Intromedic INTROMEDIC3 MiroCam Capsule Endoscope System User Manual

User Manual

Version 1.00 Date : 2011-05-11

User Manual

Warranty

Page 5

Trademarks

MiroCam®, MiroView™, IntroMedic, and the associated logos are the

registered trademarks ® or trademarks ™ 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: 82-2-801-9300

FAX: 82-2-801-9330

http://www.intromedic.com

E-mail: helpdesk@intromedic.com

Safety

Non-compliance with the user’s manual, unauthorized modifications of the

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 3

1.1 Warnings 3

1.2 Symbols for Safety 4

1.3 Function Symbols 5

1.4 Notes for Safe Use 9

2. SYSTEM OVERVIEW 3

2.1 Intended Purpose 3

2.2 Observable Diseases 4

2.3 Product Lifetime 6

2.4 Product Specification 7

3. PERFORMING CAPSULE ENDOSCOPY 3

3.1 General Comments 3

3.2 Safety Warnings 3

3.3 Examination Preparation 4

3.4 Patient Preparation 6

3.5 Sensor Placement & Capsule Ingestion 7

3.6 Uploading Images 16

3.7 Receiver Management – Post Procedure 17

Contents

Page 8

4. USING MIROVIEW™ 3

4.1 MiroView™ H/W Specifications 5

4.2 Overview – MiroView™ Server 8

4.3 Overview - MiroView™ Operator 10

4.4 Overview - MiroView™ Client 18

4.5 Overview - MiroView™ Viewer 31

4.6 Performing Capsule Endoscopy 32

4.7 How to import MiroView™ 1.0 files 52

5. USING MIROVIEW™ RTV 3

5.1 Overview 3

5.2 Using MiroView™ RTV 6

6. USING WIRELESS MIROVIEW™ RTV 3

6.1 Overview 3

6.2 Using Wireless MiroView™ RTV 6

1

Safety Information

Safety Information Chapter 1

1- 2

Chapter 1 Safety Information

1-3

1. SAFETY INFORMATION

1.1 Warnings

MiroCam® has been manufactured to conform with the International

Standard for Medical Electrical Equipment: General Requirements for

Safety IEC 60601-1, together with the Collateral Standard for

Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2.

MiroCam® 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 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.

Safety Information Chapter 1

1- 4

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.

IEC 348: Notice for the user to pay special attention to the

following details

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

IEC60601, ANNEX D: Denotes “ON” status of main power

switch

IEC60601, ANNEX D: Denotes “OFF” status of main power

switch

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

Chapter 1 Safety Information

1-5

1.3 Function Symbols

1.3.1 MiroView™ Function Symbols

The following table describes symbols or icons used in the

MiroView™ software.

Symbol Description Symbol Description

Connect to the receiver

and open receiver control

screen.

Open the report screen to

create a patient capsule

endoscopy report.

Open the patient data

screen.

Open screen to export

(save externally) selected

image data for a specific

patient.

Open screen to review for a

specific patient

Select and save an image

being reviewed.

Place a landmark in an

image being reviewed.

Open the Color

Enhancement Window

Show images in full screen Time Display

Show images in the Single

Screen

Show images in the Dual

Screen.

Show images in the Quad

Screen.

Show images in the Range

Mode.

Show images in the Map

View Play all images.

Play the selected images

only. View images via

Express Mode function.

SGIB - Play the images

captured via Suspected GI

Bleeding function.

Safety Information Chapter 1

1- 6

Symbol Description Symbol Description

Move to the previous

image.

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 next image.

Open the Positioning

Window

Open the Comparison

Window

Expand/Shrink Capture

Box Statistic Box

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

Check selected captured

images

Chapter 1 Safety Information

1-7

Symbol Description Symbol Description

Uncheck selected

captured images

Print

Review

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

Safety Information Chapter 1

1- 8

1.3.2 MiroCam® Receiver Function Symbols

Symbol Description

SIG

Indicates status of signal from capsule

Green : Signal is being received from capsule

Yellow : Signal is not being received from capsule

INI

Initialization status of Receiver Unit

Green : Receiver is initialized

Yellow : Receiver is not initialized

BAT

Battery Status

Green : Fully charged

Yellow : Not charged

Chapter 1 Safety Information

1-9

1.4 Notes for Safe Use

n Follow the safety instructions included in this User Manual and clinical

precautions advised by the medical professional.

n The manufacturer is not liable for harm or damage caused by improper,

unauthorized, unprofessional or inexpert use of the device and/or

product.

n IntroMedic Co., Ltd. is NOT responsible for physical harm or

equipment problems caused by the user’s careless operation or

mismanagement of the device and/or product.

n 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.

n User Manual must ALWAYS be with the equipment. This is the USER’S

RESPONSIBILITY.

n CAUTION: foreign substances including water, cleaning fluids,

disinfecting cleanser and such substances may harm the equipment,

and should not enter the equipment.

n ONLY authorized personnel may perform repairs. Never attempt to

open covers, panels or casings.

n DO NOT crease, bend, fold or twist the data cables. Take care to guard

them against mechanical stress (e.g. wheels or heels)!

n The sensor pads, receiver, data cables, and capsules must not be

exposed to mechanical shock (e.g. by dropping). Any damage caused

that way will void the product warranty.

n CAUTION: Damage/injuries to the sensor pad or data cable may

cause a safety hazard. Damaged items MUST be repaired

IMMEDIATELY.

n DO NOT handle fluids in the vicinity of the system.

n When using a cart purchased elsewhere, ensure the brake or latch

guard is in use to prevent the wheels from rolling.

Safety Information Chapter 1

1- 10

n DO NOT USE in moist or damp places.

n DO NOT operate the equipment with wet hands.

n Avoid using the equipment in extreme temperatures or humid

environments.

n DO NOT keep the equipment or carry out the 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.

n DO NOT disassemble or open the equipment without permission. This

will invalidate the warranty.

n DO NOT carry out the procedure in areas with high vibrations or in

environments where high electro-magnetic waves are generated.

n 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.

n CAUTION: Verify that the power voltage supplied from the power

receptacle matches with the voltage the system requires. Check

Voltage and Frequency on the AC/DC adaptor.

n CAUTION: Turn off the power switch before connecting the sensor pad.

n DO NOT discard sensor pads, cables and connectors with general

waste. Discard separately as industrial or medical waste.

n CAUTION: Discard the battery according to the regulations of industrial

waste. DO NOT discard with general waste.

n DO NOT carry out the procedure simultaneously with other procedures

using medical products or equipment.

n DO NOT use for purposes other than medical treatment.

n DO NOT connect the USB cable to the receiver while the receiver’s

data cable and sensor pads are still connected

n DO NOT charge the receiver while the receiver’s data cable and

sensor pads are still connected.

Chapter 1 Safety Information

1-11

n Connect USB cable to receiver only after mounting it on charger.

n DO NOT install any other programs onto the workstation utilized for

review and diagnosis of patient image data (i.e computers with the

MiroView™ software).

n The capsule is disposable and should not be reused.

n The capsule and sensor pads are medical waste, and should be

disposed of according to local regulations or WEEE directive on waste

disposal.

n Only use the capsule, receiver, data cables and sensor pads in the

medical environment condition.

n All products connected with the MiroCam® Endoscope system must be

compliant with requirements of IEC60950-1 or UL certifications.

n Check the outer surface of the endoscope for rough surfaces, sharp

edges, or protrusions which may cause a safety hazard.

n Please don’t try to cut the label.

Safety Information Chapter 1

1- 12

1.4.1 Environmental Conditions for Operation

n Temperature : +0 ℃ - +40℃

n Relative humidity : 45% - 75%

n 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 MiroCam® alongside or together with medical

devices or procedures involving electrical currents.

Do not use MiroCam® with h.f. surgical equipment. It may

result in burns at the site of the electrodes and possible

damage to the capsule and 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.

Chapter 1 Safety Information

1-13

1.4.2 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 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.

