Service 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 Service 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. SYSTEM OVERVIEW.................................... 3 1.1 Warnings ............................................................. 3 1.2 Symbols for Safety ............................................... 4 1.3 Function Symbols ................................................ 5 1.4 Remarks for Safe Use .......................................... 8 2. SYSTEM OVERVIEW.................................. 19 2.1 MiroCam® Overview .......................................... 19 2.2 2.3 2.4 2.
Contents 5. Storage & Transportation .................. 103 5.1 Safe Storage Conditions .................................. 103 5.2 Safety Transportion Conditions........................ 103 6. TROUBLESHOOTING .............................. 107 6.1 Introduction ..................................................... 107 6.2 Who should perform repairs............................. 107 6.3 Obtain replacement parts ................................ 107 6.4 Troubleshooting Guide....................................
Safety Information 1
Safety Information Page 2 Chapter 1
Chapter 1 Safety Information 1. SYSTEM OVERVIEW 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 IEC (The International Electrotechnical Commission) has established for medical electronic equipment to classify a connection or warning of any potential hazards.
Chapter 1 Safety Information 1.3 Function Symbols 1.3.1 Application 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 the patient data screen of the MiroCam® system. Open screen to export (save externally) selected image data for a specific patient.
Safety Information Symbol Description Show images in the quad screen. Page 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 Remarks for Safe Use Follow the safety instructions included in this Service Manual and clinical precautions advised by medical professionals. 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 use for purposes other than medical treatment. DO NOT connect the USB cable to the receiver while the receiver’s data cable and sensor pads are still connected.
Chapter 1 Safety Information 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.
Safety Information 1.4.1 Chapter 1 Environmental Condition 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.
Chapter 1 1.4.2 Safety Information Safety Precaution CAUTION - Make sure the environment is without interference from electromagnetic fields. - Make sure the environment is without noise and vibration. - DO NOT carry out the 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 capsules.
Safety Information 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 emergency treatment.) In case of any symptoms of abdominal pain, vomiting, fever, heart trouble, dizziness or seizure during or after the capsule endoscope procedure, the patient should immediately notify the physician in charge.
Chapter 1 Safety Information Always confirm that the USB is connected by checking the Receiver screen on the MiroView™ software. Always check the AC Power range before use the workstation. DO NOT touch AC Power code with wet hands. DO NOT open the receiver bag or touch receiver outside of the hospital. This device is intended for the patients over the age of 18. WARNING The Capsule takes images for 11 hours and gets naturally excreted in about 24 hours under normal conditions.
Safety Information 1.4.3 Chapter 1 Cleaning and Maintenance System and accessories All products should be cleanly maintained. For cleaning, rub 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.
System Overview 2
System Overview Page 18 Chapter 2
Chapter 2 System Overview 2. SYSTEM OVERVIEW 2.1 MiroCam® Overview MiroCam® is an orally ingested capsule endoscope designed to capture images of the small intestine lining. Captured images are viewed via the MiroCam® software for diagnosis of diseases related to the small intestine. Generally, the capsule endoscope has been developed to provide a means to view the entire small bowel, with much higher diagnostic sensitivity than other radiological techniques.
System Overview Chapter 2 Sensitivity to diagnose small bowel neoplasms can be doubled by enteroclysis, which is extremely inconvenient for the patient and must be done only in a hospital set up by an expert. The sensitivity and specificity of the diagnosis of mucosal lesion (like AVM, for example) is close to zero. Computed tomography (CT) of the abdomen is sometimes helpful in diagnosing and localizing of small bowel abnormalities, but it is unable to determine small intraluminal or mucosal lesions.
Chapter 2 System Overview document the results in a printable report. 2.3 MiroCam® Method of Action The following image displays the key components of the MiroCam capsule endoscope system. MiroView™ To enable physicians to diagnose images of a patient’s small bowel, the MiroCam method of action includes the following steps. Step 1. Image Capturing: The MiroCam capsule uses a CMOS Image sensor built in the capsule to take the pictures through the front of the optical dome.
System Overview Chapter 2 Step 2. Data transmission: The MiroCam capsule transmits the data from the capsule via E-Field Propagation. This communication method uses the human body as the medium to transmit signals from internally within the body (from the capsule) to external sensors (data cable sensor pads). Step 3.
