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| 1 | User Manual 1 | Users Manual | 1.16 MiB | May 05 2009 |
User Manual Copyright 2007 IntroMedic Co., Ltd. MM1000-0809 Version 1.24 Date : 2008-09-20 Warranty Trademarks MiroCam, MiroView, IntroMedic, and the associated logos are the registered trademarks or trademarks of IntroMedic Co., Ltd. IntroMedic Co., Ltd. July 2007. Except as required by applicable copyright laws; any use of the IntroMedic trademarks, or any reprinting, reproduction, modification, referencing and translations of the User Manual, without the prior written approval of IntroMedic Co., Ltd. is strictly prohibited. Warranty Every effort has been made to ensure the information contained in this User Manual is accurate, and is believed to be correct at time of printing. IntroMedic reserves the right to change any content contained with this User Manual without prior notice. IntroMedic Co., Ltd. warrants the product against defects in material and workmanship for a period of twelve (12) months from the date of sale, unless different local regulations apply. IntroMedic Co., Ltd. will repair or replace products that are ascertained by IntroMedic to have defects during the warranty period. IntroMedic Co., Ltd. is not liable for the defects occurred by misuse, careless handling, unauthorized modifications or erroneous use, or any use that is non-compliant with instructions detailed within this User Manual. This includes use of the product in non-appropriate locations or conditions. Any other warranties are neither represented here nor recognized by implication. To validate the warranty, please complete product registration with the local authorized IntroMedic distributor. Page 3 Warranty Exclusive warranty service The warranty service provided hereby is applicable exclusively to the purchaser of the product. IntroMedic will only warranty the product for purposes and usage as defined in this User Manual. Any usage not heeding the warnings, cautions and recommended usages as defined in this manual will nullify the warranty. Support For warranty or repair service please contact the local authorized IntroMedic distributor. For customer service or support please contact your point of purchase or IntroMedic Co., Ltd. Service agreements are only applicable to products of IntroMedic Co., Ltd. IntroMedic Customer Service TEL: 82-2-801-9300 FAX: 82-2-801-9330 http://www.intromedic.com E-mail: helpdesk@intromedic.com Safety Non-compliance with the users manual, unauthorized modifications of the product or replacement of parts, and/or opening of the product casing is prohibited and may be hazardous. Page 4 CONTENTS 1. SAFETY INFORMATION 1.1 Warnings 1.2 Symbols for Safety 1.3 Function Symbols 1.4 Notes for Safe Use 2. SYSTEM OVERVIEW Intended Purpose 2.1 2.2 Observable Diseases Contents 3 3 4 5 8 3 3 4 3. PERFORMING CAPSULE ENDOSCOPY 3 3 3 4 6 7 15 16 3.1 General Comments 3.2 Safety Warnings 3.3 Examination Preparation 3.4 Patient Preparation 3.5 Sensor Placement & Capsule Ingestion 3.6 Uploading Images 3.7 Receiver Management Post Procedure 4. USING MIROVIEW 4.1 Before Using MiroView 4.2 Administering and Initializing Patients 4.3 Viewing Setting 4.4 Creating a Report 4.5 Atlas 4.6 Backing up Patient Data 3 3 12 18 27 33 35 Page 5 Contents 5. USING MIROVIEW RTV 5.1 Overview 5.2 Using MiroView RTV 3 3 5 Page 6 Safety Information 1 Safety Information Chapter 1 1- 2 Chapter 1 Safety Information 1. SAFETY INFORMATION 1.1 Warnings together with IEC 60601-1, the Collateral Standard MiroCam has been manufactured to conform with the International Standard for Medical Electrical Equipment: General Requirements for Safety for Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2. MiroCam has been manufactured to conform to the electric shock, fire and mechanical hazard standards as defined in CAN/CSA C22.2 NO.601.1. Based on request of the buyer, IntroMedic will provide the labeling, such as ID labels, and the User Manual in the national language(s) of European countries. Translated documents will be evaluated by a local language expert, and will be confirmed by a native speaker of the respective national language. Safety Symbols: The User Manual incorporates various safety symbols to ensure safe and correct use of the product and to prevent any personal injury or property damage. These symbols are defined in the following table:
