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 3 3 4 5 8 2. SYSTEM OVERVIEW 3 2.1 Intended Purpose 2.2 Observable Diseases 3 4 3. PERFORMING CAPSULE ENDOSCOPY 3.1 3.2 3.3 3.4 3.5 3.6 3.7 General Comments Safety Warnings Examination Preparation Patient Preparation Sensor Placement & Capsule Ingestion Uploading Images Receiver Management – Post Procedure 4. USING MIROVIEW™ 4.1 4.2 4.3 4.4 4.
Contents 5. USING MIROVIEW™ RTV 5.1 Overview 5.
Safety Information 1
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 Symbol Description Connect to the receiver Open the report screen to and open receiver control create a patient capsule screen. endoscopy report. Open screen to export Open the patient data (save externally) selected screen. image data for a specific patient.
Safety Information Symbol Description Show images in the quad screen. 1- 6 Chapter 1 Symbol Description Play all images. Play the selected images SGIB - Play the images only. View images via captured via Suspected GI Quick Mode function. Bleeding function. Show images in the Show all images in the Capture Box by group. Capture Box.
Chapter 1 1.3.
Safety Information Chapter 1 1.4 Notes for Safe Use Follow the safety instructions included in this User Manual and clinical precautions advised by the medical professional. The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device and/or product. IntroMedic Co., Ltd. is NOT responsible for physical harm or equipment problems caused by the user’s careless operation or mismanagement of the device and/or product.
Chapter 1 Safety Information DO NOT operate the equipment with wet hands. Avoid using the equipment in extreme temperatures or humid environments. DO NOT keep the equipment or carry out the procedure in places such as areas exposed to direct sunlight, vicinity of heaters, vicinity of chemical materials or gases, areas moist/damp or dusty, or poorly ventilated areas. DO NOT disassemble or open the equipment without permission. This will invalidate the warranty.
Safety Information Chapter 1 DO NOT charge the receiver while the receiver’s data cable and sensor pads are still connected. Connect USB cable to receiver only after mounting it on charger. DO NOT install any other programs onto the workstation utilized for review and diagnosis of patient image data (i.e computers with the MiroView™ software). The capsule is disposable and should not be reused.
Chapter 1 1.4.1 Safety Information Environmental Conditions for Operation Temperature : +10 ℃ - +40℃ Relative humidity : 45% - 75% Atmospheric pressure : 700hPa to 1060hPa WARNING DO NOT operate the equipment in the vicinity of generators, power stations, X-ray devices, and broadcasting stations where high levels of electro-magnetic waves are generated. The electro-magnetic waves can cause equipment malfunctions.
Safety Information 1.4.2 Chapter 1 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. DO NOT use the capsule if the package is unsealed. CAUTION DO NOT reuse a used capsule.
Chapter 1 Safety Information 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.) 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.
Safety Information Chapter 1 When undergoing the capsule endoscope procedure, DO NOT make physical contact with another person undergoing the same procedure. During operation of the receiver, DO NOT touch the receiver, or get the receiver wet. Only use the provided batteries, and never remove the battery from the receiver during the procedure. During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB. This may damage the patient’s data.
Chapter 1 1.4.3 Safety Information Cleaning and Maintenance 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.
Safety Information 1- 16 Chapter 1
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 Not intended for patients with known or suspected gastrointestinal tract obstructions, perforations, strictures or fistular. Not intended for patients who have difficulty ingesting food or pills (dysphagia). Not intended for patients who have difficulty communicating. Not intended for patients with indigestion, or slow gastric emptying.
Chapter 2 2.2.3 Overview & Intended Usage Small Bowel Tumors Polyps Peutz-Jeghers Syndrome Familial adenomatous polyposis Lymphoma Carcinoid Gastro-Intestinal Stromal Tumor (GIST) Lipoma Hemangioma 2.2.4 Inflammation Intestinal Tuberculosis Typhoid Fever Angeitis Amyloidosis Eosinophilic enteritis 2.2.5 Celiac Disease 2.2.6 Behcet’s Disease 2.2.7 Cowden Disease 2.2.
