Intromedic INTROMEDIC2 Capsule Endoscope & Receiver User Manual 2

Intromedic Co., Ltd. Capsule Endoscope & Receiver 2

Contents

User Manual 2

Copyright© 2007 IntroMedic Co., Ltd. MM1100-0807 Version 1.22 Date : 2008-07-01 Service Manual
Warranty Page 3 Trademarks MiroCam®, MiroView™, IntroMedic, and the associated logos are the registered trademarks ® or trademarks ™ of IntroMedic Co., Ltd. © IntroMedic Co., Ltd. July 2007. Except as required by applicable copyright laws; any use of the IntroMedic trademarks, or any reprinting, reproduction, modification, referencing and translations of the User Manual, without the prior written approval of IntroMedic Co., Ltd. is strictly prohibited. Warranty Every effort has been made to ensure the information contained in this Service Manual is accurate, and is believed to be correct at time of printing. IntroMedic reserves the right to change any content contained with this Service Manual without prior notice. IntroMedic Co., Ltd. warrants the product against defects in material and workmanship for a period of twelve (12) months from the date of sale, unless different local regulations apply. IntroMedic Co., Ltd. will repair or replace products that are ascertained by IntroMedic to have defects during the warranty period. IntroMedic Co., Ltd. is not liable for the defects occurred by misuse, careless handling, unauthorized modifications or erroneous use, or any use that is non-compliant with instructions detailed within this Service Manual. This includes use of the product in non-appropriate locations or conditions. Any other warranties are neither represented here nor recognized by implication. To validate the warranty, please complete product registration with the local authorized IntroMedic distributor.
Warranty Page 4 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. For customer service or support please contact your point of purchase or IntroMedic Co., Ltd. Service agreements are only applicable to products of IntroMedic Co., Ltd. IntroMedic Customer Service TEL: 82-2-801-9300 FAX: 82-2-801-9330 http://www.intromedic.com E-mail: helpdesk@intromedic.com Safety Non-compliance with the user’s manual, unauthorized modifications of the product or replacement of parts, and/or opening of the product casing is prohibited and may be hazardous.
Contents Page 5 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 MiroCam System Main Components ................... 20 2.3 MiroCam® Method of Action .............................. 21 2.4 System Configuration......................................... 23 2.5 Product Specifications....................................... 27 2.6 Component List.................................................. 37 3. PRODUCT INSTALLATION ....................... 41 3.1 Component Check List ....................................... 41 3.2 Packaging Specifications................................... 42 3.3 Installation Diagram ........................................... 45 3.4 System Installation & Connection....................... 46 3.5 MiroView™ Installation....................................... 50 4. TECHNICAL DATA..................................... 93 4.1 Overview............................................................ 93 4.2 Hardware........................................................... 93 4.3 Software ............................................................ 96 4.4 Compliance / Approvals ..................................... 98
Contents Page 6 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......................................108 7. PACKING FOR SHIPMENT...................... 115 7.1 General Introduction.........................................115 7.2 Repacking in Original Packing Box ....................115 7.3 Repacking in Different Packing Box...................121 8. EMC INFORMATION................................ 125
1 Safety Information
Safety Information Chapter 1 Page 2
Chapter 1 Safety Information Page 3 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. Based on request of the buyer, IntroMedic will provide the labeling, such as ID labels, and the User & Service Manual in the national language(s) of European countries. Translated documents will be evaluated by a local language expert, and will be confirmed by a native speaker of the respective national language. Safety Symbols: The User & Service Manual incorporates various safety symbols to ensure safe and correct use of the product and to prevent any personal injury or property damage. These symbols are defined in the following table: WARNING WARNING indicates a potential hazard that, if not avoided, could result in serious personal injury or damage to the product. CAUTION CAUTION indicates a potential hazard that, if not avoided, could result in minor personal injury or damage to the product. NOTE NOTE does not indicate potential hazards as in Caution or Warning, but contains important information regarding the installation, operation or maintenance of the product.
Safety Information Chapter 1 Page 4 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. IEC 348: Notice for the user to pay special attention to the following details IEC 878-02-03: Indicates that this is classified into Type BF equipment EN 980: Denotes Date of Manufacture EN 980: Denotes Address of Manufacture IEC60601, ANNEX D: Denotes “ON” status of main power switch IEC60601, ANNEX D: Denotes “OFF” status of main power switch SN EN 980: Denotes serial number IEC 417-5031: Denotes DC (Direct Current) IEC 417-5032: Denotes AC (Alternating Current) A Denotes Ampere, the unit of current V Denotes Volt, the unit of Voltage Hz Denote Herz, the unit of Frequency IEC 417-5021: Denotes potential equalization terminal Single Use Only Use by date
Chapter 1 Safety Information Page 5 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 and open receiver control screen. Open the report screen to create a patient capsule endoscopy report. Open the patient data screen of the MiroCam® system. Open screen to export (save externally) selected image data for a specific patient. Opens screen to view MiroCam ® for a specific patient. Open screen to backup image data for a specific patient. Select and save an image being reviewed. Place a landmark in an image being reviewed. Move to the previous image. Move to the next image. Move to the previous captured image. Move to the next captured image. Play images in sequential order. Play images in reverse order. Stop playback of images. Zoom images. Show images in a single screen. Show images in the dual screen.
