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

Users manual part 5

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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.
Figure 6.93
4. When the deletion of examination data is complete, you will be returned to
the examination list screen.
OK button
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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.
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.
Figure 6.95
• The folder for the examination data will be created
automatically during the writing process.
DVD button
Drive selection box
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• The following DVD formats are supported:
• 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.
3. The selected examination data which you wish to write is displayed (see
Figure 6.96).
Figure 6.96
4. Click the [Option] button to display the DVD writing options screen (see
Figure 6.97).
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).
DVD : DVD-R, DVD+R
Select examination
data
Option button
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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).
Figure 6.99
Picture button
Movie button
OK button
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7. Check the “Password” checkbox to set a password (see Figure 6.100).
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).
Figure 6.101
• 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.
Password checkbox
Make anonymous
checkbox
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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.
Figure 6.102
• 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.
10. 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.
OK button
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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.
• 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.
1. 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).
Figure 6.103
4. Display your desired last image in the image display area (6.3 “Image
observation” on page 155).
“First”
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5. Right-click on the image and select “Last” from “Display range” in the
context menu (see Figure 6.104).
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).
Figure 6.105
“Last”
“Reset”
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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
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.
6. Format
selection area
4. Export list
3. Back button
2. Picture list
1. Movie list
5. Drive
selection box
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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
Combined m ovie
Clipped m ovie
Thum bnail R a n g e o f th e c re a te d m o v ie
Movie
Combined movie
Clipped movie
Thumbnail Range of the created movie
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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).
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. Click the [OK] button on the movie settings screen.
Clips tab
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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
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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).
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).
Figure 6.111
• The exported file name is determined automatically.
• The file is exported in AVI format.
Picture menu
Movie menu
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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.
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.
Combined movie
menu
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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.
Figure 6.113
• 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.
Clipped movie
menu
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Exporting picture / movie files
1. Click the [Export] button on the main screen (see Figure 6.114). The export
screen is displayed.
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
Export button
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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).
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.
button
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5. Select “Copy” or “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
Figure 6.119
Delete
Copy
Format
selection area
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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.
Figure 6.120
• 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.
8. 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.
OK button
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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.
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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.
Do not soak the equipment in any liquid.
It may damage the equipment.
• Recorder unit • Recorder unit cradle • Real time viewer
• Real time viewer cable • Recorder unit cradle cable • Battery charger
• Recorder unit harness • Capsule activator
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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. If the recorder unit harness becomes wet, be sure to dry it completely.
7.2 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.
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7.3 Disposal
• When disposing of any item, follow all applicable national and local laws and
guidelines.
• The capsule endoscope is discharged naturally.
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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.
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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
capsule
endoscope are not
displayed by the
real time viewer.
(When using the
real time viewer
alone.)
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
from the capsule endoscope.
Reduce the distance between the
real time viewer and the capsule
endoscope.
Images from the
capsule
endoscope are not
displayed by the
real time viewer.
(When connected
to the recorder
unit.)
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.
Irregularity Possible Cause Solution
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Recorder unit error messages
Error code on Recorder
Unit’s Display Panel Possible Cause Solution
System error 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.
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* 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
Workstation error messages
Time to replace
battery pack.*
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.
Error Code on Real Time
Viewer’s Display Panel Possible Cause Solution
Uncharged battery
pack
Recharge the battery pack, or
replace it with a charged battery
pack.
E000 System error 1. Restart the system.
2. If the error persists, contact
Olympus.
Message 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.
Error code on Recorder
Unit’s Display Panel Possible Cause Solution
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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.
Message Solutions
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In the case that you have lost your password, contact
Olympus.
The old password you typed is incorrect.
Please retype the old password.
Retype the old password.
This disk is write-protected.
Remove the write protection, or use another disk.
Remove the write protection, or use
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.
Message Solutions
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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.
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Appendix
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Appendix
Operating/storage environment
Capsule endoscope
*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
* no condensation
Recorder unit
* no condensation
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)
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)
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)
Appendix
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Real time viewer
* no condensation
Recorder unit cradle
* no condensation
Battery charger
* no condensation
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)
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)
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)
242
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Battery pack
* no condensation
