Intromedic INTROMEDIC Capsule Endoscope Receiver User Manual
Intromedic Co., Ltd. Capsule Endoscope Receiver
Contents
- 1. User Manual
- 2. User Manual 1
- 3. User Manual 2
User Manual
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| Document ID | 797303 |
| Application ID | f/2I+BqVD9aFCJ7y3tbmxg== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 81.66kB (1020756 bits) |
| Date Submitted | 2007-05-28 00:00:00 |
| Date Available | 2007-05-28 00:00:00 |
| Creation Date | 2007-05-15 10:58:20 |
| Producing Software | Acrobat Distiller 6.0.1 (Windows) |
| Document Lastmod | 2007-05-15 11:01:40 |
| Document Title | 목 차 |
| Document Creator | Wordìš© Acrobat PDFMaker 6.0 |
| Document Author: | 권성호 |
MiroCam User Manual Contents SAFETY.............................................................................................................................2 1.1 Warnings ................................................................ 2 1.2 Symbols for Safety ...................................................... 3 1.3 Function Symbols ........................................................ 4 1.4 Remarks for Safe Use .................................................... 6 Overview ..........................................................................................................................12 2.1 Description of MiroCam Capsule Endoscope System ........................ 12 2.2 System Overview ........................................................ 13 2.3 Feature of MiroCam Capsule Endoscope System ............................ 14 2.4 Function Explanation ................................................... 15 2.5 Intened Pupose and Side Effect ......................................... 18 Product.............................................................................................................................19 3.1 Pictures ............................................................... 19 3.2 Supply Items ........................................................... 21 Installation.......................................................................................................................22 4.1 Installation ........................................................... 22 Technical Data.................................................................................................................24 5.1 Overview ............................................................... 24 5.2 Hardware ............................................................... 24 5.3 Software ............................................................... 25 5.4 COMPLIANCE/APPROVALS ................................................... 25 Environment condition for storage and transport. ........................................................27 6.1 Safety environment condition for storage ............................... 27 6.2 Environment condition for transport .................................... 27 Troubleshooting...............................................................................................................28 7.1 Introduction ........................................................... 28 7.2 Who should perform repairs ............................................. 28 7.3 Obtain replacement parts ............................................... 28 7.4 Troubleshooting guide .................................................. 28 한글판 버전 1.00 MiroCam User Manual 1 SAFETY 1.1 Warnings The MiroCam® has been manufactured to conform to 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. The MiroCam® has been manufactured to conform Medical Equipment with respect to electric shock fire and mechanical hazard only CAN/CSA C22.2 NO.601.1. To guarantee safety and reliability of the equipment, special attention should be paid to all the precautions directed throughout this manual, such as " CAUTION", and " WARNING", " NOTE". Also, to prevent incorrect operations and a failure in maintenance, it is essential that you should be familiar with the functions, operation and maintenance instructions by thoroughly reading this manual before operating the equipment. WARNING "WARNING" is used to alert the user of a potential serious hazard that may lead to death or serious injury of patients and personnel. CAUTION "CAUTION' is used to indicate information the user should know to avoid a hazard that may lead to device malfunction, device failure, damage to the device, or damage to other property. NOTE "NOTE' is used to indicate important information on installation, operation, or maintenance which you should to know for the safe and effective use of the equipment. 