Olympus Medical Systems EC-1 Low Power Transmitter User Manual GT1629 FCC MAJ 1467 C1
Olympus Medical Systems Corp. Low Power Transmitter GT1629 FCC MAJ 1467 C1
Contents
- 1. Users manual Part 1
- 2. Users manual Part 2
- 3. Users manual Part 3
- 4. Users manual Part 4
- 5. Users manual part 5
Users manual part 5
Chapter 6 Capsule Endoscope Image Observation The folders and the data associated with the selected examination (image data, case data, and exported images) will be removed during the deletion process. 3. Click the [OK] button on the examination data deletion screen (see Figure 6.93). The selected examination data will be deleted. A progress screen is displayed while the examination data is being deleted. OK button Figure 6.93 4. When the deletion of examination data is complete, you will be returned to the examination list screen. 210 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation Writing examination and thumbnail data onto a DVD 1. Select the examination data you wish to write onto a DVD and click the [DVD] button on the examination list screen (see Figure 6.94). The DVD writing screen is displayed. DVD button Figure 6.94 You can select multiple examination data simultaneously. The thumbnail data associated with the selected examination data will be written automatically. 2. Use the drive selection box to select the destination drive to write the data to (see Figure 6.95). The amount of available disk space on the selected drive is displayed. Drive selection box Figure 6.95 • The folder for the examination data will be created automatically during the writing process. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 211 Chapter 6 Capsule Endoscope Image Observation • The following DVD formats are supported: DVD 3. : DVD-R, DVD+R • Though you use DVD-RW or DVD+RV, you cannot rewrite or delete data. • While it is possible to copy the data to an USB HDD, the safety of data on the USB HDD cannot be assured, so it is advised that the user first back up the examination data to a DVD. The selected examination data which you wish to write is displayed (see Figure 6.96). Select examination data Figure 6.96 4. Click the [Option] button to display the DVD writing options screen (see Figure 6.97). Option button Figure 6.97 5. Select the type of files to be written together with the examination data. Click the [Picture] button to write still images, and the [Movie] button to write video files (see Figure 6.98). 212 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation Picture button Movie button Figure 6.98 All items are selected by default. 6. Click the [OK] button to save the settings and exit the DVD writing options screen (see Figure 6.99). OK button Figure 6.99 OLYMPUS CAPSULE ENDOSCOPE SYSTEM 213 Chapter 6 Capsule Endoscope Image Observation 7. Check the “Password” checkbox to set a password (see Figure 6.100). Password checkbox Figure 6.100 If you specify a password when writing the examination data, you will be required to enter the password to open the written examination data. 8. Check the “Make anonymous” checkbox to write the examination data with the individual information removed (see Figure 6.101). Make anonymous checkbox Figure 6.101 214 • Individual information removed include “Patient name” and “Image showing individual information”. • To remove “Image showing individual information”, you will need to set the hiding feature. For more information, refer to “Hiding images” on page 216. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation 9. Click the [OK] button on the DVD writing screen (see Figure 6.102). The selected examination data will be written. The progress screen is displayed while the examination data is being written. OK button Figure 6.102 10. • To stop the writing process, click the [Cancel] button on the progress screen. • If there is insufficient storage space on the writing destination, an error message will be displayed. In that case, refer to Chapter 8, “Troubleshooting” on page 233. • The DVD drive will open after writing the data and close automatically to verify the written data. Please wait until the verification is completed. When writing of examination data is complete, the examination list screen will be displayed. Finalize the report before you write the report onto the DVD. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 215 Chapter 6 Capsule Endoscope Image Observation Hiding images You can specify images that contain the facial portrait of a patient to be hidden when copying or exporting examination data. To hide images, the “Make anonymous” checkbox must be checked when copying or writing the examination data. 1. • Specify the first image and the last image of the display range. Images between the first and last images will be included, and all other images will be excluded (hidden). • By default, the first and last images of each examination are used as the first and last images of the display range. On the main screen, open the examination data which contains the images to be hidden (“Opening examination data and thumbnail data from the examination list screen” on page 148). 2. Display your desired first image in the image display area (6.3 “Image observation” on page 155). 3. Right-click on the image and select “First” from “Display range” in the context menu (see Figure 6.103). “First” Figure 6.103 4. Display your desired last image in the image display area (6.3 “Image observation” on page 155). 