Olympus Medical Systems EC-1 Low Power Transmitter User Manual GT1629 FCC MAJ 1467 C1

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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.
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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
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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).
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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
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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
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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).
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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
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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.
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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
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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.
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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
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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.
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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.
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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
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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
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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.)
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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.
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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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