Safety Information Chapter 1 Page 6 Symbol Description Symbol Description Show images in the quad screen. Play all images. Play the selected images only. View images via Quick Mode function. SGIB - Play the images captured via Suspected GI Bleeding function. Show images in the Capture Box by group. Show all images in the Capture Box. When editing the captured image in the report mode, add a circle on the captured image. When editing the captured image in the report mode, add an arrow on the captured image. Erase the circle or arrow displayed in an image when a report is created. Select a color to use in an image when a report is created. Cancel the last action applied to an image when a report is created. Re-apply the cancelled changes when a report is created. Indicate that a report for the selected patient is being created. Indicate that a report for the selected patient has been created. Indicate that image data for the selected patient has been exported. Indicate that image data for the selected patient has been backed up. User logs out from MiroView™. Show the complete list of patients
Chapter 1 Safety Information Page 7 1.3.2 Receiver Function Symbols Symbol Description SIG Indicates status of signal from capsule Green: Signal is being received from capsule Yellow: Signal is not being received from capsule INI Initialization status of Receiver Unit Green: Receiver is initialized Yellow: Receiver is not initialized BAT Battery Status Green: Fully charged Yellow: Not charged
Safety Information Chapter 1 Page 8 1.4 Remarks for Safe Use n Follow the safety instructions included in this Service Manual and clinical precautions advised by medical professionals. n The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device and/or product. n IntroMedic Co., Ltd. is NOT responsible for physical harm or equipment problems caused by the user’s careless operation or mismanagement of the device and/or product. n Users MUST have read and understood the User Manual. ONLY trained and qualified medical professionals or authorized representatives of IntroMedic Co., Ltd. may operate the system. n User Manual must ALWAYS be with the equipment. This is the USER’S RESPONSIBILITY. n CAUTION: The equipment should not be exposed or come in contact with foreign substances including water, cleaning fluids, disinfecting cleanser; as such substances may harm the equipment n ONLY authorized personnel may perform repairs. Never attempt to open covers, panels or casings. n DO NOT crease, bend, fold or twist the data cables. Take care to guard them against mechanical stress (e.g. wheels or heels)! n The sensor pads, receiver, data cables, and capsules must not be exposed to mechanical shock (e.g. by dropping). Any damage caused will void the product warranty. n CAUTION: Damage/injuries to the sensor pad or data cable may cause a safety hazard. Damaged items MUST be repaired IMMEDIATELY. n DO NOT handle fluids in the vicinity of the system. n When using a cart, ensure the brake or latch guard is in use to prevent the cart from rolling. n DO NOT USE in moist or damp places.
Chapter 1 Safety Information Page 9 n DO NOT operate the equipment with wet hands. n Avoid using the equipment in extreme temperatures or humid environments. n DO NOT keep the equipment or carry out the procedure in places such as areas exposed to direct sunlight, vicinity of heaters, vicinity of chemical materials or gases, areas moist/damp or dusty, or poorly ventilated areas. n DO NOT disassemble or open the equipment without permission. This will invalidate the warranty. n DO NOT carry out the procedure in areas with high vibrations or in environments where high electro-magnetic waves are generated. n DO NOT pull out the power cord by grabbing the cable. When disconnecting the power cord, grasp the plug, and pull out. This prevents short-circuits, disconnection, or cord damage. n CAUTION: Verify that the power voltage supplied from the power receptacle matches with the voltage the system requires. Check Voltage and Frequency on the AC/DC adaptor. n CAUTION: Verify that all connection terminals are securely connected to the system. n CAUTION: Turn off the power switch on the receiver before connecting the sensor pads. n DO NOT discard cables and connectors with general waste. Discard separately as industrial or medical waste. n CAUTION: Discard the battery according to the regulations of industrial waste. DO NOT discard with general waste. n The capsule and sensor pads are medical waste, and should be disposed of according to local regulations or WEEE directive on waste disposal. n DO NOT carry out the procedure simultaneously with other procedures using medical products or equipment.
Safety Information Chapter 1 Page 10 n DO NOT use for purposes other than medical treatment. n DO NOT connect the USB cable to the receiver while the receiver’s data cable and sensor pads are still connected.
Chapter 1 Safety Information Page 11 n DO NOT charge the receiver while the receiver’s data cable and sensor pads are still connected. 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 In the medical environment condition, only use the capsule, receiver, data cable and sensor pads. n All products connected with the MiroCam® Endoscope system must be compliant with requirements of IEC60950-1 or UL certifications.
Safety Information Chapter 1 Page 12 1.4.1 Environmental Condition for Operation n Temperature : +10 ℃ - +40℃ n Relative humidity : 45% - 75% n Atmospheric pressure : 700hPa to 1060hPa WARNING DO NOT operate the equipment in the vicinity of generators, power stations, X-ray devices, and broadcasting stations where high levels of electro-magnetic waves are generated. The electro-magnetic waves can cause equipment malfunctions. CAUTION If the equipment has been brought in from a cold environment (stock room, airfreight) into a warm room, initial activation should take place after a few hours, to allow for temperature adjustment and balance and evaporation of condensed humidity. WARNING DO NOT operate the equipment in the vicinity of heat sources, strong electric or magnetic fields (close to a transformer), or near instruments generating high-frequency signals. WARNING Do not use MiroCam® alongside or together with medical devices or procedures involving electrical currents. Do not use MiroCam® with h.f. surgical equipment. It may result in burns at the site of the electrodes and possible damage to the capsule and receiver. Do not use the unit in close radius (within 1 m) of short wave or microwave therapy equipment. It may produce instability in the captured image. WARNING This device is a Class B device according to EN60601-1-2 standards. This equipment can cause radio interference in residential areas. In this case, the owner (or operator) can be held responsible to take appropriate measures or take proper measures for compensation.
Chapter 1 Safety Information Page 13 1.4.2 Safety Precaution CAUTION - Make sure the environment is without interference from electromagnetic fields. - Make sure the environment is without noise and vibration. - DO NOT carry out the procedure while using other equipments, devices or products. - The instruction for use of the sensor pads MUST be observed. - DO NOT use on patients with pacemakers or defibrillators. CAUTION DO NOT use the capsule if the package is unsealed. n DO NOT reuse capsules. n To prevent unexpected accidents like fire or explosion, do not use any product near or in the presence of inflammable or ignitable substances. n DO NOT disassemble the equipment case nor open the cover. In case service is required, please contact IntroMedic customer support or local point of sale immediately. n Only the accessories authorized and designed by IntroMedic Co., Ltd. should be used with this equipment. Faults resulting from the usage of unapproved or inappropriate accessories are not guaranteed against. n This equipment may have an effect on other products or be effected by other products. n Follow the Doctor’s instructions and abide by the guidelines in the User Manual. n DO NOT try to upload the data while the data cables are still connected to the receiver. n DO NOT charge the rechargeable battery in the receiver while the data cable and sensor pads are still connected to the receiver.
