Olympus EndoCapsule Instruction Manual
  1. Manuals
  2. Brands
  3. Olympus Manuals
  4. Medical Equipment
  5. EndoCapsule
  6. Instruction manual
Olympus EndoCapsule Instruction Manual

Olympus EndoCapsule Instruction Manual

Capsule endoscope system
Hide thumbs
Table of Contents

Advertisement

Quick Links

INSTRUCTIONS
OLYMPUS CAPSULE ENDOSCOPE SYSTEM

Advertisement

Table of Contents
loading

Related Manuals for Olympus EndoCapsule

Summary of Contents for Olympus EndoCapsule

  • Page 1 INSTRUCTIONS OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 3: Table Of Contents

    System components ............... Capsule endoscope set A (MAJ-1469) ........... Antenna lead set (MAJ-1474) ............Recorder unit (OLYMPUS RE-1) ............ Real time viewer (OLYMPUS VE-1) ..........Recorder unit cradle (MAJ-1484)............ Real time viewer cable (MAJ-1485) ..........Recorder unit cradle cable ..............
  • Page 4 Opening data .................. Image observation ................Generating reports ................Examination data management ............Exporting image data ..............Browsing the image observation operation history ......Chapter 7 Care Storage and Disposal ........230 Care ....................Storage ................... Disposal ..................OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 5 Contents Chapter 8 Troubleshooting ............233 Troubleshooting ................Returning the system for repair............Appendix ..................240 Operating/storage environment ..............Specifications .................... EMC information ..................OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 6 Contents OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 7: Labels And Symbols

    Labels and Symbols Labels and Symbols Safety-related labels and symbols are attached at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. Symbols The following symbols can be found on the equipment and its packaging.
  • Page 8 Labels and Symbols Do not iron. Do not dry clean. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 9: Labels

    Electrical rating / Battery capacity FCC ID number IC number Manufacturer details Sterilization lot number Refer to instructions Use by (expiration date) “Single Use” marking TYPE BF applied part marking Sterilized with ethylene oxide Preliminary OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 10 Labels and Symbols Antenna lead set Antenna lead set back panel Label Serial number CE marking Crossed-out wheeled bin' symbol Model name TYPE BF applied part marking Manufacturer details OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 11 Labels and Symbols Recorder unit Recorder unit back panel Label Serial number Model name Electrical rating/Input power Crossed-out wheeled bin' symbol TYPE BF applied part marking CE marking Manufacturer details OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 12 Labels and Symbols Real time viewer Real time viewer back panel Serial number Electrical rating / Input power Model name CE marking Crossed-out wheeled bin' TYPE BF applied part marking symbol Manufacturer details OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 13 Labels and Symbols Recorder unit cradle Recorder unit cradle bottom side Label Crossed-out wheeled bin' Model name symbol Electrical rating / Input power CE marking Manufacturer details OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 14 Battery charger bottom side Label Seller details CE marking Crossed-out wheeled Model name bin' symbol PSE marking Double insulation marking Electrical rating / Input power C-UL marking Refer to instructions Caution Lot number Country of manufacture OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 15 Labels and Symbols Battery pack Battery pack back plate Label Voltage rating Battery pack capacity Seller details Battery pack type Model name CE marking Refer to instructions Caution Lot number Country of manufacture OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 16 Labels and Symbols Recorder unit harness Label Model name CE marking Do not dry clean. Country of manufacture Do not iron. Maximum washing temperature 40°C normal process OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 17: Important Information - Please Read Before Use

    Magnetic field formed by permanent magnets or electromagnets that are used in health devices and audio speakers. RTC (Real time clock) Refers to the recorder unit internal clock. A drive which contains examination data and thumbnail data. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 18 The process in which a physician imports thumbnail data from a workstation after examination on Endo Capsule software light. Thumbnail data The data which contains thumbnails of the selected images and comments added by a physician. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 19: Exclusion Criteria