WARNING WARNING indicates a potential hazard that, if not avoided, could result in serious personal injury or damage to the product. CAUTION CAUTION indicates a potential hazard that, if not avoided, could result in minor personal injury or damage to the product. NOTE NOTE does not indicate potential hazards as in Caution or Warning, but contains the installation, operation or maintenance of the product. information regarding important 1-3 Safety Information Chapter 1 1.2 Symbols for Safety This section describes a set of symbols that the IEC (International Electrotechnical Commission) has established for medical electronic equipment to classify connections and warnings of any potential hazards. IEC 348: Notice for the user to pay special attention to the following details IEC 878-02-03: Indicates that this is classified into Type BF equipment EN 980: Denotes Date of Manufacture EN 980: Denotes Address of Manufacture IEC60601, ANNEX D: Denotes ON status of main power switch IEC60601, ANNEX D: Denotes OFF status of main power switch SN EN 980: Denotes serial number IEC 417-5031: Denotes DC (Direct Current) IEC 417-5032: Denotes AC (Alternating Current) A V Hz Denotes Ampere, the unit of current Denotes Volt, the unit of Voltage Denote Hertz, the unit of Frequency IEC 417-5021: Denotes potential equalization terminal Single Use Only Use by date 1- 4 Chapter 1 Safety Information 1.3 Function Symbols 1.3.1 MiroView Function Symbols The MiroView software. following table describes symbols or icons used in the Symbol Description Symbol Description Connect to the receiver and open receiver control screen. Open the patient data screen. Open screen to review for a specific patient Select and save an image being reviewed. Move to the previous image. Move to the previous captured image. Play images in sequential order. Stop playback of images. Show images in a single screen. Open the report screen to create a patient capsule endoscopy report. Open screen to export
(save externally) selected image data for a specific patient. Open screen to backup image data for a specific patient. Place a landmark in an image being reviewed. Move to the next image. Move to the next captured image. Play images in reverse order. Show images in full screen Show images in the dual screen. 1-5 Safety Information Chapter 1 Symbol Description Symbol Description Show images in the quad screen. Play the selected images only. View images via Quick Mode function. Show images in the Capture Box by group. When editing the captured image in the report mode, add a circle on the captured image. Erase the circle or arrow displayed in an image when a report is created. Cancel the last action applied to an image when a report is created. Indicate that a report for the selected patient is being created. Indicate that image data for the selected patient has been exported. User logs out from MiroView. Play all images. SGIB - Play the images captured via Suspected GI Bleeding function. Show all images in the Capture Box. When editing the captured image in the report mode, add an arrow on the captured image. Select a color to use in an image when a report is created. Re-apply the cancelled changes when a report is created. Indicate that a report for the selected patient has been created. Indicate that image data for the selected patient has been backed up. Show the complete list of patients 1- 6 Chapter 1 Safety Information 1.3.2 Receiver Function Symbols Symbol Description SIG INI BAT Indicates status of signal from capsule Green : Signal is being received from capsule Yellow : Signal is not being received from capsule Initialization status of Receiver Unit Green : Receiver is initialized Yellow : Receiver is not initialized Battery Status Green : Fully charged Yellow : Not charged 1-7 Safety Information Chapter 1 1.4 Notes for Safe Use
Follow the safety instructions included in this User Manual and clinical precautions advised by the medical professional. The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device and/or product. IntroMedic Co., Ltd. is NOT responsible for physical harm or equipment problems caused by the users careless operation or mismanagement of the device and/or product.
Users MUST have read and understood the User Manual. ONLY trained and qualified medical professionals or authorized representatives of IntroMedic Co., Ltd. may operate the system.
User Manual must ALWAYS be with the equipment. This is the USERS RESPONSIBILITY.
CAUTION:
foreign substances fluids, disinfecting cleanser and such substances may harm the equipment, and should not enter the equipment. including water, cleaning
ONLY authorized personnel may perform repairs. Never attempt to open covers, panels or casings.
DO NOT crease, bend, fold or twist the data cables. Take care to guard
them against mechanical stress (e.g. wheels or heels)!
The sensor pads, receiver, data cables, and capsules must not be exposed to mechanical shock (e.g. by dropping). Any damage caused that way will void the product warranty.