Overview & Intended Usage 2- 6 Chapter 2
3 Performing Capsule Endoscopy
Chapter 3 3- 2 Performing Capsule Endoscopy
Performing Capsule Endoscopy Chapter 3 3. PERFORMING CAPSULE ENDOSCOPY 3.1 General Comments This chapter describes how to operate and control MiroCam® capsule endoscope system. Installation and initial operation must be done by an Authorized IntroMedic Service Technician. 3.2 Safety Warnings WARNING Before turning on the system, check the environment condition for 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 Turn on power of MiroCam® workstation. Click Insert the ID and password and click icon to start the MiroView™ software program. icon. WARNING Before starting the system, check the power rating for the workstation. 3.3.
Performing Capsule Endoscopy Note Before clicking the Chapter 3 icon in MiroView™, 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 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. 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 One day prior to the capsule endoscope procedure - 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.
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 Pelvic 8 Line Attach sensor pads according to the number on the data cable. - Locate the center between the umbilical and the xiphoid process. From this center point, attach the sensor to the distal 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 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.
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 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. Check if the front of the capsule is flashing when it is removed from the case After washing hands, patients should grip the gold section of the capsule between the thumb and the forefinger of the both hands. 3.5.
Performing Capsule Endoscopy Chapter 3 receiver should be green. 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. Connect the data cable to the MiroCam® receiver. 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.
Chapter 3 3.5.8 Performing Capsule Endoscopy Checking and Wearing the Receiver After ingesting the capsule, make sure that the SIG indicator is green. Place the receiver in the bag. Organize the contents of the bag so that the cables are not entangled. Adjust cables, and place excess in cable bag. Adjust the bag strap as needed. Capsule endoscopy procedure will be complete after 11 hours. CAUTION Patient should not touch receiver during the procedure.
Performing Capsule Endoscopy Chapter 3 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™. 3.6.1 Transferring and Checking image data Switch on the workstation. Click the When the login window appears, enter the user ID and password, icon on the desktop to launch MiroView™. and then click the button. Connect the smaller end of the USB cable to the receiver.
Chapter 3 Performing Capsule Endoscopy 3.7 Receiver Management – Post Procedure 3.7.1 Cleaning 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.
Performing Capsule Endoscopy Chapter 3 Connect adapter DC cable to battery charger. Connect AC power code to adaptor. Connect AC power code to AC consent or multi-tap. Battery charger indicator lights: Battery is charging when green light is blinking Battery is fully charged when light is solid blue Battery is not-charging if light is yellow Note: second battery in charger will automatically begin charging once first battery is fully charged.
Chapter 3 Performing Capsule Endoscopy WARNING Try not to contact the metallic terminal board of batteries WARNING WARNING WARNING WARNING 3- 18 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. 4.1 Before Using MiroView™ MiroView™ will be pre-installed on workstations. Click the corresponding icon on the desktop to launch MiroView™. 4.1.1 Starting MiroView™ Switch on the workstation.
Chapter 4 4.1.2 Using MiroView™ MiroView™ Icons Symbol Description Description Connect to the receiver Open the report screen to and open receiver control create a patient capsule screen. endoscopy report. Open the patient data screen of the MiroCam® system. Open screen to review for a specific patient Open screen to export (save externally) selected image data for a specific patient. Open screen to backup image data for a specific patient.
Using MiroView™ Symbol Description View images via Quick Mode function. Chapter 4 Symbol Description SGIB - Play the images captured via Suspected GI Bleeding function. Show images in the Show all images in the Capture Box by group. Capture Box. When editing the captured When editing the captured image in the report mode, image in the report mode, add a circle on the add an arrow on the captured image. captured image.
Chapter 4 4.1.3 Using MiroView™ MiroView™ Menus File Menu Save Save changes (captured images, comments etc.) to Database Backup… Backup patient information and image data file (complete file) Restore… Restore patient information and image data file into MiroView (from backup file) Export Save captured images, videos and/or patient report to a designated storage space (USB etc.
Using MiroView™ Chapter 4 Tools Menu Settings… Setting MiroView™ Software View history of changes… View history of changes View personal info… Display patient information Delete Delete the selected file from the list Reload Refresh the list of patient files Play mode Change the play mode Show compare window Show comparison window Show position window Show positioning window 4-7
Chapter 4 4.1.
