Service Manual. Copyright 2007 IntroMedic Co., Ltd. Version 1.22 Date :

Transcription

1 Service Maual Copyright 2007 ItroMedic Co., Ltd. MM Versio 1.22 Date :

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3 Warraty Trademarks MiroCam, MiroView, ItroMedic, ad the associated logos are the registered trademarks or trademarks of ItroMedic Co., Ltd. ItroMedic Co., Ltd. July Except as required by applicable copyright laws; ay use of the ItroMedic trademarks, or ay repritig, reproductio, modificatio, referecig ad traslatios of the User Maual, without the prior writte approval of ItroMedic Co., Ltd. is strictly prohibited. Warraty Every effort has bee made to esure the iformatio cotaied i this Service Maual is accurate, ad is believed to be correct at time of pritig. ItroMedic reserves the right to chage ay cotet cotaied with this Service Maual without prior otice. ItroMedic Co., Ltd. warrats the product agaist defects i material ad workmaship for a period of twelve (12) moths from the date of sale, uless differet local regulatios apply. ItroMedic Co., Ltd. will repair or replace products that are ascertaied by ItroMedic to have defects durig the warraty period. ItroMedic Co., Ltd. is ot liable for the defects occurred by misuse, careless hadlig, uauthorized modificatios or erroeous use, or ay use that is o-compliat with istructios detailed withi this Service Maual. This icludes use of the product i o-appropriate locatios or coditios. Ay other warraties are either represeted here or recogized by implicatio. To validate the warraty, please complete product registratio with the local authorized ItroMedic distributor. Page 3

4 Warraty Exclusive warraty service The warraty service provided hereby is applicable exclusively to the purchaser of the product. ItroMedic will oly warraty the product for purposes ad usage as defied i this Service Maual. Ay usage ot heedig the warigs, cautios ad recommeded usages as defied i this maual will ullify the warraty. Support For warraty or repair service please cotact the local authorized ItroMedic distributor. For customer service or support please cotact your poit of purchase or ItroMedic Co., Ltd. Service agreemets are oly applicable to products of ItroMedic Co., Ltd. ItroMedic Customer Service TEL: FAX: helpdesk@itromedic.com Safety No-compliace with the user s maual, uauthorized modificatios of the product or replacemet of parts, ad/or opeig of the product casig is prohibited ad may be hazardous. Page 4

5 Cotets Cotets 1. SYSTEM OVERVIEW Warigs Symbols for Safety Fuctio Symbols Remarks for Safe Use SYSTEM OVERVIEW MiroCam Overview MiroCam System Mai Compoets MiroCam Method of Actio System Cofiguratio Product Specificatios Compoet List PRODUCT INSTALLATION Compoet Check List Packagig Specificatios Istallatio Diagram System Istallatio & Coectio MiroView Istallatio TECHNICAL DATA Overview Hardware Software Compliace / Approvals Page 5

6 Cotets 5. Storage & Trasportatio Safe Storage Coditios Safety Trasportio Coditios TROUBLESHOOTING Itroductio Who should perform repairs Obtai replacemet parts Troubleshootig Guide PACKING FOR SHIPMENT Geeral Itroductio Repackig i Origial Packig Box Repackig i Differet Packig Box EMC INFORMATION Page 6

7 Safety Iformatio 1

8 Safety Iformatio Chapter 1 Page 2

9 Chapter 1 Safety Iformatio 1. SYSTEM OVERVIEW 1.1 Warigs MiroCam has bee maufactured to coform with the Iteratioal Stadard for Medical Electrical Equipmet: Geeral Requiremets for Safety IEC , together with the Collateral Stadard for Electromagetic Compatibility Requiremet ad Tests IEC MiroCam has bee maufactured to coform to the electric shock, fire ad mechaical hazard stadards as defied i CAN/CSA C22.2 NO Based o request of the buyer, ItroMedic will provide the labelig, such as ID labels, ad the User & Service Maual i the atioal laguage(s) of Europea coutries. Traslated documets will be evaluated by a local laguage expert, ad will be cofirmed by a ative speaker of the respective atioal laguage. Safety Symbols: The User & Service Maual icorporates various safety symbols to esure safe ad correct use of the product ad to prevet ay persoal ijury or property damage. These symbols are defied i the followig table: WARNING WARNING idicates a potetial hazard that, if ot avoided, could result i serious persoal ijury or damage to the product. CAUTION CAUTION idicates a potetial hazard that, if ot avoided, could result i mior persoal ijury or damage to the product. NOTE NOTE does ot idicate potetial hazards as i Cautio or Warig, but cotais importat iformatio regardig the istallatio, operatio or maiteace of the product. Page 3

10 Safety Iformatio Chapter Symbols for Safety This sectio describes a set of symbols that IEC (The Iteratioal Electrotechical Commissio) has established for medical electroic equipmet to classify a coectio or warig of ay potetial hazards. IEC 348: Notice for the user to pay special attetio to the followig details IEC : Idicates that this is classified ito Type BF equipmet EN 980: Deotes Date of Maufacture EN 980: Deotes Address of Maufacture IEC60601, ANNEX D: Deotes ON status of mai power switch IEC60601, ANNEX D: Deotes OFF status of mai power switch SN EN 980: Deotes serial umber IEC : Deotes DC (Direct Curret) IEC : Deotes AC (Alteratig Curret) A V Hz Deotes Ampere, the uit of curret Deotes Volt, the uit of Voltage Deote Herz, the uit of Frequecy IEC : Deotes potetial equalizatio termial Sigle Use Oly Use by date Page 4

11 Chapter 1 Safety Iformatio 1.3 Fuctio Symbols Applicatio Fuctio Symbols The followig table describes symbols or icos used i the MiroView software. Symbol Descriptio Symbol Descriptio Coect to the receiver ad ope receiver cotrol scree. Ope the patiet data scree of the MiroCam system. Opes scree to view MiroCam for a specific patiet. Select ad save a image beig reviewed. Move to the previous image. Move to the previous captured image. Play images i sequetial order. Ope the report scree to create a patiet capsule edoscopy report. Ope scree to export (save exterally) selected image data for a specific patiet. Ope scree to backup image data for a specific patiet. Place a ladmark i a image beig reviewed. Move to the ext image. Move to the ext captured image. Play images i reverse order. Stop playback of images. Zoom images. Show images i a sigle scree. Show images i the dual scree. Page 5

12 Safety Iformatio Chapter 1 Symbol Descriptio Symbol Descriptio Show images i the quad scree. Play the selected images oly. View images via Quick Mode fuctio. Show images i the Capture Box by group. Whe editig the captured image i the report mode, add a circle o the captured image. Erase the circle or arrow displayed i a image whe a report is created. Cacel the last actio applied to a image whe a report is created. Idicate that a report for the selected patiet is beig created. Idicate that image data for the selected patiet has bee exported. User logs out from MiroView. Play all images. SGIB - Play the images captured via Suspected GI Bleedig fuctio. Show all images i the Capture Box. Whe editig the captured image i the report mode, add a arrow o the captured image. Select a color to use i a image whe a report is created. Re-apply the cacelled chages whe a report is created. Idicate that a report for the selected patiet has bee created. Idicate that image data for the selected patiet has bee backed up. Show the complete list of patiets Page 6

13 Chapter 1 Safety Iformatio Receiver Fuctio Symbols Symbol SIG INI BAT Descriptio Idicates status of sigal from capsule Gree: Sigal is beig received from capsule Yellow: Sigal is ot beig received from capsule Iitializatio status of Receiver Uit Gree: Receiver is iitialized Yellow: Receiver is ot iitialized Battery Status Gree: Fully charged Yellow: Not charged Page 7

