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Stryker Sidne manual

1. Device 7 Awaken Control Select Description Select Star Inserts a star symbol when dialing Clear Clears the numbers on the dialing screen Back Erases the last selected digit Call Initiates a call after the telephone number has been entered 0 9 Selects digits that make up a telephone number Sidne Feedback Messages Sidne Says Meaning Telephone number not saved The selected speed dial option has no number assigned to it 89 EN Sidne DE 2 Sidne Connection and Operation Instructions for Control of the Valleylab Force FX Electrosurgical Unit i RK Ie 90 EN Kit Overview Figure 1 shows the contents of the Sidne ESU Driver 2 0 upgrade kit Sidne 7 Stryker En 5 6 Figure 1 Contents of the kit 1 R EDAM adapter cable Sidne interface cable Sidne ESU EDAM User Insert Cover plate Sidne ESU driver USB dongle Jack screws 2 Velcro strips for mounting EDAM 91 EN Sidne Quick Start Up Guide This section is intended to give an outline of the start up instructions for experienced users Refer to the relevant section s of this addendum for further instructions 1 Ensure that the ESU and Sidne are powered Off 2 Install the cover plate if necessary 3 Connect the ESU to Sidne a Connect the EDAM adapter cable to the ESU b Connect the EDA
2. 32 EN Stryker 2 0 Liter Arthroscopy Pump 33 EN Stryker 888 988 Medical video Camera 35 EN Stryker 30L and 40L High Flow Insufflators 38 EN Stryker X6000 Q5000 Light Source 41 EN Stryker TPS 43 EN French translations are provided in accordance with CAN CSA C22 2 No 601 1 M90 Clause 6 requirements 1 EN Sidne Stryker Digital Capture System SDC Pro SDC Pro 2 SDC 46 EN Sony UP 5600MD video Printer 48 EN Sony SVO 9500 video Cassette Recorder ac X id ha aucuns 50 EN Sidne M xsi id ss nd eee eee ee ees 52 EN Stryker FloControl Arthroscopy Pump 56 EN 1088 Camera ccc sue sens RR RE en E n ewes 59 EN SIDNE Cleaning and Maintenance 63 EN Cleaning ER 63 EN Maintenance 63 EN Replacing Flses isses sss etm x waka ees 63 EN Troubleshooting 64 EN Technical Specifications 67 EN Electromagnetic Compatibility Tables 71 EN Testing Compatibility 72 EN rari 79 EN Service and Claims 80 EN International Service 81 EN Addenda to the Sidne Manual 83 EN Installing the Telephone Upgrade 84 EN Connecting a Phone Set to the Sidne 85 Sidne Feedback Message
3. Compliment Figure 34 Options voice commands interface on monitor 55 EN Sidne Stryker FloControl Arthroscopy Pump Tablet Commands Menu eun Statu Flow l min Joint Type Activated rrest1 00 Riez Wash e O Shoulder Off Pressure mm Hg Figure 1 The tablet commands menu for the arthroscopy pump Figure 2 The voice commands interface on monitor 56 EN Voice Commands Menu Device sm Awaken Control Select Description Select Ten Up Increases the pump pressure by 10 mm Hg Ten Decreases the pump pressure by 10 mm Pressure Up Increases the pump pressure by 5 mm Hg Down Decreases the pump pressure by 5 mm Hg Activate Starts the pump Off Turns the wash mode off Wash idne Arthro Turns the wash mode on and activates the Sidne On Pump pump Up Increases the flow by 0 25 L min Flow Down Decreases the flow by 0 25 L min Shoulder Selects shoulder joint type Joint Knee Selects knee joint type Small Selects small joint type Stop Stops the pump 57 EN Sidne Sidne Feedback Messages Sidne Meaning Arthroscopy Added as a prefix to the below messages when the control is issued from the pump tablet or pump front panel while not in the arthroscopy voice command menu Stopped The pump was stopped by voice tablet or front panel command Activated The pump was activated by
4. Note This frequency should match the frequency chosen for the receiver in order for the headset to communicate properly For more information on selecting an operating frequency consult 3000 Series Professional UHF Wireless Systems the user manual packaged with the headset Press the set button on the transmitter two times Edit appears on the LCD window Press the up or down arrows to select the desired frequency Hold the set button until the LCD reads STORED Slide the sliding control cover over the buttons to protect against inadvertent button selections Select the same operating frequency for the receiver Press the set button on the receiver two times Press the up or down arrows to select the same frequency selected on the transmitter Hold the set button until the LCD reads STORED Press the down arrow until QUIT appears on the LCD Press the set button until the status bar shows on the LCD Clip the transmitter to an article of clothing away from the hands and operating site Setting Up the Headpiece Warning To maintain sterility in the surgical field set up the 1 transmitter and headpiece prior to scrubbing for surgery Connect the headpiece connector to the audio input jack on the transmitter 25 EN Sidne 2 Position the headset over the head so the mouthpiece rests three finger s breadth from the corner of the mouth 3 Clip any excess cords to the back of the surgical
5. Tablet Commands Menu Status Figure 29 The tablet commands menu for the VCR While most Sidne smart devices can be simultaneously controlled through Sidne and device front panel controls this is not true for the VCR unless the dip switches on the back panel match the setting shown below 12 3456 Note Before the VCR can be controlled from its front panel the Sidne console must be powered on Only the Eject button on the VCR will function if Sidne is powered off 50 EN Q Operating the Sidne System stryker 151070 Record Pause Stop Figure 30 VCR voice commands interface on monitor VCR video Error Bar Error Message Error Condition Tape not inserted The video cassette is not inserted Tape write protected The video cassette is write protected End of tape The video cassette is at the end of the tape 51 EN Sidne Sidne Options Commands specific to the Sidne console itself can be found in the Options tablet and voice menus Figure 31 below lists the functions of the options tablet commands menu Tablet Commands Menu Web Video Mode IP 192 168 0 1 co SORS 2 Figure 31 The tablet commands menu for Sidne options 1 Web Control Enables Disables web operation of the Sidne console for servicing the unit Compliment prompts Sidne to compliment the system user Audio Options
6. 1 17 P 110 EN Electromagnetic Compatibility Tables Guidance and Manufacturer s Declaration Electromagnetic Immunity Continued Radiated RF 3 V m 3 V m IEC 61000 4 3 80MHz to 2 5 147 4P 80 MHz to 800 MHz GHz d 2 33 P 800 MHz to 2 5 GHz where is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 8 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following Cp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic pagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Sidne ESU EDAM system is used exceeds the applicable RF compliance level abov
7. 3 Vrms 3V calculated from the RF 150 kHz to equation applicable to IEC 80 MHz the frequency of the 61000 4 6 transmitter 3 V m Recommended 3 V m Separation Distance Radiated 80MHz to 2 5 GHz 61000 4 3 12 80 MHz to 800 MHz d 23 P 800 MHz to 2 5 GHz 77 EN Sidne Guidance and Manufacturer s Declaration Electromagnetic Immunity Continued where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol t9 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic pagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site sur
8. Electromagnetic Immunity Sidne ESU EDAM is intended for use in the electromagnetic environment specified below The customer or the user of Sidne ESU EDAM should ensure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Level Level Guidance Electrostatic 6kV contact 2 4 6kV Floors should be wood concrete or Discharge ESD x8kV air contact ceramic tile If floors are covered with IEC61000 4 2 x2 4 8kV air synthetic material the relative humidity should be at least 30 Electrical fast 2kV for power 2kV for Mains power quality should be that of a transient burst supply lines power supply typical commercial or hospital IEC61000 4 4 1kV for input lines Sidne environment output lines 1kV for input output lines Power frequency 3 A m Power frequency magnetic fields should 50 60Hz 3 A m be at levels characteristic of a typical magnetic field location in a typical commercial or IEC 61000 4 8 hospital environment NOTE Ut is the a c mains voltage prior to application of th e test level Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3V Portable and mobile RF communications equipment should be used no closer to any part of the Sidne ESU EDAM system including its cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d
9. Pure Sets Cut function to Pure mode Low Sets Cut function to Low mode Cut Power Down Decreases the Cut power level by one setting Power Up Increases the Cut power level by one setting For more information on power level settings refer to the Valleylab Force FX Electrosurgical Unit Manual 104 EN Voice Commands Menu Operating the ESU Table 2 shows the Sidne voice commands for controlling the ESU Each voice command is listed with a description of its function Voice Commands 198 Device Control Selection Description SIDNE ESU Power Down Decreases the Bipolar power level by one setting Power Up Increases the Bipolar power level by one setting Bipolar 1 Standard Sets Bipolar function to Standard mode Precise Sets Bipolar function to Precise mode Macro Sets Bipolar function to Macro mode Power Down Decreases the Coag power level by one setting Power Up Increases the Coag power level by one setting Coag Desiccate Sets Coag function to Desiccate mode Fulgurate Sets Coag function to Fulgurate mode Spray Sets Coag function to Spray mode Power Down Decreases the Cut power level by one setting Power Up Increases the Cut power level by one setting Cut Blend Sets Cut function to Blend mode Pure Sets Cut function to Pure mode Low Sets Cut function to Low mode Sidne will respond to
10. VCR connected 19 EN Y Sidn To the breakout cable which provides Composite 1 2 and S Video 2 4 XGA inputs 2 4 DVI XGA 1 Output a hospital grade power outlet DVI XGA 1 Input Stryker min RM 9 ES EJ Ez BP AIR Iv Power to external speakers Audio output to external speakers To any Sidne supported device i e camera VCR printer etc e DDDDDDDU p and 2 Figure 9 Standard Sidne Connections 20 EN io o g Line out to a telephone Power to the tablet and microphone headset receivers 1 DEVICE PORTS SES RES o ssssso o afi To a telephone wall jack Setting Up the Sidne System BNC en HE HUM 355 pc VCR i 1 I S Video I I I lt 2 142 3 I I I 3 E 8 I 3 I 1 I 1 SDCHD Printer S Video Monitor Figure 10 S Video Configuration with Dictation 21 EN Sidne BNC DVI XGA uone191Q 90S Printer Flat Panel Monitor Figure 11 DVI XGA 1 video Configuration with Dictation 22 EN Setting Up the Sidne System Setting Up the Tablet Refer to the Wired Tablet Insert for Tablet setup instructions 23 EN Sidne Setting
11. Voltage Complies purposes Fluctuations flicker emissions IEC61000 3 3 73 EN Sidne Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Sidne System The Sidne system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the Sidne M system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sidne system as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance m according to output power frequency of transmitter W of 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 5 10 3 8 3 8 duo 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagn
12. insert the device driver dongle into the device driver dongle port on the front console panel and follow the instructions spoken by Sidne Please refer to the user addendum for the specific device for more information 32 EN Operating the Sidne System Stryker 2 0 Liter Arthroscopy Pump Tablet Commands Menu Status Flow l min Joint Type Wash Pressure mm Hg Cr Figure 15 The tablet commands menu for the arthroscopy pump Voice Commands Menu Device T Awaken Control Select Description Select Ten Up Increases the pump pressure by 10 mm Hg Ten Down Decreases the pump pressure by 10 mm Hg Pressure Up Increases the pump pressure by 1 mm Hg Down Decreases the pump pressure by 1 mm Hg Activate Starts the pump Off Turns the wash mode off Wash Sidne Arthro On Turns the wash mode on and activates the Pump pump Up Increases the flow by 0 10 L min Flow Down Decreases the flow by 0 10 L min Shoulder Selects shoulder joint type Joint Knee Selects knee joint type Small Selects small joint type Stop Stops the pump 33 EN Sidne Figure 16 Arthroscopy Pump voice commands interface on monitor Sidne Feedback Messages Sidne Says Meaning Arthroscopy Added as a prefix to the messages below when the control is issued from the pump tablet or pump front panel while not in the arthroscopy voice command menu Stop
13. menu Also added as a prefix to the connected and disconnected messages for 30L insufflators High flow The insufflator has been set to high flow by voice command Medium flow The insufflator has been set to medium flow by voice command Low flow The insufflator has been set to low flow by voice command Activated The insufflator has been activated by voice or tablet command Stopped The insufflator has been stopped by voice or tablet command Pressure set to 15 The insufflator pressure has been set to 15 mmHg after a pressure adjustment by voice or tablet command The insufflator actual pressure is 5 mmHg higher than the selected pressure Overpressure or the actual pressure is equal to or higher than 30 mmHg This error message is played 15 seconds after the usual insufflator error sound occurs P A leakage is sensed in the pneumoperitoneum according to the insufflator Leakage algorithm for detection This error message is played 15 seconds after the usual insufflator error sound occurs i A blockage is sensed in the tube Veress cannula or trocar according to the Occlusion insufflator algorithm for detection This error message is played 15 seconds after the usual insufflator error sound occurs Low gas level The pressure of the gas supply cylinder is low lt 25 bar Gas supply empty The gas supply cylinder is empty Heater error The gas temperature is higher than