216 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation 5. Right-click on the image and select “Last” from “Display range” in the context menu (see Figure 6.104). “Last” Figure 6.104 6. To reset the display range, right-click on an image and select “Reset” from “Display range” in the context menu (see Figure 6.105). “Reset” Figure 6.105 OLYMPUS CAPSULE ENDOSCOPE SYSTEM 217 Chapter 6 Capsule Endoscope Image Observation 6.6 Exporting image data You can export image data as still images or videos. Export settings can be configured on the export screen. Export screen 3. Back button 4. Export list 2. Picture list 5. Drive selection box 1. Movie list 6. Format selection area Figure 6.106 1. Movie list Displays the list of movie files to be created. 2. Picture list Displays the list of picture files to be created. 3. Back button Returns to the main screen. 4. Export list Displays the list of movie files and picture files to be exported. 5. Drive selection box Selects the drive to which the movie files and picture files are exported. 6. Format selection area Selects the picture format used for exporting the picture files. 218 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation Movie type Movie The images before and after the selected thumbnail change into a movie. The number of images is defined in the movie settings. Combined movie The movies created for each thumbnail are combined. The number of images is defined in the movie settings. Clipped movie The images between the first and last of the selected thumbnails change into a movie. Movie M ovi Combined movie C om bined m ovie Clipped C lipped m ovimovie Thumbnail Thum bnail OLYMPUS CAPSULE ENDOSCOPE SYSTEM of the thecreated createdmmovie RRange ange of ovie 219 Chapter 6 Capsule Endoscope Image Observation Movie settings The number of images used to form a movie is set on the movie settings screen. 1. Select “Settings” from the “Tools” menu on the main screen. 2. Click the “Clips” tab. The movie settings screen is displayed (see Figure 6.107). Clips tab Figure 6.107 3. Set the number of images to be added before and after the selected thumbnail (see Figure 6.108). Figure 6.108 You can specify a number between 1 and 999. 4. 220 Click the [OK] button on the movie settings screen. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation Creating pictures / movies / combined movies / clipped movies The created pictures and movies are stored on the workstation. To export a picture or movie file, refer to “Exporting picture / movie files” on page 225. 1. On the main screen, open the examination data (see “Opening thumbnail data from the menu” on page 152). 2. Create thumbnails you wish to include in your export (see “Creating thumbnails” on page 163). 3. Select the thumbnails you wish to include in your export (see Figure 6.109). To select multiple thumbnails, click the thumbnails while holding down the [Shift] key on the keyboard. Figure 6.109 OLYMPUS CAPSULE ENDOSCOPE SYSTEM 221 Chapter 6 Capsule Endoscope Image Observation 4. To create pictures, right-click on one of the selected thumbnails and select “Export” and then “Picture” from the context menu (see Figure 6.110). Picture menu Figure 6.110 The exported file name is determined automatically. The data is exported to the D drive as generic image files. 5. To create movies, right-click on one of the selected thumbnails and select “Movie” from the context menu (see Figure 6.111). Movie menu Figure 6.111 222 • The exported file name is determined automatically. • The file is exported in AVI format. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation 6. To create a combined movie, right-click on one of the selected thumbnails and select “Combined movie” from the context menu (see Figure 6.112). The images for the selected thumbnails are combined into a movie. Combined movie menu Figure 6.112 • The “Combined movie” context menu item can be selected only when multiple thumbnails have been selected. • The exported file name is determined automatically. The data is exported as generic image files. • The file is exported in AVI format. • If the number of images that form the combined video exceeds 10000, the video will be divided into multiple files. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 223 Chapter 6 Capsule Endoscope Image Observation 7. To create a clipped movie, right-click on one of the selected thumbnails and select “Clipped movie” from the context menu (see Figure 6.113). All images between the first and the last selected thumbnails are combined into a movie. Clipped movie menu Figure 6.113 224 • The “Combined movie” context menu item can be selected only when multiple thumbnails have been selected. • The export file name is determined automatically. • The file is exported in AVI format. • If the number of images that form the combined video exceeds 10000, the video will be divided into multiple files. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation Exporting picture / movie files 1. Click the [Export] button on the main screen (see Figure 6.114). The export screen is displayed. Export button Figure 6.114 2. Use the drive selection box to select the destination drive for the export (see Figure 6.115). The amount of available disk space on the selected drive is displayed. Figure 6.115 OLYMPUS CAPSULE ENDOSCOPE SYSTEM 225 Chapter 6 Capsule Endoscope Image Observation 3. Select the picture and/or movie files you wish to export (see Figure 6.116). Figure 6.116 4. Click the [ ] button to add the picture and/or movie files you wish to export to the export list from the picture list or the movie list (see Figure 6.117). button Figure 6.117 To clear a picture or movie file from the export list select the file you wish to clear and click the [Clear] button. 