Olympus Medical Systems UPD-3 Endoscope Position Detecting Unit User Manual Instruction Manual
Olympus Medical Systems Corp. Endoscope Position Detecting Unit Instruction Manual
Contents
- 1. Instruction Manual
- 2. Excerpt of the user manual
Instruction Manual
CONFIDENTIAL DRAFT INSTRUCTIONS ENDOSCOPE POSITION DETECTING UNIT UPD-3 USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician. (For 220 – 240V type equipment) CONFIDENTIAL Contents Labels and Symbols Important Information — Please Read Before Use Summary of Equipment Functions Chapter 1 Checking the Package Contents Chapter 2 Nomenclature and Functions Chapter 3 Inspection Chapter 4 Operation Chapter 5 Functions Chapter 6 Care, Storage, and Disposal Chapter 7 Installation and Connection Chapter 8 Function setup Chapter 9 Troubleshooting Appendix CONFIDENTIAL Labels and Symbols Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are missing or illegible, contact OLYMPUS. Caution that only the exclusive Serial number plate cable can be connected. Potential equalization terminal The product name and electric rating Endoscope Position Detecting Unit UPD-3 Input: 100-240V 50/60Hz 100VA CE marking Manufacturer name ○Back cover of this instruction manual Manufacturer Authorized representative in the European Community CONFIDENTIAL Important Information — Please Read Before Use Intended use This instrument has been designed to be used with Olympus endoscopes system for detection and displaying the shape of inserted endoscope. Instruction manual This instruction manual contains essential information on using this endoscope position detecting unit safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus. CONFIDENTIAL ○Terms used in this manual Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding Isolation transformer: The isolation transformer is a safety device that is used to isolate noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock. Scope model: The scope model is a computer graphic image that models the shape of the endoscope insertion tube. CONFIDENTIAL User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures. Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this balloon control unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. Also review the manuals of all equipment that will be used during the procedure and use the equipment as instructed. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1. Repair and modification This endoscope position detecting unit does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus. This instrument is to be repaired by Olympus technicians only. CONFIDENTIAL Signal words The following signal words are used throughout this manual: [DANGER] Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. [WARNING] Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. [CAUTION] Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. [NOTE] Indicates additional helpful information. Dangers, warnings and cautions Follow the dangers and cautions given below when handling this endoscope position detecting unit. This information is to be supplemented by the dangers and cautions given in each chapter. [DANGER] •As a TYPE BF applied part, the endoscope connected to this instrument must never be applied directly to the heart. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following: − Never apply the endoscope connected to this instrument to the heart or any area near the heart. − Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with the endoscope connected to this instrument. •Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock. − When this endoscope position detecting unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient. − Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the endoscope position detecting unit immediately and contact Olympus. CONFIDENTIAL − Do not prepare, inspect or use this endoscope position detecting unit with wet hands. • Never install and operate the endoscope position detecting unit in locations where: − the concentration of oxygen is high; − oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere; − flammable gases are present in the atmosphere; − flammable liquids are near. Otherwise, explosion or fire may result because this endoscope position detecting unit is not explosion-proof. • This instrument generates AC magnetic fields. To prevent critical effects on patients, be sure to adhere to the following: − Never use the instrument on a patient with a pacemaker. The AC magnetic fields generated by the instrument may cause malfunction or damage to the pacemaker, exerting critical effects to the cardiac function of the patient. − Never use the instrument on pregnant women and women suspected of being pregnant. The effects of the AC magnetic field generated by the instrument on the unborn baby have not yet been determined. CONFIDENTIAL [WARNING] • Never insert anything into the ventilation grills of the endoscope position detecting unit. It can cause an electric shock and/or fire. • This product may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of this instrument with all equipment to be used. • Do not use this product in any place where it may be subject to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). This may impair the performance of the product. [CAUTION] • Do not touch the electrical contacts inside the instrument’s connectors. Otherwise, equipment damage and/or malfunction can occur. • Do not use a pointed or hard object to press the buttons on the front panel and/or keyboard. This may damage the buttons. • Do not apply excessive force to the connectors. Otherwise, a failure of an electrical contact may result in a malfunction. • This instrument emits RF (Radio Frequency) energy to supply data by radio communication. Therefore, it may cause electromagnetic interference in nearby electronic equipment, and is labeled with the following symbol. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location. [NOTE] • As defined by the international safety standard (IEC 60601-1), medical electrical equipment is classified into the following types: TYPE CF applied part (the instrument can safely be applied to any part of the body, including the heart), and TYPE B/BF applied part (the instrument can safely be applied to any organ except the heart). The part of the body that an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to which the instruments are connected. Before beginning the procedure, check the current leakage classification type of each instrument to be used for the procedure. Classification types are clearly specified in the instruments' instruction manuals. CONFIDENTIAL • When endoscopes are used with endoscope accessories connected with other medical electronic equipment, the leakage currents may increase. 10 CONFIDENTIAL Summary of Equipment Functions This instrument is equipment that detects and displays the spatial image of an endoscope. Some of the functions of this instrument described below are enabled only when the required equipment are connected to this instrument. For more details, refer to the instruction manuals for this instrument and the other instruments connected. Displaying the spatial image of the endoscope The spatial image of the endoscope is displayed on the monitor in real time. Zooming in or out and rotating the scope model The scope model displayed on the monitor can be zoomed in or out and rotated. Splitting the screen The scope model can be displayed on two screens by splitting the screen. Saving and selecting the screen display Up to 20 presets of the display can be saved, and one of them can be selected to use. Hand coil The relative position between the hand coil (MAJ-1859, optional) and endoscope can be detected. View tracking The orientation of the patient’s body can be detected by attaching the reference plate (MAJ-1860, optional) to the patient’s body, and the scope model can be displayed in fixed direction. 11 CONFIDENTIAL Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. ENDOSCOPE POSITION DETECTING UNIT (UPD-3) RECEIVER DISH CABLE (MAJ-1875) RECEIVER DISH (MAJ-1868) UPD CABLE(MAJ-1881) Instruction manual 12 CONFIDENTIAL Chapter 2 Nomenclature and Functions 2.1 Front panel 4. Reference plate terminal 3. Hand coil terminal 2. Power indicator 1. Power switch Control panel 1. Power switch Press to turn the endoscope position detecting unit ON or OFF. 2. Power indicator This indicator lights up when the main unit is ON. 3. Hand coil terminal The hand coil (MAJ-1859) is connected to this terminal. 4. Reference plate terminal The reference plate (MAJ-1860) is connected to this terminal. 13 CONFIDENTIAL 2.2 Control panel 3. Zoom buttons 4.Boolmark button 5. Split screen button 2. Rotate left / Rotate right button 1. Menu button 9.Enter button 6.Scope position button 7. Scope position indicator 8. Reset button 1. Menu button This button is pressed to display or exit from the menu list. 2. Rotate left / Rotate right button When the scope model display is active, these buttons are pressed to rotate the scope model or to change the posture of the figure image. When the menu list is active, these buttons are pressed to select a menu. 3. Zoom buttons These buttons are pressed to zoom the scope model display in or out (i.e., magnify or reduce it). When the menu list is active, these buttons are pressed to select a menu. 4. Bookmark button This button is pressed to mark on the display length. 5. Split screen button This button is pressed to change between split-screen and single-screen display alternately. 6. Scope position button This button is pressed to set or release the start position of the scope model. 7. Scope position indicator This indicator lights up when the start position of the scope model has been set. 8. Reset button 14 CONFIDENTIAL This button is pressed to initialize the scope model display, and the posture of the figure image. 9. Enter button This button is pressed to determine the category in the menu list. 15 CONFIDENTIAL 2.3 Rear panel 4. Scope/probe terminal 3. Receiver dish terminal 2. Connection unit terminal 1. Remote control terminal 13. XGA OUT terminal 12. Y/C OUT terminal 5. CLV terminal 6. AC power inlet 8. LINK IN terminal 9. LINK OUT terminal 10. CV remote terminal 7. Potential equalization terminal 11. SDI OUT terminal 1. Remote control terminal This terminal is the receptacle for the remote control cable to connect the endoscope position detecting unit to the remote control. 2. Connection unit terminal The MP extension cable (MAJ-Y0062) is connected to this terminal. 3. Receiver dish terminal The receiver dish cable (MAJ-1875) is connected to this terminal. 4. Scope/probe terminal The UPD cable (MAJ-1881) is connected to this terminal. 5. CLV terminal This terminal is provided for the connection to the future Olympus light source and cannot be used for the present. 6. AC power inlet Connect the provided power cord to supply AC power via this inlet. 7. Potential equalization terminal For safety purposes, this terminal is connected to a potential equalization busbar of the electrical installation. 8. LINK IN terminal This terminal is provided for the connection to the future Olympus equipment and cannot 16 CONFIDENTIAL be used for the present. 9. LINK OUT terminal This terminal is provided for the connection to the future Olympus equipment and cannot be used for the present. 10. CV remote terminal The patient data signal from the video system center is input via this terminal. The UPD data transfer cable (MAJ-604) or the data transfer cable (MAJ-1260)* is connected to this terminal. 11. SDI OUT terminal The video signal (serial digital interface / SDI signal) is output via this terminal. 12. Y/C OUT terminal The video signal (Y/C signal) is output via this terminal. 13. XGA OUT terminal The video signal (XGA signal) is output via this terminal. * This product may not be available in some areas. 17 CONFIDENTIAL 2.4 Side panels Ventilation grills Front side Ventilation grills Rear side 2.5 UPD cable (MAJ-1881) Notch Position detecting connector 2.6 Receiver dish cable (MAJ-1875) 18 CONFIDENTIAL 2.7 Receiver dish (MAJ-1868) Front side Rear side OLYMPUS Front Cable terminal 2.8 Remote control (MAJ-1890 Option) 1. Menu key 2.Enter key 3. Rotate left / Rotate right key 9. Zoom keys 8. Bookmark key 4. Split screen key 5. Scope position indicator 7. Reset key 6. Scope position key 10. Connector 19 CONFIDENTIAL 1. Menu key This key is pressed to display or exit from the menu list. 2. Enter key This button is pressed to determine the category in the menu list. 3. Rotate left / Rotate right key When the scope model display is active, these keys are pressed to rotate the scope model or to change the posture of the figure image. When the menu list is active, these keys are pressed to select a menu. 4. Split screen key This key is pressed to change between split-screen and single-screen display alternately. 5. Scope position indicator This indicator lights up when the start position of the scope model has been set. 6. Scope position key This key is pressed to set or release the start position of the scope model. 7. Reset key This key is pressed to initialize the scope model display, and the posture of the figure image. 8. Bookmark key This button is pressed to mark on the display length. 9. Zoom keys These keys are pressed to zoom the scope model display in or out (i.e., magnify or reduce it). When the menu list is active, these keys are pressed to select a menu. 10. Connector This connector connects the endoscope position detecting unit. 20 CONFIDENTIAL 2.9 Hand coil (MAJ-1859) (Option) Arrow Connector Marker section Switch To endoscope position detecting unit Water-resistant cap 2.10 Reference plate (MAJ-1860) (Option) Plate section Arrow Human-shaped index marking Connector To endoscope position detecting unit Water-resistant cap Slit 21 CONFIDENTIAL 2.11 Reference plate cover (MAJ-1880) (Option) Reference plate cover, top surface (blue) Tab Perforation Lining paper (backside) Lining paper (inside) 22 CONFIDENTIAL 2.12 Screen display ○For the operating table image 12. Current date and time 13. Patient data 1. Scope model 2.Marker model 3. Tracking icon 11. Marking 10. Marking gauge 4. View point indicator (operating table image) 5. Marker connection icon 6. Plate connection icon 7. Scope connection icon 8. Gauge 9. Display length 23 CONFIDENTIAL ○For the figure image 14. A-P indicator 15. Viewpoint indicator (figure model) 24 CONFIDENTIAL 1. Scope model The shape of the endoscope’s insertion tube will be displayed when the endoscope’s insertion tube is moved in front of the coil unit. 2. Marker model The position of the hand coil (MAJ-1859) will be displayed when the hand coil is connected and moved in front of the coil unit. 3. Tracking icon The indicator will be displayed in the tracking display mode (see Section 5.9, “View tracking”). 