한글판 버전 1.00 MiroCam User Manual 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 Date of Manufacture Address 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) Denotes Ampere, the unit of current Denotes Volt, the unit of Voltage Hz Denote Herz, the unit of Frequency IEC 417-5021: Denotes potential equalization terminal Single Use Only The Available Period 한글판 버전 1.00 MiroCam User Manual 1.3 Function Symbols 1.3.1 Apllication Function Symbols Symbol Description Functions Windows Symbol for Description Functions & Windows for Diagnosis Receiver Unit Report Function & Windows for Patient Function Database Listing Patient Image Data Function & Windows for Image Function Display and Diagnosis Patient Image Data Capturing current patient image Landmark current time of patient to the thumbnail image to the thumbnail Single previous image Single next image Previous Selected image Next Selected image Display image continuously Windows Windows for for direction Enlarge image display Single image display mode Dual image display mode Quad image display mode Display full image Display selected image Display red image Grouping image display in Single image display in Thumbnail Thumbnail Minimize application software Close application software Mark circle in current image Mark arrow in current image image 한글판 버전 1.00 Backup Display image continuously reverse Pause image display Erase circle and arrow in current Export Select marker color MiroCam User Manual Symbol 1.3.2 Description Symbol Description Undo mark in current image Redo mark in current image Doctor login Cancel login Patient’s diagnosis history Delete current patient information Progress reporting current patient Complete reporting current patient Complete Export current patient Complete backup current patient Doctor logout Display full patient list Receiver Function Symbols Symbol SIG INI BAT 한글판 버전 1.00 Description Status of capsule signal receiving Green : Good Yellow : Bad Status of initialization of Receiver Unit Green : Good Yellow : Bad Status of Battery Green : Full charged Yellow : Not charged MiroCam User Manual 1.4 Remarks for Safe Use Follow these safety instructions and the clinically adopted precautions. The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device IntroMedic.Co.Ltd., is NOT responsible for physical harm or equipment problems caused by the user’s careless operation or mismanagement. The user MUST have read and understood the user's manual. ONLY trained and qualified persons may operate the system. The user's manual must ALWAYS be with the equipment. It is the USER’S RESPONSIBILITY to ensure this! CAUTION is advised that the foreign substances, ironware or fluids, such as water or disinfecting fluid, not enter the equipment. ONLY authorized personnel may perform any type of repair. Never attempt to open the covers, panels or casings. DO NOT crease, bend, fold or twist the probe cables and take care to guard them against mechanical stress (e.g. wheels or heels)! The probes must not be exposed to mechanical shock (e.g. by dropping). Any damage caused that way invalidates the warranty. CAUTION: Damage/injuries to the probe or cable may lead to safety hazard. It is HIGHLY advised to have them repaired IMMEDIATELY. DO NOT handle fluids in the vicinity of the system. When using a cart purchased elsewhere, implement the latch guard method to prevent the wheels from rolling. DO NOT USE in moist or damp places. 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. The free repair warranty will be automatically invalidated. DO NOT carry out the procedure in areas with high vibrations or in environments where high electro-magnetic waves are generated. DO NOT pull out the power cord by grabbing the cable. When disconnecting the power cord, grab the plug and then pull out. This prevents short-circuits, disconnection, or cord damage. 