CAUTION: Damage/injuries to the sensor pad or data cable may cause a safety hazard. Damaged items MUST be repaired IMMEDIATELY.
DO NOT handle fluids in the vicinity of the system.
When using a cart purchased elsewhere, ensure the brake or latch guard is in use to prevent the wheels from rolling.
DO NOT USE in moist or damp places. 1- 8 Chapter 1 Safety Information
DO NOT operate the equipment with wet hands.
Avoid using the equipment in extreme temperatures or humid environments.
DO NOT keep the equipment or carry out the procedure in places such as areas exposed to direct sunlight, vicinity of heaters, vicinity of chemical materials or gases, areas moist/damp or dusty, or poorly ventilated areas.
DO NOT disassemble or open the equipment without permission. This will invalidate the warranty.
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, grasp the plug, and pull out. This prevents short-circuits, disconnection, or cord damage.
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 sensor pad.
DO NOT discard sensor pads, cables and connectors with general waste. Discard separately as industrial 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 use for purposes other than medical treatment.
DO NOT connect the USB cable to the receiver while the receivers data cable and sensor pads are still connected 1-9 Safety Information Chapter 1
DO NOT charge the receiver while the receivers data cable and sensor pads are still connected.
Connect USB cable to receiver only after mounting it on charger.
DO NOT install any other programs onto the workstation utilized for review and diagnosis of patient image data (i.e computers with the MiroView software). The capsule is disposable and should not be reused. The capsule and sensor pads are medical waste, and should be disposed of according to local regulations or WEEE directive on waste disposal.
Only use the capsule, receiver, data cables and sensor pads in the medical environment condition.
All products connected with the MiroCam Endoscope system must be compliant with requirements of IEC60950-1 or UL certifications. 1- 10 Chapter 1 Safety Information 1.4.1 Environmental Conditions for Operation
Temperature
Relative humidity
Atmospheric pressure
: +10 - +40
: 45% - 75%
: 700hPa to 1060hPa WARNING DO NOT operate power the equipment in stations, X-ray the vicinity of generators, devices, and broadcasting stations where high levels of electro-magnetic waves are generated. The electro-magnetic waves can cause equipment malfunctions. CAUTION If the equipment has been brought in from a cold environment (stock room, airfreight) into a warm room, initial activation should take place after a few hours, to allow temperature adjustment and balance and evaporation of condensed humidity. for WARNING DO NOT operate the equipment in the vicinity of heat sources, strong electric or magnetic fields (close to a transformer), or near instruments generating high-
frequency signals. WARNING Do not use MiroCam alongside or together with medical devices or procedures involving electrical currents. Do not use MiroCam with h.f. surgical equipment. It may result in burns at the site of the electrodes and possible damage to the capsule and receiver. Do not use the unit in close radius (within 1 m) of short wave or microwave therapy equipment. It may produce instability in the captured image. WARNING This device is a Class B device according to EN60601-1-2 standards. This equipment can cause radio interference in residential areas. In this case, the owner (or operator) can be held responsible to take appropriate measures or take proper measures for compensation. 1-11 Safety Information Chapter 1 1.4.2 Safety Precaution CAUTION - Make sure the environment is without interference from electromagnetic fields.
- Make sure the environment is without noise and
- DO NOT carry out the procedure while using other equipments, devices or products.
- The instruction for use of the sensor pads MUST be vibration. observed.
- DO NOT use on patients with pacemakers or defibrillators. CAUTION DO NOT use the capsule if the package is unsealed.
DO NOT reuse a used capsule.
To prevent unexpected accidents like fire or explosion, do not use any product near or in the presence of inflammable or ignitable substances.
DO NOT disassemble the equipment case nor open the cover. In case service is required, please contact IntroMedic customer support or local point of sale immediately.
Only the accessories authorized and designed by IntroMedic Co., Ltd. should be used with this equipment. Faults resulting from the usage of unapproved or inappropriate accessories are not guaranteed against. This equipment may have an effect on other products or be effected by other products. Follow your doctors instructions and abide by the guidelines in the User Manual.
DO NOT try to upload the data while the data cables are still connected to the receiver.