14 Safety Iformatio Chapter Remarks for Safe Use Follow the safety istructios icluded i this Service Maual ad cliical precautios advised by medical professioals. The maufacturer is ot liable for harm or damage caused by improper, uauthorized, uprofessioal or iexpert use of the device ad/or product. ItroMedic Co., Ltd. is NOT resposible for physical harm or equipmet problems caused by the user s careless operatio or mismaagemet of the device ad/or product. Users MUST have read ad uderstood the User Maual. ONLY traied ad qualified medical professioals or authorized represetatives of ItroMedic Co., Ltd. may operate the system. User Maual must ALWAYS be with the equipmet. This is the USER S RESPONSIBILITY. CAUTION: The equipmet should ot be exposed or come i cotact with foreig substaces icludig water, cleaig fluids, disifectig cleaser; as such substaces may harm the equipmet ONLY authorized persoel may perform repairs. Never attempt to ope covers, paels or casigs. DO NOT crease, bed, fold or twist the data cables. Take care to guard them agaist mechaical stress (e.g. wheels or heels)! The sesor pads, receiver, data cables, ad capsules must ot be exposed to mechaical shock (e.g. by droppig). Ay damage caused will void the product warraty. CAUTION: Damage/ijuries to the sesor pad or data cable may cause a safety hazard. Damaged items MUST be repaired IMMEDIATELY. DO NOT hadle fluids i the viciity of the system. Whe usig a cart, esure the brake or latch guard is i use to prevet the cart from rollig. DO NOT USE i moist or damp places. Page 8

15 Chapter 1 Safety Iformatio DO NOT operate the equipmet with wet hads. Avoid usig the equipmet i extreme temperatures or humid eviromets. DO NOT keep the equipmet or carry out the procedure i places such as areas exposed to direct sulight, viciity of heaters, viciity of chemical materials or gases, areas moist/damp or dusty, or poorly vetilated areas. DO NOT disassemble or ope the equipmet without permissio. This will ivalidate the warraty. DO NOT carry out the procedure i areas with high vibratios or i eviromets where high electro-magetic waves are geerated. DO NOT pull out the power cord by grabbig the cable. Whe discoectig the power cord, grasp the plug, ad pull out. This prevets short-circuits, discoectio, or cord damage. CAUTION: Verify that the power voltage supplied from the power receptacle matches with the voltage the system requires. Check Voltage ad Frequecy o the AC/DC adaptor. CAUTION: Verify that all coectio termials are securely coected to the system. CAUTION: Tur off the power switch o the receiver before coectig the sesor pads. DO NOT discard cables ad coectors with geeral waste. Discard separately as idustrial or medical waste. CAUTION: Discard the battery accordig to the regulatios of idustrial waste. DO NOT discard with geeral waste. The capsule ad sesor pads are medical waste, ad should be disposed of accordig to local regulatios or WEEE directive o waste disposal. DO NOT carry out the procedure simultaeously with other procedures usig medical products or equipmet. Page 9

16 Safety Iformatio Chapter 1 DO NOT use for purposes other tha medical treatmet. DO NOT coect the USB cable to the receiver while the receiver s data cable ad sesor pads are still coected. Page 10

17 Chapter 1 Safety Iformatio DO NOT charge the receiver while the receiver s data cable ad sesor pads are still coected. Coect USB cable to receiver oly after moutig it o charger. DO NOT istall ay other programs oto the workstatio utilized for review ad diagosis of patiet image data (i.e computers with the MiroView software). The capsule is disposable ad should ot be reused. I the medical eviromet coditio, oly use the capsule, receiver, data cable ad sesor pads. All products coected with the MiroCam Edoscope system must be compliat with requiremets of IEC or UL certificatios. Page 11

18 Safety Iformatio Chapter Evirometal Coditio for Operatio Temperature : Relative humidity : 45% - 75% Atmospheric pressure : 700hPa to 1060hPa WARNING DO NOT operate the equipmet i the viciity of geerators, power statios, X-ray devices, ad broadcastig statios where high levels of electro-magetic waves are geerated. The electro-magetic waves ca cause equipmet malfuctios. CAUTION If the equipmet has bee brought i from a cold eviromet (stock room, airfreight) ito a warm room, iitial activatio should take place after a few hours, to allow for temperature adjustmet ad balace ad evaporatio of codesed humidity. WARNING DO NOT operate the equipmet i the viciity of heat sources, strog electric or magetic fields (close to a trasformer), or ear istrumets geeratig highfrequecy sigals. WARNING Do ot use MiroCam alogside or together with medical devices or procedures ivolvig electrical currets. Do ot use MiroCam with h.f. surgical equipmet. It may result i burs at the site of the electrodes ad possible damage to the capsule ad receiver. Do ot use the uit i close radius (withi 1 m) of short wave or microwave therapy equipmet. It may produce istability i the captured image. WARNING This device is a Class B device accordig to EN stadards. This equipmet ca cause radio iterferece i residetial areas. I this case, the ower (or operator) ca be held resposible to take appropriate measures or take proper measures for compesatio. Page 12

19 Chapter 1 Safety Iformatio Safety Precautio CAUTION - Make sure the eviromet is without iterferece from electromagetic fields. - Make sure the eviromet is without oise ad vibratio. - DO NOT carry out the procedure while usig other equipmets, devices or products. - The istructio for use of the sesor pads MUST be observed. - DO NOT use o patiets with pacemakers or defibrillators. CAUTION DO NOT use the capsule if the package is usealed. DO NOT reuse capsules. To prevet uexpected accidets like fire or explosio, do ot use ay product ear or i the presece of iflammable or igitable substaces. DO NOT disassemble the equipmet case or ope the cover. I case service is required, please cotact ItroMedic customer support or local poit of sale immediately. Oly the accessories authorized ad desiged by ItroMedic Co., Ltd. should be used with this equipmet. Faults resultig from the usage of uapproved or iappropriate accessories are ot guarateed agaist. This equipmet may have a effect o other products or be effected by other products. Follow the Doctor s istructios ad abide by the guidelies i the User Maual. DO NOT try to upload the data while the data cables are still coected to the receiver. DO NOT charge the rechargeable battery i the receiver while the data cable ad sesor pads are still coected to the receiver. Page 13

20 Safety Iformatio Chapter 1 Stay away from high frequecy radiatio sites (such as high voltage, radar, istallatio power plats, MRI, CT or electric blakets etc.) durig your capsule edoscope procedure. (It may result i serious side effects requirig emergecy treatmet.) I case of ay symptoms of abdomial pai, vomitig, fever, heart trouble, dizziess or seizure durig or after the capsule edoscope procedure, the patiet should immediately otify the physicia i charge. Always check the coectio betwee the receiver ad the data cable. Always check that the battery i the receiver is fully charged before use. DO NOT use the capsule if the package is usealed. After igestig the capsule, ask patiet to check whether the capsule has bee excreted. Prior to udergoig the capsule edoscopy procedure, patiets with diabetes must be iformed via a medical professioal regardig appropriate medicatio & dosage. For more accurate data ad better aalysis, follow the Patiet Preparatio as recommeded i the User s Maual. Tell Patiet ot to bite the capsule before igestig. Patiet should avoid excessive physical activity durig the capsule edoscope procedure. Whe udergoig the capsule edoscope procedure, DO NOT make physical cotact with aother perso udergoig the same procedure. Durig operatio of the receiver, DO NOT touch the receiver, or get the receiver wet. Oly use the provided batteries, ad ever remove the battery from the receiver durig the procedure. Durig upload of the data recorded i the receiver to the PC, avoid discoectig the USB. This may damage the patiet s data. Page 14

21 Chapter 1 Safety Iformatio Always cofirm that the USB is coected by checkig the Receiver scree o the MiroView software. Always check the AC Power rage before use the workstatio. DO NOT touch AC Power code with wet hads. DO NOT ope the receiver bag or touch receiver outside of the hospital. This device is iteded for the patiets over the age of 18. WARNING The Capsule takes images for 11 hours ad gets aturally excreted i about 24 hours uder ormal coditios. If the capsule has ot bee excreted from the patiet withi 72 hours, patiet should cotact the physicia. After examiig, the physicia may eed to perform a surgical operatio or treatmet to remove the capsule. WARNING Before movig the system, always make sure to discoect the moitor from the mai system, ad the safely move the mai system ad moitor separately. Coect the mai system ad moitor oly after the hardware is fully istalled, secure ad stable. Page 15

