User Manual
User Manual Copyright© 2007 IntroMedic Co., Ltd. Version 1.
Warranty 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 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.
Contents CONTENTS 1. SAFETY INFORMATION 1.1 1.2 1.3 1.4 Warnings Symbols for Safety Function Symbols Notes for Safe Use 2. SYSTEM OVERVIEW 3 3 4 5 9 3 2.1 Intended Purpose 3 2.2 2.3 2.4 Observable Diseases Product Lifetime Product Specification 4 6 7 3. PERFORMING CAPSULE ENDOSCOPY 3.1 3.2 3.3 3.4 3.5 3.6 3.
Contents 4. USING MIROVIEW™ 3 4.1 4.2 4.3 MiroView™ H/W Specifications Overview – MiroView™ Server Overview - MiroView™ Operator 5 8 10 4.4 4.5 4.6 4.7 Overview - MiroView™ Client Overview - MiroView™ Viewer Performing Capsule Endoscopy How to import MiroView™ 1.0 files 18 31 32 52 5. USING MIROVIEW™ RTV 5.1 5.2 Overview Using MiroView™ RTV 6. USING WIRELESS MIROVIEW™ RTV 6.1 6.
1 Safety Information
Safety Information 1- 2 Chapter 1
Chapter 1 Safety Information 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.
Safety Information Chapter 1 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.
Chapter 1 Safety Information 1.3 Function Symbols 1.3.1 MiroView™ Function Symbols The following table describes symbols or icons used in the MiroView™ software. Symbol Description Connect to the receiver and open receiver control screen. Symbol Description Open the report screen to create a patient capsule endoscopy report. Open screen to export Open the patient data (save externally) selected screen. image data for a specific patient.
Safety Information Symbol Chapter 1 Description Description Move to the previous Move to the previous image. captured image. Play images in reverse order. Play Move to the next captured image. Stop playback of images. Play images in sequential order. Move to the next image.
Chapter 1 Symbol Safety Information Description Uncheck selected captured images Review Export Review Export Captured Images with EXMIF Symbol Description Print Save as PDF Open PACS function (Registered User Only) Export Captured Images as Image / Video / MiroVideo Export Segments as Export Case as Video / Image / Video / MiroVideo MiroVideo Select the area as a Deselect the area from Segment Segment 1-7
Safety Information 1.3.
Chapter 1 Safety Information 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.
Safety Information Chapter 1 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.
Chapter 1 Safety Information 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.
Safety Information 1.4.1 Chapter 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.
Chapter 1 1.4.2 Safety Information Safety Precaution CAUTION - 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. DO NOT use the capsule if the package is unsealed. n DO NOT reuse a used capsule.
Safety Information n Chapter 1 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.
Chapter 1 Safety Information 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.
Safety Information 1.4.3 Chapter 1 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.
Overview & Intended Usage 2
Overview & Intended Usage 2- 2 Chapter 2
Chapter 2 Overview & Intended Usage 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.
Overview & Intended Usage 2.1.1 Chapter 2 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.
Chapter 2 2.2.3 Overview & Intended Usage 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.
Overview & Intended Usage 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 2- 6 MiroCam® Receiver Battery : 4.
Chapter 2 Overview & Intended Usage 2.4 Product Specification 2.4.1 MiroCam® Capsule n Component Component Capsule Model Name Quantity MC1000 1 Piece (Optional) MC1000-F MC1000-G Sensor Pads n MC1000-S 10 Piece Specification Item Specification Capsule Unit Size 11 X 24 mm (MC1000, Weight 3.4 ± 0.
Overview & Intended Usage 2.4.
Chapter 2 Overview & Intended Usage Item Specification Battery Pack Type Lithium-Ion storage cell (MR1100-B) Capacity 10400mA Voltage 3.6V Recharging Time Approx. 4 hours Size 73.8 X 84.3 X 21.4mm Data Cable Channel 9 (MR1000-D) Length 90cm Receiver Bag Size 100 X 190 X 55mm Size 480 X 350 X 100mm Battery Charger Power Source Adaptor (MR1000-C) Size 135 X 75 X 105mm Weight 285g Adaptor Weight 231g (MR1000-T) Power Rating AC100~240V/ 50~60Hz Power Code Length 1.
