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Electromagnetic Compatibility

Like other electrical medical equipment, SDC Ultra™ requires special precautions

to ensure electromagnetic compatibility with other electrical medical devices. To

ensure electromagnetic compatibility (EMC), SDC Ultra must be installed and

operated according to the EMC information provided in this manual.

The SDC Ultra has been designed and tested to comply with IEC 60601-1-2:2001

requirements for EMC with other devices.

Caution Portable and mobile RF communications equipment may affect

the normal function of the SDC Ultra.

Caution Do not use cables or accessories other than those provided with

the SDC Ultra, as this may result in increased electromagnetic

emissions or decreased immunity to such emissions.

Caution If the SDC Ultra is used adjacent to or stacked with other

equipment, observe and verify normal operation of the SDC Ultra

in the configuration in which it will be used prior to using it in

a surgical procedure. Consult the tables below for guidance in

placing the SDC Ultra™

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Содержание 240-050-988

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Страница 2: ...2007 08 www stryker com 1000 401 050 B SDC Ultra User Guide 240 050 988 ...

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Страница 4: ...uring Dual Channel Images and Videos 21 Editing Video Settings 24 Entering Patient Information 29 Viewing and Annotating Images 31 Viewing and Playing Videos 32 Viewing and Editing the Video Album 33 Editing Annotations 34 Saving Information 35 Saving Settings 36 Troubleshooting 38 Cleaning and Maintenance 41 Cleaning 41 Maintenance 41 Technical Specifications 42 Environmental Specifications 42 El...

Страница 5: ......

Страница 6: ...curred during shipment If damage is detected refer to the Service and Claims section in this manual 4 Use of this device is restricted to qualified health care professionals who have a complete knowledge of the use of this equipment and the devices to which it can be connected 5 Test this equipment prior to using it in a surgical procedure This unit was fully tested at the factory before shipment ...

Страница 7: ...close attention to the care and cleaning instructions in this manual Failure to follow these instructions may result in product damage 14 Attempt no internal repairs or adjustments not specifically detailed in this operating manual Refer any readjustments modifications and or repairs to Stryker Endoscopy or its authorized representatives The warranty is void if any of these warnings are disregarde...

Страница 8: ...ymbols are defined below Warning Symbols Warning Caution See Instructions for Use Hazardous voltage present Device Symbols Mouse Keyboard Monitor Network USB Speaker Serial port Packaging Labeling Symbols Legal manufacturer Authorized representative in Europe Date of manufacture Atmospheric pressure range Ambient temperature range Relative humidity range ...

Страница 9: ...C22 2 No 601 1 M90 and UL 2601 1 Equipotentiality Protective Earth Ground Denotes compliance to 93 42 EEC Medical Device Directive This product contains electrical waste or electronic equipment It must not be disposed of as unsorted municipal waste and must be collected separately ...

Страница 10: ... USB dongles which can then be viewed from a personal computer a DVD player or from the SDC Ultra itself The SDC Ultra records images on a built in hard drive where they can be easily accessed after the surgical procedure The images stored on the hard drive can be named and burned to a CD or DVD through a touch screen control panel located on the front of the unit In addition to the touch screen c...

Страница 11: ... System Overview Front Panel 1 3 2 4 5 6 1 CD DVD drive 2 USB port 3 Eject button for CD DVD drive 4 Remote control 5 Power button 6 LCD touch screen ...

Страница 12: ...lug 8 Secondary R1 Remote connection for capture control on the secondary channel 9 Secondary R2 Remote connection for recording control on the secondary channel 10 Comp In composite video input 11 Comp Out composite video output 12 S Vid In S video input 13 S Vid Out S video output 14 DVI 2 Out Secondary channel DVI output 15 DVI 2 In Secondary channel DVI input 16 DVI 1 Out Primary channel DVI o...

Страница 13: ...re devices 20 Speaker port development use only 21 USB ports 2 22 Monitor development use only 23 Keyboard development use only 24 Mouse development use only 25 Serial port development use only 26 Network port ...

Страница 14: ...3 5 6 7 1 Channel 1 video and image capture record stop 2 Channel 2 video and image capture record stop 3 Print images 4 Display previous image on OSD 5 Voice annotation future use 6 Navigation future use 7 Select future use ...

