Intromedic INTROMEDIC5 CAPSULE ENDOSCOPE SYSTEM User Manual

Download:
Mirror Download [FCC.gov]
Document ID	2179691
Application ID	lDzQpmMw1wlbe+u+nArgNg==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	382.66kB (4783268 bits)
Date Submitted	2014-01-28 00:00:00
Date Available	2014-01-28 00:00:00
Creation Date	2014-01-28 17:30:57
Producing Software	Acrobat Distiller 7.0 (Windows)
Document Lastmod	2014-01-28 17:30:57
Document Title	User Manual
Document Author:	Donghoon Han

User Manual
User Manual
CopyrightŠ 2011 IntroMedic Co., Ltd.
Version 3.00
MM1100-U-1311
Date: 2013-11-21
Warranty
Trademarks
MiroCam®, 0LUR9LHZŒ, IntroMedic, and the associated logos are the
registered trademarks ŠRUWUDGHPDUNVŒof IntroMedic Co., Ltd. © IntroMedic
Co., Ltd. July 2007.
Except as required by applicable copyright laws; any use of the IntroMedic
trademarks, or any reprinting, reproduction, modification, referencing and
translations of the User Manual, without the prior written approval of
IntroMedic Co., Ltd. is strictly prohibited.
Warranty
Every effort has been made to ensure the information contained in this User
Manual is accurate, and is believed to be correct at time of printing.
IntroMedic reserves the right to change any content contained with this User
Manual without prior notice.
IntroMedic Co., Ltd. warrants the product against defects in material and
workmanship for a period of twelve (12) months from the date of sale, unless
different local regulations apply. IntroMedic Co., Ltd. will repair or replace
products that are ascertained by IntroMedic to have defects during the
warranty period. IntroMedic Co., Ltd. is not liable for the defects occurred by
misuse, careless handling, unauthorized modifications or erroneous use, or
any use that is non-compliant with instructions detailed within this User
Manual. This includes use of the product in non-appropriate locations or
conditions. Any other warranties are neither represented here nor recognized
by implication.
To validate the warranty, please complete product registration with the local
authorized IntroMedic distributor.
Page 5
Warranty
Exclusive warranty service
The warranty service provided hereby is applicable exclusively to the
purchaser of the product. IntroMedic will only warranty the product for
purposes and usage as defined in this User Manual. Any usage not heeding
the warnings, cautions and recommended usages as defined in this manual
will nullify the warranty.
Support
For warranty or repair service please contact the local authorized IntroMedic
distributor.
For customer service or support please contact your point of purchase or
IntroMedic Co., Ltd. Service agreements are only applicable to products of
IntroMedic Co., Ltd.
IntroMedic Customer Service
TEL: 82-2-801-9300
FAX: 82-2-801-9330
http://www.intromedic.com
E-mail: helpdesk@intromedic.com
Safety
Non-compliance with WKH XVHUÂśV PDQXDO XQDXWKRUL]HG PRGLILFDWLRQV RI WKH
product or replacement of parts, and/or opening of the product casing is
prohibited and may be hazardous.
Declaration on translation of labeling
Based on buyer's request, IntroMedic will provide the labeling, such as ID
label, Instruction for use and other promotional materials, which is translated
into the national language(s) of European countries. And it will be evaluated
by the local language expert, and will be confirmed by the native speaker of
the local language.
Page 6
Contents
CONTENTS
1. SAFETY INFORMATION
1-3
1.1
Warnings
1-3
1.2
1.3
Symbols for Safety
Function Symbols
1-5
1-6
1.4
Notes for Safe Use
1-11
2. SYSTEM OVERVIEW
2-3
2.1
2.2
2.3
Intended Purpose
Observable Diseases
Product Warranty Period
2-3
2-4
2-6
2.4
Product Specification
2-7
3. PERFORMING CAPSULE ENDOSCOPY 3-3
3.1
3.2
3.3
3.4
General Comments
Safety Warnings
Examination Preparation
Patient Preparation
3-3
3-3
3-4
3-7
3.5
Sensor Placement & Capsule Ingestion
3-9
3.6
3.7
3.8
Using Magnetic Controller
Uploading Image Data
MiroCamÂŽ Receiver Management
3-18
3-22
Post
Procedure
²
3-23
Page 7
Contents
4. 86,1*0,529,(:ΠSOFTWARE
4-3
4.1
4.2
4.3
+:6SHFLILFDWLRQVIRU0LUR9LHZŒ6RIWZDUH
Overview ² 0LUR9LHZŒ6HUYHU
Overview - 0LUR9LHZŒ2SHUDWRU
4-6
4-10
4-17
4.4
4.5
Overview - 0LUR9LHZŒ&OLHQW
Overview - 0LUR9LHZŒ9LHZHU
4-45
4-89
4.6
4.7
Performing Capsule Endoscopy
4-90
How to import 0LUR9LHZŒSoftware 1.0 Files 4-123
5. 86,1*0,529,(:Œ579
5.1
5.2
Overview
Using MiroViewŒ579
6. 86,1*:,5(/(660,529,(:Œ579L
5-3
5-3
5-5
6-3
6.1
Overview
6-3
6.2
8VLQJ:LUHOHVV0LUR9LHZŒ579L
6-6
Page 8
Safety Information
Safety Information
1- 2
Chapter 1
Chapter 1
Safety Information
1. SAFETY INFORMATION
1.1 Warnings
MiroCamÂŽ Capsule Endoscope System has been manufactured to
conform
with
the
International
Standard
for
Medical
Electrical
Equipment: IEC 60601-1, together with the Collateral Standard for
Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2.
MiroCamÂŽ Capsule Endoscope System has been manufactured to
conform to the electric shock, fire and mechanical hazard standards as
defined in CAN/CSA C22.2 NO.601.1.
Based on request of the buyer, IntroMedic will provide the labeling, such
as ID labels, and the User Manual in the national language(s) of
European countries. Translated documents will be evaluated by a local
language expert, and will be confirmed by a native speaker of the
respective national language.
1-3
Safety Information
Chapter 1
Safety Symbols: The User Manual incorporates various safety symbols
to ensure safe and correct use of the product and to prevent any
personal injury or property damage. These symbols are defined in the
following table:
WARNING
WARNING indicates a potential hazard that, if not avoided, could
result in serious personal injury or damage to the product.
CAUTION
CAUTION indicates a potential hazard that, if not avoided, could
result in minor personal injury or damage to the product.
NOTE
NOTE does not indicate potential hazards as in Caution or
Warning, but contains important information regarding the
installation, operation or maintenance of the product.
1- 4
Chapter 1
Safety Information
1.2 Symbols for Safety
This section describes a set of symbols that the IEC (International
Electrotechnical Commission) has established for medical electronic
equipment to classify connections and warnings of any potential hazards.
EN980: Attention. See instruction manual for use.
IEC 878-02-03: Indicates that this is classified into Type BF equipment
EN 980: Denotes Date of Manufacture
EN 980: Denotes Address of Manufacture
,(&$11(;''HQRWHV³21´VWDWXVRIPDLQSRZHUVZLWFK
,(&$11(;''HQRWHV³2))´VWDWXVRIPDLQSRZHUVZLWFK
SN
EN 980: Denotes serial number
IEC 417-5031: Denotes DC (Direct Current)
IEC 417-5032: Denotes AC (Alternating Current)
Denotes Ampere, the unit of current
Denotes Volt, the unit of Voltage
Hz
Denote Hertz, the unit of Frequency
IEC 417-5021: Denotes potential equalization terminal
Single Use Only
Use by date
EN980: Authorized representative in the European community
IPX
Protected against the effects of continuous immersion in water
1-5
Safety Information
Chapter 1
1.3 Function Symbols
1.3.1
0LUR9LHZŒSoftware Function Symbols
The following table describes symbols or icons used in the
MiroViewŒSoftware.
1.3.1.1 0LUR9LHZŒClient
Symbol
Description
Open the
screen.
1- 6
Symbol
patient
data
Description
Open screen to review a
specific patient
Open the report screen to
create a patient capsule
endoscopy report.
Open screen to export
(save externally) selected
image data for a specific
patient.
Print the selected report on
the List.
Delete the selected case
on the List.
Add a new review for the
selected case on the List.
Delete the selected review
on the List.
Open the
dialog.
Find the Item from the list
with the keyword typed in
the search box.
Recycle
Bin
Show all the items on the
List.
Open the Position Window
Show images in the Single
View.
Show images in the Dual
View.
Show images in the Quad
View.
Show images in the Range
View.
Show images in the Map
View.
Play all images.
Play the selected images
only. View images via
Express Play function.
SGIB - Play the images
captured via Suspected GI
Bleeding function.
Chapter 1
Safety Information
Symbol
Description
Symbol
Description
Move to the first image in
the video.
Move to the previous
captured image.
Play images in reverse
order.
Stop playback of images.
Play
Play images in sequential
order.
Move to the next captured
image.
Move to the final image in
the video.
Open the
Window
Expand/Shrink
Box
Comparison
Capture
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status is Capture Box.
Click this icon to change
WKH VWDWXV WR Âľ)LQGLQJ
6XPPDU\ER[Âś
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status is Drag Bag. Click
this icon to change the
VWDWXVWRÂľ&DSWXUH%R[Âś
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status
is
Finding
Summary Box. Click this
icon to change the status
WRÂľ'UDJ%DJÂś
Add a Circle on the image
Add a Line on the image
Delete selected Circle /
Line
Color Palette
Undo the action
Redo the action
Show
Markers
Circumference
1-7
Safety Information
Symbol
Chapter 1
Description
Description
Check
the
selected
captured images
Uncheck the selected
captured images
Print
Preview
Save as PDF
Export Review
Open
PACS
function
(Registered User Only)
Export Captured Images
with EXMIF
Export Captured Images
as Image / Video /
MiroVideo
Export
Segments
as
Image / Video / MiroVideo
Export Case as Video /
MiroVideo
Select the
Segment
Deselect the area from
Segment
1- 8
Symbol
area
as a
Chapter 1
Safety Information
1.3.1.2 0LUR9LHZŒOperator
Symbol
Symbol
Description
Open the
screen.
patient
data
Print the selected report on
the List.
Open the
dialog.
Recycle
Bin
Description
Connect
to
the
MiroCamÂŽ Receiver and
open MiroCamÂŽ Receiver
control screen.
Delete the selected case
on the List.
Export the case selected
on the List.
Find the Item from the list
with the keyword typed in
the search box.
Show all the items on the
List.
Upload the image data from
the selected MiroCamÂŽ
Receivier
Show / Edit the patient
information
for
the
selected
MiroCamÂŽ
Receiver
Initialize
the
selected
MiroCamÂŽ Receiver
Unformatted
the
MiroCamÂŽ Receiver.
Unconnected
Empty
the
Receiver.
MiroCamÂŽ
Prepared the MiroCamÂŽ
Receiver.
Recorded the MiroCamÂŽ
Receiver.
Uploaded the MiroCamÂŽ
Receiver.
1-9
Safety Information
1.3.2
Chapter 1
MiroCamÂŽ Receiver Function Symbols
Symbol
Description
SIG
Indicates status of signal from the MiroCamÂŽ Capsule.
Green : Signal is being received from the MiroCamÂŽ
Capsule.
Yellow : Signal is not being received from the
MiroCamÂŽ Capsule.
INI
Initialization status of the MiroCamÂŽ Receiver
Green : MiroCamÂŽ Receiver is initialized
Yellow : MiroCamÂŽ Receiver is not initialized
BAT
Battery Status
Green : Fully charged
Yellow : Not charged
Wi-Fi
Wi-Fi Switch Status
(LED) On : Enabled
(LED) Off : Disabled
1- 10
Chapter 1
Safety Information
1.4 Notes for Safe Use
„
Follow the safety instructions included in this User Manual and
clinical precautions advised by the medical professional.
„
The manufacturer is not liable for harm or damage caused by
improper, unauthorized, unprofessional or inexpert use of the device
and/or product.
„
IntroMedic Co., Ltd. is NOT responsible for physical harm or
HTXLSPHQW SUREOHPV FDXVHG E\ WKH XVHUÂśV FDUHOHVV RSHUDWLRQ RU
mismanagement of the device and/or product.
„
Users MUST have read and understood the User Manual. ONLY
trained
and
qualified
medical
professionals
or
authorized
representatives of IntroMedic Co., Ltd. may operate the system.
„
User Manual must ALWAYS be with the equipment. This is the
86(5Âś65(63216,%,/,7<.
„
CAUTION: foreign substances including water, cleaning fluids,
disinfecting cleanser and such substances may harm the equipment,
and should not enter the equipment.
„
ONLY authorized personnel may perform repairs. Never attempt to
open covers, panels or casings.
„
DO NOT crease, bend, fold or twist the data cable (or data belt). Take
care to guard them against mechanical stress (e.g. wheels or heels)!
„
The sensor pads, the MiroCamÂŽ Receiver, the data cable, the data
belt and the capsule must not be exposed to mechanical shock (e.g.
by dropping). Any damage caused that way will void the product
warranty.
„
CAUTION: Damage/injuries to the sensor pad, data cable or data belt
may cause a safety hazard. Damaged items MUST be repaired
IMMEDIATELY.
„
DO NOT handle fluids in the vicinity of the system.
1-11
Safety Information
„
Chapter 1
When using a cart purchased elsewhere, ensure the brake or latch
guard is in use to prevent the wheels from rolling.
„
DO NOT USE in moist or damp places.
„
DO NOT operate the equipment with wet hands.
„
Avoid using the equipment in extreme temperatures or humid
environments.
„
DO NOT keep the equipment or carry out the MiroCamÂŽ Capsule
endoscopy procedure in places such as areas exposed to direct
sunlight, vicinity of heaters, vicinity of chemical materials or gases,
areas moist/damp or dusty, or poorly ventilated areas.
„
DO NOT disassemble or open the equipment without permission.
This will invalidate the warranty.
„
DO NOT carry out the MiroCamÂŽ Capsule endoscopy procedure in
areas with high vibrations or in environments where high electromagnetic waves are generated.
„
DO NOT pull out the power cord by grabbing the cable. When
disconnecting the power cord, grasp the plug, and pull out.
This
prevents short-circuits, disconnection, or cord damage.
„
CAUTION: Verify that the power rating supplied from the power
receptacle matches with the voltage the system requires. Check
Voltage and Frequency on the AC/DC adaptor.
„
CAUTION: Turn off the power switch before connecting the sensor
pad.
„
DO NOT discard sensor pads, cables and connectors with general
waste. Discard separately as industrial or medical waste.
„
DO NOT carry out the MiroCamÂŽ Capsule endoscopy procedure
simultaneously with other procedures using medical products or
equipment.
„
1- 12
DO NOT use for purposes other than medical treatment.
Chapter 1
„
Safety Information
DO NOT connect the USB cable to the MiroCamÂŽ Receiver while the
MiroCamÂŽ ReceiverÂśVdata cable is still connected to sensor pads or
data belt.
„
DO NOT charge the MiroCamÂŽ Receiver while the MiroCamÂŽ
5HFHLYHUÂśV GDWD FDEOH LV VWLOO FRQQHFWHG WR VHQVRU SDGV RU GDWD EHOW
while still attached to the human body.
„
Connect USB cable to the MiroCamÂŽ Receiver only after mounting it
on charger.
„
DO NOT install any other programs onto the workstation utilized for
review and diagnosis of patient image data (i.e computers with the
0LUR9LHZΠSoftware).
„
The MiroCamÂŽ Capsule is disposable and should not be reused.
„
The sensor pads and data belt are medical waste, and should be
disposed of according to local regulations or WEEE directive on
waste disposal.
„
Only use the capsule, the MiroCamÂŽ Receiver, the data cables, the
sensor pads and the data belt in the medical environment condition.
„
All products connected with the MiroCamÂŽ Endoscope system must
be compliant with requirements of IEC60950-1 or UL certifications.
„
Check the outer surface of the endoscope for rough surfaces, sharp
edges, or protrusions which may cause a safety hazard.
„
3OHDVHGRQÂśWWU\WRFXWWKHODEHO
1-13
Safety Information
1.4.1
Chapter 1
Environmental Conditions for Storage
„
Temperature
: -10 ୅ ~ 70 ୅ (Operating 0 ୅ ~ 40 ୅)
„
Relative humidity
: 10 % ~ 80 % (Operating 45 % ~ 75 %)
„
Atmospheric pressure
: 700hPa to 1060hPa
WARNING DO NOT operate the equipment in the vicinity of
generators, power stations, X-ray devices, and
broadcasting stations where high levels of electro-magnetic
waves are generated. The electro-magnetic waves can
cause equipment malfunctions.
CAUTION If the equipment has been brought in from a cold
environment (stock room, airfreight) into a warm room,
initial activation should take place after a few hours, to
allow for temperature adjustment and balance and
evaporation of condensed humidity.
WARNING DO NOT operate the equipment in the vicinity of heat
sources, strong electric or magnetic fields (close to a
transformer), or near instruments generating
high-frequency signals.
WARNING DO NOT use MiroCamÂŽ alongside or together with medical
devices or procedures involving electrical currents.
DO NOT use MiroCamÂŽ with h.f. surgical equipment. It
may result in burns at the site of the electrodes and
possible damage to the MiroCamÂŽ Capsule and the
MiroCamÂŽ Receiver.
DO NOT use the unit in close radius (within 1 m) of short
wave or microwave therapy equipment. It may produce
instability in the captured image.
WARNING This device is a Class B device according to EN60601-1-2
standards. This equipment can cause radio interference in
residential areas. In this case, the owner (or operator) can
be held responsible to take appropriate measures or take
proper measures for compensation.
1- 14
Chapter 1
1.4.2
Safety Information
Safety Precaution
CAUTION -
Make sure the environment is without interference from
electromagnetic fields.