22 Safety Iformatio Chapter Cleaig ad Maiteace System ad accessories - All products should be clealy maitaied. For cleaig, rub lightly with a soft cloth wet with warm water at least oce a week. Do ot use orgaic solvets such as lacquer, thier, ethylee ad oxide because they ca damage the equipmet. Be careful that foreig substaces do ot eter the mai system whe cleaig. - ALWAYS operate the equipmet uder saitary evirometal coditios. DO NOT use heat or gas for disifectio of the capsule. Service Documet If required, or upo request, the local ItroMedic Distributor (authorized ItroMedic Represetative) may provide block diagrams, lists of spare parts, descriptios, adjustmet istructios or other related iformatio which may help qualified techical persoel i repairig specified parts of the equipmet which have bee defied repairable by ItroMedic Co., Ltd.. Movig the Equipmet - CAUTION whe movig equipmet. - WARNING: Excessive impact/shock causes iteral damage. - If wirig is coected/discoected whe movig, check the wirig status after movig. - If damage to the equipmet is discovered after movig, immediately cotact ItroMedic or local Distributor. Page 16

23 System Overview 2

24 System Overview Chapter 2 Page 18

25 Chapter 2 System Overview 2. SYSTEM OVERVIEW 2.1 MiroCam Overview MiroCam is a orally igested capsule edoscope desiged to capture images of the small itestie liig. Captured images are viewed via the MiroCam software for diagosis of diseases related to the small itestie. Geerally, the capsule edoscope has bee developed to provide a meas to view the etire small bowel, with much higher diagostic sesitivity tha other radiological techiques. Further, the capsule edoscope avoids a great deal of discomfort associated with traditioal edoscopy, while allowig the patiet to maitai a ormal schedule. Additioal methods for screeig of the small bowel primarily iclude barium x-rays ad eteroscopy, but the diagostic value of these tests for a wide variety of specific lesios is low. Followig is further descriptio of the methods. Eteroscopy is a method to perform direct visual ispectio of the small bowel mucosa beyod the reach of stadard upper edoscopes. The procedure ca be accomplished of the small by examiatio with either push or sode type edoscopes, or operative eteroscopy. Eteroscopy of the small itestie is difficult, requires a legthy examiatio time, ca oly partially visualize the small itestie, is extremely ucomfortable, ad is ot performed o a widespread basis. Barium X-rays of the small bowel are curretly the primary radiographic meas of diagosig a small bowel eoplasm, ad the best way to locate small bowel lesios. However, the procedure has limited sesitivity. Page 19

26 System Overview Chapter 2 Sesitivity to diagose small bowel eoplasms ca be doubled by eteroclysis, which is extremely icoveiet for the patiet ad must be doe oly i a hospital set up by a expert. The sesitivity ad specificity of the diagosis of mucosal lesio (like AVM, for example) is close to zero. Computed tomography (CT) of the abdome is sometimes helpful i diagosig ad localizig of small bowel abormalities, but it is uable to determie small itralumial or mucosal lesios. It is widely accepted that the aforemetioed methods for diagosig small bowel diseases ad disorders are limited. Capsule Edoscopy is a great advacemet, providig a much more thorough diagostic method. ItroMedic s MiroCam Capsule Edoscope System is desiged to aid the gastroeterologist i visualizig ad diagosig disease of the small bowel i a efficiet, cost effective, ad comfortable maer MiroCam System Mai Compoets Capsule:The MiroCam Capsule moves slowly through the small itestie tract, capturig images of the etire small itestie at 3 frames/sec. Receiver:The MiroCam Receiver provides 9 receivig chaels through which sigals ca be received. The pair of chaels which have the best sigal characteristics are selected ad used for the receipt of the of image sigals. The receive also coects to MiroView software to upload images take of the patiet s GI tract. MiroView Software: MiroView eables the gastoreterologist to perform a diagostic reiview of the patiet s small bowel, ad Page 20

27 Chapter 2 System Overview documet the results i a pritable report. 2.3 MiroCam Method of Actio The followig image displays the key compoets of the MiroCam capsule edoscope system. MiroView To eable physicias to diagose images of a patiet s small bowel, the MiroCam method of actio icludes the followig steps. Step 1. Image Capturig: The MiroCam capsule uses a CMOS Image sesor built i the capsule to take the pictures through the frot of the optical dome. The LED light flashes each time the picture is take to brighte the dark digestive orga. The capsule captures 3 pictures per secod ad seds the images to the receiver immediately. For trasmissio, the images take from the capsule are trasformed to data that is possible to trasmit to the receiver through the huma body. Page 21

28 System Overview Chapter 2 Step 2. Data trasmissio: The MiroCam capsule trasmits the data from the capsule via E-Field Propagatio. This commuicatio method uses the huma body as the medium to trasmit sigals from iterally withi the body (from the capsule) to exteral sesors (data cable sesor pads). Step 3. Data Receptio ad Storage: To retrieve the sigal emitted from the capsule, the MiroCam system eeds to attach receptio poles (sesors attached to data cables) o the exterior of the huma body to retrieve the sigal. The sigal is the chaged ito a data format that is feasible for image processig, ad stored oto the memory of the receiver. Step 4. Data Upload: The image data is uploaded from the receiver to the MiroView software (software o a PC workstatio) via a stadard USB data cable. This data is uploaded after the patiet has completed the procedure (i.e. sesor pads / data cables are ot attached to patiet). Step 5. Image Restoratio & Display: After all stored image data i the receiver has bee trasferred to the image processig software (MiroView ), the software chages the trasferred image data by usig a image recostructio algorithm to a RGB sigal. The recostructed image data is saved alog with patiet iformatio, ad viewed by the physicia to diagose diseases of the small bowel. MiroView ca recall the saved data aytime, as the user desires to perform a diagostic review of the patiet images. Page 22

29 Chapter 2 System Overview 2.4 System Cofiguratio The MiroCam System cosists of a imagig capsule, sigal receiver, ad the MiroView software for image viewig. The overall system cofiguratio is as follows: MiroCam System Block Diagram Capsule Receiver Software System Iterface Data Commuicatio Image Sesor Data Storage Image Processig Data Trasmiter Data Recover Image Display Page 23

30 System Overview Chapter Capsule The capsule cosists of a optical dome, LED module, imagig & commuicatio module, battery, power supply module, cage pi ad cage. The capsule ca operate iside a huma body for more tha 11 hours. This mechaical device is eclosed i a harmless plastic capsule. The dome ad the capsule body are boded with a medical grade adhesive. The surface of the plastic body is gold-plated for sigal trasmissio. LED module Lez module PCB sesor Battery Power supply Dome <Capsule Structure> CMOS Image Sesor Specificatios Image size : 320 * 320 pixel Operatio voltage : 3V Operatio Frequecy :12MHz Image Frame : 3 Frame / sec Receiver The MiroCam Receiver cosists of the data cable, sigal iput block, aalog block, digital cotrol block, data storage block ad USB commuicatio block. Followig is some more iformatio about the Page 24

31 Chapter 2 System Overview idividual compoets. u Sigal iput block icludes 9 chael coectors ad a multiplexer u Aalog block has a amplifier ad filter for aalog to digital coversio. This coverts the image data trasmitted by the capsule. u Digital cotrol block icludes a digital image processig uit ad demodulatio uit. This block also saves the data. u All image data is saved to flash memory ad trasferred to image processig workstatio by USB chael u The receiver is divided ito a restoratio part that restores the actual data, ad a trasmitter part that trasmits the image data to MiroView. More specifically, the receiver ca be divided ito the receivig block, sigal iput block, aalog block, digital block, storage block ad USB trasmissio block. After processig the coverted sigals, the digital block demodulates image data ad saves it. The saved data is the trasferred to MiroView software (o a PC) via the USB trasmissio module. Receiver Power Source: The MiroCam receiver operates via a battery, completely idepedet of ay other power sources. The receiver of the MiroCam capsule edoscope system icludes amplifier ad filter compoets, which covert the image data trasmitted by the capsule. The receiver is divided ito a restoratio part that restores the actual data, ad a trasmitter part that trasmits the image data to MiroView. More specifically, the receiver ca be divided ito the receivig block, sigal iput block, aalog block, digital block, storage block ad USB trasmissio Page 25

32 System Overview Chapter 2 block. The sigal iput block is implemeted with 9 sigal lies ad coectors while the aalog block amplifies, filters ad performs AD coversio. After processig the coverted sigals, the digital block demodulates image data ad saves it. The saved data is the trasferred to MiroView software (o a PC) via the USB trasmissio module MiroView (Software) MiroView, the applicatio software for the MiroCam capsule edoscope system, cosists of a image-processig module that restores the received image data to actual images, ad a output module for image output. The recorded images ca be viewed via a covetioal PC or Notebook usig ItroMedic s proprietary software. MiroView is compatible with Widows operatig systems. Selected images ca be edited ad saved i a CD or DVD. The software icludes a umber of features ad fuctios to assist i the efficiecy ad sesitivity of the diagosis. Page 26