14. EDAM A LED should be flashing green within 20 seconds of powering On the ESU A different LED output may indicate device problems If the LED does not flash green after 20 seconds refer to the Troubleshooting Guide of this addendum for instructions 7 Power On the ESU Please retain this addendum for future reference 101 EN Sidne Operating the ESU Sidne ESU Tablet Commands Figure 13 shows the Sidne tablet commands menu for the ESU Table 1 on the next page describes the tablet commands and their functions Tablet Commands Menu Figure 13 The Sidne tablet commands menu for the ESU 102 EN Operating the ESU Stryker v7 S Figure 14 The voice commands interface on the monitor 103 EN Sidne Tablet Commands ded Device Control Selection Description SIDNE ESU Standard Sets Bipolar function to Standard mode Precise Sets Bipolar function to Precise mode gt Macro Sets Bipolar function to Macro mode Bipolar Power Down Decreases the Bipolar power level by one setting Power Up Increases the Bipolar power level by one setting Desiccate Sets Coag function to Desiccate mode Fulgurate Sets Coag function to Fulgurate mode Coag Spray Sets Coag function to Spray mode Power Down Decreases the Coag power level by one setting Power Up Increases the Coag power level by one setting Blend Sets Cut function to Blend mode
15. ESU Refer to the Valleylab Force FX Electrosurgical Unit Manual for further details Refer to the Valleylab Force FX Electrosurgical Unit Manual for further details The EDAM LED should flash green when the system is functioning normally 108 EN Electromagnetic Compatibility Tables Electromagnetic Compatibility Tables Like other electrical medical accesories the Sidne ESU EDAM requires special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC the Sidne ESU EDAM must be installed and operated according to the EMC information provided in this manual Warning Do not use cables or accessories other than those A provided with the Sidne ESU EDAM as this may result in increased electromagnetic emissions or decreased immunity to such emissions Warning If the Sidne ESU EDAM is used adjacent to or stacked A with other equipment observe and verify normal operation of the Sidne ESU EDAM in the configuration it will be used in prior to using it in a surgical procedure Consult the tables below for guidance in positioning the Sidne ESU EDAM Caution Portable and mobile RF communications equipment A may affect the normal function of the Sidne ESU EDAM The Sidne ESU EDAM has been designed and tested to comply with IEC 60601 1 2 2001 requirements for EMC with other devices 109 EN Sidne Guidance and Manufacturer s Declaration
16. OF THE SOFTWARE OR AGAINST INFRINGEMENT IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICES OR THE SOFTWARE THOSE WARRANTIES DO NOT ORIGINATE FROM AND ARE NOT BINDING ON MS Note on Java Support The SOFTWARE may contain support for programs written in Java Java technology is not fault tolerant and is not designed manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail safe performance such as in the operation of nuclear facilities aircraft navigation or communication systems air traffic control direct life support machines or weapons systems in which the failure of Java technology could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U S TWO HUNDRED FIFTY DOLLARS U S 250 00 Limitations on reverse engineering decompilation and Disassembly You may not reverse engineer decompile or disassemble the SOFTWARE except and only to the extent that Such activity is expressly permitted by applicable law
17. Up the Headset Note For more information on the microphone headset consult 3000 Series Professional UHF Wireless Systems the user manual packaged with the headset Setting Up the Receiver 1 2 3 24 EN Attach the two provided antennae to the rear receiver panel Position the receiver on a stable surface near the Sidne console Connect the power cord Connect one end to the power input jack on the rear receiver panel Connect the other end to the 16 volt power jack on the rear Sidne console panel Connect the receiver cable Connect one end to the unbalanced audio output jack on the rear receiver panel Connect the other end to one of the microphone headset jacks on the front Sidne console panel Power on the receiver The receiver will only power on if the Sidne console is powered on The LCD screen will read WAIT The alert indicator will shine red until the transmitter is powered on Setting Up the Sidne System Setting Up the Transmitter Warning To maintain sterility in the surgical field set up the 2 3 transmitter and headpiece prior to scrubbing for surgery Ensure the batteries are installed in the transmitter Release the battery door and insert two AA batteries observing polarity Close the battery door Power on the transmitter by holding the power button for three continuous seconds Select an operating frequency for the transmitter
18. driver dongle 4 Insert the dongle into the device driver dongle port on the front Sidne panel see Figure 12 siis Figure 12 Inserting the dongle into Sidne Note After installation the driver dongle will work only with the system to which it has been installed It can be reinstalled on that system but it will not work with other systems 5 Follow the voice instructions given by Sidne 100 EN Installing the ESU Driver Upgrade Caution Programming the digital board may take several AN minutes To avoid equipment damage please do not remove the dongle card before Sidne says Please remove card When Sidne says this do this Software card detected Please stand Wait for the next instruction Programming 10 complete Wait for the next instruction Programming failed Remove and reinsert the dongle Programming complete Wait for the next instruction Please remove card Remove the driver dongle from the Sidne console Sidne will announce the completion percentage throughout the installation process Do not remove the dongle until Sidne says please remove card Sidne will announce this message only if the programming has failed 6 Wait as Sidne restarts When the console says Sidne ready the driver is installed and ready for use Caution Sidne should say ESU Connected and the
19. notwithstanding this limitation SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS You may permanently transfer rights under this EULA only as part of a permanent sale or transfer of the Device and only if the recipient agrees to this EULA If the SOFTWARE is an upgrade any transfer must also include all prior versions of the SOFTWARE EXPORT RESTRICTIONS You acknowledge that SOFTWARE is subject to U S export jurisdiction You agree to comply with all applicable international and national laws that apply to the SOFTWARE including the U S Export Administration Regulations as well as end user end use and destination restrictions issued by U S and other governments For additional information see http www microsoft com exporting Electromagnetic Compatibility Tables Electromagnetic Compatibility Tables Like other electrical medical equipment Sidne requires special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC Sidne must be installed and operated according to the EMC information provided in this manual Warning The radiated output power of Sidne is below the FCC A radio frequency exposure limits Nevertheless the device should be used in such a manner that the potential for human contact with the antenna during normal operation is minimized In order to avoid the possibility of exceeding the FCC radio frequency exposure limits huma
20. operated via tablet or voice commands See Setting Up the Console for information on connecting a phone to the Sidne system Tablet Commands Menu Speed Dial 7 10 Volume Figure 4 The tablet commands menu for the telephone 1 Speed Dial Buttons Select a phone number previously programmed by the user 2 Number Buttons 3 Number Screen Displays the selected numbers 4 Private Deactivates the speaker phone restricting audio signals to the telephone receiver 5 Speaker Activates the speaker phone 6 Clear Clears all numbers from the number screen 7 Pause Inserts a pause between numbers 8 Back Erases the last digit selected 9 End Hangs up the phone 10 Answer Dial Picks up the phone dials the number selected on the number screen 11 Volume Increases the volume 12 Volume Decreases the volume 86 EN Installing the Telephone Upgrade Making a Call To make a phone call using the Sidne console 1 Enter the phone number using either the number buttons or the speed dial buttons 2 Press the Answer Dial button Setting the Speed Dial 1 Enter the desired number using the number buttons 2 Hold down the corresponding speed dial button for 5 seconds The button text will flash orange when the number has been saved Note To erase the number associated with a speed dial button clear the number screen and then hold that speed dial button for five seconds When the butt
21. operating and maintenance instructions in the literature accompanying the product A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage Refer all service to authorized personnel To avoid potential serious injury to the user and the patient and or damage to this device please note the following warnings 1 To avoid potential serious injury to the user and patient and or damage to this device read the Valleylab Force FX Electrosurgical Unit ESU operating manual thoroughly and be familiar with its contents prior to using this equipment 2 The ESU is designed to be used by a qualified physician familiar with its use Misusing the ESU may cause injury to the patient and or damage system components 3 Carefully unpack the kit and check if any damage occurred during shipment If damage is detected DO NOT use the equipment Warning AN To avoid potential serious injury to the user and the patient and or damage to this device please note the following electrical warnings 93 EN Sidne 1 To prevent electrical shock to the patient and or operating room personnel do not immerse the ESU or allow fluid to enter the chassis or connector 2 Before and after each use inspect the cord insulation for cracks nicks cuts dents or depressions Any irregularity will decrease the insulation effectiveness and may result in shocks to the patient and or operating room personnel 3 To p
22. speed to low range Stop Stops the handpiece motor Stop Stops the handpiece motor 44 EN Q AUTOADUT Operating the Sidne System stryker vs 15108 Handpiece Irrigation Oscillate Forward Reverse Preset Stop 999099 AER eee E Figure 24 Shave voice commands interface on monitor Sidne Feedback Messages Sidne Corrective Action if Meaning applicable Shaver This precedes connected and disconnected messages See TPS TPS console has detected an error See the TPS console screen for the console condition error message and the appropriate corrective action 45 EN Sidne Stryker Digital Capture System SDC Pro SDC Pro 2 SDC HD Tablet Commands Menu Capture Image Previous Image Video Image Status Stopped Disk Space Record Disk Space Left 90 Disk Figure 25 The tablet commands menu for the SDC Voice Commands Menu Awaken Device Control Select Description Select Record Initiates video recording Capture Captures the video image Stop Stops video recording Activate Initiates data writing to a Make recordable disk erp C Is writing d disk and Digital Cancel ancels writing data to a disk an Sidne Capture sends Sidne back one menu Previous Image Record Dictation Off Dictation Displays the previous captured
23. the console when pressed once powers off the console when pressed again Product Description Intended Use 1 2 3 4 5 6 25 23 22 CTI e 7 aic 8 a 8118 1 T 115 119 I gs JB aL ig i c i Y pas 24 12 Vg 2120 19 18 17 16 15 4141311 10 Figure 3 The Sidne console rear panel 10 11 12 13 Tablet Mic Power Jack Connects to the tablet power cable 15 16 DVI I XGA Output Connects to a flat panel monitor Analog video In Out Connects with the video in out breakout cable which provides S video connections 2 through 4 one Composite in and one Composite out XGA Inputs 2 3 and 4 Connect to a surgical camera For service use only Do not use Audio Out Connects to external speakers Device Ports Connect operating room devices to the Sidne console Voice Output for SDC Connects to audio input on an SDC for dictation onto a CD DVD Voice Output for VCR Connects to audio input on a VCR for dictation onto a VHS tape Wireless Receiver Antenna Receives wireless communication signals from the tablet Disabled Do not use Phone Line In Brings dial tone from a wall jack to the Sidne console Phone Gives dial tone from the Sidne console to a regular telephone Speaker Power Jack Supplies power to external speakers which powers the tablet and two wireless headset receivers