CAUTION DO NOT use the capsule if the package is unsealed.

n DO NOT reuse a used capsule.

n To prevent unexpected accidents like fire or explosion, do not use any

product near or in the presence of inflammable or ignitable substances.

n 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.

n 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.

n This equipment may have an effect on other products or be effected by

other products.

n Follow your doctor’s instructions and abide by the guidelines in the

User Manual.

n DO NOT try to upload the data while the data cables are still

connected to the receiver.

n DO NOT charge the rechargeable battery in the receiver while the data

cable and sensor pads are still connected to the receiver.

Safety Information Chapter 1

1- 14

n Stay away from high frequency radiation sites (such as high voltage,

radar, installation power plants, MRI, CT or electric blankets etc.)

during your capsule endoscope procedure. (It may result in serious

side effects requiring an emergency operation.)

n In case of any symptoms of abdominal pain, vomiting, fever, heart

trouble, dizziness or seizure during or after the capsule endoscope

procedure, please notify your doctor.

n Always check the connection between the receiver and the data cable.

n Always check that the battery in the receiver is fully charged before

use.

n DO NOT use the capsule if the package is unsealed.

n After ingesting the capsule, always check whether the capsule has

been e xcreted.

n Prior to undergoing the capsule endoscopy procedure, patients with

diabetes must be informed via a medical professional regarding

appropriate medication & dosage.

n 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 procedure. The patient must fast for 11 hours prior to ingesting the

capsule.

n If recommended by the physician, the patient may take a laxative prior

to the procedure.

n DO NOT smoke for at least 12 hours prior to the capsule endoscope

procedure.

n DO NOT apply body lotion before the procedure.

n DO NOT bite the capsule.

n Avoid excessive physical activity during the capsule endoscope

procedure.

n 4 hours after ingesting the capsule, patients may have liquid food.

n It is recommended to drink mineral water (non-colored liquid)

Chapter 1 Safety Information

1-15

frequently, so that it may raise the possibility to take much better

quality of the image.

n When undergoing the capsule endoscope procedure, DO NOT make

physical contact with another person undergoing the same procedure.

n During operation of the receiver, DO NOT touch the receiver, or get the

receiver wet.

n Only use the provided batteries, and never remove the battery from the

receiver during the procedure.

n During upload of the data recorded in the receiver to the workstation,

avoid disconnecting the USB. This may damage the patient’s data.

n Always confirm that the USB is connected by checking the Receiver

screen on the MiroView™ software.

n Always check the AC Power range before use the workstation.

n DO NOT touch AC Power code with wet hands.

n DO NOT open the receiver bag or touch receiver outside of the

hospital.

n This device is intended for patient over the age of 18.

WARNING The Capsule takes a picture for 11 hours and gets naturally

excreted in about 24 hours under normal conditions. If the

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 moving the system, always make sure to disconnect

the monitor from the main system, and then safely move

the main system and monitor separately. Connect the main

system and monitor only after the hardware is fully

installed, secure and stable.

Safety Information Chapter 1

1- 16

1.4.3 Cleaning and Maintenance

n 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.

n 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. .

n 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.

2

Overview & Intended Usage

Overview & Intended Usage Chapter 2

2- 2

Chapter 2 Overview & Intended Usage

2-3

2. SYSTEM OVERVIEW

MiroCam® 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 MiroView™ software for diagnosis of

diseases related to the small intestine.

The MiroCam® capsule endoscope system consists of the MiroCam®

capsule, MiroCam® receiver, MiroView™ software, and accessories.

2.1 Intended Purpose

MiroCam® 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 (MiroView™), and accessories.

Overview & Intended Usage Chapter 2

2- 4

2.1.1 Contraindications

n Not intended for patients with known or suspected gastrointestinal

tract obstructions, perforations, strictures or fistular.

n Not intended for patients who have difficulty ingesting food or pills

(dysphagia).

n Not intended for patients who have difficulty communicating.

n Not intended for patients with indigestion, or slow gastric emptying.

n Not intended for patients who may be affected by electromagnetic

radiation, such as pregnant women, infants, and patients with heart

disease or epilepsy.

n Not intended for patients with diverticulosis in the Small Bowel.

n Not intended for patients who are recommended against having the

procedure by a Physician.

n Not intended for patients with pacemakers and/or defibrillators.

n This device is intended for patient over the age of 18.

2.2 Observable Diseases

2.2.1 Obscure gastrointestinal bleeding (OGIB)

n Angioectasia

n Meckel diverticulum

n NSAIDs

2.2.2 Crohn’s Disease

Chapter 2 Overview & Intended Usage

2-5

2.2.3 Small Bowel Tumors

n Polyps

n Peutz-Jeghers Syndrome

n Familial adenomatous polyposis

n Lymphoma

n Carcinoid

n Gastro-Intestinal Stromal Tumor (GIST)

n Lipoma

n Hemangioma

2.2.4 Inflammation

n Intestinal Tuberculosis

n Typhoid Fever

n Angeitis

n Amyloidosis

n Eosinophilic enteritis

2.2.5 Celiac Disease

2.2.6 Behcet’s Disease

2.2.7 Cowden Disease

2.2.8 Cronkhite-Canada Syndrom

Overview & Intended Usage Chapter 2

2- 6

2.3 Product Lifetime

2.3.1 Maximum Storage Time of MiroCam® Capsule

n MC1000-C : 1 Year

n MC1000-F : 1 Year

n MC1000-G : 1 Year

2.3.2 MiroCam® Receiver, MR1000

n MiroCam® Receiver Battery : 4.62 Year

Chapter 2 Overview & Intended Usage

2-7

2.4 Product Specification

2.4.1 MiroCam® Capsule

n Component

Component Model Name Quantity

Capsule MC1000

MC1000-F

MC1000-G

1 Piece (Optional)

Sensor Pads MC1000-S 10 Piece

n Specification

Item Specification

Size 11 X 24 mm

Weight 3.4 ± 0.05g

Frame Rate 3 frame/sec

Field of View 150 degrees

Battery Life 12 hours

Pixels 102,400

Lighting 6 LEDs

Capsule Unit

(MC1000,

MC1000-F,

MC1000-G)

Communication

Method

Human Body

Communication

Overview & Intended Usage Chapter 2

2- 8

2.4.2 MiroCam® Receiver

n Component

Component Model Name Quantity

Receiver Unit MR1100 1 piece

Battery Pack MR1100-B 2 piece

Data Cable MR1000-D 1 piece

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 Code MR1000-P 1 piece

Measuring Tape MR1000-M 1 piece

USB Cable MR1000-U 1 piece

n Specification

Item Specification

Battery Life 12 Hours

Size 83.5 X 138 X 28 mm

Receiver Unit

(MR1100)

Weight 350g(including Battery)

Chapter 2 Overview & Intended Usage

2-9

Item Specification

Type Lithium-Ion storage cell

Capacity 10400mA

Voltage 3.6V

Recharging Time Approx. 4 hours

Battery Pack

(MR1100-B)

Size 73.8 X 84.3 X 21.4mm

Channel 9 Data Cable

(MR1000-D) Length 90cm

Receiver Bag

(MR1000-G)

Size 100 X 190 X 55mm

System Carrying

Case(MR1000-A)

Size 480 X 350 X 100mm

Power Source Adaptor

Size 135 X 75 X 105mm

Battery Charger

(MR1000-C)

Weight 285g

Weight 231g Adaptor

(MR1000-T) Power Rating AC100~240V/ 50~60Hz

Power Code

(MR1000-P)

Length 1.5m

Measuring Tape

(MR1000-M)

Length 1.5m

Overview & Intended Usage Chapter 2

2- 10

2.4.3 MiroCam® Software

n Component

Component Model Name Version

MiroView™ Workstation MiroView™ 2.5

MiroView™ RTV MiroView™ RTV 1.0

Wireless MiroView™ RTV Wireless MiroView™ RTV 1.0

3

Performing Capsule Endoscopy

Chapter 3 Performing Capsule Endoscopy

3- 2

Performing Capsule Endoscopy Chapter 3

3-3

3. PERFORMING CAPSULE ENDOSCOPY

3.1 General Comments

n This chapter describes how to operate and control MiroCam®

capsule endoscope system.

n 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 MiroCam® capsule endoscope system.

