IntroMedic MiroCam User manual

User Manual

Copyright© 2011 IntroMedic Co., Ltd. MM1100-U-1311
Version 3.00 Date: 2013-11-21
User Manual

Warranty
Page 5
Trademarks
MiroCam®, 0LUR9LHZ, IntroMedic, and the associated logos are the
registered trademarks RUWUDGHPDUNVof 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.

Warranty
Page 6
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: [phone]
FAX: [phone]
http://www.intromedic.com
E-mail: [e-mail]
Safety
Non-compliance with WKH XVHU¶V 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.

Contents
Page 7
CONTENTS
1. SAFETY INFORMATION 1-3
1.1 Warnings 1-3
1.2 Symbols for Safety 1-5
1.3 Function Symbols 1-6
1.4 Notes for Safe Use 1-11
2. SYSTEM OVERVIEW 2-3
2.1 Intended Purpose 2-3
2.2 Observable Diseases 2-4
2.3 Product Warranty Period 2-6
2.4 Product Specification 2-7
3. PERFORMING CAPSULE ENDOSCOPY 3-3
3.1 General Comments 3-3
3.2 Safety Warnings 3-3
3.3 Examination Preparation 3-4
3.4 Patient Preparation 3-7
3.5 Sensor Placement & Capsule Ingestion 3-9
3.6 Using Magnetic Controller 3-18
3.7 Uploading Image Data 3-22
3.8 MiroCam® Receiver Management ²Post
Procedure 3-23

Contents
Page 8
4. 86,1*0,529,(: SOFTWARE 4-3
4.1 +:6SHFLILFDWLRQVIRU0LUR9LHZ6RIWZDUH 4-6
4.2 Overview ²0LUR9LHZ6HUYHU 4-10
4.3 Overview - 0LUR9LHZ2SHUDWRU 4-17
4.4 Overview - 0LUR9LHZ&OLHQW 4-45
4.5 Overview - 0LUR9LHZ9LHZHU 4-89
4.6 Performing Capsule Endoscopy 4-90
4.7 How to import 0LUR9LHZSoftware 1.0 Files 4-123
5. 86,1*0,529,(:579 5-3
5.1 Overview 5-3
5.2 Using MiroView579 5-5
6. 86,1*:,5(/(660,529,(:579L 6-3
6.1 Overview 6-3
6.2 8VLQJ:LUHOHVV0LUR9LHZ579L 6-6

1
Safety Information

Safety Information Chapter 1
1- 2

Chapter 1 Safety Information
1-3
1. SAFETY INFORMATION
1.1Warnings
MiroCam® 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.
MiroCam® 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.

Safety Information Chapter 1
1- 4
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.

Chapter 1 Safety Information
1-5
1.2Symbols 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
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,(&$11(;''HQRWHV³2))´VWDWXVRIPDLQSRZHUVZLWFK
SN EN 980: Denotes serial number
IEC 417-5031: Denotes DC (Direct Current)
IEC 417-5032: Denotes AC (Alternating Current)
A Denotes Ampere, the unit of current
V 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

Safety Information Chapter 1
1- 6
1.3 Function Symbols
1.3.1 0LUR9LHZSoftware Function Symbols
The following table describes symbols or icons used in the
MiroViewSoftware.
1.3.1.1 0LUR9LHZClient
Symbol
Description Symbol Description
Open the patient data
screen.
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 Recycle Bin
dialog.
Find the Item from the list
with the keyword typed in
the search box.
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
1-7
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 Comparison
Window
Expand/Shrink Capture
Box
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status is Capture Box.
Click this icon to change
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6XPPDU\ER[¶
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status is Finding
Summary Box. Click this
icon to change the status
WRµ'UDJ%DJ¶
Indicating the current
Capture Box / Finding
Summary Box / Drag Bag
status is Drag Bag. Click
this icon to change the
VWDWXVWRµ&DSWXUH%R[¶
Show Circumference
Markers
Add a Circle on the image Add a Line on the image
Delete selected Circle /
Line
Color Palette
Undo the action Redo the action

Safety Information Chapter 1
1- 8
Symbol Description Symbol 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 area as a
Segment
Deselect the area from
Segment

Chapter 1 Safety Information
1-9
1.3.1.2 0LUR9LHZOperator
Symbol Description
Symbol
Description
Open the patient data
screen.
Connect to the
MiroCam® Receiver and
open MiroCam® Receiver
control screen.
Print the selected report on
the List.
Delete the selected case
on the List.
Open the Recycle Bin
dialog.
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 MiroCam®
Receivier
Show / Edit the patient
information for the
selected MiroCam®
Receiver
Initialize the selected
MiroCam® Receiver
Unconnected
Unformatted the
MiroCam® Receiver.
Empty the MiroCam®
Receiver.
Prepared the MiroCam®
Receiver.
Recorded the MiroCam®
Receiver.
Uploaded the MiroCam®
Receiver.

Safety Information Chapter 1
1- 10
1.3.2 MiroCam® Receiver Function Symbols
Symbol Description
SIG
Indicates status of signal from the MiroCam® Capsule.
Green : Signal is being received from the MiroCam®
Capsule.
Yellow : Signal is not being received from the
MiroCam® Capsule.
INI
Initialization status of the MiroCam® Receiver
Green : MiroCam® Receiver is initialized
Yellow : MiroCam® 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

Chapter 1 Safety Information
1-11
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 XVHU¶V 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(5¶65(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 MiroCam® 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.

Safety Information Chapter 1
1- 12
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 MiroCam® 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 MiroCam® Capsule endoscopy procedure in
areas with high vibrations or in environments where high electro-
magnetic 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 MiroCam® Capsule endoscopy procedure
simultaneously with other procedures using medical products or
equipment.
DO NOT use for purposes other than medical treatment.