24. video image Initiates voice recording Stops voice recording Dictation Off Stops voice recording There is no menu timeout associated with the Dictation gt Record gt Dictation Off menu level Any of the following voice commands will exit this voice menu level Dictation Sidne and Exit 46 EN iO Operating the Sidne System Stryker v 7 S 2 Record Capture Stop Make Disk Previous Image Dictation Figure 26 SDC HD voice commands interface on monitor Sidne Feedback Messages Sidne Says Digital capture Disk not present Meaning Added as a prefix to the below messages when a command is issued from the tablet or SDC front panel while not in the digital capture voice command menu Also added as a prefix to the connected and disconnected messages There is no disk present in the SDC Video not present There is no video signal detected at the SDC video input Error saving data There is an error saving data to the disk or network Stopped Recording or playing has been stopped Recording Video recording has been started Saving data The SDC is writing data to the disk or network Save complete Writing data to the disk or network has been completed Initializing The SDC is initializing Dictation recording Voice r
25. voice tablet or front panel command Wash mode off The wash mode was stopped by voice tablet or front panel command Wash mode The wash mode was activated by voice tablet or front panel command selected Knee joint Knee joint preset settings were selected by voice tablet or front panel selected command Shoulder joint Shoulder joint preset settings were selected by voice tablet or front panel selected command Small joint Small joint preset settings were selected by voice tablet or front panel selected command Tubing not The pump detects that the tubing is not inserted when the pump is turned on inserted Overpressure The pump detects an overpressure condition Note When the pump displays an error message it shuts itself off This will cause Sidne to say Arthroscopy pump disconnected 1000400723a 58 EN 1088 Camera Tablet Commands Menu Enhancement 22009 9 9 4 sh XAr omuo Figure 1 The tablet commands menu for the 1088 Camera Figure 2 The 1088 voice commands interface on monitor 59 EN Sidne Tablet Commands To Device ion f Control Select Description Level Selection Decreases digital enhancement image sharpness Enhancement Increases digital enhancement image sharpness E Decreases the light level in
26. 0400732a 62 EN SIDNE Cleaning and Maintenance SIDNE Cleaning and Maintenance Cleaning Warning Unplug the Sidne console from the electrical outlet A before cleaning the unit Caution Do not immerse the console tablet or headset in any liquid as product damage will result Caution Do not use solvents such as alcohol or cleaning Jl solutions that contain ammonia to clean the console tablet or headset as product damage may result Caution Do not sterilize the console tablet or headset as A product damage may result 1 Wipe the console with a soft cloth dampened in a mild cleaning solution 2 Clean the console with disinfectant if needed 3 Perform the same two steps for cleaning the tablet and headset Maintenance The Sidne system requires no preventative or periodic maintenance The fuse on the console may be replaced at the hospital by a qualified technician Warning To reduce the risk of electrical shock do not open the A Sidne console tablet or headset There are no user serviceable components inside Should service be needed notify your local Stryker representative Replacing Fuses 1 Unplug the Sidne console from the electrical outlet and disconnect the power cord from the rear console panel 2 Unlatch the fuse holder next to the AC connection on the rear console panel and remove the fuse You may need to press the tab on the fuse holder with a slender screwdriver to releas
27. 4 2000 Fax 408 754 2505 Addenda to the Sidne Manual Addenda to the Sidne Manual Installing the Telephone Upgrade 83 EN Sidne Operating and Maintenance Manual Addendum 90 EN Installing the Tablet Battery Pack 113 EN Sidne Tablet Recharging Cradle 114 EN All of these addenda are commercially available to users Please contact your local Stryker Representative for ordering information 83 EN Sidne Installing the Telephone Upgrade Follow the instructions below to install the Sidne Telephone Installation 2 0 upgrade on the Sidne console 1 Power on the Sidne console and wait until Sidne says Sidne ready 2 Remove the cap from the telephone driver dongle see the figure below l ste Figure 1 The Telephone driver dongle 3 Insert the dongle into the device driver dongle port on the front Sidne panel see the figure below Figure 2 The device driver dongle port on the SIDNE front panel 4 Follow the voice instructions given by Sidne Sidne Says Meaning Software card detected Please Wait for the next instruction stand by Please remove card Remove the driver dongle from the Sidne console 5 Wait as Sidne restarts When the console says Sidne ready telephone connected the driver is installed and ready for use Note After installatio
28. 41 C Requires service 30L insufflators The insufflator needs to be serviced by an authorized technician 40 EN Operating the Sidne System Stryker X6000 Q5000 Light Source Tablet Commands Menu Brightness Shutter Figure 21 The tablet commands menu for the light source Voice Commands Menu Device m Awaken Control Select Description Select Light Sets the light source to automatically TM Siding Source maintain a set brightness Manual Disables the automatic shutter Brighter Increases the brightness by one step Darker Decreases the brightness by one step Sets the light source to standby minimum Standby brightness Active Activates the light source removes it from standby 41 EN Sidne Automatic Manual Brighter Darker Standby Activate ihe gt muc Figure 22 Light Source voice commands interface on monitor Sidne Feedback Messages Sidne Says Meaning a Added as a prefix to the below messages when a control is issued by Light Source the tablet or light source front panel while not in the light source voice command menu The light source brightness has been set to manual by voice tablet or Manual front panel command Automatic The light source brightness has been set to automatic by voice tablet or front panel command ER The light sour
29. 642 4422 or phone your local Stryker Endoscopy sales representative 2 When returning equipment for service package all the components carefully in the original shipping container if possible 3 Ship the Sidne unit prepaid and insured to your local Stryker Endoscopy distributor or to Stryker Endoscopy Customer Service Attention Repair Department 5900 Optical Court San Jose CA 95138 USA Note The device described in this manual is continually being reviewed and improvements may be made without notice Stryker is a registered trademark of Stryker Corporation 80 EN International Service International Service For service in the U S A call your Stryker Endoscopy representative or Stryker Endoscopy Customer Service at 1 800 624 4422 Outside of the U S A please contact your Stryker Endoscopy distributor at one of the following locations Stryker Corporation 2725 Fairfield Road Kalamazoo MI 49002 USA Phone 1 269 385 2600 Telex 224464 STRYKER KMZ Fax 1 269 385 1996 Stryker Canada 45 Innovation Drive Hamilton Ontario CANADA L9H 7L8 Phone 905 690 5700 800 668 8323 toll free Fax 1 905 690 5698 Stryker Deutschland GmbH Gewerbeallee 18 D 45478 Mulheim an der Ruhr GERMANY Phone 49 208 999 060 Fax 49 208 999 0666 Stryker Latin America 15100 N W 67th Ave Suite 210 Miami Florida 33014 USA Phone 1 305 821 1888 Fax 1 305 826 0067 Stryker B V Marinus van Meelwe
30. EN Sidne OPERATING AND MAINTENANCE MANUAL English Sidne Operating and Maintenance Manual Sidne OPERATING AND MAINTENANCE MANUAL v 6 6 STATUS stryker 5900 Optical Court Tel 800 624 4422 San Jose CA 95138 Fax 800 729 2917 USA Before operating SIDNE for the first time attach the antenna to the back of the SIDNE unit as shown Table of Contents Table of Contents Table of Contents 1 EN Warnings and Cautions 4 EN Avertissements et pr cautions 6 EN Product Description Intended Use 8 EN The Sidne Console 9 EN Tlie TableE emet etie e Rc to e ede E 12 EN The Microphone Headset 14 EN Setting Up the Sidne System 18 EN Setting Up the Console 18 EN Setting Up the Tablet 23 EN Setting Up the Headset 24 EN Setting Up the Receiver 24 EN Setting Up the Transmitter 25 EN Setting Up the Headpiece 25 EN Selecting the Video Source 26 EN Operating the Sidne System 27 EN Issuing Commands with the Tablet 27 EN Issuing Commands with the Microphone Headset 2 2 etc as beam ERR RAE er RE ES 29 EN Global Commands 31 EN Device Specific Commands
31. M adapter cable to the EDAM c Connect the Sidne interface cable to the EDAM d Connect the Sidne interface cable to Sidne e Mount the EDAM Power On the Sidne console Install the ESU driver upgrade 6 Sidne will restart Wait for Sidne to say Sidne ready before powering On the ESU Caution Sidne should say ESU Connected and the EDAM A LED should be flashing green within 20 seconds of powering On the ESU A different LED output may indicate device problems If the LED does not flash green after 20 seconds refer to the Troubleshooting Guide of this addendum for instructions 7 Power On the ESU This completes the installation procedure 92 EN Connecting the Electrosurgical Unit ESU Connecting the Electrosurgical Unit ESU Warnings and Cautions Please read this addendum and follow its instructions carefully The words warning caution and note carry special meanings and should be carefully reviewed Warning Caution Note AN N Warning AN The personal safety of the patient or physician may be involved Disregarding this information could result in injury to the patient or physician Special service procedures or precautions must be followed to avoid damaging the instrument Special information to make maintenance easier or important information more clear An exclamation mark within a triangle is intended to alert the user to the presence of important
32. Replace the battery 65 EN Sidne Tablet beeps and enters search mode Check the battery strength After approximately 500 charges the battery will no longer hold a full two hour charge and will need to be replaced Contact a Stryker representative to order a new battery Invalid Card Detected is heard when using dongle 66 EN The dongle being used may be single use only Please contact your local Stryker Representative Check the version of the dongle being used All 1 0 version dongles will only work with older versions of Sidne All 2 0 version dongles will work with old and new versions of Sidne Technical Specifications Technical Specifications Environmental Specifications Operating Temperature Humidity Altitude Vibration Shock Shipping Storage Temperature Humidity Altitude Vibration Shock Package Drop 10 to 40 C 20 to 95 RH 1 000 to 15 000 feet above sea level 300 to 4500 meters above sea level 0 2g 25 500Hz Controller 2g 11105 half sine Hand Control tablet 2g 11ms half sine 30 to 55 C 10 to 95 RH 1 000 to 20 000 feet above sea level 300 to 6 100 meters above sea level 1g 25 500Hz Hand control tablet 10g 11ms half sine no damage 6 any face or corner System Input Power Requirements Voltage Frequency Current Fuse Rating 120 240 VAC switchable 50 60Hz 8 4 A T8 0A 250V 67 EN Sidne Electromagnetic I
33. S Video Out Connects to devices such as a monitor video printer VCR or SDC S Video 1 In Connects to a surgical camera 11 EN Sidne 17 DVI I XGA 1 Input Connects to a surgical camera 18 Equipotential Ground Terminal 19 Power On Off Switch Enables the system to power on when the I position powers off the system when in the O position 20 Voltage Selector Selects either 120 or 240 Volts 21 AC Power Supply Input 22 USB 2 0 Ports Reserved for future use 23 Firewire Ports Reserved for future use 24 USB 1 1 Port Reserved for future use 25 Ethernet Port Reserved for future use The Tablet The remote control tablet provides manual controls for the Sidne system and any devices connected to the console The tablet has an interactive touch screen that displays the devices connected to the Sidne system and provides a control menu for each device When a command is selected by touching the tablet screen the tablet relays the command to the Sidne console where it is routed to the appropriate device The tablet can be powered by rechargeable batteries for up to two continuous hours allowing for wireless use or by a power cord that connects to the rear panel of the Sidne console Note The tablet batteries will recharge automatically when the tablet power cord is connected to the Sidne console when on but it is recommended that they be charged using the cradle see Cradle Addendum Full ch
34. Selects one of two female or male voices for the Sidne console adjusts the Sidne system volume Video Source Selections Selects the primary video source usually the source the camera is connected to Note The video source must be selected in order for the image to 52 EN display properly on the operating room monitor Select the source the camera is connected to Shift video Mode Shifts video signal to compensate for other devices Infinity SDC HD etc When Sidne receives an input signal from one of these devices there may be a slight shift in monitor picture due to variation in tolerance Pressing this button will cause Sidne to automatically shift between modes i e Mode 1 Mode 2 and will adjust the monitor picture Set IP When this button is pressed the following screen appears for Infinity and SDC HD systems Operating the Sidne System Video Mode Please input a valid IP address Figure 32 The enter IP address screen on the tablet Specify the IP address of the devices that Sidne will communicate with If a valid address is entered the following screen will appear Web Video Mode 6 d o Audio Video Source 00 Or Ox x GEES 0000 Cmm 0000 Gp Figure 33 The valid IP address screen on the tablet If an incorrect address is entered the following screen will appear Note Sidne and the Tablet must be restarted to reflect the chan