Chapter 2 System Overview 2.4 System Configuration The MiroCam® System consists of an imaging capsule, signal receiver, and the MiroView™ software for image viewing.
System Overview 2.4.1 Chapter 2 Capsule The capsule consists of an optical dome, LED module, imaging & communication module, battery, power supply module, cage pin and cage. The capsule can operate inside a human body for more than 11 hours. This mechanical device is enclosed in a harmless plastic capsule. The dome and the capsule body are bonded with a medical grade adhesive. The surface of the plastic body is gold-plated for signal transmission.
Chapter 2 System Overview individual components. Signal input block includes 9 channel connectors and a multiplexer Analog block has an amplifier and filter for analog to digital conversion. This converts the image data transmitted by the capsule. Digital control block includes a digital image processing unit and demodulation unit. This block also saves the data.
System Overview Chapter 2 block. The signal input block is implemented with 9 signal lines and connectors while the analog block amplifies, filters and performs AD conversion. After processing the converted signals, the digital block demodulates image data and saves it. The saved data is then transferred to MiroView™ software (on a PC) via the USB transmission module. 2.4.
Chapter 2 System Overview 2.5 Product Specifications 2.5.1 Capsule Capsule consists of the optical dome, lens, led lighting module, gold-band, battery, power module, case pin and case. The capsule operates for about 11 hours in the human body. The electrical components are enclosed by a plastic cage that is safe and does not harm the human body. Dimensions Size(mm) Weight(g) 10.8(L1) x 24(L2) x 19(L3) x 5(L4) x6(L5) 3.
System Overview Description No. Chapter 2 Title 1 Main Body - 2 Optical - Dome - 3 Gold-Band - 4 Lens - 5 Cage - 6 White LED - Page 28 Function Main Device of MiroCam MC1000 This transmits light from the outside of Capsule and its transparency is over 98%. Made from COC. This transmits light source of image from the LED of inside of capsule. Gold coating that transmits the image data from the capsule to the human body.
Chapter 2 System Overview Specifications - Size : 10.8 X 24mm - Weight : 3.25g - Material : Human Compliance Plastic - Light : 6 white LED - View Angle : 150°(In image) - View Depth : 3 cm - Enlargement Ratio : 1:8 - Detectable Range : under 0.1mm - Sampling Ratio : 2.
System Overview 2.5.2 Chapter 2 Receiver Receiver consists of the data cable, signal input block, analog block, digital control block, data storage block and USB communication block. Signal input block has 9 channel connectors and a multiplexer. Analog block has an amplifier and filter for analog to digital conversion. Digital control block has a digital image processing unit and demodulation unit. All image data are saved to flash memory and transferred to image processing workstation by USB channel.
Chapter 2 System Overview Description e d f g c No. h Title ① Main Body - ② 9-Channel - Connector ③ LED Display - ④ USB Connector - ⑤ Power Switch - ⑥ Battery - Function Main Device of MiroCam MR1000. Durable connector to deliver the signal from the data cables to the receiver. Display status of Receiver. Signal display to indicate normal operation, including battery, initialization status and signal reception.
System Overview Page 32 Specifications - Operation System : Firmware - Recording Time : 12 Hours - Weight : 350g, include battery - Operation Voltage : 3.7V, 0.45A - Battery Type: Lithium Ion Battery (3.7V, 8.
Chapter 2 2.5.3 System Overview MiroView™ Image processing workstation consists of image processing software (MiroView™) and hardware workstation. MiroView™ operates on windows XP, enabling viewing and saving of image data. 2.5.4 Software Version : MiroView™ Version 1.
System Overview 2.5.5 Chapter 2 Accessories Data Cable L1 L2 Part No. Description Size(mm) MR1000-D Image data receiving 700(L1) cable 110(L3) L3 Weight(g) x 90(L2) x 155 Sensor Pads Part No.
Chapter 2 System Overview USB Cable Part No. Description Size(mm) Weight(g) MR1000-U Image data uploading 1500 50 cable Battery Charger L H W Part No. Description Size(mm) Weight(g) MR1000-C Receiver Battery 135(H) x 105(L) x 350 Charger 150(W) - Input Specification : 9Vdc, 3A - Output Specification : 4.