한글판 버전 1.00 MiroCam User Manual 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. CAUTION: Verify that all connection terminals are securely connected to the system. CAUTION: Turn off the power switch before connecting the probe. DO NOT discard probes, cables and connectors with general waste. Separately discard as industrial waste or medical waste. CAUTION: Discard the battery according to the regulations of industrial waste. DO NOT discard with general waste. DO NOT carry out the procedure simultaneously with other procedures using medical products or equipment. DO NOT carry out the procedure on patients with pacemakers and/or defibrillators. DO NOT use for purposes other than medical treatment. DO NOT connect the USB cable to the receiver while the receiver’s patch probes are still connected DO NOT charge the receiver while the receiver’s patch probes 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. DO NOT carry out the procedure on patients with known or suspected gastrointestinal tract obstruction, perforation, stricture or fistular. DO NOT carry out the procedure on patients who have difficulty swallowing food or pills(dysphagia). DO NOT carry out the procedure on patient who have difficulty communicating. DO NOT carry out the procedure on patient with indigestion or delay in gastric emptying. DO NOT carry out the procedure on patient who may be affected by electromagnetic radiation, such as pregnant women, infants, and patients with heart disease or epileptics. DO NOT carry out the procedure on patients with diverticulosis in the Small Bowel. DO NOT carry out the procedure on patients who are recommended against having the procedure by a Physician. The capsule is disposable and should not be reused. 한글판 버전 1.00 MiroCam User Manual 1.4.1 Environmental Conditions for Operation Temperature : -10 ℃ - +70 ℃ (Operating : +10 ℃ - +40℃) Relative humidity : 10% - 80% (Operating : 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 electromagnetic 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 this device when the output contains d.c. components. Do not use the unit 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. 한글판 버전 1.00 MiroCam User Manual 1.4.2 Safety Precautions 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 probes MUST be observed. DO NOT use on patients with pacemakers or defibrillators. NOTE This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of U.S. FCC Rules. CAUTION EQUIPOTENTIAL BONDING: In hospital, doctors and patients are subjected to dangerous, uncontrollable compensating currents. These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms. The safest solution to the problem is consistent equipotential bonding. Medical equipment is connected with connecting leads made up with angle sockets to the equipotential bonding network in medical rooms. CAUTION DO NOT use the capsule if the package is unsealed. If capsule package is unsealed, it can be infected. DO NOT reuse a used capsule. To prevent unexpected accidents like fire or explosion, do not use it near or in the presence of inflammable or ignitable substances. DO NOT disassemble the equipment case nor open the cover. In case of problems in equipment or need for other service, please contact our head office or a customer support staff immediately. Only the accessories authorized and designed by our company should be used with this equipment. Faults resulting from the usage of unapproved or inappropriate accessories are not guaranteed against. This equipment may have an effect on other products or be effected by them. Follow your doctor’s instructions and abide by the guidelines in the user manual. DO NOT try to upload the data while the patch probes are still connected to the receiver. DO NOT charge the rechargeable battery in the receiver while the patch probes are still connected to the receiver. Stay away from high frequency radiation sites (such as high voltage, radar, installation power plants, MRI, CT or electric blankets etc.) during your capsule endoscope procedure. (It may result in serious side effects requiring an emergency operation.) 한글판 버전 1.00 MiroCam User Manual 10 In case of any symptoms of abdominal pain, vomiting, fever, heart trouble, dizziness or seizure during or after the capsule endoscope procedure, please notify your doctor. Always check the connection between the receiver and the patch probes. Always check that the battery in the receiver is fully charged before use. DO NOT use the capsule if the package is unsealed. After ingesting the capsule, always check whether the capsule has been excreted. Prior to undergoing the capsule endoscopy procedure, patients with diabetes must control their insulin doses. For more accurate data and better analysis, patients can have solid food for lunch, but must have liquid food as dinner on the day before the procedure and need to fast for 12 hours before the procedure. 12 hours before the procedure, take a laxative such as Sodium phosphate or PEG solution. DO NOT smoke for 12 hours prior to the capsule endoscope procedure. DO NOT apply body lotion to your body before the procedure. DO NOT bite the capsule before swallowing. Avoid excessive physical activity during the capsule endoscope procedure. 