CAUTION In case the system has been brought from cold

environment (stock room or airfreight) into a warm room,

you should 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) should be

connected to 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 Receiver turns yellow after ingesting

the capsule, immediately contact the physician.

CAUTION If SIG indictor of the Receiver does not turn green when the

patient holds the capsule by the gold bands, immediately

stop the procedure.

NOTE If images of the small bowel are not captured during the

procedure, ensure the capsule has been excreted by the

patient and perform procedure again.

Chapter 3 Performing Capsule Endoscopy

3- 4

3.3 Examination Preparation

The following steps (3.3.1 to 3.3.4) explain the process to initialize the

receiver and register patient data for the capsule endoscopy procedure.

For more information see section 4.2.

3.3.1 Start System

n Turn on power of MiroCam® workstation.

n Click icon to start the MiroView™ 2.0 Operator.

n Insert the ID and password and click icon.

WARNING Before starting the system, check the power rating for the

workstation.

3.3.2 Initialize the Receiver

n Connect the smaller connector of USB Cable to Receiver unit.

n Connect normal connector of USB cable to workstation.

n Turn on the power of the Receiver unit.

n Click icon in MiroView™ 2.0 Operator.

n After completing the required fields, click the button to

save the patient information onto the Receiver.

Performing Capsule Endoscopy Chapter 3

3-5

Note Before execute MiroView™ 2.0 Operator, connect USB

cable to MiroCam® Receiver unit.

WARNING If MiroCam® receiver unit is initialized, any patient data

stored on the device will be deleted permanently.

3.3.3 Receiver Preparation

n Connect battery to the Receiver unit.

- Insert pins on back side of the Receiver unit in the slots on the

battery.

- Press battery to receiver until clasp locks battery in place.

n Turn on power switch of receiver unit.

n Check battery indicator (BAT) of upper side of receiver unit. If

battery is fully charged, light will be green. If light is not green,

charge the battery.

n Check initialization indicator (INI) of upper side of receiver unit.

Prior to beginning a procedure, this light must be green.

n Connect data cable to receiver unit.

Indicator Description

SIG Indicates status of signal from capsule

Green : Signal is being received from capsule

Yellow : Signal is not being received from capsule

INI Initialization status of Receiver Unit

Green : Receiver is initialized

Yellow : Receiver is not initialized

BAT

Battery Status

Green : Fully charged

Yellow : Not charged

WARNING DO NOT do begin procedure when receiver unit’s battery

indicator is not green. This indicates battery is not fully

charge or out of order, and patient data may be lost.

Chapter 3 Performing Capsule Endoscopy

3- 6

3.4 Patient Preparation

Provide the patient with the following instructions to prepare for the

capsule endoscope procedure.

3.4.1 Patient Preparation

n One day prior to the capsule endoscope 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

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 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

capsule endoscope procedure, and should not ingest any

medicine at least 2 hours prior to the 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.

- Physician is recommended to prescribe patient an anti-foaming

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

procedure.

- On the day of the capsule endoscope test, the patient should

wear comfortable and loose cloths. One-piece clothing should

not be worn.

- Prior to the procedure, do not apply any lotions or perfumes.

n On the day of capsule endoscope procedure

- After arriving in a hospital at the appointed time, the patient

should submit an examination permission form and check in.

n After ingesting capsule endoscope

- The patient should refrain from taking any food or drink two

hours after ingesting the MiroCam® capsule endoscope. Water

is permitted after two hours.

Performing Capsule Endoscopy Chapter 3

3-7

- 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 MiroCam® capsule, the patient should contact

physician or nurse immediately.

3.5 Sensor Placement & Capsule Ingestion

Following is the detailed procedure required to correctly administer the

capsule endoscope procedure.

Chapter 3 Performing Capsule Endoscopy

3- 8

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.

1

4

6

7

8

Xiphoid process Line

Pelvic Line

5

R

2

3

Performing Capsule Endoscopy Chapter 3

3-9

3.5.2

n Attach sensor pads according to the number on the data cable.

-

Locate the center between the umbilical and the x iphoid process.

From this center point, attach the sensor to the distal point on

the right flank of the patient’s body.

-

Place the sensor pad on the xiphoid process l ine, 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 point on

the left flank of the patient’s body.

-

Place the sensor pad on the right pelvic line, 2 cm behind

sensor #1.

-

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.

5

8

Pelvic

Line

Xiphoid

process Line

1

4

Chapter 3 Performing Capsule Endoscopy

3- 10

- 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.

Performing Capsule Endoscopy Chapter 3

3-11

3.5.3 Removing Capsule from Packaging

While holding the MiroCam® upside down, peel off the sterilized

packaging cover.

3.5.4 Removing the Case

Turn the package over, the MiroCam® case will slip out of the

packaging. While holding the MiroCam® case, open the lid.

3.5.5 Removing the Capsule

Grip capsule with right hand, and remove from cast. Do not touch the

dome of the capsule.

Chapter 3 Performing Capsule Endoscopy

3- 12

n Make sure that the capsule packaging is not damaged in any way.

When removed capsule from case, the capsule should be flashing.

CAUTION Do not use a capsule endoscope when the packaging or

the capsule is damaged.

n Check if the front of the capsule is flashing when it is removed

from the case

n After washing hands, patients should grip the gold section of the

capsule between the thumb and the forefinger of the both hands.

NOTE After turning the receiver power on, if a signal is not received

by the receiver within 50 seconds (i.e. the SIG indicator does

not turn green), the SIG indicator will flash orange and the

receiver will make a ‘beep’ ‘beep’ warning sound. This will

occur until a signal is received or the power is turned off.

In this case, you must begin the procedure immediately or

turn the receiver off until ready to begin the procedure.

Performing Capsule Endoscopy Chapter 3

3-13

3.5.6 Checking Operation of the Receiver and Signal Reception

After the patient holds the capsule as detailed above, the signal

indicator on the receiver is green and signal indication melody is

generated.. If signal indicator is yellow, there is no signal being

received from the capsule.

n Switch on the receiver.

n Check if the battery indicator (BAT) at the top of the receiver shows

that the battery is fully charged. The battery indicator on the

receiver should be green.

n Check if the initialize indicator (INI) at the top of the receiver shows

that initialization is complete. The INI indicator on the receiver

should be green.

n Connect the data cable to the MiroCam® receiver.

n After patient grasps capsule by opposing gold bands (as detailed

in picture above, check the SIG indicator on the receiver is green

and signal indication melody is generate.

CAUTION If the battery indicator on the receiver shows that the

battery is not fully charged, do not start the endoscopy

procedure. The battery may be depleted during the

procedure and images may not be saved properly.

CAUTION Please be noticed to confirm the shape and the direction of

the connector when you connect the data cable to

MiroCam® Receiver, since it may cause cable damage

problem.

Chapter 3 Performing Capsule Endoscopy

3- 14

3.5.7 Ingesting the Capsule

After checking if the signal indicator on the receiver is green, ingest

the capsule with water.

CAUTION Do NOT bite the capsule while ingesting.

Performing Capsule Endoscopy Chapter 3

3-15

3.5.8 Checking and Wearing the Receiver

n After ingesting the capsule, make sure that the SIG indicator is

green.

n Place the receiver in the bag.

n Organize the contents of the bag so that the cables are not

entangled.

n Adjust cables, and place excess in cable bag.

n Adjust the bag strap as needed.

n Capsule endoscopy procedure will be complete after 11 hours.

CAUTION Patient should not touch receiver during the procedure. This

may lead to loss of image data.

CAUTION During the 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.

Chapter 3 Performing Capsule Endoscopy

3- 16

3.6 Uploading Images

Once the capsule endoscopy procedure is complete, upload image data

from the receiver to the workstation and start diagnosis of the data using

MiroView™ 2.0 Software.

3.6.1 Transferring and Checking image data

n Switch on the workstation.

n Click the icon on the desktop to launch MiroView™ 2.0

Operator.

n When the login window appears, enter the user ID and password,

and then click the button.

n Connect the smaller end of the USB cable to the receiver.

n Connect the other end of the USB cable to the workstation.

n Click the button in MiroView™ 2.0 Operator.

n When the image data in the MiroCam® receiver is successfully

uploaded, execute MiroView™ 2.0 client to review and report.