System Overview Chapter 2 Adaptor L H D W Part No.
Chapter 2 System Overview 2.6 Component List The components of the MiroCam® System are as follows: No.
System Overview Page 38 Chapter 2
Product Installation 3
Product Installation Page 40 Chapter 3
Chapter 3 Product Installation 3. PRODUCT INSTALLATION Installation and initial operation of the system should be performed by authorized IntroMedic service personnel. . The following component list should be rechecked prior to product installation. 3.1 Component Check List No.
Product Installation Chapter 3 3.2 Packaging Specifications 3.2.
Chapter 3 3.2.
Product Installation 3.2.
Chapter 3 Product Installation 3.3 Installation Diagram The recommended configuration of the MiroCam® Capsule Endoscope System is as follows: Note: configuration may change.
Product Installation Chapter 3 3.4 System Installation & Connection 3.4.1 Connect data cable Check the data cable’s direction. Hold green cover of data cable and insert into the receiver. 3.4.2 Connect USB cable Page 46 Hold small side of USB cable and insert into the receiver.
Chapter 3 Product Installation Hold large side of USB cable and insert into the workstation. WARNING DO NOT connect the USB cable to the receiver while the receiver’s sensor pads and data cable are still connected. WARNING Connect USB cable to receiver only after mounting it on charger. 3.4.3 Connect battery charger Battery charger connection diagram.
Product Installation Page 48 Insert dc-jack of adaptor into battery charger.
Chapter 3 Product Installation Insert power-jack of power cord into adaptor. Connect power plug of power cord into AC consent. WARNING Always check the AC Power range before connect power plug into AC consent. WARNING DO NOT touch AC power code with wet hand.
Product Installation Chapter 3 3.5 MiroView™ Installation For installation and operation of MiroView™ application software, the workstation must be prepared. Recommended workstation specifications are provided to the local IntroMedic Representative, who will install the system and software. 3.5.
Chapter 3 Product Installation Setup graphic resolution - Click mouse right button. - Click properties in command list. - In display properties window click settings tab.
Product Installation - Chapter 3 Setting screen resolution by 1280 * 1024 and color quality by Highest(32 bit). Page 52 button. - Click - Confirm monitor setting by clicking button.
Chapter 3 Product Installation Setup windows account button and select ‘Control Panel’. - Click - Select ‘User Account’.
Product Installation - Chapter 3 Select “Admin” account. NOTE If you can’t see admin account, create admin account by select “Create a new account”. - Page 54 Select ‘Create a password’.
Chapter 3 Product Installation - Enter new password miro06 and click button - Select ‘Create a new account’.
Product Installation - Enter new account name miro and click - Check account type by ‘limited’ and click button.
Chapter 3 Product Installation - Select “miro” account - Select ‘Create a password’.
Product Installation - Chapter 3 Enter new password miro06 and click button Page 58 button - Click - Select ‘Create a new account’.
Chapter 3 Product Installation - Enter new account name MiroCam and click button - Check account type by ‘Computer administrator’ and click button.
Product Installation Chapter 3 Autonomous log-on for the user - Select ‘Change the way users log on or off’ - Uncheck ‘Use the button.
Chapter 3 Product Installation - Click button and select ‘Run’.
Product Installation - Chapter 3 Uncheck ‘User must enter user name and password to use this computer’ and click - Change User name to MiroCam instead of Administrator and click - Page 62 button button. Log-off and Log-on with using ‘MiroCam’ account.
Chapter 3 Product Installation Setup wallpaper - Copy ‘IPW Installation Ver 1.0.1.x (2007.x.x)’ from the IPW installation CD to desktop. - Copy ‘Logo.jpg’ file to ‘C:\logo.jpg’ - Double click ‘logo.jpg’ file to execute Windows Fixture and Fax Viewer.
Product Installation 3.5.2 Chapter 3 Database setup Open ‘1. DB Setup (postgresql-8.2.3-1)’ folder. Double click ‘postgresql-8.2.smi’ file to execute. Check English/English and click Page 64 button.
Chapter 3 Product Installation Click button. Click button. Click button.
Product Installation Chapter 3 Change ‘Account name’ to miro and enter miro06 for ‘Account password’ and ‘Verify password’. Click button. WARNING There is a default value for the ‘Account Domain’. This should NOT be changed, although it may be different than detailed in the image above. Click button. Click button.