Safety Information Chapter 1 Page 14 n Stay away from high frequency radiation sites (such as high voltage, radar, installation power plants, MRI, CT or electric blankets etc.) during your capsule endoscope procedure. (It may result in serious side effects requiring emergency treatment.) n 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. n Always check the connection between the receiver and the data cable. n Always check that the battery in the receiver is fully charged before use. n DO NOT use the capsule if the package is unsealed. n After ingesting the capsule, ask patient to check whether the capsule has been excreted. n Prior to undergoing the capsule endoscopy procedure, patients with diabetes must be informed via a medical professional regarding appropriate medication & dosage. n For more accurate data and better analysis, follow the Patient Preparation as recommended in the User’s Manual. n Tell Patient not to bite the capsule before ingesting. n Patient should avoid excessive physical activity during the capsule endoscope procedure. n When undergoing the capsule endoscope procedure, DO NOT make physical contact with another person undergoing the same procedure. n During operation of the receiver, DO NOT touch the receiver, or get the receiver wet. n Only use the provided batteries, and never remove the battery from the receiver during the procedure. n During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB. This may damage the patient’s data.
Chapter 1 Safety Information Page 15 n Always confirm that the USB is connected by checking the Receiver screen on the MiroView™ software. n Always check the AC Power range before use the workstation. n DO NOT touch AC Power code with wet hands. n DO NOT open the receiver bag or touch receiver outside of the hospital. n This device is intended for 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. If the capsule has not been excreted from the patient within 72 hours, patient should contact the physician. After examining, the physician may need to perform a surgical operation or treatment to remove the capsule. WARNING Before moving the system, always make sure to disconnect the monitor from the main system, and then safely move the main system and monitor separately. Connect the main system and monitor only after the hardware is fully installed, secure and stable.
Safety Information Chapter 1 Page 16 1.4.3 Cleaning and Maintenance n 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. DO NOT use heat or gas for disinfection of the capsule. n Service Document If required, or upon request, the local IntroMedic Distributor (authorized IntroMedic Representative) may provide block diagrams, lists of spare parts, descriptions, adjustment instructions or other related information which may help qualified technical personnel in repairing specified parts of the equipment which have been defined repairable by IntroMedic Co., Ltd. . n Moving the Equipment - CAUTION when moving equipment. - WARNING: Excessive impact/shock causes internal damage. - If wiring is connected/disconnected when moving, check the wiring status after moving. - If damage to the equipment is discovered after moving, immediately contact IntroMedic or local Distributor.
2 System Overview
System Overview Chapter 2 Page 18
Chapter 2 System Overview Page 19 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. Further, the capsule endoscope avoids a great deal of discomfort associated with traditional endoscopy, while allowing the patient to maintain a normal schedule. Additional methods for screening of the small bowel primarily include barium x-rays and enteroscopy, but the diagnostic value of these tests for a wide variety of specific lesions is low. Following is further description of the methods. Enteroscopy is a method to perform direct visual inspection of the small bowel mucosa beyond the reach of standard upper endoscopes. The procedure can be accomplished of the small by examination with either push or sonde type endoscopes, or operative enteroscopy. Enteroscopy of the small intestine is difficult, requires a lengthy examination time, can only partially visualize the small intestine, is extremely uncomfortable, and is not performed on a widespread basis. Barium X-rays of the small bowel are currently the primary radiographic means of diagnosing a small bowel neoplasm, and the best way to locate small bowel lesions. However, the procedure has limited sensitivity.
System Overview Chapter 2 Page 20 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. It is widely accepted that the aforementioned methods for diagnosing small bowel diseases and disorders are limited. Capsule Endoscopy is a great advancement, providing a much more thorough diagnostic method. IntroMedic’s MiroCam Capsule Endoscope System is designed to aid the gastroenterologist in visualizing and diagnosing disease of the small bowel in an efficient, cost effective, and comfortable manner. . 2.2 MiroCam System Main Components — Capsule:The MiroCam Capsule moves slowly through the small intestine tract, capturing images of the entire small intestine at 3 frames/sec. — Receiver:The MiroCam Receiver provides 9 receiving channels through which signals can be received. The pair of channels which have the best signal characteristics are selected and used for the receipt of the of image signals. The receive also connects to MiroView™ software to upload images taken of the patient’s GI tract. — MiroView™ Software: MiroView™ enables the gastorenterologist to perform a diagnostic reiview of the patient’s small bowel, and
Chapter 2 System Overview Page 21 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. 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. The LED light flashes each time the picture is taken to brighten the dark digestive organ. The capsule captures 3 pictures per second and sends the images to the receiver immediately. For transmission, the images taken from the capsule are transformed to data that is possible to transmit to the receiver through the human body. MiroView™
System Overview Chapter 2 Page 22 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. Data Reception and Storage: To retrieve the signal emitted from the capsule, the MiroCam system needs to attach reception poles (sensors attached to data cables) on the exterior of the human body to retrieve the signal. The signal is then changed into a data format that is feasible for image processing, and stored onto the memory of the receiver. Step 4. Data Upload: The image data is uploaded from the receiver to the MiroView software (software on a PC workstation) via a standard USB data cable. This data is uploaded after the patient has completed the procedure (i.e. sensor pads / data cables are not attached to patient). Step 5. Image Restoration & Display: After all stored image data in the receiver has been transferred to the image processing software (MiroView™), the software changes the transferred image data by using an image reconstruction algorithm to a RGB signal. The reconstructed image data is saved along with patient information, and viewed by the physician to diagnose diseases of the small bowel. MiroView™ can recall the saved data anytime, as the user desires to perform a diagnostic review of the patient images.
Chapter 2 System Overview Page 23 2.4 System Configuration The MiroCam® System consists of an imaging capsule, signal receiver, and the MiroView™ software for image viewing. The overall system configuration is as follows: Image SensorData Transmiter Data RecoverData StorageSystem Interface Data CommunicationImage ProcessingImage DisplayCapsule Receiver SoftwareMiroCam System Block Diagram
System Overview Chapter 2 Page 24 2.4.1 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. <Capsule Structure> CMOS Image Sensor Specifications · Image size : 320 * 320 pixel · Operation voltage : 3V · Operation Frequency :12MHz · Image Frame : 3 Frame / sec 2.4.2 Receiver The MiroCam® Receiver consists of the data cable, signal input block, analog block, digital control block, data storage block and USB communication block. Following is some more information about the Power supply LED module Lenz module Dome PCB sensor Battery
Chapter 2 System Overview Page 25 individual components. u Signal input block includes 9 channel connectors and a multiplexer u Analog block has an amplifier and filter for analog to digital conversion. This converts the image data transmitted by the capsule. u Digital control block includes a digital image processing unit and demodulation unit. This block also saves the data. u All image data is saved to flash memory and transferred to image processing workstation by USB channel u The receiver is divided into a restoration part that restores the actual data, and a transmitter part that transmits the image data to MiroView™. More specifically, the receiver can be divided into the receiving block, signal input block, analog block, digital block, storage block and USB transmission block. 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. Receiver Power Source: The MiroCam receiver operates via a battery, completely independent of any other power sources. The receiver of the MiroCam® capsule endoscope system includes amplifier and filter components, which convert the image data transmitted by the capsule. The receiver is divided into a restoration part that restores the actual data, and a transmitter part that transmits the image data to MiroView™. More specifically, the receiver can be divided into the receiving block, signal input block, analog block, digital block, storage block and USB transmission
System Overview Chapter 2 Page 26 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. 2.4.3 MiroView™ (Software) MiroView™, the application software for the MiroCam® capsule endoscope system, consists of an image-processing module that restores the received image data to actual images, and an output module for image output. The recorded images can be viewed via a conventional PC or Notebook using IntroMedic’s proprietary software. MiroView™ is compatible with Windows operating systems. Selected images can be edited and saved in a CD or DVD. The software includes a number of features and functions to assist in the efficiency and sensitivity of the diagnosis.