WARNING For more information on using MiroView™, please refer to

Chapter 4, Using MiroView™ 2.0.

Performing Capsule Endoscopy Chapter 3

3-17

3.7 Receiver Management – Post Procedure

3.7.1 Cleaning

n Remove data cable from receiver unit.

n Capsule and sensor pads should not be reused.

n To clean the MiroCam® Receiver unit and 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 MiroCam® 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 cables, do

not use the cleaning tools such as brush and sandpaper.

3.7.2 Charging Battery

n Battery must be recharged after every procedure.

n Battery can be individually recharged or with receiver unit.

n Battery must be recharged in battery charger.

n If two batteries are inserted in charger, the batteries will

automatically consecutively charge (not simultaneous).

Chapter 3 Performing Capsule Endoscopy

3- 18

n Connect adapter DC cable to battery charger.

n Connect AC power code to adaptor.

n Connect AC power code to AC consent or multi-tap.

n Battery charger indicator lights:

n Battery is charging when green light is blinking

n Battery is fully charged when light is solid blue

n Battery is not-charging if light is yellow

n Note: second battery in charger will automatically begin

charging once first battery is fully charged.

Performing Capsule Endoscopy Chapter 3

3-19

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

receiver.

WARNING Recharge the MiroCam® receiver batteries with the

adaptor and the battery charger only from IntroMedic.

Improper adaptors and battery chargers cause serious

damage.

Charging

Waiting

Charging

Charged

Chapter 3 Performing Capsule Endoscopy

3- 20

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.

4

Using MiroView™

Chapter 4 Using MiroView™

4- 2

Using MiroView™ Chapter 4

4-3

4. USING MIROVIEW™

MiroView™ is a computer software program that aids in diagnosis of disease

of the small bowel via displaying images obtained from the MiroCam®

capsule.

MiroView™ version 2.5 is an update to the MiroView™ version 1.0. The

updated functionalities and user interface further enhance the efficiency and

effectiveness of the MiroCam® capsule endoscopy procedure.

Following is a list of new & updated features:

- User Interface

v MiroView™ enables adjustable resolution, to appropriately fit to the

screen size.

v MiroView™ has been designed with a dark background to reduce eye

strain.

v MiroView™ provides intuitive and unified icons so that the user can

adapt quickly.

- Reporting Tool

- Express View

- Range View

- Network Support

- Account Management

- Multi-Review / Report Generation Support

- Multi-Receiver Management Support

The workstation where the MiroView™ is installed properly has icons for four

applications on the Desktop folder: MiroView™ Client, MiroView™ Operator,

MiroView™ Server, and MiroView™ Viewer. However this manual will not

explain how to use the MiroView™ Viewer. For additional information for

MiroView™ Viewer, please refer to the MiroView™ Viewer Instruction Manual.

To get the installation procedure for MiroView™, refer to the MiroCam®

Service Manual.

Chapter 4 Using MiroView™

4- 4

MiroView™

Client

MiroView™

Operator

MiroView™

Server

MiroView™

Viewer

This program is

used for reviewing the

images from the

MiroCam® capsule

and generating a

patient report. The

MiroView™ Server

should be started

prior to starting the

MiroView™ Client.

This program is

used for managing

the receivers

(initialize, upload etc.)

and managing user

accounts. The

MiroView™ Server

should be started

prior to starting

MiroView™ Operator.

The server stores

the patient data files.

Start the MiroView™

Server prior to

starting MiroView™

2.0 or MiroView™

Operator.

The MiroView™

Viewer is used for

reviewing the images

exported from the

MiroView™ Software;

EXMIF or JPEG

images.

Functions:

- List Mode

- Review Mode

- Report Mode

- Export Mode

- Image Atlas

- SGIB

(Suspected

GI Bleeding)

- Positioning Window

- Network connectivity

- Multi-Review

- Express View

- Range View

- Map View

- GI Dictionary

- Finding / Diagnosis

Information

Functions:

- Input Patient

Information

- Receiver

Initialization

- Upload Data from

Receiver

- Data Backup

- Account

Management

- Network connectivity

Functions:

- DB, Mass storage

- Network connectivity

Functions:

- Study Information

- Image Information

- Show Findings /

Diagnosis

Using MiroView™ Chapter 4

4-5

4.1 MiroView™ H/W Specifications

4.1.1 MiroView™ Server

n Minimum Hardware Requirements

- OS: Windows Vista Business

- CPU: > Core 2 Duo E6300

- Memory: > DDR II 4GByte

- Video Card: Windows Compatible

- HDD: SATA 500GB

- ODD: DVD+-RW

- Monitor Resolution: 1024x768

n Recommended Hardware Requirements

- OS: Windows Vista Business

- CPU: > Core 2 Duo E6300

- Memory: > DDR II 4GByte

- Video Card: Windows Compatible

- HDD: SATAII RAID 1TB

- ODD: DVD+-RW

- Monitor Resolution: 1680x1050

4.1.2 MiroView™ Client

n Minimum Hardware Requirements

- OS: Windows XP, Vista or Windows7

- CPU: Pentium4 2 Ghz

- Memory: 1GB

- Video Card: Geforce 7600GT 128MB

- HDD: SATA 160GB

- ODD: DVD+-RW

- Monitor Resolution: 1024x768

- Sound Card / Mike / Speaker

n Recommended Hardware Requirements

- OS: Windows XP, Vista or Windows7

Chapter 4 Using MiroView™

4- 6

- 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

4.1.3 MiroView™ Operator

n Minimum Hardware Requirements

- OS: Windows XP, Vista or Windows7

- CPU: Pentium4 2 Ghz

- Memory: 1GB

- Video Card: Windows Compatible

- HDD: SATA 160GB

- ODD: DVD+-RW

- Monitor Resolution: 1024x768

n Recommended Hardware Requirements

- OS: Windows XP, Vista or Windows7

- CPU: > Core 2 Duo E6300

- Memory: 1GB

- Video Card: Windows Compatible

- HDD: SATA 160GB

- ODD: DVD+-RW

- Monitor Resolution: 1024x768

4.1.4 MiroView™ Viewer

n Hardware Requirements

- OS: Windows XP, Vista or Windows7

- CPU: Pentium4 2Ghz

- Memory: 1GB

- Video Card: Windows Compatible

- HDD: SATA 160GB

- ODD: DVD+-RW

- Monitor Resolution: 1024x768

Using MiroView™ Chapter 4

4-7

CAUTION MiroView™ cannot be viewed on a monitor with a resolution

under 1024x768.

NOTE The GUI is best viewed on a wide monitor of 19” or larger.

Chapter 4 Using MiroView™

4- 8

4.2 Overview – MiroView™ Server

The MiroView™ Server software is intended to be used as a system

administrative managing tool. The MiroView™ Server manages file

systems and database systems.

When powering up the workstation, MiroView™ Server will start

automatically. If the following window appears, please set up the

configuration for the first run.

n Set the port number for the Network. If unknown, please leave this

field as ‘2000’. This field should be managed by your Network

Administrator in your hospital.

n Set the password for ‘Administrator’ account. Additional accounts

can be made via Account Manager function, after logging on the

MiroView™ Operator as ‘Administrator’.

n Confirm the password.

n Type the Hospital Name.

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Using MiroView™ Chapter 4

4-9

n Type the Address that should appear on the Capsule Endoscope

Report.

n Type the Telephone Number that should appear on the Capsule

Endoscope Report.

n After setting up the Configuration Windows, MiroView™ Server

window above will appear. Click the icon to hide the window.

…

†

Chapter 4 Using MiroView™

4- 10

4.3 Overview - MiroView™ Operator

MiroView™ Operator software is intended to be used for administrative

purposes, including account and receiver management.

4.3.1 Start MiroView™ Operator

n Double click the icon to run the MiroView™ Operator.