    The operator of this system must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in endoscopic procedures. This manual, therefore, does not explain or discuss endoscopic procedures. • Analysis of the captured endoscopic images require substantial training. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 20: Instrument Compatibility

    Some problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting” on page 233. If the problem cannot be resolved using the information in Chapter 8, contact Olympus. FCC warning Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

  • Page 21: Danger, Warnings And Cautions

    Danger, warnings and cautions Follow the dangers, warnings and cautions given below when handling the Olympus capsule endoscope system. This information is to be supplemented by the dangers, warnings and cautions given in each chapter. Instruct the patient to stay away from generators of strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope.
  • Page 22 DC magnetic fields. • Before use, check that the surface of the capsule endoscope is clear of roughness, sharp edges, and projections. They may cause internal injury to the patient. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 23 Failure to do so may prevent the proper reception of capsule endoscope images. • Perform the examination with all 8 antenna pads attached to the patient. The examination may fail with even one antenna pad not properly attached. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 24 There may also be other residual material within the gastrointestinal tract. For these reasons, it may not be possible to capture images of some parts of the small intestine. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 25 When the real time viewer is receiving capsule endoscope images directly, an icon ( ) is displayed on its display panel. • The real time viewer is to be used within the hospital only, and is not to be given to the patient. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 26: Danger, Warnings And Cautions For Patients

    Failure to follow instructions may interfere with the examination. • Instruct the patient to handle the external equipment attached to his/her body with care, and to avoid sudden movements. Failure to follow instructions may interfere with the examination. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 27 0°C/32°F. Failure to follow instructions may cause the battery pack to deteriorate rapidly, resulting in the examination ending prematurely. • Provide your emergency contact number for the patient on the “Caution for Capsule Endoscopy Patients”, included in the capsule endoscope set A (MAJ-1469). OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 28: Expiration Date Of The Capsule Endoscope

    8 continuous hours for observation for whole small bowel in every case. • Please the capsule endoscope be swallowed by a patient soon after the capsule endoscope turned on to avoid consumption of the battery before examination. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 29: Battery Charger

    1.5 second intervals. • The battery charger will not charge the battery if the battery pack or the battery charger is damaged. In this case, the charge lamp will blink in yellow at 0.5 second intervals. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 30: Battery Pack

    Do not use or store the battery pack near flames or a source of high temperature (over 80°C/176°F) such as a stove. If the plastic separator is damaged by heat, the battery pack will be short-circuited internally, causing excessive heat, release of smoke, explosion, and/or a fire. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 31 Use the battery pack only for this equipment. Using the battery pack in other equipment could cause its performance to deteriorate rapidly, or, depending on the equipment, cause damage from overcurrent, excessive heat, release of smoke, explosion, and/or a fire. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 32 The life span of a battery pack is approximately 1 year from the date of purchase, or 320 recharging cycles, whichever is first. When the battery pack approaches its end-of-life, the recorder unit will prompt for replacement. Order a new battery pack and replace. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 33: Emc (Electromagnetic Compatibility)

    Central frequency: 315MHz endoscope) Required bandwidth: 7MHz Required bandwidth: 7MHz Modulation method: Minimum shift Modulation method: Minimum shift keying (MSK) keying (MSK) High frequency output: +37dBµV/m High frequency output: +37dBµV/m (when inside body) phantom (when inside body) phantom OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 34 Important Information - Please Read Before Use OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 35: Chapter 1 Checking The Package Contents

    Match all items in the package with the components shown in this chapter. 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. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 36: Capsule Endoscope System Set A (Maj-1467)

    Real time viewer cable Antenna lead set Recorder unit cradle Recorder unit harness Battery pack (2 pcs.) Real time viewer Battery charger Recorder unit Real time viewer (OLYMPUS VE-1) Recorder unit (OLYMPUS RE-1) Real time viewer cable (MAJ-1485) OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 37 Power supply cable Power supply cable Battery charger (MAJ-1476) Antenna lead set (MAJ-1474) Battery pack (MAJ-1473) x 2 Recorder unit harness (MAJ-1475) Recorder unit cradle cable Instruction manual AC adapter Recorder unit cradle (MAJ-1484) Antenna locations guide OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 38: Capsule Endoscope Set A (Maj-1469)

