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Summary of Contents for Boston Scientific SpyGlass DS
- Page 1 SpyGlass ™ Digital Controller User’s Manual User’s Manual ���������������������������������������������������������������������������������������������������������� 2 Black (K) ∆E ≤5.0...
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Page 2: Table Of Contents
Disposal of the Product, Accessories, and Packing Materials ��������������������������������������������������������������������������� 16 TROUBLESHOOTING AND RESPONDING TO ERROR CODES ������������������������������������������������������������������������������������ 17 Troubleshooting Chart ������������������������������������������������������������������������������������������������������������������������������������������������ 17 WARRANTY ������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 19 Limited Warranty ��������������������������������������������������������������������������������������������������������������������������������������������������������� 19 Obtaining Warranty Service from Boston Scientific Corporation ���������������������������������������������������������������������� 19 APPENDICES ���������������������������������������������������������������������������������������������������������������������������������������������������������������������� 19 Black (K) ∆E ≤5.0... -
Page 3: Introduction
A thorough understanding of the techniques, principles, clinical applications and risks associated with ERCP and cholangio-pancreatoscopy procedures is suggested before using the controller as part of the SpyGlass DS and DS II Direct Visualization System (hereafter referred to as the SpyGlass DS System). Contents •... -
Page 4: Specifications
SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope™ DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller. The SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter are intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. -
Page 5: Precautions
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SpyGlass DS System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 6: Adverse Events
To prevent damage, do not access the controller cabinet. • Connecting catheters other than a SpyScope™ DS Catheter to the controller can damage the controller. Only connect a SpyScope DS Catheter to the controller. See the “SpyGlass DS Digital Controller Compatibility” section. •... -
Page 7: Spyglass™ Ds Digital Controller Compatibility
Sony LMD1951MD monitor • Sony LMD1950MD monitor An irrigation pump is required to perform procedures with the SpyGlass DS System. Boston Scientific has tested the SpyGlass Irrigation Pump (M00546140) to ensure it is compatible with the SpyGlass DS System. SETUP AND OPERATION Front Panel Features Figure 1, Table 2, and Table 3 illustrate and describe the controller’s front panel features. - Page 8 Feature Description Indicates you must use BF applied parts. Light On/Off Button—Pressing this button alternately turns the light off and on. Light On/Off Button—When the controller is on, each press of the Light On/Off button toggles the light between on and off. When the light is on, the button illuminates blue.
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Page 9: Rear Panel Features
Rear Panel Features Figure 2 and Table 4 illustrate and describe the controller’s rear panel features. Figure 2� Illustration of back panel features Table 4� Description of back panel features Feature Description USB port access cover (tool required). DVI Output Connector—Video output connector for compatible DVI-capable monitors. Symbol indicating video outputs. -
Page 10: Patient Environment
Feature Description Symbol for potential equalization conductor Potential Equalization Conductor—Provides a means of securely linking the potential equalization conductor of the controller to ground. Fuse Holder Module and Power Cord Connector—The fuse holder module provides access to the controller electrical fuses. The power cord connector accepts the AC power cord that connects to an AC Main or the SpyGlass™... - Page 11 3. Place the controller and the video monitor on an equipment cart such as the SpyGlass™ Components Travel Cart or on an existing endoscopy tower in the procedure room. See the “SpyGlass DS Digital Controller Compatibility” section for additional information if needed.
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Page 12: Starting The Controller
Figure 4� Back panel connection points DVI connector VGA connector S-video connector Potential equalization conductor Ensure Pal/NTSC switch is in the correct position for the video standard used in your country Mains power Starting the Controller Follow the steps below to start the controller. You can start the controller with or without the catheter connection cable plugged into the controller. - Page 13 If the SpyScope™ DS Catheter is already connected, this screen will not appear, proceed to step 3. Note: If you do not want the Boston Scientific watermark (e) to appear on the screen, simultaneously press buttons for at least 3 seconds while the cable connect screen is displayed on the monitor. To redisplay the watermark, press the buttons for at least 3 seconds.