226 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation 5. Select “Copy” or “Delete”. Copy Delete Figure 6.118 6. You can copy the picture files in one of the following four formats (see Figure 6.119). • BMP (bitmap) • JPEG • TIFF • PNG Format selection area Figure 6.119 OLYMPUS CAPSULE ENDOSCOPE SYSTEM 227 Chapter 6 Capsule Endoscope Image Observation 7. Click the [OK] button on the export screen (see Figure 6.120). The selected files will be exported. The progress screen is displayed while the files are being exported. OK button Figure 6.120 8. • To stop the export process, click the [Cancel] button on the progress screen. • If there is insufficient storage space on the export destination, an error message will be displayed. In this case, refer to Chapter 8, “Troubleshooting” on page 233. When exporting is complete, you will be returned to the export screen. The picture or movie files is exported to the following location. (∗) Words in parentheses vary according to the exported data. 228 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 6 Capsule Endoscope Image Observation 6.7 Browsing the image observation operation history Operation history for the image observation is automatically recorded. 1. From the “Tools” menu on the main screen, select “Diagnosis log” and then “View” (see Figure 6.121). The diagnosis log screen is displayed. Figure 6.121 • Date, time, and user name for each operation are recorded in the log. • To export a diagnosis log, select “Diagnosis log” and then “Export” from the “Tools” menu on the main screen. • The log can be exported in text format. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 229 Chapter 7 Care Storage and Disposal Chapter 7 Care Storage and Disposal 7.1 Care • After wiping with a place of moistened gauze, dry the capsule endoscope system thoroughly before using it again. If it is used while still wet, there is the risk of electrical shock. • When cleaning the capsule endoscope system, always wear appropriate personal protection equipment. Blood, mucous and other potentially infectious material adhering the video system center could pose and infection control risk. • Do not soak the system components in water, or sterilize them using autoclave or gas. Doing so will damage the system. • Do not wipe the external surfaces with hard or abrasive wiping material. Doing so will scratch the surface. After using the system, immediately perform the following cleaning procedure. 1. Remove dust, dirt, and other stains on the surface of the antenna pads and the antenna lead set using a piece of gauze moistened with a neutral detergent, then wipe the surfaces using a piece of gauze moistened with 70% ethyl or isopropyl alcohol. 2. Remove dust, dirt, and other stains on the surface of the following equipment using a piece of gauze moistened with a neutral detergent, then wipe the surfaces using a piece of gauze moistened with 70% ethyl or isopropyl alcohol. After doing so, dry them thoroughly. • Recorder unit • Recorder unit cradle • Real time viewer • Real time viewer cable • Recorder unit cradle cable • Battery charger • Recorder unit harness • Capsule activator Do not soak the equipment in any liquid. It may damage the equipment. 230 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 7 Care Storage and Disposal 3. If the recorder unit harness has become stained, first clean off the stain using a piece of gauze moistened with a neutral detergent, then wipe off with a piece of cloth moistened with water. Alternatively, the recorder unit harness can be machine-washed. Do not iron or dry clean the recorder unit harness to shrink slightly. Note that machine-washing may cause the recorder unit harness to shrink slightly. 4. 7.2 If the recorder unit harness becomes wet, be sure to dry it completely. Storage • Store the unused capsule endoscopes in a dark place, at temperature from 0°C/32°F to 25°C/77°F. Avoid storing the capsule endoscopes in a refrigerator or a freezer, as it may cause condensation. • Keep water and any other liquid away from the system components. It may cause equipment damage. • Do not store the system in a location exposed to direct sunlight, UV rays, X-rays, radio activity, or strong electromagnetic radiation (e.g. near microwave therapy equipment, shortwave therapy equipment, MRI equipment, radio, or mobile phones). They may damage the system. • Do not store the system in a location affected by high temperature, high humidity, barometric pressure, dust, salt or ozone. They may damage the system. • Store the system in a location immune to vibrations and impacts. They may damage the system. After cleaning the equipment according to the procedure given in Section 7.1, “Care”, be sure to dry it off thoroughly. When the equipment is dry, place them into their designated positions in the carrying cases for storage. Store the carrying cases in a clean and dry location. For details of the storage environment, refer to “Operating/storage environment” on page 240 in the Appendix. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 231 Chapter 7 Care Storage and Disposal 7.3 Disposal • When disposing of any item, follow all applicable national and local laws and guidelines. • The capsule endoscope is discharged naturally. 232 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 8 Troubleshooting Chapter 8 Troubleshooting If, during the inspections described in Chapter 5, “Capsule Endoscope Procedures” on page 96, the system or any of its components appears to have problems, refer to 8.1 “Troubleshooting” on page 233 to correct the problem. If the problem persists, stop using the system, and refer to 8.2 “Returning the system for repair” on page 239 to correct the situation. If the problem cannot be resolved by these countermeasures, contact Olympus. Never use the system if any abnormality is suspected. Damage to or irregularity in the system not only causes malfunctioning, but may also cause injury to the patient’s body cavity. 