    (reusable), and 50 antenna lead cover (disposable). For a single examination, 1 capsule endoscope, 1 capsule activator, and 10 antenna lead cover (including 2 spare) are used. Capsule endoscope (in sterile container) (OLYMPUS EC TYPE 1) x 5 Capsule activator (reusable) (MAJ-1478) Caution for capsule endoscopy patients x 5 Antenna lead cover (set of 50 pcs., disposable)

  • Page 39: Workstation (Olympus Ws-1)

    Chapter 1 Checking the Package Contents Workstation (OLYMPUS WS-1) LCD monitor (MAJ-1481) Workstation hardware (MAJ-1479) Printer (MAJ-1480) Mouse Keyboard USB memory USB HDD Instruction manual CD-R (Endo Capsule Instruction manual (for (for printer) software light) LCD monitor) Figure 1.1 OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 40 MAJ-1485 1 pc. Recorder unit cradle MAJ-1484 1 pc., with AC adapter, recorder unit cradle cable Workstation OLYMPUS WS-1 Workstation hardware, LCD monitor, and printer Workstation hardware MAJ-1479 Workstation main body, keyboard, mouse, USB memory (2GB), conversion cable, and Endo Capsule software...
  • Page 41 Chapter 1 Checking the Package Contents The following items are optional third-party products that may be purchased separately: USB HDD: MAXTOR E30G300 (320GB) For further information, please contact Olympus. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 42: Chapter 2 Nomenclature And Functions

    (MAJ-1470) 1 pc. Capsule endoscope (OLYMPUS EC TYPE 1) 5 pcs. 11. Antenna lead set (MAJ-1474) 2. Real time viewer (OLYMPUS VE-1) 10. Recorder unit (OLYMPUS RE-1) 3. Battery charger (MAJ-1476) 9. Recorder unit cradle (MAJ-1484) 4. Battery pack (MAJ-1473) 8.
  • Page 43 Takes endoscopic pictures of the gastrointestinal tract, and transmits the image data by radio transmission. Consists of: • Capsule endoscope (OLYMPUS EC TYPE 1) 5 pcs. • Capsule activator 1 pc. • Antenna lead cover 50 pcs. 2. Real time viewer (OLYMPUS VE-1) Monitors the operation of the capsule endoscope before and during the examination.

  • Page 44: Capsule Endoscope Set A (Maj-1469)

    Chapter 2 Nomenclature and functions Capsule endoscope set A (MAJ-1469) Capsule endoscope (OLYMPUS EC TYPE1) 2. Top cover 3. Objective lens 1. Exterior package 4. Illumination LED (white LED) 5. Battery 1. Exterior package Exterior package of the capsule endoscope.
  • Page 45 Peel off the lining paper to attach the antenna pad to the patient. 7. Arrow When removing the lining paper from the antenna lead cover, or when removing the antenna lead cover from the patient, start peeling at the position marked by the arrow. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 46: Antenna Lead Set (Maj-1474)

    1. Antenna pad 2. Antenna cable 3. Connection unit 1. Antenna pad Receives signals from the capsule endoscope. 2. Antenna cable Transfers the received signals to the connection unit. 3. Connection unit Connected to the recorder unit. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 47: Recorder Unit (Olympus Re-1)

    Chapter 2 Nomenclature and functions Recorder unit (OLYMPUS RE-1) 1. Indicator lamp 2. Power lamp 3. Display panel 4. Battery pack removal ribbon 11. Power switch 5. Battery pack slot cover 10. Antenna lead set connector 6. Battery pack slot (on backside) 7.
  • Page 48 Attach the antenna lead set here. 11. Power switch Turn the recorder unit ON by holding down the switch for 1 seconds or more. Turn the recorder unit OFF by holding down the switch for 2 seconds or more. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 49: Real Time Viewer (Olympus Ve-1)