Make sure the environment is without noise and
vibration.
DO NOT carry out the MiroCamÂŽ Capsule endoscopy
procedure while using other equipments, devices or
products.
The instruction for use of the sensor pads MUST be
observed.
DO NOT use on patients with pacemakers or
defibrillators.
DO NOT use the MiroCamÂŽ Capsule if the package is
unsealed.
„
DO NOT reuse a used capsule.
„
To prevent unexpected accidents like fire or explosion, do not use any
product near or in the presence of inflammable or ignitable
substances.
„
DO NOT disassemble the equipment case nor open the cover. In
case service is required, please contact IntroMedic customer support
or local point of sale immediately.
„
Only the accessories authorized and designed by IntroMedic Co., Ltd.
should be used with this equipment. Faults resulting from the usage
of unapproved or inappropriate accessories are not guaranteed
against.
„
This equipment may affect on other products or be affected by other
products.
„
)ROORZ \RXU GRFWRUÂśV LQVWUXFWLRQV DQG DELGH E\ WKH JXLGHOLQHV LQ WKH
User Manual.
„
DO NOT try to upload the image data while the data cable or data
belt is still connected to the MiroCamÂŽ Receiver.
1-15
Safety Information
„
Chapter 1
DO NOT change the rechargeable battery in the MiroCamÂŽ Receiver
while the data cable or data belt is still connected to the MiroCamÂŽ
Receiver.
„
Stay away from high frequency radiation sites (such as high voltage,
radar, installation power plants, MRI, CT or electric blankets etc.)
during your capsule endoscopy procedure. (It may result in serious
side effects requiring an emergency operation.)
„
In case of any symptoms of abdominal pain, vomiting, fever, heart
trouble, dizziness or seizure during or after the MiroCamÂŽ Capsule
endoscopy procedure, please notify your doctor.
„
Always check whether the data cable or data belt is connected to the
MiroCamÂŽ Receiver.
„
Always check that the battery in the MiroCamÂŽ Receiver is fully
charged before use.
„
DO NOT use the MiroCamÂŽ Capsule if the package is unsealed.
„
After ingesting the capsule, always confirm whether the MiroCamÂŽ
Capsule has been excreted. Excretion of the MiroCamÂŽ Capsule can
be confirmed with an X-ray procedure.
„
Prior to undergoing the MiroCamÂŽ Capsule endoscopy procedure,
patients with diabetes must be informed via a medical professional
regarding appropriate medication & dosage.
„
For more accurate data and better analysis, patients can have solid
food for lunch, but must have liquid food for dinner on the day prior to
the MiroCamÂŽ Capsule endoscopy procedure. The patient must fast
for 11 hours prior to ingesting the MiroCamÂŽ Capsule.
„
If recommended by the physician, the patient may take a laxative
prior to the MiroCamÂŽ Capsule endoscopy procedure.
„
DO NOT smoke for at least 12 hours prior to the MiroCamÂŽ Capsule
endoscopy procedure.
1- 16
Chapter 1
„
Safety Information
DO NOT apply body lotion before the MiroCamÂŽ Capsule endoscopy
procedure.
„
DO NOT bite the capsule.
„
Avoid excessive physical activity during the MiroCamÂŽ Capsule
endoscopy procedure.
„
4 hours after ingesting the capsule, patients may have liquid food.
„
It is recommended to drink mineral water (non-colored liquid)
frequently, so that it may raise the possibility to take much better
quality of the image.
„
When undergoing the MiroCamÂŽ Capsule endoscopy procedure, DO
NOT make physical contact with another person undergoing the
same procedure.
„
During the MiroCamÂŽ Capsule endoscopy procedure, DO NOT touch
the MiroCamÂŽ Receiver, or get the MiroCamÂŽ Receiver wet.
„
Only use the provided batteries, and never remove the battery from
the MiroCamÂŽ Receiver during the MiroCamÂŽ Capsule endoscopy
procedure.
„
Avoid disconnecting the USB while uploading the image data from the
MiroCamÂŽ Receiver to the workstation.
„
Always confirm that the USB is connected by checking the MiroCamÂŽ
Receiver screen on the 0LUR9LHZΠSoftware.
„
Always check the AC Power rating prior to using the workstation.
„
DO NOT touch AC power cable with wet hands.
„
DO NOT open the MiroCamÂŽ Receiver bag or touch the MiroCamÂŽ
Receiver outside of the hospital.
„
DO NOT use on patient with electrical implantable device.
„
Magnetic controller must be stored in special storage box.
„
If electrical risk is detected from the MiroCamÂŽ Receiver, remove the
battery.
1-17
Safety Information
Chapter 1
WARNING The MiroCamÂŽ Capsule takes images for 12 hours and
naturally excretes in about 24 hours under normal
conditions. If the MiroCamÂŽ Capsule has not been
excreted from the patient within 72 hours, patient should
contact the physician. After examining, the physician may
need to perform a surgical operation or treatment to
remove the capsule.
WARNING Before doing capsule endoscopy with MC1000-WM, always
WARNING
1- 18
check whether the previous capsule is retained or not in
human body. If the previous capsule is detected in human
body, remove it by surgical treatment. When two
MC1000-WM are existed in human body at the same time,
those can stick to each other.
Make sure the capsule had been excreted before going
through an MRI, CT and etc. It may cause injury to the
patient.
Chapter 1
1.4.3
Safety Information
Cleaning and Maintenance
„
Capsule
The capsule is disposable and should not be reused.
„
System and accessories
All products should be cleanly maintained. For cleaning, rub them
lightly with a soft cloth wet with warm water at least once a week.
DO NOT use organic solvents such as lacquer, thinner, ethylene
and oxide because they can damage the equipment. Be careful
that foreign substances do not enter the main system when
cleaning.
ALWAYS operate the equipment under sanitary environmental
conditions. DO NOT use heat or gas for disinfection of the capsule.
„
Service Document
If required, or upon request, the local IntroMedic distributor
(authorized IntroMedic representative) may provide block diagrams,
lists of spare parts, descriptions, adjustment instructions or other
related information which may help qualified technical personnel in
repairing specified parts of the equipment which have been defined
repairable by IntroMedic Co., Ltd. .
„
Moving the Equipment
CAUTION when moving equipment.
WARNING: Excessive impact/shock causes internal damage.
If wiring is connected/disconnected when moving, check the exact
wiring status after moving.
If damage to the equipment is discovered after moving,
immediately contact IntroMedic or local Distributor.
1-19
Safety Information
1- 20
Chapter 1
Overview & Intended Usage
Overview & Intended Usage
2- 2
Chapter 2
Chapter 2
Overview & Intended Usage
2. SYSTEM OVERVIEW
MiroCamÂŽ is an orally ingested capsule endoscope designed to capture
and wirelessly transmit images of the lining of the small intestine.
Captured images are viewed via the 0LUR9LHZŒ6RIWZDUH for diagnosis
of diseases related to the small intestine.
The MiroCamÂŽ Capsule Endoscope System consists of the MiroCamÂŽ
Capsule, the MiroCam® Receiver, the 0LUR9LHZŒ 6RIWZDUH, and
accessories.
2.1 Intended Purpose
MiroCamÂŽ is intended for visualization of the small bowel mucosa as an
adjunctive tool in the detection of abnormalities of the small bowel. The
device captures images of the small bowel with a wireless camera
contained in a capsule. This device includes an ingestible capsule
(containing a light source, camera, transmitter, and battery), an
electrode array, a receiving/recording unit, a data storage device,
computer software to process the images (0LUR9LHZΠSoftware), and
accessories.
2-3
Overview & Intended Usage
2.1.1
Chapter 2
Contraindications
„
Not intended for patients with known or suspected gastrointestinal
tract obstructions, perforations, strictures or fistular.
„
Not intended for patients who have difficulty ingesting food or pills
(dysphagia).
„
Not intended for patients who have difficulty communicating.
„
Not intended for patients with indigestion, or slow gastric emptying.
„
Not intended for patients who may be affected by electromagnetic
radiation, such as pregnant women, infants, and patients with
heart disease or epilepsy.
„
Not intended for patients with diverticulosis in the Small Bowel.
„
Not intended for patients who are recommended against having
the MiroCamÂŽ Capsule endoscopy procedure by a Physician.
„
Not intended for patients with pacemakers and/or defibrillators.
„
This device is intended for use in adults and children from two
years of age. If a patient is younger than 18, the doctor should
decide whether to perform the MiroCamÂŽ Capsule endoscopy
procedure.
2.2 Observable Diseases
2.2.1
2.2.2
2- 4
Obscure gastrointestinal bleeding (OGIB)
„
Angioectasia
„
Meckel diverticulum
„
NSAIDs
&URKQÂśV'LVHDVH
Chapter 2
2.2.3
Overview & Intended Usage
Small Bowel Tumors
„
Polyps
„
Peutz-Jeghers Syndrome
„
Familial adenomatous polyposis
„
Lymphoma
„
Carcinoid
„
Gastro-Intestinal Stromal Tumor (GIST)
„
Lipoma
„
Hemangioma
2.2.4
Inflammation
„
Intestinal Tuberculosis
„
Typhoid Fever
„
Angeitis
„
Amyloidosis
„
Eosinophilic enteritis
2.2.5
Celiac Disease
2.2.6
%HKFHWÂśV'LVHDVH
2.2.7
Cowden Disease
2.2.8
Cronkhite-Canada Syndrom
2-5
Overview & Intended Usage
2.3 Product Warranty Period
2.3.1
Maximum Storage Time of MiroCamÂŽ Capsule
„
MC1000
: 1 Year
„
MC1000-F
: 1 Year
„
MC1000-G
: 1 Year
„
MC1000-W
: 1 Year
„
MC1000-WG
: 1 Year
„
MC1000-WM
: 1 Year
„
MC1000-B
: 1 Year
„
MC1200
: 1 Year
„
MC1200-B
: 1 Year
„
MC1200-G
: 1 Year
„
MC1200-M
: 1 Year
„
MC1600
: 1 Year
„
MC1600-B
: 1 Year
„
MC1600-G
: 1 Year
„
MC1600-M
: 1 Year
2.3.2
2- 6
MiroCamÂŽ Receiver, MR1100
„
MiroCamÂŽ Receiver:1 Year
„
MiroCamÂŽ Receiver Battery: 6 Months
Chapter 2
Chapter 2
Overview & Intended Usage
2.4 Product Specification
2.4.1
MiroCamÂŽ Capsule
„
Component
Component
Capsule
Model Name
MC1000
Quantity
1 Piece (Selection)
MC1000-F
MC1000-G
MC1000-W
MC1000-WG
MC1000-WM
MC1000-B
MC1200
MC1200-B
MC1200-G
MC1200-M
MC1600
MC1600-B
MC1600-G
MC1600-M
Sensor Pads
MC1000-S
10 Piece
Magnetic
MC1000-C
1 Piece (Optional)
Controller
2-7
Overview & Intended Usage
„
Chapter 2
Specification
Item
Capsule Unit
Size
10.8 X 24 mm
(MC1000,
Weight
3.25 Âą 0.05 g (-F)
MC1000-F,
MC1000-G)
Magnetic
Controller
(MC1000-C)
2- 8
Specification
3.5 Âą 0.05 g
Frame Rate
3 frame/sec
Field of View
150 degrees
Battery Life
12 hours
Pixels
102,400
Lighting
6 LEDs
Communication
Human Body
Method
Communication
Length
27.3 cm
Chapter 2
Overview & Intended Usage
Item
Capsule Unit
Size
10.8 X 24.5 mm
10.8 X 25.5 mm (-WM)
(MC1000-W,
MC1000-WG,
Specification
Weight
MC1000-WM,
3.25 Âą 0.05g
4.75 Âą 0.05g (-WM)
MC1000-B)
Frame Rate
3 frame/sec
Field of View
170 degrees
Battery Life
12 hours
8 hours (-WM)
Pixels
102,400
Lighting
6 LEDs
Communication
Human Body
Method
Communication
2-9
Overview & Intended Usage
Chapter 2
Item
Specification
Capsule Unit
Size
10.8 X 24.5 mm
(MC1200
Weight
3.2 Âą 0.05 g
MC1200-B
MC1200-G,
MC1200-M)
4.5 Âą 0.05 g (-M)
Frame Rate
3 frame/sec
Field of View
170 degrees
Battery Life
12 hours
8 hours (-M)
2- 10
Pixels
102,400
Lighting
6 LEDs
Communication
Human Body
Method
Communication
Chapter 2
Overview & Intended Usage
Item
Specification
Capsule Unit
Size
10.8 X 24.5 mm
(MC1600
Weight
3.2 Âą 0.05 g
MC1600-B
MC1600-G,
MC1600-M)
4.5 Âą 0.05 g (-M)
Frame Rate
6 frame/sec
Field of View
170 degrees
Battery Life
12 hours
8 hours (-M)
Pixels
102,400
Lighting
6 LEDs
Communication
Human Body
Method
Communication
2-11
Overview & Intended Usage
2.4.2
Chapter 2
MiroCamÂŽ Receiver
„
Component
Component
Model Name
Quantity
Receiver
MR1100
1 piece
Battery Pack
MR1100-B
2 piece
Data Cable
MR1000-D
1 piece
Data Belt
MR1000-D(M),
1 piece
MR1000-D(L)
„
Receiver Bag
MR1000-G
1 piece
System Carrying Case
MR1000-A
1 piece
Battery Charger
MR1000-C
1 piece
Adaptor
MR1000-T
1 piece
Power Cable
MR1000-P
1 piece
Measuring Tape
MR1000-M
1 piece
USB Cable
MR1100-U
1 piece
Specification
Item
2- 12
Specification
Receiver
Battery Life
12 Hours
(MR1100)
Size
85 X 140 X 40 mm
Weight
350g (including Battery)
Chapter 2
Overview & Intended Usage
Item
Specification
Battery Pack
Type
Lithium-Ion storage cell
(MR1100-B)
Capacity
10400 mA
Voltage
3.6 V
Recharging Time
Approx. 4 hours
Size
73.8 X 84.3 X 21.4 mm
Data Cable
Channel
(MR1000-D)
Size
700 x 900 x 110 mm
Data Belt
Channel
Size
1000 X 180 mm (M)
(MR1000-D(M),
MR1000-D(L))
Receiver Bag
1500 X 180 mm (L)
Size
100 X 190 X 55 mm
Size
480 X 350 X 100 mm
Battery Charger
Power Source
Adaptor
(MR1000-C)
Size
135 X 75 X 105 mm
Weight
285 g
Adaptor
Weight
231g
(MR1000-T)
Power Rating
AC100~240V/
(MR1000-G)
System Carrying
Case(MR1000-A)
50~60
Hz
2-13
Overview & Intended Usage
Chapter 2
Item
Power Cable
Specification
Length
1.5 m
Length
1.5 m
(MR1000-P)
Measuring Tape
(MR1000-M)
2.4.3
MiroCamÂŽ Software
„
Component
Component
Model Name
0LUR9LHZŒ:RUNVWDWLRQ
0LUR9LHZΠSoftware
2.5
0LUR9LHZŒ579
0LUR9LHZŒ579
2.0
Wireless MiroViewŕł° RTVi
Wireless
1.4
RTVi
2- 14
Version
MiroViewŕł°
3
Performing Capsule Endoscopy
Performing Capsule Endoscopy
3- 2
Chapter 3
Chapter 3
Performing Capsule Endoscopy
3. PERFORMING CAPSULE ENDOSCOPY
3.1 General Comments
„
This chapter describes how to operate and control the MiroCamÂŽ
Capsule Endoscope System.
„
Installation and initial operation must be done by an Authorized
IntroMedic Service Technician.
3.2 Safety Warnings
WARNING Before turning on the system, check the environment
condition for the MiroCamÂŽ Capsule Endoscope System.
WARNING This device is intended for use in adults and children from
two years of age. If a patient is younger than 18, the doctor
should decide whether to perform the MiroCamÂŽ Capsule
endoscopy procedure.
CAUTION In case the system has been brought from cold
environment (stock room or airfreight) into a warm room,
first switch on it after some hours for temperature balance
and removing of condensation humidity (Risk of leakage
current).
CAUTION For the electrical safety, make sure that peripheral
equipments (external PC, Monitor, printer etc) are
connected to a wall socket of independent power supply
with a perfect ground. Particularly make sure whether or not
those peripheral equipments should be authorized for
medical usage.
CAUTION DO NOT touch the dome of the capsule.
CAUTION If SIG indicator of the MiroCamÂŽ Receiver turns yellow
after ingesting the capsule, immediately contact the
physician.
3-3
Performing Capsule Endoscopy
Chapter 3
CAUTION If SIG indictor of the MiroCamÂŽ Receiver does not turn
green when the patient holds the MiroCamÂŽ Capsule by
the gold bands, immediately stop the MiroCamÂŽ Capsule
endoscopy procedure.
NOTE If images of the small bowel are not captured during the
MiroCamÂŽ Capsule endoscopy procedure, ensure the
MiroCamÂŽ Capsule has been excreted by the patient and
perform procedure again.
3.3 Examination Preparation
The following steps (3.3.1 to 3.3.4) explain the process to initialize the
MiroCamÂŽ Receiver and register patient data for the MiroCamÂŽ Capsule
endoscopy procedure. For more information, see section 4.2.
3.3.1
Start System
„
Turn on the power of the workstation.
„
Click the
„
Type the ID and the password in each field, and then click the
to start the 0LUR9LHZŒOperator.
WARNING Before starting the system, check the power rating for the
workstation.
3- 4
Chapter 3
3.3.2
Performing Capsule Endoscopy
Initialize the MiroCamÂŽ Receiver
„
Connect the smaller side of the USB Cable to the MiroCamÂŽ
Receiver
„
Connect the larger side of the USB cable to the workstation.