Chapter 2 System Overview Page 27 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. n Dimensions Size(mm) Weight(g) 10.8(L1) x 24(L2) x 19(L3) x 5(L4) x6(L5) 3.25
System Overview Chapter 2 Page 28 n Description No. Title Function 1 Main Body - Main Device of MiroCam MC1000 2 Optical Dome - 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. 3 Gold-Band - Gold coating that transmits the image data from the capsule to the human body. 4 Lens - The lens concentrates the light emitted by the LEDs, and focuses the image for the CMOS image sensor. 5 Cage - Protects the interior capsule components. - Prevents entry of foreign materials into capsule. - Cage is composed of an FDA certified safe material, harmless to the human body. 6 White LED - LED illuminates the dark spaces inside the human body GI tract. - The illumination enables images to be captured.
Chapter 2 System Overview Page 29 n 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 : 2.9 fps - Operating time : 11 hours - Mechanical Safety : Compatible ISO60601-1-1 - Biocompatibility Safety : Compatible ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11 - Chemical Safety : Safe in pH=2 ~ pH=8 - Battery Type : Silver Oxide Cell - Operation Temperature : 20 ~ 40℃ - Storage Temperature : 0 ~ 50℃
System Overview Chapter 2 Page 30 2.5.2 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. n Dimensions Size(mm) Weight(g) 140(H) x 85(W) x 40(L) 350 HWL
Chapter 2 System Overview Page 31 n Description No. Title Function ① Main Body - Main Device of MiroCam MR1000. ② 9-Channel Connector - Durable connector to deliver the signal from the data cables to the receiver. ③ LED Display - Display status of Receiver. - Signal display to indicate normal operation, including battery, initialization status and signal reception. ④ USB Connector - USB Communication connector for image data transmission to Image processing workstation. ⑤ Power Switch - Turn Main power of Receiver on or off. ⑥ Battery - Rechargeable battery for MiroCam Receiver unit. - Output voltage : 3.7Vdc - Output Current : 8.8A ‚ƒ„…†
System Overview Chapter 2 Page 32 n 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, 8.8A) - Battery Weight : 215g - Operation Temperature : 0 ~ 40℃ - Storage Temperature : 0 ~ 55℃ - Category : Type BF
Chapter 2 System Overview Page 33 2.5.3 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. n Software Version : MiroView™ Version 1.00 n Operating System : Windows XP Professional n Language : English n Data Export : JPEG Image, AVI Video Clip, PDF Data Report n Data Display : Single or Multi Image, Time Bar, Diagnosis Data n Event Marker : Small Image and comments n Display Ratio : 5 ~ 30 fps n Display Mode : Single View, Dual View, Quad View n Running Mode : Normal View, Quick View, Blood View 2.5.4 Recommended Workstation Specifications n Operating System : Windows XP Professional n CPU : Core 2 Duo E6300(1.86GHz/2M) n Memory : DDR II 1GByte(667MHz) n Display Adaptor : Geforce 7600GT 256MB n Hard Disk : SATA II 160GB, SATA II 320GB n ODD : DVD-RW n Monitor Resolution : 1280 X 1024 n Monitor Contrast : 700 : 1 n Printer Resolution : 4800 X 1200 dpi n Printer Paper : A4
System Overview Chapter 2 Page 34 2.5.5 Accessories n Data Cable n Sensor Pads Part No. Description Size(mm) Weight(g) MR1000-D Image data receiving cable 700(L1) x 90(L2) x 110(L3) 155 Part No. Description Size(mm) Weight(g) MR1000-S Image data receiving sensors 60 5 L1 L2 L3
Chapter 2 System Overview Page 35 n USB Cable n Battery Charger - Input Specification : 9Vdc, 3A - Output Specification : 4.2Vdc, 4A Part No. Description Size(mm) Weight(g) MR1000-U Image data uploading cable 1500 50 Part No. Description Size(mm) Weight(g) MR1000-C Receiver Battery Charger 135(H) x 105(L) x 150(W) 350 W L H
System Overview Chapter 2 Page 36 n Adaptor - Input Specification : 110~220Vac, 50~60/Hz - Output Specification : 9Vdc, 3A - Compliance with requirements of IEC601-1 Part No. Description Size(mm) Weight(g) MR1000-T Receiver Battery Charging Adaptor 95(W) x 55(L) x 30(H) x 750(D) 240 W H L D
Chapter 2 System Overview Page 37 2.6 Component List The components of the MiroCam® System are as follows: No. Product Name Model Name Q’ty Description Note 1 Capsule Endoscope MC1000 1 ea Capsule for imaging 2 Receiver MR1000-R 1 ea Receiver for data storage 3 Battery Pack MR1000-B 2 ea Batteries for receiver 4 Receiver Bag MR1000-G 1 ea Portable receiver bag 5 Data Cable MR1000-D 1 ea Data cable 6 Battery Charger MR1000-C 1 ea Battery Charger 7 Adapter MR1000-T 1 ea Adaptor for charging 8 USB Cable MW1000-U 1 ea Communication cable for workstation 9 Measuring Tape MR1000-M 1 ea 10 Sensor Pad MR1000-S 1 pk Signal-receiving pad 11 Software MW1000-SV1.0 1 ea Software for image diagnosis 12 User Manual MM1000 1 ea Instruction for use 13 Service Manual MM1100 1 ea Instruction for service <Table 1> List of Component
System Overview Chapter 2 Page 38
3 Product Installation
Product Installation Chapter 3 Page 40
Chapter 3 Product Installation Page 41 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 Name Model Name Q’ty Description Note 1 Capsule Endoscope MC1000 1 ea Capsule for imaging 2 Receiver MR1000-R 1 ea Receiver for data storage 3 Battery Pack MR1000-B 2 ea Batteries for receiver 4 Receiver Bag MR1000-G 1 ea Portable receiver bag 5 Data Cable MR1000-D 1 ea Data cable 6 Battery Charger MR1000-C 1 ea Battery Charger 7 Adapter MR1000-T 1 ea Adaptor for charging 8 USB Cable MW1000-U 1 ea Communication cable for workstation 9 Measuring Tape MR1000-M 1 ea 10 Sensor Pad MR1000-S 1 pk Signal-receiving pad 11 Software MW1000-SV1.0 1 ea Software for image diagnosis 12 User Manual MM1000 1 ea Instruction for use 13 Service Manual MM1100 1 ea Instruction for service