8.1 Troubleshooting The following table lists the possible causes of and countermeasures for troubles that may occur due to equipment setting errors or deterioration of consumables. Also refer to “Recorder unit error messages” on page 235 and “Real time viewer error messages” on page 236 on pages 235 to 236. Troubles or failures other than those listed in the following table require 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 (refer to Section 8.2). Irregularity Possible Cause Solution Capsule endoscope’s LED fails to illuminate. The power is not turned ON. Use the capsule activator to turn the power ON. The capsule endoscope is broken. Use a new capsule endoscope. Recorder unit’s power fails to come ON. The battery pack is missing. Insert a charged battery pack. The battery pack is low. Recharge the battery pack. Recorder unit’s power lamp fails to illuminate. The recorder unit is broken. Try turning on the recorder unit power again. If problem persists, contact Olympus. Real time viewer’s power fails to come ON. The battery pack is missing. Insert a charged battery pack. The battery pack is low. Recharge the battery pack. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 233 Chapter 8 Troubleshooting Irregularity Possible Cause The real time viewer’s power lamp fails to illuminate. The real time viewer is broken. Try turning on the viewer power again. If the problem persists, contact Olympus. Images from the The real time viewer is broken. Contact Olympus. The capsule endoscope is broken. Use a new capsule endoscope. The real time viewer is too far Reduce the distance between the from the capsule endoscope. real time viewer and the capsule endoscope. The antenna lead set cable is broken. Contact Olympus. The real time viewer cable is not connected. Connect the real time viewer cable properly. The antenna lead set is not connected to the recorder unit. Connect the antenna lead set to the recorder unit properly. The antenna lead set is too far from the capsule endoscope. Reduce the distance between the antenna and the capsule endoscope. The recorder unit fails to turn OFF. The power switch is not held down long enough. Hold down the power switch for 2 seconds or more. The battery charger’s charge lamp blinks in yellow. (1.5 second intervals) The battery pack cannot be recharged because its temperature is below 0°C (32°F). Charge the battery at or above 0°C (32°F). The battery charger’s charge lamp blinks in yellow. (0.5 second intervals) The battery pack or the battery charger is broken. Use another battery pack or battery charger. capsule endoscope are not displayed by the real time viewer. (When using the real time viewer alone.) Images from the capsule endoscope are not displayed by the real time viewer. (When connected to the recorder unit.) 234 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Solution Chapter 8 Troubleshooting Recorder unit error messages Error code on Recorder Unit’s Display Panel Possible Cause System error Solution 1. Restart the system. 2. If the error persists, contact Olympus. RTC error 1. Connect the recorder unit to the workstation, and perform initialization. 2. If error persists after initialization, contact Olympus. Internal memory error Contact Olympus. Battery pack error Replace with a new battery pack. Internal memory full Connect the recorder unit to the workstation, and download the data from the Recorder Unit. Uncharged battery pack Recharge the battery pack, or replace it with a charged battery pack. Patient Information not registered Connect the recorder unit to the workstation, and perform initialization. Low battery pack Recharge the battery pack, or replace it with a charged battery pack. Less than 8 hours of storage space left in internal memory Connect the recorder unit to the workstation, and download the data from the Recorder Unit. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 235 Chapter 8 Troubleshooting Error code on Recorder Unit’s Display Panel Possible Cause Time to replace battery pack. Solution Order a new battery pack from Oympus, and replace it. If you continue to use the battery pack for a prolonged period with these warning icons are displayed, the low battery pack icon ( on page 235) may blink in continuously, and may not allow the examination to be performed. Antenna lead set disconnected Connect the antenna lead set to the recorder unit. 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. Real time viewer error messages Error Code on Real Time Viewer’s Display Panel Possible Cause Uncharged battery pack E000 System error Solution Recharge the battery pack, or replace it with a charged battery pack. 1. Restart the system. 2. If the error persists, contact Olympus. Workstation error messages Message 236 Solutions System error occurred. (E∗∗∗) Contact service center. Contact Olympus. System is unstable. Shutdown and restart workstation. Shut down and restart workstation. User ID and/or password is incorrect. Enter correct user ID/password (case sensitive). Enter correct user ID/password (case sensitive) with the right uppercase/lowercase combination. Invalid value entered in date and/or time. Enter correct value. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 8 Troubleshooting Message Solutions Possible recorder failure. Contact Olympus. Error occurred during communication with recorder. Check connection between workstation and recorder Invalid value entered in date of birth. Enter correct value. Invalid value entered in height. Enter correct value. Invalid value entered in weight. Enter correct value. Invalid value entered in waist size. Enter correct value. Possible recorder failure. If initialization fails, send recorder for repair. Try again. Contact Olympus if the initialization fails again. Cannot download because there is not enough disk space available. Back up examination data to the workstation to free up space for download. Low disk space on workstation for saving download data. Back up examination data from the workstation to free up space for download. If the recorder can not be recognized, turn off the recorder and remove it from the cradle. Then, connect the recorder to the cradle again. Connect the recorder to the cradle again. Unusable file. Contact Olympus. Cannot open file because password is incorrect. Enter correct password. Cannot open thumbnail data because examination data and thumbnail data are for different examinations. Open the appropriate findings file that matches the examination data. Cannot check out data because destination does not have sufficient disk space. Create enough disk space to check out. Examination data contains multiple capsule IDs. Before starting the observation, check the images before and after the capsule ID change to determine whether to use this examination data in the diagnosis. Before starting the observation, check the images before and after the capsule ID change to determine whether to use this examination data in the diagnosis. Cannot check in data because destination does not have sufficient disk space. Create sufficient disk space to check in. Cannot copy data because destination does not have sufficient disk space. Create sufficient disk space to copy data. Cannot write data because destination does not have sufficient disk space. Create sufficient disk space to write data. Cannot import data because workstation does not have sufficient disk space. Create sufficient disk space to import data. Create sufficient disk space to import data. Cannot open history because report file does not exist. Contact Olympus. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 237 Chapter 8 Troubleshooting Message The old password you typed is incorrect. Please retype the old password. Solutions Retype the old password. Remove the write protection, or use This disk is write-protected. Remove the write protection, or use another disk. another disk. One of the hard drives is corrupt. Contact Service Center for repairs. Contact Olympus. The DVD type is not supported. Use a DVD of the type specified in the manual. Printer power is off. Turn on the printer. Cannot display print preview because printer driver is not installed. Install the printer driver. Invalid data. Contact Olympus. The system cannot find the file specified. Contact Olympus. The system cannot find the path specified. Contact Olympus. The specified module could not be found. Contact Olympus. A file name cannot contain any of following charactors : ¥/:*?"<>| Contact Olympus. The media is write protected. Remove the write protection or use another media. The process cannot access the file because it is being used by another process. Contact Olympus. The specified file is read only. Contact Olympus. The system cannot open the file. Contact Olympus. Access is denied. Contact Olympus. The process cannot access the file because another process has locked a portion of the file. Contact Olympus. The directory or file cannot be created. Contact Olympus. The file name is too long. Shorten the file name and retry. There is not sufficient disk space in workstation. Contact Olympus. The process cannot access the file. Contact Olympus. In the case that you have lost your password, contact Olympus. 238 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Chapter 8 Troubleshooting 8.2 Returning the system for repair Olympus is not liable for any injury or damage occurring as a result of repairs attempted by non-Olympus personnel. Before sending the system for repair, contact Olympus. With the system, include a description of malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem. To purchase accessories and consumables, contact Olympus. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 239 Appendix Appendix Operating/storage environment Capsule endoscope Operating Environment Storage Environment Ambient temperature 10 to 40°C (50 to 104°F) 0 to 25°C (32 to 77°F) *1 Relative humidity N/A 30 to 85% *2 Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) *1 Storage outside the storage environment range may cause condensation and/or deterioration of the battery. *2 no condensation (inside the capsule endoscope) Antenna lead set Operating Environment Storage Environment Ambient temperature 0 to 50°C (32 to 122°F) –20 to +70°C (–4 to +158°F) Relative humidity 30 to 90% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) no condensation Recorder unit Operating Environment Ambient temperature 0 to 50°C (32 to 122°F) –20 to +70°C (–4 to +158°F) Relative humidity 30 to 90% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) 240 Storage Environment no condensation OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Real time viewer Operating Environment Storage Environment Ambient temperature 10 to 40°C (50 to 104°F) –20 to +50°C (–4 to +122°F) Relative humidity 30 to 85% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) no condensation Recorder unit cradle Operating Environment Storage Environment Ambient temperature 10 to 40°C (50 to 104°F) –20 to +70°C (–4 to +158°F) Relative humidity 30 to 85% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) no