„
Turn on the MiroCamÂŽ Receiver.
„
Click the
in the 0LUR9LHZΠOperator to initialize the
MiroCamÂŽ Receiver.
„
Click the
in the 0LUR9LHZΠOperator to input patient
information.
„
After completing the required fields, click the
to save the
patient information onto the MiroCamÂŽ Receiver.
WARNING If the MiroCamÂŽ Receiver is initialized, any patient data
stored on the device will be deleted permanently.
NOTE During initialization with MR1100, it is not possible to cancel
the process.
3.3.3
MiroCamÂŽ Receiver Preparation
„
Connect the battery to the MiroCamÂŽ Receiver.
Insert pins and bumps on back side of the MiroCamÂŽ
Receiver in the slots on the battery.
Press battery to the MiroCamÂŽ Receiver until clasp locks
battery in place.
„
Turn on the power switch of the MiroCamÂŽ Receiver.
„
Check the battery indicator (BAT) of upper side of the MiroCamÂŽ
Receiver. If the battery is fully charged, the LED light will be
green. If the LED light is not green, charge the battery.
3-5
Performing Capsule Endoscopy
„
Chapter 3
Check the initialization indicator (INI) of upper side of the
MiroCamÂŽ Receiver. Prior to beginning a procedure, this light
„
must be green.
Connect the data cable to the MiroCamÂŽ Receiver.
Indicator
SIG
INI
BAT
Wi-Fi
Description
Indicates status of signal from capsule
Green : Signal is being received from capsule
Yellow : Signal is not being received from capsule
Initialization status of the MiroCamÂŽ Receiver
Green : The MiroCamÂŽ Receiver is initialized
Yellow : The MiroCamÂŽ Receiver is not initialized
Battery Status
Green : Fully charged
Yellow : Not charged
Wi-Fi Switch Status
(LED) On : Enabled
(LED) Off : Disabled
WARNING DO NOT do begin the MiroCamÂŽ Capsule endoscopy
CAUTION
3- 6
procedure when the MiroCamÂŽ ReceiverÂśVEDWWHU\LQGLFDWRU
is not green. This indicates battery is not fully charged or
out of order, and patient data may be lost.
Switch the MiroCamÂŽ Receiver off prior to connect the
sensor pad.
Chapter 3
Performing Capsule Endoscopy
3.4 Patient Preparation
Provide the patient with the following instructions to prepare for the
MiroCamÂŽ Capsule endoscopy procedure.
3.4.1
Patient Preparation
„
One day prior to the MiroCamÂŽ Capsule endoscopy procedure
Lunch: Patient can have a normal mean around noon,
followed by a liquid diet as instructed by the physician.
The patient should fast for at least 12 hours prior to the
MiroCamÂŽ Capsule endoscopy procedure. Patient may only
drink water (no food or other beverages such as milk or
coffee).
The patient should not take any medications two hours before
ingesting the MiroCamÂŽ Capsule endoscope.
Male patients may need to shave area, as advised by
physician or nurse.
Patient should stop taking iron supplements 1 week before
the MiroCamÂŽ Capsule endoscopy procedure, and should
not ingest any medicine at least 2 hours prior to the
MiroCamÂŽ Capsule endoscopy procedure.
Diabetic patients need to follow any changes to insulin
dosage as prescribed by the physician.
Physician is recommended to prescribe patient a laxative
such as PEG or Sodium Phosphate. Patient should ingest
laxative 12 hours prior to procedure.
3-7
Performing Capsule Endoscopy
Chapter 3
Physician is recommended to prescribe patient an antifoaming agent (such as simethicone), to reduce bubbles in
the GI tract. This should be ingested after the laxative.
The patient should abstain from smoking 12 hours before the
MiroCamÂŽ Capsule endoscopy procedure.
On the day of the MiroCamÂŽ Capsule endoscope test, the
patient should wear comfortable and loose cloths. One-piece
clothing should not be worn.
Prior to the MiroCamÂŽ Capsule endoscopy procedure, do not
apply any lotions or perfumes.
„
On the day of capsule endoscopy procedure
After arriving in a hospital at the appointed time, the patient
should submit an examination permission form and check in.
„
After ingesting capsule endoscope
The patient should refrain from ingesting any food or drink
(except water) two hours after swallowing the MiroCamÂŽ
Capsule endoscope.
Patient is recommended to drink water every half hour during
the MiroCamÂŽ Capsule endoscopy procedure.
The patient can start with light food after 4 hours. When the
examination is complete, the patient can start having normal
meals.
In case of any abdominal pain, nausea or vomiting after
ingesting the MiroCamÂŽ capsule, the patient should contact
physician or nurse immediately.
3- 8
Chapter 3
Performing Capsule Endoscopy
3.5 Sensor Placement & Capsule Ingestion
Following is the detailed procedure required to correctly administer the
MiroCamÂŽ Capsule endoscopy procedure.
3.5.1
Connecting Sensor Pads
After attaching sensor pads to the data cables, attach the sensor
pad correctly to each area as shown below.
Xiphoid
process Line
Pelvic Line
3-9
Performing Capsule Endoscopy
Chapter 3
3.5.2
Xiphoid
process Line
„
Pelvic
Line
Attach sensor pads according to the number on the data cable.
Locate the center between the umbilical and the xiphoid
process. From this center point, attach the sensor to the distal
SRLQWRQWKHULJKWIODQNRIWKHSDWLHQWÂśVERG\
Place the sensor pad on the xiphoid process line, directly
below the right clavicle.
Place the sensor pad on the xiphoid process line, directly
below the left clavicle.
Locate the center between the umbilical and the xiphoid
process. From this center point, attach the sensor to the distal
SRLQWRQWKHOHIWIODQNRIWKHSDWLHQWÂśVERG\
Place the sensor pad on the right pelvic line, 2 cm behind
sensor #1.
3- 10
Chapter 3
Performing Capsule Endoscopy
Place the sensor on the right inguinal line, 2 cm to the outside
of sensor #2.
Place the sensor on the right inguinal line, 2 cm to the outside
of sensor #3.
Place the sensor pad on the right pelvic line, 2 cm behind
sensor #4.
Place the sensor directly below the right clavicle.
CAUTION The numbering of the data cables and sensor pad must
match the specified area. Please follow the numbering
sequence appropriately.
CAUTION To prevent entanglement of the data cables during
procedure, organize cables and place appropriately in cable
bag.
WARNING Correct image signal may not be obtained if a sensor pad is
not in direct, immediate contact with the skin. Ensure the
sensor pads are in direct contact with the skin. Shaving
may be required for male patients.
„
The pictures below show the sensor pads attached in the correct
locations.
3-11
Performing Capsule Endoscopy
3.5.3
Chapter 3
Connecting Data Belt
„
Attach stitched point on the belly button.
„
Tighten the data belt around the waist with the velcro.
„
Use the data belt as shown below.
CAUTION Do not attached the Data belt above clothing
„
After placing sensor pads on the patient, connect the cable to the
MiroCamÂŽ Receiver as detailed in the following image.
3- 12
Chapter 3
3.5.4
„
Performing Capsule Endoscopy
Removing Capsule from Package
While holding the case upside down, peel off the sterilized package
cover.
3.5.5
„
Removing the Case
Turn the package over, the MiroCamÂŽ case will slip out of the package.
While holding the case, open the lid.
3-13
Performing Capsule Endoscopy
3.5.6
Chapter 3
Removing the Capsule
„
Grip capsule with right hand, and remove from cast. DO NOT
touch the dome of the capsule.
„
Make sure that the MiroCamÂŽ Capsule packaging is not
damaged in any way. When removed capsule from case, the
MiroCamÂŽ Capsule should be flashing.
CAUTION Do not use a MiroCamÂŽ Capsule Endoscope if the
packaging or the MiroCamÂŽ Capsule is damaged.
CAUTION Do not touch the dome of the MiroCamÂŽ Capsule. This may
result in poor image quality.
„
Check if the front of the MiroCamÂŽ Capsule is flashing when it is
removed from the case
3- 14
Chapter 3
„
Performing Capsule Endoscopy
After washing hands, patients should grip the gold section of the
MiroCamÂŽ Capsule between the thumb and the forefinger of the
both hands.
CAUTION Initialize the MiroCamÂŽ Receiver prior to the MiroCamÂŽ
Capsule Endoscopy Procedure. Once the MiroCamÂŽ
Receiver confirms signal transmissions with a green SIG
indicator, the receiver will start recording for 12 hours, even
while the power switch of the MiroCamÂŽ Receiver is in the
off position.
3.5.7
Checking Operation of the MiroCamÂŽ Receiver and Signal
Reception
After the patient holds the MiroCamÂŽ Capsule as detailed above,
the signal indicator on the MiroCamÂŽ Receiver is green and signal
indication melody is generated. If signal indicator is yellow, there is
no signal being received from the capsule.
„
Switch on the MiroCamÂŽ Receiver.
„
Check if the battery indicator (BAT) at the top of the MiroCamÂŽ
Receiver shows that the battery is fully charged. The battery
indicator on the MiroCamÂŽ Receiver should be green.
„
Check if the initialize indicator (INI) at the top of the MiroCamÂŽ
Receiver shows that initialization is complete. The INI indicator on
the MiroCamÂŽ Receiver should be green.
3-15
Performing Capsule Endoscopy
Chapter 3
„
Connect the data cable to the MiroCamÂŽ Receiver.
„
After patient grasps capsule by opposing gold bands (as detailed
in picture above, check the SIG indicator on the MiroCamÂŽ
Receiver is green and signal indication melody is generate.
CAUTION If the battery indicator on the MiroCamÂŽ Receiver shows
that the battery is not fully charged, do not start the
endoscopy procedure. The battery may be depleted during
the MiroCamÂŽ Capsule endoscopy procedure and images
may not be saved properly.
CAUTION Please be noticed to confirm the shape and the direction of
the connector when you connecting the data cable to the
MiroCamÂŽ Receiver, since it may cause cable damage
problem.
3.5.8
Ingesting the Capsule
After checking if the signal indicator on the MiroCamÂŽ Receiver is
green, ingest the MiroCamÂŽ Capsule with water.
CAUTION DO NOT bite the MiroCamÂŽ Capsule while ingesting.
NOTE To increase the effectiveness of the MiroCamÂŽ Capsule
endoscopy procedure, please be sure to drink water on a
regular basis.
3- 16
Chapter 3
Performing Capsule Endoscopy
WARNING The MiroCamÂŽ Capsule should enter the stomach. Make
WARNING
3.5.9
sure to always check that the MiroCamÂŽ Capsule enter the
stomach by checking the images on the MiroViewΠRTV
(or the Wireless MiroViewΠRTVi) and color of SIG
indicator on the MiroCamÂŽ Receiver turns green right after
ingesting the capsule.
DO NOT USE a MiroCamÂŽ Capsule that has been dropped
or coughed up by a patient. New MiroCamÂŽ Capsule
must be used. Take note of the new MiroCamÂŽ Capsule
number. The MiroCamÂŽ Receiver does not need to be
initialized again prior to swallowing the MiroCamÂŽ Capsule.
Checking and Wearing the MiroCamÂŽ Receiver
„
After ingesting the capsule, make sure that the SIG indicator is
green.
„
Place the MiroCamÂŽ Receiver in the bag.
„
Organize the contents of the bag so that the cables are not
entangled.
„
Adjust cables, and place excess in cable bag.
„
Adjust the bag strap as needed.
3-17
Performing Capsule Endoscopy
„
Chapter 3
The MiroCamÂŽ Capsule endoscopy procedure will be complete
after 12 hours.
CAUTION Patient should not touch the MiroCamÂŽ Receiver during the
MiroCamÂŽ Capsule endoscopy procedure. This may lead to
loss of image data.
CAUTION During the MiroCamÂŽ Capsule endoscopy procedure the
SIG indicator should be green.
In this case, check data cable to ensure it is securely
inserted and check the sensor pads to ensure these are
fixed to the body.
3.5.10 During the Procedure
„
After ingesting the MiroCamÂŽ Capsule Endoscope instruct the
patient to:
Immediately report any episodes of abdominal pain,
nausea or vomiting, to the Nurse or Physician in charge.
After ingesting the MiroCamÂŽ Capsule you may ingest
water, and only water. At least 250ml of water should be
ingested per hour.
Four hours after swallowing the MiroCamÂŽ Capsule, you
will be permitted to resume a clear liquid diet. A clear
liquid diet includes water, clear broth, Jell-O, Sprite,
apple juice, and popsicles. No solid foods, milk or milk
products, or dark-colored liquids are allowed. A light diet
(e.g. applesauce, cereal, toast) can be resumed six
hours after the MiroCamÂŽ Capsule was swallowed.
Do not touch or disturb the MiroCamÂŽ Receiver or get
them wet for the duration of the procedure. The
MiroCamÂŽ Receiver and sensors must remain on the
body for a period of 12 hours after ingestion of the
MiroCamÂŽ Capsule.
3- 18
Chapter 3
Performing Capsule Endoscopy
If a sensor pad or cable is removed during the
procedure, the patient can replace the sensor pad or
cable and take a note of the time of the occurrence.
Patient should not exercise or lift heavy items
Daily activities, aside from strenuous activities are
permitted for the patient.
Please refrain from bathing or showering while sensor
pads and MiroCamÂŽ Receiver are attached to your
body.
Patient must Avoid MRI rooms at the hospital and radio
transmission towers.
Patient should not use electric blankets or electric
heating pads.
Use of computers, radios, cell phones are permitted
Keep away from other patients who are undergoing the
MiroCamÂŽ Capsule endoscopy procedure.
Once the patient has ingested a MiroCamÂŽ Capsule,
the patient may leave the clinic.
WARNING Patient should not open the MiroCamÂŽ Receiver bag. The
safety of ESD (electrostatic discharge) when the patient
leaves the clinic is not published.
WARNING Patient should not contact any electric device to the patient
abdomen directly. This may lead to loss of image data.
CAUTION Tell the patient to notify the nurse or physician of symptoms
of abdominal pain, or vomiting during or after the
MiroCamÂŽ Capsule endoscopy procedure.
CAUTION Tell the patient to avoid excessive physical activity during
the MiroCamÂŽ Capsule endoscopy procedure.
CAUTION 4 hours after ingesting the MiroCamÂŽ Capsule patients may
resume a liquid diet.
3-19
Performing Capsule Endoscopy
Chapter 3
CAUTION When undergoing the MiroCamÂŽ Capsule endoscopy
procedure, DO NOT make physical contact with another
person undergoing the same procedure.
3.5.11 Completion of the Procedure
„
The MiroCamÂŽ Receiver set, sensor pad and cables can be
removed by the patient 12 hours after ingestion of the MiroCamÂŽ
Capsule.
„
Hospital or clinic is to arrange the time for the patient to return the
MiroCamÂŽ Receiver set.
3.5.12 After the Procedure
- Inform the patient that:
„
The MiroCamÂŽ Capsule will be naturally excreted.
„
Instruct patient to contact nurse or physician if the patient feels
acute or continuing abdominal pain.
„
Meals: eat as usual.
„
The day following the MiroCamÂŽ Capsule endoscopy procedure
the patient may resume all usual activities.
„
MRI examinations: patient should avoid MRI examinations prior
to excretion of the MiroCamÂŽ Capsule.
WARNING After ingesting the MiroCamÂŽ Capsule, always check
whether the MiroCamÂŽ Capsule has been excreted.
The MiroCamÂŽ Capsule captures images for up to 12 hours
and gets naturally excreted in about 24 hours under normal
conditions. If the MiroCamÂŽ Capsule has not been excreted
from the patient within 72 hours, patient should contact the
physician. If examination confirms retention of the
MiroCamÂŽ Capsule, surgical or medical treatment to
remove the MiroCamÂŽ Capsule may be necessary.
NOTE The MiroCamÂŽ Capsule and sensor pads are medical
waste, and should be disposed of according to local
regulations or Waste Electrical and Electronic Equipment
(WEEE) directive on waste disposal.
3- 20
Chapter 3
Performing Capsule Endoscopy
3.6 Using Magnetic Controller
„
After ingesting the capsule, make sure that the SIG indicator is green.
„
Connect to the 0LUR9LHZŒ5TV or Wireless 0LUR9LHZŒRTVi and then
confirm current location of capsule.
„
Control the direction of the MiroCamÂŽ Capsule in human body with the
magnetic controller like following pictures.
„
Lead the MiroCamÂŽ Capsule into the duodenum with magnetic
controller by FKHFNLQJ WKH LPDJHV RQ WKH 0LUR9LHZΠ579 or the
Wireless MiroViewΠRTVi.
CAUTION If the patient feels pain during doctor controls a magnetic
CAUTION
capsule with magnetic controller, carry out conventional
endoscopy.
DO NOT put any steel or magnetic materials within 1m
radius during the MiroCamÂŽ Capsule endoscopy
procedure.
3-21
Performing Capsule Endoscopy
Chapter 3
3.7 Uploading Image Data
Once the MiroCamÂŽ Capsule endoscopy procedure is complete, upload
the image data from the MiroCamÂŽ Receiver to the workstation and start
diagnosis of the data using 0LUR9LHZŒSoftware.
3.7.1
Transferring and Checking image data
„
Switch on the workstation.
„
Connect the smaller end of the USB cable to the MiroCamÂŽ
Receiver
„
Click the
„
When the login window appears, enter the user ID and password,
on the desktop to launch 0LUR9LHZŒOperator.
and then click the
„
Connect the smaller end of the USB cable to the MiroCamÂŽ
Receiver.
„
Connect the other end of the USB cable to the workstation.
„
Click the
„
After the image data in the MiroCamÂŽ Receiver has been
in 0LUR9LHZŒOperator.
successfully uploaded, execute 0LUR9LHZΠClient to review and
report on the patient file.