Overview & Intended Usage 2.4.3 Chapter 2 MiroCam® Software n Component Component 2- 10 Model Name Version MiroView™ Workstation MiroView™ 2.5 MiroView™ RTV MiroView™ RTV 1.0 Wireless MiroView™ RTV Wireless MiroView™ RTV 1.
3 Performing Capsule Endoscopy
Chapter 3 3- 2 Performing Capsule Endoscopy
Performing Capsule Endoscopy Chapter 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.
Chapter 3 Performing Capsule Endoscopy 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 n Insert the ID and password and click icon to start the MiroView™ 2.0 Operator. icon. WARNING Before starting the system, check the power rating for the workstation. 3.3.
Performing Capsule Endoscopy Chapter 3 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.
Chapter 3 Performing Capsule Endoscopy 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 - - - - - n On the day of capsule endoscope procedure - n After arriving in a hospital at the appointed time, the patient should submit an examination permission form and check in.
Performing Capsule Endoscopy - - Chapter 3 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 3.5.1 Performing Capsule Endoscopy Connecting Sensor Pads After attaching sensor pads to the data cables, attach the sensor pad correctly to each area as shown below.
Performing Capsule Endoscopy Chapter 3 3.5.2 Xiphoid process Line 1 5 4 8 Pelvic Line n Attach sensor pads according to the number on the data cable. - Locate the center between the umbilical and the xiphoid process. From this center point, attach the sensor to the distal point on the right flank of the patient’s body. - Place the sensor pad on the xiphoid process line, directly below the right clavicle. - Place the sensor pad on the xiphoid process line, directly below the left clavicle.
Chapter 3 Performing Capsule Endoscopy - 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 CAUTION WARNING match the specified area. Please follow the numbering sequence appropriately. To prevent entanglement of the data cables during procedure, organize cables and place appropriately in cable bag.
Performing Capsule Endoscopy 3.5.3 Chapter 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 n Performing Capsule Endoscopy 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.
Performing Capsule Endoscopy 3.5.6 Chapter 3 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.
Chapter 3 3.5.7 Performing Capsule Endoscopy 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 3.5.8 Chapter 3 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.
Chapter 3 Performing Capsule Endoscopy 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.
Performing Capsule Endoscopy Chapter 3 3.7 Receiver Management – Post Procedure 3.7.1 Cleaning n n n Remove data cable from receiver unit. Capsule and sensor pads should not be reused. 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.
Chapter 3 3- 18 Performing Capsule Endoscopy n Connect adapter DC cable to battery charger. n n n Connect AC power code to adaptor. Connect AC power code to AC consent or multi-tap. 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 Waiting Charging Charging Charged WARNING If the indicator on the battery charger is blinking yellow WARNING WARNING there is a bad connection. Please disconnect the battery from the battery charger and try again. Only use batteries provided by IntroMedic. Usage of inappropriate batteries can cause serious damage to the receiver. Recharge the MiroCam® receiver batteries with the adaptor and the battery charger only from IntroMedic.
Chapter 3 Performing Capsule Endoscopy WARNING Try not to contact the metallic terminal board of batteries WARNING WARNING WARNING WARNING 3- 20 with conductive objects or human body. It can cause an electric shock or damage and/or breakage of the batteries. Do not use the batteries with visible surface damage on. Usage of damaged batteries can result in leakage of contents of the batteries. To avoid the risk of explosion, keep batteries away from fire.
Using MiroView™ 4
Chapter 4 4- 2 Using MiroView™
Using MiroView™ Chapter 4 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.
Chapter 4 Using MiroView™ MiroView™ MiroView™ MiroView™ MiroView™ Client Operator Server 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.
Using MiroView™ Chapter 4 4.1 MiroView™ H/W Specifications 4.1.1 MiroView™ Server n Minimum Hardware Requirements - n Recommended Hardware Requirements - 4.1.
Chapter 4 4.1.3 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 MiroView™ Operator n Minimum Hardware Requirements - n 4.1.