4. Viewpoint indicator (Operating table image) The arrow indicator and operating table image show the angle in which the scope model on the screen is viewed. This indicator appears when “Operating table image” is selected from “Setting the viewing image” in the setup menu (see “User preset”). 5. Marker connection icon The indicator will be displayed when the hand coil is connected. The color represents the connection and detection status (see Section 5.5, “Connection indicators”). 6. Plate connection icon The indicator will be displayed when the reference plate is connected. The color represents the connection and detection status (see Section 5.5, “Connection indicators”). 7. Scope connection icon The indicator will be displayed when an applicable endoscope or position detecting probe is connected to the endoscope position detecting unit. The color represents the connection and detection status (see Section 5.5, “Connection indicators”). 8. Gauge The gauge is used as a reference for identifying the size of the displayed scope model. It will be displayed when “Enable information display” is set (see Section 8.3, “User preset”). 9. Display length The display length shows an actual length of the scope model displayed on the screen. (For the display range, see Section 4.2, “Scope model display range”.) It will be displayed when “Enable information display” is set (see Section 8.3, “User preset”). The display length does not show the actual length of the endoscope inserted in the patient’s body. 10. Marking gauge The display length is shown with the vertical axis. It will be displayed when “Enable information display” is set (see Section 5.6, “Bookmark”). 25 CONFIDENTIAL 11. Marking Markings can be put beside the marking gauge according to the points where you want to mark while inserting the endoscope into the patient. It will be displayed when “Enable information display” is set (see Section 5.6, “Bookmark”). 12. Current date and time Current date and time of the day will be displayed when “Enable information display” is set (see Section 8.3, “User preset”). 13. Patient data The data will be displayed when the video system center is connected and when “Enable information display” is set (see Section 8.3, “User preset”). 14. A-P indicator The indicator is displayed when “Figure image” is selected from “Setting the viewing image” in the setup menu. The indicator shows the anterior and posterior sides of the figure image. 15. Viewpoint indicator (Figure image) The arrow indicator and figure image show the angle in which the scope model on the screen is viewed. This indicator appears when “Figure image” is selected from “Setting the viewing image” in the setup menu (see Section 8.3, “User preset”). ○ Figure image The figure image is displayed when “Figure image” is selected from “Setting the viewing image” in the setup menu. The viewpoint indicator is displayed with a relative angle against the figure image on the screen. The posture of the figure image can be changed as the patient’s posture changes. [NOTE] The viewpoint indicator arrow shows the angle in which the scope model on the screen is viewed regardless of the posture of the figure image. The view angle is indicated against the receiver dish. 26 CONFIDENTIAL Chapter 3 Inspection [WARNING] Before each case, inspect this endoscope position detecting unit as instructed below. Inspect other equipment to be used with this endoscope position detecting unit as instructed in their respective instruction manuals. Should any irregularity be observed, do not use the endoscope position detecting unit and see Chapter 9, “Troubleshooting”. If the irregularity is still observed after consulting Chapter 9, contact Olympus. Damage or irregularities may compromise patient or user safety and may result in more severe equipment damage. Prepare the endoscope position detecting unit and other ancillary equipment before each particular case. Refer to the respective instruction manual for each piece of equipment. 3.1 Inspection work flow Please see the inspection work flow in Figure 3.1 below. Follow each step of the work flow for inspection of the light source before use. 1. Check if the endoscope position detecting unit is installed in an appropriate location. Section 3.2, “Inspection of the installation location” 2. Confirm that the endoscope position detecting unit is turned ON normally. Section 3.3 “Turning power ON” 3. Confirm the contents in the screen display. Section 3.4, “Inspection of the screen display” 4. Inspect all necessary functions. 5. Turn OFF the endoscope position detecting unit. Section 3.7, “Power OFF” 27 CONFIDENTIAL 3.2 Inspection of the installation location Check if the endoscope position detecting unit (UPD-3) is installed in an appropriate location. 1. Confirm that no video monitor or PC monitor is near the endoscope position detecting unit. Keep a distance of at least 30 cm between the video monitor or the PC monitor and the endoscope position detecting unit. [CAUTION] If a video monitor or PC monitor is located near the endoscope position detecting unit, the scope model display may be distorted or deformed due to the strong magnetic fields produced by the monitor. Keep the endoscope or the position detecting probe, the reference plate, and/or the hand coil connected with the main unit away from another main unit at least 2 m when two or more endoscope position detecting units are used. Otherwise, the scope model display may be extremely distorted or deformed due to the strong magnetic fields produced by one another. If the distance between the two endoscope position detecting units is less than 2 m, changing the frequencies used for position detection may allow the use of two or more endoscope position detecting units. When two or more endoscope position detecting units are used with a distance of less than 2 m, contact Olympus. 2. Confirm that no large metallic object is near the coil unit of the endoscope position detecting unit. Keep a distance of at least 30 cm between the large metallic object and the endoscope position detecting unit. [CAUTION] If a metallic object is located near the endoscope position detecting unit, the scope model display may also be distorted or deformed. 3.3 Turning power ON [WARNING] • Keep the endoscope or the position detecting probe, the reference plate, and/or the hand coil connected with the main unit away from another main unit at least 2 m when two or more endoscope position detecting units are used. Otherwise, the scope model display may be extremely distorted or deformed. • When two or more endoscope position detecting units are used, do not turn the main units ON at the same time. Otherwise, the scope model display may be extremely distorted or deformed. 28 CONFIDENTIAL 1. Confirm that the ventilation grills on the right side and left side panels of the endoscope or the endoscope position detecting unit are not covered with dust or other materials. 2. Confirm that the endoscope or the position detecting probe is connected to the main unit. [NOTE] For connecting the endoscope or the position detecting probe to the main unit, refer to Section 4.4, “Connection of the endoscope or the position detecting probe”. 3. Press the power switch of the instrument. The power indicator lights up (see Figure). Power switch Power indicator ○ If the power fails to come ON If the power fails to come ON, turn the endoscope position detecting unit OFF. Then, confirm that the power cord is connected firmly. Then, turn the endoscope position detecting unit ON again. If the power still fails to come ON, contact Olympus. 29 CONFIDENTIAL 3.4 Inspection of the screen display 1. Confirm that the LCD monitor shows the endoscope position display as shown in Figure. The screen display varies depending on the setup of the main unit or connection status of equipment. For details, see Section 2.12, “Screen display”. 2. Change the shape of the endoscope’s insertion tube or the position detecting probe’s insertion tube into a circular or straight shape in front of the coil unit of the endoscope position detecting unit. Then confirm that the shape of the scope model is the same as the shape of the endoscope’s insertion tube. Also, confirm that the angle of the viewpoint indicator is the same as the angle in which the scope model on the screen is viewed. Confirm that the shape of the scope model is the same as the shape of the endoscope’s insertion tube even when the receiver dish is facing down or up. Facing down Facing up 3. Confirm that the displayed date and time are correct. If correction is required, follow the procedure in “Setting the date and time” [CAUTION] The posture of the figure image on the screen must always be set to be equal to the actual posture of the patient. If the posture of the figure image on the screen is not equal to the posture of the patient, the scope model display may be incorrectly orientated. 30 CONFIDENTIAL For the operating table image For the figure image 31 CONFIDENTIAL 3.5 Inspection of the hand coil (MAJ-1859) 1. Confirm that there is no noticeable deformation, scratch, or crack on the marker section. 2. Confirm that there is no noticeable deformation, scratch, or crack on the hand coil cover (MAJ-1879). 3.6 Inspection of the reference plate (MAJ-1860) 1. Confirm that there is no noticeable deformation, scratch, or crack on the plate section. 2. Confirm that there is no scratch, break, or fissure on the reference plate belt 3.7 Power OFF Press the power switch of the instrument (see Figure) to turn the instrument OFF. The indicator above the switch goes off. 32 CONFIDENTIAL Chapter 4 Operation This chapter explains the work flow of endoscopic observation using the endoscope position detecting unit. For information on how to use the functions that are not explained in this chapter, refer to chapter 5, “Functions”. The operator of the endoscope position detecting unit must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic techniques. This manual, therefore, does not explain or discuss clinical endoscopic procedures. It only describes basic operation and precautions related to the operation of the endoscope position detecting unit. [DANGER] The endoscope position detecting unit is designed only to assist the insertion of an endoscope. Never insert the endoscope into the patient’s body by observing only the endoscope position display of the endoscope position detecting unit. Be sure to observe the endoscopic image and insert the endoscope while confirming safety. If the endoscope is inserted without observing the endoscopic image, patient injury could result. [WARNING] • Be sure to wear protective equipment such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. Otherwise, dangerous chemicals and/or potentially infectious material such as blood and/or mucus of the patient may cause an infection. • Anytime you observe an irregularity in this endoscope position detecting unit, stop using it immediately, turn it OFF, and solve the problem according to Chapter 9, “Troubleshooting”. If the problems cannot be resolved by the described remedial action, do not use this endoscope position detecting unit again and immediately contact Olympus. Using a defective endoscope position detecting unit may cause patient injury. • When the monitor display freezes, such as when the displayed time will not change or if the scope model will not move when the endoscope’s insertion tube is moved, or when the switches on the control panel are not accepted, turn the endoscope position detecting unit OFF and ON again. If the problem still occurs, contact Olympus. • When using spray-type medical agents such as lubricant, anesthetic, or alcohol, use them away from the endoscope position detecting unit so that the medical agents do not contact the endoscope position detecting unit. Medical agents might enter the endoscope position detecting unit through the ventilation grills and cause the failure. • Do not use a humidifier near the endoscope position detecting unit as dew condensation possibly might occur and it may cause the failure. • Use only Olympus high-frequency electrosurgical equipment with this unit. Non-Olympus equipment can cause interference on the monitor display or a loss of the scope model. 33 CONFIDENTIAL [CAUTION] • Do not use this endoscope position detecting unit in locations exposed to strong electromagnetic radiation (e.g., in the vicinity of microwave therapeutic equipment, MRI, short-wave therapeutic equipment, radio equipment, or cellular/portable phone). Damage to the endoscope position detecting unit may result. Electromagnetic radiation can interfere with the monitor display. • When the endoscope position detecting unit is used on a patient with an artificial material implant, the displayed scope model shape may differ from its actual shape. • Do not approach the following equipment with a magnetic storage medium (magnetic card, floppy disk, etc.): the endoscope, the position detecting probe, the reference plate (MAJ-1859), or the hand coil (MAJ-1860) connected to the endoscope position detecting unit. Otherwise, the data stored on the magnetic storage medium may be destroyed or lost due to the AC magnetic fields generated by these devices. 34 CONFIDENTIAL 4.1 Operation flow Please see the operation work flow in Figure below. Follow each step of the work flow for using the endoscope position detecting unit. 1. Adjust the position of the receiver dish. ”Adjusting the position of the receiver dish” 2. Connect the endoscope or the position detecting probe to the main unit. Section 4.4, “Connection of the endoscope or the position detecting probe” 3. Inspect the instruments before use. Chapter 3, “Inspection” 4. Connect the hand coil (MAJ-1859). Section 5.8 ”Connection of the hand coil (MAJ-1859) When the hand coil is not used, this procedure is unnecessary. 