When executed for the first time, the following window will appear.

n Input “127.0.0.1” for the IP Address and “2000” for the Port.

n Direct the “Local File Path” to the caching folder and choose the

preferred Language settings and press button to access

MiroView™ Operator.

n After MiroView™ Operator has launched, the Log-in window will

appear.

Using MiroView™ Chapter 4

4-11

n Input ‘Administrator’ for ID and password. Then press the

button.

CAUTION ID and password are encrypted. Do not forget the ID and

password.

CAUTION Before MiroView™ Operator has launched, you must create

the password for the administrator account. When running

the MiroView™ Server for first time, the user must create

the password for the administrator account.

NOTE You can create new and edit existing accounts by using the

Account Management tool on MiroView™ Operator.

Chapter 4 Using MiroView™

4- 12

The following subsections describe the main interfaces and functions

of the MiroView™ Operator.

4.3.2 List Mode

○

1 List Mode Opens List Mode

○

2 Receiver Mode Opens Receiver Mode

○

3 Print Report Print out the selected Report

○

4 Recycle Bin Open Recycle Bin Window

○

5 Export Export the selected Report

○

6 Search Search Cases and/or Reviews by keyword

○

7 Show all Refresh and Show all the Cases and Review on

the List

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Using MiroView™ Chapter 4

4-13

4.3.3 Receiver Mode

Screen enables administration and status display for upto four

receivers.

○

1 Upload Upload images in the receiver to the server

○

2 Input Patient’s

Information

Input Patient’s Information to the selected

receiver

○

3 Initialization Delete all data from the receiver and/or

prepare the receiver for the next patient.

○

4 Receiver Port Shows the status of the connected receiver for

each of the four ports

○

5 Detail View Shows the patient’s information for the

selected receiver

„

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Chapter 4 Using MiroView™

4- 14

4.3.4 Receiver Initialization

Click the button to initialize the selected receiver.

Using MiroView™ Chapter 4

4-15

4.3.5 Inputting Patient Information

Click the button to enter the patient information. After

completing the required fields, click the button to save the

patient information onto the Receiver. The fields in the patient

information are editable and additional fields can be added. This can

be accessed via Tools à Preferences à Receiver à Set à Add /

Modify.

* indicates required fields.

Chapter 4 Using MiroView™

4- 16

4.3.6 Data Upload

After the capsule endoscopy procedure, upload the data from the

Receiver to the MiroCam® system via MiroView™ Operator. Click

the button to upload the data from the Receiver.

After the image data in the MiroCam® Receiver has been

successfully uploaded, enter the List Mode and check if the new Case

has been created.

- Double click the icon to run MiroView™ Client.

- Select the newly uploaded Case and enter the Review Mode.

- Play the case to check the uploaded image data.

CAUTION If you fail to upload the data from the Receiver,

disconnect and reconnect the USB cable from the

workstation, then turnoff the MiroCam® Receiver

and turn it back on. Try uploading again. If the

problem persists, please contact IntroMedic.

NOTE If the user uploads a patient data which has been

uploaded before, an error message ‘Data has been

previously uploaded. Would you like to upload

again?’ will appear.

NOTE Upload progress will be displayed. The user can

stop the process while uploading by clicking the

button.

Using MiroView™ Chapter 4

4-17

4.3.7 User Account Management

MiroView™ Operator enables management of multiple users &

Groups. Users can be organized into Groups to readily control

access. The following screen can be accessed by Tools à Account

Manager.

Chapter 4 Using MiroView™

4- 18

Add an account. Click button to show the window as

displayed below.

ID: User ID

Password: Password

Name: User Name

Type: User type.

- Super User: can access all the reviews in the System

- User: can access all the reviews in the Group of the User’s

- Operator: can log in via MiroView™ Operator S/W only.

※ Administrator account can log in via both MiroView™ Client and

MiroView™ Operator.

Group: Set of users in the same Clinic or Laboratory.

4.4 Overview - MiroView™ Client

4.4.1 Start MiroView™ Client

n Double Click the button to run MiroView™ Client.

n Enter the User ID and password and click the button.

Using MiroView™ Chapter 4

4-19

4.4.2 List Mode

n List

○

1 List Mode Open List Mode

○

2 Review Mode Open Receiver Mode

○

3 Report Mode Open Report Mode

○

4 Export Mode Open Export Mode

○

5 Print Report Print selected Report

○

6 Add a Review Add a Review for the Selected Case

○

7 Delete Case Delete selected Case

○

8 Delete Review Delete selected Review

○

9 Recycle Bin Open Recycle Bin

○

10 Search Search Cases and/or Reviews by key word

○

11 Show all Refresh and Show all the Cases/Reviews on the

List

○

12 Selection Bar A rectangular area to show selected item

○

13 Detail View Show Detail Information for selected Case or

Review



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…

†

‡

ˆ

‰

Š

○

11

○

12

○

13

Chapter 4 Using MiroView™

4- 20

4.4.3 Review Mode

Select a case to review on the List Mode and click the icon to

enter the Review Mode.

n Capture Box Mode

○

1 List Mode Open List Mode

○

2 Review Mode Open Review Mode

○

3 Report Mode Open Report Mode

○

4 Export Mode Open Export Mode

○

5 Positioning Window Current position of the capsule in 2D

○

6

Single View Change to Single View

○

7 Dual View Change to Dual View

○

8 Tri View Change to Quad View

○

9 Range View Change to Range View

○

10 Normal View Shows all images taken by the

Capsule

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28

○

5

○

6

○

7

○

8

○

9

○

10

○

11

○

12

○

13

○

14

○

15

○

16

○

17

○

18

○

19

○

20

○

21

○

22

○

23

○

24

○

25

○

26

○

27

Using MiroView™ Chapter 4

4-21

○

11 Express View Actively removes images based upon

similarity; effectively reducing the

number of images for review. This

mode is recommended to review the

patient file.

○

12 SGIB Shows images that have 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.

○

13 Previous Image Go to Previous Image

○

14 Previous Capture Go to Previous Capture

○

15 Play Backward Play Backward

○

16 Pause / Resume Pause / Resume

○

17 Play Forward Play Forward

○

18 Next Capture Go to the Next Capture

○

19 Next Image Go to the Next Image

○

20 Capture Image capture button.

○

21 Landmark Set landmarks for transition points in

the GI tract.

○

22 Image Enhancement Alter images characteristics (ie. color,

saturation etc.) to assist in identifying

abnormalities.

○

23 Time Display Displays the time duration of the

capsule from procedure start.

○

24 Zoom View Fit image to full screen

○

25 Comparison Window Displays the image selected from the

Image Atlas.

○

26 Thumbnail Extension Extends the Capture Box to display all

captured images.

○

27 Capture Box Toggle the Capture Box to Thumbnail

and Finding Summary Box

Chapter 4 Using MiroView™

4- 22

n Finding Summary Box

○

28 Finding Summary Box Toggle the Capture Box to Thumbnail

and Finding Summary Box Initially, a

captured image will be classified as a

generic ‘capture’. A user may classify

a finding through the reporting tool

Auto-Finding Checker, which will then

appear in the appropriate category in

the Finding Summary Box (if it is one

of the major categories).

○

28

Using MiroView™ Chapter 4

4-23

n Mode Control

- Zoom View

Click the icon to change to Zoom View mode

NOTE Play Slide Control is available on the Zoom View

mode to set playing direction and speed.

NOTE Move the cursor away from the bottom of the

screen and the Play Control will appear.

Chapter 4 Using MiroView™

4- 24

- Viewing Modes

Select one of the icons for preferred Viewing

Mode.

Single View Dual View

Quad 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 clicking and

dragging the mouse icon on the time boundary.

Using MiroView™ Chapter 4

4-25

Map View

The icons will change to playing Mode, as detailed below.

Normal Mode Express Mode

SGIB Mode

※ Map View

This view has been designed to

assist in findings by showing all

the images on the same page

like a wall paper.

You can move the cursor on the

designated image to see the

original image in detail.

Chapter 4 Using MiroView™

4- 26

n Activated Windows

- Positioning Window

Displays the location of where the

capsule took the current image.

- Comparison Window

Displays the image selected from the

Image Atlas.