Chapter 3 Enter miro for ‘Superuser name’ and enter miro06 for ‘Password’ and ‘Password (again)’. Click Product Installation Check ‘PL/pgsql’ and click button. button.
Product Installation Chapter 3 Check ‘Adminpack’ and click Click Page 68 button. button.
Chapter 3 Click Product Installation button.
Product Installation 3.5.3 Chapter 3 Software installation Page 70 MiroView™ application software installation. - Open ‘Installshield’ folder and double click ‘1.
Chapter 3 Product Installation - Click button. - Check ‘No more query’ and click button.
Product Installation Page 72 - Click - Click - Click Chapter 3 button. button. button.
Chapter 3 Product Installation - Click button. - Uncheck ‘No more query’ and click - Click button, button.
Product Installation Page 74 Chapter 3 Codec Installation. - Open ‘Install shield’ folder and double click ‘2.
Chapter 3 Product Installation Registry Installation. - Open ‘Install shield’ folder and double click ‘3. RGB Table(0814)’. - Click button. - Click button.
Product Installation 3.5.4 Chapter 3 Device driver installation Connect a receiver with the PC via USB port Check ‘Yes, now and every time I connect a device’ and click button. Check ‘Install from list or specific location (Advanced)’ and click button.
Chapter 3 Product Installation Click button. Select ‘C:\USB Driver’ folder and click Click button. button.
Product Installation Click Chapter 3 button. NOTE USB driver installation process should be undergone for every USB port to to be used for uploading the receiver data. If you connect the receiver via a different USB port from the one with the installed the driver with, then the driver must be set up again.
Chapter 3 3.5.5 Product Installation Make the tables on the database button and select ‘All program Æ postgreSQL 8.2’. Click Select ‘pgAdmin III’ Double click ‘PostgreSQL Database Server 8.
Product Installation Chapter 3 Enter miro06. Select ‘postgres’ and click the right button on the mouse and run ‘Restore’ in the pop-up menu. Click button and look for ‘miro.backup’ in the installation folder on desktop.
Chapter 3 Product Installation Click button. Click button. If you see done button, the restoration is successfully complete. Click done button.
Product Installation 3.5.6 Chapter 3 Finalize Execute MiroView™ Software by double-clicking If the form for registration appears, setting up the MiroView™ is icon. successfully complete. Move this folder with pushing the left button on the mouse and dragging to the desktop.
Chapter 3 Product Installation Cut two folders; ‘IPW Installation…...’ and ‘Postgres……’. Paste to the E drive. Log off and log on whit ‘admin’ account.
Product Installation Cut two folders; ‘IPW Installation…...’ and ‘Postgres……’ from E drive. Page 84 Chapter 3 Paste to the desktop.
Chapter 3 Click Product Installation button and select ‘Run’ and type “gpedit.msc” into the form and Enter. Select ‘User Configuration Æ Administrative Template Æ Windows Components Æ Windows Explorer’ on the left side of the window and double click ‘Hide these specified drives in My Computer’.
Product Installation Chapter 3 If a form appears like below, check on ‘Enabled’ and select “Restrict A, B and C drives only” and OK. Double clicked the specified items like below and get them to “Enabled”.
Chapter 3 Product Installation - Line Enabled item list Description 2 Remove the folder Options menu item from the Tools manu 3 Remove File menu from the Windows Explorer 4 Remove “Map Network Drive” and “Disconnect Network Drive” 5 Remove search button from Windows Explorer 6 Remove Windows Explorer’s default context menu 7 Hide the Manage item on the Windows Explorer context memu 10 Hide these specified drives in My Computer 12 Remove Hardware tab 13 Remove DFS tab 14 Remove Securi
Product Installation Chapter 3 Select ‘User Configuration Æ Administrative Template Æ Start Menu and Taskbar on the left side of the window and set items to “Enabled” like below. Line Enabled item list Description 1 Remove user’s folders from the Start Menu 2 Remove links and access to Windows Update 3 Remove common program groups from Start Menu.
