irrigation: Activates or trigger device. In this mode, the console adjustment screen. deactivates handpiece handpiece operates at constant irrigation. set-point speed/power level. Allows access to the surgeon Advanced: - Accesses the advanced footswitch mapping screen. Button: Access button mapping screen. Return to full screen: Return from Big to full handpiece NOTE: TPS Console models REF 5100-1 and 5100-201 do screen. not display options related to handpiece irrigation. 11

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 The irrigation setting is not displayed on this screen. maximum power set at 100%. However, it can be seen on the Handpiece Adjust- ments screen. ENDO, TPS2 and the footswitch icons indicate other instruments are plugged into the console. 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 OSCILLATE into the console. TPS Universal and Micro Drills TPS MicroDriver and Universal METHOD OF OPERATION Driver The Universal Drill can be operated with the TPS Universal Handswitch or TPS Footswitch. METHOD OF OPERATION The TPS MicroDriver can be operated with its built- Handswitch Handpiece selection can be made by depress- in trigger and rotary control switch or with the TPS ing the handswitch once. The handpiece select icon changes Footswitch. to indicate the active handpiece. Depress the handswitch NOTE: The handpiece will not run when the rotary again to run the handpiece. switch is in the SAFE position. Handpiece runs from start-up to the maximum selected Trigger The built-in speed control trigger(s) runs speed. Speed and cutting direction corresponds to what is the handpiece from start-up to the maximum selected on the screen. selected speed. Footswitch Handpiece runs from start-up to the maximum selected speed. MicroDriver only: Select cutting direction with the rotary switch on the handpiece. Direction icon will Handpiece direction is controlled by selecting the forward or highlight to match the rotary switch position. reverse pedals. The direction icon on the screen changes when the corresponding footswitch pedal is depressed. 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 de- pressed 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 Manual 272-704 1000-400-120 275-701 1000-400-034 275-705 1000-400-034 275-601 1000-400-034 290-601 1000-400-288 IMPORTANT INFORMATION The hand-controlled Endo Shaver can be controlled by the footswitch or by the hand- control 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 hand- pieces 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 ATTACHMENT: Use the arrow icon on the left to scroll screen to access this screen. 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 Selecting the proper attachment will optimize the perfor- screen. And return to the handpiece screen by mance of the handpiece for the attachment and display touching the handpiece title displayed on this screen. the appropriate speed scale on the handpiece screen. Depending on the type of handpiece, one or more of RUN MODE: Use the RUN MODE toggle button to the following options will be available. 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 Accelerate: At 100%, handpiece speed maximum setting only. Varying pressure on accelerates quickly. Acceleration slows as the the handswitch does not vary the handpiece setting approaches zero. speed. Turns: Use to set the number of turns per One touch: Toggle the handpiece on and off direction when running a handpiece in the with a single touch of a trigger device. The oscillate mode. The minimum setting will set trigger device can be the handswitch or the oscillate function to operate in a TIME- handpiece trigger buttons. BASED mode where the number of turns are based on the speed of the handpiece. 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 Adjust- ments. 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 dis- played. 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. Example of big screen. 18

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 ADJUST- MENTS 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 prefer- ences. 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 follow- ing function options. And stop on the desired func- tion 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 Button Function displays the active function of the forward (clockwise) direction. corresponding button. Reverse: Pedal setting default is overridden. Use the arrow icons to scroll through the functions and Pedal will provide handpiece rotation in the stop on the desired setting. 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. Handpiece operates in the low speed range. Reset all: Press to return all pedals and buttons back to their default setting. Handpiece operates in oscillate mode. Reset: Press to return the selected footswitch RUN MODE button back to its default setting. 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 func- tions. 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 Button Function Description Button Function Description Main trigger Starts handpiece in default direction Osc <> High/low Toggles the run mode between oscillate and mode. and high or low. FWD trigger Starts handpiece in forward High <> Low Toggles the run mode between high and direction in default mode. low. REV trigger Starts handpiece in reverse Forward <> Reverse Toggles the running direction. direction in default mode. Change port Changes the active handpiece port. OSC trigger Starts handpiece in oscillate mode. Change attachment Scrolls through the attachment list for the Speed increment Increments the set point speed. selected handpiece. Speed decrement Decrements the set point speed. Pump flush Turns the pump on at the flush rate. Once started the pump can be stopped by Water increment Increments the pump flow set point. pressing the button again or by starting the handpiece. Water decrement Decrements the pump flow set point. Make port active Makes the selected handpiece active. Water on/off 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