WARNING )RUPRUHLQIRUPDWLRQRQXVLQJ0LUR9LHZΠSoftware please
refer to Chapter 4. 8VLQJ0LUR9LHZΠSoftware.
3- 22
Chapter 3
Performing Capsule Endoscopy
3.8 MiroCamÂŽ Receiver Management Âą Post Procedure
3.8.1
Cleaning
„
Remove data cable (or data belt) from the MiroCamÂŽ Receiver .
„
Capsule, data belt and sensor pads should not be reused.
„
To clean the MiroCamÂŽ Receiver and the workstation, dampen a
soft cloth with warm water or with a commercial, nonabrasive
cleaner (or a mild soap or detergent solution) and wipe the
exterior surface lightly. DO NOT allow any liquids to come in
contact with the power connector, cable connector or switches.
DO NOT allow any liquids to penetrate connectors or openings in
the system cover. Cleaning of the system and accessories should
be conducted at least once a week.
CAUTION DO NOT immerse the MiroCamÂŽ Capsule Endoscope
System or its accessories in liquid or clean with caustic or
abrasive cleaners. DO NOT spray or pour any liquid on the
system or its accessories. DO NOT use the organic
solvents such as a lacquer, thinner, ethylene and oxide
because they can damage the equipment. When cleaning
the data cable, do not use the cleaning tools such as brush
and sandpaper.
3-23
Performing Capsule Endoscopy
3.8.2
Chapter 3
Charging Battery
„
Battery must be recharged after every procedure.
„
Battery can be individually recharged using the battery charger or
while attached to the MiroCamÂŽ Receiver.
„
Battery must be recharged in the battery charger.
„
If two batteries are inserted in charger, the batteries will
automatically consecutively charge (not simultaneous).
„
3- 24
Connect adapter DC cable to battery charger.
Chapter 3
Performing Capsule Endoscopy
„
Connect AC power cable to adaptor.
„
Connect AC power cable to AC outlet or multi-tap.
„
Battery charger indicator lights:
Battery is charging when green light is blinking
Battery is fully charged when light is solid blue
Battery is not-charging if light is yellow
NOTE Second Battery in charger will automatically begin charging
once first battery is fully charged.
Waiting
Charging
Charging
Charged
3-25
Performing Capsule Endoscopy
Chapter 3
WARNING If the indicator on the battery charger is blinking yellow
there is a bad connection. Please disconnect the battery
from the battery charger and try again.
WARNING Only use batteries provided by IntroMedic. Usage of
inappropriate batteries can cause serious damage to the
MiroCamÂŽ Receiver.
WARNING Recharge the batteries with the adaptor and the battery
charger only from IntroMedic. Improper adaptors and
battery chargers cause serious damage.
WARNING Try not to contact the metallic terminal board of batteries
with conductive objects or human body. It can cause an
electric shock or damage and/or breakage of the
batteries.
WARNING DO NOT use the batteries with visible surface damage
on. Usage of damaged batteries can result in leakage of
contents of the batteries.
WARNING To avoid the risk of explosion, keep batteries away from
fire.
WARNING Treat the batteries carefully from serious impact or shock.
This can cause serious damage to the batteries.
WARNING DO NOT expose the batteries to liquids. This can cause
serious damage.
3- 26
8VLQJ0LUR9LHZŒSoftware
Using MiroViewΠSoftware
4- 2
Chapter 4
Using 0LUR9LHZΠSoftware
Chapter 4
4. USING 0,529,(:ΠSOFTWARE
The 0LUR9LHZΠSoftware is a computer software program that aids in
diagnosis of disease of the small bowel via displaying images obtained from
the MiroCamÂŽ Capsule.
Following is a list of new & updated features:
- User Interface
™ The
0LUR9LHZΠSoftware
enables
adjustable
resolution,
to
appropriately fit to the screen size.
™ The 0LUR9LHZŒ Software has been designed with a dark
background to reduce eye strain.
™ The 0LUR9LHZŒSoftware provides intuitive and unified icons so that
the user can adapt quickly.
- Reporting Tool
- Express Play
- SGIB Play
- Range View
- Map View
- Network Support
- Account Management
- Multi-Review / Report Generation
- Multi-Receiver Management
- Multi-Data Path
- Customizing Print Dialog
- Data Multi-Language
- ODF Report
- Drag Bag
- Finding Setting (Custom Finding)
4-3
Using MiroViewΠSoftware
Chapter 4
The workstation where the 0LUR9LHZΠSoftware is installed properly has
icons for four applications on the Desktop folder: 0LUR9LHZΠClient,
0LUR9LHZŒOperator, 0LUR9LHZŒServer, and 0LUR9LHZŒViewer. However
this manual will not explain details on how to use the 0LUR9LHZŒViewer. For
additional information for 0LUR9LHZŒViewer, please refer to the 0LUR9LHZŒ
9LHZHU ,QVWUXFWLRQ 0DQXDO 7R JHW WKH LQVWDOODWLRQ SURFHGXUH IRU 0LUR9LHZŒ
Software, refer to the MiroCamÂŽ Service Manual.
4- 4
Using 0LUR9LHZΠSoftware
Chapter 4
0LUR9LHZŒClient
0LUR9LHZŒOperator
0LUR9LHZŒServer
0LUR9LHZŒViewer
This program is used
for reviewing the
images from the
MiroCamÂŽ Capsule
and generating a
patient report. The
0LUR9LHZŒServer
should be started prior
to starting the
0LUR9LHZŒClient.
This program is used
for managing the
MiroCamÂŽ Receivers
(initialize, upload etc.)
and managing user
accounts. The
0LUR9LHZŒServer
should be started prior
WRVWDUWLQJ0LUR9LHZŒ
Operator.
The server stores the
patient data files. Start
the 0LUR9LHZŒ
Server prior to starting
0LUR9LHZŒSoftware
or 0LUR9LHZŒ
Operator.
The
0LUR9LHZŒViewer is
used for reviewing,
editing and creating
the images exported
IURPWKH0LUR9LHZŒ
Software; EXMIF or
JPEG images.
Functions:
Functions:
Functions:
Functions:
- List Mode
- Review Mode
- Report Mode
- Export Mode
- Image Atlas
- SGIB
(Suspected
GI Bleeding)
- Express Play
- Position Window
- Network connectivity
- Multi-Review
- Range View
- Map View
- GI Dictionary
- Finding / Diagnosis
Information
- Input Patient
Information
- Receiver
Initialization
- Upload Image Data
from Receiver
- Data Backup
- Account
Management
- Patient Manager
- DB, Mass storage
-Network connectivity
- Study Information
- Image Information
- Show Findings /
- Multiple Data Path
Diagnosis
-Network connectivity
- Drag Bag
4-5
Using MiroViewΠSoftware
4.1 H/W Specifications for 0LUR9LHZΠSoftware
0LUR9LHZŒServer
4.1.1
„
Minimum Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Windows Vista Business (32 bit, 64 bit),
Windows 7 (32 bit, 64 bit)
CPU: > Core 2 Duo E6300
Memory: > DDR II 4GByte
Video Card: Windows Compatible
HDD: SATA 500GB
ODD: DVD+-RW
Monitor Resolution: 1024x768
„
Recommended Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Windows Vista Business (32 bit, 64 bit),
Windows 7 (32 bit, 64 bit)
4- 6
CPU: > Core 2 Duo E6300
Memory: > DDR II 4GByte
Video Card: Windows Compatible
HDD: SATAII RAID 1TB
ODD: DVD+-RW
Monitor Resolution: 1680x1050, 1280 x 1024
Chapter 4
Using 0LUR9LHZΠSoftware
Chapter 4
0LUR9LHZŒClient
4.1.2
„
Minimum Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Vista or Windows7 (32 bit, 64 bit)
CPU: Pentium4 2GHz
Memory: 1GB
Video Card: Geforce 7600GT 128MB
HDD: SATA 160GB
ODD: DVD+-RW
Monitor Resolution: 1024x768
Sound Card / Mike / Speaker
„
Recommended Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Vista or Windows7 (32 bit, 64 bit)
CPU: > Core 2 Duo E6300
Memory: > DDR II 2GByte
Video Card: > Geforce 7600GT 128MB
HDD: SATA II 500 GB
ODD: DVD+-RW
Monitor Resolution: 1680x1050
Sound Card / Mike / Speaker
4-7
Using MiroViewΠSoftware
0LUR9LHZŒOperator
4.1.3
„
Minimum Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Vista or Windows7 (32 bit, 64 bit)
CPU: Pentium4 2GHz
Memory: 1GB
Video Card: Windows Compatible
HDD: SATA 160GB
ODD: DVD+-RW
Monitor Resolution: 1024x768
„
Recommended Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Vista or Windows7 (32 bit, 64 bit)
4- 8
CPU: > Core 2 Duo E6300
Memory: 1GB
Video Card: Windows Compatible
HDD: SATA 160GB
ODD: DVD+-RW
Monitor Resolution: 1680x1050
Chapter 4
Using 0LUR9LHZΠSoftware
Chapter 4
0LUR9LHZŒViewer
4.1.4
„
Hardware Requirements
OS: Windows XP (32 bit, 64 bit),
Vista or Windows7 (32 bit, 64 bit)
CPU: Pentium4 2GHz
Memory: 1GB
Video Card: Windows Compatible
HDD: SATA 160GB
ODD: DVD+-RW
Monitor Resolution: 1024x768
CAUTION The 0LUR9LHZΠSoftware cannot be viewed on a monitor
with a resolution under 1024x768.
NOTE 7KH*8,LVEHVWYLHZHGRQDZLGHPRQLWRURI´RUODUJHU
4-9
Using MiroViewΠSoftware
Chapter 4
4.2 Overview ± 0LUR9LHZŒServer
The 0LUR9LHZΠServer software is intended to be used as a system
administrative managing tool. The 0LUR9LHZΠServer manages file
systems and database systems.
When switching the workstation on, the 0LUR9LHZΠServer will start
automatically. When the following window appears, set up the
configuration and press the
to continue.
ཛ
Set the port number for the Network. If unknown, please leave the
ILHOG DV ¾œ 7KLV ILHOG VKRXOG EH PDQDJHG E\ D 1HWZRUN
Administrator at the hospital.
4- 10
Chapter 4
ཛྷ
Using 0LUR9LHZΠSoftware
6HW WKH SDVVZRUG IRU Âľ$GPLQLVWUDWRUÂś DFFRXQW $GGLWLRQDO DFFRXQWV
can be made via Account Manager function after logging in the
0LUR9LHZŒ2SHUDWRUDVµ$GPLQLVWUDWRU¶
ཝ
Confirm the password.
ཞ
Set the Active Path; Video Path and Data Path as the desirable
path. Select one of multiple paths from the paths list for the active
path. The paths list can be modified via Server Menu Æ Multi Data
Path on the 0LUR9LHZŒServer running.
§
,QSXWWKH+RVSLWDOÂśV1DPHLQWKLVILHOG
ŕ˝ 
,QSXWWKH+RVSLWDOÂśVAddress in this field.
ཥ
,QSXWWKH+RVSLWDOÂśV7HOHSKRQHQXPEHULQWKLVILHOG
4-11
Using MiroViewΠSoftware
„
After setting up the Configuration Windows, the 0LUR9LHZŒ
Server window above will appear. Click the
window.
4- 12
Chapter 4
to hide the
Using 0LUR9LHZΠSoftware
Chapter 4
„
The Video Path list and the Data Path list for the Active Paths can
be modified via Server Menu Æ Multi Data Path on the
0LUR9LHZŒServer running.
Login window will appear. Input the password for the
Administrator account.
4-13
Using MiroViewΠSoftware
Case Path Setting will appear. Click the
the Active Path Setting.
4- 14
Chapter 4
to show
Using 0LUR9LHZΠSoftware
Chapter 4
to set the path for the Video Path and the
Click the
Data Path respectively.
4-15
Using MiroViewΠSoftware
The user can modify the Video Path and Menu Path using
the
Chapter 4
(add path) and
(remove path) as well.
,I WKH $FWLYH 3DWKÂś PHPRU\ EHFRPHV LQVXIILFLHQW WR XVH
(below 10GBytes), set the path as new one larger than 30
GB.
NOTE The 0LUR9LHZΠServer provides the task manager to show
the activating status on the server. The 0LUR9LHZΠServer
offers the case list and the analysis function as well.
4- 16
Using 0LUR9LHZΠSoftware
Chapter 4
4.3 Overview - 0LUR9LHZŒOperator
The 0LUR9LHZΠOperator software is intended to be used for
administrative purposes, including the Account Manager, the Patient
Manager and the MiroCamÂŽ Receiver management functionality.
Start 0LUR9LHZŒOperator
4.3.1
„
Double-click the
to run the 0LUR9LHZΠOperator.
When
executed for the first time, the following window will appear.
„
,QSXW³´IRUWKH,3$GGUHVVDQG³´IRUWKH3RUW
ଖ If the 0LUR9LHZŒ Server is installed on the network, input the
workstation¶V,3RQZKLFKWKH0LUR9LHZŒServer is installed for
this field, and the port which the 0LUR9LHZΠServer is using,
referring to the IT engineer in the hospital to point the operator
to the 0LUR9LHZŒServer.
4-17
Using MiroViewΠSoftware
„
Chapter 4
Set the Active Path; Video Path and Data Path as the desirable
path. Select one of multiple paths from the paths list for the active
path.
„
Direct the Default Export Data Folder.
„
Choose the preferred Language settings and press
access the 0LUR9LHZŒOperator.
„
After the 0LUR9LHZΠOperator has launched, the Log-in window
to
will appear.
„
,QSXWÂľ$GPLQLVWUDWRUÂśIRU,'DQGGHVLJQDWHGSDVVZRUG7KHQSUHVV
the
„
Press the
is using.
4- 18
to change the IP address the 0LUR9LHZΠServer
Using 0LUR9LHZΠSoftware
Chapter 4
„
After clicking the
the window will appear like the above.
Type the 0LUR9LHZŒServer IP address and port. Then press the
after inputting ID and password.
CAUTION DO NOT forget the ID and password after they are
encrypted.
CAUTION Before the 0LUR9LHZΠOperator is launched, a password
for the administrator account should be created. When
running the 0LUR9LHZΠServer for the very first time, a
password for the administrator account should be created.
NOTE Create new and edit existing accounts by using the
µAccount Manager¶ menu in 0LUR9LHZŒ Operator.
„
The following subsections describe the main interfaces and
functions of the 0LUR9LHZŒOperator.
4-19
Using MiroViewΠSoftware
4.3.2
Chapter 4
List Mode
cd
ij
efgh
ÂŁ
List Mode
Opens List Mode
¤
Receiver Mode
Opens Receiver Mode
ÂĽ
Print Report
Print out the selected Report
ÂŚ
Delete Case
Delete the selected Cases
§
Recycle Bin
Open Recycle Bin Window
¨
Export
Export the selected Report
Š
Search
ÂŞ
Show all
Search Cases and/or Reviews by keyword
Refresh and Show all the Cases and Review on
the List
NOTE Right click the mouse at the list item to use the context menu
functionality, for example the Backup function.
4- 20
Using 0LUR9LHZΠSoftware
Chapter 4
4.3.3
Receiver Mode
Screen enables administration and status display for up to four
MiroCamÂŽ Receivers.
c d e
ÂĽ
ÂŚ
ÂŁ
¤
ÂĽ
ÂŚ
§
Upload
Upload image data in the MiroCamÂŽ Receiver
to the server
,QSXW
3DWLHQWÂśV ,QSXW 3DWLHQWÂśV ,QIRUPDWLRQ WR WKH VHOHFWHG
Information
Receiver
Initialization
Delete all data from the MiroCamÂŽ Receiver
and/or prepare the MiroCamÂŽ Receiver for the
next patient
Receiver Port
Shows the status of the connected the
MiroCamÂŽ Receiver for each of the four ports
Detail Information
6KRZV WKH SDWLHQWÂśV LQIRUPDWLRQ IRU WKH
selected Receiver
4-21
Using MiroViewΠSoftware
Chapter 4
CAUTION When running MiroViewΠOperator on a 64bits
OS, Do not turn off or disconnect the MiroCamÂŽ
Receiver while uploading a patient file.
4.3.4
Receiver Initialization
Click the
4- 22
to initialize the selected Receiver.
Using 0LUR9LHZΠSoftware
Chapter 4
4.3.5
Inputting Patient Information
Click the
to enter the patient information. After completing the
required fields, click the
to save the patient information
onto the MiroCamÂŽ Receiver. The fields in the patient information
are editable and additional fields can be added.
This can be
accessed via Tools Æ Preferences Æ Receiver Æ Set Æ Add /
0RGLI\ 7KH ILHOG ³5HDVRQ IRU UHIHUUDO´ LV QHZO\ DGGHG RQ WKH
0LUR9LHZΠSoftware version.)
* indicates required fields.
4-23
Using MiroViewΠSoftware
4.3.6
Chapter 4
Image Data Upload
After the MiroCamÂŽ Capsule endoscopy procedure, upload the
image data from the MiroCamÂŽ Receiver to the MiroCamÂŽ system
via the 0LUR9LHZΠOperator. Click the
to upload the image
data from the MiroCamÂŽ Receiver.
After the image data in the MiroCamÂŽ Receiver has been
successfully uploaded, enter the List Mode and check if the new
Case has been created.
- Double-click the
to run the 0LUR9LHZŒClient.
- Select the newly uploaded image data and enter the Review Mode.
- Play the case to check the uploaded image data.
CAUTION If uploading of the image data failed, disconnect
the USB cable from the workstation, turn off the
MiroCamÂŽ Receiver and back on. Reconnect the
USB cable to the workstation and try uploading
once more. If the problem continues, please
contact the local IntroMedic distributor.