- Image Enhancement Window

Alter images characteristics (ie. color,

saturation etc.) to assist in identifying

abnormalities.

Using MiroView™ Chapter 4

4-27

4.4.4 Report Mode

Select the desired review for the Case from the List Mode and click the

icon to move to the Report Mode.

n Report Mode

○

1 List Mode Open List Mode

○

2 Review Mode Open Review Mode

○

3 Report Mode Open Report Mode

○

4 Export Mode Open Export Mode

○

5 Scale Opens graduated scale for display on the

image

○

6 Drawing Tools Enables users to include annotations for the

image.

○

7 Image

Enhancement

Alter images characteristics (ie. color,

saturation etc.) to assist in identifying

abnormalities.

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11

○

12

○

13

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Chapter 4 Using MiroView™

4- 28

○

8 GI Dictionary Provides the frequently-used-words to search.

○

9 Text Comments Write comments for the Capture on the main

display and the report.

(Image Comments, Reason for Referral,

Procedure info & findings, Summary &

Recommendation)

○

10 Audio Comment Record voice commenst

(The user can record min 3 sec ~ max 300

sec for each Capture)

○

11 Input Word Input the selected word into the text editor.

○

12 Add Word Add the typed word into the Dictionary.

○

13 Delete Word Delete selected word from the Dictionary.

NOTE Additional tabs in the report can be created or

modified via Tools -> Preferences -> Report

Using MiroView™ Chapter 4

4-29

4.4.5 Export Mode

○

1 List Mode Open List Mode

○

2 Review Mode Open Review Mode

○

3 Report Mode Open Report Mode

○

4 Export Mode Open Export Mode

○

5 Check

Captured

Image

Select Captured image and add to the list to

print/export.

○

6 Uncheck

Captured

Image

Deselect Captured image and remove from the

candidate list to print/export.

○

7 Print Print out the report for the Review.

○

8 Preview Preview the report

○

9 Save as PDF Save the report as a PDF file.

○

10 Export Review Export Review data only without Video. Review

data is the own format of MiroView™, which

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11

○

12

○

13

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15

Chapter 4 Using MiroView™

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contains Captured Images and Comments by

the user.

○

11 Send to PACS Send selected captured images to PACS system

via DICOM Sender

○

12 Export EXMIF Export Captured Images as EXMIF

(eXchangeable Medical Information Format)

○

13 Export Export Captured Images as Image, Video, or

MiroVideo. MiroVideo is the own video format for

MiroView™.

○

14 Export

Segment

Export segment as Video, MiroVideo

○

15 Export Entire Export entire file as Video, MiroVideo

Using MiroView™ Chapter 4

4-31

4.5 Overview - MiroView™ Viewer

4.5.1 Start MiroView™ Viewer

n Double Click the button to run MiroView™ Viewer. Open a

Image File (EXMIF-Exchangeable Medical Image Format data or

JPEG) via ‘File -> Open’ function.

○

1 Image Display Image Display Area (EXMIF or JPEG)

○

2 Title Title for the image in the Image Display

○

3 Description Description for the image in the Image Display

○

4 Study

Information

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

○

5 Image

Information

Creator Information and/or Finding Comments

for the image in the Image Display

○

6 Findings Findings information the creator captured and

commented before for the image in the Image

Display.

○

7 Diagnosis Diagnosis information the creator captured and

commented on for the image in the Image

Display.

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Chapter 4 Using MiroView™

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4.6 Performing Capsule Endoscopy

4.6.1 Initializing Receiver

n Connect the Receiver to the workstation via USB port.

n Run the MiroView™ Operator by double clicking the icon on the

desktop or from the Windows Start-up menu. Log in.

n Enter the Receiver mode and select the Receiver port to initialize.

Using MiroView™ Chapter 4

4-33

n Click the icon. The following message will appear.

n Click ‘Yes’ to start the initializing process.

n After the initializing process is complete, the following message will

appear.

Chapter 4 Using MiroView™

4- 34

n Click ‘OK’ and the Patient Information window will appear. Input

the patient information for each field.

n Click ‘Check Name’ button to input the patient name and then click

the ‘Check Doctor Name’ button to input the doctor name.

(The fields marked with * is required.)

n Click to save the Patient Information to the Receiver. The

Receiver is now ready for the procedure.

NOTE The fields in the patient information are editable,

and additional fields can be added. This can be

accessed via Tools à Preferences à Receiver

à Set à Add / Modify.

Using MiroView™ Chapter 4

4-35

4.6.2 Upload Data (MiroView™ Operator)

n Connect the Receiver to the workstation via USB port.

n Run the MiroView™ 2.0 Operator by double clicking the icon on

the desktop or from the Windows Start-up menu. Log in.

n After switching the Receiver on, enter the Receiver mode and

select the proper Receiver port to upload the patient file.

Chapter 4 Using MiroView™

4- 36

n Click the button to start the Upload.

n After completing the Upload, the following message will appear.

4.6.3 Review (MiroView™ Client)

n Run MiroView™ Client by double clicking the icon on the desktop

or from the Windows Start-up menu. Log in.

*If you want to run the MiroView™ Client as Local Mode, click

‘Local’ button on the Log-in screen.

Using MiroView™ Chapter 4

4-37

n Select the Patient Video Data on the List Mode

- Select a patient video data to review from the List Mode and click

the icon 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.

Chapter 4 Using MiroView™

4- 38

n Review the Patient Video on the Review Mode

NOTE For efficient video playback the video is cached

locally in the server. During this buffering process,

the video may be reviewed.

– Click the ‘Range View’ icon to readily set landmarks.

Using MiroView™ Chapter 4

4-39

- Use the Range View and Normal View to find all the landmarks.

NOTE Click the landmark icon and select landmark type:

Esophagus, Gastric, Duodenum, IleoCecal, and

Cecal.

- After marking the necessary landmarks, play the video via the

Express mode and capture abnormalities and / or suspected disease

pathologies in the small bowel.

Chapter 4 Using MiroView™

4- 40

NOTE The user can press ‘Enter’ key to capture the

image.

- To identify abnormalities and/or disease pathology more easily, use

the Image Enhancement function to adjust preferred image settings.

Click the icon to open the Image Enhancement window.

Using MiroView™ Chapter 4

4-41

Composing the Report on the Report Mode

- After capturing images of suspected disease in the Review Mode

pathology, click the icon to enter the Report Mode.

- Use the auto complete dictionary slide and choose available

disease pathology from the list.

- Completing the report:

1. Complete image comments for captured images (as required)

2. Complete the following tabs: Reason for referral; Procedure

Info & Findings; and Summary & Recommendations

3. After completing the report, enter the Export Mode to print out

the complete report and/or export MiroView™ 2.0 data.

Chapter 4 Using MiroView™

4- 42

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.

Using MiroView™ Chapter 4

4-43

n Print report, create file and export the Review on the Export

Mode.

- Select the images to select and click button to add the

selected captured images to the candidate list to export. (You

can remove the selected images from the candidate list using

the button)

Chapter 4 Using MiroView™

4- 44

- Click the button to use export function. A window will

appear like below.

- Select the File Type to export and change the desired file

location on the Selected Folder and click the button.

A window will appear with a progress bar.

Using MiroView™ Chapter 4

4-45

- - The user can use the button for EXMIF, the button

for Segment Export (Video / Miro Video) and the button

for Export Case function.

NOTE Select the segments on the Timebar to export. If

no segment is selected, the button to export

segments would be disabled.

NOTE MiroVideo includes Reviews and selected

Segments so that the user can confirm the

contents and edit from ‘Open Case / Review file…’,

‘Import Case / Review file…’ main menu.

Chapter 4 Using MiroView™

4- 46

n Print Report and save the report as PDF on the Report Preview

- Click the icon to print reports and/or click the icon to

save the report as PDF.

- Show report preview on the screen.

- The user can print out the report and save the report to PDF file

in this screen.

- If the user selects the 6 images or 9 images per page mode and

tries to print out, the message ‘If you proceed with the current

Layout mode, image comments may be omitted and not printed.

Please select another Layout Mode to include all comments in the

report.’ will appear.