    Chapter 2 Nomenclature and functions Real time viewer (OLYMPUS VE-1) 1. Display panel (color) 8. Internal antenna 2. Battery pack removal ribbon (embedded) 7. Power lamp 3. Battery pack slot cover 6. Power switch 4. Battery pack slot 5. Real time viewer cable connector (rubber cap) 1.
  • Page 50 Chapter 2 Nomenclature and functions 7. Power lamp Illuminates green when the real time viewer is turned ON. 8. Internal antenna (embedded) Receives signals from the capsule endoscope in proximity. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 51: Recorder Unit Cradle (Maj-1484)

    ON. Remove the antenna lead set from the recorder unit before attaching the recorder unit to the recorder unit cradle. 4. Power connector Connect the power supply cable here. 5. Recorder unit cradle cable connector Connect the recorder unit cradle cable here. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 52: Real Time Viewer Cable (Maj-1485)

    Connects the recorder unit cradle to the workstation, and transfers data between the recorder unit and the workstation. 2. Connectors Connect to the USB connector on the workstation, and to the recorder unit cradle cable connector on the recorder unit cradle. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 53: Battery Charger (Maj-1476)

    Connects the battery charger to an AC power source. 2. Battery pack slot Place the battery pack in this slot. 3. Charge lamp Illuminates yellow when the battery pack begins charging. Illuminates green when charging is completed. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 54: Battery Pack (Maj-1473)

    2. Connector Connects to the connector in the battery pack slot of the receiver/real time viewer. Also connected to the connector in the battery pack slot of the recharger. 3. Negative (–) terminal Outputs negative voltage. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 55: Recorder Unit Harness (Maj-1475)

    Stores the recorder unit during the examination. 4. Connector cover Covers the connector on the recorder unit to which the real time viewer cable is connected. 5. Pouch cover Secures the recorder unit and the antenna cables to the pouch. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 56: Workstation (Olympus Ws-1)

    4. Mouse For screen operation. 5. Keyboard For data input. 6. USB memory Used for data storage. 2GB capacity. 7. USB HDD (recommended) Used for data backup. If unavailable, please contact Olympus. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 57 Chapter 2 Nomenclature and functions OLYMPUS WS-1 contains workstation hardware (MAJ-1479), LCD monitor (MAJ-1481) and printer (MAJ-1480). OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 58: Chapter 3 Installation And Connection Of The Workstation

    Use in a combustible atmosphere is prohibited. The system is not explosion-proof, and may cause an explosion or a fire. • When turning the system OFF, follow the proper shutdown procedure. Failure to do so may result in equipment damage. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 59 Chapter 3 Installation and Connection of the Workstation • Installing applications not recommended by Olympus on the workstation, or upgrading the Operating System (OS) are prohibited. • Use only the dedicated cables. Use of other cables may result in malfunction and/or equipment damage.

  • Page 60: Installation Of Workstation And Peripherals

    When doing so, be sure not to tangle the cables or trap them under any equipment. Also, be sure not to block the ventilation grills on the workstation and the printer. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 61: Connection Of Equipment

    • Do not use extension power supply cables. A fire or electric shock may result. If the extension of power supply cables is necessary, please contact Olympus. • Do not place the power strip on the floor. Exposure to water and/or dust may cause fire or electric shock.
  • Page 62 (see Figure 3.1). Connect the printer to the workstation. Prepare the printer according to the instruction manual of the printer. Connect the power supply cables for the workstation, LCD monitor, printer, USB HDD, and recorder unit cradle. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 63 Connect the power cables for all equipment to wall power outlets. The conversion cable is equipped with two connectors on the monitor end, but only one of them can be used. Connect the monitor cable to the connector labeled “1”. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 64: Installation Of Endo Capsule Software Light