NOTE 0DNH VXUH WKH SDWLHQWÂśV QDPH KDV EHHQ LQSXWWHG
properly prior to uploading the image data. If the
image data is uploaded with the wrong patient
name, it could result in misdiagnosis or delay in
diagnosis.
NOTE If the user uploads an image data which has been
XSORDGHGEHIRUHDQHUURUPHVVDJHÂľ'DWDKDVEHHQ
previously uploaded. Would you like to upload
agDLQ"ÂśZLOODSSHDU
NOTE The user can stop the uploading of the image data
while uploading process file by clicking the
4- 24
Using 0LUR9LHZΠSoftware
Chapter 4
4.3.7
User Account Management
The 0LUR9LHZŒOperator enables management of multiple users &
Groups.
Users can be organized into Groups to readily control
access. The following screen can be accessed by Tools Æ Account
Manager.
4-25
Using MiroViewΠSoftware
„
Click the
Chapter 4
to show the window as displayed below
to create a new user ID.
ID: User ID
Password: Password
Name: User Name
Type: User type.
- User: can access own reviews and all the reviews in the
*URXSRIWKH8VHUÂśVRQO\
- Super User: can access all the reviews in the System
- Operator: can log in via the 0LUR9LHZΠOperator S/W
only.
୔ Administrator account can log in via both the
0LUR9LHZŒ Client and the 0LUR9LHZŒOperator.
Group: Set of users in the same Clinic or Laboratory.
„
4- 26
Click the
to delete the selected account
Using 0LUR9LHZΠSoftware
Chapter 4
4.3.8
Patient Manager
The 0LUR9LHZΠOperator enables management of Patient. The
following screen can be accessed by Tools Æ Patient Manager
„
Click the
to show the window as displayed below
WRFUHDWHDSDWLHQWÂśV,'
ID: ID for the new patient.
Name3DWLHQWÂśVQDPH
Date of birth: The date of birth for the patient which will
appear on the report
Gender7KHSDWLHQWÂśVJHQGHU
4-27
Using MiroViewΠSoftware
4.3.9
Chapter 4
Preferences
To set and/or change the settings for the 0LUR9LHZΠOperator,
access Preferences via Tools Æ Preferences.
Preferences for the 0LUR9LHZΠOperator falls into two categories:
Global and Local.
Global preference is saved on the 0LUR9LHZΠServer and has in
effect for all the users using the 0LUR9LHZŒServer.
Local preference is saved on the workstation on which the
0LUR9LHZŒOperator is installed and has in effect for the workstation
only.
4- 28
Using 0LUR9LHZΠSoftware
Chapter 4
Global
Local
ÂŁ
Settings
¤
PACS
ÂĽ
Settings
ÂŚ
User
§
Network
¨
List
Š
Receiver
ÂŞ
Print
- Hospital Information
- Measurement
- Agent & Distributor Information
- PACS Registration
- Technical Settings
- Language
- GI Tract Color Reference
- Free Hard Disk
- Display
- Default Export Data Folder
- Finding Setting
- 8VHUÂśV,QIRUPDWLRQ
- Change Password
- 0LUR9LHZŒServer
- Server Manager
- Display Âą Show/Hide Columns
- Patient Information Configuration
- Multiple Upload
- Page Setup
4-29
Using MiroViewΠSoftware
Chapter 4
1) Global Settings
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
¨
Š
i.
Hospital Information
ཛ
Country Âą Choose the Country where the hospital is located.
ཛྷ
Hospital Name Âą ,QSXWWKH+RVSLWDOÂśV1DPHLQWKLVILHOG
ཝ
Address Âą ,QSXWWKH+RVSLWDOÂśV$GGUHVVLQWKLVILHOG
ཞ
Telephone Âą ,QSXW WKH+RVSLWDOÂśV7HOHSKRQHQXPEHULQWKLV
field.
ཟ
Logo Image Âą Add the Logo Image
୔ These information will be applied and shown on the final
report.
4- 30
Using 0LUR9LHZΠSoftware
Chapter 4
ii.
Measurement
ŕ˝ 
Height Âą &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVKHLJKW
ཥ
Weight - &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVZHLJKW
ར
Waist - &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVZDLVW
୔ These information will be applied and shown on the case
information and patient information
ÂŞ
ÂŤ
iii.
Agent & Distributor Information
ལ
$JHQF\,QSXWWKH$JHQF\ÂśVLQIRUPDWLRQLQWKLVILHOG
ཤ
Contact: Input the contact information for the agency.
4-31
Using MiroViewΠSoftware
Chapter 4
2) Global PACS
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
i.
Registration:
Process
to
enable
the
PACS
related
functionalities.
. PACS registration window will
Click the
appear like the below.
Carry out in alphabetical order like following picture.
Ú
Û
Ü
NOTE Generation key is a key that unlocks the PACS
function on the MiroCamÂŽ workstation.
4- 32
Using 0LUR9LHZΠSoftware
Chapter 4
Generation key will be generated automatically. Click
to send the Generation key to IntroMedic.
the
Mail Box window will appear like below.
Input the e-mail address of the hospital administrator in
WKH Âľ)URPÂś ILHOG ,QSXW DOO WKH UHTXLUHG LQIRUPDWLRQ WR
send to IntroMedic: Hospital name, Hospital address,
Main
contact,
Telephone,
E-mail
address
and
Generation key.
Click the
to send the information to
IntroMedic. IntroMedic will reply with the Registration
Key to the
4-33
Using MiroViewΠSoftware
Chapter 4
e-PDLO DGGUHVV W\SHG LQ Âľ)URPÂś ILHOG ,W ZLOO WDNH WLPH WR
receive the reply.
to close the Mail Box window.
Click the
After receiving the Registration Key, input the Key in the
Registration Key field on PACS registration window.
Click the
ii.
to finalize the registration process.
Caller: Technical properties for Caller.
ཛ
Title: Input the Title for Caller.
ཛྷ
Modality: Input the Modality for Caller.
ཝ
Port: Input the port number to use for Caller.
iii.
Image Storage Server: Technical properties for Image
Storage.
ཞ
Title: Input the title for Image Storage Server.
ཟ
IP Address: Input the IP Address for Image Storage Server.
ŕ˝ 
Port: Input the port number to connect to Image Storage
Server.
4- 34
Using 0LUR9LHZΠSoftware
Chapter 4
¨
Š
ÂŞ
ÂŤ
ÂŹ
­
ÂŽ
ÂŻ
iv.
Work list Server: Technical property for Work list Server.
ཥ
Title: Input the Title for Work list Server.
ར
IP Address: Input the IP Address for Work list Server.
ལ
Port: Input the port number to connect to Work list Server.
v.
Other Settings: Technical properties for PACS setting.
ཤ
PACS Module: Choose the appropriate PACS Module,
DreamWell or Vieworks.
ོ
Log Level: Choose the appropriate Log Level for the PACS
functionality: Level 0, Level 1 and Level 2.
ཌ
Time Delay
Choose the Time delay from 0 to 9 seconds.
ཧ
Station Name
ཨ
Wild-card character
4-35
Using MiroViewΠSoftware
Chapter 4
3) Local Settings
¢
ÂŁ
i.
ii.
Language
ཛ
Display: Choose the display language.
ཛྷ
CEST: Choose the CEST language.
GI Tract Color Reference: Show the color references for the
GI Tract.
Free Hard Disk: Decide the number of cases on the local
drive.
NOTE
4- 36
If the number of cases saved from the Server is more
than the number of Keeping Case, it will automatically
delete the oldest cases from the local drive.
Using 0LUR9LHZΠSoftware
Chapter 4
¤
iv.
Display
ཝ Display: Font setting to display.
v.
Default Export Data Folder: Direct the folder for exporting
data. Click the
vi.
to open the browser.
Finding Setting: Configure the finding setting. Click the
to open the configuration dialogue.
4-37
Using MiroViewΠSoftware
Chapter 4
4) Local User
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
8VHUÂśV,QIRUPDWLRQ6HWPRGLI\WKHLQIRUPDWLRQIRUWKHXVHU
i.
ཛ
User Name: Input User Name which will be used for log-in
ID.
ཛྷ
Email Address: Type in the e-mail address here.
ཝ
Telephone: Type in the telephone number here.
ii.
4- 38
Change Password
ཞ
Current: Input the current password
ཟ
New: Input the desired password to use.
ŕ˝ 
Confirm: Input the desired password again.
Using 0LUR9LHZΠSoftware
Chapter 4
5) Local Network
¢
ÂŁ
¤
0LUR9LHZŒServer
i.
ཛ
IP Address: Input the IP Address where the 0LUR9LHZŒ
Server is installed.
ཛྷ
Port: Input the port number to connect with 0LUR9LHZŒ
Server.
ii.
Server Manager
ཝ
Port: Input the port number for connection between the
Server Manager and the 0LUR9LHZŒServer.
4-39
Using MiroViewΠSoftware
Chapter 4
6) Local List
i.
Display
Columns: Configure the columns which will appear on List.
4- 40
Using 0LUR9LHZΠSoftware
Chapter 4
7) Local Receiver
i.
Patient Information Configuration: Configure the items
shown
on
Patient
Information
after
initializing
the
MiroCamÂŽ Receiver.
4-41
Using MiroViewΠSoftware
- Click the
Chapter 4
to show the Patient Information
Configuration window.
Add/Delete/Modify the items. After completing the tasks,
click the
ii.
to close the window.
Multiple Upload
Count: Set the number of MiroCamÂŽ Receivers to upload
to the 0LUR9LHZŒOperator at once. Choose a number, 1
to 4.
4- 42
Using 0LUR9LHZΠSoftware
Chapter 4
8) Local Print
¢
ÂŁ
i.
Page Setup
ཛ
Footer: Type in the string for footer which will appear on
the final report.
¤ Page Setup: Edit the layout of the report.
4-43
Using MiroViewΠSoftware
- Click the
Chapter 4
to show the Page Setup window.
- Choose the paper type; A4 or Letter and adjust the
margins for Header, Footer, Right and Left.
4- 44
Using 0LUR9LHZΠSoftware
Chapter 4
4.4 Overview - 0LUR9LHZŒClient
Start 0LUR9LHZŒClient
4.4.1
„
The 0LUR9LHZΠClient is used to review images from the
MiroCamÂŽ Capsule procedure and generating a patient report.
2WKHU IXQFWLRQV LQFOXGHG ,Q 0LUR9LHZΠ&OLHQW DUH Network
Connectivity, List Mode, Review Mode, Report Mode, Export
Mode,
Image
Atlas,
Multi-Review,
SGIB(Suspected
GI
Bleeding)Play, Express View, Range View, Map View, Positioning
Window, GI Dictionary, and Finding / Diagnosis Information.
„
Double-click the
to run the 0LUR9LHZΠClient. When
executed for the first time, the following window will appear.
4-45
Using MiroViewΠSoftware
„
Chapter 4
,QSXW³´IRUWKH,3$GGUHVVDQG³´IRUWKH3RUW
If the 0LUR9LHZΠServer is installed on the network, input the
workstation¶V ,3 RQ ZKLFK WKH 0LUR9LHZŒ Server is installed for
this field, and the port which the 0LUR9LHZΠServer is using,
referring to the IT engineer in the hospital.
„
'LUHFWWKH³Active Path´WRWKHFDFKLQJIROGer.
„
Direct the Default Export Data Folder.
„
Choose the preferred Language settings and press
to
access the 0LUR9LHZŒClient.
„
After the 0LUR9LHZŒClient has launched, the Log-in window will
appear.
„
,QSXWÂľ$GPLQLVWUDWRUÂśIRU,'DQGSDVVZRUGDOUHDG\W\SHGLQ7KHQ
press the
„
Press the
is using.
4- 46
to change the IP address the 0LUR9LHZΠServer
Using 0LUR9LHZΠSoftware
Chapter 4
„
After clicking the
the window will appear as the above. Type
the 0LUR9LHZΠServer IP address and port. Then press the
after inputting ID and password.
(Use the
to change the port number for the Server Manager,
which is used to manage the server availability)
CAUTION ID and password are encrypted. DO NOT forget the ID and
password.
CAUTION Before the 0LUR9LHZŒClient has launched, a password for
the administrator account should be created. When running
the 0LUR9LHZŒServer for the first time, a password for the
administrator account should be created.
NOTE Create new and edit new or existing accounts by using the
Account Management tool on the 0LUR9LHZŒOperator.
NOTE Access to the 0LUR9LHZΠClient at Local Mode by clicking
the
to use the 0LUR9LHZΠClient without connecting
to the 0LUR9LHZŒServer.
4-47
Using MiroViewΠSoftware
4.4.2
Chapter 4
List Mode
„
List
c d ef
11
Ěş
12
Ěş
13
Ěş
4- 48
ÂŁ
¤
ÂĽ
ÂŚ
§
¨
Š
ÂŞ
ÂŤ
ÂŹ
­
List Mode
Review Mode
Report Mode
Export Mode
Print Report
Delete Case
Add a Review
Delete Review
Recycle Bin
Search
Show all
ÂŽ
ÂŻ
Selection Bar
Detail View
Open List Mode
Open Review Mode
Open Report Mode
Open Export Mode
Print selected Report
Delete Selected Case
Add a Review for the Selected Case
Delete selected Review
Open Recycle Bin
Search Cases and/or Reviews by key word
Refresh and Show all the Cases/Reviews on the
List
A rectangular area to show selected item
Show Detail Information for selected Case or
Review
Using 0LUR9LHZΠSoftware
Chapter 4
4.4.3
Review Mode
Select a case to review on the List Mode and click the
to enter
the Review Mode.
„
Capture Box Mode
cde f
26
Ěş
27
Ěş
28
Ěş
29
Ěş
14 Ěş
15 Ěş
16
17 Ěş
18 Ěş
19 Ěş
20 Ěş
21 Ěş
13 Ěş
22 Ěş
23 Ěş
11 Ěş
12 Ěş
24
5 Ěş
6Ěş
7Ěş
8Ěş
9Ěş
10 Ěş
Ěş
Ěş
ÂŁ
¤
ÂĽ
ÂŚ
§
List Mode
Review Mode
Report Mode
Export Mode
Position Window
¨
Š
ÂŞ
Single View
Dual View
Quad View
25
Ěş
Open List Mode
Open Review Mode
Open Report Mode
Open Export Mode
Current position of the
MiroCamÂŽ Capsule in 2D
Change to Single View
Change to Dual View
Change to Quad View
4-49
Using MiroViewΠSoftware
4- 50
Chapter 4
ÂŤ
ÂŹ
­
Range View
Map View
Normal Play
Change to Range View
Change to Map View
Show all images.
ÂŽ
Express Play
ÂŻ
SGIB Play
°
Âą
Ô§
First Frame
Previous
Captured
Image
Play in reverse
This mode actively removes images
based
upon
similarity;
effectively
reducing the number of images for
review. This mode is recommended to
review the patient file but not to diagnose
the patient symptoms.
Shows the images that have a high
possibility of bleeding and / or blood. This
mode may assist in finding areas of
suspected bleeding; however, it is NOT
100% reliable, and should only be used
as an adjunctive tool to assist in
reviewing the images.
Go to the First Image Frame
Go to Previous Captured Image Frame
Ô¨
Play / Pause
Play / Pause
ÔŠ
Play
Play Forward
ÔŞ
Next Captured Image
Go to the Next Captured Image
ÔŤ
Last Frame
Go to the final Image Frame

Capture Image
Image capture button.

Set landmark

Image Enhancement
Landmark button. Use this to set
landmarks for transition points in the GI
tract.
Show the Image Enhancement window

Full Screen Mode
Fit image to full screen

Time Display

Annotation
Handle
Display the time duration of the
MiroCamÂŽ Capsule from procedure start.
Expand / Shrink the control panel
(Show / Hide the Capture Box)
The video image area may widen by
Annotation Box Handle.
Box
Play in reverse
Using 0LUR9LHZΠSoftware
Chapter 4

Comparison Window

Thumbnail Extension

Capture Box /
Finding
Summary
Box / Drag Bag
Toggle Icon
„
Display the image selected from the
Image Atlas
Extend the Capture Box to display all
captured images.
(Hide the Video area)
Replace the Capture Box with Finding
Summary Box or Drag Bag.
Finding Summary Box


Finding
Box
Summary
Displays Capture Box, Thumbnail and
Finding Summary Box.
This is changed by clicking the
When new findings are added in Report
mode, new information for captured
image will be shown in Finding Summary
Box.
4-51
Using MiroViewΠSoftware
Chapter 4
Choose a section of Summary Box to show the thumbnails.
When a section of Summary Box is selected, the thumbnails
will be shown in the screen. Click the
thumbnail mode.
4- 52
to close the
Using 0LUR9LHZΠSoftware
Chapter 4
„
Drag Bag
Choose a section of Drag Bag to show the captured images.
There are two ways to set the captured image, the drag bag:
set the main image to a drag directly and capture the main
image first and set the image to a drag bag via the pop-up
menu.
4-53
Using MiroViewΠSoftware
i.
Chapter 4
Left click the mouse and drag the mouse downwards.
Fan shaped Drag Bags will appear like below.
Release the mouse in one of them.
ii.
Left click the mouse and drag to upper direction. Fan
shapes for Landmarks will appear like below. Release
the mouse on one of them.
4- 54
Using 0LUR9LHZΠSoftware
Chapter 4
iii.
Right click the mouse on a captured image and then
set the image to a Drag Bag.
4-55
Using MiroViewΠSoftware
„
Chapter 4
Mode Control
Full Screen Mode
Click the
to change to Zoom View mode
NOTE Play Slide Control is available on the Full Screen
Mode to set playing direction, playing speed and
playing status: Play and Pause.
NOTE Move the cursor away from the bottom of the
screen and the Play Control will appear.