condensation Battery charger Operating Environment Storage Environment Ambient temperature 0 to 40°C (32 to 104°F) –20 to +50°C (–4 to +122°F) Relative humidity 30 to 85% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) no condensation OLYMPUS CAPSULE ENDOSCOPE SYSTEM 241 Appendix Battery pack Operating Environment Ambient temperature 0 to 50°C (32 to 122°F) Recharging: 0 to 40°C (32 to 104°F) Discharging: 0 to +50°C (–4 to +140°F) Relative humidity 30 to 90% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) Storage Environment 0 to 50°C (–32 to 122°F) Avoid prolonged storage at temperatures exceeding 40°C/104°F. 10 to 95% * 700 to 1060 hPa (10.2 to 15.4 psia) no condensation Recorder unit harness Operating Environment Storage Environment Ambient temperature 0 to 50°C (32 to 122°F) –20 to +70°C (–4 to +158°F) Relative humidity 30 to 90% * 10 to 95% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) no condensation Antenna lead cover Operating Environment Ambient temperature 10 to 45°C (50 to 113°F) Up to 27°C (80.6°F) Relative humidity 30 to 90% * 40 to 60% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) 242 Storage Environment no condensation OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Workstation hardware Operating Environment Storage Environment Ambient temperature 5 to 35°C (41 to 95°F) –40 to +60°C (–40 to +140°F) Relative humidity 8 to 85% 8 to 90% * Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) Printer Operating Environment Storage Environment Ambient temperature 15 to 35°C (59 to 95°F) –40 to +70°C (–40 to +158°F) Relative humidity 20 to 80% 20 to 80% Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) 700 to 1060 hPa (10.2 to 15.4 psia) LCD monitor Operating Environment Ambient temperature 15 to 35°C (59 to 95°F) Relative humidity 20 to 80% Barometric pressure 700 to 1060 hPa (10.2 to 15.4 psia) OLYMPUS CAPSULE ENDOSCOPE SYSTEM 243 Appendix Specifications System chart Antenna lead set Capsule endoscope Real time viewer Recorder unit Real time viewer cable UP UP Receiver unit cradle cable Battery charger Recorder unit cradle Workstation 244 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix The system (components within the bold dotted line) is IEC 60601-1 certified in a configuration that includes the capsule endoscope, antenna lead set, recorder unit, real time viewer, and real time viewer cable. The recorder unit cradle, recorder unit cradle cable, battery charger, and workstation are IEC 60950 certified. • In order to provide the intended functionality, the system emits RF energy while in operation. This may affect electrical devices in the vicinity. The patient should keep a distance from such devices. • Testing has shown only minimal effect on other electrical equipment while the system is operating. However, when inspecting or using the capsule endoscope, do so in a location such as a shielded room, where there is no risk that the system will interfere with the operation of other electrical equipment. • The system conducts weak radio communication. Images may be lost or distorted when operating in an environment affected by electromagnetic transmissions (such as that of portable RF communication devices). Avoid use in such environments. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 245 Appendix Capsule endoscope Capsule endoscope (OLYMPUS EC TYPE 1) Product Name Optics Field of view (maximum) 145° Depth of field 0 to 20 mm Sampling Rate Power Supply 2 fps Power source Internal battery Voltage DC 2.7 to 3.1V Current 1 – 30 mA Battery Life Size Classification as Medical Electrical Equipment 8 hours Weight 3.8 g Dimensions ø 11 mm (diameter) × 26 mm (length) Type of protection against electric shock Internal power supply Degree of protection against electric shock TYPE BF Degree of protection against explosion Use under combustible atmosphere prohibited. Medical Device Directive This device complies with the requirements of directive 93/42/EEC concerning medical devices. Classification: Class IIa This device complies with the EMC requirements of EN 60601-1-2 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55011 R&TTE Directive EMC This device complies with the requirements of directive 1999/5/EEC. Classification: Class II Applied standard; IEC 60601-1-2:2001 IEC 60601-2-18:1996 246 This instrument complies with the standard listed in the left column only when connecting with the instruments listed in the system diagram on page 244. CISPR 11 of emission: Group 1, Class B OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Product Name Year of Manufacturer 2005033 Capsule endoscope (OLYMPUS EC TYPE 1) The year of manufacture is indicated by the first 4 digits of the serial number. * The year of manufacture indicates the serial number of MAJ-1469. FCC ID :38QEC-1 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. IC :4763B-EC1 OLYMPUS CAPSULE ENDOSCOPE SYSTEM “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 opertation of the device.” 