Chapter 3 Line Product Installation Description 9 Remove Help menu from Start menu 10 Remove Run menu from Start menu 11 Remove My Pictures icon from Start menu 12 Remove My Music icon from Start menu 13 Remove My Network Places icon from Start menu 17 Remove Drag-and-drop context menus on the Start menu 18 Prevent changes to taskbar and Start Menu Settings 19 Remove access to the context menus for the taskbar 20 Do not keep history of recently opened documents 21 Clear history of rec
Product Installation Chapter 3 Select ‘User Configuration Æ Administrative Template Æ Control Panel’ on the left side of the window and set ‘Prohibit access to the Control Panel’ to “Enabled” like below. Installation is finished.
Technical Data 4
Technical Data Page 92 Chapter 4
Chapter 4 Technical Data 4. TECHNICAL DATA 4.1 Overview Product Name: MiroCam Capsule Endoscope System Model Name: MiroCam Serial Number: Refer to the label which is attaching in the reverse side of the product. Manufacturer: IntroMedic. Co., Ltd. Manufacturer Address 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 4.2 Classification of Equipment 4.
Technical Data Chapter 4 FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE 4.2.6 According to the mode of operation : Continuous Operation with Short-Time Loading Equipment 4.3 Hardware 4.3.1 Capsule (Model: MC1000-C) Size: 10.8 X 24mm Weight: 3.25g Material: Human Compliance Plastic Light: 6 white LED View Angle: 150°(In image) View Depth: 3 cm Enlargement Ratio: 1:8 Detectable Range: under 0.1mm Sampling Ratio: 2.
Chapter 4 Technical Data Operation System: Firmware Recording Time: 12 Hours Weight: 350g, include battery Operation Voltage: 3.7V, 0.45A Battery Type: z MR1000: Lithium Ion Battery (3.7V, 8.8A) z MR2000: Lithium Ion Battery (3.7V, 10.4A) Battery Weight: 215g Operation Temperature: 0 ~ 40℃ Storage Temperature: 0 ~ 55℃ Category: Type BF Life Time: 4.62 Year 4.3.
Technical Data Display Adaptor: Geforce 7600GT 256MB Hard Disk: SATA II 160GB, SATA II 320GB ODD: DVD-RW Monitor Resolution: 1280 X 1024 Monitor Contrast: 700 : 1 Printer Resolution: 4800 X 1200 dpi Printer Paper: A4 Chapter 4 4.4 Software 4.4.1 Version MiroView Version 1.1.5 4.4.
Chapter 4 Color status Display User Friendly software feature Automated detection of GI tract bleeding Color of images are virtually natural Technical Data Page 97
Technical Data Chapter 4 4.5 Compliance / Approvals The MiroCam capsule endoscope system and accessories complies with the Medical Device Directive 93/42/EEC (CE0843).
Chapter 4 4.5.1 Technical Data FCC Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
Technical Data Page 100 Chapter 4
Storage & Transportation 5
Storage & Transportation Page 102 Chapter 5
Storage & Transportation Chapter 5 5. Storage & Transportation 5.1 Safe Storage Conditions Environmental condition for storage - Temperature : -10℃ - +70℃ - Relative humidity : 10% - 80% - Atmospheric pressure : 700hPa to 1060hPa Keep in the place that is not in contact with water Keep in the place out of direct light Keep away from hazardous materials for the human body. Keep away from children. Do not store with chemicals. For cleaning, only use gauze with water.
Storage & Transportation Page 104 Chapter 5
Troubleshooting 6
Troubleshooting Page 106 Chapter 6
Chapter 6 Troubleshooting 6. TROUBLESHOOTING 6.1 Introduction This chapter explains how to troubleshoot the MiroCam® capsule endoscope system if problems arise. Tables are supplied that list possible difficulties, probable cause, and recommended actions to correct. 6.2 Who should perform repairs Only qualified service personnel should open the MiroCam® Capsule Endoscope System housing, remove and replace components, or make adjustments. 6.
Troubleshooting Chapter 6 6.4 Troubleshooting Guide Condition The MiroCam capsule Recommended Action 1. Ensure that the MiroCam capsule endoscope endoscope system workstation main system is plugged into an workstation fails to operational AC outlet in accordance with the input power-up when the specification rated on the side panel of the I/O power switch is on. workstation main system. 2. If the condition persists, contact IntroMedic Co., Ltd. or local representative. The MiroCam capsule 1.