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. 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 This is the key pad screen used to new surgeon name, use the key pad to delete (DEL) the enter the doctor's name and name existing name then key-in the new name. Upon completion, of procedure. 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 Padlock opened to gather preferences. selected settings will be continuously updated with current settings. Padlock closed to store preferences. Select to add a surgeon name. 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 listed under the surgeon will be moved under procedures? 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 Action to Take Error 001. Console hardware fault detected. Return console to Stryker for repair. Error 002. Console hardware fault detected. Turn unit off and on again. If problem persists, return Contact your Stryker service representative. console to Stryker for repair. Error 003. Console hardware fault detected. Turn console off and on again. If problem persists, return Contact your Stryker service representative. console to Stryker for repair. Error 004. Footswitch fault detected, right pedal will be disabled. Unplug Footswitch from console and plug in again. Contact your Stryker service representative. If problem persists, return footswitch to Stryker for repair. Error 005. Footswitch fault detected, left pedal will be disabled. Unplug Footswitch from console and plug in again. Contact your Stryker service representative. If problem persists return footswitch to Stryker for repair. Error 006. Footswitch unreadable. Unplug Footswitch from console and Contact your Stryker service representative. plug in again. If problem persists, return footswitch to Stryker for repair. Error 007. Handpiece fault detected, handpiece triggers will be Unplug cord from handpiece and plug in again. disabled. Contact your Stryker service representative. If problem persists, return handpiece to Stryker for repair. Error 008. Handpiece unreadable. Unplug handpiece from console and plug in again. Contact your Stryker service representative. If problem persists, return handpiece Stryker for repair. Error 009. Handpiece requires additional console hardware. Call your Stryker Instruments sales representative. Contact your Stryker service representative. Error 010 Handpiece requires additional console hardware. Call your Stryker Instruments sales representative. Contact your Stryker service representative. Error 011 Handpiece requires additional console hardware. Call your Stryker Instruments sales representative. Contact your Stryker service 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 Class I 5100-50 TPS Irrigation Console PORT TYPE SYMBOL Size: 11.8 in. [299 mm] width 7.0 in. [179 mm] height Endo B 9.0 in. [229 mm] depth 12.2 in. [310 mm] depth (units with irrigation pump) TPS1 BF Weight: 9 lbs. [4.1 Kg] TPS2 BF 14.1 lbs. [6.4 Kg] (units with irrigation pump) Models: 5100-201 TPS Hermes READY™ Console IPX0 Ordinary Equipment 5100-250 TPS Hermes READY™ Irrigation Console Protective Earth Ground Size: 11.8 in. [299 mm] width 7.0 in. [179 mm] height Duty Cycle: Continuous operation with 9.4 in. [240 mm] depth intermittent loading 12.7 in. [322 mm] depth (units with irrigation pump) Refer to cycle times defined in the TPS handpiece instruc- Weight: 9 lbs. [4.1 Kg] tions. 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, These conditions apply to all components of the TPS system and carefully follow all setup instructions. 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: Operation Storage and Transportation • Never force a connector into a port. If the connector and port do not join with reasonable ease, they probably don't match. Temperature: Make sure that the connector matches the port and that you have positioned the connector correctly in relation to the port. 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 • Plug the TPS console and other operating room equipment into unit to unit or by power supply fluctuations. 