247 Appendix Recorder unit Product Name Power Supply Power source Battery pack (MAJ-1473) Voltage DC 6.7V – 8.4V Current 550 mA Battery Life Size Classification as Medical Electrical Equipment Recorder Unit (OLYMPUS RE-1) 8 hours or longer Weight 515 g (including battery) Dimensions 90 mm (W) × 175 mm (H) × 43 mm (D) Type of protection against electric shock Internal power supply Degree of protection against electric shock TYPE BF Degree of protection against explosion Use under combustible atmosphere prohibited. Medical Device Directive This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 60601-1-2 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55011 WEEE Directive 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. Year of manufacture 248 1512345 The year of manufacture is indicated by the second digit of the serial number. OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Product Name EMC Applied standard; IEC 60601-1-2:2001 Recorder Unit (OLYMPUS RE-1) This instrument complies with the standard listed in the left column only when connecting with the instruments listed in the system diagram on page 244. CISPR 11 of emission: Group 1, Class B (with battery pack inserted) Real time viewer Product Name Power Supply Power source Battery pack (MAJ-1473) Voltage DC 6.7V – 8.4V Current 750 mA Battery Life Size Classification as Medical Electrical Equipment Real Time Viewer (OLYMPUS VU-1) 3 hours or longer Weight 550 g (including battery) Dimensions 90 mm (W) × 175 mm (H) × 43 mm (D) Type of protection against electric shock Internal power supply Degree of protection against electric shock TYPE BF Degree of protection against explosion Use under combustible atmosphere prohibited. Medical Device Directive and R&TTE Directive This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 60601-1-2 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55011 This device complies with the requirements of directive 1995/5/EEC. Classification: Class I OLYMPUS CAPSULE ENDOSCOPE SYSTEM 249 Appendix Product Name Real Time Viewer (OLYMPUS VU-1) WEEE Directive 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. Year of manufacture EMC 1512345 The year of manufacture is indicated by the second digit of the serial number. Applied standard; IEC 60601-1-2:2001 This instrument complies with the standard listed in the left column only when connecting with the instruments listed in the system diagram on page 244. CISPR 11 of emission: Group 1, Class B (with battery pack inserted) Recorder unit cradle Product Name Power Supply Size Medical Device Directive Recorder Unit Cradle (MAJ-1484) Voltage AC 100 – 240V Frequency 50 – 60Hz Current 2A Weight Main body:230 g Dimensions 128 mm (W) × 80.8 mm (H) × 114.5 mm (D) AC Adapter:275 g This device complies with the requirements of directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 55022 and EN 55024 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55022 250 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Product Name WEEE Directive Recorder Unit Cradle (MAJ-1484) 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. Year of manufacture 1512345 The year of manufacture is indicated by the second digit of the serial number. Battery charger Product Name Power Supply Size Battery Charger (MAJ-1476) Voltage AC 100 – 240V Frequency 50 – 60Hz Current AC 100V 53VA / AC 240V 70VA Weight 330 g Dimensions 110 mm (W) × 48.6 mm (H) × 150 mm (D) Medical Device Directive This device complies with the requirements of directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 55022 and EN 55024 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55022. WEEE Directive 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. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 251 Appendix Battery pack Product Name Battery pack (MAJ-1473) Type Lithium-Ion storage cell Capacity 3600mAh Voltage 7.4V Recharging Time Approx. 2 hours Size Weight 180 g Dimensions 72 mm (W) × 24.7 mm (H) × 60 mm (D) Medical Device Directive This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 60601-1-2 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55011. In accordance with the EU Batteries Directive, the battery packs are marked with a recycle logo. Follow all applicable regulations in their handling. If you are unsure of the regulations for your country, contact Olympus. Real time viewer cable Product Name Length 252 Real Time Viewer cable (MAJ-1485) 1.05 m OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Antenna lead set Product Name Size Antenna Lead Set (MAJ-1474) Weight 200 g Dimensions 88 mm (W) × 68.7 mm (H) × 23 mm (D) The number of antennas Medical Device Directive and R&TTE Directive This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 60601-1-2 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55011 This device complies with the requirements of directive 1995/5/EEC. Classification: Class I WEEE Directive 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. Antenna lead cover Product Name Size Dimensions Antenna Lead Cover (MAJ-1470) 92 mm (W) × 66 mm (H) OLYMPUS CAPSULE ENDOSCOPE SYSTEM 253 Appendix Recorder unit harness Product Name Size Recorder Unit Harness (MAJ-1475) Weight 220 g Dimensions 1770 mm (W) × 220 mm (H) Workstation hardware Product Name Workstation Hardware (MAJ-1479) Power Supply AC 100 – 240V / 50 – 60 Hz / 400 Hz Power Consumption 450W Size Function Weight 12.1 kg Dimensions 168 mm (W) × 450 mm (H) × 456 mm (D) Initialize Transfer the patient information and examination data from a workstation to a recorder before the examination. Download Transfer the recorded data from a recorder to a workstation after the examination. Observation Display images downloaded from a recorder. Making report Insert the images and add comments to make a report. Exporting picture / movie Make pictures and movies from the selected thumbnails and export them. Red color detection Select images showing the suspected bleeding symptom from all the recorded images. Medical Device Directive This device complies with the requirements of directive 93/42/EEC concerning medical devices. Classification: Class I This device complies with the EMC requirements of EN 55022 and EN 55024 when used in combination with devices bearing CE marking either on the products or in its instructions. Emission: Class B of EN 55022 254 