Using MiroView™ Chapter 4 CAUTION MiroView™ cannot be viewed on a monitor with a resolution NOTE under 1024x768. The GUI is best viewed on a wide monitor of 19” or larger.
Chapter 4 4.2 Using MiroView™ 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. ‚ ƒ „ n n n n 4- 8 Set the port number for the Network. If unknown, please leave this field as ‘2000’.
Using MiroView™ Chapter 4 … † n n n Type the Address that should appear on the Capsule Endoscope Report. Type the Telephone Number that should appear on the Capsule Endoscope Report. After setting up the Configuration Windows, MiroView™ Server window above will appear. Click the icon to hide the window.
Chapter 4 Using MiroView™ 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 n Input “127.0.0.1” for the IP Address and “2000” for the Port.
Using MiroView™ n Chapter 4 Input ‘Administrator’ for ID and password. Then press the button. CAUTION ID and password are encrypted. Do not forget the ID and CAUTION password. 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™ The following subsections describe the main interfaces and functions of the MiroView™ Operator. 4.3.
Using MiroView™ 4.3.3 Chapter 4 Receiver Mode Screen enables administration and status display for upto four ‚ ƒ receivers. „ … 1 ○ 2 ○ 3 ○ Upload Input Patient’s Information Initialization 4 ○ Receiver Port 5 ○ Detail View Upload images in the receiver to the server Input Patient’s Information to the selected receiver Delete all data from the receiver and/or prepare the receiver for the next patient.
Chapter 4 4.3.4 Receiver Initialization Click the 4- 14 Using MiroView™ button to initialize the selected receiver.
Using MiroView™ 4.3.5 Chapter 4 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 4.3.6 Using MiroView™ 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.
Using MiroView™ 4.3.7 Chapter 4 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™ Add an account. Click displayed below. button to show the window as 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.
Using MiroView™ 4.4.
Chapter 4 4.4.3 Using MiroView™ Review Mode Select a case to review on the List Mode and click the enter the Review Mode.
Using MiroView™ 11 ○ Express View 12 ○ SGIB 13 ○ 14 ○ 15 ○ 16 ○ 17 ○ 18 ○ 19 ○ 20 ○ 21 ○ Previous Image Previous Capture Play Backward Pause / Resume Play Forward Next Capture Next Image Capture Landmark 22 ○ Image Enhancement 23 ○ Time Display 24 ○ 25 ○ Zoom View Comparison Window 26 ○ Thumbnail Extension 27 ○ Capture Box Chapter 4 Actively removes images based upon similarity; effectively reducing the number of images for review. This mode is recommended to review the patient file.
Chapter 4 n Using MiroView™ Finding Summary Box 28 ○ 28 ○ 4- 22 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).
Using MiroView™ n Chapter 4 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™ - Viewing Modes Select one of the icons for preferred Viewing Mode. Single View Quad View Dual View Range View NOTE Range View has been designed to assist in readily finding transition points in the GI tract. The display will show 9 images before and 9 images after the current position. The 9 images are defaulted to 10 minutes apart, resulting in an overview of 90 minutes prior to, and 90 minutes after the current position.
Using MiroView™ Chapter 4 ※ 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. Map View The icons will change to playing Mode, as detailed below.
Chapter 4 n Using MiroView™ 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™ 4.4.4 Chapter 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 ‚ƒ „ …† ‡ ˆ 11 ○ 12 ○ 13 ○ Š ‰ 1 ○ 2 ○ 3 ○ 4 ○ 5 ○ List Mode Review Mode Report Mode Export Mode Scale 6 ○ Drawing Tools 7 ○ Image Enhancement Open List Mode Open Review Mode Open Report Mode Open Export Mode Opens graduated scale for display on the image Enables users to include annotations for the image.
Chapter 4 8 ○ Using MiroView™ GI Dictionary Provides the frequently-used-words to search. 9 ○ Text Comments 10 ○ Audio Comment 11 ○ 12 ○ 13 ○ Input Word Add Word Delete Word Write comments for the Capture on the main display and the report. (Image Comments, Reason for Referral, Procedure info & findings, Summary & Recommendation) Record voice commenst (The user can record min 3 sec ~ max 300 sec for each Capture) Input the selected word into the text editor. Add the typed word into the Dictionary.