5. Connect the reference plate (MAJ-1860). Section 5.10 ”Connection of the reference plate(MAJ-1860)” When the reference plate is not used, this procedure is unnecessary. 6. Turn the main unit and equipment ON. Section 3.3, “Turning power ON” 7. Select the screen display setup. When the previous setup is selected, this procedure is unnecessary. 8. Perform examination. For details on each function, refer to Chapter 5, “Functions". 9. Disconnect the endoscope or the position detecting probe. Section 4.8, “Operation at the end of an examination” 10. Care after use. Chapter 6, “Care, storage and disposal” 35 CONFIDENTIAL 4.2 Scope model display range Scope model and actual positioning The relationship between the monitor screen display and the actual positioning of the endoscope position detecting unit (UPD-3) during the initial setup shown in Figure Monitor screen In the “From the top” display mode In the “From the bottom” display mode Actual positioning Receiver dish (Top View) Operating table For the display modes, see “Setting the display mode” 36 CONFIDENTIAL The start position of scope model and actual positioning The position where the scope model display starts on the monitor screen is variable depending on whether the reference plate (MAJ-1860) is connected and/or the scope model display range is set. For setting the scope model display range, see Section 5.7, “Setting the scope model display range” ○When the reference plate is not connected and the scope model display range is not set Receiver dish (Top view) Operating table 13cm When the receiver dish is viewed from the front, the position A located at about 13 cm to the right from its right end (see Figure) corresponds to the start position of the scope model on the screen. However, the scope model will not be displayed when the distal end of the endoscope is located to the right of line A. The center of the bottom of the monitor display corresponds to the start position of the scope model. 37 CONFIDENTIAL ○When the reference plate is connected and the scope model display range is not set Receiver dish (Top view) Operating table 6cm Reference plate Cable outlet When the endoscope position detecting unit is viewed from the front, the position B located at 6 cm toward the reference plate from its cable outlet (see Figure) corresponds to the start position of the scope model on the screen. The part of the endoscope located to the left of line B facing the endoscope position detecting unit will be displayed as the scope model. However, the scope model will not be displayed when the distal end of the endoscope is located to the right of line B. The center of the bottom of the monitor display corresponds to the start position of the scope model. The coordinate axis on the screen corresponds to the coordinate axis as shown in Figure. 38 CONFIDENTIAL ○When the reference plate is not connected and the scope model display range is set Receiver dish (Top view) Operating table Set position of the display range When the display range is set, the set position C (see Figure) becomes the start position of the scope model, and the part of the endoscope located to the left of line C facing the endoscope position detecting unit will be displayed as the scope model. However, the scope model will not be displayed when the distal end of the endoscope is located to the right of line C. The center of the bottom of the monitor display corresponds to the start position of the scope model. If the display range is not set, the start position of the scope model becomes identical to “When the reference plate is not connected and the scope model display range is not set” For setting the display range, refer to Section 5.7, “Setting the scope model display range” 39 ○When the reference plate is connected and the scope model display range is set Receiver dish (Top view) Operating table Reference plate Cable outlet Set position of the display range When the display range is set, the set position D (see Figure) becomes the start position of the scope model, and the part of the endoscope located to the left of line D facing the endoscope position detecting unit will be displayed as the scope model. However, the scope model will not be displayed when the distal end of the endoscope is located to the right of line D. The center of the bottom of the monitor display corresponds to the start position of the scope model. The coordinate axis on the screen corresponds to the coordinate axis as shown in Figure. If the display range is not set, the start position of the scope model becomes identical to “When the reference plate is connected and the scope model display range is not set” 40 CONFIDENTIAL 4.3 Adjusting the position of the receiver dish [WARNING] •When adjusting the height of the receiver dish, or when adjusting the height of the operating table if it is adjustable, be careful not to have your hand, foot, or the patient’s body caught between the receiver dish and the operating table. Otherwise, operator and/or patient injury may result. Be careful not to have your fingers caught between the arms when they are closed. Operator and patient injury may result. Do not allow the patient to hold the receiver dish or receiver dish stand. Otherwise, the stand may be toppled, and patient injury may result. [CAUTION] Keep the receiver dish at the same height as the patient’s body. If the distance between the patient’s body and the receiver dish is too large, the scope model may be displayed incorrectly. 1. Adjust the position of the receiver dish. 41 CONFIDENTIAL 4.4 Connection of the endoscope or the position detecting probe Connect the endoscope to the endoscope position detecting unit (UPD-3) by using the UPD cable (MAJ-1881). [WARNING] Do not place the UPD cable on the operating table. This could result in an infection when the patient contacts the UPD cable. Also, the scope model display may become distorted or deformed. [CAUTION] • Always turn the endoscope position detecting unit OFF before connecting or disconnecting the UPD cable. Otherwise, equipment damage or malfunction may result. • Do not apply excessive force to the UPD cable; it may cause equipment damage. • Do not immerse the UPD cable in liquids or allow it to become wet; it may cause equipment damage or malfunction. • Do not touch the electrical contacts inside the endoscope position detecting unit’s connectors; ○Connecting the UPD cable to the endoscope Align the notch on the endoscope plug of the UPD cable with mark 3 on the UPD scope connector of the endoscope and push the endoscope plug into the UPD scope connector until it stops (see Figure). [NOTE] If force is used on the UPD cable, the endoscope is designed to detach at the endoscope plug, not at the endoscope connector. 42 CONFIDENTIAL ○Connecting the UPD cable to the position detecting probe 1. Holding the electrical connector of the position detecting probe and the connector of the UPD cable connected to the endoscope position detecting unit, align the index on the position detecting probe’s electrical connector with the notch on the UPD cable’s position detecting connector, and connect them (see Figure).. 4.5 Turning power ON [WARNING] When two or more endoscope position detecting units are used, do not turn the main units ON at the same time. Otherwise, the scope model. Press the power switch to turn ON the endoscope position detecting unit, confirm that the power indicator on the main unit is lit (see Figure). Power switch Power indicator 4.6 Starting the endoscopic examination 1. Confirm the direction in which the endoscope is pointing by checking the viewpoint indicator arrow. When the viewpoint indicator arrow is selected not to be displayed, press the “Enter” button to display it. [NOTE] 43 For setting the viewpoint indicator arrow, refer to 44 CONFIDENTIAL • Fusion: When different sections of the insertion tube of the endoscope come close to each other, the overlapped areas in the scope model display may be shown as if they are fused (see Figure). • Overlapping of intersected sections: When different sections of the insertion tube of the endoscope become close to each other, the intersected areas in the scope model display may be shown upside down or in an inaccurate shape. [WARNING] If the insertion tube of the endoscope forms a loop during an examination, and the overlapped areas in the scope model display may be shown as if they are fused, the intersected areas may be shown upside down or in an inaccurate shape. In such a case, dissolve the fusion in the display by moving the endoscope slightly while observing the scope model display to undo the loop of the insertion tube. It is also possible to correct the way the overlapped areas of the insertion tube are displayed and then undo the loop if the current status requires it. If you attempt to undo the loop of the insertion tube by observing the scope model display while the overlapped areas in it are shown as fused or in an inaccurate shape, patient injury could result. Influence of electromagnetic radiation This instrument which utilizes weak AC magnetic fields is subject to electromagnetic radiation (noise). To reduce the influence of electromagnetic radiation, this instrument performs the following: ○Selection of frequencies for use This instrument automatically selects frequencies of AC magnetic fields for use. After measuring the noise levels at predetermined three frequencies, this instrument selects a frequency generating the lowest noise level at powering ON this instrument. 45 CONFIDENTIAL [NOTE] Fixing the frequency to use is also possible. See Section 8.2 “System setup”. ○Selection of display speed Under the environment with high level noise, the scope model will be displayed at lower speed so that this instrument can get enough signals. After measuring the noise levels, this instrument selects speed to display the scope model at powering ON. [NOTE] - If the scope model display wavers significantly or becomes unstable when operating the endoscope position detecting unit, the cause may be increased external noise. In that case, bring the receiver dish to the patient as close as possible. If no improvement is observed, turn the endoscope position detecting unit OFF and turn it ON again. - Fixing the display speed is also possible. See Section 8.2 “System setup”. 4.8 Operation at the end of an examination 1. Turn the endoscope position detecting unit and ancillary equipment OFF. 2. Disconnect the UPD cable (MAJ-1881) from the endoscope. 3. Disconnect the hand coil (MAJ-1859) and reference plate (MAJ-1860) from the endoscope position detecting unit. [CAUTION] Be sure to turn the endoscope position detecting unit OFF before connecting or disconnecting the UPD cable, reference plate, and hand coil to or from the endoscope position detecting unit. Otherwise, the endoscope, endoscope position detecting unit, reference plate, and/or hand coil may be damaged. 4. Remove the reference plate cover (MAJ-1880) from the reference plate. 46 Chapter 5 Functions This chapter describes functions of the buttons of main unit and usage of the hand coil and the reference plate. Before use, refer to the “Function setup” for functions that need to be set in “System setup” and “User preset”. 5.1 Rotating the scope model The scope model can be rotated as required. [WARNING] Make sure to match the posture of the figure image with that of the patient. Improper operation due to a mismatch between the posture of the patient, the actual endoscope position in the patient cavity, and the position displayed on the UPD screen may result in patient injury and/or perforation. Press the “Rotate left” or “Rotate right” button on the control panel (see Figure). The scope model will be rotated as shown in Figure. Rotate left Rotate right [NOTE] • After the settings are completed, the setup is held in memory even after the endoscope position detecting unit is turned OFF. The previous setup will be recalled the next time the unit is turned ON. • The rotation angle of the scope model can be saved and recalled as described in “User preset” • The viewpoint indicator arrow on the screen shows the direction in which the scope model is viewed. For showing the arrow, refer to 47 CONFIDENTIAL • By rotating the scope model, the scope model may be out of the screen. For redisplaying the scope model, press the reset switch. 5.2 Varying the size of the scope model The size of the scope model as well as the sizes of the marker and gauge can be varied as described below. [NOTE] • With the initial setup, the zooming ratio is set to the middle ratio. • After this setup is completed, the settings are held in memory even after the endoscope position detecting unit is turned OFF. The previous setup will be recalled the next time the unit is turned ON. • The zooming ratio of the scope model can be saved and recalled as described in Section 8.3 “User preset.” • By zooming in the scope model, the scope model may be hidden from view. For redisplaying the scope model, press the reset switch. • Pressing the reset switch recalls the zooming ratio that has been saved in the previous “ ” operation. Press the “ZOOM IN” or “ZOOM OUT” button on the control panel (see Figure). The scope model will be zoomed in or out (i.e., magnified or reduced) as shown in Figure. ZOOM IN ZOOM OUT 48 CONFIDENTIAL 5.3 Splitting the screen The scope model can be displayed on two screens by splitting the screen. [NOTE] After this setup is completed, the settings are held in memory even after the endoscope position detecting unit is turned OFF. The previous setup will be recalled the next time the unit is turned ON. Each press of the split screen button on the control panel changes the split-screen display and single-screen display alternately (see Figure). SPLIT SCREEN Splitting the screen for the operating table image Single-screen display Split-screen display [NOTE] • One screen shows the single screen display and the other shows the single screen view as well as the 90° rotated view in the split screen. • The view angles in the right and left sides of the split screen are indicated by the viewpoint indicator of the operating table image in each screen. • By pressing the split screen switch, the scope model is redisplayed so that the center of the top or bottom of the split screen corresponds with the start position of the scope model. 