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Printer Product name Printer (MAJ-1480) Power consumption 75W Size Weight 9 kg Dimensions 510 mm (W) x 210 mm (H) x 420 mm (D) LCD monitor Product name LCD monitor (MAJ-1481) Power consumption 25W Size Weight 5.7 kg Dimensions 351 mm (W) x 422 mm (H) x 210 mm (D) OLYMPUS CAPSULE ENDOSCOPE SYSTEM 255 Appendix EMC information Compliance information and suggested electromagnetic environment: electromagnetic emission The system is designed for use under the following electromagnetic environment. Emission Standard Radio Frequency Applicability Group 1 In order to provide the intended functionality, the system must emit RF energy while in operation. This may affect electrical devices in the vicinity. Radio Frequency Emission CISPR 11 Class B The amount of RF emission by the system is very small, with little possibility of affecting nearby electrical equipment. Harmonic Emissions IEC 61000-3-2 Not applicable The system is not powered by a commercial power source. Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Not applicable The system is not powered by a commercial power source. Emission CISPR 11 256 Notes OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Compliance information and suggested electromagnetic environment: electromagnetic immunity Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2 IEC 60601-1-2 Testing Level Contact: ±2, ±4, ±6kV Aerial: ±2, ±4, ±8kV Compatibili ty Level See left Suggested Environment Material unlikely to produce static electricity, such as wood, concrete, or ceramic tiles, are recommended for the floor. If the floor is made of materials that are likely to produce static electricity, maintain the relative humidity above 30%. Electrical Fast Transient / Burst IEC 61000-4-4 Power line ±2kV I/O line ±1kV Not applicable The system does not have a cable for this signal. Surge IEC 61000-4-5 Differential mode: ±0.5, ±1kV Common mode: ±0.5, ±1, ±2kV Not applicable The system is not powered by a commercial power source. Voltage Dips, Short Interrutions and Voltage Variations on <5%UT (>95% dip in UT) Not applicable for 0.5 cycle The system is not powered by a commercial power source. Power Supply Input Lines IEC 61000-4-11 40%UT (60% dip in UT) for 5 cycle 70%UT (30% dip in UT) for 25 cycle <5%UT (>95% dip in UT) for 5 sec. Power Frequency 3A/m (50/60Hz) Magnetic Field IEC 61000-4-8 OLYMPUS CAPSULE ENDOSCOPE SYSTEM See left Power frequency magnetic field should be similar in characteristics to general locations within a standard commercial or medical environment. 257 Appendix Cautions and recommended electromagnetic environment regarding portable and mobile RF communications equipment such as a cellphone Immunity Test IEC 60601-1-2 Testing Level Compatibility Level Radiated Immunity IEC 61000-4-3 3V/m (80MHz 2.5GHz) See left Conducted Immunity IEC 61000-4-6 3Vrms Not applicable Recommended separation distance d=1.2√P 80MHz to 800MHz d=1.2√P 80MHz to 2.5GHz — Keep portable RF communication devices away from all parts of the system (including the cables) by at least the recommended separation distance, computed for the transmission frequency. Here, P is the maximum power export of the device, as specified in watts (W) by the manufacturer, and d is the recommended separation distance in meters (m). The system satisfies the requirements for IEC 60601-1-2 compliance, but may experience electromagnetic interference in an electromagnetic environment exceeding the requirements. The system may experience electromagnetic interference near high frequency operating devices, and other devices marked with the following symbols. 258 OLYMPUS CAPSULE ENDOSCOPE SYSTEM Appendix Recommended separation distance between system and portable RF communication equipment Separation Distance Based on Transmission Frequency (m) Maximum Power Output of Transmitter P(W) 0.15 MHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 The above table provides some calculations of the distance between the system and the transmitter. The values may vary depending on the architectural structure and the environment in which the system is used. OLYMPUS CAPSULE ENDOSCOPE SYSTEM 259 Appendix 260 OLYMPUS CAPSULE ENDOSCOPE SYSTEM ©2005 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION. Microsoft, Windows, Windows, NT, PowerPoint, and MS-DOS are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (0426)46-2429 Telephone: (0426)42-2111 Distributed by Two Corporate Center Drive, PO Box 9058 Melville, N.Y. 11747-9058, U.S.A. Fax: (631)844-5442 Telephone: (631)844-5000 One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A. Fax: (845)398-9444 Telephone: (845)398-9400 6100 Blue Lagoon Drive, Suite 390 Miami, FL 33126-2087, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332 (Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany (Letters) Postfach 10 49 08, 20034 Hamburg, Germany Telephone: (040)237730 KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Fax: (01702)465677 Telephone: (01702)616333 117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia Fax: (095)958-2277 Telephone: (095)958-2245 Room 1406, E Tower, GongYuan No.6 Royal Palace, No.6 GongYuanXiJie, Jian Guo Men Nei, DongCheng District, Beijing, 100005, China Fax: (10)6518-0865 Telephone: (10)6518-8080 8F, Hyundai Marines Bldg., 646-1, Yeoksam-Dong, Kangnam-Gu, Seoul 135-080 Korea Fax: (02)6255-3499 Telephone: (02)1544-3200 491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010 31 Gilby Road, Mount Waverley, VIC., 3149, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400 GT1629 FCC Printed in Japan 20050124 *0000
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