33 Chapter 2 System Overview 2.5 Product Specificatios Capsule Capsule cosists of the optical dome, les, led lightig module, gold-bad, battery, power module, case pi ad case. The capsule operates for about 11 hours i the huma body. The electrical compoets are eclosed by a plastic cage that is safe ad does ot harm the huma body. Dimesios Size(mm) 10.8(L1) x 24(L2) x 19(L3) x 5(L4) x6(l5) 3.25 Weight(g) Page 27

34 System Overview Chapter 2 Descriptio No. Title Fuctio 1 Mai Body - Mai Device of MiroCam MC Optical - This trasmits light from the outside of Capsule ad its trasparecy is over 98%. Dome - Made from COC. - This trasmits light source of image from the LED of iside of capsule. 3 Gold-Bad - Gold coatig that trasmits the image data from the capsule to the huma body. 4 Les - The les cocetrates the light emitted by the LEDs, ad focuses the image for the CMOS image sesor. 5 Cage - Protects the iterior capsule compoets. - Prevets etry of foreig materials ito capsule. - Cage is composed of a FDA certified safe material, harmless to the huma body. 6 White LED - LED illumiates the dark spaces iside the huma body GI tract. - The illumiatio eables images to be captured. Page 28

35 Chapter 2 System Overview Specificatios - Size : 10.8 X 24mm - Weight : 3.25g - Material : Huma Compliace Plastic - Light : 6 white LED - View Agle : 150 (I image) - View Depth : 3 cm - Elargemet Ratio : 1:8 - Detectable Rage : uder 0.1mm - Samplig Ratio : 2.9 fps - Operatig time : 11 hours - Mechaical Safety : Compatible ISO Biocompatibility Safety : Compatible ISO , ISO , ISO , ISO Chemical Safety : Safe i ph=2 ~ ph=8 - Battery Type : Silver Oxide Cell - Operatio Temperature : 20 ~ 40 - Storage Temperature : 0 ~ 50 Page 29

36 System Overview Chapter Receiver Receiver cosists of the data cable, sigal iput block, aalog block, digital cotrol block, data storage block ad USB commuicatio block. Sigal iput block has 9 chael coectors ad a multiplexer. Aalog block has a amplifier ad filter for aalog to digital coversio. Digital cotrol block has a digital image processig uit ad demodulatio uit. All image data are saved to flash memory ad trasferred to image processig workstatio by USB chael. Dimesios H W L Size(mm) 140(H) x 85(W) x 40(L) 350 Weight(g) Page 30

37 Chapter 2 System Overview Descriptio ƒ No. Title Fuctio 1 Mai Body - Mai Device of MiroCam MR Chael - Durable coector to deliver the sigal from the data cables to the Coector receiver. 3 LED Display - Display status of Receiver. - Sigal display to idicate ormal operatio, icludig battery, iitializatio status ad sigal receptio. 4 USB Coector - USB Commuicatio coector for image data trasmissio to Image processig workstatio. 5 Power Switch - Tur Mai power of Receiver o or off. 6 Battery - Rechargeable battery for MiroCam Receiver uit. - Output voltage : 3.7Vdc - Output Curret : 8.8A Page 31

38 System Overview Chapter 2 Specificatios - Operatio System : Firmware - Recordig Time : 12 Hours - Weight : 350g, iclude battery - Operatio Voltage : 3.7V, 0.45A - Battery Type: Lithium Io Battery (3.7V, 8.8A) - Battery Weight : 215g - Operatio Temperature : 0 ~ 40 - Storage Temperature : 0 ~ 55 - Category : Type BF Page 32

39 Chapter 2 System Overview MiroView Image processig workstatio cosists of image processig software (MiroView ) ad hardware workstatio. MiroView operates o widows XP, eablig viewig ad savig of image data. Software Versio : MiroView Versio 1.00 Operatig System : Widows XP Professioal Laguage : Eglish Data Export : JPEG Image, AVI Video Clip, PDF Data Report Data Display : Sigle or Multi Image, Time Bar, Diagosis Data Evet Marker : Small Image ad commets Display Ratio : 5 ~ 30 fps Display Mode : Sigle View, Dual View, Quad View Ruig Mode : Normal View, Quick View, Blood View Recommeded Workstatio Specificatios Operatig System : Widows XP Professioal 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 Moitor Resolutio : 1280 X 1024 Moitor Cotrast : 700 : 1 Priter Resolutio : 4800 X 1200 dpi Priter Paper : A4 Page 33

40 System Overview Chapter Accessories Data Cable L1 L2 L3 Part No. Descriptio Size(mm) Weight(g) MR1000-D Image data receivig 700(L1) x 90(L2) x 155 cable 110(L3) Sesor Pads Part No. Descriptio Size(mm) Weight(g) MR1000-S Image data receivig sesors 60 5 Page 34

41 Chapter 2 System Overview USB Cable Part No. Descriptio Size(mm) Weight(g) MR1000-U Image data uploadig cable Battery Charger L H W Part No. Descriptio Size(mm) Weight(g) MR1000-C Receiver Battery 135(H) x 105(L) x 350 Charger 150(W) - Iput Specificatio : 9Vdc, 3A - Output Specificatio : 4.2Vdc, 4A Page 35

42 System Overview Chapter 2 Adaptor L H D W Part No. Descriptio Size(mm) Weight(g) MR1000-T Receiver Battery 95(W) x 55(L) x 240 Chargig Adaptor 30(H) x 750(D) - Iput Specificatio : 110~220Vac, 50~60/Hz - Output Specificatio : 9Vdc, 3A - Compliace with requiremets of IEC601-1 Page 36

43 Chapter 2 System Overview 2.6 Compoet List The compoets of the MiroCam System are as follows: No. Product Name Model Name Q ty Descriptio Note 1 Capsule Edoscope MC ea Capsule for imagig 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 chargig 8 USB Cable MW1000-U 1 ea Commuicatio cable for workstatio 9 Measurig Tape MR1000-M 1 ea 10 Sesor Pad MR1000-S 1 pk Sigal-receivig pad 11 Software MW1000-SV1.0 1 ea Software for image diagosis 12 User Maual MM ea Istructio for use 13 Service Maual MM ea Istructio for service <Table 1> List of Compoet Page 37

44 System Overview Chapter 2 Page 38

45 Product Istallatio 3

46 Product Istallatio Chapter 3 Page 40

47 Chapter 3 Product Istallatio 3. PRODUCT INSTALLATION Istallatio ad iitial operatio of the system should be performed by authorized ItroMedic service persoel.. The followig compoet list should be rechecked prior to product istallatio. 3.1 Compoet Check List No. Product Name Model Name Q ty Descriptio Note 1 Capsule Edoscope MC ea Capsule for imagig 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 chargig 8 USB Cable MW1000-U 1 ea Commuicatio cable for workstatio 9 Measurig Tape MR1000-M 1 ea 10 Sesor Pad MR1000-S 1 pk Sigal-receivig pad 11 Software MW1000-SV1.0 1 ea Software for image diagosis 12 User Maual MM ea Istructio for use 13 Service Maual MM ea Istructio for service Page 41

48 Product Istallatio Chapter Packagig Specificatios Capsule Edoscope Receiver set Box : 485 X 120 X 400 mm Page 42

49 Chapter 3 Product Istallatio Capsule Edoscope Box : 210 X 206 X 95 mm Page 43

50 Product Istallatio Chapter Accessory Box : 352 X 396 X 78 mm Page 44

51 Chapter 3 Product Istallatio 3.3 Istallatio Diagram The recommeded cofiguratio of the MiroCam Capsule Edoscope System is as follows: Note: cofiguratio may chage. Charger Charger Arm Moitor Keyboard Priter Mouse Product Table Page 45

52 Product Istallatio Chapter System Istallatio & Coectio Coect data cable Check the data cable s directio. Hold gree cover of data cable ad isert ito the receiver Coect USB cable Hold small side of USB cable ad isert ito the receiver. Page 46