Troubleshooting Chapter 6 If you see following message when you use MiroView™ software, check possible cause and action before contacting IntroMedic. 1 Error Message Possible cause Action The selected drive The CD/DVD drive Exchange the does not support does not support CD/DVD drive for CD/DVD burning. CD/DVD burning. DVD multi or DVD writable drive. 2 The selected drive User selected wrong Select the DVD does not support drive. writable drive and try again. CD/DVD burning.
Troubleshooting 7 Chapter 6 An error arose while Improper export Check the drive to trying to export. destination selected. export. Check if the drive has Please try again. sufficient space. 8 An error arose while MiroView™ software trying to export. installation problem. Contact IntroMedic. Please try again. 9 There is no data to There is no data to If you did not capture export. export. any image, then this is not an error. If persists, contact IntroMedic.
Troubleshooting Chapter 6 13 Failed to create the The disk space is not Delete data (patient file. enough. files) from the List Mode. 14 Not enough storage The disk space is not Delete data (patient space. enough. files) from the List Mode.. 15 Failed to find the file. Synchronization error Contact IntroMedic between files and list 16 The file type does not File version error. Contact IntroMedic Failed to access the Reboot. match. 17 Database error DB server.
Troubleshooting 22 Chapter 6 Cannot upload The receiver is turned Turn on the receiver because receiver is off. and try again. Fill out all the required There are the fields Make sure all require fields. which you did not fields are filled. not connected. 23 enter the contents into. 24 25 26 Failed to upload data Connection error Check the connection from receiver.
Packing for shipment 7
Packing for shipment Page 114 Chapter 7
Chapter 7 Packing for shipment 7. PACKING FOR SHIPMENT To ship the MiroCam® Capsule Endoscope System for any reason, follow the instructions in this chapter. 7.1 General Introduction Pack the MiroCam capsule endoscope system carefully. Failure to follow the instructions in this chapter may result in loss or damage not covered by the IntroMedic Co., Ltd. warranty. If the original shipping box is not available, use another suitable box.
Packing for shipment Repacking MiroCam® capsule Page 116 - Insert capsule storage case into capsule box. - Close capsule box.
Packing for shipment Chapter 7 Repacking MiroCam® receiver unit - Insert receiver unit into system carry case. - Insert system carry case into receiver unit box.
Packing for shipment - Page 118 Close receiver unit box.
Packing for shipment Chapter 7 Repacking MiroCam® capsule endoscope system. - System repacking diagram.
Packing for shipment - Page 120 System repacking procedure.
Chapter 7 Packing for shipment 7.3 Repacking in Different Packing Box If the original packing box is not available: Place the MiroCam capsule endoscope system in a plastic bag. Locate a corrugated cardboard shipping box with at least 200 pounds per square inch (psi) bursting strength. Fill the bottom of the box with at least 2 inches of packing material. Place the bagged unit on the layer of packing material and fill the box completely with packing material.
Packing for shipment Page 122 Chapter 7
EMC Information 8
EMC Information Page 124 Chapter 8
EMC Information Chapter 8 8. EMC INFORMATION 8.1 Guidance and manufacturer’s electromagnetic emissions declaration - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Compliance RF Emissions Electromagnetic environment guidance The EUT uses RF energy only for its internal function.
Chapter 8 EMC Information 8.2 Guidance and manufacturer’s electromagnetic immunity declaration - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment.
EMC Information Chapter 8 8.3 Guidance and manufacturer’s electromagnetic immunity declaration - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment.
Chapter 8 EMC Information a survey, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol : NOTE 1 ) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
EMC Information Chapter 8 8.4 Recommended separation distances between portable and mobile RF communications equipment and the EUT Intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Chapter 8 EMC Information 8.5 Immunity and Compliance Level Immunity test IEC 60601 Test Actual Immunity Compliance Level Level Level 3Vrms 3Vrms 3V/m 3V/m Conducted RF 3Vrms IEC 61000-4-6 150kHz to 80MHz Radiated RF 3Vrms IEC 61000-4-3 80MHz to 2.
EMC Information Chapter 8 8.6 Guidance and manufacturer’s electromagnetic immunity declaration - The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an electromagnetic environment.
EMC Information Chapter 8 NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.
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.