Using MiroView™ Chapter 4 Drawing Tool (Used in Comparison Window & Report Mode) <> Delete a selected arrow or circle (After selecting a or more diagram) <> + <> Delete all arrows / circles <> + <> Undo <> + <> Redo +<> 4-9
Chapter 4 4.1.5 Using MiroView™ Basic Screen Layout cdefgh i j c Receiver d List e Review f Report g Export h Backup i Whole List j Active Item Connect to the receiver and switch to the control screen. Switch to the patient data screen of the MiroCam® system. Switch to the screen where images for the selected patient can be reviewed. Switch to the screen where a report for the selected patient can be created. Switch to the screen where image data for the selected patient can be exported.
Using MiroView™ Chapter 4 cd c Review View d Report View 4-11
Chapter 4 4.1.6 Using MiroView™ Basic Procedure button In the patient list, select a desired patient and press the to review data for the selected patient. Press the button to play the images. Press the button to stop playback of the images. Press the button to save the current image in the Capture Box. Press the button to create and print a report for the patient being diagnosed. button to upload the data from the receiver or to Press the initialize the receiver. 4.
Using MiroView™ Chapter 4 button to continue. - Press the - The initialization screen will appear. - Click the Yes button to initialize. When the progress bar is full and the ‘complete’ message appears, the initialization is complete. - Click the the patient.
Chapter 4 Using MiroView™ 4- 14 Complete all fields and click ready for use. button. Receiver is Upload image data for patient button. - Press the - Connect the receiver’s USB cable to the receiver. - Press the appears.
Using MiroView™ Chapter 4 When the progress bar is full and the ‘complete’ message appears, the upload is complete. Play and diagnose image data for a patient - Select the desired patient from the patient list. - Press the button. - Press the button to play and diagnose image data. Printing Patient Report - Press the button. Create a report. Print the report CAUTION The installation and initial operation of the system should be performed by authorized service personnel from IntroMedic.
Chapter 4 4.2.2 Using MiroView™ MiroView™ Setting Settings Menu is selected from Tools Menu User Option Tab within Settings Menu - 4- 16 Name of hospital: Input the hospital name DB server: IP address for using a DB (PostGreSql server). Consult with IT staff to properly use this option. Language: Select preferred language. Measurement units: Choose preferred measurement units. User Name: Change the name of doctor which appears in the top right of the MiroView program.
Using MiroView™ Chapter 4 jpeg, avi only, jpeg only, avi + jpeg. Selecting ‘All’ includes all files (both included and not-included in report). - View Style: Select preferred viewing style. Miscellaneous Tab within Setting Menu - New User: Create a new ID. Only the master user can use this function. Current User: Change the password of the current user. Select Image: Save a logo image to insert into the report. Appropriate image file size should be used. Delete Image: Delete logo image.
Chapter 4 Using MiroView™ 4.3 Viewing Setting Single view - Dual view - 4- 18 icon in the upper right corner of MiroView™. Click the The Single View screen will appear, allowing viewing of a single image. icon in the upper right corner of MiroView™. Click the The Dual View screen will appear, allowing viewing of two images at a time. In this screen, images are displayed alternately in each pane.
Using MiroView™ Chapter 4 Quad view - icon in the upper right corner of MiroView™. Click the The Quad View screen will appear, allowing viewing of four images at a time. In this screen, images are displayed alternately in each pane. CAUTION Because the playback speed varies depending on the view type, use the view that is most comfortable and appropriate for diagnosis. Do not be confused due to odd image on the center. The S/W distorts center of an image to fill out.
Chapter 4 4.3.1 Using MiroView™ Viewing Mode Setting icon in the upper right corner of MiroView™ to view Click the images in normal playback mode, in which all images are displayed. icon in the upper right corner of MiroView™ to view Click the images in brief playback mode, in which the selected images are displayed based on their similarities. This mode will skip images which are the same. CAUTION Quick View mode does not display all images, so it is not intended for diagnosis.
Using MiroView™ 4.3.2 Chapter 4 Setting and Using Capture Box Save data in capture box Clicking the button in the upper right corner of MiroView™ displays the area corresponding to the current image in the time bar and saves the image group for the area in the Capture Box. Use the capture ( ) button to save images. Images will be displayed in the Capture Box.
Chapter 4 Using MiroView™ Save data in capture box Click the icon in the center of the MiroView™ screen to specify the start point of each area of the GI tract. Images for each area of the GI tract are displayed in the time bar and are saved in the Capture Box. Specify playback position Drag and drop the position control bar in the time bar to place an image to display in the center of the screen.