53 Chapter 3 Product Istallatio Hold large side of USB cable ad isert ito the workstatio. WARNING DO NOT coect the USB cable to the receiver while the receiver s sesor pads ad data cable are still coected. WARNING Coect USB cable to receiver oly after moutig it o charger Coect battery charger Battery charger coectio diagram. Page 47

54 Product Istallatio Chapter 3 Isert dc-jack of adaptor ito battery charger. Page 48

55 Chapter 3 Product Istallatio Isert power-jack of power cord ito adaptor. Coect power plug of power cord ito AC coset. WARNING Always check the AC Power rage before coect power plug ito AC coset. WARNING DO NOT touch AC power code with wet had. Page 49

56 Product Istallatio Chapter MiroView Istallatio For istallatio ad operatio of MiroView applicatio software, the workstatio must be prepared. Recommeded workstatio specificatios are provided to the local ItroMedic Represetative, who will istall the system ad software Preparatio(Prior to Istallig MiroView Software) Setup hard disk drive - This process should be doe by the hardware vedor - HDD must have three partitios : C, D ad E drive - C drive should have larger space tha 150GB for database - D drive should have larger space tha 50GB for MiroView - E drive should have larger space tha 250GB for patiet data. Page 50

57 Chapter 3 Product Istallatio Setup graphic resolutio - Click mouse right butto. - Click properties i commad list. - I display properties widow click settigs tab. Page 51

58 Product Istallatio Chapter 3 - Settig scree resolutio by 1280 * 1024 ad color quality by Highest(32 bit). - Click butto. - Cofirm moitor settig by clickig butto. Page 52

59 Chapter 3 Product Istallatio Setup widows accout - Click butto ad select Cotrol Pael. - Select User Accout. Page 53

60 Product Istallatio Chapter 3 - Select Admi accout. NOTE If you ca t see admi accout, create admi accout by select Create a ew accout. - Select Create a password. Page 54

61 Chapter 3 Product Istallatio - Eter ew password miro06 ad click butto - Select Create a ew accout. Page 55

62 Product Istallatio Chapter 3 - Eter ew accout ame miro ad click butto - Check accout type by limited ad click butto. Page 56

63 Chapter 3 Product Istallatio - Select miro accout - Select Create a password. Page 57

64 Product Istallatio Chapter 3 - Eter ew password miro06 ad click butto - Click butto - Select Create a ew accout. Page 58

65 Chapter 3 Product Istallatio - Eter ew accout ame MiroCam ad click butto - Check accout type by Computer admiistrator ad click butto. Page 59

66 Product Istallatio Chapter 3 Autoomous log-o for the user - Select Chage the way users log o or off - Ucheck Use the Welcome scree ad click butto. Page 60

67 Chapter 3 Product Istallatio - Click butto ad select Ru. - Eter cotrol userpasswords2 ad click butto Page 61

68 Product Istallatio Chapter 3 - Ucheck User must eter user ame ad password to use this computer ad click butto - Chage User ame to MiroCam istead of Admiistrator ad click butto. - Log-off ad Log-o with usig MiroCam accout. Page 62

69 Chapter 3 Product Istallatio Setup wallpaper - Copy IPW Istallatio Ver x (2007.x.x) from the IPW istallatio CD to desktop. - Copy Logo.jpg file to C:\logo.jpg <Copy> <Paste> - Double click logo.jpg file to execute Widows Fixture ad Fax Viewer. - Move the mouse poiter to ceter of the picture ad click the right butto o the mouse ad click Set as Desktop Backgroud Page 63

70 Product Istallatio Chapter Database setup Ope 1. DB Setup (postgresql ) folder. Double click postgresql-8.2.smi file to execute. Check Eglish/Eglish ad click butto. Page 64

71 Chapter 3 Product Istallatio Click butto. Click butto. Click butto. Page 65

72 Product Istallatio Chapter 3 Chage Accout ame to miro ad eter miro06 for Accout password ad Verify password. Click butto. WARNING There is a default value for the Accout Domai. This should NOT be chaged, although it may be differet tha detailed i the image above. Click butto. Click butto. Page 66

73 Chapter 3 Product Istallatio Eter miro for Superuser ame ad eter miro06 for Password ad Password (agai). Click butto. Check PL/pgsql ad click butto. Page 67

74 Product Istallatio Chapter 3 Check Admipack ad click butto. Click butto. Page 68

75 Chapter 3 Product Istallatio Click butto. Page 69

76 Product Istallatio Chapter Software istallatio MiroView applicatio software istallatio. - Ope Istallshield folder ad double click 1. MiroViewSetup - Click butto Page 70

77 Chapter 3 Product Istallatio - Click butto. - Check No more query ad click butto. Page 71

78 Product Istallatio Chapter 3 - Click butto. - Click butto. - Click butto. Page 72

79 Chapter 3 Product Istallatio - Click butto. - Ucheck No more query ad click butto, - Click butto. Page 73

80 Product Istallatio Chapter 3 Codec Istallatio. - Ope Istall shield folder ad double click 2. Codec Istall - If this widow appear, click butto - Click butto Page 74

81 Chapter 3 Product Istallatio Registry Istallatio. - Ope Istall shield folder ad double click 3. RGB Table(0814). - Click butto. - Click butto. Page 75

82 Product Istallatio Chapter Device driver istallatio Coect a receiver with the PC via USB port Check Yes, ow ad every time I coect a device ad click butto. Check Istall from list or specific locatio (Advaced) ad click butto. Page 76

83 Chapter 3 Product Istallatio Click butto. Select C:\USB Driver folder ad click butto. Click butto. Page 77

84 Product Istallatio Chapter 3 Click butto. NOTE USB driver istallatio process should be udergoe for every USB port to to be used for uploadig the receiver data. If you coect the receiver via a differet USB port from the oe with the istalled the driver with, the the driver must be set up agai. Page 78

85 Chapter 3 Product Istallatio Make the tables o the database Click butto ad select All program à postgresql 8.2. Select pgadmi III Double click PostgreSQL Database Server 8.2 (Localhost : 5432) Page 79

86 Product Istallatio Chapter 3 Eter miro06. Select postgres ad click the right butto o the mouse ad ru Restore i the pop-up meu. Click butto ad look for miro.backup i the istallatio folder o desktop. Page 80

87 Chapter 3 Product Istallatio Click butto. Click butto. If you see doe butto, the restoratio is successfully complete. Click doe butto. Page 81

88 Product Istallatio Chapter Fialize Execute MiroView Software by double-clickig ico. If the form for registratio appears, settig up the MiroView is successfully complete. Move this folder with pushig the left butto o the mouse ad draggig to the desktop. Page 82

89 Chapter 3 Product Istallatio Cut two folders; IPW Istallatio... ad Postgres. Paste to the E drive. Log off ad log o whit admi accout. Page 83

90 Product Istallatio Chapter 3 Cut two folders; IPW Istallatio... ad Postgres from E drive. Paste to the desktop. Page 84

91 Chapter 3 Product Istallatio Click butto ad select Ru ad type gpedit.msc ito the form ad Eter. Select User Cofiguratio à Admiistrative Template à Widows Compoets à Widows Explorer o the left side of the widow ad double click Hide these specified drives i My Computer. Page 85

92 Product Istallatio Chapter 3 If a form appears like below, check o Eabled ad select Restrict A, B ad C drives oly ad OK. Double clicked the specified items like below ad get them to Eabled. Page 86

93 Chapter 3 Product Istallatio - Eabled item list Lie Descriptio 2 Remove the folder Optios meu item from the Tools mau 3 Remove File meu from the Widows Explorer 4 Remove Map Network Drive ad Discoect Network Drive 5 Remove search butto from Widows Explorer 6 Remove Widows Explorer s default cotext meu 7 Hide the Maage item o the Widows Explorer cotext memu 10 Hide these specified drives i My Computer 12 Remove Hardware tab 13 Remove DFS tab 14 Remove Security tab 17 No Computer Near Me i my Network Places 18 No Etire Network i My Network Places 23 Do ot move deleted files to the Recycled bi 26 Remove Shared Documets from My Computer Page 87

94 Product Istallatio Chapter 3 Select User Cofiguratio à Admiistrative Template à Start Meu ad Taskbar o the left side of the widow ad set items to Eabled like below. - Eabled item list Lie Descriptio 1 Remove user s folders from the Start Meu 2 Remove liks ad access to Widows Update 3 Remove commo program groups from Start Meu. 4 Remove My Documet ico from Start Meu 5 Remove programs o Settig meu 6 Remove Network Coectios from start meu 7 Remove Favorites meu from Start meu 8 Remove Search meu from Start meu Page 88