Using MiroView™ 4.4.5 Chapter 4 Export Mode ‚ƒ „ …† 1 ○ 2 ○ 3 ○ 4 ○ 5 ○ 6 ○ 7 ○ 8 ○ 9 ○ 10 ○ List Mode Review Mode Report Mode Export Mode Check Captured Image Uncheck Captured Image Print Preview Save as PDF Export Review 11 ○ ‡ ˆ‰ Š○ 12 ○ 13 ○ 14 ○ 15 Open List Mode Open Review Mode Open Report Mode Open Export Mode Select Captured image and add to the list to print/export. Deselect Captured image and remove from the candidate list to print/export. Print out the report for the Review.
Chapter 4 11 ○ Send to PACS 12 ○ Export EXMIF 13 ○ Export 14 ○ Export Segment Export Entire 15 ○ 4- 30 Using MiroView™ contains Captured Images and Comments by the user. Send selected captured images to PACS system via DICOM Sender Export Captured Images as EXMIF (eXchangeable Medical Information Format) Export Captured Images as Image, Video, or MiroVideo. MiroVideo is the own video format for MiroView™.
Using MiroView™ Chapter 4 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.
Chapter 4 Using MiroView™ 4.6 Performing Capsule Endoscopy 4.6.1 4- 32 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 n Click the n Click ‘Yes’ to start the initializing process. n After the initializing process is complete, the following message will appear. icon. The following message will appear.
Chapter 4 n n Using MiroView™ Click ‘OK’ and the Patient Information window will appear. Input the patient information for each field. 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.
Using MiroView™ 4.6.2 Chapter 4 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™ n Click the n After completing the Upload, the following message will appear. 4.6.3 button to start the Upload. 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™ n Chapter 4 Select the Patient Video Data on the List Mode - Select a patient video data to review from the List Mode and click the 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 n Using MiroView™ 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 - 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™ 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 4- 40 icon to open the Image Enhancement window.
Using MiroView™ Chapter 4 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.
Chapter 4 Using MiroView™ 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 CAUTION CAUTION 4- 42 from/to the workstation while recording the audio comment. Sound Card Driver must be installed prior to using the Recording function. Prior to recording the comments, close all the applications using the Sound Card such as music/video player.
Using MiroView™ n Chapter 4 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.
Chapter 4 Using MiroView™ - 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 A window will appear with a progress bar. 4- 44 button.
Using MiroView™ - Chapter 4 - 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 segments would be disabled. button to export 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 n Using MiroView™ 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.
Using MiroView™ 4.6.4 Chapter 4 Image Atlas n Atlas Reference images are searchable by Capsule Endoscopy Structured Terminology (CEST), Endoscopy 2005; 37: 951 - 959 C Given Imaging Ltd.
Chapter 4 Using MiroView™ mail 8 ○ Delete Atlas Delete the selected Atlas Image(s) Image(s) 9 ○ 10 ○ 11 ○ 12 ○ 13 ○ 14 ○ 15 ○ Print Atlas Image(s) Save as PDF Print the selected Atlas image(s) Show/Hide Marks Search Show / Hide Marks on the Atlas Image(s) Comparison Window Browser Tab(Findings / Diagnosis) Recent Images Show the Comparison Window Save the selected Atlas Image(s) as PDF Search the Atlas Image Area where to select the Category of the Atlas Image to see.
Using MiroView™ 17 ○ 18 ○ 19 ○ Chapter 4 Image Information Findings / Diagnosis Atlas Thumbnail Area(2) Show the Information for the Atlas Image Comparison Window Show the Current Image and Comparison Image at once.
Chapter 4 n Using MiroView™ Import Atlas Images from file(s) MiroView™ allows the user to import image files for personal purpose. - Click the to import.
Using MiroView™ Chapter 4 - Select the file to import and click ‘Open’ - Complete the ‘Title’, ‘Description’ and ‘Image Information’ fields and click ‘OK’.
Chapter 4 Using MiroView™ 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.
Using MiroView™ 3. Chapter 4 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 4.7.2 Using MiroView™ Import MiroView 1.0 files n Run the MiroView™ 2.0 Operator or MiroView™ 2.0 Client.