49 CONFIDENTIAL Splitting the screen for the figure image Single-screen display Split-screen display [NOTE] • The screen with the view angle selected from the menu is displayed. • The view angles on the right and left sides of the split screen are indicated by the A-P indicator and the figure image respectively. • By pressing the split screen switch, the scope model is redisplayed so that the center of the top or bottom of the split screen corresponds 50 CONFIDENTIAL 5.4 Resetting the setup Pressing the reset switch resets the settings made in the previous “User preset” operation. When no operations are made in the Section 8.3 “User preset”, the factory default settings are recalled. 1. Press the reset button (see Figure). RESET 2. The following settings are reset to the settings made in the previous “User preset” operation. • Viewing image selection • Figure image and view angle (for the figure image selection) • View indicator arrow (for the figure image selection) • A-P indicator selection (for the figure image selection) • Display mode selection • Scope model thickness setup • Information display selection • Rotation angle of scope model (for the operating table image selection) or posture of the figure image (for the figure image selection) • Zooming ratio of scope model [NOTE] • By pressing the reset switch, the scope model is redisplayed so that the center of the bottom of the screen corresponds with the start position of the scope model. 51 CONFIDENTIAL 5.5 Connection indicators When the endoscope or the position detecting probe, reference plate (MAJ-1860), and/or hand coil (MAJ-1859) are connected, the corresponding connection indicators are displayed. The color of each connection indicator varies depending on the connection and detection status. The endoscope position display shows the scope connection indicator, probe connection indicator, plate connection indicator, and marker connection indicator in the colors listed in Table (see Figure). Item Display Connection status Green color Yellow Red Description Normal Out of detection area, no accuracy and/or unstable Abnormal or failure 52 CONFIDENTIAL 5.6 Bookmark Markings are put beside the marking gauge according to the points where you want to mark. ○ Marking 1. Press the “BOOKMARK” button on the control panel when a desired marking point is found (see Figure). BOOKMARK 2. A Marking is put beside the marking gauge according to the point where you want to mark (see Figure). Marking gauge Marking Display length ○Deleting the markings 53 CONFIDENTIAL 1. Press the “BOOKMARK” button on the control panel awhile (see Figure). 2. All markings are deleted. [NOTE] •The markings are shown based on the display length. They may not correspond to the position in the actual intestinal tract. •Markings can be put every 1 cm. •Close markings may be shown as one. •The same position cannot be marked. •Up to 50 markings can be put beside the marking gauge. The error message will be displayed when more than 50 markings are marked. •All markings are deleted automatically under the following cases. - When the main unit is turned OFF. - When the UPD cable (MAJ-1881) is disconnected from the endoscope or the position detecting probe. 5.7 Setting the scope model display range When the scope model display range is set, the scope model display outside the range will be erased. [NOTE] • After this setup is completed, the settings are held in memory even after the endoscope position detecting unit is turned OFF. The previous setup will be recalled if the hand coil is connected the next time the unit is turned ON. • Even when the unit is turned OFF while the display range is set, the display range setup is canceled if the hand coil is not connected the next time the unit is turned ON. • The scope model is redisplayed so that the center of the bottom of the screen corresponds with the start position of the scope model. • When the tracking indicator disappears even if the reference plate is connected, the scope model display range cannot be set. • The setup of the scope model display range is canceled by disconnecting the hand coil when the scope model display range is set. ○When using the hand coil (MAJ-1859) [NOTE] • When the marker connection indicator is yellow, the scope position switch does not work. For connecting the hand coil, refer to “Connection of the hand coil (MAJ-1859) . 54 CONFIDENTIAL 1. Confirm that the marker connection indicator is green, indicating that the hand coil is available (see Figure). Marker connection indicator (Green) 2. Place the hand coil to the position where you want to start the scope model, and then press the scope position switch on the hand coil (see Figure). “Scope position” switch 3. The scope model outside the start position is erased the start position is located at the edge of the screen, and the scope position indicator lights up. 4. Press the scope position switch again or press the scope position button on the control panel to cancel the setup of the start position of the scope model. The scope position indicator will be turned off. ○When using the endoscope or the position detecting probe 55 CONFIDENTIAL 1. Place the distal end of the endoscope or the position detecting probe to the position where you want to start displaying the scope model, and then press the "SCOPE POSITION" button on the control panel (see Figure). Scope position indicator Scope position 2. The scope model outside the start position is erased, the start position is located at the edge of the screen, and the scope position indicator lights up. 3. Press the scope position button again to cancel the setup of the start position of the scope model. The scope position indicator will be turned off. [NOTE] For the start position of the scope model, refer to Section 4.2, “Scope model display range”. 5.8 Connection of the hand coil (MAJ-1859) Connect the hand coil when it will be used. [WARNING] •Avoid bringing the hand coil or hand coil cover in contact with the skin of the operator and/or patient. Otherwise, infection of the patient and/or operator may result. [CAUTION] •Connect the hand coil to either the main unit or the connection unit (MAJ-Y0093). Otherwise, it does not operate. 1. Contact the hand coil with its arrow mark on the plug facing upwards with the hand coil terminal on the main unit (see Figure). 56 CONFIDENTIAL 2. Hold the plug and insert it straight to the hand coil terminal until it clicks 3. Fit the hand coil cover around the hand coil (see Figure). 4. When the hand coil becomes necessary during examination, the operator should hold it in his or her hand (see Figure). [NOTE] For details on the hand coil function, refer to Section 4.2 “Scope model display range” and 57 CONFIDENTIAL “Setting the scope model display range”. 5. To disconnect the hand coil, hold the connecting section of the connector and pull it straight out (see Figure). 5.9 View tracking When the reference plate (MAJ-1860) is used, the rotation of the scope model is controlled by the reference plate. When the reference plate is attached to the patient’s body, any rotation of the patient will accordingly cause a rotation of the scope model (view tracking). Confirm that the reference plate connection indicator is green. In this condition, the scope model display changes to the tracking display and the tracking. Tracking indicator Plate connection indicator [NOTE] •When the tracking indicator disappears while attaching the reference plate to the patient, the scope model cannot be tracked. In this case, move the patient near the coil unit to display the tracking indicator. •For usage of the reference plate, refer to “Connection of the reference plate (MAJ-1860) 58 CONFIDENTIAL and “Attaching the reference plate (MAJ-1860) to the patient’s body”. 5.10 Connection of the reference plate (MAJ-1860) Connect the reference plate when the tracking function is required (see Section 5.9, “View tracking”). Disconnect the reference plate when the tracking function is not required. [CAUTION] •Connect the reference plate to either the main unit or the connection unit (MAJ-1928). Otherwise, it does not operate. 1. Insert the reference plate with its arrow on the connector facing upwards to the reference plate connector on the main unit (see Figure). 2. Hold the connector and insert it straight to the reference plate connector until it clicks. 3. To disconnect the reference plate, hold the connecting section of the connector and pull it straight out (see Figure). 59 CONFIDENTIAL 5.11 Attaching the reference plate (MAJ-1860) to the patient’s body [WARNING] • Avoid bringing the reference plate, reference plate cover, and reference plate belt (MAJ-1029) in contact with the skin of the operator and/or patient. Otherwise, an infection may result. [CAUTION] • Attach the reference plate parallel to the back of the patient and fit the central axis of the reference plate to the patient’s central axis. Otherwise, the scope model may disappear during the examination, may not be displayed, or may be incorrectly displayed. • Attach the reference plate properly to the patient’s body. Otherwise, the scope model will not be displayed correctly. − If the reference plate is attached in a manner that the slit contacts the patient’s abdomen, the scope model display will reverse the left and right. − If the reference plate is attached so that the cable comes on the side of the patient’s feet, the scope model display may be shown upside down, or may not be shown at all. [NOTE] For details on the reference plate function, refer to the “View tracking”. ○When the reference plate cover (MAJ-1880) is used [CAUTION] • Patients with allergies may experience reddening or irritation of the skin caused by the adhesive on the antenna lead covers. • Use a reference plate cover before expiration date. Otherwise, the reference plate may not be securely adhered to the patient’s body. The expiration date of the reference plate cover is shown on the package. 60 CONFIDENTIAL 1. Insert the reference plate into the reference plate cover so that the human-shaped index marking on the reference plate is on the same side as the blue surface of the reference plate cover (see Figure). blue side REFERENCE PLATE COVER REFERENCE PLATE 2. Peel off the lining paper from the inside of the reference plate cover (on the blue side), and adhere the reference plate securely to the reference plate cover (see Figure). 3. Dry the patient’s body by wiping with a dry piece of gauze. If there is too much hair in a particular location to securely adhere the reference plate cover, shave as necessary. 4. Place the contact surface of the reference plate on the patient’s abdomen so that the cable comes on the side of the patient’s legs. 5. Remove the lining paper on the back of the reference plate cover by peeling from the point indicated by the arrow (see Figure), and then press down firmly on the reference plate to attach it to the patient. 61 CONFIDENTIAL [CAUTION] The reference plate cover used before has lost its adhesiveness. When reattaching the reference plate, replace the cover with a new one. ○Removing the reference plate cover from the reference plate 1. Remove the reference plate from the reference plate covers. The reference plate cover can be easily removed by holding the tab and tearing the center section 2. Carefully remove the reference plate cover from the patient. [CAUTION] Do not fold or crease the reference plate when removing it from the reference plate cover. Otherwise, the reference plate may be damaged. [NOTE] 62 CONFIDENTIAL The reference plate covers are single-use only. ○When the reference plate cover (MAJ-1880) is not used 1. Pass the reference plate belt through the slit (see Figure). 2. Place the contact surface of the reference plate on the patient’s abdomen and align the orientation of the patient’s body with that of the human-shaped index marking of the reference plate so that the cable comes on the side of the patient’s foot. 3. Wrap the reference plate belt around the patient’s body and fasten the reference plate using the surface fastener on the reference plate belt. [CAUTION] • Do not tighten the reference plate belt too much. Excessive tightening can cause patient pain. • Attach the reference plate belt firmly around the patient’s body so that the reference plate will not move. Otherwise, the scope model display will be unstable. 63 CONFIDENTIAL 5.12 Operation using the remote control The remote control (MAJ-1890) can operate the same function as the control panel does. [CAUTION] • Do not use a pointed or hard object to press the keys on the remote control. This may damage the keys. •Properly install the remote control. If it is not properly installed, the remote control may be damaged. Install the remote control on a stable, level surface so that the cable between the endoscope position detecting unit and remote control is not stretched. •When operating the remote control, hold the control not the cable. Otherwise, the cable may break. •Do not fix the cable using surgical clamps, such as Pean, because the cable may break. For displaying the scope model, refer to the “Setting the scope model display range”. [NOTE] For connecting the remote control, refer to Section 7.7, “Remote control.”. 