95 Chapter 3 Product Istallatio Lie Descriptio 9 Remove Help meu from Start meu 10 Remove Ru meu from Start meu 11 Remove My Pictures ico from Start meu 12 Remove My Music ico from Start meu 13 Remove My Network Places ico from Start meu 17 Remove Drag-ad-drop cotext meus o the Start meu 18 Prevet chages to taskbar ad Start Meu Settigs 19 Remove access to the cotext meus for the taskbar 20 Do ot keep history of recetly opeed documets 21 Clear history of recetly opeed documets o exit 22 Tur off persoalized meus 28 Prevet groupig of taskbar items 30 Lock the Taskbar 34 Remove frequet programs list from the Start meu 36 Remove the Ulock PC butto from the Start meu 37 Remove user ame from Start meu Page 89

96 Product Istallatio Chapter 3 Select User Cofiguratio à Admiistrative Template à Cotrol Pael o the left side of the widow ad set Prohibit access to the Cotrol Pael to Eabled like below. Istallatio is fiished. Page 90

97 Techical Data 4

98 Techical Data Chapter 4 Page 92

99 Chapter 4 Techical Data 4. TECHNICAL DATA 4.1 Overview Product Name: MiroCam Capsule Edoscope System Model Name: MiroCam Serial Number: Refer to the label which is attachig i the reverse side of the product. Maufacturer: ItroMedic. Co., Ltd. Maufacturer Address Suite 1104, E&C Veture Dream Tower 6-Cha Guro-Dog, Guro-Gu, Seoul, KOREA Tel : Fax : help@itromedic.com 4.2 Classificatio of Equipmet Accordig to the type of protectio agaist electric shock : Iterally Powered Equipmet Accordig to the degree of protectio agaist electric shock : Type BF Applied Part Accordig to the degree of protectio agaist igress of water : IPX Accordig to the method of sterilizatio or disifectio : Equipmet ot usable sterilizatio & disifectio Accordig to the degree of safety of applicatio i the presece of a FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE : Equipmet ot suitable for use i the presece of a Page 93

100 Techical Data Chapter 4 FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE Accordig to the mode of operatio : Cotiuous Operatio with Short-Time Loadig Equipmet 4.3 Hardware Capsule (Model: MC1000-C) Size: 10.8 X 24mm Weight: 3.25g Material: Huma Compliace Plastic Light: 6 white LED View Agle: 150 (I image) View Depth: 3 cm Elargemet Ratio: 1:8 Detectable Rage: uder 0.1mm Samplig Ratio: 2.9 fps Workig time: 11 hours Mechaical Safety: Compatible ISO Biocompatibility Safety: Compatible ISO , ISO , ISO , ISO Chemical Safety: Safe i ph=2 ~ ph=8 Battery Type: Silver Oxide Cell Operatio Temperature: 20 ~ 40 Storage Temperature: 0 ~ 50 Recommeded Maximum Storage Time: 1 Year Receiver(Model: MR1000-R, MR2000-R) Page 94

101 Chapter 4 Techical Data Operatio System: Firmware Recordig Time: 12 Hours Weight: 350g, iclude battery Operatio Voltage: 3.7V, 0.45A Battery Type: l l MR1000: Lithium Io Battery (3.7V, 8.8A) MR2000: Lithium Io Battery (3.7V, 10.4A) Battery Weight: 215g Operatio Temperature: 0 ~ 40 Storage Temperature: 0 ~ 55 Category: Type BF Life Time: 4.62 Year Battery Charger(MR1000-C) Iput Voltage: 9VDC Iput Curret: 3A Output Voltage: 4.2VDC Output Curret: 4A Operatio Display: LED Display Adaptor Maufacturer: BridgePower Corporatio(JEC Korea) Adaptor Model: JMW128XA0902F Recommeded Image Workstatio Operatig System: Widows XP Professioal CPU: Core 2 Duo E6300(1.86GHz/2M) Memory: DDR II 1GByte(667MHz) Page 95

102 Techical Data Chapter 4 Display Adaptor: Geforce 7600GT 256MB Hard Disk: SATA II 160GB, SATA II 320GB ODD: DVD-RW Moitor Resolutio: 1280 X 1024 Moitor Cotrast: 700 : 1 Priter Resolutio: 4800 X 1200 dpi Priter Paper: A4 4.4 Software Versio MiroView Versio Specificatio Moitor Cotrast: 700 : 1 Laguage: Eglish Data Export: JPEG Image, AVI Video Clip, PDF Data Report Data Display: Sigle or Multi Image, Time Bar, Diagosis Data Evet Marker: Small Image with Explaatio Display Ratio: 5 ~ 30 fps Display Mode: Sigle View, Dual View, Quad View Ruig Mode: Normal View, Quick View, Blood View Error Ratio: Uder 100 image cotiuously Feature Laguage: Eglish Page 96

103 Chapter 4 Techical Data Color status Display User Friedly software feature Automated detectio of GI tract bleedig Color of images are virtually atural Page 97

104 Techical Data Chapter Compliace / Approvals The MiroCam capsule edoscope system ad accessories complies with the Medical Device Directive 93/42/EEC (CE 0843 ). I additio, the product complies with IEC : A1: A2:1995 Medical Electrical Equipmet, Part 1 : Geeral requiremet for safety (EN : A1: A2:1995) EN :2001 Medical Electrical Equipmet, Part 1 : Geeral requiremet for safety Collateral Stadard : Medical Electrical System EN :2001 Medical Electrical Equipmet, Part 1 : Geeral requiremet for safety Collateral Stadard : Electromagetic compatibility EN :1998 Medical Electrical Equipmet, Part 1 : Geeral requiremet for safety Collateral Stadard : Programmable Electrical Medical System EN :1996 Medical Electrical Equipmet, Part 2 : Particular requiremet for the safety of edoscope equipmet EN :2003 Biological evaluatio of medical devices, Part 1: Evaluatio ad Testig Third Editio Page 98

105 Chapter 4 Techical Data FCC Statemet This device complies with Part 15 of the FCC Rules. Operatio is subject to the followig two coditios: (1) this device may ot cause harmful iterferece, ad (2) this device must accept ay iterferece received, icludig iterferece that may cause udesired operatio. CAUTION: Chages or modificatios ot expressly approved by the party resposible for compliace could void the user's authority to operate the equipmet. NOTE: This equipmet has bee tested ad foud to comply with the limit for a Cass B digital device, pursuat to Part 15 of the FCC Rules. These limits are desiged to provide reasoable protectio agaist harmful iterferece i a residetial istallatio. This equipmet geerates, uses ad ca radiate radio frequecy eergy ad, if ot istalled ad used i accordace with the istructios, may cause harmful iterferece to radio commuicatios. However, there is o guaratee that iterferece will ot occur i a particular istallatio, which ca be determied by turig the equipmet off ad o, the user is ecouraged to try to correct the iterferece by oe or more of the followig measures: - Reoriet or relocate the receivig atea. - Icrease the separatio betwee the equipmet ad receiver. - Coect the equipmet ito a outlet o a circuit differet from that to which the receiver is coected. Page 99

106 Techical Data Chapter 4 Page 100

107 Storage & Trasportatio 5

108 Storage & Trasportatio Chapter 5 Page 102

109 Chapter 5 Storage & Trasportatio 5. Storage & Trasportatio 5.1 Safe Storage Coditios Evirometal coditio for storage - Temperature : Relative humidity : 10% - 80% - Atmospheric pressure : 700hPa to 1060hPa Keep i the place that is ot i cotact with water Keep i the place out of direct light Keep away from hazardous materials for the huma body. Keep away from childre. Do ot store with chemicals. For cleaig, oly use gauze with water. Other liquid like alcohol should ot be used. Use the provided battery charger for chargig. If product is ot used for a extesive period of time, please separate the battery from the receiver uit. 5.2 Safety Trasportio Coditios - Temperature : Relative humidity : 10% - 80% - Atmospheric pressure : 700hPa to 1060hPa - Product MUST be hadled with care, ad ot dropped. Page 103