4- 56
Using 0LUR9LHZΠSoftware
Chapter 4
Viewing Modes
Select one of the
for preferred Viewing
Mode.
Single View
Quad View
Dual View
Range View
NOTE Range View has been designed to assist in readily
finding transition points in the GI tract. The display
will show 9 images before and 9 images after the
current position. The 9 images are defaulted to 10
minutes apart, resulting in an overview of 90
minutes prior to, and 90 minutes after the current
position. The number of images displayed is set at
9, and is not configurable. The 90 minute duration
is configurable and can be adjusted by dragging
the side line in blue on the Time Bar and dragging
the mouse icon on the time boundary. It can also
be adjusted by going to Tools -> Preference ->
Review.
4-57
Using MiroViewΠSoftware
Chapter 4
Map View
- Use the wheel of the mouse to zoom in/out the map.
- Double-click the desired image to capture. Right click the mouse for
the desirable image to capture or set landmark.
- Click the desirable image and press  to play the adjacent
image frames.
NOTE Map view has been designed to assist in reviewing
the patient file by showing all the images on the
same page to assist in readily identifying
landmakers and potential bleeding areas.
Move the cursor on the designated image to see
the original image in detail.
4- 58
Using 0LUR9LHZΠSoftware
Chapter 4
The
will change to playing Mode, as below.
Normal Play
Express Play
SGIB Play
NOTE The Express Play shows the meaningful images
only so that the user can review the whole video
for the patient quickly. When entering the Express
Play, the 0LUR9LHZΠSoftware will show the
message, The Express Play is not intended to
detect abnormalities and should not be used as a
substitute for reviewing the entire video.
NOTE The SGIB Play shows the images in red or the
obscure bleeding images. IntroMedic does not
guarantee the performance and/or accuracy. Thus,
use this function for reference only.
4-59
Using MiroViewΠSoftware
„
Chapter 4
Position Window
Divides the body into 8 areas and
displays the location of where the
MiroCamÂŽ Capsule took the current
image.
Organ Bar
NOTE User is able to choose the option of selecting the
type of Position Window between line and region.
NOTE User is able to change the Position Window
Setting via Tools -> Preference
4- 60
Chapter 4
Using 0LUR9LHZΠSoftware
NOTE User can now choose the Organ bar option. This
organ bar also displays the entire trajectory of the
MiroCamÂŽ Capsule in the GI track.
4-61
Using MiroViewΠSoftware
„
Chapter 4
Comparison Window
Displays the image shown from the
Image Atlas lastly.
„
Image Enhancement Window
Alter images characteristics (ie. color,
saturation etc.) to assist in identifying
abnormalities:
Color Weakness
Image
reviewer
adjustment
who
for
has
the
color
blindness.
ALICE
Image
adjustment
NBI(Narrow Band Image)
4- 62
as
Using 0LUR9LHZΠSoftware
Chapter 4
4.4.4
Report Mode
Select the desired review for the Case from the List Mode and click the
to move to the Report Mode.
„
Report Mode
1 Ěş
2 Ěş
3 Ěş
Ěş
5 ¨
Ěş
Ěş
Ěş
12
Ěş
13
Ěş
ÂŤ
14
Ěş
15
Ěş
ྣ
ÂŹ
4-63
Using MiroViewΠSoftware
ÂŁ
¤
ÂĽ
ÂŚ
§
Chapter 4
¨
List Mode
Review Mode
Report Mode
Export Mode
Circumference
markers
Drawing Tools
Š
Image Enhancement
ÂŞ
Thumbnail Area
ÂŤ
Image Comments
ÂŹ
Diagnosis
­
Audio Comment
ÂŽ
GI Dictionary
Open List Mode
Open Review Mode
Open Report Mode
Open Export Mode
Opens graduated scale for display on
the image
Enables users to include annotations for
the image.
Alter images characteristics (ie. color,
saturation etc.) to assist in identifying
abnormalities.
Show the adjacent captured images
so that the user can select/deselect
the captured images to export.
Write comments for the Capture on the
main display and the report.
(Image Comments, Reason for Referral,
Procedure info & findings, Summary &
Recommendation)
Provides the Level of certainty of
diagnosis.
Record voice comment
(The user can record the voice, from 3
seconds to 180 seconds for each
captured image)
Provides the frequently-used-words to
search.
ÂŻ
Input Selected Word
°
Add
Word
Dictionary
Remove word
Dictionary
Âą
4- 64
to
from
Input the selected word into the text
editor.
Add the typed word into the Dictionary.
Delete selected
Dictionary.
word
from
the
Using 0LUR9LHZΠSoftware
Chapter 4
NOTE User is able to change the Panel Layout like
following pictures via Tools -> Preference -> Local
-> Report
NOTE Comments can be completed automatically by
NOTE
pressing  or  on
the keyboard.
Refer to 4.6.4 5HYLHZ 0LUR9LHZΠ&OLHQW for
more information.
Additional tabs in the report can be created or
modified via Tools -> Preferences -> Report
NOTE Right click the mouse on Text Comments area to
use Annotations.
Refer to 4.6.4 5HYLHZ 0LUR9LHZΠ&OLHQW for
more information.
NOTE Patient information, including the reason for
referral, is registered in the MiroCamÂŽ Receiver
via 0LUR9LHZŒ2SHUDWRU
4-65
Using MiroViewΠSoftware
4.4.5
Chapter 4
Export Mode
1 Ěş
2 Ěş
3 Ěş
Ěş
g h
4- 66
7 Ěş
8 Ěş
Ěş
10 Ěş
11
Ěş
12 Ěş
13 Ěş
14 Ěş
15 Ěş
16 Ěş
17
Ěş
Using 0LUR9LHZΠSoftware
Chapter 4
ÂŁ
¤
ÂĽ
ÂŚ
§
Š
ÂŞ
ÂŤ
ÂŹ
List Mode
Review Mode
Report Mode
Export Mode
Check
Captured
Image
Uncheck
Captured
Image
Print
Preview
Save as PDF
Export Review
­
Send to PACS
ÂŽ
Export EXMIF
ÂŻ
Export Images
°
Export
Segment
Export Entire
Add segments
Remove
segments
¨
Âą
Ô§
Ô¨
Open List Mode
Open Review Mode
Open Report Mode
Open Export Mode
Select Captured image and add to the list to
print/export.
Deselect Captured image and remove from the
candidate list to print/export.
Print out the report for the Review.
Preview the report
Save the report as a PDF file.
Export Review data only without the Video.
Review data is the own format of the
0LUR9LHZΠSoftware, which contains Captured
Images and Comments by the user.
Send selected captured images to PACS system
via DICOM Sender
Export Captured Images as EXMIF
EXchangeable Medical Information Format)
Export Captured Images as Image, Video, or
MiroVideo. MiroVideo is the own video format for
the 0LUR9LHZΠSoftware.
Export segment as Video, MiroVideo
Export entire file as Video, MiroVideo
Add the selected range as segments
Remove the selected range from segments.
4-67
Using MiroViewΠSoftware
4.4.6
Chapter 4
Preferences
Preferences for the 0LUR9LHZΠClient falls into two categories:
Global and Local.
Global preference is saved on the 0LUR9LHZΠServer and has in
effect for all the users using the 0LUR9LHZŒServer.
Local preference is saved on the workstation on which the
0LUR9LHZΠClient is installed and has in effect for the workstation
only.
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
¨
Š
ÂŞ
ÂŤ
ÂŹ
4- 68
Using 0LUR9LHZΠSoftware
Chapter 4
Global
Local
ÂŁ
Settings
- Hospital Information
- Measurement
- Agent & Distributor Information
- PACS Registration
- Technical Settings
- User added comment tab
¤
PACS
ÂĽ
Report
ÂŚ
Settings
§
User
¨
Network
Š
List
ÂŞ
Review
ÂŤ
Report
- Range View
- Summary Control
- Capture
- Captured Image Box
- Drag Bag
- SGIB Play
- Express Play
- Position Window
- Panel Layout
ÂŹ
Export
- Export AVI (captured images)
­
Print
- Page Setup
- Language
- GI Tract Color Reference
- Captured Image Box
- Free Hard Disk
- Display
- Default Export Data Folder
- Auto Recover Information
- Finding Setting
- 8VHUÂśV,QIRUPDWLRQ
- Change Password
- 0LUR9LHZŒServer
- Server Manager
- Display Âą Show/Hide Columns
4-69
Using MiroViewΠSoftware
Chapter 4
1) Global Settings
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
¨
Š
i.
Hospital Information
ཛ
Country Âą Choose the Country where the hospital is located.
ཛྷ
Hospital Name Âą ,QSXWWKH+RVSLWDOÂśV1DPHLQ this field.
ཝ
Address Âą ,QSXWWKH+RVSLWDOÂśV$GGUHVVLQWKLVILHOG
ཞ
Telephone Âą ,QSXW WKH+RVSLWDOÂśV7HOHSKRQHQXPEHULQWKLV
field.
ཟ
Logo Image Âą Add the Logo Image
୔ These information will be applied and shown on the final
report.
4- 70
Using 0LUR9LHZΠSoftware
Chapter 4
ii.
Measurement
ŕ˝ 
Height Âą &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVKHLJKW
ཥ
Weight - &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVZHLJKW
ར
Waist - &KRRVHWKHPHDVXUHPHQWXQLWIRUSDWLHQWÂśVZDLVW
୔ These information will be applied and shown on the case
information and patient information
ÂŞ
ÂŤ
iii.
Agent & Distributor Information
ལ
$JHQF\,QSXWWKH$JHQF\ÂśVLQIRUPDWLRQLQWKLVILHOG
ཤ
Contact: Input the contact information for the agency.
4-71
Using MiroViewΠSoftware
Chapter 4
2) Global PACS
¢¢
ÂŁÂŁ
¤¤
ÂĽÂĽ
ÂŚÂŚ
§§
i.
Registration:
Process
to
enable
the
PACS
related
functionalities.
. PACS registration window will
Click the
appear like below.
Ú
Û
Ü
4- 72
Using 0LUR9LHZΠSoftware
Chapter 4
Generation key will be generated automatically.
Click the
to send the generation key to
IntroMedic. Mail Box window will appear like below.
Input the e-PDLODGGUHVVLQWKHILHOGÂľ)URPÂśfor receiving
the Registration Key. Fill in the information for the items
in the text box: Hospital name, Hospital address, Main
contact, Telephone, E-mail address and Generation key.
Click the
to send the information to
IntroMedic. IntroMedic will reply with the Registration
Key to the e-PDLO DGGUHVV W\SHG LQ Âľ)URPÂś ILHOG ,W ZLOO
take time to receive the reply.
4-73
Using MiroViewΠSoftware
Chapter 4
to close the Mail Box window.
Click the
After receiving the Registration Key, input the Key in the
Registration Key field on PACS registration window.
Click the
ii.
to finalize the registration process.
Caller: Technical properties for Caller.
ཛ
Title: Input the Title for Caller.
ཛྷ
Modality: Input the Modality for Caller.
ཝ
Port: Input the port number to use for Caller.
iii.
Image Storage Server: Technical properties for Image
Storage.
ཞ
Title: Input the title for Image Storage Server.
ཟ
IP Address: Input the IP Address for Image Storage Server.
ŕ˝ 
Port: Input the port number to connect to Image Storage
Server.
4- 74
Using 0LUR9LHZΠSoftware
Chapter 4
¨
Š
ÂŞ
ÂŤ
ÂŹ
­
ÂŽ
ÂŻ
iv.
Worklist Server: Technical property for Worklist Server.
ཥ
Title: Input the Title for Worklist Server.
ར
IP Address: Input the IP Address for Worklist Server.
ལ
Port: Input the port number to connect to Worklist Server.
v.
Other Settings: Technical properties for PACS setting.
ཤ
PACS Module: Choose the appropriate PACS Module of
DreamWell or Vieworks.
ོ
Log Level: Choose the appropriate Log Level for the PACS
functionality: Level 0, Level 1 and Level 2.
ཌ
Time Delay: Choose the Time delay from 0 to 9 seconds.
ཧ
Station Name
ཨ
Wild-card character
4-75
Using MiroViewΠSoftware
Chapter 4
3) Global Report
i.
User added comment tab: If checking on the checkbox and
typing the desired string into the textbox, a comment tab
will be added on the Report Mode. To apply the change,
click
4- 76
Using 0LUR9LHZΠSoftware
Chapter 4
4) Local Settings
¢
ÂŁ
i.
Language
ཛ
Display: Choose the display language.
ཛྷ
CEST: Choose the CEST language.
ཝ
GI Tract Color Reference: Show the color references for
the GI Tract.
ii.
Captured Image Box: Check the check box to show GI tract
reference colors in the background of Captured Image Box.
4-77
Using MiroViewΠSoftware
Chapter 4
¤
iii.
Free Hard Disk
Keep the number of cases on the local drive. If the cases
are cached from the Server more than the configured
number, the oldest case on the local drive will be freed up.
iv.
Display
Display: Font setting to display.
v.
Default Export Data Folder: Direct the folder for exporting
data. Click the
vi.
to open the browser.
AutoRecover Information
Save Frequency: The 0LUR9LHZΠClient saves the auto
recovery information while the user is reviewing the patient
file, periodically. Choose the period to save the auto
recovery information from 0 to 60 minutes.
4- 78
Using 0LUR9LHZΠSoftware
Chapter 4
vii.
Finding Setting: Configure the finding setting. Click the
to open the configuration dialogue.
5)
Local User
¢
ÂŁ
¤
ÂĽ
ÂŚ
§
8VHUÂśV,QIRUPDWLRQ6HWPRGLI\WKHLQIRUPDWLRQIRUWKHXVHU
i.
ཛ
User Name: Input User Name which will be used for log-in
ID.
ཛྷ
Email Address: Type in the e-mail address here.
ཝ
Telephone: Type in the telephone number here.
ii.
Change Password
ཞ
Current: Input the current password
ཟ
New: Input the desired password to use.
ŕ˝ 
Confirm: Input the desired password again.
4-79
Using MiroViewΠSoftware
Chapter 4
6) Local Network
¢
¢
ÂŁ
ÂŁ
¤
¤
0LUR9LHZŒServer
i.
ཛ
IP Address: Input the IP Address where the 0LUR9LHZŒ
Server is installed.
ཛྷ
Port: Input the port number to connect with the 0LUR9LHZŒ
Server.
Server Manager: Utility to manage the 0LUR9LHZΠServer
ii.
remotely.
ཝ
Port: Input the port number for connection between Server
Manager and the 0LUR9LHZŒServer.
4- 80
Using 0LUR9LHZΠSoftware
Chapter 4
7) Local List
i.
Display
Columns: Configure the columns which will appear on List.
4-81
Using MiroViewΠSoftware
Chapter 4
8) Review
¢
ÂŁ
¤
i.
Range View
ཛ
Range View Previous Offset: Set the range for range view.
ཛྷ
Range View Next Offset: Set the range for range view.
ii.
Summary Control
ཝ
Summary Item Range: Set the period of one item on the
Finding Summary Box.
iii.
Capture
Add to report: If the checkbox is checked, the captured
images will be shown on Report Mode and added to the
final report. The added captured image can be removed
from the Report Mode.
4- 82
Using 0LUR9LHZΠSoftware
Chapter 4
iv.
Captured Image Box
Captured Image Option: If the checkbox is checked, the
video will stop when capturing an image on Review Mode.
ÂĽ
ÂŚ
§
¨
Š
v.
Drag Bag: Drag Bag related setting. Add/Remove the Drag
Bags and set a Bag to Default Bag by choosing one from
the combo list. The Bags will be applied for the reviews
added newly. If the user makes a new review for a case or
open a case not reviewed and choose finding box for the
captured image box, the drag bags which are modified on
this preference will be shown.
4-83
Using MiroViewΠSoftware
ཞ
Chapter 4
Default Bag: Set a Bag to Default Bag by choosing one
from the combo list on Drag Bag mode.
vi.
SGIB Play
ཟ
Bleeding probability: Choose the Bleeding probability to
play on SGIB Play. Set this value as Low to show many
images on SGIB Play or set high to show little images.
vii.
Express Play
ŕ˝ 
Quality: Choose the Quality to play on Express Play. Set
this value as Low to skip more images on Express Play
than High.
viii.
Position Window
ཥ
Type: Choose the type for the Position Window. If Line is
chosen, the trace of the MiroCamÂŽ Capsule will be
displayed in line. If Region is chosen, the position of the
MiroCamÂŽ Capsule will be displayed on region segmented.
ར
Organ Bar: Choose the Organ Bar status. If Show is
chosen, the Organ Bar will appear on the Position Window.
4- 84
Using 0LUR9LHZΠSoftware
Chapter 4
9) Local Report
i.
Panel Layout: Choose the Panel Layout. The Panel Layout
will be shown as per the choice.
4-85
Using MiroViewΠSoftware
10) Export
¢
ÂŁ
i.
4- 86
Export AVI
ཛ
Save as AVI: Set the length of the AVI to export.
ཛྷ
FPS (AVI): Set the frame rate of the AVI to export.
Chapter 4
Using 0LUR9LHZΠSoftware
Chapter 4
11) Local Print
¢
ÂŁ
ii.
Page Setup
ཛ
Footer: Type in the string for footer which will appear on
the final report.
4-87
Using MiroViewΠSoftware
Chapter 4
¤ Page Setup: Edit the layout of the report.
- Click the
to show the Page Setup window.
- Choose the paper type; A4 or Letter and adjust the
margins for Header, Footer, Right and Left.