64 CONFIDENTIAL Chapter 6 Care, Storage, and Disposal 6.1 Care If the endoscope position detecting unit and accessories are soiled, perform the following cleaning procedure immediately after use. If cleaning is delayed, residual organic debris will begin to solidify, and it may be difficult to effectively clean the endoscope position detecting unit. The endoscope position detecting unit should also be cleaned routinely. [WARNING] After cleaning the main unit and accessories, dry them thoroughly before use. If they are used while still wet, there is the risk of electric shock. [CAUTION] • Do not clean the output connector, the terminals, or the AC power mains inlet. Cleaning them can deform or corrode the contacts, which could damage the endoscope position detecting unit. • Do not autoclave or gas sterilize the endoscope position detecting unit. These methods will damage it. • The UPD cable is not waterproof and should not be cleaned together with the endoscope. Otherwise, the equipment will malfunction. • Do not wipe the external surface with hard or abrasive material. The surface will be scratched. • Alcohol is flammable. Handle with care. 65 CONFIDENTIAL ○Compatible reprocessing methods and chemical agents Compatibility summary The instruments shown below are compatible with several methods of reprocessing. For appropriate reprocessing methods, refer to Table below, the recommendations of your infection control committee, and all national and local hospital guidelines and policies. 70% ethyl alcohol Detergent solution or isopropyl Hand coil (MAJ-1859) Hand coil cover (MAJ-1879) Reference plate (MAJ-1860) compatible not compatible [WARNING] Alcohol is not a sterilant or high-level disinfectant. ○Detergent solution Use a medical-grade, low-foaming, neutral pH detergent, or enzymatic detergent and follow the manufacturer’s dilution and temperature recommendations. Contact Olympus for the names of specific brands that have been tested for compatibility with these instruments. Do not reuse detergent solutions. [WARNING] Excessive detergent foaming can prevent fluid from adequately contacting components. ○Care of the hand coil (MAJ-1859), hand coil cover (MAJ-1879), and reference plate (MAJ-1860) 1. Turn the endoscope position detecting unit OFF and disconnect the power cord. 2. To remove dust and dirt on the respective accessories, wipe them using a lint-free cloth moistened with neutral detergent. 3. If the accessories are soiled with patient blood or debris, wipe off all gross debris using neutral detergent and then decontaminate their surfaces using a lint-free cloth moistened 66 CONFIDENTIAL with 70% ethyl or isopropyl alcohol or follow the instructions described in Section 6.2 “Cleaning procedures for accessories. 4. Make sure that the accessories are completely dry after wiping. ○Care of the main unit and accessories other than the hand coil (MAJ-1859), hand coil cover (MAJ-1879), and reference plate (MAJ-1860) 1. Turn the endoscope position detecting unit OFF and disconnect the power cord. 2. To remove dust and dirt on the main unit and accessories, wipe them using a lint-free cloth moistened with neutral detergent. 3. If the accessories are soiled with patient blood or debris, wipe off all gross debris using neutral detergent and then decontaminate their surfaces using a lint-free cloth moistened with 70% ethyl or isopropyl alcohol. 4. Make sure that the accessories are completely dry after wiping. 6.2 Cleaning procedures for accessories This section includes the cleaning procedures for the accessories and reprocessing equipment listed below. •Hand coil (MAJ-1859) •Hand coil cover (MAJ-1879) •Reference plate (MAJ-1860) ○Attaching the water-resistant cap (MAJ-1899) [CAUTION] • The electrical connector of the hand coil or reference plate is not waterproof. Before immersing the endoscope, always attach the water-resistant cap. Otherwise, equipment damage may result. • Always use a dry water-resistant cap. Any water remaining on the water-resistant cap may cause damage to the equipment. 1. Confirm that the inside of the water-resistant cap is dry and free from debris. If the inside of the water-resistant cap is wet or there is debris present, wipe with a dry, lint-free clean cloth. 67 CONFIDENTIAL Connector Water-resistant cap 2. Put the water-resistant cap on the connector and turn it clockwise to close. ○Manual cleaning [CAUTION] Make sure that the items immersed in detergent solution do not contact one another. 1. Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin that is deep enough to allow all equipment to be completely immersed. 2. Immerse all equipment in the detergent solution. Using a clean, soft brush or lint-free cloth, meticulously clean all external surfaces in detergent solution. 3. Soak all equipment for the amount of time and at the temperature recommended by the detergent manufacturer. 4. Remove all equipment from the detergent solution and place it in clean water. 5. Remove all equipment from the clean water. 6. Using a clean, lint-free cloth, thoroughly wipe and dry the external surfaces of all equipment. 7. Thoroughly wipe all external surfaces using a lint-free cloth moistened with 70% ethyl or isopropyl alcohol. 8. Make sure that the accessories are completely dry after wiping. 68 CONFIDENTIAL 6.3 Storage [CAUTION] Do not store the endoscope position detecting unit in locations exposed to direct sunlight, X-rays, radioactivity, or strong electromagnetic radiation (e.g., in the vicinity of microwave therapeutic equipment, MRI, short-wave therapeutic equipment, radio equipment, or cellular/portable phone). Damage to the endoscope position detecting unit may result. 1. Turn the endoscope position detecting unit OFF and disconnect the power cord. 2. Disconnect all ancillary equipment connected to the endoscope position detecting unit. 3. Store the equipment at room temperature in the horizontal position in a clean, dry, and stable location. 69 CONFIDENTIAL Chapter 7 Installation and Connection [WARNING] • Review this chapter thoroughly, and prepare the instruments properly before use. If the equipment is not properly prepared before each use, equipment damage, patient and operator injury and/or fire can occur. • When non-medical electrical ancillary equipment is used, connect its power cord via an isolation transformer prior to connecting it to this endoscope position detecting unit. [CAUTION] •Turn OFF all instruments before connecting them. Otherwise, equipment damage or malfunction may result. • Use appropriate cables only. Otherwise, equipment damage or malfunction can result. • Properly and securely connect all cables. Otherwise, equipment damage or malfunction can result. • The cables should not be sharply bent, pulled, twisted or crushed. Cable damage can result. • Never apply excessive force to connectors. This could damage the connectors. • Use this instrument only under the conditions described in “Transportation, storage, and operation environment” and “Specifications” in the Appendix. Otherwise, improper performance, compromised safety and/or equipment damage may result. • When moving the receiver dish stand from one location to another, firmly hold the handle with one hand and the pole with the other. Otherwise, the stand may topple, which may result in operator injury or damage of the endoscope position detecting unit. Prepare this endoscope position detecting unit and compatible equipment (shown in the “System chart” in the Appendix) before each use. Referring to the instruction manuals of each system component, install and connect the equipment according to the procedure described in this chapter. 70 CONFIDENTIAL 7.1 Installation work flow Please see the installation work flow in Figure below. Follow each step of the work flow before using the endoscope position detecting unit and the ancillary equipment. 1. Install the endoscope position detecting unit and the ancillary equipment to the mobile workstation, etc. Section 7.2, “Installation of the equipment” 2. Install the receiver dish. Section 7.3, “Installation of the receiver dish”. 3 Connect the endoscope position detecting unit and the ancillary equipment to the mobile work station, etc. From Section 7.4, “Connection of the receiver dish” to Section 7.8 “Video system center”. 4. Connect the instruments to the power source. Section 7.9 “Connection to an AC mains power supply”. 5. Set up the system setup. Section 8.2 “System setup”. 6. Set up the user preset. Section 8.3 “User preset”. 71 CONFIDENTIAL 7.2 Installation of the equipment [WARNING] • Keep the ventilation grills of the endoscope position detecting unit clear. The ventilation grills are located on the side panels. Blockage can cause overheating and equipment damage. • Clean and vacuum dust the ventilation grills using a vacuum cleaner. Otherwise, the endoscope position detecting unit may break down from over heating. • Place the endoscope position detecting unit on a stable, level surface. Otherwise, the endoscope position detecting unit may topple down or drop, and user or patient injury may occur, or equipment damage can result. • If a trolley other than the mobile workstation (WM-NP1 or WM-WP1) is used, confirm that the trolley can withstand the weight of the equipment installed on it. • Do not install the endoscope position detecting unit near a source of strong magnetic wave (microwave treatment device, short wave treatment device, MRI, radio equipment, etc.). Otherwise, the endoscope position detecting unit may malfunction. •Do not fix the cable using surgical clamps, such as Pean, because the cable may break. •Do not allow the cables to catch operator’s legs. Otherwise, the operator and equipment may be toppled. •Connect the cables securely and lock the connectors if they have locks. Otherwise, the equipment may not operate correctly. ○ Installation on the mobile workstation (WM-NP1, WM-WP1) 1. Place the mobile workstation on a level and flat floor. Lock the caster brakes by pushing them down (see Figure). 2. Install the mobile shelf of the mobile workstation according to the configuration of the equipment installed on it as described in the mobile workstation's instruction manual. 3. Place the endoscope position detecting unit on the mobile shelf of the mobile workstation. 72 CONFIDENTIAL ○ Installation in another location When the equipment is installed in the location other than in the mobile workstation, put it in the level position. 7.3 Installation of the receiver dish ○How to assemble the receiver dish stand [CAUTION] •The weight is very heavy. Be careful not to drop it while assembling the stand. Otherwise, user injury may result. •Assemble the receiver dish stand on a level and flat floor. Otherwise, the receiver dish stand may topple, which may result in user injury or damage of the stand. 1. Insert the end of the pole with a screw hole into the hole of the base (see Figure). The pole is inserted. 73 CONFIDENTIAL 2. Lay down the assembled pole and the base gently on the floor. Attach the weight to the base so that the grooves of the weight fit the base (see Figure) Groove [CAUTION] •Be sure to attach the weight to the base. Otherwise, the stand may topple. 3. Tighten the weight, the base, and the pole together with an M8 x 50screw. The screw must be tightened firmly so that the pole and the base do not wobble (see Figure). 4. Lift up the pole and the base and lock the casters. Two casters have locking mechanism (see Figure). 74 CONFIDENTIAL 5. Attach the handle to the pole with an M5×40 screw. There are two holes on the pole. Use the hole on the side where the protrusions for the cable pocket are located (see Figure). 6. Put the handle cover on the top end of the pole and slide it down to the handle so as to cover the mounting part of the handle to the pole (see Figure). Mounting part of the handle to the pole 75 CONFIDENTIAL 7. Close the hinge of the arm and insert a pin into a hole of the hinge (see Figure). Pin Close 8. Put the mounting part of the arm on the top end of the pole and slide it down to any appropriate position. Turn the knob to fix the arm after setting the arm so that the arm will stay within the range of the opening area of the handle. Loosening the knob completely causes the knob to be detached from the arm and the internal part of the knob to drop off. Tighten the knob to the necessary extent (see Figure). Knob Arm Opening area of the handle 76 CONFIDENTIAL 9. Sandwich the pole with the arm covers right and left. The grooves on the inner faces of the arm covers right and left must be engaged (see Figure). Arm cover left Arm cover right 10. Push down the arm cover to a position at which the arm cover completely covers the mounting part of the hinge (see Figure). 11. Place a cap in the hole of the top end of the pole (see Figure). 77 CONFIDENTIAL 12. Attach two cable holders to two locations on the pole shown with the red arrows in the Figure (see Figure). Cable holder (Two) Attach to the pole in the direction shown with the arrow. Attach the cable holder here Attach the cable holder here 78 CONFIDENTIAL ○Installation of the holder for hc-rp and the remote control holder onto the receiver dish stand The holder for hc-rp can hold the hand coil (MAJ-1859) and the reference plate (MAJ-1860).The remote control holder can hold the remote control (NAJ-1890). The holder hc-rp and the remote control holder are included in the receiver dish stand supplementary set (MAJ-1978). [NOTE] The holder for hc-rp and the remote control holder are optional. 1. Install the holder attachment onto the top of the pole (see Figure). If the cap is attached to the top of the pole, remove it before installing the holder for hc-rp. Holder attachment The Holder attachment is installed. Fix with the screw included in the supplementary set 79 CONFIDENTIAL 2. Attach the remote control holder and two MP holders to the holder mount (see Figure). MP Holders (two) Remote control holder The MP holders attached to the holder attachment. ○Installation of the receiver dish (MAJ-1868) Install the receiver dish (MAJ-1868) to the receiver dish stand (MAJ-1907). For installation of the receiver dish to any other stand, contact Olympus. 1. Install the receiver dish to the receiver dish stand using the four screw holes on the back of the receiver dish as shown in the Figure. 80 CONFIDENTIAL Install the receiver dish so that the blue line is on the top. Four screw holes on the back of the receiver dish Four screws Use the screws packaged with the receiver dish arm. 81 CONFIDENTIAL Top Bottom ○ Installation of the holder to the receiver dish The holder can hold the hand coil (MAJ-1859). The holder and the M plate are included in the receiver dish stand supplementary set (MAJ-1978). [NOTE] The holder and the M plate are optional. 