Using MiroView™ Chapter 4 View saved images The captured images group and landmarked images can be viewed in the Capture Box. Captured images cannot be viewed in the Quad View screen. Use the left or right arrow to view the saved images from start to finish. Previous Next Image NOTE Using the Mouse Wheel When paused, move the mouse wheel down to view the 'next image’ and move it up to view the ‘previous image.’ During playback, you can display the previous or next images by using the mouse wheel.
Chapter 4 4.3.3 Using MiroView™ Setting and Using Tracking Function Click the button in the lower center of the screen. The route taken by a capsule will be displayed in 2D based on actual human anatomy.
Using MiroView™ 4.3.4 Chapter 4 Setting and Using Comparison Window The current image can be compared with existing images of other patients in the Compare window to readily identify disease pathologies or abmormalities. Click the Click the Image data that will be displayed in the Compare window can be button in the right side of the screen. button in the Compare window. selected and sorted.
Chapter 4 Using MiroView™ The In the Compare window, circle or arrow marks can be placed or function can be used in the Compare window. removed to highlight a specific area.
Using MiroView™ Chapter 4 4.4 Creating a Report After reviewing images, a diagnostic report can be created for the patient. Access via the 4.4.1 icon. Editing Report icon in the upper left corner of MiroView™. Click Enter patient information, and procedure findings in the appropriate text boxes; choose a desired text box from the tab. The tab is editable. Click the onto the tab. icon to add and name a text box A specific image can be selected, and related comments entered in the text box.
Chapter 4 Using MiroView™ Check the Final Approval option in the lower right corner. Press the button to save the created report. Press the button to print a report for the selected patient. CAUTION If Final Approval is not checked, a report cannot be used as a medical examination certificate. However, if it is checked, the report becomes a finalized medical examination certificate that is not editable.
Using MiroView™ 4.4.2 Chapter 4 Settings button to change settings. Press the Press the right-mouse button to see the pop-up menu.
Chapter 4 4- 30 Using MiroView™ Press the right-mouse button on the desired text line to edit. Pop-up menu will appear and select ‘Edit Caption’ to change text. Add images or logos to report: o Click ‘Add Image’ on the pop-up menu.
Using MiroView™ Chapter 4 o Rectangular area appears. o Click the right-mouse button on the rectangular area. Click ‘Select Image’.
Chapter 4 Using MiroView™ o Select the desired image or logo to insert. o Image box can be resized and moved to the desired location.
Using MiroView™ Chapter 4 4.5 Atlas For reference, the MiroCam® Image Atlas provides an extensive image library of disease pathology and normal anatomy. Users can access the Atlas DB via ‘Atlas’ function on the Help menu. 4.5.1 Accessing Atlas Execute ‘Atlas’ from the Help menu Select image from categories in the bottom left.
Chapter 4 Using MiroView™ Click on an image from the Image Atlas to add to the Comparison Window in Review Mode CAUTION My Atlas DB is not available in MiroView™ Express but only in MiroView™.
Using MiroView™ Chapter 4 4.6 Backing up Patient Data 4.6.1 Backing up Image Data The entire image data for the selected patient can be backed up onto a DVD, an external HDD or a USB flash memory. Select a patient to back up from the patient list in MiroView™ and click the Click the icon. icon and then move and save image data onto a DVD. If needed, insert an additional DVD and continue to save the data. CAUTION The number of DVDs required for backup is displayed.
Chapter 4 4.6.2 Using MiroView™ Exporting Image Data Selected images and report files for a patient can be exported to a CD/DVD, an external HDD or a USB flash memory. Select a patient to back up from the patient list in MiroView™ and click the icon. Click the Burn icon and then move and save the image data onto a DVD. If needed, insert an additional DVD or CD and continue to save the data. CAUTION The number of DVDs or CDs required for exporting is displayed.
Using MiroView™ 4.6.3 Chapter 4 Exporting Image Data for MiroView™ Express MiroView™ Express Overview MiroView™ Express software is a ‘light’ version of the MiroView™ software, which can be installed on laptops or a PC (at home or the office), and is designed to enable Physicians to more readily review patient files. To view a patient file with MiroView™ Express, it is necessary to export the desired patient file from the MiroView™ workstation (via the Export for Express function).
Chapter 4 Using MiroView™ Select the location of the storage device and complete the ‘File name’ field. A progress bar will appear. When complete, the following message “Exporting has been completed.” will appear.