Страница 15: ...op of the SDC Ultra to ensure proper ventilation Warning RF and other mobile communications equipment may affect the normal function of the SDC Ultra When placing the SDC Ultra follow the instructions located in the Electromagnetic Compatibility section of this manual 2 Connect peripheral devices according to the interconnection diagram on the following pages Warning When the SDC Ultra is intercon...

Страница 16: ...cifications for approved printers and transformers 3 Connect the AC power Connect the provided power cord to the AC inlet on the rear console panel Connect the other end to a hospital grade power outlet Warning Do not use extension cords or three prong to two prong adapters when connecting the AC power Warning Check the power cord assembly periodically for damaged insulation or connectors ...

Страница 17: ...with the 1188 Camera and SIDNE Caution The other ports not listed in this section are intended for use by service technicians or for future device upgrades Do not connect any devices to these ports as unexpected results may occur ...

Страница 18: ...tab as the FTP Address and JOHND as the Username 3 Press Add so that SDC Ultra will remember the username and the FTP Address in the list SDC Ultra can remember up to 20 usernames and FTP addresses 4 Select the Write Videos check box on the Network tab if you want to write videos to the network 5 To save the images and videos press the Save to Network button from the Save menu A confirmation scree...

Страница 19: ...t in step 5 uncheck the anonymous login box and enter the password Directory Structure Default FTP path SDC Username MMDDYYYY_HHMMSS where First 13 characters of the Patient s Name ID entered Username Doctor s Username which can be the same as his her Notematic ID MMDDYYYY_HHMMSS Date Time stamp to guarantee uniqueness Note If there are any problems writing the data check if the read write permiss...

Страница 20: ... Started Home Screen 4 2 1 3 Select from the following options 1 Press New Case to begin a new patient case 2 Press Current Case to load the current patient information images and videos 3 Press Archive to view cases that were saved to the hard drive a USB dongle or a disc 4 Press Load Patient List to preload patient information before surgery ...

Страница 21: ...e birth date Enter the sex 3 Select the Surgeon from the drop down menu To add or delete an item on the list press add or delete 4 Select the procedure from the drop down menu 5 Navigational buttons Press the down arrow to access the secondary screen See the section in this manual called Entering Patient Information Press the Add button to add the patient information Press the MWL button to displa...

Страница 22: ...hived case to media 3 Navigational buttons Press Hard Drive to view cases stored on the hard drive Press USB to view cases stored on the USB Press Disc to view cases stored on a CD or DVD 4 Press the Check mark icon to select a patient record 5 Press the Up Down arrows to scroll through the list of patients 6 Press Delete all to delete all patient information stored on the hard drive 7 Press Delet...

Страница 23: ...t Information to enter patient information 5 Press Capture to display the capture screen 6 Press Album to edit or view images or videos 7 Press Save to display the save screen 8 Video size 9 Navigational buttons Press Single Channel Dual Channel to toggle between single and double channel mode Press Video Settings to change video options Press Printer Settings to change printer options 10 The numb...

Страница 24: ...to toggle between recording and pausing the video mode Press the Capture button to begin capturing images 15 Press the left right arrow buttons to scroll through images Recording Press the Record button on the Capture screen to record video 2 1 1 Press the Pause button to pause recording 2 Press the Stop button to stop recording ...

Страница 25: ...20 Pausing Press the Pause button on the Recording screen to pause video 2 1 1 Press the Resume button to continue recording 2 Press the Stop button to stop recording ...

Страница 26: ...2 Press Single Channel Dual Channel to toggle between single and double channel mode 3 Press Print to print images that have not previously been printed 4 Press Stop to stop recording 5 Press the Record Pause button to toggle between recording and pausing the recording mode 6 Press the Capture button to begin capturing images with PIP 7 Press Dual Capture to view and individually control the prima...

Страница 27: ...s the Synchronize button on the Dual Capture screen 3 1 2 1 Press the Capture button to capture images on both channels simultaneously 2 Press the Record button to record video on both channels simultaneously 3 Press the Stop button to stop recording on both channels simultaneously ...

Страница 28: ...on the Dual Capture screen 5 3 4 6 2 1 1 Press Capture to capture images on channel 1 2 Press Record to record video on channel 1 3 Press Stop to stop recording on channel 1 4 Press Capture to capture images on channel 2 5 Press Record to record video on channel 2 6 Press Stop to stop recording on channel 2 ...