Using MiroView™ Chapter 4

4-47

4.6.4 Image Atlas

n Atlas

Reference images are searchable by Capsule Endoscopy

Structured Terminology (CEST), Endoscopy 2005; 37: 951 - 959

(February 16, 2002 ○

C Given Imaging Ltd.)

○

1 Atlas Default Atlas Images

○

2 My Atlas Atlas Images configured by the user

○

3 Atlas + My Atlas Show Atlas Images and My Atlas Images at

once.

○

4 Import Atlas

Images from file

Import Atlas Images from file; BMP, JPEG,

GIF, EMF, WMF, TIFF and PNG file format.

○

5 Export Atlas

Images to file(s)

Export Atlas Images to file; BMP, JPEG, GIF,

EMF, WMF, TIFF and PNG file format.

○

6 Edit Information Edit the Information for the selected Atlas

Image.

○

7 Export Atlas

Image(s) to E-

Export Atlas selected Atlas Image(s) and

sends it / them to another doctor via E-mail.

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15

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12

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11

Chapter 4 Using MiroView™

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mail

○

8 Delete Atlas

Image(s)

Delete the selected Atlas Image(s)

○

9 Print Atlas

Image(s)

Print the selected Atlas image(s)

○

10 Save as PDF Save the selected Atlas Image(s) as PDF

○

11 Show/Hide

Marks

Show / Hide Marks on the Atlas Image(s)

○

12 Search Search the Atlas Image

○

13 Comparison

Window

Show the Comparison Window

○

14

Browser

Tab(Findings /

Diagnosis)

Area where to select the Category of the Atlas

Image to see.

○

15 Recent Images Images that the user saw on the Comparison

Window

○

18

○

19

○

17

Using MiroView™ Chapter 4

4-49

○

17 Image

Information

Show the Information for the Atlas Image

○

18 Findings /

Diagnosis

Show the Findings / Diagnosis Information

○

19 Atlas Thumbnail

Area(2)

Search the Atlas Image

○

20 Comparison

Window

Show the Current Image and Comparison

Image at once.

○

20

Chapter 4 Using MiroView™

4- 50

n Import Atlas Images from file(s)

MiroView™ allows the user to import image files for personal

purpose.

- Click the icon to open the ‘Open’ Browser to look for the files

to import.

Using MiroView™ Chapter 4

4-51

- Select the file to import and click ‘Open’

- Complete the ‘Title’, ‘Description’ and ‘Image Information’ fields and click

‘OK’.

Chapter 4 Using MiroView™

4- 52

4.7 How to import MiroView™ 1.0 files

4.7.1 Preparing files for import

n Run the MiroView™ 1.0

n Export files by clicking ‘Export for MiroView Express’ function on

MiroView™ 1.0

Before using the Export to MiroView Express function, you must insert

DVD media to the DVD writer or connect the external hard disk or USB

flash memory to the workstation via USB port.

1. Select a patient file from the list to export to MiroView Express.

2. Execute ‘Export to MiroView Express…’ on the main menu

Using MiroView™ Chapter 4

4-53

3. If the form, ‘Save As’ appears like below, select the location to export and

fill in the ‘File name’ field and click ‘Save’.

4. The window appears like below and if the function ends successfully you

will see the message, “Exporting has been completed.”

Chapter 4 Using MiroView™

4- 54

4.7.2 Import MiroView 1.0 files

n Run the MiroView™ 2.0 Operator or MiroView™ 2.0 Client.

n Execute the ’Import Case / Review File… -> Import Case’ in the ‘List’

menu

Using MiroView™ Chapter 4

4-55

n Select MiroView™ 1.0 files from the file extension drop-down box and

look for the file to upgrade

n Look for the File with extension ‘.MiroCam’ and click ‘Open’

Chapter 4 Using MiroView™

4- 56

n Task Manager will appear and will proceed with importation of the file.

If the Doctor name on the file is not registered on the MiroView™ 2.0

Server, ‘Doctor in charge’ registration process will start.

Using MiroView™ Chapter 4

4-57

n If the Reviewer name on the file is not registrered on the MiroView™

2.0 Server, ‘Reviewer’ registration process will start.

n Complete necessary fields and click ‘OK’.

Chapter 4 Using MiroView™

4- 58

n Progress bar will appear.

n Upgrading MiroView™ 1.0 file to MiroView™ 2.0 file will be completed.

5

Using MiroView™ RTV

Chapter 5 Using MiroView™ RTV

5- 2

Using Wireless MiroView™ RTV Chapter 5

5-3

5. USING MIROVIEW™ RTV

MiroView™ RTV, the application software for the MiroCam® System Real-

time Viewer, consist of a data transmission module that directly receives

the image data from the MiroCam® Receiver and an output module for

image display.

5.1 Overview

MiroView™ RTV software can be installed on any mobile platform. Click

the corresponding icon on the desktop to launch the MiroView™ RTV.

5.1.1 Basic Screen Layout

 Patient

Information

Display patient name, ID, gender and age

‚ Operation

Button

Change MiroView™ RTV operation status

between start, pause and resume.

ƒ Main Display Display captured image.

„ Time Display Indicates the MiroCam® capsule endoscope

procedure time.

‚ Start / Pause / Resume

ƒ Main Display

 Name / ID / Gender / Age

„ Time Display

Chapter 5 Using MiroView™ RTV

5- 4

5.1.2 Basic Mobile PC Layout

 USB Port USB Port for connect with MiroCam® Receiver

‚ DC-Jack Connector for Mobile PC Charger

ƒ Power Switch Mobile PC Power on switch.

WARNING Only recharge the mobile PC batteries when MiroCam®

Receiver does not connect to the mobile PC.

WARNING For safe use of mobile PC, please refer to mobile PC User

Manual.



ƒ

‚

Using Wireless MiroView™ RTV Chapter 5

5-5

5.1.3 Recommended Hardware Specification

n Operating System : Windows XP Professional

n CPU : A110 800Mhz

n Memory : DDR II 1GByte(667MHz)

n Display Adaptor : Windows Compatible

n Hard Disk : Over 1GB

n Monitor Resolution : 1024x600

n Monitor Contrast : Windows Compatible

n In compliance with IEC60950-1 or IEC60601-1

Chapter 5 Using MiroView™ RTV

5- 6

5.2 Using MiroView™ RTV

5.2.1 Before Using MiroView™ RTV

n The MiroView™ RTV software is pre-install on mobile PC

WARNING Do not use MiroView™ RTV software and mobile PC before

upgrading the MiroCam® Receiver.

WARNING Do not upgrade MiroCam® Receiver during the MiroCam®

capsule endoscopy procedure, it may result in loss if image

data.

n Connect the data cable for the Real-time Viewer to the MiroCam®

Receiver.

NOTE The data cable for MiroView™ RTV has no cover for the

USB port on the MiroCam® Receiver.

n Fallow the MiroCam® capsule endoscopy procedure.

NOTE For more information on the MiroCam® capsule endoscope

procedure, please refer to Chapter 3, Performing Capsule

Endoscopy.

Using Wireless MiroView™ RTV Chapter 5

5-7

5.2.2 Starting MiroView™ RTV

n Switch on the mobile PC.

n Click the icon on the desktop to launch MiroView™ RTV.

n Connect the small side of the USB cable to the MiroCam®

Receiver.

n Connect the large side of the USB cable to the Mobile PC.

n Click the button to start image display

n Click the button to stop image display

n Click the button to restart image display

n Click the button on the top-right to close the MiroView™ RTV.

NOTE Start, Pause, and Resume use the same button. The

function (Start, Pause or Resume) changes based upon the

status of MiroView™ RTV software.

CAUTION MiroView™ RTV is not software for to be used for

diagnostic purposes. Use the MiroView™ software for

viewing the patient images for diagnostic purposes.

CAUTION Do not disconnect the MiroCam® Receiver while the RTV is

in use. If the MiroCam® Receiver is disconnected during

use, the software may need to be restarted.

NOTE If an error message appears while using MiroView™ RTV,

reconnect the USB cable between MiroCam® Receiver and

Mobile PC

Chapter 5 Using MiroView™ RTV

5- 8

5.2.3 After Using MiroView™ RTV

n Disconnect USB cable from MiroCam® Receiver and mobile PC.

n Continue MiroCam® capsule endoscope procedure.