110 Storage & Trasportatio Chapter 5 Page 104

111 Troubleshootig 6

112 Troubleshootig Chapter 6 Page 106

113 Chapter 6 Troubleshootig 6. TROUBLESHOOTING 6.1 Itroductio This chapter explais how to troubleshoot the MiroCam capsule edoscope system if problems arise. Tables are supplied that list possible difficulties, probable cause, ad recommeded actios to correct. 6.2 Who should perform repairs Oly qualified service persoel should ope the MiroCam Capsule Edoscope System housig, remove ad replace compoets, or make adjustmets. 6.3 Obtai replacemet parts ItroMedic Techical Service provides techical assistace iformatio ad replacemet parts. To obtai replacemet parts, cotact ItroMedic Co., Ltd. or your local represetative. Refer to part ames ad part umbers listed o Chapter 2.6, Compoet List. Page 107

114 Troubleshootig Chapter Troubleshootig Guide Coditio The MiroCam capsule edoscope system workstatio fails to power-up whe the I/O power switch is o. The MiroCam capsule edoscope system receiver uit fails to power-up whe the I/O power switch is o. Capsule is ot blikig whe take out of the case. INI LED o receiver uit is yellow, ad does ot tur gree whe held appropriately by patiet. BAT LED, o receiver uit is yellow. Recommeded Actio 1. Esure that the MiroCam capsule edoscope workstatio mai system is plugged ito a operatioal AC outlet i accordace with the iput specificatio rated o the side pael of the workstatio mai system. 2. If the coditio persists, cotact ItroMedic Co., Ltd. or local represetative. 1. Recharge battery of receiver uit. 2. Replace battery of receiver uit. 3. If the coditio persists, cotact ItroMedic Co., Ltd or local represetative. 1. DO NOT use the capsule. Use a alterate capsule. 2. Cotact ItroMedic Co., Ltd. for replacemet of capsule. 1. Iitialize receiver uit via MiroView software. 2. If the coditio persists, cotact ItroMedic Co., Ltd. 1. Recharge battery of receiver uit. 2. Replace battery of receiver uit. 3. If the coditio persists, cotact ItroMedic Co., Ltd. Page 108

115 Chapter 6 Troubleshootig If you see followig message whe you use MiroView software, check possible cause ad actio before cotactig ItroMedic. Error Message Possible cause Actio 1 The selected drive does ot support CD/DVD burig. 2 The selected drive does ot support CD/DVD burig. 3 BACKUP or EXPORT is ot yet complete. Wait for process to fiish ad try agai. The CD/DVD drive does ot support CD/DVD burig. User selected wrog drive. The user executed BACKUP or EXPORT fuctio while the burig process is operatig. Exchage the CD/DVD drive for DVD multi or DVD writable drive. Select the DVD writable drive ad try agai. Wait util the process has stopped ad try agai. 4 The selected capture caot be added. MiroView software istallatio problem. 5 The selected MiroView software ladmark caot be istallatio problem. added. 6 Failed to save. MiroView software istallatio problem. Cotact to ItroMedic. Cotact to ItroMedic. Cotact to ItroMedic. Page 109

116 Troubleshootig Chapter 6 7 A error arose while tryig to export. Please try agai. 8 A error arose while tryig to export. Please try agai. 9 There is o data to export. Improper export destiatio selected. MiroView software istallatio problem. There is o data to export. Check the drive to export. Check if the drive has sufficiet space. Cotact ItroMedic. If you did ot capture ay image, the this is ot a error. If persists, cotact ItroMedic. 10 Failed to make a video file because Microsoft MPEG4-V2 codec does ot exist. MiroView software Istallatio problem Cotact ItroMedic 11 Not eough memory. The system resources are ot sufficiet to support MiroView Reboot. 12 The file buffer size is over the limit. The system resources are ot sufficiet to support MiroView. Reboot. Page 110

117 Chapter 6 Troubleshootig 13 Failed to create the file. The disk space is ot eough. Delete data (patiet files) from the List Mode. 14 Not eough storage space. The disk space is ot eough. 15 Failed to fid the file. Sychroizatio error betwee files ad list 16 The file type does ot File versio error. match. 17 Database error Failed to access the DB server. 18 The priter driver is A priter driver (MM ot istalled. PDF Maker) is ot istalled. 19 The PDF covertig Caot create the module is ot report PDF file istalled. because PDF covertig module is ot istalled. 20 Receiver is Caot cotiue to discoected while upload because uploadig receiver has become discoected. 21 Caot upload Improper coectio because receiver is betwee the receiver ot coected. ad the PC Delete data (patiet files) from the List Mode.. Cotact ItroMedic Cotact ItroMedic Reboot. Cotact ItroMedic Cotact ItroMedic Check the coectio betwee the receiver ad the PC. Check the coectio betwee the receiver ad the PC Page 111

118 Troubleshootig Chapter 6 22 Caot upload because receiver is ot coected. 23 Fill out all the required fields. 24 Failed to upload data from receiver. 25 Failed to complete restoratio. 26 Failed to complete restoratio due to some missig files. 27 Please isert disk umber ##. 28 Wrog disk. Please isert a disk of the same origial file. 29 The backup disk ifo is icorrect. The receiver is tured off. There are the fields which you did ot eter the cotets ito. Coectio error betwee the receiver ad the PC MiroView software istallatio problem. Backup error The user iserted wrog disk while restorig the data The user iserted wrog disk while restorig the data Backup error Tur o the receiver ad try agai. Make sure all require fields are filled. Check the coectio betwee the receiver ad the PC Cotact to ItroMedic Back up the data ad restore agai Isert disk with umber ##. Isert the disk of the same origial file. Back up the data ad restore agai Warig If the problem arises agai, cotact to ItroMedic Service ceter. Page 112

119 Packig for shipmet 7

120 Packig for shipmet Chapter 7 Page 114

121 Chapter 7 Packig for shipmet 7. PACKING FOR SHIPMENT To ship the MiroCam Capsule Edoscope System for ay reaso, follow the istructios i this chapter. 7.1 Geeral Itroductio Pack the MiroCam capsule edoscope system carefully. Failure to follow the istructios i this chapter may result i loss or damage ot covered by the ItroMedic Co., Ltd. warraty. If the origial shippig box is ot available, use aother suitable box. Retur the product with a detailed, writte descriptio of the problem. 7.2 Repackig i Origial Packig Box If available, use the origial packig box ad packig materials as illustrated figures i below. Page 115

122 Packig for shipmet Chapter 7 Repackig MiroCam capsule - Isert capsule storage case ito capsule box. - Close capsule box. Page 116

123 Chapter 7 Packig for shipmet Repackig MiroCam receiver uit - Isert receiver uit ito system carry case. - Isert system carry case ito receiver uit box. Page 117

124 Packig for shipmet Chapter 7 - Close receiver uit box. Page 118

125 Chapter 7 Packig for shipmet Repackig MiroCam capsule edoscope system. - System repackig diagram. Upper Case shield Capsule box Middle case shield Receiver uit box Lower case shield System box Page 119

126 Packig for shipmet Chapter 7 - System repackig procedure. Page 120

127 Chapter 7 Packig for shipmet 7.3 Repackig i Differet Packig Box If the origial packig box is ot available: Place the MiroCam capsule edoscope system i a plastic bag. Locate a corrugated cardboard shippig box with at least 200 pouds per square ich (psi) burstig stregth. Fill the bottom of the box with at least 2 iches of packig material. Place the bagged uit o the layer of packig material ad fill the box completely with packig material. Seal the packagig box with packig tape. Label packig box with shippig address, retur address, ad the writte descriptio. Page 121

128 Packig for shipmet Chapter 7 Page 122

129 EMC Iformatio 8

130 EMC Iformatio Chapter 8 Page 124

131 Chapter 8 EMC Iformatio 8. EMC INFORMATION 8.1 Guidace ad maufacturer s declaratio - electromagetic emissios The EUT is iteded for use i the electromagetic eviromet specified below. The customer or the user of the EUT should assure that it is used i such a eviromet. Electromagetic eviromet - Immuity test Compliace guidace RF Emissios CISPR 11 Group 1 The EUT uses RF eergy oly for its iteral fuctio. Therefore, its RF emissios are very low ad are ot likely to cause ay iterferece i earby electroic equipmet RF Emissios The EUT is suitable for use i ail establishmets, icludig domestic CISPR 11 establishmets ad those directly Class B coected to the public low-voltage power supply etwork that supplies buildigs used for domestic purposes Harmoic emissios Class A IEC Voltage fluctuatios/ Flicker emissios Complies IEC Page 125