    Insert the installation CD into the CD-ROM drive. The CD will auto-run, and the Main menu is displayed. On the Main menu, click “Install Endo Capsule Software Light”. The installer will be launched. Follow the instructions on the screen to install the software. Product ID: d2Ht-mx9e-weVz-Kr7b OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 65 In the control panel, double-click “Add or Remove Programs”. The “Add or Remove Programs” screen is displayed. In the “Change or Remove Programs” tab, select the Endo Capsule software light. Click the “Change/Remove” button and follow the instructions on the screen. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 66: Chapter 4 Workstation Access And Setup

    • Turn OFF the workstation when it is not in use. • Remove the USB devices from the workstation and restart the workstation when it does not work properly. Then connect the removed USB devices again. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 67: Login

    Turn ON the monitor and the workstation. The system starts automatically, and the login screen is displayed (see Figure 4.1). Figure 4.1 Enter your user ID and password (see ). User ID Password Figure 4.2 OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 68 Chapter 4 Workstation Access and Setup • When logging in for the first time, enter “olympus” as the user ID and password. After you log in, add a user in the user settings. • Characters that can be used for user IDs and passwords are shown in Table 4.1:...
  • Page 69 Click the [Shutdown] button to turn OFF the workstation. • If the message in Figure 4.4 is displayed, the user ID or password is incorrect. Click the [OK] button, and then check and re-enter the user ID and password. OK button Figure 4.4 OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 70 To change the system time, click the [No] button. If you do not need to change the system time, click the [Yes] button. The main screen is displayed. Set the correct date and time. Figure 4.6 OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 71 If you wish to cancel changing the system time, click the [Cancel] button. On the confirmation screen for the user name and system time, click the [Yes] button. The observation screen is displayed. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 72: Start-Up Of Endo Capsule Software Light

    Double-click the icon of Endo Capsule Software Light on the desktop. Endo Capsule Software Light runs and the user name screen is displayed. Figure 4.7 Enter the user name and click [OK] button. Figure 4.8 Entering the use name is necessary. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 73 Chapter 4 Workstation Access and Setup The main screen is displayed. Figure 4.9 Other software installed on the workstation may cause a software conflict, and prevent Endo Capsule software light from functioning properly. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 74: Nomenclature And Functions Of The Main Screen

    4. Recorder button 5. Menu bar 10. Time display 14. Antenna display 11. Time bar 9. Thumbnail view 12. Average color bar 15. Antenna button 8. Image operation buttons 13. Red color detection bar Figure 4.10 OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

  • Page 75: Capsule Endoscope

    Red color detection function Detects red color in images and indicates the position of red-color detected image data. • Auto review speed adjustment function Adjusts the review speed automatically during the playback or the reverse playback. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 76 Sets the level of structure enhancement. 5. Landmarks button Displays the feature setting screen for setting the feature for thumbnails. 6. Capture button Makes a thumbnail in the image display area. 7. Last button Displays the last image data. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 77 Plays back images at the speed set by a user. 17. Adjust button Automatically adjusts the review speed during the playback. 18. Red button Plays back only the image data detected by the red detection function. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 78 This menu is displayed by clicking “File” on the menu bar (see Figure 4.12). File menu Figure 4.12 Open examination Opens examination data. Close examination Closes examination data. Open thumbnail Opens thumbnail data. Close thumbnail Closes thumbnail data. Save thumbnail Saves thumbnail data. Log off Displays the login screen. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 79 Sets up the time display on the thumbnail. Select from “Real Time” or “Relative Time”. Settings Displays the settings screen. History Displays the history display screen. Diagnosis log Displays the diagnosis log. Select from “view” or “export”. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...
  • Page 80 Chapter 4 Workstation Access and Setup Help menu This menu is displayed by clicking “Help” on the menu bar (see Figure 4.14). Help menu Figure 4.14 Help Displays the help. About Displays the version information of the system. OLYMPUS CAPSULE ENDOSCOPE SYSTEM...

Table of Contents