Страница 29: ...video settings press the Video Settings button on the Capture screen 1 4 3 2 1 Select the Record Format from the drop down menu 2 Select the Camera from the drop down menu 3 Select the Signal from the drop down menu 4 Press the left arrow button to return to the previous screen ...

Страница 30: ...tton 3 2 1 1 Select the Record Format from the drop down menu 2 Select the Camera from the drop down menu 3 Select the Signal from the drop down menu Editing PIP Settings To edit PIP settings press the Video Settings button on the Capture screen and then press the PIP settings button 1 1 Press the corresponding quadrant to display the location of the picture in picture ...

Страница 31: ...EC Display to toggle between On display live video on the OSD and Off 4 Press Live Video Time out to display the amount of time the image is displayed on the OSD before reverting back to live video 5 Press Remote 2 Control to toggle between Pause recording and Stop 6 Press Auto Cut Off to toggle between DVD CD and None DVD will stop recording when it reaches 4 GB CD when it reaches 600MB and None ...

Страница 32: ...n to indicate the number of copies to print 2 Press the minus or plus sign to indicate the number of images to print per page 3 Press Advanced Printer Settings to edit options 4 Press Prints Pending to cancel the number of jobs pending to print 5 Press Auto Print to toggle between On automatically prints the selected Images Per Page and Off ...

Страница 33: ...en and then press the More Settings button 3 2 1 1 Press the corresponding minus or plus buttons to edit the brightness contrast phase chroma or sharpness of channel 1 or channel 2 images 2 Press the Default Settings to reset the image options to the factory default settings 3 Press Print to print the selected images ...

Страница 34: ... the sex Enter the patient s ID Enter the first name 2 Press the down arrow to display the second data entry screen See the Entering Patient Information Second Data entry Screen 3 Select a procedure from the drop down menu To add or delete an item to or from the list press add or delete 4 Select a surgeon from the drop down menu To add or delete an item to or from the list press add or delete ...

Страница 35: ...second data entry screen 1 3 2 6 4 5 1 Enter the facility 2 Enter the accession number 3 Press the up arrow to return to the primary data entry screen 4 Select a station from the drop down menu To add or delete an item on the list press add or delete 5 Enter the details 6 Enter the referred the doctor who referred the patient for surgery To add or delete an item on list press add or delete ...

Страница 36: ...Press Image Album to display the editing screen for the album 4 Press Video Album to annotate video and playback video 5 Press the arrow buttons to scroll through the images 6 Press Select Deselect All to select or deselect images for printing 7 Press the image twice to display the image in the center 8 Press Edit Annotations to edit or add annotations to images and video 9 Press Printer to print ...

Страница 37: ...roll through the images 2 Press the Select Deselect All button to select or deselect images for printing and saving 3 Press the Stop button to stop playing the video 4 Press the small right arrow button to play the video on the OSD 5 Press the Channel button to select which channel to play video 6 Press the Annotate button to go to the annotation screen ...

Страница 38: ...Video Album To view and edit the album press the Annotation button on the video album screen 2 1 1 Press the Annotations button to bring up the editing annotations screen 2 Press Playback Video to display the playback mode screen ...

Страница 39: ...eo button 3 2 1 1 Select the specialty from the drop down menu To add or delete an item on the list press add or delete 2 Select the procedure from the drop down menu To add or delete an item on the list press add or delete 3 Select the annotation from the drop down menu To add or delete an item on the list press add or delete ...

Страница 40: ... CD DVD to save the selected case to a CD or DVD 2 Press Eject to eject the CD or DVD 3 Press USB to save images or video to the USB 4 Press Save to Network to save images or video on the PACS or FTP network 5 Press Save Settings to edit the save options 6 Press the network drop down menu to select a network address ...

Страница 41: ...ween BMP JPEG JPEG2000 TGA TIFF and PNG 2 Press Encryption to toggle between On and Off 3 Press More Settings to display more save settings See the More Save Settings section of this manual 4 Select the destination for writing videos when saving a case to the USB and the Network 5 To select the Network Type press the corresponding box ...

Страница 42: ... Settings button on the Save screen 2 1 1 Press the corresponding minus or plus buttons to edit the brightness contrast phase chroma or sharpness of channel 1 or channel 2 images 2 Press the Default Settings to reset the image options to the factory default settings ...