Using MiroView™ n Chapter 4 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 ‘.
Chapter 4 n Using MiroView™ 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™ n Chapter 4 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™ n Progress bar will appear. n Upgrading MiroView™ 1.0 file to MiroView™ 2.0 file will be completed.
Using MiroView™ RTV 5
Chapter 5 5- 2 Using MiroView™ RTV
Using Wireless MiroView™ RTV Chapter 5 5. USING MIROVIEW™ RTV MiroView™ RTV, the application software for the MiroCam® System Realtime 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.
Chapter 5 5.1.2 Using MiroView™ RTV Basic Mobile PC Layout ‚ ƒ USB Port for connect with MiroCam® Receiver USB Port Connector for Mobile PC Charger ‚ DC-Jack Power Switch Mobile PC Power on switch. ƒ 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.
Using Wireless MiroView™ RTV 5.1.
Chapter 5 Using MiroView™ RTV 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.
Using Wireless MiroView™ RTV 5.2.2 Chapter 5 Starting MiroView™ RTV n Switch on the mobile PC. n n Click the icon on the desktop to launch MiroView™ RTV. 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.
Chapter 5 5.2.3 5- 8 Using MiroView™ RTV 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 5- 2 Using Wireless MiroView™ RTV
Using Wireless MiroView™ RTV Chapter 5 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.
Chapter 6 Using Wireless MiroView™ RTV Patient ‚ Information Receiver Scan Button ƒ Main Display „ Time Display 6.1.2 Display patient name, ID, gender and age Show the available Receiver Access Points so that the user can choose to see the patient image. Display captured image. Indicates the MiroCam® capsule endoscope procedure time.
Using Wireless MiroView™ RTV Patient ‚ Information Receiver Scan Button ƒ Main Display „ Time Display 6.1.3 Chapter 5 Display patient name, ID, gender and age Show the available Receiver Access Points so that the user can choose to see the patient image. Display captured image. Indicates the MiroCam® capsule endoscope procedure time.
Chapter 6 Using Wireless MiroView™ RTV 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 n Fallow the MiroCam® capsule endoscopy procedure. Turn on the Wi-Fi switch on the MiroCam® Receiver System during the Capsule Procedure.
Using Wireless MiroView™ RTV Chapter 5 n Click the n Click the button on the right-top to show the available MiroCam® Receiver Access Points icon on the desktop to launch MiroView™ RTV.
Chapter 6 5- 8 Using Wireless MiroView™ RTV n If no available Receiver® Access Points are shown on the list, the image will appear like below. Please make sure that the WifiSwtich 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 n Chapter 5 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 l Step3. Set the IP for the desirable AP. (Setup as Static; IP Address : 192.168.3.200, Subnet Mask: 255.255.255.
Using Wireless MiroView™ RTV n Chapter 5 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 6.2.2 Using Wireless MiroView™ RTV Running MiroView™ RTV n n Fallow the MiroCam® capsule endoscopy procedure. 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 n Click the RTV. n The Splash window will appear for a while and will disappear.
Chapter 6 n Using Wireless MiroView™ RTV After the splash window disappears, the real time play will be started automatically. (The number of receiver is one). ※ n 5- 14 If there are two or more Receiver AP is available, the Receiver AP List window will be shown. Choose one to continue as below: After reviewing the real time play is completed, click the home button to close.
Using Wireless MiroView™ RTV Chapter 5 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 will appear.
Chapter 6 n Using Wireless MiroView™ RTV 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 n 5- 16 Turn off the Wi-Fi switch on the MiroCam® receiver system. Continue MiroCam® capsule endoscope procedure.
Appendix A
Case Form Report A- 2
Case Form Report Trial ID : Version No. : 1.0 : 30/07/2007 CASE REPORT FORM Subject No.: Principal Investigator Subject Initials : Center No.: : Center Name : Address : Telephone No. : Fax No.
Case Form Report 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.
Case Form Report 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 1. 2. 3. 4. 5.
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 Disposal of Old Electrical & Electronic Equipment Applicable in the European Union and other European countries with separate collection systems 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.