35. a chain of menus projected onto the upper right hand corner of the operating room monitor Note Note Sidne provides a ten second window in which to make a command in the second and third menus and a three second window in the fourth menu Should a command not be issued within the window Sidne will return to the previous menu When two microphones are used simultaneously Sidne will give priority to Microphone A the microphone plugged into the top microphone port on the console 29 EN Sidne 30 EN Menu 1 The first menu known as the Sidne menu shows the Sidne logo Saying Sidne will awake the system and access the second menu Menu 2 The second menu known as the Device menu lists all the devices connected to the Sidne M console Saying the name of a device as it appears on screen will access the third menu Menu 3 The third menu known as the Command menu lists the device controls as they appear on the device itself Saying any one of the controls as it appears on screen will either activate that control or access the fourth menu Operating the Sidne System Note All available commands will appear in orange Commands that are unavailable due to device behavior will appear in white Menu 4 The fourth menu lists options specific to individual controls For example choosing enhancement on the Camera Command menu Menu 3 accesses up and do
36. ace any defective parts thereof and return it to the purchaser This warranty does not apply to any product that has been subject to misuse neglect or improper installation or has been altered adjusted or tampered with by any person other than Stryker Endoscopy authorized personnel If upon examination by authorized service personnel it is determined that the malfunction is due to misuse or abuse warranty provisions will not apply An estimate of the cost of repair work will be given to the purchaser prior to servicing and repairing the product Products repaired under Stryker Endoscopy s standard repair program will be issued a thirty day warranty against defects in both materials and workmanship provided the original warranty period has passed Products submitted due to defects in materials and workmanship during the warranty period will be repaired at no charge to the purchaser No agent employee or representative of Stryker Endoscopy has the authority to bind the Company to any other warranty affirmation or representation concerning this product All components are covered by warranty for one year as described above Note This warranty applies to customers in the United States only Outside of the U S A contact your Stryker sales representative or your local Stryker subsidiary 79 EN Sidne Service and Claims If service is needed either during or after the warranty period 1 Contact Stryker Endoscopy at 1 800
37. amp 2 CSA C22 2 N 601 1 M90 et UL N 2601 1 French translations are provided in accordance with CAN CSA C22 2 No 601 1 90 Clause 6 requirements 7 EN Sidne Product Description Intended Use The Stryker Intelligent Device Network Sidne operating room control system is an electronic medical device intended for use in surgical procedures The Sidne system facilitates operating room management by centralizing control of the various electronic devices used in the operating room Medical cameras image capture systems insufflators and other operating room devices connected to the Sidne system can be controlled through commands issued to the Sidne console The Sidne console is controlled by a touch screen interactive tablet or through commands spoken into a microphone headset V Sidne gt stryker 9 Figure 1 The Sidne system 8 EN Product Description Intended Use The Sidne system is packaged with the following components 1 Sidne console 1 tablet 1 Audio Technica wireless headset kit 8 6 foot Serial USB device connector cables 1 Hospital grade AC power cord 1 Speaker power cable 1 Tablet power cable 1 12 foot S video cable 1 video out cable 1 Audio out cable SDC compatible 1 Audio out cable VCR compatible 1 Audio Technica Line cable The three main components of the Sidne system are 1 The Sidne console 2 The rem
38. arging time is two hours The tablet features several controls which are described in Figure 4 12 EN Product Description Intended Use 1 2 3 4 5 6 7 Figure 4 The remote control tablet front and right side view 1 Tablet Indicator Light Shines orange while the tablet boots up shines green when the tablet is ready for use 2 Battery Indicator Light Indicates the charge left in the tablet battery Green over 80 Orange between 80 and 20 Red less than 20 3 Touch View screen Displays control menus for operating the Sidne system and any devices connected to it 4 On Screen Keyboard Button Displays hides the on screen keyboard when pressed 5 DC Power Input Connects the tablet to the Sidne console for DC power and battery recharging 6 Power On Off Switch Powers the tablet on or off when held for 3 continuous seconds Suspends the tablet if pressed and released quickly To activate press button again 7 Stylus Acts as a pointer to select options on the tablet touch screen Pull gently on the stylus to release it from its housing Caution The extra ports and buttons on the tablet not described in A this manual are not intended for use and may cause unexpected results if used 13 EN Sidne Caution Do not open the battery compartment or try to replace the A batteries as battery function may be compromised Contact your local Stryker representative for assistance The Microphone Head
39. ce has been activated by voice tablet or front panel Activated command Standing By The light source has been placed in the standby mode by voice tablet or front panel command 42 EN Operating the Sidne System Stryker TPS Shaver Tablet Commands Menu Rotation Figure 23 The tablet commands menu for the shaver 43 EN Sidne Voice Commands Menu Device Awaken Control Select Description Select Clear Error Hidden Clears the pending TPS console error Command message Next Port Selects the handpiece connected to the next port Endo Selects the handpiece connected to the Endo port Handpiece TPS 1 Selects the handpiece connected to the TPS 1 port TPS2 Selects the handpiece connected to the TPS 2 port Oscillate Activate Starts the handpiece motor at the preset speed in the Oscillate mode Activate Starts the handpiece motor at the preset speed in the Forward mode Forward High Sets the Endo handpiece speed to high range Sidne Shaver Low Sets the Endo handpiece speed to low range Activate Starts the handpiece motor at the preset speed in the reverse mode Reverse High Sets the Endo handpiece speed to high range Low Sets the Endo handpiece speed to low range Up Increases the handpiece preset speed Down Reduces the handpiece preset speed Preset High Sets the handpiece speed to high range Low Sets the handpiece
40. chirurgicale L unit a subi des tests pouss s en usine avant son exp dition 5 Netenter aucun r glage ou r paration qui ne soit pas sp cifiquement d crit dans ce manuel d utilisation 6 Suivre scrupuleusement les instructions d entretien et de nettoyage expos es dans ce manuel Tout manquement peut tre source de d g ts 7 Lire int gralement le mode d emploi avant d assembler ou de connecter l unit Le non respect de ces mises en garde entraine la nullit de la garantie Stryker Endoscopy n accepte la pleine responsabilit quant aux effets nuisibles sur la s curit la fiabilit et les performances de l quipement que dans les conditions suivantes Les r glages modifications et ou r parations sont ex cut es exclusivement par Stryker Endoscopy L installation lectrique de la salle d op ration o cet quipement est utilis est conforme aux normes CEI CEC et NEC en vigueur Avertissement Selon la loi f d rale am ricaine ce dispositif ne A peut tre utilis que par un m decin ou sur son ordre Stryker Endoscopy se r serve le droit d apporter des am liorations au x duit s d crit s dans le pr sent document Il se peut par cons quent que l quipement utilis diff re l g rement dans sa conception et ses sp cifications de l quipement d crit Toutes les sp cifications sont sujettes modification sans pr avis Prendre contact avec le distributeur Stryker Endoscopy le plus che dont l
41. d Maintenance 117 EN Cleaning isses ssa nmn we ewe 117 EN Maintenance 117 EN Warranty and Repairs 117 EN 4EN Sidne Warnings and Cautions To avoid potential serious injury to the user and the patient and or damage to this device the user must 1 Read this operating manual thoroughly and be familiar with its contents prior to using this equipment 2 Carefully unpack the unit and check if any damage occurred during shipment If damage is detected please refer to the Service and Claims section in this manual 3 Bea qualified physician having complete knowledge of the use of this equipment 4 Test this equipment prior to a surgical procedure This unit was fully tested at the factory before shipment 5 Attempt no internal repairs or adjustments not specifically detailed in this operating manual 6 Pay close attention to the care and cleaning instructions in this manual A deviation may cause damage 7 Read the entire instruction manual before assembling or connecting the unit The warranty is void if any of these warnings are disregarded Stryker Endoscopy accepts full responsibility for the effects on safety reliability and performance of the equipment only if Readjustments modifications and or repairs are carried out exclusively by Stryker Endoscopy The electrical installation of the relevant operating room complies with the applicable IEC CEC a
42. ded antenna Product Description Intended Use Ground Lift Switch Disconnects the ground pin of the balanced output jack 6 from ground Slide the switch to the right to eliminate humming caused by a ground loop otherwise slide the switch to the left for regular use Balanced Audio Output Jack Connects to an XLRM type connector to connect the receiver to a mixer or integrated amplifier Unbalanced Audio Output Jack Connects to an unbalanced mixer Power Input Jack Connects to the DC plug from the Sidne console 17 EN Sidne Setting Up the Sidne System Setting Up the Console Warning When Sidne is interconnected with other electrical A equipment leakage currents may be additive Ensure all systems are installed according to the requirements of IEC 60601 1 1 Warning Ensure that the power switch is set to 120 V or 240 Vas AN appropriate prior to plugging in the device User injury and or product damage may result in the use of an incorrect power setting To set up the console make the following connections 1 Connect the AC power see Figure 9 Plug in the female end of the AC power cord to the AC power supply input on the rear console panel Plug in the male end of the AC power cord to a hospital grade electrical outlet Caution Use only hospital grade power cables such as the AN cable provided with the Sidne system Using other cables may result in increased RF emissions or decreased system
43. digital enhancement image p sharpness Enhancement Decreases digital enhancement Down A image sharpness Zoom Out Zooms out continuously Zoom In Zooms in continuously Sidne Camera Stop Stops zoom Laparoscopy Selects laparoscopy specialty setting Specialty Arthroscopy Selects arthroscopy specialty setting Standard Selects standard specialty setting Automatic Sets the shutter to automatically control brightness Shutter Turns off the automatic shutter Manual allowing for manual control of brightness Up Increments the gain level Gain Down Decrements the gain level This is a global command which can be issued from any menu Itis not visible on this menu 36 EN Operating the Sidne System stryker vs 151070 White Balance Enhancement Zoom Out Zoom In Stop Specialty Shutter Gain Figure 18 Medical video Camera voice commands interface on monitor Sidne Feedback Messages Sidne Says Meaning Camera Added as a prefix to the below messages when the control is issued from the tablet or camera front panel while not in the camera voice command menu Also added as a prefix to the connected and disconnected messages Shutter manual The camera shutter was set to manual by voice tablet or front panel command Shutter automatic The camera shutter was set to automatic by voice tablet or front panel command W
44. e the Sidne ESU EDAM system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Sidne ESU EDAM unit b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 111 EN Sidne Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Sidne ESU EDAM system The Sidne ESU EDAM system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the Sidne ESU EDAM system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sidne ESU EDAM system as recommended below according to the maximum output power of the communications equipment Separation distance m according to frequency of transmitter Rated maximum output power W of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 P d 1 17 JP d 2 33 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum ou