4- 88
Using 0LUR9LHZΠSoftware
Chapter 4
4.5 Overview - 0LUR9LHZŒViewer
Start 0LUR9LHZŒViewer
4.5.1
„
Double-click the
to run the 0LUR9LHZΠViewer. Open an
Image File (EXMIF-Exchangeable Medical Image Format data or
-3(* YLDÂľ)LOH-!2SHQÂśIXQFWLRQ
ÂŁ
¤
ÂĽ
ÂŚ
Image Display
Title
Description
Study
Information
§
¨
Image
Information
Findings
Š
Diagnosis
Image Display Area (EXMIF or JPEG)
Title for the image in the Image Display
Description for the image in the Image Display
General Information (Software / Manufacturer /
Hospital Information), Patient Information
(Doctor, Patient Body Shape) and Study
Information (Doctor, Receiver, Capsule and
Procedure Information) for the image in the
Image Display
Creator Information and/or Finding Comments
for the image in the Image Display
Findings information the creator captured and
commented before for the image in the Image
Display.
Diagnosis information the creator captured and
commented on for the image in the Image
Display.
4-89
Using MiroViewΠSoftware
Chapter 4
4.6 Performing Capsule Endoscopy
4.6.1
Initializing Receiver
„
Connect the MiroCamÂŽ Receiver to the workstation via USB port.
„
Run the 0LUR9LHZŒOperator by double-clicking the
desktop or from the Windows Start-up menu. Log in.
„
Carry out in alphabetical order like following picture.
Ú
Û
Ü
4- 90
on the
Using 0LUR9LHZΠSoftware
Chapter 4
„
Enter the MiroCamÂŽ Receiver mode and select the MiroCamÂŽ
Receiver port to initialize and click the
Û
Ú
„
When following message will appear, click the
to
start the initializing process.
4-91
Using MiroViewΠSoftware
„
Chapter 4
After the initializing process is complete, the following message
will appear.
„
and the Patient Information window will
Click the
appear. Input the patient information for each field.
„
Click the
to input the patient name and then click the
to input the doctor name.
7\SHLQWKHSDWLHQWÂśVQDPHDQGWKH,'LQWRWKHDSSURSULDWHILHOGV
directly.)
„
Carry out in alphabetical order like following picture.
Ú
Û
Ü
Ý
Þ
ß
Ă 
ĂĄ
â
(The fields marked with * is required.)
4- 92
Using 0LUR9LHZΠSoftware
Chapter 4
„
Click the
to save the Case Information to the MiroCamÂŽ
Receiver. The MiroCamÂŽ Receiver is now ready for the
MiroCamÂŽ Capsule endoscopy procedure.
NOTE The fields in the Case Information are editable,
and additional fields can be added. This can be
accessed via Tools Æ Preferences Æ Receiver
Æ Set Æ Add / Modify.
4.6.2
Upload Image Data (0LUR9LHZŒOperator)
„
Connect the MiroCamÂŽ Receiver to the workstation via USB port.
„
Run the 0LUR9LHZŒOperator by double-clicking the
on the
desktop or from the Windows Start-up menu. Log in.
„
Carry out in alphabetical order like following picture.
Ú
Û
Ü
4-93
Using MiroViewΠSoftware
„
Chapter 4
After switching the MiroCamÂŽ Receiver on, enter the MiroCamÂŽ
Receiver mode and select the proper the MiroCamÂŽ Receiver
port to upload the image data.
„
Carry out in alphabetical order like following picture.
Û
Ú
„
4- 94
Click the
to start the Upload.
Using 0LUR9LHZΠSoftware
Chapter 4
„
After completing the Upload, the following message will appear.
CAUTION When the MiroView˞ Operator is running on a
64bits OS, Do not turn off or disconnect any
MiroCamÂŽ Receivers connected to the workstation
while uploading.
4.6.3
Change Patient Information After uploading the Image Data
(Optional)
„
From the 0LUR9LHZŒ 2SHUDWRU XQGHU µ7RROV¶ -! 6HOHFW µ&DVH
,QIRUPDWLRQÂś
4-95
Using MiroViewΠSoftware
„
7KHQ Âľ&DVH ,QIRUPDWLRQÂś GLDORJ ER[ ZLOO SRSV XS &KDQJH WKH
patient information and click the
4- 96
Chapter 4
Using 0LUR9LHZΠSoftware
Chapter 4
4.6.4
Review (0LUR9LHZŒClient)
„
Run the 0LUR9LHZΠClient by double-clicking the
on the
desktop or from the Windows Start-up menu. Log in.
„
Carry out in alphabetical order like following picture.
Ú
Û
Ü
„
Click the
on the Log-in screen to run the 0LUR9LHZŒ
client as Local Mode. (See  8VLQJ 0LUR9LHZΠ&OLHQW DW
Local PC without FRQQHFWLQJ WR 0LUR9LHZΠ6HUYHU for
details.)
$W WKH ILUVW UXQQLQJ RI Âľ/RFDO 0RGHÂś WKH ZLQGRZ ZLOO DSSHDU
like below. Input the appropriate values in to the empty fields
and click the
to proceed.
Carry out in alphabetical order like following picture.
Ú
Û
Ü
Ý
4-97
Using MiroViewΠSoftware
Chapter 4
Open the Case/Review via Menu Æ Home Æ Open
&DVH5HYLHZILOHÂŤ.
Choose a file to open and click the
After completely reviewing the file, save the review via
MenuÆ Home Æ Save Active Review so that the user can
import the edited review file on the MLUR9LHZŒ6HUYHULQWKH
future.
4- 98
Using 0LUR9LHZΠSoftware
Chapter 4
„
Select the Patient Video Data on the List Mode
- Select a patient video data to review from the List Mode and click
the
to enter the Review Mode.
- Check to see if another user is reviewing the patient file on the
Current User column in the List Mode.
- If the patient file is being reviewed by another user, a message will
appear.
4-99
Using MiroViewΠSoftware
„
Chapter 4
Review the Patient Video on the Review Mode
NOTE When using network connection between the
0LUR9LHZΠServer and the 0LUR9LHZΠClient, for
efficient video playback the video is cached locally
in the server. During this buffering process, the
video may be reviewed.
Âą Click the
4- 100
to readily set landmarks
Using 0LUR9LHZΠSoftware
Chapter 4
- Use the Range View and Map View to find all the landmarks.
NOTE Click the
and select landmark type:
Esophagus, Gastric, Duodenum, Ileo-cecal, Cecal
and User landmark.
- After marking the necessary landmarks, play the video via the
Express Play and capture abnormalities and / or suspected disease
pathologies in the small bowel.
4-101
Using MiroViewΠSoftware
Chapter 4
NOTE 7KH XVHU FDQ SUHVV Âľ(QWHUÂś NH\ WR FDSWXUH WKH
image.
To identify abnormalities and/or disease pathology more easily,
use the Image Enhancement function to adjust preferred
image settings. Click the
window.
4- 102
to open the Image Enhancement
Using 0LUR9LHZΠSoftware
Chapter 4
„
Converting AVI File
Click two images (the first image and the last image) while
holding the < Ctrl > key among the to convert the segment to
an AVI file.
Right mouse click and select ÂľSaveÂś from dialog box.
4-103
Using MiroViewΠSoftware
Chapter 4
2QO\FKHFNÂľ6DYHVHOHFWHGUDQJHDV9LGHR
Carry out in alphabetical order like following picture.
Ú
Û
„
Choose the location you want to save this file and click the
„
4- 104
Click the
to save selected range as Video.
Using 0LUR9LHZΠSoftware
Chapter 4
„
Composing the Report on the Report Mode
- After capturing images of suspected disease in the Review
Mode pathology, click the
to enter the Report Mode.
Use the auto complete dictionary slide and choose available
disease pathology from the list.
7KH XVHU FDQ XVH KRW NH\ Âľ&WUO  6SDFHÂś RU Âľ&WUO  (QWHUÂś WR XVH
auto complete function while composing comments. Select a
word from the list after pressing the hot key.
4-105
Using MiroViewΠSoftware
Chapter 4
The user can add the word shown on the GI Dictionary into the
text comment by double-clicking the appropriate word or clicking
the
The user can prepare Annotations for use by right clicking the
mouse in the comments area.
4- 106
Click ÂľEdit AnnotationÂś.
Click the
Input annotation and then click the
Using 0LUR9LHZΠSoftware
Chapter 4
Completing the report:
Complete image comments for captured images (as
required)
Complete the following tabs: Reason for referral; Procedure
Info & Findings; and Summary & Recommendations
After completing the report, enter the Export Mode to print
out the complete report and/or export the 0LUR9LHZŒ
Software data.
NOTE The GI Dictionary tab and findings tab allow the
user to adjust the findings and the level of severity.
The user can use the GUI easily.
CAUTION DO NOT detach and/or attach the Microphone
from/to the workstation while recording the audio
comment.
CAUTION Sound Card Driver must be installed prior to using
the Recording function.
CAUTION Prior to recording the comments, close all the
applications using the Sound Card such as
music/video player.
4-107
Using MiroViewΠSoftware
„
Chapter 4
Print report, create file and export the Review on the Export
Mode.
Select the images to select and click the
and add the
selected captured images to the candidate list to export.
(Remove the selected images from the candidate list using
the
The Âľ6DYHDV3')ÂśIXQFWLRQLVXSGDWHG
NOTE User is able to change default settings on whether
or not to add the images on the report via Tools ->
Preference -> Review.
4- 108
Using 0LUR9LHZΠSoftware
Chapter 4
Check to include on the report when capturing the image.
Uncheck to not include the images on the report.
Click the
to use export function. A window will appear like
below.
4-109
Using MiroViewΠSoftware
Select the File Type to export and change the desired file
location on the Selected Folder and click the
window will appear with a progress bar.
4- 110
Chapter 4
. A
Using 0LUR9LHZΠSoftware
Chapter 4
The user can use the
for EXMIF. When clicking the
the window will appear like below. The user can configure the
EXMIF properties: title and description. Findings will be saved
as the JPEG file format(.jpg) and diagnosis images will be
saved as the multiple image file format(.tiff)
The user can use the
Video) and the
for Segment Export (Video / Miro
for Export Case function.
NOTE Select the segments on the Timebar to export by
selecting two captured images to set as the start
point and the end point respectively, or by clicking
the landmark flag. If no segment is selected, the
to export segments would be disabled.
NOTE MiroVideo includes selected Segments so that the
XVHUFDQFRQILUPWKHFRQWHQWVDQGHGLWIURPÂľ2SHQ
&DVH5HYLHZILOHœ¾,PSRUW&DVH5HYLHZILOHœ
main menu.
CAUTION It is highly recommended to constantly back up
patient data through export function in order to
prevent the data loss.
4-111
Using MiroViewΠSoftware
„
Chapter 4
Print Report and save the report as PDF on the Report Preview
- Click the
to print reports and/or click the
to save the
report as PDF.
- Show report preview on the screen. The user can include or
exclude findings/diagnosis data on the final report via Menu Æ
Preview Æ Including findings & diagnosis data.
- The user can print out the report and save the report to PDF file
in this screen.
- IIWKHXVHUVHOHFWVWKHLPDJHVSHUSDJHPRGHWKHPHVVDJHÂľ,I
you proceed with the current Layout mode, image comments
may be omitted and not printed. Please select 3 images per
SDJH PRGH WR LQFOXGH DOO FRPPHQWV LQ WKH UHSRUWÂś ZLOO DSSHDU
This will be defaulted during the next use in that the workstation
for all users.
- If the user selects the Draft report, no captured images will be
included in the final report.
4- 112
Using 0LUR9LHZΠSoftware
Chapter 4
to print the report, the Print window will appear.
Click the
Choose the desirable Printer, Print Ranage, Copies/format,
Print Option and Layout.
Carry out in alphabetical order like following picture.
Ú
Û
Ü
Ý
Þ
ß
The 0LUR9LHZΠSoftware privides the ODF for the soft copy
of the report so that the user can open the ODF report in
other word processors; MS Word and Haansoft; ODF is
available for 3 images layout only.
NOTE The previous software version (0LUR9LHZŒ
Software 1.0) did not support the draft report style.
4-113
Using MiroViewΠSoftware
„
Chapter 4
Back up the segment
If a hospital wants only back up small bowel section, they can
XVH WKLV IHDWXUH )URP Âľ([SRUWÂś PRGH VHOHFW WKH UDQJH DQG FOLFN
the
4- 114
Click the
to add segment first.
., Export Segments as Video/MiroVideo.
Using 0LUR9LHZΠSoftware
Chapter 4
6HOHFWÂľ5HYLHZ'DWD0LUR9LGHRV PHF DQGFOLFNthe
Carry out in alphabetical order like following picture.
Ú
Û
4.6.5
Image Atlas
„
Atlas
The following picture show via Help Æ Atlas
11
cde hijklĚş
12
Ěş
13
Ěş
16
Ěş
14
Ěş
15
Ěş
4-115
Using MiroViewΠSoftware
ÂŁ
¤
ÂĽ
Atlas
My Atlas
Atlas + My Atlas
ÂŚ
Import
Atlas
Images from file
Export
Atlas
Images to file(s)
Edit Information
§
¨
Š
ÂŞ
ÂŤ
ÂŹ
­
ÂŽ
ÂŻ
°
Âą
Ô§
4- 116
Export
Atlas
Image(s) to Email
Delete Atlas
Image(s)
Print Atlas
Image(s)
Save as PDF
Show/Hide
Marks
Search
Comparison
Window
Browser
Tab(Findings /
Diagnosis)
Recent Images
Atlas Thumbnail
Area
Chapter 4
Default Atlas Images
Atlas Images configured by the user
Show Atlas Images and My Atlas Images at
once.
Import Atlas Images from file; BMP, JPEG,
GIF, EMF, WMF, TIFF and PNG file format.
Export Atlas Images to file; BMP, JPEG, GIF,
EMF, WMF, TIFF and PNG file format.
Edit the Information of the selected Atlas
Image.
Export selected Atlas Image(s) and send it /
them to another doctor via E-mail.
Delete the selected Atlas Image(s)
Print the selected Atlas image(s)
Save the selected Atlas Image(s) as PDF
Show / Hide Marks on the Atlas Image(s)
Search the Atlas Image
Show the Comparison Window
Area to select the Category of the Atlas Image
and to see the selected image.
Images the user saw on the Comparison
Window
Area to select the Atlas Image. Double-click
the Atlas Image to see the Image Information.
Using 0LUR9LHZΠSoftware
Chapter 4
17
Ěş
18
Ěş
19
Ěş
Ô¨
ÔŠ
ÔŞ
Study
Information
/ Image
Information
Findings /
Diagnosis
Atlas
Thumbnail
Area(2)
Show the Information of the Atlas Image
Show the Findings / Diagnosis Information
Search the Atlas Image
4-117
Using MiroViewΠSoftware
Chapter 4
20
Ěş
ÔŤ
4- 118
Comparison Window
Show
the
Current
Image
Comparison Image at once.
and
Using 0LUR9LHZΠSoftware
Chapter 4
„
To compare a captured image with ATLAS image, click the
(Optional).
„
6HOHFW DQ LPDJH IURP 0LUR9LHZΠAtlas to compare the atlas
image with the captured image for a side by side comparison.
(Option)
4-119
Using MiroViewΠSoftware
Chapter 4
„
Double-click an ATLAS image for selection.
„
To show the ATLAS image on the comparison window, click the
on the ATLAS mode.
4- 120
Using 0LUR9LHZΠSoftware
Chapter 4
„
The comparison windows will appear. Figure out the current
image and comparison image.
„
Import Atlas Images from file(s)
The 0LUR9LHZΠSoftware allows the user to import image files for
personal purpose.
Click the
WR RSHQ WKH Âľ2SHQÂś %URZVHU WR ORRN IRU WKH ILOHV WR
import.
4-121
Using MiroViewΠSoftware
„
Chapter 4
Import Atlas Images from file(s)
The 0LUR9LHZŒSoftware allows the user to import image files for
personal purpose.
Click the
WR RSHQ WKH Âľ2SHQÂś %URZVHU WR ORRN IRU WKH ILOHV WR
import.
Select the file to import and click the
&RPSOHWH WKH Âľ7LWOHÂś Âľ'HVFULSWLRQÂś DQG Âľ,PDJH ,QIRUPDWLRQÂś ILHOGV
and click the
4- 122
Using 0LUR9LHZΠSoftware
Chapter 4
4.7 How to import 0LUR9LHZŒSoftware 1.0 Files
4.7.1
Preparing files for import
„
5XQWKH0LUR9LHZŒSoftware 1.0
„
([SRUW ILOHV E\ FOLFNLQJ µ([SRUW IRU the 0LUR9LHZŒ ([SUHVV¶
function or back up files by using Backup Mode on the
0LUR9LHZΠSoftware 1.0. Before using the Export to the
0LUR9LHZΠExpress function, insert DVD media to the DVD
writer or connect the external hard disk or USB flash memory to
the workstation via USB port.
0LUR9LHZΠSoftware supports
the
0LUR9LHZΠSoftware Case / Review files, the
0LUR9LHZŒ  H[SUHVV ILOHV (the MiroCam®
Capsule
Endoscope
System
companying
with .MMV) and the 0LUR9LHZΠSoftware 1.0
backup files(.ifo companying with .ict and .frg files)
to import.
NOTE The
„
Select a patient file from the list to export to the 0LUR9LHZŒ
Express.
„
([HFXWHµ([SRUWWRthe 0LUR9LHZŒ([SUHVV«¶RQWKHPDLQPHQX
4-123
Using MiroViewΠSoftware
„
Chapter 4
,I WKH IRUP Âľ6DYH $VÂś DSSHDUV OLNH EHORZ VHOHFW WKH ORFDWLRQ WR
H[SRUWDQGILOOLQWKHÂľ)LOHQDPHÂśILHOGDQGFOLFNÂľ6DYHÂś
„
Carry out in alphabetical order like following picture.