Product Installation Chapter 3 Page 42 3.2 Packaging Specifications 3.2.1 Capsule Endoscope Receiver set Box : 485 X 120 X 400 mm
Chapter 3 Product Installation Page 43 3.2.2 Capsule Endoscope Box : 210 X 206 X 95 mm
Product Installation Chapter 3 Page 44 3.2.3 Accessory Box : 352 X 396 X 78 mm
Chapter 3 Product Installation Page 45 3.3 Installation Diagram The recommended configuration of the MiroCam® Capsule Endoscope System is as follows: Note: configuration may change. Monitor Charger Charger Arm Printer Product Keyboard Mouse Table
Product Installation Chapter 3 Page 46 3.4 System Installation & Connection 3.4.1 Connect data cable n Check the data cable’s direction. n Hold green cover of data cable and insert into the receiver. 3.4.2 Connect USB cable n Hold small side of USB cable and insert into the receiver.
Chapter 3 Product Installation Page 47 n 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 n Battery charger connection diagram.
Product Installation Chapter 3 Page 48 n Insert dc-jack of adaptor into battery charger.
Chapter 3 Product Installation Page 49 n Insert power-jack of power cord into adaptor. n 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 Page 50 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. 3.5.1 Preparation(Prior to Installing MiroView Software) n Setup hard disk drive - This process should be done by the hardware vendor - HDD must have three partitions : C, D and E drive - C drive should have larger space than 150GB for database - D drive should have larger space than 50GB for MiroView™ - E drive should have larger space than 250GB for patient data.
Chapter 3 Product Installation Page 51 n Setup graphic resolution - Click mouse right button. - Click properties in command list. - In display properties window click settings tab.
Product Installation Chapter 3 Page 52 - Setting screen resolution by 1280 * 1024 and color quality by Highest(32 bit). - Click button. - Confirm monitor setting by clicking button.
Chapter 3 Product Installation Page 53 n Setup windows account - Click button and select ‘Control Panel’. - Select ‘User Account’.
Product Installation Chapter 3 Page 54 - Select “Admin” account. NOTE If you can’t see admin account, create admin account by select “Create a new account”. - Select ‘Create a password’.
Chapter 3 Product Installation Page 55 - Enter new password miro06 and click button - Select ‘Create a new account’.
Product Installation Chapter 3 Page 56 - Enter new account name miro and click button - Check account type by ‘limited’ and click button.
Chapter 3 Product Installation Page 57 - Select “miro” account - Select ‘Create a password’.
Product Installation Chapter 3 Page 58 - Enter new password miro06 and click button - Click button - Select ‘Create a new account’.
Chapter 3 Product Installation Page 59 - Enter new account name MiroCam and click button - Check account type by ‘Computer administrator’ and click button.
Product Installation Chapter 3 Page 60 n Autonomous log-on for the user - Select ‘Change the way users log on or off’ - Uncheck ‘Use the Welcome screen’ and click button.
Chapter 3 Product Installation Page 61 - Click button and select ‘Run’. - Enter control userpasswords2 and click button
Product Installation Chapter 3 Page 62 - Uncheck ‘User must enter user name and password to use this computer’ and click button - Change User name to MiroCam instead of Administrator and click button. - Log-off and Log-on with using ‘MiroCam’ account.
Chapter 3 Product Installation Page 63 n 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’ <Copy> <Paste> - Double click ‘logo.jpg’ file to execute Windows Fixture and Fax Viewer. - Move the mouse pointer to center of the picture and click the right button on the mouse and click ‘Set as Desktop Background’
Product Installation Chapter 3 Page 64 3.5.2 Database setup n Open ‘1. DB Setup (postgresql-8.2.3-1)’ folder. n Double click ‘postgresql-8.2.smi’ file to execute. n Check English/English and click button.
Chapter 3 Product Installation Page 65 n Click button. n Click button. n Click button.
Product Installation Chapter 3 Page 66 n 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. n Click button. n Click button.
Chapter 3 Product Installation Page 67 n Enter miro for ‘Superuser name’ and enter miro06 for ‘Password’ and ‘Password (again)’. Click button. n Check ‘PL/pgsql’ and click button.
Product Installation Chapter 3 Page 68 n Check ‘Adminpack’ and click button. n Click button.
Chapter 3 Product Installation Page 69 n Click button.
Product Installation Chapter 3 Page 70 3.5.3 Software installation n MiroView™ application software installation. - Open ‘Installshield’ folder and double click ‘1. MiroViewSetup’ - Click button
Chapter 3 Product Installation Page 71 - Click button. - Check ‘No more query’ and click button.
Product Installation Chapter 3 Page 72 - Click button. - Click button. - Click button.
Chapter 3 Product Installation Page 73 - Click button. - Uncheck ‘No more query’ and click button, - Click button.
Product Installation Chapter 3 Page 74 n Codec Installation. - Open ‘Install shield’ folder and double click ‘2. Codec Install’ - If this window appear, click button - Click button
Chapter 3 Product Installation Page 75 n Registry Installation. - Open ‘Install shield’ folder and double click ‘3. RGB Table(0814)’. - Click button. - Click button.
Product Installation Chapter 3 Page 76 3.5.4 Device driver installation n Connect a receiver with the PC via USB port n Check ‘Yes, now and every time I connect a device’ and click button. n Check ‘Install from list or specific location (Advanced)’ and click button.