45. e the latch 3 Replace the fuse with a fuse of the same value and rating pushing gently until the tab snaps in place Warning To avoid the risk of fire use only replacement fuses specified in the Specifications section of this manual 63 EN Sidne Troubleshooting Problem Possible Solution No voice feedback using Ensure the volume is not set at For the tablet or Voice voice menus say Sidne Options Control Interface Audio and set the volume For tablet options select Options and adjust the volume with the button Adjust the volume level using the tablet or voice control interface No video output when e Check the Sidne console video input the Sidne console is and output connection s powered Check that the input selector on the video monitor is set properly Check that the input selector on Sidne is set to the proper input For voice menus select Sidne Options video Source and choose the source the camera is connected to For tablet menus select Options and then select one of the options listed below the heading video Source Check that the input source e g medical video camera is powered and is producing an image e Check that the camera cable length Switch camera rear panel is set properly It should match the actual camera cable length 10 or 20 Check other devices in the video loop Disconnect and reconnect all video cables No
46. ecording has been started Limit reached Either a video recording image capture or dictation recording limit has been reached 47 EN Sidne Sony UP 5600MD video Printer Tablet Commands Menu ayout 1 per Page 2 per Page Picture Print Capture Picture Figure 27 The tablet commands menu for the printer Voice Commands Menu Awaken Sidne 48 EN Device Select Printer Control Select Description Memory Displays the printer s image memory Live Displays the live image Print Issues a print command to the video printer More Increments by 1 the number of copies to be printed Copies Less Decrements by 1 the number of copies to be printed One Selects one picture per page Layout Two Selects two pictures per page Four Selects four pictures per page Operating the Sidne System Stryker yA SIOP Memory Live Print Copies Layout Figure 28 Printer voice commands interface on monitor Sidne Feedback Messages Sidne Says Meaning Printer Added as a prefix to the below messages when the control is issued by the tablet or printer while not in the printer voice command menu Live image displayed The printer is set to display the live image Memory image displayed The printer is set to display the memory image 49 EN Sidne Sony SVO 9500 video Cassette Recorder VCR
47. es coordonn es sont indiqu es dans la section Autres services d assistance ou appeler le repr sentant ou 6 EN Avertissements et pr cautions l agent Stryker Endoscopy local pour obtenir des informations sur les modifications et les nouveaux duits Lire ce manuel et suivre scrupuleusement les instructions qu il contient Les termes Warning avertissement Caution attention et Note remarque ont une importance particuli re d crite ci dessous Avertissement La s curit personnelle du patient ou du m decin peut tre menac e Le non respect des consignes donn es peut entrainer des dommages corporels pour le patient ou le m decin Attention C dures ou pr cautions particuli res devant tre respect es pour viter d endommager l instrument Remarque Informations sp ciales destin es faciliter la maintenance ou rendre plus claires certaines informations importantes uN Un point d exclamation dans un triangle a pour objet d attirer l attention de l utilisateur sur la pr sence d instructions d utilisation et de maintenance importantes dans la documentation du duit Un clair dans un triangle avertit de la pr sence de tension dangereuse Faire effectuer toute intervention sur l quipement par du personnel agr Autres symboles 4 Plage de temp rature ambiante DA Plage d humidit relative X Plage de pression atmosph rique Indique la conformit avec les normes CEI 601 1 El amendements 1
48. et and console Observe the critical care devices for per function Note Note Note 72 EN Should a device demonstrate irregular behavior while Sidne is in operation increase the distance between the device and the Sidne console and repeat step 2 until normal behavior is restored Consult the tables below for guidance in placing the Sidne console For extra information about this test method please refer to the Electromagnetic Compatibility section in this manual or to the ANSI C63 18 standard The radio frequency communication range of Sidne has been moderated to 30 40 feet to help manage electromagnetic interference Electromagnetic Compatibility Tables Guidance and Manufacturer s Declaration Electromagnetic Emissions Sidne is intended for use in the electromagnetic environment specified below The customer or the user of Sidne should ensure that it is used in such an environment Electromagnetic Environment Emissions test Compliance guidance RF emissions Group 1 Sidne must emit CISPR electromagnetic energy in 11 order to perform its intended function Nearby electronic equipment may be affected RF emissions Class B Sidne is suitable for use in CISPR all establishments including 11 domestic establishments and none Class those directly connected to the A public low voltage power ns supply network that supplies buildings used for domestic
49. etic pagation is affected by absorption and reflection from structures objects and people 74 EN Electromagnetic Compatibility Tables Guidance and Manufacturer s Declaration Electromagnetic Immunity Sidne is intended for use in the electromagnetic environment specified below The customer or the user of Sidne should ensure that it is used in such an environment 00600 Compianeg Immunity Test Environment Test Level Level Guidance Electrostatic 6kV 2 4 6kV Floors should be Discharge ESD contact contact wood concrete IEC61000 4 2 48kVair 2 4 8kV air Of ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for 0 5 1 2kV Mains power transient burst power for power quality should IEC61000 4 4 supply lines supply lines be e ofa 1kV for 0 25 0 5 1k PIC input output V for input li hospital ines output lines environment Surge 1kV 0 5 IKV Mains power IEC61000 4 5 differential differential quality should mode mode be that of a 42kV 0 5 1 2kV Pical commercial or common common f hospital mode mode E environment 75 EN Sidne Guidance and Manufacturer s Declaration Electromagnetic Immunity Continued Voltage dips 596 Ut 596 Ut Mains power short 295 dip gt 95 dipin quality should interruption
50. example rather than connect a camera directly to a monitor or recording device connect it directly to Sidne After connecting the camera to Sidne connect the monitor and recording device to Sidne 6 Connect Sidne to a telephone line if desired see Figure 9 Note The telephone option is only available if the supplemental telephone driver has been installed Connect a telephone cord from a telephone wall jack to the line in jack on the rear Sidne console Connect any external telephone to the phone jack on the rear Sidne console 7 Connect the tablet see Setting Up the Tablet and the headset see Setting Up the Headset see also Figure 9 8 Apply power to the devices connected to the Sidne console 9 Apply power to the Sidne console For first use only Switch the on off switch on the rear console panel to on represented by the I symbol Note Turning on the unit using the on off switch on the rear console panel will fully power up the unit In this case it is not necessary to press the on off button on the front console panel For every subsequent use Press the on off button on the front console panel to activate the system After the Sidne system boots up the console says Greetings One moment please Sidne ready The Sidne System will review the connected operating room devices list them in order and announce any device error conditions For example Insufflator Camera
51. g Oytoscopy to Cytoscopy Changes the Camera s specialty setting Microscope to Microscope Specialty Flexecope Changes the Camera s specialty setting to Flexscope Changes the Camera s specialty setting Standard to Standard Le Changes the Camera s specialty setting Mini to Mini Lap ENT Changes the Camera s specialty setting to ENT Automatic Camera shutter automatically controls Shutter brightness Manual User manually controls brightness Up Increases the gain level in increments Gain Down Decreases the gain level in increments Brighter Increases the light level in increments Sidne Camera Light Darker Decreases the light level in increments This is a global command which can be issued from any menu a Zoom Out and Zoom In will continue until you say Stop 61 EN Sidne Sidne Feedback Messages Sidne Voice Message Meaning Connected Camera is turned on and plugged into Sidne White Balance White Balance successfully completed Complete White Balance Invalid White Balance was unsuccessful Shutter Automatic Shutter mode is set to automatic Shutter Manual Shutter mode is set to manual Added as a prefix to the above messages when a feedback message Camera is announced while not in the Camera Voice Command Mode Also added as a prefix to the Connected and Disconnected messages 100
52. g 17 P O Box 8747 5657 En Eindhoven THE NETHERLANDS Phone 31 40 2922522 Fax 31 40 2922555 Stryker Osteonics SA 5 Chemin des Aulx 5 1228 Plan les Ouates Case Postale 725 1212 Grand Lancy 1 Geneve SWITZERLAND Phone 41 22 884 0111 Fax 41 22 884 0199 Stryker European Rep RA QA Manager ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex FRANCE Phone 33 1 48175000 Fax 33 1 48632175 Stryker India Private Limited First Floor C 5 SDA Commercial Complex New Delhi 110 017 INDIA Phone 91 11 686 6740 Fax 91 11 696 6020 Stryker Australia Unit 58 2a Herbert St St Leonards NSW 2065 AUSTRALIA Phone 02 9467 1000 Fax 02 9467 1010 Stryker Singapore PTE LTD 70 Bendemeer Road 03 32 Hiap Huat House SINGAPORE 339940 Phone 65 293 0119 Fax 65 293 7028 Stryker Pacific Ltd Suite 2501 Citibank Tower Citibank Plaza 3 Garden Road Central HONG KONG Phone 61 2 9415 5100 Fax 61 29 4294127 Stryker Mexico S A de C V Calle Sacramento 410 Col Insurgentes San Borja C P 03100 Mexico D F MEXICO Phone 525 488 0890 Fax 525 488 0891 81 EN Sidne Stryker Finland PL 80 Makelankatuz FIN 00501 Helsinki FINLAND Phone 358 0 9 7744 680 Fax 358 0 9 7744 6820 Stryker Korea 11F Dong Sung Bldg 154 24 Samsung dong Kangnam ku Seoul KOREA 135 090 Phone 82 2 34517572 Fax 82 2 552 4156 Stryker China Limited Room 903 905 Office Tower 2 Beijing Su
53. ges to the Options menu 53 EN Sidne Voice Commands Menu Show Status Device TU Awaken Control Select Description Select Female 1 Selects female voice 1 for Sidne audio feedback Female 2 Selects female voice 2 for Sidne audio feedback Audio Male 1 Selects male voice 1 for Sidne audio feedback Male 2 Selects male voice 2 for Sidne audio feedback 0 10 Adjusts the volume from 1 to 10 Hide Status Hides the status bar on the bottom of the monitor screen video Shows the status bar on the bottom of the monitor screen Selects one of four S video ports as the input S video 1 4 port the camera is connected to Composite Selects the composite port as the input port Sidne Options the camera is connected to Source XGA 1 4 Selects one of four XGA ports as the input port the camera is connected to DVI Selects the DVI port as the input port the camera is connected to Hidden command shifts video signal to Shift Mode compensate for other devices Infinity SDC HD etc Pointer Makes the pointer appear on the monitor screen Web On Off Enables disables web operation Start Starts the timer Timer Stop Stops the timer Clear Clears the timer Compliment Prompts Sidne to compliment the surgeon or system operator 54 EN Operating the Sidne System Stryker 151074 Audio Video Source Pointer Web Timer
54. gown Note Repeat the steps listed under Setting Up the Headset if a second headset will be connected to the Sidne console Selecting the Video Source In order to display the camera image properly Sidne must know where the camera has been connected Use the tablet or microphone headset to tell Sidne which video input port the camera is connected to For more information on navigating tablet and voice command menus see the Operating the Sidne System and Sidne Options sections in this manual 1 To select the video source by using the tablet Press the Options icon on the tablet screen Press the icon that corresponds with the video source input port the camera is connected to 2 To select the video source by using the microphone headset Say Say Options after Options has appeared on the monitor Say Source after Source has appeared on the monitor Say the name of the video input port the camera is connected to after it has appeared on the monitor 26 EN Operating the Sidne System Operating the Sidne System Warning Sidne is not intended for use with robotic surgical systems Using Sidne with a robotic surgical system may cause unexpected results and harm the patient Warning To maintain harmony with existing hospital networks AN notify hospital IT staff that Sidne uses an 802 11b wireless network before using the system in the operating roo