Recorder unit harness
* no condensation
Antenna lead cover
* no condensation
Operating Environment Storage 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)
0 to 50°C
(–32 to 122°F)
Avoid prolonged storage at
temperatures exceeding
40°C/104°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)
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)
Operating Environment Storage 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)
Appendix
243
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Workstation hardware
Printer
LCD monitor
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)
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)
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)
244
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Specifications
System chart
UP
UP
Antenna lead set
Capsule endoscope
Real time viewer
Recorder unit
Recorder unit cradle
Real time viewer cable
Receiver unit cradle cable
Workstation
Battery charger
Appendix
245
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
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.
246
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Capsule endoscope
Product Name Capsule endoscope
(OLYMPUS EC TYPE 1)
Optics Field of view (maximum) 145°
Depth of field 0 to 20 mm
Sampling Rate 2 fps
Power Supply Power source Internal battery
Voltage DC 2.7 to 3.1V
Current 1 – 30 mA
Battery Life 8 hours
Size Weight 3.8 g
Dimensions ø 11 mm (diameter) × 26 mm (length)
Classification as
Medical Electrical
Equipment
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 This device complies with the
requirements of directive
1999/5/EEC.
Classification: Class II
EMC Applied standard;
IEC 60601-1-2:2001
IEC 60601-2-18:1996
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
Appendix
247
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Year of
Manufacturer 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 “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.”
Product Name Capsule endoscope
(OLYMPUS EC TYPE 1)
2005033
248
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Recorder unit
Product Name Recorder Unit (OLYMPUS RE-1)
Power Supply Power source Battery pack (MAJ-1473)
Voltage DC 6.7V – 8.4V
Current 550 mA
Battery Life 8 hours or longer
Size Weight 515 g (including battery)
Dimensions 90 mm (W) × 175 mm (H) × 43 mm (D)
Classification as
Medical Electrical
Equipment
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 The year of manufacture is indicated
by the second digit of the serial
number.
1512345
Appendix
249
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
* (with battery pack inserted)
Real time viewer
EMC 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
Product Name Real Time Viewer (OLYMPUS VU-1)
Power Supply Power source Battery pack (MAJ-1473)
Voltage DC 6.7V – 8.4V
Current 750 mA
Battery Life 3 hours or longer
Size Weight 550 g (including battery)
Dimensions 90 mm (W) × 175 mm (H) × 43 mm (D)
Classification as
Medical Electrical
Equipment
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
Product Name Recorder Unit (OLYMPUS RE-1)
250
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
* (with battery pack inserted)
Recorder unit cradle
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 The year of manufacture is indicated
by the second digit of the serial
number.
EMC 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
Product Name Recorder Unit Cradle (MAJ-1484)
Power Supply Voltage AC 100 – 240V
Frequency 50 – 60Hz
Current 2A
Size Weight Main body:230 g AC Adapter:275 g
Dimensions 128 mm (W) × 80.8 mm (H) × 114.5 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
Product Name Real Time Viewer (OLYMPUS VU-1)
1512345
Appendix
251
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Battery charger
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 The year of manufacture is indicated by the
second digit of the serial number.
Product Name Battery Charger (MAJ-1476)
Power Supply Voltage AC 100 – 240V
Frequency 50 – 60Hz
Current AC 100V 53VA / AC 240V 70VA
Size 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.
Product Name Recorder Unit Cradle (MAJ-1484)
1512345
252
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Battery pack
Real time viewer cable
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.
Product Name Real Time Viewer cable (MAJ-1485)
Length 1.05 m
Appendix
253
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Antenna lead set
Antenna lead cover
Product Name Antenna Lead Set (MAJ-1474)
Size Weight 200 g
Dimensions 88 mm (W) × 68.7 mm (H) × 23 mm (D)
The number of
antennas 8
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.
Product Name Antenna Lead Cover (MAJ-1470)
Size Dimensions 92 mm (W) × 66 mm (H)
254
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Recorder unit harness
Workstation hardware
Product Name Recorder Unit Harness (MAJ-1475)
Size Weight 220 g
Dimensions 1770 mm (W) × 220 mm (H)
Product Name Workstation Hardware (MAJ-1479)
Power Supply AC 100 – 240V / 50 – 60 Hz / 400 Hz
Power
Consumption 450W
Size Weight 12.1 kg
Dimensions 168 mm (W) × 450 mm (H) × 456 mm (D)
Function 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
Appendix
255
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Printer
LCD monitor
Product name Printer (MAJ-1480)
Power consumption 75W
Size Weight 9kg
Dimensions 510 mm (W) x 210 mm (H) x 420 mm (D)
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)
256
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
EMC information
Compliance information and suggested electromagnetic
environment: electromagnetic emission
The system is designed for use under the following electromagnetic
environment.
Emission Standard Applicability Notes
Radio Frequency
Emission
CISPR 11
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.
Appendix
257
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Compliance information and suggested electromagnetic
environment: electromagnetic immunity
Immunity
Test
IEC 60601-1-2
Testing Level
Compatibili
ty Level Suggested Environment
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
Contact: ±2, ±4, ±6kV
Aerial: ±2, ±4, ±8kV
See left 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
Power Supply
Input Lines
IEC 61000-4-11
<5%UT (>95% dip in UT)
for 0.5 cycle
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.
Not
applicable
The system is not
powered by a commercial
power source.
Power
Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
3A/m See left Power frequency
magnetic field should be
similar in characteristics to
general locations within a
standard commercial or
medical environment.
258
Appendix
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
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
Recommended separation
distance
Radiated
Immunity
IEC 61000-4-3
3V/m
(80MHz -
2.5GHz)
See left d=1.2√P 80MHz to 800MHz
d=1.2√P 80MHz to 2.5GHz
Conducted
Immunity
IEC 61000-4-6
3Vrms Not applicable —
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.
Appendix
259
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Recommended separation distance between system and
portable RF communication equipment
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.
Separation Distance Based on Transmission Frequency
(m)
Maximum Power
Output of
Transmitter P(W)
0.15 MHz to 80 MHz
d = 1.2
80 MHz to 800 MHz
d = 1.2
800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.21.22.3
10 3.8 3.8 7.3
100 12 12 23
PPP
260
Appendix
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
(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany
(Letters) Postfach 10 49 08, 20034 Hamburg, Germany Telephone: (040)237730
Two Corporate Center Drive, PO Box 9058 Melville, N.Y.
11747-9058, U.S.A.
Fax: (631)844-5442 Telephone: (631)844-5000
KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom
Fax: (01702)465677 Telephone: (01702)616333
491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373
Fax: 6834-2438 Telephone: 6834-0010
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
117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia
Fax: (095)958-2277 Telephone: (095)958-2245
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Fax: (03)9543-1350 Telephone: (03)9265-5400
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Fax: (305)261-4421 Telephone: (305)266-2332
Distributed by
Printed in Japan 20050124 *0000
GT1629 FCC
One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A.
Fax: (845)398-9444 Telephone: (845)398-9400
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Fax: (02)6255-3499 Telephone: (02)1544-3200

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