DO NOT charge the rechargeable battery in the receiver while the data cable and sensor pads are still connected to the receiver. 1- 12 Chapter 1 Safety Information
Stay away from high frequency radiation sites (such as high voltage, radar, installation power plants, MRI, CT or electric blankets etc.) during your capsule endoscope procedure. (It may result in serious side effects requiring an emergency operation.) In case of any symptoms of abdominal pain, vomiting, fever, heart trouble, dizziness or seizure during or after the capsule endoscope procedure, please notify your doctor.
Always check the connection between the receiver and the data cable.
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 be informed via a medical professional regarding appropriate medication & dosage. For more accurate data and better analysis, patients can have solid food for lunch, but must have liquid food for dinner on the day prior to the procedure. The patient must fast for 11 hours prior to ingesting the capsule. If recommended by the physician, the patient may take a laxative prior to the procedure.
DO NOT smoke for at least 12 hours prior to the capsule endoscope procedure.
DO NOT apply body lotion before the procedure.
DO NOT bite the capsule.
Avoid excessive physical activity during the capsule endoscope
procedure. 2 hours after ingesting the capsule, patients may drink water, and after 4 hours, patients may have liquid food. 1-13 Safety Information Chapter 1
When undergoing the capsule endoscope procedure, DO NOT make physical contact with another person undergoing the same procedure.
During operation of the receiver, DO NOT touch the receiver, or get the receiver wet.
Only use the provided batteries, and never remove the battery from the receiver during the procedure.
During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB. This may damage the patients data.
Always confirm that the USB is connected by checking the Receiver screen on the MiroView software.
Always check the AC Power range before use the workstation.
DO NOT touch AC Power code with wet hands.
DO NOT open the receiver bag or touch receiver outside of the hospital. This device is intended for patient over the age of 18.
WARNING The Capsule takes a picture for 11 hours and gets naturally excreted in about 24 hours under normal conditions. If the capsule has not been excreted from the patient within 72 hours, patient should contact the physician. After examining, the physician may need to perform a surgical operation or treatment to remove the capsule. WARNING Before moving the system, always make sure to disconnect the monitor from the main system, and then safely move the main system and monitor separately. Connect the main system and monitor only after the hardware is fully installed, secure and stable. 1- 14 Chapter 1 Safety Information 1.4.3 Cleaning and Maintenance
System and accessories
- All products should be cleanly maintained. For cleaning, rub them lightly with a soft cloth wet with warm water at least once a week. Do not use organic solvents such as lacquer, thinner, ethylene and oxide because they can damage the equipment. Be careful that foreign substances do not enter the main system when cleaning.
- ALWAYS operate the equipment under sanitary environmental conditions. DO NOT use heat or gas for disinfection of the capsule.
Service Document If required, or upon request, the local IntroMedic Distributor (authorized IntroMedic Representative) may provide block diagrams, lists of spare parts, descriptions, adjustment instructions or other related information which may help qualified technical personnel in repairing specified parts of the equipment which have been defined repairable by IntroMedic Co., Ltd.
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 discovered after moving, immediately contact IntroMedic or local Distributor.
1-15 Safety Information Chapter 1 1- 16 Overview & Intended Usage 2 Overview & Intended Usage Chapter 2 2- 2 Chapter 2 Overview & Intended Usage 2. SYSTEM OVERVIEW MiroCam is an orally ingested capsule endoscope designed to capture and wirelessly transmit images of the lining of the small intestine. Captured images are viewed via the MiroView software for diagnosis of diseases related to the small intestine. The MiroCam capsule endoscope system consists of the MiroCam capsule, MiroCam receiver, MiroView software, and accessories. 2.1 Intended Purpose MiroCam is intended for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule
(containing a light source, camera, transmitter, and battery), an electrode array, a receiving/recording unit, a data storage device, computer software to process the images (MiroView), and accessories. 2-3 Overview & Intended Usage Chapter 2 2.1.1 Contraindications
Not intended for patients with known or suspected gastrointestinal tract obstructions, perforations, strictures or fistular.
Not intended for patients who have difficulty ingesting food or pills
(dysphagia).
Not intended for patients who have difficulty communicating.
Not intended for patients with indigestion, or slow gastric emptying.