Chapter 3 Product Installation Page 77 n Click button. n Select ‘C:\USB Driver’ folder and click button. n Click button.
Product Installation Chapter 3 Page 78 n Click 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 Product Installation Page 79 3.5.5 Make the tables on the database n Click button and select ‘All program à postgreSQL 8.2’. n Select ‘pgAdmin III’ n Double click ‘PostgreSQL Database Server 8.2 (Localhost : 5432)’
Product Installation Chapter 3 Page 80 n Enter miro06. n Select ‘postgres’ and click the right button on the mouse and run ‘Restore’ in the pop-up menu. n Click button and look for ‘miro.backup’ in the installation folder on desktop.
Chapter 3 Product Installation Page 81 n Click button. n Click button. n If you see done button, the restoration is successfully complete. Click done button.
Product Installation Chapter 3 Page 82 3.5.6 Finalize n Execute MiroView™ Software by double-clicking icon. n If the form for registration appears, setting up the MiroView™ is successfully complete. n Move this folder with pushing the left button on the mouse and dragging to the desktop.
Chapter 3 Product Installation Page 83 n Cut two folders; ‘IPW Installation…...’ and ‘Postgres……’. n Paste to the E drive. n Log off and log on whit ‘admin’ account.
Product Installation Chapter 3 Page 84 n Cut two folders; ‘IPW Installation…...’ and ‘Postgres……’ from E drive. n Paste to the desktop.
Chapter 3 Product Installation Page 85 n Click button and select ‘Run’ and type “gpedit.msc” into the form and Enter. n Select ‘User Configuration à Administrative Template à Windows Components à Windows Explorer’ on the left side of the window and double click ‘Hide these specified drives in My Computer’.
Product Installation Chapter 3 Page 86 n If a form appears like below, check on ‘Enabled’ and select “Restrict A, B and C drives only” and OK. n Double clicked the specified items like below and get them to “Enabled”.
Chapter 3 Product Installation Page 87 - Enabled item list Line 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 Security tab 17 No “Computer Near Me” in my Network Places 18 No “Entire Network” in My Network Places 23 Do not move deleted files to the Recycled bin 26 Remove Shared Documents from My Computer
Product Installation Chapter 3 Page 88 n Select ‘User Configuration à Administrative Template à Start Menu and Taskbar on the left side of the window and set items to “Enabled” like below. - Enabled item list Line 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. 4 Remove My Document icon from Start Menu 5 Remove programs on Setting menu 6 Remove Network Connections from start menu 7 Remove Favorites menu from Start menu 8 Remove Search menu from Start menu
Chapter 3 Product Installation Page 89 Line 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 recently opened documents on exit 22 Turn off personalized menus 28 Prevent grouping of taskbar items 30 Lock the Taskbar 34 Remove frequent programs list from the Start menu 36 Remove the “Unlock PC” button from the Start menu 37 Remove user name from Start menu
Product Installation Chapter 3 Page 90 n Select ‘User Configuration à Administrative Template à Control Panel’ on the left side of the window and set ‘Prohibit access to the Control Panel’ to “Enabled” like below. n Installation is finished.
4 Technical Data
Technical Data Chapter 4 Page 92
Chapter 4 Technical Data Page 93 4. TECHNICAL DATA 4.1 Overview n Product Name: MiroCam Capsule Endoscope System n Model Name: MiroCam n Serial Number: Refer to the label which is attaching in the reverse side of the product. n Manufacturer: IntroMedic. Co., Ltd. n 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 4.2.1 According to the type of protection against electric shock : Internally Powered Equipment 4.2.2 According to the degree of protection against electric shock : Type BF Applied Part 4.2.3 According to the degree of protection against ingress of water : IPX0 4.2.4 According to the method of sterilization or disinfection : Equipment not usable sterilization & disinfection 4.2.5 According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE : Equipment not suitable for use in the presence of a
Technical Data Chapter 4 Page 94 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) n Size: 10.8 X 24mm n Weight: 3.25g n Material: Human Compliance Plastic n Light: 6 white LED n View Angle: 150°(In image) n View Depth: 3 cm n Enlargement Ratio: 1:8 n Detectable Range: under 0.1mm n Sampling Ratio: 2.9 fps n Working time: 11 hours n Mechanical Safety: Compatible ISO60601-1-1 n Biocompatibility Safety: Compatible ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11 n Chemical Safety: Safe in pH=2 ~ pH=8 n Battery Type: Silver Oxide Cell n Operation Temperature: 20 ~ 40℃ n Storage Temperature: 0 ~ 50℃ n Recommended Maximum Storage Time: 1 Year 4.3.2 Receiver(Model: MR1000-R, MR2000-R)
Chapter 4 Technical Data Page 95 n Operation System: Firmware n Recording Time: 12 Hours n Weight: 350g, include battery n Operation Voltage: 3.7V, 0.45A n Battery Type: l MR1000: Lithium Ion Battery (3.7V, 8.8A) l MR2000: Lithium Ion Battery (3.7V, 10.4A) n Battery Weight: 215g n Operation Temperature: 0 ~ 40℃ n Storage Temperature: 0 ~ 55℃ n Category: Type BF n Life Time: 4.62 Year 4.3.3 Battery Charger(MR1000-C) n Input Voltage: 9VDC n Input Current: 3A n Output Voltage: 4.2VDC n Output Current: 4A n Operation Display: LED Display n Adaptor Manufacturer: BridgePower Corporation(JEC Korea) n Adaptor Model: JMW128XA0902F02 4.3.4 Recommended Image Workstation n Operating System: Windows XP Professional n CPU: Core 2 Duo E6300(1.86GHz/2M) n Memory: DDR II 1GByte(667MHz)
Technical Data Chapter 4 Page 96 n Display Adaptor: Geforce 7600GT 256MB n Hard Disk: SATA II 160GB, SATA II 320GB n ODD: DVD-RW n Monitor Resolution: 1280 X 1024 n Monitor Contrast: 700 : 1 n Printer Resolution: 4800 X 1200 dpi n Printer Paper: A4 4.4 Software 4.4.1 Version n MiroView Version 1.1.5 4.4.2 Specification n Monitor Contrast: 700 : 1 n Language: English n Data Export: JPEG Image, AVI Video Clip, PDF Data Report n Data Display: Single or Multi Image, Time Bar, Diagnosis Data n Event Marker: Small Image with Explanation n Display Ratio: 5 ~ 30 fps n Display Mode: Single View, Dual View, Quad View n Running Mode: Normal View, Quick View, Blood View n Error Ratio: Under 100 image continuously 4.4.3 Feature n Language: English