55. harging the Tablet and Tablet Battery Warning To reduce the risk of electrical shock never touch any A part of the cradle and the patient simultaneously To charge a battery that is still connected to the tablet 1 Insert the tablet into the tablet charging dock as shown in Figure 2 below Note The Battery Charge LED on the cradle will not illuminate while an entire tablet is docked in the cradle Instead the Battery LED on the tablet itself will shine orange while the battery charges and will shine green once the battery has been fully charged 115 EN Sidne Figure 2 Inserting the tablet into the charging dock 2 Allow the battery to charge completely before removing it from the cradle To charge a battery that has been disconnected from the tablet 1 Insert the battery into the battery charging dock as shown in Figure 3 below The Battery Charge LED on the cradle will flash orange while the battery charges Figure 3 Inserting a battery into the battery charging dock 2 Remove the battery when the Battery Charge LED on the cradle shines green Electrical Ratings 100 240V 50 60Hz 1A 116 EN Cradle Cleaning and Maintenance Cradle Cleaning and Maintenance Cleaning Warning To reduce the risk of electrical shock unplug the cradle from the electrical outlet before cleaning the unit Caution Do not immerse the cradle in any liquid as product damage will result Caution Do not use sol
56. he EDAM Stryker recommends securing the EDAM in one of the following positions Rear left hand corner of the ESU A secure location on a cart 1 Remove the velcro strips from the kit 2 Carefully peel the protective paper backing covering the adhesive side of the velcro strips 3 Attach one velcro strip to the underside side without label of the EDAM and the other velcro strip to the ESU or cart 4 Securely mount the EDAM in the desired location using the velcro strips see Figure 10 98 EN Connecting the Electrosurgical Unit ESU Figure 10 Mounting the EDAM to the ESU 99 EN Sidne Installing the ESU Driver Upgrade Note Read the Notes and Cautions section at the end of this procedure before using the Sidne console to control the ESU Note Do not attempt to install any other software driver until the installation of the ESU Driver is complete and the Sidne console has restarted after step 6 of this section The Sidne ESU Driver 2 0 upgrade allows the Sidne console to communicate with the Valleylab Force FX Electrosurgical Unit ESU Follow the instructions below to install the Sidne ESU Driver 2 0 upgrade on the Sidne console 1 Ensure that the ESU is powered Off 2 Power On the Sidne console and wait until Sidne says Sidne ready 3 Remove the cap from the ESU driver dongle see Figure 11 T a stjer Y Figure 11 Removing the cap from the ESU
57. hite balance complete The white balance operation has completed White balance invalid The white balance operation was not successful 37 EN Sidne Stryker 30L and 40L High Flow Insufflators Tablet Commands Menu Pre High Fle Medium Flow Low Flow Activate Stop Figure 19 The tablet commands menu for the insufflator Tablet Commands Menu Awaken Device Select Control Select Description Sidne Insufflator Down Decreases the preset pressure by 1 mm Hg Increases the preset pressure by1 mm Hg Pressure Up Increases the pump pressure by 1 mm Hg Decreases the pump pressure by 1 mm Hg High Flow Sets the insufflator flow rate to flow level 3 Medium Flow Sets the insufflator flow rate to flow level 2 Low Flow Sets the insufflator flow rate to flow level 1 Activate Activates insufflation Stop Stops insufflation 38 EN Operating the Sidne System SN 10 409 oye stryker v7 S Pressure High Flow Medium Flow Low Flow Activate Stop Figure 20 Insufflator voice commands interface on monitor 39 EN Sidne Sidne Feedback Messages Sidne Says Meaning Added as a prefix to the below messages when the control is issued by the Insufflator tablet or insufflator front panel while not in the insufflator voice command
58. immunity 2 Connect the operating room devices that will be controlled by Sidne see Figure 9 Connect the square end of a device cable to the device port on the operating room device Connect the rectangular end of the device cable to one of the eight device ports on the rear console panel 3 Connect any external audio output if desired see Figure 9 Connect external speakers to the external speaker port on the rear console panel Note The Sidne console is equipped with internal speakers that provide audio feedback Connecting external speakers will enhance audio feedback messages but is not necessary Connect audio output for recording devices such as a SDC to the appropriate voice output port 9 for VCR 10 for SDC on the rear console panel if desired 4 Connect any video inputs 18 EN Setting Up the Sidne System Connect video inputs such as cameras to an XGA port see Figure 11 or a S Video port see Figure 10 To take advantage of the high definition support provided by Sidne connect the DVI XGA inputs to a high definition camera system such as the Stryker 1088 Medical Video Camera Ensure that the camera is set to high definition mode 5 Connect any video outputs Connect any video outputs such as monitors or recording devices to the S video out port see Figure 10 Note When connecting video and audio inputs and outputs make Sidne the first connection in the loop For
59. increments Light Increases the light level in increments Zooms Camera out continuously Zoom Zooms Camera in continuously Standard Changes the Camera s specialty setting to Standard Arthrosco Changes the Camera s specialty SIDNE Camera ii setting to Arthroscopy Laparoscopy Changes the Camera s specialty setting to Laparoscopy Mini Lap Changes the Camera s specialty setting to Mini Lap Specialty Microscope Changes the Camera s specialty setting to Microscope Cytoscopy Changes the Camera s specialty setting to Cytoscopy Flexscope Changes the Camera s specialty setting to Flexscope ENT Changes the Camera s specialty setting to ENT White Balance Automatically adjusts the white balance 60 EN Voice Commands To Device P Control Select Description Level Selection Captures the image displayed on the Image Capture monitor via a video printer or digital capture system White Balance ae adjusts the white U Increases digital enhancement image sharpness Enhancement Down Decreases digital enhancement image sharpness Zoom Out Zooms Camera out continuously Zoom In Zooms Camera in continuously Stop Stops Camera zoom Changes the Camera s specialty setting Laparoscopy to Laparoscopy Changes the Camera s specialty setting Arthroscopy to Arthroscopy SIDNE Camera Changes the Camera s specialty settin
60. m The Sidne system and the devices connected to it can be controlled by commands issued through either the tablet or the microphone headset Sidne provides both audio and visual feedback to acknowledge commands Visual feedback appears on the tablet screen when the tablet is used and on the operating room monitor when the microphone headset is used Note All devices connected to the Sidne system can still be operated by their front panel controls They will continue to function even if Sidne is powered off Issuing Commands with the Tablet After the Sidne console and tablet have booted up the tablet displays the home option screen The home option screen displays three folders stacked one on top of the other Inside each folder are icons representing each of the devices connected to the Sidne console see Figure 13 Figure 13 The tablet home option screen 27 EN Sidne 1 Folders 2 Device icons Touching a device icon brings up a device specific option menu that displays the same controls found on the actual device For example the camera option menu offers controls for light enhancement zoom white balance and specialty see Figure 14 below S P E C l A L T Y Enhancement Light DD Standard Microscope White Balance Laparoscopy Flexscope Figure 14 The camera option menu The device shown on the tablet screen can be controlled by touching the options displayed
61. mbols 4 Ambient temperature range 4 Relative humidity range X Atmospheric pressure range Denotes compliance to CSA C22 2 No 601 1 M90 Ip and UL 2601 1 0 This device includes RF transmitters and emits nonionizing radiation FCC Federal Communications Commission United States IC Industry Canada Note The term IC before the certification registration number signifies that the Industry Canada technical specifications were met This device complies with Part 15 of the FCC rules Operation is subject to the following 2 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 5 EN Sidne Avertissements et pr cautions Pour evictor de graves pleasures potentiates l utilisateur et au patient et ou des d g ts ce dispositif l utilisateur doit r pondre certaines conditions et ou suivre certaines c dures 1 Lire int gralement ce manuel d utilisation et se familiariser avec son contenu avant d utiliser cet quipement 2 D baller l unit avec pr caution et v rifier les dommages ventuels survenus pendant l exp dition Si l unit n est pas intacte se reporter la section Assistance et r clamations de ce manuel 3 tre un m decin qualifi parfaitement au courant des modalit s l utilisation de cet quipement 4 Tester cet quipement avant toute intervention
62. n the driver dongle will work only with the system on which it has been installed It can be reinstalled on that system but it will not work with other systems 84 EN Installing the Telephone Upgrade Connecting a Phone Set to the Sidne Console Follow the diagram below to connect a phone set to the Sidne console To a telephone handset o nt nt BLUE CSS TRS ey Sidne rear console panel From a telephone wall jack Figure 3 The phone connections on the SIDNE rear panel Note The phone feature is compatible with analog phone lines only Note When using the telephone handset voice signals will be received through the earpiece on the handset When using the microphone headset voice signals will be received through the external speakers on the Sidne console Sidne Feedback Messages Sidne may offer the following voice messages while in the telephone mode For a complete list of telephone voice and tablet controls see the Sidne Operating and Maintenance Manual p n 1000 400 653 Sidne Says Meaning Telephone Added as a prefix to the below messages Number not saved The selected speed dial option has no number assigned to it Number saved A speed dial number has just been saved Incoming call An incoming call has arrived 85 EN Sidne A telephone connected to the Sidne console can be
63. n Dong An Plaza 138 Wang Fu Jing Da Jie Beijing 100006 P R CHINA Phone 86 10 65136183 Fax 86 10 83913571 Stryker Japan Dai Tokyo Kasai Shinjuku Bldg 3 25 3 Yoyogi Shibuya ku Tokyo 151 0053 JAPAN Phone 813 535 29106 Fax 813 535 21789 Stryker Europe Headquarters Cite Centre Grand Rue 92 CH 1820 Montreux SWITZERLAND Phone 41 21 966 1201 Fax 41 21 966 1200 Stryker Taiwan 5F 1 23 Pa Te Road Section 1 Taipei TAIWAN R O C Phone 886 2 2322 2895 Fax 886 2 2357 8543 Stryker U K Ltd Hambridge Road Newbury Berkshire RG14 5 EP UNITED KINGDOM Phone 44 1635 262400 Fax 44 1635 262464 82 EN Stryker Middle East Africa Via Della Posta 6934 Bioggio SWITZERLAND Phone 4021 212 1122 Fax 4021 212 1133 NV Stryker SA Belgium Ikaros Business Park Fase III Ikaroslaan 12 1930 Zaventem Brussels BELGIUM Phone 32 2 717 92 10 Fax 32 2 717 92 49 Stryker Chile Avenida Nueva Tajamar 481 Oficina 805 Piso 8 Torre Norte Santiago CHILE Phone 562 244 3600 Fax 562 244 3696 Stryker Spain Manuel Tovar 35 28034 Madrid SPAIN Phone 34 91 7283500 Fax 34 91 3580748 Stryker AB Scandinavia Krossverksgatan 3 S 216 10 Malm SWEDEN Phone 46 40 69 18 100 Fax 46 40 69 18 190 Stryker AB Denmark Sankt Annae Plads 9 1021 Copenhagen DENMARK Phone 45 33 9360 99 Fax 45 33 9320 69 MANUFACTURER Stryker Endoscopy Inc 5900 Optical Court San Jose CA 95138 USA Phone 408 75
64. n proximity to the antenna should be more than 20cm during normal operation Warning Do not use cables or accessories other than those A provided with Sidne as this may result in increased electromagnetic emissions or decreased immunity to such emissions Warning If Sidne is used adjacent to or stacked with other A equipment verify normal operation of Sidne in the configuration in which it will be used prior to using it in a surgical procedure Perform the steps in the section Testing Compatibility below to ensure electro magnetic compatibility among operating room devices Caution Portable and mobile RF communications equipment may affect the normal function of Sidne Caution To prevent radio interference with any licensed AN service Sidne is intended to be operated indoors and away from windows to provide maximum shielding Caution Any changes or modifications not explicitly approved AN by Stryker Endoscopy could cause Sidne to cease to comply with FCC rules and thus void the user s authority to operate the equipment 71 EN Sidne Testing Compatibility 1 Identify any critical care medical devices located within the communication range of Sidne 2 Test each device for compatibility with the Sidne system Power on the critical care devices Perform a variety of functions with the Sidne system Issue commands with both the tablet and headset and power on and off the tablet heads
65. nd NEC requirements Warning Federal law United States of America restricts this device to use by on order a physician Stryker Endoscopy reserves the right to make improvements on the product s described herein Product s therefore may not agree in detail to the published design or specifications All specifications are subject to change without notice Please contact the local Stryker Endoscopy Distributor listed in the nternational Service section or phone your local Stryker Endoscopy sales representative or agent for information on changes and new products 4EN Warnings and Cautions Please read this manual and follow its instructions carefully The words warning caution and note carry special meanings and should be carefully reviewed Warning The personal safety of the patient or physician may be involved Disregarding this information could result in injury to the patient or physician Caution Special service procedures or precautions must be followed to avoid damaging the instrument Note Special information to make maintenance easier or important information more clear AN An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the literature accompanying the product x A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage Refer all service to authorized personnel Other Sy