Ú
Û
„
A window will appear like below and if the function ends
VXFFHVVIXOO\ $ PHVVDJH ZLOO DSSHDU Âł([SRUWLQJ KDV EHHQ
FRPSOHWHG´
4- 124
Chapter 4
4.7.2
Using 0LUR9LHZΠSoftware
Import 0LUR9LHZŒSoftware 1.0 files
„
Run the 0LUR9LHZŒOperator or 0LUR9LHZŒClient.
„
([HFXWHWKHÂś,PSRUW&DVH5HYLHZ)LOHÂŤ-!,PSRUW&DVHÂśLQWKHÂľ/LVWÂś
menu
4-125
Using MiroViewΠSoftware
„
Chapter 4
Select the 0LUR9LHZΠSoftware 1.0 files from the file extension
drop-down box and look for the file to upgrade
„
/RRNIRUWKH)LOHZLWKH[WHQVLRQÂľ0LUR&DPÂśDQGFOLFNÂľImportÂś.
„
Carry out in alphabetical order like following picture.
Ú
Û
4- 126
Using 0LUR9LHZΠSoftware
Chapter 4
„
Task Manager will appear and will proceed with importation of the
file.
„
Progress bar will appear.
„
Upgrading the 0LUR9LHZŒ Software 1.0 file to the 0LUR9LHZŒ
Software file will be completed.
4-127
Using MiroViewΠSoftware
4.7.3
„
Chapter 4
0LUR9LHZŒSoftware 1.0 files Batch Import
If the 0LUR9LHZŒSoftware 1.0 is already installed on the workstation,
user can use the 0LUR9LHZΠSoftware 1.0 files Batch Import
function via  Tools -> Import from the 0LUR9LHZŒSoftware
1.0> in 0LUR9LHZŒOperator (or  Home -> Import from the
0LUR9LHZΠSoftware 1.0> in the 0LUR9LHZΠClient) so that
0LUR9LHZŒcan use the imported cases. Choose the cases to import
and click the
„
To import cases without video file, uncheck the check box on the
Video column.
4- 128
Using 0LUR9LHZΠSoftware
Chapter 4
Using 0LUR9LHZΠClient at Local PC without connecting to
4.7.4
0LUR9LHZŒServer
„
Run the 0LUR9LHZΠClient by double-clicking the
on the
desktop or from the Windows Start-up menu. Log in.
„
Carry out in alphabetical order like following picture.
Ú
Û
Ü
*If running the 0LUR9LHZΠClient as Local Mode, click the
on the Log-in screen.
„
$W WKH ILUVW UXQQLQJ RI Âľ/RFDO 0RGHÂś WKH ZLQGRZ ZLOO DSSHDU OLNH
below. Input the appropriate values in to the empty fields and
click the
„
to proceed.
Carry out in alphabetical order like following picture.
Ú
Û
Ü
Ý
4-129
Using MiroViewΠSoftware
„
Chapter 4
Open the Case/Review via Menu Æ Home Æ Open Case/Review
ILOHÂŤ
„
Choose a file to open and click the
„
After completely reviewing the file, save the review via MenuÆ
Home Æ Save Active Review so that the user can import the
edited review file on the 0LUR9LHZŒServer in the future.
4- 130
8VLQJ0LUR9LHZŒ579
8VLQJ0LUR9LHZŒ579
5- 2
Chapter 5
Chapter                                        8VLQJ0LUR9LHZŒRTV
5. 86,1*0,529,(:Œ579
The 0LUR9LHZŒ 579 D software application of the MiroCam® System
Real-time Viewer, consist of a data transmission module that directly
receives the image data from the MiroCamÂŽ Receiver and an output
module for image display.
5.1 Overview
The MiroViewΠ579VRIWZDUHFDQEH LQVWDOOHGRQDQ\PRELOHSODWIRUP
&OLFN WKH FRUUHVSRQGLQJ LFRQ RQ WKH GHVNWRS WR ODXQFK WKH 0LUR9LHZŒ
RTV.
Basic Screen Layout
ÂŁ
¤
¢
ÂĽ
c Patient
Display patient name, ID, gender and age
Change the 0LUR9LHZΠ579 RSHUDWLRQ VWDWXV
between start, pause and resume.
Display captured image.
Indicates the MiroCamÂŽ Capsule endoscopy
procedure time.
Information
Operation
Button
Main Display
Time Display
5-3
8VLQJ0LUR9LHZŒ579
Chapter 5
Recommended Hardware Specification
„
OS: Windows Vista (32 bit), Windows XP (32 bit),
Windows7 (32 bit)
5- 4
„
CPU: Atom
„
Memory: 1GB or higher
„
Display Adaptor: Windows Compatible
„
Hard Disk: 80GB memory space available
„
Monitor Resolution: 1024 X 600 or higher
„
Monitor Contrast : Windows Compatible
„
In compliance with IEC60950-1 or IEC60601-1
N450(1.66GHz) or higher
Chapter                                        8VLQJ0LUR9LHZŒRTV
5.2 8VLQJ0LUR9LHZŒ579
%HIRUH8VLQJ0LUR9LHZŒ579
5.2.1
„
Installing tKH0LUR9LHZŒ579VRIWZDUHon a mobile PC.
WARNING Only recharge the Mobile PC batteries when MiroCamÂŽ
Receiver does not connect to the Mobile PC.
WARNING For safe use of the Mobile PC, please refer to the Mobile
PC User Manual.
WARNING DO NOT use the 0LUR9LHZŒ579VRIWZDUHDQGthe Mobile
PC before upgrading MR1000.
WARNING DO NOT upgrade MiroCamÂŽ Receiver during the
MiroCamÂŽ Capsule endoscopy procedure, it may result
loss of image data.
WARNING UVH WKH 0LUR9LHZΠRTV Software to check if the
MiroCamÂŽ Capsule entered to the duodenum, small bowl;
during a capsule endoscopy procedure. Thus, prior to
UXQQLQJ WKH 0LUR9LHZΠRTV software, please make sure
that the MiroCamÂŽ Capsule endoscopy procedure has
been undergone.
„
Connect the data cable of the Real-time Viewer to the MiroCamÂŽ
Receiver.
NOTE The data cable for the MiroViewŒ579KDVQRFRYHUIRUWKH
USB port on the MiroCamÂŽ Receiver.
„
Follow the MiroCamÂŽ Capsule endoscopy procedure.
5-5
8VLQJ0LUR9LHZŒ579
Chapter 5
NOTE For more information on the MiroCamÂŽ Capsule endoscopy
procedure, please refer to Chapter 3, Performing Capsule
Endoscopy.
Starting 0LUR9LHZΠRTV
5.2.2
„
Switch on the Mobile PC.
„
„
Click the
on the screen to launch the 0LUR9LHZŒ579
Connect the small side of the USB cable to the MiroCamÂŽ
Receiver.
„
Connect the large side of the USB cable to the Mobile PC.
„
Click the
to start image display
„
Click the
to stop image display
„
Click the
to restart image display
„
Click the
on the top-ULJKWWRFORVHWKH0LUR9LHZŒ579
NOTE To Start, Pause, and Resume use the same button. The
function (Start, Pause or Resume) changes based upon the
status of the 0LUR9LHZŒ579VRIWZDUH
CAUTION DO NOT disconnect the MiroCamÂŽ Receiver while the RTV
software is running. If the MiroCamÂŽ Receiver is
disconnected during use, the software may need to be
restarted.
5- 6
Chapter                                        8VLQJ0LUR9LHZŒRTV
NOTE If an error message appears while using the 0LUR9LHZŒ
RTV, reconnect the USB cable between the MiroCamÂŽ
Receiver and the Mobile PC
After Using 0LUR9LHZΠRTV
5.2.3
„
„
Disconnect USB cable between the MiroCamÂŽ Receiver and the
Mobile PC.
Continue MiroCamÂŽ Capsule endoscopy procedure.
5-7
8VLQJ0LUR9LHZŒ579
5- 8
Chapter 5
6
Using :LUHOHVV0LUR9LHZŒ579L
Using Wireless MiroViewΠRTVi
6- 2
Chapter 6
Chapter 6
Using Wireless MiroViewΠRTVi
6. USING :,5(/(660,529,(:Œ579L
The :LUHOHVV 0LUR9LHZŒ 579L, a software application of MiroCam®
System Real-time Viewer, consist of a data transmission module that
directly receives the image data from the MiroCamÂŽ Receiver and an
output module for image display. The :LUHOHVV 0LUR9LHZΠ579L
receives image data via Wi-Fi channel.
6.1 Overview
The :LUHOHVV0LUR9LHZŒ579L software can be installed on iOS running
on iPad / iPhone. Click the corresponding on the desktop to launch the
:LUHOHVV0LUR9LHZŒ579L.
6-3
Using Wireless MiroViewΠRTVi
6.1.1
Chapter 6
Basic Screen Layout Âą iPhone
ÂŁ
¢
¤
ÂĽ
c Patient
Display patient name, ID, gender and age
High Dynamic Range Image Button
Display captured image.
Indicates the MiroCamÂŽ Wi-Fi operation time
ྜྷ
6- 4
ÂŚ
Information
HDR Button
Main Display
Wi-Fi
Operation
Time
Recording
time
Indicates the MiroCamÂŽ Capsule recording time.
Chapter 6
Using Wireless MiroViewΠRTVi
Basic Screen Layout Âą iPad
6.1.2
ÂŁ
¢
¤
ÂĽ
ÂŚ
c Patient
Display patient name, ID, gender and age
High Dynamic Range Image Button
Display captured image.
Indicates the MiroCamÂŽ Wi-Fi operation time
ྜྷ
Information
HDR Button
Main Display
Wi-Fi
Operation
Time
Recording
time
Indicates the MiroCamÂŽ Capsule recording time.
NOTE If turning the iPad upright as Portrait View, the MiroCamÂŽ
Receiver List will disappear from the Main Display to be
enlarged.
6.1.3
Recommended Hardware Platform
„
iPhone 3G, 3GS, 4, 4S, 5
„
iPad I, II (with only Wi-Fi)
6-5
Using Wireless MiroViewΠRTVi
Chapter 6
6.2 Using :LUHOHVV0LUR9LHZŒ579L
Before Using :LUHOHVV0LUR9LHZŒ579L
6.2.1
„
Installing tKH :LUHOHVV 0LUR9LHZΠ579L VRIWZDUH on iOS on
iPhone or iPad.
„
The effective distance between the MiroCamÂŽ Receiver and
iPhone or iPad is within 3m.
WARNING Use the :LUHOHVV0LUR9LHZŒ579L Software to check if the
MiroCamÂŽ Capsule entered to the duodenum and small
bowl during a capsule endoscopy procedure. Thus, prior to
running the :LUHOHVV 0LUR9LHZΠ579L software, please
make sure that the MiroCamÂŽ Capsule endoscopy
procedure has been undergone.
NOTE For more information on the MiroCamÂŽ Capsule endoscopy
procedure, please refer to Chapter 3, Performing Capsule
Endoscopy.
NOTE When the :LUHOHVV 0LUR9LHZΠ579L run at first, network
configuration for iPhone or iPad is required.
6.2.2
6- 6
Turn on the Wi-Fi function of the MiroCamÂŽ Receiver.
„
Press the Wi-Fi switch of MiroCamÂŽ Receiver.
„
Keep pressing it until the buzzer sounds.
Chapter 6
Using Wireless MiroViewΠRTVi
WARNING DO NOT press the Wi-Fi switch when the buzzer sounds. It
can cause the lost of captured images.
WARNING The Wi-Fi switch of MiroCamÂŽ Receiver can be turned on
involuntarily. Therefore, be careful it is not turned on.
WARNING The MiroViewΠRTVi application can only be used for a
total of 30 minutes during the entire MiroCamÂŽ Capsule
Endoscopy Procedure.
6.2.3
Wireless MiroViewŒ579L.
„
Run the Settings for the iOS.
6-7
Using Wireless MiroViewΠRTVi
„
Chapter 6
Turn on the Wi-Fi. If Wi-Fi is already turned on, please turn it off
and turn it back on. Carry out in alphabetical order like following
picture.
Ú
6- 8
Û
Chapter 6
6.2.4
Using Wireless MiroViewΠRTVi
TCP/IP Configuration (for the first time to connect a MiroCamÂŽ
Receiver access point: AP)
„
Check a network with SSID of MiroCam_xxx in the network list.
„
Click the
on the SSID (MiroCam_xxx).
NOTE TCP/IP configuration is needed once at first.
6-9
Using Wireless MiroViewΠRTVi
„
Click the
„
Click the
Chapter 6
on the top-left after entering the IP Address and
Subnet Mask. (Setup as Static; IP Address: 192.168.3.200,
Subnet Mask:255.255.255.0)
„
Carry out in alphabetical order like following picture.
Ú
Û
6- 10
Chapter 6
Using Wireless MiroViewΠRTVi
„
Click the SSID.
„
Click the
6-11
Using Wireless MiroViewΠRTVi
„
Chapter 6
Enter the password '1234567890' in the field with instruction of
system. Afterward, click the
.Carry out in alphabetical
order like following picture.
Û
Ú
„
6- 12
Press home button when network connection finished.
Chapter 6
Using Wireless MiroViewΠRTVi
Running :LUHOHVV0LUR9LHZŒ579L
6.2.5
„
Click the
on the desktop to launch the :LUHOHVV0LUR9LHZŒ
RTVi.
„
The Splash window will appear for a while and then will disappear.
6-13
Using Wireless MiroViewΠRTVi
„
Chapter 6
Enter the password '1234567890' in the field with instruction of
. Carry out in alphabetical
system. Afterward, click the
order like following picture.
Ú
Û
6- 14
Chapter 6
„
Using Wireless MiroViewΠRTVi
Check whether Patient Information, MiroCamÂŽ Receiver Scan
Button, Main Display, Wi-Fi Operation Time and Recording time
are displayed normally.
ÂŁ
¢
¤
ÂĽ
ÂŚ
c Patient
Display patient name, ID, gender and age
High Dynamic Range Image Button
Display captured image.
Indicates the MiroCamÂŽ Wi-Fi operation time
ྜྷ
Information
HDR Button
Main Display
Wi-Fi
Operation
Time
Recording
time
Indicates the MiroCamÂŽ Capsule recording time.
6-15
Using Wireless MiroViewΠRTVi
Chapter 6
After Using :LUHOHVV0LUR9LHZŒ579L
6.2.6
„
7R FORVH WKH :LUHOHVV 0LUR9LHZΠ579L press the home button
and then check whether the Wi-Fi light of the MiroCamÂŽ
Receiver is off.
NOTE If MiroCamÂŽ Receiver is turned off, following window will
appear after about 10 seconds. To Close this window, click
the
„
6- 16
Run the Settings for the iOS.
Chapter 6
„
Using Wireless MiroViewΠRTVi
Turn Wi-Fi off and turn it back on.
6-17
Using Wireless MiroViewΠRTVi
6- 18
Chapter 6
Appendix
Case Form Report
A- 2
Case Form Report
Trial ID :
Version No. : 1.0 : 30/07/2007
CASE REPORT FORM
Subject No.:
Principal
Investigator
Subject Initials :
Center No.:
Center Name
Address
Telephone No.
Fax No.
E-mail
CONFIDENTIAL
A-3
Case Form Report
Version No. : 1.0 :
Trial ID :
30/07/2007
Screening
Subject No.:
Subject Initials :
Center No.:
Date of Informed consent signed
Inclusion Criteria
Yes
No
N/A
1. Informed consent form voluntarily signed
2. Male / Female subject of age 19 years~70 years.
If there is one or more PDUNRIÂľ1RÂś\RXVKDOOEHFRQWUDGLFWHGIRUWKLVFOLQLFDOWHVW
CONFIDENTIAL
A- 4
Case Form Report
Trial ID :
Version No. : 1.0 : 30/07/2007
Screening
Subject No.:
Subject Initials :
Center No.:
Date of visit :
Exclusion Criteria
Yes
1.
2.
3.
4.
No
Do you have a gastrointestinal disorder (suspected
malignantlesions or gastrointestinal obstructive disorders,
perforation, stenosis or fistula)?
Do you have a cardiovascular disorder (dysrhythemia, trouble
with cardiac conduction system, hypertension(high blood
pressure) or ischemic heart disease)?
Have you been diagnosed of cardiac insufficiency, angina
pectoris or cardiac arrest (heart attack) in recent 6 months?
Are you with (or implanted) medical devices such as cardiac
pacemaker or defibrillator?
5. Do you have a swallowing disorder?
6. Do you have delayed gastric emptying or serious gastric
disorder?
7. Are you a pregnant or nursing woman, or a woman of child
bearing potential?
8. Are you an infant or epileptic? Are you easily affected by
electronic waves?
9. Do you have several small bowel diverticulums ?
10.
Did you fail to obtain a voluntary agreement?
11.
Are you judged unqualified for this test by doctors or nurses?
,IWKHUHLVRQHRUPRUHPDUNRIÂľ
Source Exif Data: 
File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : Yes
XMP Toolkit                     : 3.1-701
Producer                        : Acrobat Distiller 7.0 (Windows)
Create Date                     : 2014:01:28 17:30:57+09:00
Modify Date                     : 2014:01:28 17:30:57+09:00
Metadata Date                   : 2014:01:28 17:30:53+09:00
Document ID                     : uuid:CFCE4C80F687E311B214D267C525B990
Instance ID                     : uuid:b63b3b84-a1c3-41f4-8159-bfc0e84d0513
Derived From Instance ID        : uuid:29b92451-cca0-4e4c-841c-7700d2026abe
Derived From Document ID        : uuid:5ac2e9e9-5cfb-4971-afcc-51fa218ae9c3
Format                          : application/postscript
Creator                         : Donghoon Han
Title                           : 
Page Count                      : 233
Author                          : Donghoon Han

EXIF Metadata provided by EXIF.tools