6

Using Wireless MiroView™ RTV

Chapter 6 Using Wireless MiroView™ RTV

5- 2

Using Wireless MiroView™ RTV Chapter 5

5-3

6. USING WIRELESS MIROVIEW™ RTV

Wireless MiroView™ RTV, the application software for the MiroCam®

System Real-time Viewer, consist of a data transmission module that

directly receives the image data from the MiroCam® Receiver and an

output module for image display. Wireless MiroView™ RTV receive image

data via Wi-Fi channel.

6.1 Overview

Wireless MiroView™ RTV software can be installed on I-OS 3 or I-OS 4

running on I-Pad / I-Phone / I-Pod Touch. Click the corresponding icon on

the desktop to launch the Wireless MiroView™ RTV.

6.1.1 Basic Screen Layout – I-Phone / I-Pod Touch

 ID / Name / Gender / Age

② Receiver Scan

③ Main Display

④ Time Display

Chapter 6 Using Wireless MiroView™ RTV

5- 4

 Patient

Information

Display patient name, ID, gender and age

‚ Receiver

Scan Button

Show the available Receiver Access Points so

that the user can choose to see the patient

image.

ƒ Main Display Display captured image.

„ Time Display Indicates the MiroCam® capsule endoscope

procedure time.

6.1.2 Basic Screen Layout – I-Pad

NOTE If turning the I-Pad upright as Portrait View, Receiver List

will disappear for the Main Display to be enlarged.

 ID / Name / Gender / Age

② Receiver Scan

③ Main Display

④ Time Display

Using Wireless MiroView™ RTV Chapter 5

5-5

 Patient

Information

Display patient name, ID, gender and age

‚ Receiver

Scan Button

Show the available Receiver Access Points so

that the user can choose to see the patient

image.

ƒ Main Display Display captured image.

„ Time Display Indicates the MiroCam® capsule endoscope

procedure time.

6.1.3 Recommended Hardware Platform

n I-Phone 3G, 3GS, 4G

n I-Pod Touch 3G

n I-Pad

Chapter 6 Using Wireless MiroView™ RTV

5- 6

6.2 Using Wireless MiroView™ RTV

6.2.1 Network configuration for Wireless MiroView™ RTV

n The Wireless MiroView™ RTV software is pre-installed on I-OS 3 /

I-OS 4 running on I-Phone, I-Pod Touch or I-Pad.

NOTE When the Wireless MiroView RTV run first, network

configuration for I-Phone and I-Pad is required.

n Fallow the MiroCam® capsule endoscopy procedure.

n Turn on the Wi-Fi switch on the MiroCam® Receiver System

during the Capsule Procedure.

NOTE For more information on the MiroCam® capsule endoscope

procedure, please refer to Chapter 3, Performing Capsule

Endoscopy.

Using Wireless MiroView™ RTV Chapter 5

5-7

n Click the icon on the desktop to launch MiroView™ RTV.

n Click the button on the right-top to show the available

MiroCam® Receiver Access Points

Chapter 6 Using Wireless MiroView™ RTV

5- 8

n If no available Receiver® Access Points are shown on the list, the

image will appear like below. Please make sure that the Wifi-

Swtich on the Receiver is turned on.

n If the MiroCam® Receiver Access Points are shown on the list.

Click the desirable AP (Access Point) to show the patient’s image.

Using Wireless MiroView™ RTV Chapter 5

5-9

n At the first time to connect to the AP, IP setting is required as below

steps:

l Step 1. Press the Home Button on the I-Phone/I-Pad/I-Pod touch

to close the Wireless MiroView™ RTV Software.

l Step 2. Run the Settings for the I-OS.

Chapter 6 Using Wireless MiroView™ RTV

5- 10

l Step3. Set the IP for the desirable AP. (Setup as Static; IP

Address : 192.168.3.200, Subnet Mask: 255.255.255.0)

Using Wireless MiroView™ RTV Chapter 5

5-11

n After completing the IP setting, close the setting window by clicking

the home button on the I-Phone/I-Pad/I-Pod touch and go back to

the desktop.

Chapter 6 Using Wireless MiroView™ RTV

5- 12

6.2.2 Running MiroView™ RTV

n Fallow the MiroCam® capsule endoscopy procedure.

n Turn on the Wi-Fi switch on the MiroCam® Receiver System

during the Capsule Procedure.

NOTE For more information on the MiroCam® capsule endoscope

procedure, please refer to Chapter 3, Performing Capsule

Endoscopy.

Using Wireless MiroView™ RTV Chapter 5

5-13

n Click the icon on the desktop to launch Wireless MiroView™

RTV.

n The Splash window will appear for a while and will disappear.

Chapter 6 Using Wireless MiroView™ RTV

5- 14

n After the splash window disappears, the real time play will be

started automatically. (The number of receiver is one).

※ If there are two or more Receiver AP is available, the

Receiver AP List window will be shown. Choose one to

continue as below:

n After reviewing the real time play is completed, click the home

button to close.

Using Wireless MiroView™ RTV Chapter 5

5-15

n To terminate the Software completely, double click the home button.

The menu will pop up like below.

n Press the Wireless MiroView RTV icon for a while. The mark

will appear.

Chapter 6 Using Wireless MiroView™ RTV

5- 16

n Click the icon, then the Wireless MiroView RTV will be

terminated completely.

CAUTION Wireless MiroView™ RTV is not to be used for diagnostic

purposes. Use the MiroView™ software for viewing the

patient images for diagnostic purposes.

6.2.3 After Using Wireless MiroView™ RTV

n Turn off the Wi-Fi switch on the MiroCam® receiver system.

n Continue MiroCam® capsule endoscope procedure.

A

Appendix

Case Form Report

A- 2

Case Form Report

A-3

Trial ID : Version No. : 1.0 : 30/07/2007

CASE REPORT FORM

Subject No.: Subject Initials : Center No.:

Principal

Investigator :

Center Name :

Address :

Telephone No. :

Fax No. :

E-mail :

CONFIDENTIAL

Case Form Report

A- 4

Trial ID : Version No. : 1.0 :

30/07/2007

Screening

Subject No.: Subject Initials : Center No.:

Date of Informed consent signed

D M M Y Y Y Y

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 mark of ‘No’, you shall be contradicted for this clinical test.

CONFIDENTIAL

Case Form Report

A-5

Trial ID : Version No. : 1.0 : 30/07/2007

Screening

Subject No.: Subject Initials : Center No.:

Date of visit :

D M M Y Y Y Y

Exclusion Criteria

Yes No N/A

1. Do you have a gastrointestinal disorder (suspected

malignantlesions or gastrointestinal obstructive disorders,

perforation, stenosis or fistula)?

2. Do you have a cardiovascular disorder (dysrhythemia, trouble

with cardiac conduction system, hypertension(high blood

pressure) or ischemic heart disease)?

3. Have you been diagnosed of cardiac insufficiency, angina

pectoris or cardiac arrest (heart attack) in recent 6 months?

4. 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?

If there is one or more mark of ‘Yes’, you shall be contradicted for this clinical test.

CONFIDENTIAL

Case Form Report

A- 6

EC Representative

SeDa S.p.A

20090 Trezzano sul Naviglio(MI),

Via Toistoi, 7 Italy

Key Contact: Roberta Cimolato

Office: +39-02-484241

Mobile: +39-02-48424290

Email: roberta.cimolato@sedaitaly.it

IntroMedic Co.,Ltd.

Suite 1104, E&C Venture Dream Tower 6-Cha

197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719

Tel : +82-2-801-9300

Fax : +82-2-801-9330

http://www.intromedic.com

e-mail : help@intromedic.com

0297

Disposal of Old

Electrical &

Electronic

Equipment

Applicable in the

European Union

and other

European

countries with

separate collection

systems

Intromedic INTROMEDIC3 MiroCam Capsule Endoscope System User Manual

Intromedic Co., Ltd. MiroCam Capsule Endoscope System Users Manual

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