132 EMC Iformatio Chapter Guidace ad maufacturer s declaratio - electromagetic immuity The EUT is iteded for use i the electromagetic eviromet specified below. The customer or the user of the EUT should assure that it is used i such a eviromet. Immuity test IEC Test level Compliace level Electromagetic eviromet - guidace Electrostatic discharge (ESD) IEC Electrical fast trasiet/burst IEC Surge IEC Voltage dips, short iterruptios ad voltage variatios o power supply iput lies IEC Power frequecy (50/60Hz) magetic field IEC ±6kV Cotact ±8kV air ±6kV Cotact ±8kV air ±2kV for power ±2kV for power supply lies supply lies ± 1kV for ± 1kV for iput/output lies iput/output lies ±1kV differetial ±1kV differetial mode mode ±2kV commo ±2kV commo mode mode <5% Uт <5% Uт (>95% dip i Uт) (>95% dip i for 0.5cycle Uт) 40% Uт for 0.5cycle (60% dip i Uт ) 40% Uт for 5 cycle (60% dip i Uт ) 70% Uт for 5 cycle (30% dip i Uт) 70% Uт for 25 cycle (30% dip i Uт) <5% Uт for 25 cycle (<95% dip i Uт ) <5% Uт for 5 s (<95% dip i Uт ) for 5 s Floors should be wood, cocrete or ceramic tile. If floors are covered with sythetic material, the relative humidity should be at least 30%. Mais power quality should be that of a typical commercial or hospital eviromet. Mais power quality should be that of a typical commercial or hospital eviromet. Mais power quality should be that of a typical commercial or hospital eviromet. If the user of the EUT image itesifier requires cotiued operatio durig power mais iterruptios, it is recommeded that the EUT image itesifier be powered from a uiterruptible power supply or a battery. 3 A/m 3 A/m Power frequecy magetic fields should be at levels characteristic of a typical locatio i a typical commercial or hospital eviromet. NOTE Uт is the a.c. mais voltage prior to applicatio of the test level. Guidace ad maufacturer s declaratio - electromagetic immuity Page 126

133 Chapter 8 EMC Iformatio 8.3 Guidace ad maufacturer s declaratio - electromagetic immuity The EUT is iteded for use i the electromagetic eviromet specified below. The customer or the user of the EUT should assure that it is used i such a eviromet. Immuity test IEC test level Compliace Level Electromagetic eviromet - guidace Coducted RF IEC Radiated RF IEC 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 ad mobile RF commuicatios equipmet should be used o closer to ay part of the EUT, icludig cables, tha the recommeded separatio distace calculated from the equatio applicable to the frequecy of the trasmitter. Recommeded separatio distace 80MHz to 800MHz 800MHz to 2.5GHz where P is the maximum output power ratig of the trasmitter i watts (W) accordig to the trasmitter maufacturer ad d is the recommeded separatio distace i meters (m). Field stregths from fixed RF trasmitters, as deter-mied by a electromagetic site Page 127

134 EMC Iformatio Chapter 8 survey, a should be less tha the compliace level i each frequecy rage. b Iterferece may occur i the viciity of equipmet marked with the followig symbol : NOTE 1 ) At 80MHz ad 800MHz, the higher frequecy rage applies. NOTE 2) These guidelies may ot apply i all situatios. Electromagetic propagatio is affected by absorptio ad reflectio from structures, objects ad people. a Field stregths from fixed trasmitters, such as base statios for radio (cellular/cordless) telephoes ad lad mobile radios, amateur radio, AM ad FM radio broadcast ad TV broadcast caot be predicted theoretically with accuracy. To assess the electromagetic eviromet due to fixed RF trasmitters, a electromagetic site survey should be cosidered. If the measured field stregth i the locatio i which the EUT is used exceeds the applicable RF compliace level above, the EUT should be observed to verify ormal operatio. If abormal performace is observed, additioal measures may be ecessary, such as re-orietig or relocatig the EUT. b Over the frequecy rage 150kHz to 80MHz, field stregths should be less tha [V 1] V/m. Page 128

135 Chapter 8 EMC Iformatio 8.4 Recommeded separatio distaces betwee portable ad mobile RF commuicatios equipmet ad the EUT Iteded for use i a electromagetic eviromet i which radiated RF disturbaces are cotrolled. The customer or the user of the EUT ca help prevet electromagetic iterferece by maitaiig a miimum distace betwee portable ad mobile RF commuicatios equipmet (trasmitters) ad the EUT as recommeded below, accordig to the maximum output power of the commuicatios equipmet. Rated maximum output power Separatio distace accordig to frequecy of trasmitter[m] 80MHz to 800MHz to 150kHz to 80MHz 800MHz 2.5GHz of trasmitter [W] V 1=3Vrms E 1=3V/m E 1=3V/m For trasmitters rated at a maximum output power ot listed above, the recommeded separatio distace d i metres (m)ca be estimated usig the equatio applicable to the frequecy of the trasmitter, where p is the maximum output power ratig of the trasmitter i watts (W) accordig to the trasmitter maufacturer. NOTE 1) At 80MHz ad 800MHz, the separatio distace for the higher frequecy rage applies. NOTE 2) These guidelies may ot apply i all situatios. Electromagetic propagatio is affected by absorptio ad reflectio from structures, objects ad people. Page 129

136 EMC Iformatio Chapter Immuity ad Compliace Level Immuity test IEC Test Level Actual Immuity Level Compliace Level Coducted RF IEC Vrms 150kHz to 80MHz 3Vrms 3Vrms Radiated RF IEC Vrms 80MHz to 2.5GHz 3V/m 3V/m Page 130

137 Chapter 8 EMC Iformatio 8.6 Guidace ad maufacturer s declaratio - electromagetic immuity The EUT is iteded for use i the electromagetic eviromet specified below. The customer or the user of the EUT should assure that it is used i such a electromagetic eviromet. Immuity test IEC test level Compliace level Electromagetic eviromet - guidace Coducted RF 3 Vrms 3 Vrms The EUT must be used oly i a shielded locatio with a IEC khz to 150 khz to miimum RF shieldig effectiveess ad, for each cable 80MHz 80MHz that eters the shielded locatio with a miimum RF shieldig effectiveess ad, for each cable that eters the shielded locatio Radiated RF 3 V/m 3 V/m Field stregths outside the shielded locatio from fixed IEC MHz to 80MHz to RF trasmitters, as determied by a electromagetic 2.5GHz 2.5GHz site survey, should be less tha 3V/m. a Iterferece may occur i the viciity of equipmet marked with the followig symbol: Page 131

138 EMC Iformatio Chapter 8 NOTE 1) These guidelies may ot apply i all situatios. Electromagetic propagatio is affected by absorptio ad reflectio from structures, objects ad people. NOTE 2) It is essetial that the actual shieldig effectiveess ad filter atteuatio of the shielded locatio be verified to assure that they meet the miimum specificatio. a Field stregths from fixed trasmitters, such as base statios for radio (cellular/cordless) telephoes ad lad mobile radios, amateur radio, AM ad FM radio broadcast ad TV broadcast caot be predicted theoretically with accuracy. To assess the electromagetic eviromet due to fixed RF trasmitters, a electromagetic site survey should be cosidered. If the measured field stregth outside the shielded locatio i which the EUT is used exceeds 3V/m, the EUT should be observed to verify ormal operatio. If abormal performace is observed, additioal measures may be ecessary, such as relocatig the EUT or usig a shielded locatio with a higher RF shieldig effectiveess ad filter atteuatio. Page 132

139 EC Represetative NaoMedical Largo do Sequeira 7 G3 P.E Lisboa Portugal Key Cotact: Nuo Nicola Covacich Office: Mobile: or uo.icola@ao-medical.org Disposal of Old Electrical & Electroic Equipmet Applicable i the Europea Uio ad other Europea coutries with separate collectio systems ItroMedic Co.,Ltd. Suite 1104, E&C Veture Dream Tower 6-Cha Guro-Dog, Guro-Gu, Seoul, KOREA Tel : Fax : help@itromedic.com 0843

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