1. Remove the two screws out of the four which are fixing the receiver dish (MAJ-1868) as shown in Figure (see Figure). Remove two screws 82 CONFIDENTIAL 2. Install the M plate as shown in the figure. Then attach the holder to the M plate (see Figure). Tighten the screws again MP holder The MP holder is attached The M plate is installed. ○Installation of the cable pocket The cable pocket is included in the receiver dish stand supplementary set (MAJ-1978). [NOTE] The cable pocket is optional. 83 CONFIDENTIAL 1. Attach the cable pocket to the pole of the receiver dish stand so that the two projections on the pole stay in the two holes of the cable pocket. ○Installation of the holder for hc-rp (MAJ-1938) to the mobile workstation The holder for hc-rp can hold the hand coil (MAJ-1859) or the reference plate (MAJ-1860). The holder for hc-rp can be installed to the following mobile workstations WM-P1 and WM-260* series [NOTE] The holder for hc-rp (MAJ-1938) is optional. * This product may not be available in some areas. 84 CONFIDENTIAL 1. Install the plate to the top tray of the mobile workstation. Install the screw, washers and nut in the order shown in Figure. Use these screw holes Plate Screw Wave washer Top tray Flat washer Nut Plate Mobile workstation 1. Install two holders onto the plate (see Figure). Holder Two holders are installed. 7.4 Connection of the receiver dish 1. Check that no video monitor, PC monitor, or a large metallic object is near the receiver dish. Keep a distance of at least 30 cm between the video monitor, PC monitor, or metallic object and the receiver dish. [CAUTION] 85 CONFIDENTIAL • If a video monitor or PC monitor is located near the coil unit of the endoscope position detecting unit, the scope model display may be distorted or deformed due to strong magnetic fields produced by the monitor. • If a metallic object is located near the coil unit of the endoscope position detecting unit, the scope model display may also be distorted or deformed. • In some cases, the material and/or structure of the operating table may cause distortion or deformation of the scope model display. [NOTE] If you have any questions or problems with the installation location of the endoscope positioning detecting unit or the material and/or structure of the operating table in use, contact Olympus. 2. For connecting the receiver dish to the endoscope position detecting unit, use the cable listed below. Model MAJ-1875 Product name Receiver dish cable Note 7m RECEIVER DISH UPD-3 MAJ-1868 Connector MAJ-1875 7.5 Video equipment [NOTE] See the instruction manual for the video equipment to be used. 86 CONFIDENTIAL ○When the XGA monitor is used The recommended XGA monitor is shown in the Table Model ET1528L-7CWM-1-BG-G PLT210-W0X Product name touch monitor LCD monitor The video cable for the personal computer (VGA) on the market is used. UPD-3 XGA OUT Video cable for the personal computer (VGA) on the market To the XGA monitor’s input ○When the video equipment with Y/C input is used The video cable for the Y/C on the market is used. UPD-3 Y/C OUT Video cable for the Y/C on the market To the video equipment’s input 87 CONFIDENTIAL ○When the video equipment with SDI input is used For connecting the SDI video equipment to the endoscope position detecting unit, use the cable listed below. Table Model MAJ-1464 Product name SDI cable Note 22m UPD-3 MAJ-1464 SDI OUT To the video equipment’s input 7.6 UPD cable [WARNING] Do not place the UPD cable on the operating table. This could result in an infection when the patient contacts the UPD cable. Also, the scope model display may become distorted or deformed. [CAUTION] • Always turn the endoscope position detecting unit OFF before connecting or disconnecting the UPD cable. Otherwise, equipment damage or malfunction may result. • Do not apply excessive force to the UPD cable; it may cause equipment damage. • Do not immerse the UPD cable in liquids or allow it to become wet; it may cause equipment damage or malfunction. • Do not touch the electrical contacts inside the endoscope position detecting unit’s connectors; it may cause equipment damage or malfunction. Use the cable shown in Table Table Model MAJ-1881 Product name UPD cable Note 88 CONFIDENTIAL 7.7 Remote control [WARNING] •Install the remote control on a stable, level surface so that the cable between the endoscope position detecting unit and remote control is not stretched. Otherwise, the remote control may slip or fall and result in patient/operator injury or damage to the equipment. The following remote control shown in Table is available. Table Model MAJ-1890 Product name Remote control Note REMOTE CONTROL UPD-3 MAJ-1890 7.8 Video system center [NOTE] See the instruction manual for the video system center. When connecting the video system center to the position detecting unit, the following patient data displayed on the video system center can be output to the position detecting unit. • ID number • Patient’s name • Sex and Age • Date of birth 89 CONFIDENTIAL ○ For CV-180 [CAUTION] When displaying the image of the position detecting unit (UPD-3) using the PinP function of the CV-180, use the high definition LCD monitor. Otherwise, the scope model may not be displayed clearly For connecting the video system center to the endoscope position detecting unit, use the cable listed below. Table Model MAJ-604 Product name Data transfer cable Note UPD-3 CV REMOTE MAJ-604 PC REMOTE CV-180 ○ For CV-260SL/260 * For connecting the video system center to the endoscope position detecting unit, use the cable listed below. Model MAJ-1260* Product name Data transfer cable Note 90 CONFIDENTIAL UPD-3 CV REMOTE MAJ-1260* OPTION B CV-260SL/260 * These Products may not be available in some areas. ○ For CV-160 For connecting the video system center to the endoscope position detecting unit, use the cable listed below. Model MAJ-604 Product name Data transfer cable Note UPD-3 CV REMOTE MAJ-604 D.FILE REMOTE CV-160 ○ For CV-240 * For connecting the video system center to the endoscope position detecting unit, use the 91 CONFIDENTIAL cable listed below. Model MAJ-604 Product name Data transfer cable Note UPD-3 CV REMOTE MAJ-604 DGTL FILE CV-240 * This product may not be available in some areas. 92 CONFIDENTIAL 7.9 Connection to an AC mains power supply [DANGER] • Be sure to connect the power plug of the power cord directly to a grounded wall mains outlet. If the endoscope position detecting unit is not grounded properly, it can cause an electric shock and/or fire. • Do not connect the power plug to the 2-pole power circuit with a 3-pole to 2-pole adapter. It can prevent proper grounding and cause an electric shock. [WARNING] • Always keep the power plug dry. A wet power plug may cause electric shocks. • Confirm that the hospital-grade wall mains outlet to which this instrument is connected has adequate electrical capacity that is larger than the total power consumption of all connected equipment. If the capacity is insufficient, fire can result or circuit breaker may trip and turn OFF this instrument and all other equipment connected to the same power circuit. • When using the mobile workstation (WM-NP1, WM-WP1), confirm that the mobile workstation has adequate electrical capacity that is larger than the total power consumption of all connected equipment. If the capacity is insufficient, drop in the supply voltage can result or the electric protective device may trip and turn OFF all the equipment connected to the mobile workstation. • When non-medical ancillary electrical equipment is used, always connect the equipment to a wall mains outlet via an isolation transformer. Otherwise, electric shock can result. • The total power consumption of all connected equipment to the isolation transformer should not exceed the rating of the isolation transformer. If it exceeds, add another isolation transformer. Otherwise, the equipment may not work correctly. • Do not bend, pull or twist the power cord. Equipment damage including separation of the power plug and disconnection of the cord wire as well as fire or electric shock can result. • Be sure to connect the power plug securely to prevent erroneous unplugging during use. Otherwise, the equipment will not function. • Do not extend a single wall mains outlet into multiple outlets for connecting the power cords of both the electrosurgical unit and light source. Otherwise, malfunction of the equipment may result. ○When the mobile workstation (WM-NP1, WM-WP1) is used 1. Confirm that the endoscope position detecting unit is OFF. 2. Connect the power cord provided with the mobile workstation to the AC power inlet of the endoscope position detecting unit and the AC mains outlet of the mobile workstation (see Figure) 93 3. Connect the power cords provided with the mobile workstation to the AC power inlets of the ancillary equipment and the AC mains outlets of the mobile workstation. 4. Connect the power cord of the mobile workstation to the wall mains outlet. ○When a mobile workstation other than the WM-NP1 and WM-WP1 is used or when no mobile workstation is used 1. Confirm that the endoscope position detecting unit is OFF. 2. Connect the power cord provided with the endoscope position detecting unit first to its AC power inlet, then to the wall mains outlet. 3. Connect the instruments listed in the following table to the wall mains outlet. 4. Connect the instruments listed in the following table to the isolation transformer. 5. Connect the power cord of the isolation transformer to the wall mains outlet. ○When the mobile workstation (WM-NP1 94 CONFIDENTIAL (OEV143, OEV203, OEV181H, OEV191, OEV191H, OEV261H) OEP printers Video printer The devices to be connected to the isolation transformer Model Product name VTR VTR Other than OEV video Video monitor monitors Other than OEP video Video printer printers 95 CONFIDENTIAL Chapter 8 Function setup The following settings are set to use the position detecting unit and equipment connected to the position detecting unit properly. Setting menu System setup Description Sets the basic functions of the position detecting unit. For details on the functions, refer to “system setup”. Sets the functions used during the examination. For details on the functions, refer to “User preset”. Adjusts the scope display. For details, refer to “ ” . User preset Adjustment [NOTE] The functions can be set even if the endoscope or the position detecting probe is not connected to the position detecting unit. 8.1 Basic operation of the menu Buttons in the menu For the buttons and their functions, see Table below. Button Function ROTATE LEFT Moves the cursor to the left. ROTATE RIGHT ZOOM IN Moves the cursor to the right. Moves the cursor up. ZOOM OUT ENTER MENU Moves the cursor down. Determines the category selected by the cursor. Displays or closes the window. MENU ZOOM IN ROTATE RIGHT ENTER ROTATE LEFT ZOOM OUT 96 CONFIDENTIAL 1. Press the “MENU” button on the control panel to display the menu list on the scope model display (see Figure). Menu list Cursor 2. Move the cursor on the setting item and press the “ENTER” button to display the setting window (see Figure). Cursor 97 CONFIDENTIAL 3. Move the cursor on the setting item in the setting window and press the “ENTER” button to display the window of the selected setting item (see Figure). Window Cursor 4. Move the cursor to select the setting. 5. Press the “ENTER” button to change the setting, and the window exits; select the “CANCEL” button and press the “ENTER” button to keep the setting, and the window exits. 6. Select the “Back” button and press the “Enter” button to return to the upper level. 7. After all settings are completed, select the “Exit” and press the “ENTER” button. When any settings are changed, the confirmation window is displayed. For details on operations here, refer to Table. Confirmation window Cursor 98 CONFIDENTIAL Selection Yes No Cancel Description Changes settings and exits from the menu. Not change settings and exits from the menu. Returns the menu window to continue to change the settings. 8.2 System setup Set various settings, such as the display setting and system date. Settings of the display ○Date and time display 1. Set the display of date and time in the scope model display. Setting value ON OFF Description Displays the current date and time in the scope model display. Not display the current date and time in the scope model display. ○Patient data display 1. Set the display of patient data in the scope model display. Setting value ON OFF Description Displays the patient data in the scope model display. Not display the patient data in the scope model display. [NOTE] The patient data is displayed when the video system center is connected to the position detecting unit. Settings of the miscellanea ○Frequency of transmitting 99 CONFIDENTIAL 1. Set the frequency for detecting the scope model. Setting value Automatic f1 f2 f3 f4 Description Automatically selects the frequency for detecting the scope model from “f1” to “f4”. Use the frequency set in the "f1”. Use the frequency set in the "f2”. Use the frequency set in the "f3”. Use the frequency set in the "f4”. [CAUTION] Do not change this setting in ordinary cases. Otherwise, the scope model display may be distorted or deformed. ○Fusion avoidance function 1. Set the fusion avoidance function. Setting value ON OFF Description Activate the fusion avoidance function. Inactivate the fusion avoidance function. [CAUTION] Do not change this setting in ordinary cases. Otherwise, the scope model display may be distorted or deformed. ○Marking remote This function is the future extension; it is not used currently. ○Model shading 1. Enhance the contrast of the shading of the scope model Setting value Description Standard No enhancement is made to the shading contrast of the scope model Enhancement Enhances the shading contrast of the scope model 100 CONFIDENTIAL Date and time of the system ○Date Set the current date. 1. Move the cursor on the year, month, or date and press the “ZOOM IN” or “ZOOM OUT” button to change the numerical value (see Figure). Year Month Date ○Time Set the current time. 1. Move the cursor on the hour, minute, or second and press the “ZOOM IN” or “ZOOM OUT” button to change the numerical value (see Figure). Hour Minute Second 101 CONFIDENTIAL ○Display format 1. Set the date display format. Date display format • MM/DD/YYYY • MM-DD-YYYY • MM.DD.YYYY • MM DD YYYY • DD/MM/YYYY • DD-MM-YYYY • DD.MM.YYYY • DD MM YYYY • YYYY/MM/DD • YYYY-MM-DD • YYYY.MM.DD • YYYY MM DD Description YYYY:Year MM:Month DD:Date ○Hand coil switch 1. Set the functions to be assigned to the remote switch of the hand coil. Setting value Scope position ROTATE LEFT Split screen Description Sets the scope position Rotates the scope model in the left direction Changes the screen between the split-screen and the single-screen ○Display speed 1. Set the display speed of the scope model. Setting value Automatic Low Medium High Description Displays the scope model at high or medium speed depending on the external noise of this instrument Displays the scope model at low speed Displays the scope model at medium speed Displays the scope model at high speed [CAUTION] Do not change this setting in ordinary cases. Otherwise, the scope model display may be unstable. [NOTE] - When the Automatic is selected, the Medium speed mode to display the scope model is 102 CONFIDENTIAL disabled. - For details of the automatic change of the display speed, see Section 4.7 “Displaying the scope model”. Connection of the video system center ○Connecting terminal 1. Set the communication mode with the video system center. Setting value Description Communication A Communication B A communication mode using the “LINK IN" connector. This is a future extension. A communication mode using the “CV REMOTE” connector. 