Страница 43: ... list SIDNE Comm Error Ensure that SIDNE is connected properly Reboot the SDC Ultra and SIDNE Error printing No image captured selected Capture images and then select them to print Error saving settings To restore previous settings reboot the system FTP connection error Ensure that the FTP server is up and the network cable is plugged in Error Media unavailable Please insert connect a valid media ...

Страница 44: ...ve video on the monitor Check the cable connections Ensure that the camera is powered on Ensure that the proper video source is selected If the video is routed through SIDNE ensure that SIDNE is powered on No live video in PIP on preview Check the cable connections Ensure that the camera is powered on Ensure that the proper video source is selected If the video is routed through SIDNE ensure that ...

Страница 45: ...chived cases from DVD CD Reboot the system if you have just written the case Check the disc on a different system No videos written to the USB Ensure write videos to USB in the save settings is selected No videos written to the network Ensure write videos to Network in the save settings is selected Selecting the security feature Ensure that the user names and passwords for the system have been set...

Страница 46: ...eaning Caution Do not immerse the console in any liquid as product damage will result Caution Do not use alcohol solvents or cleaning solutions that contain ammonia to clean the unit as product damage may result Caution Do not sterilize the unit as product damage may result Maintenance SDC Ultra requires no preventative or periodic maintenance However Stryker recommends you reboot the system daily...

Страница 47: ... via DVI I connectors Video Outputs 1 S Video 1 Composite 2 DVI and 2 RGBHV via DVI I connectors Audio Stereo Line and Microphone input 2 speaker outputs Image Resolution Progressive scan image capture 1280 1024 Disc Capacity 100 images and 99 video files with auto cutoff for CD 600MB DVD 4 0 GB or none 20 GB maximum case size permitted File Format Images Bitmap BMP JPEG JPEG2K Tagged Image File F...

Страница 48: ...A maximum Safety and EMC Compliance IEC 60601 1 1988 A1 1991 A2 1995 CAN CSA C22 2 No 601 1 M90 UL 60601 1 2003 AS NZS 3200 1 0 1998 IEC 60601 1 1 2000 IEC 60601 1 2 2001 A1 2004 IEC 60601 1 4 1996 A1 1999 Equipment Classification Class I equipment No applied part Water ingress protection IPX0 Continuous Operation Size control unit 12 5 W 16 2 D 7 0 H Network 10 100 Mbps ethernet Auto Printing 1 2...

Страница 49: ...44 Printers Supported HP 8250 HP D7160 Isolation Transformer Stryker 240 099 050 2KVA transformer Stryker 240 050 705 180VA transformer Display 8 TFT LCD with digital touch screen ...

Страница 50: ... requirements for EMC with other devices Caution Portable and mobile RF communications equipment may affect the normal function of the SDC Ultra Caution Do not use cables or accessories other than those provided with the SDC Ultra as this may result in increased electromagnetic emissions or decreased immunity to such emissions Caution If the SDC Ultra is used adjacent to or stacked with other equi...

Страница 51: ...ause any interference in nearby electronic equipment RF emissions CISPR 11 Class A SDC Ultra is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This system may cause radio interference or may disrupt...

Страница 52: ...itters as determined by an electromagnetic site survey a should be less that the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fr...

Страница 53: ...r input output lines Surge IEC61000 4 5 1kV differential mode 0 5 1kV differential mode Mains power quality should be that of a typical commercial or hospital environment 2kV common mode 0 5 1 2kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 5 Ut 95 dip in Ut for 0 5 cycle Mains power quality should be...

Страница 54: ...st and TV broadcast can not 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 SDC Ultra system is used exceeds the applicable RF compliance level above the SDC Ultra system should be observed to verify normal operation If abno...

Страница 55: ...n distance m according to frequency of transmitter 150 kHz to 80 MHz d 1 17 P 80 kHz to 800 MHz d 1 17 P 800 kHz to 2 5 GHz d 1 17 P 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 not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the f...

Страница 56: ...roduct 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 purchas...

Страница 57: ...resentative 2 When returning equipment for service package all the components carefully in the original shipping container if possible 3 Ship the 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 Stryker is a registered trademark of Stryker Corporation ...

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Страница 61: ...San Jose CA 95138 USA 1 408 754 2000 1 800 624 4422 www stryker com European Representative Regulatory Manager Stryker France ZAC Satolas Green Pusignan Av De Satolas Green 69881 MEYZIEU Cedex France 2007 08 www stryker com 1000 401 050 B ...

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