Chapter 4 Technical Data Page 97 n Color status Display n User Friendly software feature n Automated detection of GI tract bleeding n Color of images are virtually natural
Technical Data Chapter 4 Page 98 4.5 Compliance / Approvals The MiroCam capsule endoscope system and accessories complies with the Medical Device Directive 93/42/EEC (CE0843). In addition, the product complies with IEC 60601-1:1988 + A1:1991 + A2:1995 (EN 60601-1:1990 + A1:1992 + A2:1995) Medical Electrical Equipment, Part 1 : General requirement for safety EN 60601-1-1:2001 Medical Electrical Equipment, Part 1 : General requirement for safety Collateral Standard : Medical Electrical System EN 60601-1-2:2001 Medical Electrical Equipment, Part 1 : General requirement for safety Collateral Standard : Electromagnetic compatibility EN 60601-1-4:1998 Medical Electrical Equipment, Part 1 : General requirement for safety Collateral Standard : Programmable Electrical Medical System EN60601-2-18:1996 Medical Electrical Equipment, Part 2 : Particular requirement for the safety of endoscope equipment EN 10993-1:2003 Biological evaluation of medical devices, Part 1: Evaluation and Testing Third Edition
Chapter 4 Technical Data Page 99 4.5.1 FCC Statement n 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. n CAUTION: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. n NOTE: This equipment has been tested and found to comply with the limit for a Cass B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving antenna. - Increase the separation between the equipment and receiver. - Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Technical Data Chapter 4 Page 100
5 Storage & Transportation
Storage & Transportation Chapter 5 Page 102
Chapter 5 Storage & Transportation Page 103 5. Storage & Transportation 5.1 Safe Storage Conditions n Environmental condition for storage - Temperature : -10℃ - +70℃ - Relative humidity : 10% - 80% - Atmospheric pressure : 700hPa to 1060hPa n Keep in the place that is not in contact with water n Keep in the place out of direct light n Keep away from hazardous materials for the human body. n Keep away from children. n Do not store with chemicals. n For cleaning, only use gauze with water. Other liquid like alcohol should not be used. n Use the provided battery charger for charging. n If product is not used for an extensive period of time, please separate the battery from the receiver unit. 5.2 Safety Transportion Conditions - Temperature : -10℃ - +70℃ - Relative humidity : 10% - 80% - Atmospheric pressure : 700hPa to 1060hPa - Product MUST be handled with care, and not dropped.
Storage & Transportation Chapter 5 Page 104
6 Troubleshooting
Troubleshooting Chapter 6 Page 106
Chapter 6 Troubleshooting Page 107 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. 6.3 Obtain replacement parts IntroMedic Technical Service provides technical assistance information and replacement parts. To obtain replacement parts, contact IntroMedic Co., Ltd. or your local representative. Refer to part names and part numbers listed on Chapter 2.6, Component List.
Troubleshooting Chapter 6 Page 108 6.4 Troubleshooting Guide Condition Recommended Action The MiroCam capsule endoscope system workstation fails to power-up when the I/O power switch is on. 1. Ensure that the MiroCam capsule endoscope workstation main system is plugged into an operational AC outlet in accordance with the input specification rated on the side panel of the workstation main system. 2. If the condition persists, contact IntroMedic Co., Ltd. or local representative. The MiroCam capsule endoscope system receiver unit fails to power-up when the I/O power switch is on. 1. Recharge battery of receiver unit. 2. Replace battery of receiver unit. 3. If the condition persists, contact IntroMedic Co., Ltd or local representative. Capsule is not blinking when taken out of the case. 1. DO NOT use the capsule. Use an alternate capsule. 2. Contact IntroMedic Co., Ltd. for replacement of capsule. INI LED on receiver unit is yellow, and does not turn green when held appropriately by patient. 1. Initialize receiver unit via MiroView™ software. 2. If the condition persists, contact IntroMedic Co., Ltd. BAT LED, on receiver unit is yellow. 1. Recharge battery of receiver unit. 2. Replace battery of receiver unit. 3. If the condition persists, contact IntroMedic Co., Ltd.
Chapter 6 Troubleshooting Page 109 If you see following message when you use MiroView™ software, check possible cause and action before contacting IntroMedic. Error Message Possible cause Action 1 The selected drive does not support CD/DVD burning. The CD/DVD drive does not support CD/DVD burning. Exchange the CD/DVD drive for DVD multi or DVD writable drive. 2 The selected drive does not support CD/DVD burning. User selected wrong drive. Select the DVD writable drive and try again. 3 BACKUP or EXPORT is not yet complete. Wait for process to finish and try again. The user executed BACKUP or EXPORT function while the burning process is operating. Wait until the process has stopped and try again. 4 The selected capture cannot be added. MiroView™ software installation problem. Contact to IntroMedic. 5 The selected landmark cannot be added. MiroView™ software installation problem. Contact to IntroMedic. 6 Failed to save. MiroView™ software installation problem. Contact to IntroMedic.
Troubleshooting Chapter 6 Page 110 7 An error arose while trying to export. Please try again. Improper export destination selected. Check the drive to export. Check if the drive has sufficient space. 8 An error arose while trying to export. Please try again. MiroView™ software installation problem. Contact IntroMedic. 9 There is no data to export. There is no data to export. If you did not capture any image, then this is not an error. If persists, contact IntroMedic. 10 Failed to make a video file because Microsoft MPEG4-V2 codec does not exist. MiroView™ software Installation problem Contact IntroMedic 11 Not enough memory. The system resources are not sufficient to support MiroView™ Reboot. 12 The file buffer size is over the limit. The system resources are not sufficient to support MiroView™. Reboot.