8.3 User preset Each function can be set by user or endoscope. Up to 20 presets of the display can be saved. ○Basic operation of the user preset 1. Display the “User preset” window, move the cursor on the “Call” or “Edit” in the window, and press the “ENTER” button on the control panel. 103 CONFIDENTIAL User list Call Edit Delete Operation Function Select Recalls the desired setup to set each function. Edit Edit the desired user preset data. Delete Deletes the data of selected user. Edit Sets the new user preset, and edits and/or deletes the data of the selected user. 2. When selecting the “Edit” button and pressing the “Enter” button, “Register“ button and “Delete” button will be displayed. ○Setting the new user preset 104 CONFIDENTIAL 1. Move the cursor on the “New” in the User preset window and press the “ENTER” button on the control panel. 2. The setting window for setting each category is displayed (see Figure). For each setting, refer to the following instructions. Cursor [NOTE] •Each preset data is saved in the user list in order (from No.1 to No.20). The number is suffixed on each user’s name. •When the user list is full, a new preset data cannot be saved. Delete the unnecessary data to save the new data. 105 CONFIDENTIAL 3. Move the cursor on the “Tab” and press the “ROTATE LEFT” or “ROTATE RIGHT” button to change the setting page. Tab Tab Change the page by pressing the “ROTATE LEFT” or “ROTATE RIGHT” button Tab ○Selecting the user preset 1. Move the cursor on the “Select” in the user preset window and press the “ENTER” button on the control panel. 106 CONFIDENTIAL 2. Move the cursor on a desired user’s name to recall and press the “ENTER” button on the control panel (see Figure). User list Cursor Select 3. The selected preset is called, and the scope model display is returned. [NOTE] The list of the user preset currently called is displayed in violet. ○Editing the user preset 1. Move the cursor on the “Edit” in the user preset window and press the “ENTER” button. 2. Move the cursor on the desired user’s name to edit and press the “ENTER" button (see Figure). User list Cursor Edit 107 CONFIDENTIAL 3. The setting window for setting each category is displayed. For each setting, refer to the following instructions. 4. Move the cursor on the “Tab” and press the “ROTATE LEFT” or “ROTATE RIGHT” button to change the setting page (see Figure). Tab Tab Change the page by pressing the “ROTATE LEFT” or “ROTATE RIGHT” button Tab ○Deleting the user preset 1. Move the cursor on the “Delete” in the user preset window and press the “ENTER” button. 108 CONFIDENTIAL 2. Move the cursor on the desired user’s name to delete and press the “ENTER" button (see Figure). User list Delete 3. The confirmation window is displays (see Figure). When deleting the preset, move the cursor on the “Yes” and press the “ENTER” button. Information display ○Displaying the gauge 1. Set the display of gauge in the scope model display. Setting value ON OFF Description Displays the gauge in the scope model display. Not display the gauge in the scope model display. 109 CONFIDENTIAL ○Displaying the marking 1. Set the display of marking in the scope model display. Setting value ON OFF Description Displays the marking in the scope model display. Not display the marking in the scope model display. ○Displaying the display length 1. Set the display of the display length in the scope model display Setting Value Description ON Displays the display length in the scope model display. OFF Not display the display length in the scope model display. Scope model ○Zooming ratio 1. Set the zooming ratio of the scope model. The ratio can be changed from 0.5 to 3.0 times in steps of 0.1 times. [NOTE] • For zooming in or out the scope model, refer to Section 5.2, “Varying the size of the scope model”. • Pressing the “Reset” button or selecting the desired user preset recalls the zooming ratio that has been saved in the user preset operation. ○Scope model thickness 1. Adjust the scope model thickness from -7 to +7. Display mode 110 CONFIDENTIAL ○Changing the display mode 1. Set the viewing direction of the scope model. Setting value Description From the top Displays the scope model from the top to the bottom in the screen. From the bottom Displays the scope model from the bottom to the top in the screen. [NOTE] For displaying the scope model and its actual position, refer to the Section 4.2, “Scope model display range”. ○Changing the perspective 1. Set the perspective of the scope model. Setting value ON OFF Description The perspective of the scope model is enabled. The perspective of the scope model is disabled. Perspective OFF Perspective ON ○Start position of the scope model 1. Set the start position of the scope model. Setting value Description ON The center of the bottom of the monitor display corresponds to the start position of the scope model. When the display mode is set to “From the top”, the center of the top of the 111 CONFIDENTIAL monitor display corresponds to the start position of the scope model. OFF The scope model moves according to the actual endoscope’s movement. Figure When the start position of the scope model is set to “ON” The scope model is always displayed in the center of the screen regardless the actual endoscope’s movement. Actual endoscope’s positioning (top view) Receiver dish Operation table Start position of the scope model 112 CONFIDENTIAL Figure When the start position of the scope model is set to “ON” The scope model is displayed according to the actual endoscope’s movement. Actual endoscope’s positioning (top view) Receiver dish Operation table Start position of the scope model 113 CONFIDENTIAL ○Changing the viewing image 1. Select the viewing image. Setting value Operating table image Figure image Operating table image Description Displays the operating table image. Displays the figure image. Figure image ○For operating table image Set the view angle of the operating table image in respective left and right sides of the split screen. 1. Move the cursor on the "Left screen” and press the “ENTER” button on the control panel. 2. Press the Zoom in or Zoom out button to select the view(ing) angle in the left screen. Possible choices of the viewing angles Left screen Right screen 3. Move the cursor on the “Right screen” and press the “ENTER” button on the control panel. 4. Press the Zoom in or Zoom out button to select the view(ing) angle in the right screen. 5. Press the “MENU” button to close the window. 114 CONFIDENTIAL ○For figure image Set the view angle of the figure image in respective left and right sides of the split screen. 1. Move the cursor on the "Posture” and press the “ENTER” button on the control panel. 2. Press the Zoom in or Zoom out button to select the posture of the figure image. Possible choices of the postures of figure images Posture of the figure image 3. Move the cursor on the “Left screen” and press the “ENTER” button on the control panel. 4. Press the Zoom in or Zoom out button to select the view(ing) angle in the left screen. Left side of the split screen Possible choices of view angles Right side of the split screen 115 CONFIDENTIAL 5. Move the cursor on the “Right screen” and press the “ENTER” button on the control panel. 6. Press the Zoom in or Zoom out button to select the view(ing) angle in the right screen. [NOTE] • The view angle against the figure image can be selected from four angles: anterior, posterior, right lateral, or left lateral. Other angles cannot be selected. • The view angle in the left side of the split screen can be selected as either anterior or posterior. The view angle in the right side of the split screen can be selected as either right lateral or left lateral. • The view angle in the single screen is the same as selected for the front/back view or lateral view. Other angles cannot be selected. ○Displaying the viewpoint indicator arrow 1. Set the display of the viewpoint indicator arrow for the figure image. Setting value ON OFF ○Displaying Description Displays the viewpoint indicator arrow for the figure image. Not display the viewpoint indicator arrow for the figure image. position of the figure image 1. Set the displaying position of the figure image Setting value Lower left Upper right Description Displays the figure image at the lower left part of the screen. Displays the figure image at the upper right part of the screen. ○Displaying the AP symbol 1. Set the display of the AP icon in the left screen in the split-screen display mode. Setting value ON OFF Description Displays the AP symbol in the left screen. Not display the AP symbol in the left screen. 116 CONFIDENTIAL ○Automatic resetting of the posture of the figure image 1. Set automatic resetting of the viewing angle and the posture of the figure image at completion of the examination. Setting value Description ON Resets the viewing angle automatically at completion of the examination. OFF Not reset the viewing angle automatically at completion of the examination. [NOTE] For the method to change the viewing angle, see Section 5.1 “Rotating the scope model”. ○Single screen 1. Set the view angle in the single screen. Setting value Left side Right side View angle in the single screen The view angle in the left side of the split screen. The view angle in the right side of the split screen. ○Setting the background color in right and left sides of the split screen 1. The background color of the respective right and left sides of the split screens can be selected. Setting value Black Green Blue 117 CONFIDENTIAL Bluish violet gradation ○Resetting 1. Select whether the view angle is reset automatically at the end of the examination. Setting value ON OFF Description Resets the view angle automatically at the end of the examination. Not reset the view angle automatically at the end of the examination. [NOTE] For changing the view angle, refer to Section 5.1, “Rotating the scope model”. ○Displaying the viewpoint indicator arrow 1. Select whether the viewpoint indicator arrow for the figure image is displayed. Setting value ON OFF Description Displays the viewpoint indicator arrow for the figure image. Not display the viewpoint indicator arrow for the figure image. 118 CONFIDENTIAL 8.4 Adjustment ○Submenu of adjustment 1. Move the cursor on the “Adjustment” in the submenu list and press the “ENTER” button on the control panel to display the window for adjustment. 2. Move the cursor on the category to be adjusted and press the “ENTER” button on the control panel. ○Fine correction for rotation The view angle can be corrected. 1. Move the cursor on the “X axis” and press the “ROTATE LEFT” or “ROTATE RIGHT” button on the control panel to rotate the scope model. Button ROTATE LEFT ROTATE RIGHT Rotation of the scope model Rotates 2.5 degrees in an upward direction. Rotates 2.5 degrees in a downward direction. Up/downward rotation Right/leftward rotation Reset Preview 119 CONFIDENTIAL 2. Move the cursor on the “Right/leftward rotation” and press the “ROTATE LEFT” or “ROTATE RIGHT” button on the control panel to rotate the scope model. The followings are the buttons and their rotation directions and angles. Button Rotation of the scope model ROTATE LEFT Rotates 2.5 degrees in a leftward direction. ROTATE RIGHT Rotates 2.5 degrees in a rightward direction. 3. Move the cursor on the “Preview” button and press the “ENTER” button to reduce the size of menu list. Press the “ENTER" button again return the small size of menu list to its original size. 4. After the setup is completed, press the “MENU” button on the control panel. ○Brightness and contrast adjustment 1. Move the cursor on the “Brightness” button and press the “ROTATE RIGHT” or “ROTATE LEFT” button to adjust the brightness. Brightness Contrast 2. Move the cursor on the “Contrast” button and press the “ROTATE RIGHT” or “ROTATE LEFT” button to adjust the brightness. 3. Move the cursor on the “Preview” button and press the “ENTER” button to reduce the size of menu list. Press the “ENTER" button again return the small size of menu list to its original size. 120 CONFIDENTIAL 4. After the setup is completed, press the “MENU” button on the control panel. 121 CONFIDENTIAL Chapter 9 Troubleshooting If the endoscope position detecting unit is visibly damaged, does not function as expected, or is found to have irregularities during the inspection described in Chapter 3, “Inspection” and Chapter 7, “Installation and Connection”, or the use described in Chapter 4, “Operation”, do not use the endoscope position detecting unit and contact Olympus. Some problems that appear to be malfunctions may be correctable by referring to Section 9.1, “Troubleshooting guide”. If the problem cannot be resolved by the described remedial action, stop using the endoscope position detecting unit and contact Olympus. [DANGER] Never use the endoscope position detecting unit if an abnormality is suspected. Damage or irregularity in the instrument may compromise patient or user safety and may result in more severe equipment damage. 