66. nterference Sidne has been designed and tested to comply with the requirements of EN60601 1 2 2001 for electromagnetic compatibility Classifications Class I equipment Continuous Operation Water Ingress protection IPXO Ordinary protection No applied part Controller video Input Component S video Four S video XGA Four XGA DVD One DVI Composite One Composite Controller video Outputs Component S video One S video XGA One XGA DVD One DVI Composite One Composite Audio Outputs 2 Feedbacks Line Out 2 Voice Outputs Line Out Controller video Resolution NTSC 720 x 480 XGA DVI 1024 x 768 59 94 Hz refresh rate 68 EN Technical Specifications Component Dimensions Controller 17cm h x 32cm w x 41cm d 9 8 kg Cables Hospital grade power cables Wireless Communication Specifications IEEES02 11 b Frequency range 2 4 2 485 GHz Modulation DSS Direct Spread Spectrum Power 100mw UHF Wireless Systems Wireless Headset and Receiver UHF Operating Frequency 655 500 to 680 375 MHz Number of Channels 200 total Frequency Stability 0 005 Phase Lock Loop frequency control Modulation Mode FM Normal Deviation 10 kHz Operating Range 300 feet typical Operating Temp Range 41 F to 113 F 5 C to 45 C Frequency Response 70 Hz to 15 kHz Microsoft XP Embedded Software End User License Agreement EULA You have acquired a device DEVICE tha
67. on text flashes orange the number is erased strykerv 151074 Speed Dial Answer Hang Up Audio Redial Dial Figure 5 Telephone voice commands interface on monitor 87 EN Sidne Voice Commands Menu Device Awaken Control Select Description Select Selects the phone number programmed for Outside 1 5 Outside 1 2 3 4 or 5 u Selects the phone number programmed for ts Doctor 1 2 3 4 or 5 Blood Lab Selects the phone number programmed for Blood Lab Emergency Selects the phone number programmed for Emergency Outpatient Selects the phone number programmed for Outpatient Pathology a the phone number programmed for Speed atho ogy Dial Radiology Selects the phone number programmed for Radiology Recovery Selects the phone number programmed for Recovery Sidne Telephone Histology Selects the phone number programmed for Histology Nurses Selects the phone number programmed for Nurses Office Selects the phone number programmed for Office Home Selects the phone number programmed for Home Answer Answers the phone Hang Up Hangs up the phone Audio 0 10 Adjusts the volume between 1 and 10 Redial Redials the last number dialed Cancel Cancels dialing Dial Pause Inserts a pause between digits when dialing Pound Inserts a pound sign when dialing 88 EN Installing the Telephone Upgrade
68. on the screen 28 EN Press any icon once to activate that feature For example to select the arthroscopy setting for the surgical camera press the Arthroscopy icon once Selected options are displayed in orange lettering available options are displayed in white lettering unavailable options are displayed in gray lettering Press any or icon once to adjust by one increment For example pressing the icon beneath the zoom status bar advances the zoom one step The status bar located above the and buttons will reflect the change Press and hold any or icon to adjust at a steady rate For example holding the icon beneath the zoom status bar advances the zoom gradually The status bar located above the and buttons will reflect the change Operating the Sidne System Press the X icon to exit For example pressing the X in the upper right hand corner of the menu exits that device menu and returns to the home option screen Caution AN Never use sharp objects such as pens pencils or operating room instruments to select options from the tablet touch screen Sharp objects will damage the screen and void the warranty Issuing Commands with the Microphone Headset The Sidne system and the devices connected to it can also be operated by spoken commands issued through the microphone headset Sidne displays the available commands through
69. ote control tablet 3 The microphone headset Each of these three main components is described in detail in the following pages The Sidne Console The Sidne console is the primary component of the Sidne system The console provides connection ports for the various operating room devices which it controls by processing voice and tablet commands issued by the surgeon and operating room staff The front console panel provides several features whose functions are listed in Figure 2 below Figure 3 lists the features of the rear console panel 9 EN Sidne gt SYNCHRONIZE O status Figure 2 The Sidne console front panel 1 10 EN CD ROM Drive Will play compact discs with a future Sidne driver Insert the CD with the bottom side facing the CD eject button CD ROM Indicator Light Indicates the presence of a disk in the CD ROM drive CD Eject Button Ejects CDs from the CD ROM Drive Microphone Headset Jacks Connect microphone headsets to the console for voice controlled operation Device Driver Dongle Port Connects to a USB dongle for uploading device drivers to the Sidne system System Status LED Blinks green while the console boots up shines green when the console is ready for use Tablet Synchronization Button Synchronizes wireless communication between the console and the tablet Power On Off Button Powers on
70. ped The pump was stopped by voice tablet or front panel command Activated The pump was activated by voice tablet or front panel command Wash mode off The wash mode was stopped by voice tablet or front panel command Shoulder joint um Je The wash mode was activated by voice tablet or front panel command Knee joint Knee joint preset settings were selected by voice tablet or front panel selected command Shoulder joint preset settings were selected by voice tablet or front panel 34 EN selected command Small joint Small joint preset settings were selected by voice tablet or front panel selected command Error The pump error indicator on the pump front panel is illuminated Tubing not The pump detects that the tubing is not inserted when an activate command is inserted given by voice tablet or front panel command Overpressure The pump detects an overpressure condition Operating the Sidne System Stryker 888 988 Medical video Camera Tablet Commands Menu era Figure 17 The tablet commands menu for the camera 35 EN Sidne Voice Commands Menu Device Awaken Control Select Description Select Captures the image displayed on the Image Capture monitor via a video printer or digital capture system White Balance Initiates white balance U Increases
71. revent injury or electrical shock to the patient and or operating room personnel always power Off the ESU when connecting or disconnecting accessories Caution To avoid potential damage to this device please note the following cautions 1 Always power Off the ESU before connecting or disconnecting the Sidne interface kit 2 Ensure that the Sidne ESU EDAM hereafter referred to as EDAM is securely mounted to the ESU or cart 94 EN Connecting the Electrosurgical Unit ESU Installing the Cover Plate Ensure that the cover plate is mounted to the ESU before connecting to Sidne If the cover plate is mounted proceed to Connecting Sidne to the Valleylab Force FX Electrosurgical Unit ESU If the cover plate is not mounted continue with steps below Required Equipment The following equipment is required to perform this procedure Sharp knife Phillips head screwdriver Nut driver Cover Plate Installation 1 Remove the cover plate from the interface kit 2 Usinga sharp knife cut out the serial port slot from the indented side of the cover plate The serial port slot is the rectangle on the left see Figure 2 Figure 2 Cutting the serial port slot from the cover plate Note You may remove other panels from the cover plate if necessary The panels may also be pushed out by hand 3 Remove the two screws that hold the metal plate covering the ESU s serial port Remove the metal plate
72. s 85 EN Sidne Operating and Maintenance Manual Addendum 90 EN Kit Overview 91 EN 2 EN Table of Contents Quick Start Up Guide 92 EN Connecting the Electrosurgical Unit ESU io once eee dro MDC LE ts 93 EN Warnings and Cautions 93 EN Installing the Cover Plate 95 EN Required 95 EN Cover Plate Installation 95 EN Connecting Sidne to the Valleylab Force FX Electrosurgical Unit ESU 97 EN Mounting the EDAM 98 EN Installing the ESU Driver Upgrade 100 EN Operating the ESU 102 EN Sidne ESU Tablet Commands 102 EN Voice Commands Menu 105 EN Sidne Feedback Messages 106 EN Troubleshooting Guide 107 EN Electromagnetic Compatibility Tables 109 EN Installing the Tablet Battery Pack 113 EN Sidne Tablet Recharging Cradle 114 EN Operating and Maintenance Manual 114 EN Product Description Intended Use 114 EN Cradle Operation 115 EN Setting Up the Cradle 115 EN Charging the Tablet and Tablet Battery 115 EN Electrical Ratings 116 EN 3 EN Sidne Cradle Cleaning an
73. s and in Ut for Ut for 1 be that of a voltage 0 5 cycle cycle typical variations on 40 Ut 40 Ut commercial Or power supply 60 dip in 60 dipin bospital input lines Ut for 5 Ut for 5 indian If the user o IEC61000 4 11 cycles cycles siduefMrequites 70 Ut 70 Ut continued 30 dip in 30 dip in operation during Ut for 25 Ut for 25 power mains cycles cycles interruptions it lt 5 Ut lt 5 Ut is recommended 295 dip gt 95 dip in that Sidne be in Ut for 5 Ut for 5 sec Powered from T an constant power supply or a battery Power frequency 3 A m 3 A m Power 50 60Hz frequency magnetic field magnetic fields IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ut is the a c mains voltage prior to application of the test level 76 EN Electromagnetic Compatibility Tables Guidance and Manufacturer s Declaration Electromagnetic Immunity Sidne is intended for use in the electromagnetic environment specified below The customer orthe user of Sidne should ensure that it is used in such an environment Immunity IEC 60601 Compliance Blectoming n Test Test Level Level Paynen Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Sidne system including its cables than the recommended separation distance Conducted
74. see Figure 3 95 EN Y Sidn m Figure 3 Removing the metal plate 4 If jack screw posts are not present in the left nine pin connector use the nut driver to insert the new jack screw posts see Figure 4 Empty slots Inserted jack screw posts Figure 4 Inserting jack screw posts 5 Place the new cover plate so that the opening allows access to the ESU s serial port the nine pin connector on the left Replace and secure the two screws see Figure 5 Figure 5 Installing the new cover plate 96 EN Connecting the Electrosurgical Unit ESU Connecting Sidne to the Valleylab Force FX Electrosurgical Unit ESU Figure 6 ESU EDAM adapter cable and EDAM 1 Ensure that the ESU and the Sidne console are powered Off 2 Connect the male end of the EDAM adapter cable to the serial port on the rear panel of the ESU see Figure 7 Figure 7 Connecting the EDAM adapter cable to the ESU 3 Connect the female end of the of the EDAM adapter cable to the nine pin connector on the EDAM see Figure 8 Figure 8 Connecting the EDAM adapter cable to the EDAM 97 EN Sidn D Connect the Sidne interface cable to the USB connector on the EDAM 5 Connect the other end of the Sidne interface cable to one of the eight USB ports on the Sidne console see Figure 9 Figure 9 ESU connected to Sidne The Sidne console is now connected to the ESU Mounting t
75. set The microphone headset provides voice activated control of the Sidne System and any devices connected to the console When a command is spoken into the microphone headset the headset transmits the command via radio frequency to the Sidne console where it is then routed to the appropriate device The headset comprises three main components which are described in Figures 5 through 8 below 1 The headset Figure 5 2 The transmitter Figure 6 3 The receiver front panel Figure 7 rear panel Figure 8 S Figure 5 The headset 1 Headpiece Fits over the top of the head or above the ear and behind the head positioning the microphone in front of the mouth 2 Microphone Mouthpiece Fits three fingers breadth away from the corner of the mouth to receive spoken commands 3 Headpiece Connector Connects to the transmitter 14 EN Product Description Intended Use Figure 6 The transmitter 1 Antenna 2 Power on LED Shines red when the transmitter is powered on 3 Audio Input Jack Connects the transmitter to the headpiece connector 4 Mounting Clip Clips to clothing for easy support 5 Mode Set Button Accesses transmitter modes when pressed once repeated pressing advances through the different modes locks the mode setting when held for several seconds 6 Battery Door provides access to the transmitter batteries 2 AA batteries 7 Sliding Control Cover protects the transmitter bu