Using MiroView™ 4.6.4 Chapter 4 Importing Image Data for MiroView™ Express After reviewing the patient file with MiroView Express, the changed data (i.e. saved images, comments, reports etc.) can be synchronized with the patient file in the MiroView workstation via the ‘Import from MiroView Express’ function. Select ‘Import from MiroView Express’ from the File tab in MiroView™. Select the patient file to import (from the external storage device with the patient file).
Chapter 4 Using MiroView™ Confirm file by click A progress bar will appear. When import is complete, following message “Import from Button. MiroView Express is complete.” will appear. CAUTION For further information about MiroView™ Express, please refer to the MiroView™ Express User Guide included with the installation CD, and/or contact your local IntroMedic Representative for assistance.
Using MiroView™ RTV 5
Chapter 5 5- 2 Using MiroView™ RTV
Using 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 receiver and an output module for image display. 5.1 Overview MiroView™ RTV will be pre-installed on UMPC(Ultra-Mobile PC) that provided by IntroMedic. Click the corresponding icon on the desktop to launch the MiroView™ RTV. 5.1.
Chapter 5 5.1.2 Using MiroView™ RTV Basic UMPC Layout c d e USB Port for connect with MiroCam® Receiver c USB Port DC-Jack Connector for UMPC Charger d Power Switch UMPC Power on switch. e WARNING Only use UMPC provided by IntroMedic. Usage of inappropriate UMPC can cause serious harm to the patient. WARNING Only recharge the UMPC batteries with the adaptor from IntroMedic. Use of the improper adaptor can cause serious damage to patient and UMPC.
Using MiroView™ RTV Chapter 5 5.2 Using MiroView™ RTV with MiroCam® Receiver MR1000 5.2.1 Before Using MiroView™ RTV The MiroView™ RTV software is pre-install on UMPC provided by IntroMedic. WARNING Do not use MiroView™ RTV software and UMPC 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 . Connect the data cable for the Real-time Viewer to the MiroCam® receiver.
Chapter 5 5.2.2 Using MiroView™ RTV Starting MiroView™ RTV Switch on the UMPC. Click the icon on the desktop to launch MiroView™ RTV. Connect the small side of the USB cable to the receiver. Connect the large side of the USB cable to the UMPC. Click the button to start image display Click the button to stop image display Click the button to restart image display Click the button on the top-right to close the MiroView™ RTV.
Using MiroView™ RTV 5.2.3 Chapter 5 After Using MiroView™ RTV Disconnect USB cable from MiroCam® Receiver and UMPC. Charge the UMPC by using the adaptor provided by IntroMedic. Continue MiroCam® capsule endoscope procedure. 5.3 Using MiroView™ RTV with MiroCam® Receiver MR2000 5.3.1 Before Using MiroView™ RTV The MiroView™ RTV software is pre-install on UMPC provided by IntroMedic. Fallow the MiroCam® capsule endoscopy procedure.
Chapter 5 5.3.2 Using MiroView™ RTV Starting MiroView™ RTV Switch on the UMPC. Click the icon on the desktop to launch MiroView™ RTV. Connect the small side of the USB cable to the receiver. Connect the large side of the USB cable to the UMPC. Click the button to start image display Click the button to stop image display Click the button to restart image display Click the button on the top-right to close the MiroView™ RTV.
Using MiroView™ RTV 5.3.3 Chapter 5 After Using MiroView™ RTV Disconnect USB cable from MiroCam® Receiver and UMPC. Charge the UMPC by using the adaptor provided by IntroMedic. Continue MiroCam® capsule endoscope procedure.
Chapter 5 5- 10 Using MiroView™ RTV
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 : Date of Informed consent signed Center No.: 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.: Date of visit : Subject Initials : D M Center No.: M Y Y Y Y Exclusion Criteria Yes No 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.
Case Form Report A- 6
EC Representative NanoMedical Largo do Sequeira 7 G3 P.E. 1100-587 Lisboa Portugal Key Contact: Nuno Nicola Covacich Office: +351-21-884-3140 Mobile: +351964468482 or +351961300259 Email: nuno.nicola@nano-medical.org Disposal of Old Electrical & Electronic Equipment Applicable in the European Union and other European countries with separate collection systems IntroMedic Co.,Ltd.