9.1 Troubleshooting guide The following table shows the possible causes of and countermeasures against troubles that may occur due to equipment setting errors or deterioration of consumable. Troubles or failures other than those listed in the following table need repair. As repair performed by persons who are not qualified by Olympus could cause patient or user injury and/or equipment damage, be sure to contact Olympus for repair. Irregularity description The endoscope position detecting unit cannot be turned on. Possible cause Solution The endoscope position detecting unit is not connected to hospital-grade power outlet. Connect the endoscope position detecting unit to the power outlet using the power cord. Power is not supplied to the hospital-grade power outlet. The scope model is not The setup menu is displayed on the being displayed. monitor. Supply power properly to the power outlet. Display the scope model as described in “Saving and recalling the display setup”. The UPD cable is not Connect the UPD cable. connected. 122 CONFIDENTIAL The UPD cable is not Connect the UPD cable to the connected to the endoscope. endoscope. The monitor cable is not Connect the monitor cable. connected. The monitor failure. cable Replace the monitor cable. The reference plate (MAJ-1860) is attached improperly to the patient’s body. Attach the reference plate properly to the patient’s body as described in “Attaching the reference plate (MAJ-1860) to the patient’s body”. The scope model Set an optimum zooming zooming ratio is ratio. improper. Press the reset switch to initialize the zooming ratio. The scope model Set an optimum rotation rotation angle is angle. improper. Press the reset switch to initialize the rotation angle. The monitor display is The monitor disturbed. failure. cable Replace the monitor cable. The scope model A strong magnetic field display is unstable. source is near the endoscope position detecting unit. Move the endoscope position detecting unit away from the strong magnetic field source. Decrease the display speed of the scope model. See Section 8.2 “System setup”. There is a large metallic Move the endoscope position object near the detecting unit away from the endoscope position large metallic object. detecting unit. 123 CONFIDENTIAL The reference plate (MAJ-1860) is attached improperly to the patient’s body. Attach the reference plate properly to the patient’s body as described in “Attaching the reference plate (MAJ-1860) to the patient’s body”. The scope model A strong magnetic field display is distorted. source is near the endoscope position detecting unit. Move the endoscope position detecting unit away from the strong magnetic field source. Decrease the display speed of the scope model. See Section 8.2 “System setup”. There is a large metallic Move the endoscope position object near the detecting unit away from the endoscope position large metallic object. detecting unit. The material and/or Contact Olympus. structure of the operating table causes distortion of the scope model. Patient data is not The video system center Connect the video system displayed. is not connected. center as described in “Connection to the video system center”. 124 CONFIDENTIAL ○ Error messages Message Possible cause Solution The scope shape can not be displayed. CLV-UPD cable is not connected, or there is malfunction in endoscope, CLV-UPD cable or CLV. When the problem is not solved even if the CLV-UPD cable is reconnected, please contact the Olympus service center. The scope shape cannot be displayed. The scope connection may be wet. Check the connection and re-insert the scope again. If the error continues, please contact the Olympus service center. The scope shape can not be The endoscope or displayed. There is connection cable can be malfunction in endoscope or malfunctioning. UPD cable. Please contact the Olympus service center. •Contact Olympus. •If another endoscope functions normally, the endoscope has been used can be malfunctioning. The receiver dish cable is connected incorrectly. For connecting the receiver dish cable, refer to Section 7.3, “Installation of the receiver dish”. The date/time internal battery has expired. As a result, the date/time may be inaccurate. Please contact the Olympus service center. The internal battery for saving the date and time data is dead. •Contact Olympus. The previously used settings could not be restored. All settings will be restored to factory settings. Please apply custom settings afterwards as needed. Saving the previous settings has failed. All settings return to the factory default settings. Reset the all settings. The scope position could not When the display range Move the reference plate to a The receiver dish or receiver dish cable is not connected. Please connect the receiver dish or receiver dish cable. There is malfunction in UPD-3. Please contact the Olympus service center. 125 CONFIDENTIAL be set. The reference plate is out of the setting range for scope position. Change the reference plate to tracking mode, then set the scope position again. of the scope model is set, the reference plate was located outside of the detection area of the receiver dish. location within the detection area of the receiver dish and perform the setting again. See Section 5.7 “Setting the scope model display range”. The scope position settings could not be set. There is malfunction in the hand coil. Please contact the Olympus service center. The hand coil may be malfunctioning. Contact Olympus. The scope position could not be set. The scope or probe is not connected. Please connect the scope or probe and set the scope position again. Setting the scope model display range was performed without connecting the endoscope or the position detecting probe to the endoscope position detecting unit. Connect the endoscope or the position detecting probe to the endoscope position detecting unit. The bookmark was not saved. Bookmarks cannot exceed 50 per case. Please delete an existing bookmark before saving a new one. More than 50 markings attempt to be put. Delete the all markings and put new markings again. See Section 5.6, “Marking”. The hand coils can not be used because two hand coils are connected at the same time. Please do not connect the hand coil which will not be used. The hand coils were connected to both the main unit and the connection unit. Disconnect either of the hand coils connected to the main unit and the connection unit. The reference plate can not be used because two reference plates are connected at the same time. Please do not connect the reference plate which will not be used. The reference plates were connected to both the main unit and the connection unit. Disconnect either of the reference plates connected to the main unit and the connection unit The scope shape can not be displayed because the connection with the video system center was lost. Please check the video system center connection. Remote connection settings 126 CONFIDENTIAL with the video system center are not correct. Please change the remote connection settings to LINK-IN. There is an error in date input field. Are you sure you want to exit without saving? The hand coil switch is depressed. Please check the switch. The front panel or remote controller button is depressed. Please check the buttons. Writing settings from the maintenance computer. Please do not turn off the power to the UPD-3 until the writing process is complete. The settings cannot be restored because no backup data exists. This will restore the factory settings and delete all data. Are you sure you want to proceed? 127 CONFIDENTIAL 9.2 Returning the endoscope position detecting unit for repair [CAUTION] Olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-Olympus personnel. When returning the video system center for repair, contact Olympus. With the video system center, include a description of the malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem. Include a repair purchase order. [NOTE] When the accessories of the position detecting unit, contact Olympus to purchase a replacement. 128 CONFIDENTIAL Appendix System chart (1/3) CISPR11 Class B UPD-Y0003 UPD-3 RECEIVER DISH CABLE MAJ-1875 RECEIVER DISH CABLE MAJ-1927 RECEIVER D ISH MAJ-1868 RECEIVER DISH ARM MAJ-1962 RECEIVER DISH STAND MAJ-1907 UNIFIED CABLE MAJ-1964 : shows accessories of UPD-Y0003 HOLDER ATT ACHMENT CONNECTION REMOTE CONT ROL UNIT COVER HOLDER : Part of this submission : These items are used exclusively : These items are used exclusively CONNECTION CABLE POCKET MP HOLDER M PLAT E UNIT HOLDER RECEIVER DISH STAND SUPPLEMENTARY SET MAJ-1978 129 CONFIDENTIAL System chart (2/3) UPD-Y0003 UPD-3 REMOT E CONTROL MAJ-1890 CISPR11 Class B HAND COIL CO VER MAJ-1879 HAND COIL MAJ-1859 WATER-RESISTANT CAP MAJ-1899 REFERENCE PLATE BELT MAJ-1029 REFERENCE PLAT E COVER MAJ-1880 REFERENCE PLATE MAJ-1860 : shows accessories of UPD-Y0003 : Part of this submission : These items are used exclusively WATER-RESISTANT CAP MAJ-1899 : These items are used exclusively 130 CONFIDENTIAL System chart (3/3) Video Monitor ET 1528L-7CWM-1-BG-G (Elo T ouchSystems,Inc.) PLT210-W0X (TOTOKU ELECT RIC CO. LT D) HOLDER PLATE H OLDER FOR HC-RP MAJ-1938 WM-NP1, W M-W P1 CISPR11 Class A VGA video c able CLV-160, CLV-180 UPD-Y0003 UPD-3 COLONOVIDEOSCOPE CF-Q160DL/I, CF-H180DL/I CV-160, CV-165, CV-180 POSITION DET ECTING PROBE MAJ-1300 CISPR11 Class B DATA TRANSFER CABLE MAJ-604 UPD C ABLE MAJ-1881 Y/C cable MH-985 : shows accessories of UPD-Y0003 : Part of this submission : These items are used exclusively : These items are used exclusively Video Tape Rec order COLOR VIDEO PRINTER OEP-3,OEP-4 131 CONFIDENTIAL Transportation, storage, and operation environment Transportation and storage environment Ambient temperature humidity −25 to +70°C (−13 to +158°F) Relative 10 - 95% 700 - 1060 hPa Operation environment Atmospheric pressure Ambient temperature Relative humidity Atmospheric pressure 30 - 85% (without condensation) 10 - 40°C (50 - 104°F) 700 - 1060 hPa (0.7 - 1.1 kgf/cm2) (10.2 - 15.4 psia) Specifications Power supply Item Voltage fluctuation Frequency Frequency Fluctuation Input current Size Classification (medical electrical equipment) Specifications 100 – 120 VAC 220 – 240 VAC (see the electrical rating label on the rear panel) ±10% 50/60 Hz ±1 Hz 100VA (at 100 – 240 VAC) Dimensions 370 (W) × 80.7 (H) ×482 (D) mm Weight Type of protection against electric shock 9 kg Class I Degree of protection against electric shock of applied part TYPE BF applied part Where no classification mark appears, the equipment is a TYPE BF applied part. 132 CONFIDENTIAL Item Explosion proofing degree Video outputs signal XGA Specifications Use in a flammable atmosphere is prohibited 1024×768 Horizontal frequency 48.5kHz Vertical frequency 60Hz Y/C NTSC, PAL SD-SDI SMPTE259M 133 CONFIDENTIAL Item Medical Device Directive (For 220 – 240 type equipment) WEEE Directive (For 220 – 240 type equipment) EMC Applied standard; IEC 60601-1-2: 2007 Specifications This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a This device complies with the EMC requirements of EN 60601-1-2: 2001 when used in combination with devices bearing CE marking either on the products or in its instructions for use. Emission: Class A of EN 55011 In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately. Refer to your local Olympus distributor for return and/or collection systems available in your country. This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 3 (IEC 60601-1-2: 2007). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1. 134 CONFIDENTIAL Item Specifications Year of 7001234 The last digit of the year of manufacture manufacture The last digit of the year of manufacture is the second digit of the serial number. Degree of Reference plate Hand TYPE BF applied part protection coil against electric shock Specification of radio transmitter Center frequency: Bandwidth: Modulation RF (Radio Frequency) output power: 9.888Hz, 10.712Hz, 11.536Hz ±20Hz No modulation 70dBμV/m or less (at a distance of 3 meters) 135 CONFIDENTIAL EMC information This model is intended for use in the electromagnetic environments specified below. The user and the medical staff should ensure that it is used only in these environments. ○Magnetic emission environments compliance information and recommended electromagnetic 136 CONFIDENTIAL ○ Electromagnetic immunity compliance information and recommended electromagnetic environments [NOTE] UT is the a.c. mains power supply prior to application of the test level. 137 CONFIDENTIAL ○ Cautions and recommended electromagnetic environment regarding portable and mobile RF communications equipment such as a cellular phones. [NOTE] • 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). • This instrument complies with the requirements of IEC 60601-1-2: 2001. However, under electromagnetic environment that exceeds its noise level, electromagnetic interference may occur on this instrument. • Electromagnetic interference may occur on this instrument near a high-frequency electrosurgical equipment and/or other equipment marked with the following symbol: 138 CONFIDENTIAL ○ Recommended separation distance between portable and mobile RF communications equipment and this instrument [NOTE] The guidance may not apply in some situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Portable and mobile RF communications equipment such as cellular phones should be used no closer to any part of this instrument, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. FCC information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC ID:S8QUPD-3 IC information This equipment complies with the IC RSS210. IC: 4763B-UPD3 FCC warnings Change or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. All interface cables used to connect peripherals must be shielded in order to comply with the limits for a digital device pursuant to Subpart B of Part 15 of FCC Rules. IC note Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 139 CONFIDENTIAL XGT6302 00 001 140
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