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 demon- strated 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 Phone: 41-21-963-87-01 Stryker Far East Inc., Singapore Phone: 65-287-8851 European Headquarters Fax: 41-21-963-87-00 Block 204, #04-103 65-287-8353 Cite-Centre, Grand-Rue 92 Hougang Street 21 Fax: 65-382-3920 CH-1820 Montreux, Switzerland Singapore 1953 Stryker BV Phone: 31-40-292-2522 Stryker Far East Inc., Taiwan Phone: 886-2-2322-2895 Postbus 8747 Fax: 31-40-292-2555 5F-1, 23 Pa-Te Road Fax: 886-2-2357-8543 5605 LS Eindhoven Section 1, Taipei, Taiwan ROC The Netherlands Stryker Korea Phone: 82-2-565-7303 Stryker Corp.- U.K.Branch Phone: 44-163-52-62400 11F, Dongsung B/D, 158-24 Fax: 82-2-552-4156 Medway House Fax: 44-163-55-80300 Samsung-dong, Kangman-ku, 5000 Newbury Business Park Seoul 135-090, Korea London Road, Newbury Berkshire, U.K. RG14 2ST Stryker Malaysia Phone: 603-715-3650 No 55, Lorung Rahim Kajai 13 Fax: 603-715-5228 Stryker Deutschland GmbH Phone: 49-20899-9060 Taman Tun Dr. Ismail Gewerbeallee 18 Fax: 49-208999-0666 6000 Kuala Lumpur, Malaysia D-45478 Mulheim an der Ruhr Germany Stryker Singapore Ltd. Phone: 65-293-0119 70 Bendemeer Road Fax: 65-293-7028 Stryker Polska Sp. Zo.o Phone: 48-22-631-20-13 #03-02 Hiap Juat House ul. Kolejowa 10/21 Fax: 48-22-631-20-15 Singapore 339940 01-217 Warsawa, Poland Stryker Middle East-Africa Phone: 971-2-312-145 Stryker Finland Phone: 358-9-477-3400 PO Box 26589 Fax: 971-2-313-698 Nuijamiestentie 5B, Fax: 011-358-9-477-3344 Abu Dhabi, UAE Fin-00400 Helsinki, Finland Nippon Stryker K.K. Phone: 81-6-6203-2060 4-7 Awajimachi Nichome, Chuo-ku Fax: 81-6-6202-3548 Stryker France SARL Phone: 33-1-48-17-50-00 Osaka 541-0047, Japan BP 50040-95946 Roissy CDG Fax: 33-1-48632175 France Stryker Korea Limited Phone: 82-2-718-2972 Room 1407, Guhsung Bldg. Fax: 82-2-718-2974 Dimso Iberica SA Phone: 34-1323-1731 541, Dohwa-Dong, Mapo-Ku Calle Puente Cesures Fax: 34-1315-2782 Seoul, Korea 1 Bajos 28020 Madrid Stryker Americas-Middle East Phone: 269-385-2600 Stryker Portugal, Produtos Medicos, Lda. Phone: 351-1-839 49 10 2725 Fairfield Road 800-726-2725 Avenida Marechal Gomes da Costa, 35 Fax: 351-1-839 49 19 Kalamazoo, Michigan 49002 USA Fax: 269-385-1062 1 800-255 Lisbon Portugal Mailing Address: P.O. Box 4085 Stryker Italy SrL Phone: 39-06-330541 Kalamazoo, Michigan 49003-4085 USA Via Ghisalba, 158 Fax: 39-06-33625826 00188 Rome Stryker Chile SRL Phone:562-244-3600 Italy Avenida Nueve Tajamar 481 Fax: 562-244-3696 Torre Norte Piso 8 Oficina 805 Stryker South Africa Phone: 27-11-888-4841 Santiago, Chile 195 DF Malan Drive Fax: 27-11-782-4080 2195 Northcliff Stryker Latin America Phone: 305-821-1888 Johannesburg, South Africa Plaza Royale, Suite 304 Fax: 305-826-0067 15600 NW 67th Ave Stryker C.I.S. Phone: 7-095-917 3484 Miami Lakes, FL 33014 Pokerovka Str 42/5 Fax: 7-095-97 3484 3rd Floor Stryker Mexico, S.A. de C.V. Phone: 525-488-0890 103062 Moscow, Russia Montecito No. 38 Piso 12 Fax: 525-488-0891 Oficina 31, Col. Napoles Stryker China, Limited Phone: 852-814-7463 Mexico D.F. 03810 10/F., Sungib Industrial Centre FAX: 852-873-0210 53 Wong Chuk Hang Road Stryker Canada - Toronto Phone: 905-332-3235 Aberdeen, Hong Kong 3375 North Service Road Fax: 905-332-7674 Unit C-9 Stryker Australia Pty. Ltd. Phone: 61-29-439-5100 Burlington, Ontario Unit 20/39 Herbert St. Fax: 61-29-439-6400 Canada L7N3G2 St. Leonards NSW 2065 PO Box 50 Stryker Canada - Montreal Phone: 514-685-4024 Australia 72 3rd Avenue North Fax: 514-685-4024 Roxboro, Quebec Stryker Beijing Liaison Office Phone: 86-1-831-3388 Canada H8Y 2L9 Room 2037, Xiyuan Hotel Extension: 2037 Beijing, China Fax: 86-1-831-4577 Extension: 2037 Stryker Far East Inc., India Phone: 91-11-686-25677 1st floor 94 Uday Park Fax: 91-11-651-5496 New Delhi 110 049 India 26

27

4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-800-253-321 1-269-323-7700 28


Document Created: 2003-07-07 15:01:35
Document Modified: 2003-07-07 15:01:35
© 2024 FCC.report
This site is not affiliated with or endorsed by the FCC