Chapter 6 Troubleshooting Page 111 13 Failed to create the file. The disk space is not enough. Delete data (patient files) from the List Mode. 14 Not enough storage space. The disk space is not enough. Delete data (patient files) from the List Mode.. 15 Failed to find the file. Synchronization error between files and list Contact IntroMedic 16 The file type does not match. File version error. Contact IntroMedic 17 Database error Failed to access the DB server. Reboot. 18 The printer driver is not installed. A printer driver (MM PDF Maker) is not installed. Contact IntroMedic 19 The PDF converting module is not installed. Cannot create the report PDF file because PDF converting module is not installed. Contact IntroMedic 20 Receiver is disconnected while uploading Cannot continue to upload because receiver has become disconnected. Check the connection between the receiver and the PC. 21 Cannot upload because receiver is not connected. Improper connection between the receiver and the PC Check the connection between the receiver and the PC
Troubleshooting Chapter 6 Page 112 22 Cannot upload because receiver is not connected. The receiver is turned off. Turn on the receiver and try again. 23 Fill out all the required fields. There are the fields which you did not enter the contents into. Make sure all require fields are filled. 24 Failed to upload data from receiver. Connection error between the receiver and the PC Check the connection between the receiver and the PC 25 Failed to complete restoration. MiroView™ software installation problem. Contact to IntroMedic 26 Failed to complete restoration due to some missing files. Backup error Back up the data and restore again 27 Please insert disk number ##. The user inserted wrong disk while restoring the data Insert disk with number ##. 28 Wrong disk. Please insert a disk of the same original file. The user inserted wrong disk while restoring the data Insert the disk of the same original file. 29 The backup disk info is incorrect. Backup error Back up the data and restore again Warnning If the problem arises again, contact to IntroMedic Service center.
7 Packing for shipment
Packing for shipment Chapter 7 Page 114
Chapter 7 Packing for shipment Page 115 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. Return the product with a detailed, written description of the problem. 7.2 Repacking in Original Packing Box If available, use the original packing box and packing materials as illustrated figures in below.
Packing for shipment Chapter 7 Page 116 n Repacking MiroCam® capsule - Insert capsule storage case into capsule box. - Close capsule box.
Chapter 7 Packing for shipment Page 117 n Repacking MiroCam® receiver unit - Insert receiver unit into system carry case. - Insert system carry case into receiver unit box.
Packing for shipment Chapter 7 Page 118 - Close receiver unit box.
Chapter 7 Packing for shipment Page 119 n Repacking MiroCam® capsule endoscope system. - System repacking diagram. Upper Case shield Capsule box Middle case shield Receiver unit box Lower case shield System box
Packing for shipment Chapter 7 Page 120 - System repacking procedure.
Chapter 7 Packing for shipment Page 121 7.3 Repacking in Different Packing Box If the original packing box is not available: n Place the MiroCam capsule endoscope system in a plastic bag. n Locate a corrugated cardboard shipping box with at least 200 pounds per square inch (psi) bursting strength. n Fill the bottom of the box with at least 2 inches of packing material. n Place the bagged unit on the layer of packing material and fill the box completely with packing material. n Seal the packaging box with packing tape. n Label packing box with shipping address, return address, and the written description.
Packing for shipment Chapter 7 Page 122
8 EMC Information
EMC Information Chapter 8 Page 124
Chapter 8 EMC Information Page 125 8. EMC INFORMATION 8.1 Guidance and manufacturer’s declaration - electromagnetic emissions 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 Electromagnetic environment -guidance RF Emissions CISPR 11 Group 1 The EUT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The EUT is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ Flicker emissions IEC 61000-3-3 Complies
EMC Information Chapter 8 Page 126 8.2 Guidance and manufacturer’s declaration - electromagnetic immunity 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 IEC 60601 Test level Compliance level Electromagnetic environment -guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV Contact ±8kV air ±6kV Contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC 61000-4-4 ±2kV for power supply lines ± 1kV for input/output lines ±2kV for power supply lines ± 1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1kV differential mode ±2kV common mode ±1kV differential mode ±2kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% Uт (>95% dip in Uт) for 0.5cycle 40% Uт (60% dip in Uт ) for 5 cycle 70% Uт (30% dip in Uт) for 25 cycle <5% Uт (<95% dip in Uт ) for 5 s <5% Uт (>95% dip in Uт) for 0.5cycle 40% Uт (60% dip in Uт ) for 5 cycle 70% Uт (30% dip in Uт) for 25 cycle <5% Uт (<95% dip in Uт ) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the EUT image intensifier requires continued operation during power mains interruptions, it is recommended that the EUT image intensifier be powered from an uninterruptible power supply or a battery. Power frequency (50/60Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE Uт is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration - electromagnetic immunity
Chapter 8 EMC Information Page 127 8.3 Guidance and manufacturer’s declaration - electromagnetic immunity 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 IEC 60601 test level Compliance Level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80MHz 3 V/m 80 MHz to 2.5GHz 3 Vrms 150 kHz to 80MHz 3 V/m 80MHz to 2.5GHz Portable and mobile RF communications equipment should be used no closer to any part of the EUT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site 80MHz to 800MHz 800MHz to 2.5GHz
EMC Information Chapter 8 Page 128 survey, a 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. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
Chapter 8 EMC Information Page 129 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. The customer or the user of the EUT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EUT as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter[m] 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz Rated maximum output power of transmitter [W] V1=3Vrms E1=3V/m E1=3V/m 0.01 0.116 0.1166 0.2333 0.1 0.368 0.3687 0.7378 1 1.166 1.1660 2.3333 10 3.687 3.6872 7.3785 100 11.660 11.6600 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for 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 Page 130 8.5 Immunity and Compliance Level Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level Conducted RF IEC 61000-4-6 3Vrms 150kHz to 80MHz 3Vrms 3Vrms Radiated RF IEC 61000-4-3 3Vrms 80MHz to 2.5GHz 3V/m 3V/m
Chapter 8 EMC Information Page 131 8.6 Guidance and manufacturer’s declaration - electromagnetic immunity 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 3 Vrms 150 kHz to 80MHz 3 V/m 80 MHz to 2.5GHz 3 Vrms 150 kHz to 80MHz 3 V/m 80MHz to 2.5GHz The EUT must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.a Interference may occur in the vicinity of equipment marked with the following symbol:
EMC Information Chapter 8 Page 132 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. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
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 IntroMedic Co.,Ltd. Suite 1104, E&C Venture Dream Tower 6-Cha 197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719 Tel : +82-2-801-9300 Fax : +82-2-801-9330 http://www.intromedic.com e-mail : help@intromedic.com 0843 Disposal of Old Electrical & Electronic Equipment Applicable in the European Union and other European countries with separate collection systems

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