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Page 14: Configure The Monitor For The Video Mode
4. Shortly after the catheter loading screen appears, a live video image will appear on the live video screen (g). If the live image does not appear, consult the trouble shooting section. (g) Live video screen with example image Configure the Monitor for the Video Mode Configure the monitor according to the monitor’s user guide. -
Page 15: Adjusting The Brightness Of The Video Image And Operating Light On/Off Button
3. Unplug the SpyScope DS Catheter from the controller. 4. Press the controller’s Power button to restart the controller. 5. If the controller fails to start, contact Boston Scientific. Recovery from a Controller Lock Up Follow these steps to recover from a controller lock up: 1. -
Page 16: Considerations When Using A Laser Or Ehl Device
Periodically check the power cord assembly for damage to the insulation or connectors. In the event that the controller requires repair or replacement, contact Boston Scientific. Cleaning and Disinfection Disconnect the power cord before cleaning or disinfecting the unit. -
Page 17: Troubleshooting And Responding To Error Codes
Troubleshooting Chart Most operating problems are easily resolved. If the controller does not operate as expected, try to resolve the problem with this troubleshooting chart before contacting Boston Scientific for technical support (Table 5). Table 5� Controller troubleshooting chart Symptom... - Page 18 Brightness setting is Adjust brightness using brightness too low control buttons. Debris covering the distal Clean the distal tip by irrigating, or removing & Video image is too dark. tip of the SpyScope™ DS wiping it with 15 to 70 percent isopropyl alcohol in Catheter purified water solution using a cotton swab.
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Page 19: Warranty
Boston Scientific Corporation’s control may directly affect the product and results obtained from it. Boston Scientific Corporation shall repair or replace, at its option, any part of the product that Boston Scientific Corporation determines was defective at time of shipment if notice thereof is received within one year of shipment. - Page 20 Appendix 1—Guidance and Manufacturer’s Declaration-Electromagnetic Emissions The SpyGlass™ DS Digital Controller is intended for use in the electromagnetic environment specified below (Table 6). The customer or the user of the SpyGlass DS Digital Controller should assure that it is used in such an environment.
- Page 21 Appendix 2—Guidance and Manufacturer’s Declaration-Electromagnetic Immunity The SpyGlass™ DS Digital Controller is intended for use in the electromagnetic environment specified below (Table 7). The customer or the user of the SpyGlass DS Digital Controller should assure that it is used in such an environment.
- Page 22 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 SpyGlass DS Digital Controller is used exceeds the applicable RF compliance level above, the SpyGlass DS Digital Controller should be observed to verify normal operation.
- Page 23 Appendix 3—Guidance and Manufacturer’s Declaration-Electromagnetic Immunity The SpyGlass™ DS Digital Controller is intended for use in the electromagnetic environment specified below (Table 8). The customer or the user of the SpyGlass DS Digital Controller should assure that it is used in such an environment.
- Page 24 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 SpyGlass DS Digital Controller is used exceeds the applicable RF compliance level above, the SpyGlass DS Digital Controller should be observed to verify normal operation.
- Page 25 The SpyGlass DS Digital Controller is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SpyGlass DS Digital Controller can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SpyGlass DS Digital Controller as recommended below, according to the maximum output power of the communications equipment (Table 9).
- Page 26 Appendix 5—Medical Design Criteria and Specifications The SpyGlass™ DS Digital Controller meets medical design criteria and specifications (Table 11): Table 11� Medical design criteria and specification Design Criteria for SpyGlass DS Digital Controller Specification Type of protection against electric shock...
- Page 27 Catalog Number Type BF Applied Part Número de catálogo Pieza tipo BF aplicada Numéro de catalogue Pièce appliquée de type BF Bestell-Nr. Angelegtes Teil vom Typ BF Numero di catalogo Parte applicata di tipo BF Catalogusnummer Patiëntverbinding type BF Referência Peça aplicada Tipo BF Consult instructions for use.
- Page 28 Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA Customer Service 888-272-1001 Do not use if package is damaged. Recyclable Package 2018-08 50511978-01 Rev. B © 2018 Boston Scientific Corporation or its affiliates. All rights reserved. Black (K) ∆E ≤5.0...
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