2 hours after swallowing the capsule, patients may drink water, and after 4 hours, patients may have liquid food. When undergoing the capsule endoscope procedure, DO NOT makes physical contact with another person undergoing this same procedure. During operation of the receiver, DO NOT touches it or gets it wet. Use the provided batteries only and never take it out of the receiver body during the procedure. During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB(It may damage the patient’s data). Always confirm that the USB is connected by checking on the screen of the MiroCam application program. 한글판 버전 1.00 MiroCam User Manual 1.4.3 11 Cleaning and maintenance 1.4.3.1 System and accessories Other units and accessories should be cleanly maintained. For cleaning, rub them lightly with a soft cloth wet with warm water at least once a week. Do not use organic solvents such as lacquer, thinner, ethylene and oxide because they can damage the equipment. Be careful that foreign substances do not enter the main system when cleaning. Please maintain the probe according to the disinfection instructions. The vaginal manometry probe must not be cleaned with a wet towel before usage. Use the vaginal probe ONLY after putting a disposable latex condom on it, and then discard only the condom after use. The patch probe for abdominal attachment must not be rubbed or wiped. ALWAYS operate the equipment under sanitary environmental conditions. DO NOT use heat or gas for the disinfection of the probes and cables. CLEAN vaginal probes, anal probes, patch probes and vaginal manometry probe should ALWAYS be used. 1.4.3.2 Service documents If required, or upon request, the supplier may provide block diagrams, list 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 the manufacturer. 1.4.3.3 Moving the Equipment CAUTION when moving equipment. WARNING: Excessive impact/shock causes internal damage. If wiring is connected/disconnected when moving, check the exact wiring status after moving. If damage to the equipment is found out after moving, immediately contact the company or dealer. 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 moving is finished and the systems structure is settled and stabilized. 한글판 버전 1.00 MiroCam User Manual 12 2 Overview 2.1 Description of MiroCam Capsule Endoscope System MiroCam is Capsule Endoscope Systems and accessories to be used to diagnosis of patients. It consists of the capsule and receiver. 2.1.1 Photos 2.1.1.1 Capsule 2.1.1.2 Receiver 2.1.1.3 Accessory 한글판 버전 1.00 MiroCam User Manual 13 2.2 System Overview MiroCam Capsule Endoscope Systems consist of Capsule Receiver and Image Processing Workstation (Software). MiroCam System Block Diagram Capsule Receiver Software DSP Data Communication FPGA Image Processing Image Sensor Data Transmittion Analog Amplifier Analog Filter Image Display 2.2.1 Capsule MiroCam Capsule Endoscope System’ Capsule Unit consists of optical dome, white LED, image sensor, lens and gold courted cage. 2.2.2 Receiver MiroCam Capsule Endoscope System’s Receiver unit consist of 8 channel connector, differential amplifier, filter, data demodulator, data storage memory and USB communication channel. 2.2.3 IPW MiroCam Capsule Endoscope System’s Software is running on the Microsoft Windows XP using the IBM compatible PC platform and provide easy-to-use icon menu. It consist of Image reconstruction part and Image display part. 한글판 버전 1.00 MiroCam User Manual 2.3 Feature of MiroCam Capsule Endoscope System 2.3.1 Main Feature Capsule High Resolution Image (320 X 320) Widest Field of view (150 degrees) Smallest Capsule size (11 X 24mm) Longest operation time Receiver Built-in circuit protection functions Small, light and easy to carry around IPW User Friendly software feature Red Color Detection Color of images are virtually natural Dual and quad image views System Over Intel P4 3.0GHz Over 1G Byte Memory Over 100GByte Hard Disk 한글판 버전 1.00 14 MiroCam User Manual 15 2.4 Function Explanation 2.4.1 Display flow Report View Image Review 2.4.2 Function of Control and Display of Signal All operations start after completing or selecting the patient registration on the default screen. If select Patient in Patient List for data review and press window is displayed. Press 한글판 버전 1.00 button for playing image data. button, Review MiroCam User Manual 16 Press Press button for save current image to thumbnail. Press button for recording diagnosis data and printing paper. Press button for operation for receiver unit initialization and image data button for stop playing image data. upload. 