76. stays flashing Stryker sales representative for firmware upgrade b EDAM LED e ESU is not communicating properly with stays solid the Sidne ESU EDAM Ensure that the red ESU is properly connected to Sidne See the Connecting Sidne to the Valleylab Force FX Electrosurgical Unit section of this addendum for more details Attempt the following solutions in order 1 Power Off ESU 2 Ensure that the ESU EDAM adapter cable is plugged into the EDAM 3 Ensure that the ESU EDAM adapter cable is plugged into the ESU 4 Power On ESU 107 EN Sidne Problem Possible Solution c EDAM LED Sidne is not communicating properly with stays solid the Sidne ESU EDAM See the yellow Connecting Sidne to the Valleylab Force 2 Sidne says ESU Disconnected 3 Sidne says Check patient return electrode 4 Sidne says Error Check generator FX Electrosurgical Unit section of this addendum for more details Attempt the following fixes in order 1 Power Off ESU Ensure Sidne is powered On Ensure that the Sidne interface cable is plugged into the EDAM 4 Ensure that the Sidne interface cable is plugged into Sidne 5 Power On ESU Power Off ESU Ensure that the ESU is properly connected to Sidne See the Connecting Sidne to the Valleylab Force FX Electrosurgical Unit section of this addendum for further instructions Power On
77. t includes software licensed by Stryker Endoscopy from Microsoft Licensing Inc or its affiliates MS Those installed software products of MS origin as well as associated media printed materials and online or electronic documentation SOFTWARE are protected by international intellectual property laws and treaties The SOFTWARE is licensed not sold All rights reserved IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT EULA DO NOT USE THE DEVICE OR COPY THE SOFTWARE INSTEAD PROMPTLY CONTACT STRYKER ENDOSCOPY FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE FOR A REFUND ANY USE OF THE SOFTWARE INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA OR RATIFICATION OF ANY PREVIOUS CONSENT 69 EN Sidne GRANT OF SOFTWARE LICENSE This EULA grants you the following license 70 EN You many use the SOFTWARE only on the DEVICE NOT FAULT TOLERANT The software is not fault tolerant Stryker Endoscopy has independently determined how to use the software in the device and MS has relied upon Stryker Endoscopy to conduct sufficient testing to determine that the software is suitable for such use NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE is provided AS IS and with all faults THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT
78. the tablet the other charges a battery that has been removed from the tablet The features of the cradle are listed in Figure 1 below Figure 1 The Sidne Tablet Recharging Cradle 1 Battery Charge LED flashes orange while the battery is recharging shines green when the battery is fully charged 2 Power LED shines green when the cradle is plugged in to an AC outlet 3 Tablet Charging Dock holds the tablet during the charging session 4 Battery Charging Dock holds a tablet battery during the charging session 114 EN Cradle Operation Cradle Operation Setting Up the Cradle Warning To reduce the risk of electrical shock do not use the cradle within a 1 5 meter radius of the patient Warning To reduce the risk of electrical shock use only the AN supplied DC adapter and hospital grade AC power cord with the cradle Warning To reduce the risk of electrical shock do not connect the cradle to extension cord Do not connect the cradle to a multiple socket outlet to which other medical devices are connected 1 Position the cradle on a flat level surface near a hospital grade outlet 2 Connect the DC power adapter to the hospital grade power cable 3 Connect the DC adapter cable to the DC input port on the rear of the cradle 4 Connect the hospital grade power cable to a hospital grade AC outlet The Power LED on the cradle will shine green indicating the cradle is connected to a power source C
79. these commands with or without the word Power i e Power Up or Up Power Down or Down Ror more information on power level settings refer to the Valleylab Force FX Electrosurgical Unit Manual 105 EN Sidne Sidne Feedback Messages Table 3 shows the Sidne feedback messages and their meanings Sidne Feedback Messages Sidne Voice Message Meaning Connected ESU is turned On and plugged into Sidne Disconnected ESU has been disconnected or turned Off Check Patient Return Electrode Return Electrode Monitor fault has been detected video Error is displayed above the status bar for 10 seconds Error Check Generator ESU generator error code has been detected Check ESU panel display All commands are grayed out and video Error is displayed until the ESU is turned Off and On ESU Added as a prefix to the above messages when a feedback message is announced while not in the ESU Command Mode Also added as a prefix to the Connected and Disconnected messages 106 EN Troubleshooting Guide Troubleshooting Guide Table 4 shows the most common errors and possible solutions to each Troubleshooting Guide Problem Possible Solution 1 No access to This problem has several possible causes ESU through Please see solutions for each problem Sidne a EDAM LED e Contact Stryker Endoscopy or your local
80. tput power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic pagation is affected by absorption and reflection from structures objects and people 1000400733b 112 EN Installing the Tablet Battery Pack Installing the Tablet Battery Pack Before performing the instructions listed under Setting Up the Tablet in the Sidne Operating and Maintenance Manual 1000 400 653a follow these instructions for installing the tablet battery pack 1 Insert the battery pack into the battery slot 2 Lockthe battery latch e NA Note The tablet will not power on unless the battery latch is locked 113 EN Sidne Sidne Tablet Recharging Cradle Operating and Maintenance Manual Product Description Intended Use Caution The Sidne Tablet Recharging Cradle is intended for AN use only with the Sidne tablet and tablet battery Do not use the cradle to recharge any other battery or unit Damage to the cradle and or device may result The Sidne Tablet Recharging Cradle is an optional battery charging station intended for recharging the batteries of the Sidne tablet The cradle features two charging docks one charges the tablet battery while the battery is still attached to
81. ttons from inadvertent selections 8 Up Down Arrows Scroll through various transmitter settings 9 Power Mute Button Powers on the transmitter when held for 3 seconds powers off the transmitter when held for another 3 seconds when the transmitter is on mutes RF signals when pressed 10 LCD Window Displays transmitter options status 15 EN Y Sidn paudio technica TUNER 1 2 3 4 5 6 Figure 7 The receiver front panel 1 2 3 4 Power Switch Powers the system on and off Alert Indicator Shines red to indicate that the transmitter is in the mute mode or is powered off or to indicate system warnings such as weak transmitter battery or no poor RF communication between the transmitter and receiver LCD Window Indicates control settings and status readings Tuner Operator Indicator Indicates which tuner A or B has better reception and is in operation Up Down Buttons Advance through menus select operating frequency edit receiver function choices Mode Set Button Works in conjunction with the up down buttons to step through menus choose operating frequency and select function Figure 8 The receiver rear panel 1 16 EN AF Level Control Adjusts the audio output level of both AF output jacks Cord Hook Secures the DC power cord to the receiver to avoid inadvertent disconnection Antenna Input Jack B Connects to a provided antenna Antenna input Jack A Connects to a provi
82. tus Saying Hide Status will hide the status bar on the Device menu or Sidne menu 5 Shaver Stop Saying Shaver Stop issues a Stop command to any shaver connected to the system 1088 Digital Camera 40L High Flow 988 Digital Camera Insufflator 888 3 Chip Camera 30L High Flow 688 1 Chip Camera Insufflator SDC Pro 2 0L Arthroscopy Pump SDC Pro2 Toshiba Mega Hi Printer SDC HD Sony MD51 Printer X6000 Xenon Light Sony UP5600 Printer Source Sony 9500 VCR Q5000 Light Source Sony 2100 VCR TPS Arthroscopy Telephone Shaver FloControl Pump Valley Lab ESU These drivers are available for purchase Contact your local Stryker Representative for ordering information Device Specific Commands The Sidne system is compatible with a wide variety of Sidne smart operating room devices such as the devices listed below Each of these devices has its own set of voice and tablet commands as well as a unique set of audio feedback messages that come from the Sidne console Tablet command menus and voice command menus for each device are listed in the following pages Note Should the Sidne system list a device as unknown a device driver may need to be loaded onto the Sidne console to enable compatibility Contact a Stryker representative to determine compatibility with the Sidne system and to acquire a device driver To load the device driver onto the Sidne system
83. vents such as alcohol or cleaning solutions that contain ammonia to clean the cradle as product damage may result Caution Do not sterilize the cradle as product damage may result 1 Wipe the cradle with a soft dry cloth Maintenance The cradle requires no preventative or periodic maintenance Warranty and Repairs Refer to the Sidne Operation and Maintenance Manual for warranty and repair information 1000400716a 117 EN stryker CE Stryker European Representative Regulatory Manager ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France 5900 Optical Court San Jose CA 95138 USA 1 408 754 2000 1 800 624 4422 1000 400 653 Rev D
84. vey should be considered If the measured field strength in the location in which the Sidne system is used exceeds the applicable RF compliance level above the Sidne system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Sidne unit b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 78 EN Warranty The warranty set forth herein is exclusive and in lieu of all other warranties remedies obligations and liabilities of Stryker Endoscopy expressed or implied including the implied warranties of merchantability and fitness for use and of consequential damages This product is being sold only for the purpose described herein In no event shall Stryker Endoscopy be liable for any breach of warranty in any amount exceeding the purchase price of the product Stryker Endoscopy warrants this product against defects in both materials and workmanship to the registered owner at the time of purchase This warranty is valid only to the original purchaser of Stryker Endoscopy products directly from a Stryker Endoscopy authorized agent The warranty cannot be transferred or assigned by the original purchaser The purchaser is responsible for returning defective equipment to the factory at his or her own expense Stryker Endoscopy or its representative will service the equipment repair or repl
85. video output when Check all items listed above the Sidne console is not powered 64 EN Poor video quality Troubleshooting Check all video cables and connections Ensure that there are no loose ended unterminated video cables Check settings on other devices in the video loop Sidne not recognizing any voice commands Ensure the frequencies on the receiver and transmitter match Ensure that microphone placement is correct as described in this manual Ensure that the user is waking the system up using the Sidne command Ensure the microphone batteries are not dead Ensure the transmitter is not set to Mute Ensure the transmitter is powered on Sidne not recognizing some voice commands Ensure that microphone placement is correct as described in this manual Sidne compatible device does not appear on the Sidne device menu or tablet option screen Check Sidne interface cables at both ends to ensure proper connection Check that the device is powered Disconnect and reconnect Sidne interface cables Make sure the device driver software for the Sidne compatible device has been loaded onto the Sidne console System error reported by audio feedback anda red front panel LED Cycle the power on the Sidne console If the error is repeated proceed according to Service and Claims section in this manual Wireless headset shows Low Battery
86. wn on the Camera s Menu 4 Note To exit any menu and return to the Sidne Menu say Exit Global Commands Although most voice commands can be issued only from their respective menus some voice commands are available from more than one menu 2 voice commands may be issued at any time and from any menu Menus 1 4 1 Sidne Saying Sidne will take the system to Menu 2 Device Menu where all available devices are listed on the upper right hand corner of the operating room monitor Image Capture Saying Image capture will capture the image displayed on the monitor to a recording device 5 voice commands may be issued at any time from Menus 2 4 These commands are not available from Menu 1 1 2 Exit Saying Exit at any menu will take the system to the Sidne menu Menu 1 Picture Saying Picture will capture the image displayed on the monitor and print it out on any connected printer Show Status Saying Show Status while in the Command menu of any device will display the status bar of the device onscreen at all times For example saying Show Status in the Arthropump Command menu will display the Arthropump status bar onscreen at all times Saying Sidne will return the display to the Device menu while continuing to display the Arthropump 31 EN Sidne status bar The display bar will remain on the Device menu and Sidne menu until the user says Hide Status 4 Hide Sta

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