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.
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 2
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.
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.
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.).
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.
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.
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.
CONFIDENTIAL • When endoscopes are used with endoscope accessories connected with other medical electronic equipment, the leakage currents may increase.
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.
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.
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.
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.
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.
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.
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.
CONFIDENTIAL 2.4 Side panels Ventilation grills Front side Ventilation grills Rear side 2.5 UPD cable (MAJ-1881) Notch Position detecting connector 2.
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.
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.
CONFIDENTIAL 2.9 Hand coil (MAJ-1859) (Option) Arrow Connector Marker section Switch To endoscope position detecting unit Water-resistant cap 2.
CONFIDENTIAL 2.
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.
CONFIDENTIAL ○For the figure image 14. A-P indicator 15.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CONFIDENTIAL 4.
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.
CONFIDENTIAL ○When the reference plate is connected and the scope model display range is not set Receiver dish (Top view) Operating table X Y Z 6cm Reference plate Cable outlet B 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.
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 C 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.
CONFIDENTIAL ○When the reference plate is connected and the scope model display range is set Receiver dish (Top view) Operating table X Y Reference plate Cable outlet Z Ｄ 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.
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.
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.
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.
CONFIDENTIAL For setting the viewpoint indicator arrow, refer to “○Viewpoint indicator arrow” 2. Start the endoscopic examination as indicated in the instruction manual for the endoscope in use. [NOTE] For the start position of the scope model, refer to Section 4.2, “Scope model display range” 4.7 Displaying the scope model The scope model is displayed as described below. • Gray scale: The shape of the endoscope is represented as a gray cylinder.
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.
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.
CONFIDENTIAL 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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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”.
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.
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.
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.
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).
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CONFIDENTIAL 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.
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 “ ” .
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).
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CONFIDENTIAL 4. After the setup is completed, press the “MENU” button on the control panel.
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”.
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. 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. The reference plate (MAJ-1860) is attached improperly to the patient’s body.
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”. 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”.
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.
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.
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.
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.
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 DISH 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 POC KET MP HOLDER M PLAT E UNIT HOLDER RECEIVER DISH
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 : show showss 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.
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 10 - 40°C (50 - 104°F) 30 - 85% (without condensation) 700 - 1060 hPa (0.7 - 1.1 kgf/cm2) (10.2 - 15.
CONFIDENTIAL Item Explosion proofing degree Video outputs signal XGA Specifications Use in a flammable atmosphere is prohibited 1024×768 Horizontal frequency 48.
CONFIDENTIAL Item Medical Device Directive (For 220 – 240 V type equipment) WEEE Directive (For 220 – 240 V 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.
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.
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.
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.
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.
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.
CONFIDENTIAL XGT6302 00 001 140