2.4.3 Sequence of Operation Initialize Receiver Unit ① Connect USB Cable between Receiver unit with Workstation Æ ② Click Æ ③ Click button button ④ Click Input Patient Info button Æ ⑤ Input Patient information Æ ⑥ Click Save button Upload Image Data ① Connect USB Cable between Receiver unit with Workstation Æ ② Click Æ ③ Click button button Display Image Data and Diagnosis ① Select Patient in Patient List for data review Æ ② Click button Æ ③ Click button Print Diagnosis Data ① Select Patient in Patient List for data review Æ ② Click button Æ ③ Input diagnosis result Æ ④ Insert diagnosis point in patient image data 한글판 버전 1.00 MiroCam User Manual 2.4.4 17 Connection and Disconnection Part Where When Method Patch Connector of Before Connection : Hold the connector on the end of Probe upper side of process the receiver’s patch probe and put it into the receiver unit capsule socket of the top of the patch. endoscope Disconnection : Hold the connector on the end of the receiver’s patch probe and pull it out by hands.. USB USB Cable Connector of capsule and push it into the USB connector on the side left of endoscope of the receiver. After process Connection : Hold the USB cable connector side receiver unit Disconnection : Hold the connector on the tip of the USB cable and pull it out by hands. Cradle Lower side of After process Connection : Place down the receiver into the receiver unit capsule Cradle as its slot. . endoscope Disconnection : Pull out the receiver from the Cradle vertically. Adaptor Rear side of System Connection : Put the DC cable of the charger cradle Installiation into the DC jack of the Cradle.. Disconnection : Pull out the connector of the DC cable of the charger by hands. 한글판 버전 1.00 MiroCam User Manual 18 2.5 Intened Pupose and Side Effect 2.5.1 Intended Purpose MiroCam is intended for the detection of pathologies as an adjunctive tool in the diagnosis of small bowel gastrointestinal disorders and diseases. 한글판 버전 1.00 MiroCam User Manual 3 Product 3.1 Pictures 3.1.1 Main Device Capsule Receiver 한글판 버전 1.00 19 MiroCam User Manual 3.1.2 Accessories Patch Cable Model : 21-1-19-1, 10P Manufacturer : Mednis USB Cable Model : AV22201-06 Manufacturer : BELKIN Cradle Model : MR1000-C Manufacturer : JEC Korea Adaptor Model : JMW128KAXXXXNXX(Compliance with requirements of IEC601-1) Manufacturer : JEC Korea 한글판 버전 1.00 20 MiroCam User Manual 21 3.2 Supply Items 3.2.1 Basic Supply Item No. Model MiroCam Quantity Description Replace Product Code Period Capsule MC1000-C 1 ea Receiver MR1000-R 1 ea Cradle MR1000-C 1 ea Adaptor MR1000-A 1 ea Power Code MR1000-P 1 ea Patch Probe MR1000-S 1 pk Single use Ground Pad MR1000-E 1 ea Single use Patch Cable MR1000-D 1 ea 6 month Software MW1000-S 1 ea 10 Sack MR1000-K 1 ea 11 PC MW1000-P 1 ea 12 Monitor MW1000-L 1 ea 13 Printer MW1000-I 1 ea 14 Keyboard MW1000-K 1 ea 15 Mouse MW1000-M 1 ea 16 Back MR1000-G 1 ea 17 Cart MW1000-C 1 ea 18 User Manual MW1000-U 1 ea 3.2.2 No. Optional Supply Item Model Battery 한글판 버전 1.00 MiroCam Product Quant Code ity Period 1 ea 6 month MR1000-B Description Replace MiroCam User Manual 22 4 Installation 4.1 Installation 4.1.1 Specification of packing MiroCam Capsule Endoscope System Box MiroCam MADE IN KOREA BARCODE LABEL 340.00 190.00 480.00 No. N/S Pulp MAT'L Q'TY. MODEL --REMARK Box ITEM 1/1 MiroCam Capsule Endoscope Receiver Set Box MiroCam 100.00 MADE IN KOREA BARCODE LABEL 100.00 210.00 No. N/S Pulp --- MAT'L Q'TY. REMARK MODEL Box ITEM Receiver Box 1/1 한글판 버전 1.00 MiroCam User Manual 23 MiroCam Capsule Endoscope Battery Charger Box MiroCam MADE IN KOREA BARCODE LABEL 150.00 150.00 350.00 No. N/S Pulp MAT'L Q'TY. --REMARK MODEL Box ITEM Charger Box 1/1 MiroCam Capsule Endoscope Accessory Box MiroCam 140.00 BARCODE LABEL 460.00 MADE IN KOREA 640.00 No. N/S Pulp --- MAT'L Q'TY. REMARK MODEL ITEM Box Accessory Box 1/1 한글판 버전 1.00 MiroCam User Manual 5 Technical Data 5.1 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. 5.2 Hardware 5.2.1 5.2.2 5.2.3 Capsule 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 Working time : Over 11 Hours Mechanical Safety : Compatible ISO60601-1-1 Chemical Safety : Safe in pH=2 ~ pH=8 Battery Type : Silver Oxide Cell(3Vdc, 70mA) Operation Temperature : 20 ~ 40℃ Storage Temperature : 0 ~ 50℃ Receiver Operation System : Firmware Recording Time : 11 Hours Weight : 350g, include battery Operation Voltage : 3.7Vdc, 0.45A Battery Type: Lithium Ion Battery (3.7Vdc, 8.8A) Battery Weight : 215g Operation Temperature : 0 ~ 40℃ Storage Temperature : 0 ~ 55℃ Category : Type BF Image Workstation Operating System : Windows XP Professional 한글판 버전 1.00 24 MiroCam User Manual 5.2.4 CPU : Core 2 Duo E6300(1.86GHz/2M) Memory : DDR II 1GByte(667MHz) 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 25 Cradle Input Voltage : 110~220VAC Input Current : 3A Output Voltage ; 4.2VDC Output Current : 4A Operation Display : LED Display 5.3 Software 5.3.1 Version 5.3.2 5.3.3 MiroCam Application Software Version 1.00 Specification Language : English Data Export : JPEG Image, AVI Video Clip, PDF Data Report Data Display : Single or Multi Image, Time Bar, Color Bar, Diagnosis Data Event Marker : Small Image with Explanation Display Ratio : 5 ~ 30 fps Display Mode : Single View, Dual View, Quad View Running Mode : Normal Mode, Fast Mode Feature Color status Display User Friendly software feature Automated detection of GI tract bleeding Color of images are virtually natural 5.4 COMPLIANCE/APPROVALS The MiroCam capsule endoscope system and accessories complies with the Medical Device Directive 93/42/EEC (CE0843). 한글판 버전 1.00 MiroCam User Manual 26 In addition, the product complies with IEC 60601-1:1988 + A1:1991 + A2:1995 (EN 60601-1:1990 + A1:1992 + A2:1995) EN 60601-1-2 EN 10993-1 EN 10993-10 The possibility of hazards arising from software errors was minimized in compliance with EN1441 and EN60601-1-4. 5.4.1 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. 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 ina particular installation, which can be determined by turning the equipment off and on, the user is encourage 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. Consult the dealer or an experienced radio/TV technician for help 한글판 버전 1.00 MiroCam User Manual 27 6 Environment condition for storage and transport. 6.1 Safety environment condition for storage 6.1.1 Receiver unit Environment condition for storage Temperature : -10℃ - +70℃ Relative humidity : 10% - 80% Atmospheric pressure : 700hPa to 1060hPa Keep in the place which is not contacted with water. Keep in the place where the direct light dose not shines. Keep in the place which is not contacted with something that is a hazardous to the human body. Keep in the place which the kid’s hand dose not closes. Don’t keep it in the (storing) place for chemicals or near gas. When you clean up the outside of the product, only use gauze with water. Other liquid like alcohol should not be allowed. When you charge the battery, please use the cradle. If you don’t use this product for so long, please separate the battery from the body of it. 6.1.2 Image Workstation Treat this based upon the way how to handle a general PC. 6.2 Environment condition for transport Temperature : -10℃ - +70℃ Relative humidity : 10% - 80% Atmospheric pressure : 700hPa to 1060hPa 한글판 버전 1.00 MiroCam User Manual 28 7 Troubleshooting 7.1 Introduction This section explains how to troubleshoot the MiroCam capsule endoscope system if problems arise. Tables are supplied that list of possible difficulties, probable cause, and recommended actions to correct the difficulties. 7.2 Who should perform repairs Only qualified service personnel should open the HMT2100 housing, remove and replace components, or make adjustments. 7.3 Obtain replacement parts IntroMedic Technical Services 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 Section 3.2, Supply Items. 7.4 Troubleshooting guide Condition Recommended Action 1. The MiroCam capsule 1. Ensure that the MiroCam capsule endoscope workstation main endoscope workstation system fails to power-up when the I/O power switch is on. 2. The MiroCam capsule 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.. 1. Recharging battery of receiver unit. endoscope system 2. Replacement battery of receiver unit. receiver unit fails to 3. If the condition persists, contact IntroMedic Co.,Ltd.. power-up when the I/O power switch is on. 3. It's not blinking when it's out of the case. 4. INI LED, on receiver unit, is lighted as 1. DO NOT use this capsule and retry another capsule. 2. Contact IntroMedic Co.,Ltd. for replacement capsule. 1. Initialization receiver unit in MiroCam application software. 2. If the condition persists, contact IntroMedic Co.,Ltd.. yellow. 5. BAT LED, on receiver 1. Recharging battery of receiver unit. unit, is lighted as 2. Replacement battery of receiver unit. yellow. 3. If the condition persists, contact IntroMedic Co.,Ltd.. 한글판 버전 1.00
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