Not intended for patients who may be affected by electromagnetic radiation, such as pregnant women, infants, and patients with heart disease or epilepsy.
Not intended for patients with diverticulosis in the Small Bowel.
Not intended for patients who are recommended against having the procedure by a Physician.
Not intended for patients with pacemakers and/or defibrillators.
This device is intended for patient over the age of 18. 2.2 Observable Diseases 2.2.1 Obscure gastrointestinal bleeding (OGIB)
Angioectasia
Meckel diverticulum
NSAIDs 2.2.2 Crohns Disease 2- 4 Chapter 2 Overview & Intended Usage 2.2.3 Small Bowel Tumors
Polyps
Peutz-Jeghers Syndrome
Familial adenomatous polyposis Lymphoma
Carcinoid
Gastro-Intestinal Stromal Tumor (GIST) Lipoma
Hemangioma 2.2.4 Inflammation
Intestinal Tuberculosis Typhoid Fever
Angeitis
Amyloidosis
Eosinophilic enteritis 2.2.5 Celiac Disease 2.2.6 Behcets Disease 2.2.7 Cowden Disease 2.2.8 Cronkhite-Canada Syndrom 2-5 Overview & Intended Usage Chapter 2 2- 6 Performing Capsule Endoscopy 3 Chapter 3 Performing Capsule Endoscopy 3- 2 Performing Capsule Endoscopy Chapter 3 3. PERFORMING CAPSULE ENDOSCOPY 3.1 General Comments
This chapter describes how to operate and control MiroCam capsule endoscope system. Installation and initial operation must be done by an Authorized IntroMedic Service Technician. 3.2 Safety Warnings WARNING Before turning on the system, check the environment condition for MiroCam capsule endoscope system. CAUTION In case CAUTION For the system has been brought from cold environment (stock room or airfreight) into a warm room, you should for temperature balance and removing of condensation humidity (Risk of leakage current). it after some hours first switch on the electrical safety, make sure that peripheral equipments (external PC, Monitor, printer etc) should be connected to wall socket of independent power supply with a perfect ground. Particularly make sure whether or not those peripheral equipments should be authorized for medical usage. CAUTION DO NOT touch the dome of the capsule. CAUTION if SIG indicator of the Receiver turns yellow after ingesting CAUTION If SIG indictor of the Receiver does not turn green when the patient holds the capsule by the gold bands, immediately stop the procedure. the capsule, immediately contact the physician. NOTE If images of the small bowel are not captured during the procedure, ensure the capsule has been excreted by the patient and perform procedure again. 3-3 Chapter 3 Performing Capsule Endoscopy 3.3 Examination Preparation The following steps (3.3.1 to 3.3.4) explain the process to initialize the receiver and register patient data for the capsule endoscopy procedure. For more information see section 4.2. 3.3.1 Start System
Turn on power of MiroCam workstation.
Click icon to start the MiroView software program.
Insert the ID and password and click icon. WARNING Before starting the system, check the power rating for the 3.3.2 workstation. Initialize the Receiver
Connect the smaller connector of USB Cable to Receiver unit.
Connect normal connector of USB cable to workstation.
Turn on the power of the Receiver unit. icon in MiroView.
Click icon in the top right of MiroView screen.
Click
After end of formatting of MiroCam Receiver unit, complete patient information and click button. 3- 4 Performing Capsule Endoscopy Chapter 3 Note Before clicking the icon in MiroView, connect USB cable to MiroCam Receiver unit. WARNING If MiroCam receiver unit is initialized, any patient data stored on the device will be deleted permanently. 3.3.3 Receiver Preparation
Connect battery to the receiver unit.
Insert pins on back side of the receiver unit in the slots on the battery.
- Press battery to receiver until clasp locks battery in place. Turn on power switch of receiver unit.
Check battery indicator (BAT) of upper side of receiver unit. If battery is fully charged, light will be green. If light is not green, charge the battery.
Check initialization indicator (INI) of upper side of receiver unit. Prior to beginning a procedure, this light must be green.
Connect data cable to receiver unit. Indicator Description SIG INI BAT Indicates status of signal from capsule Green : Signal is being received from capsule Yellow : Signal is not being received from capsule Initialization status of Receiver Unit Green : Receiver is initialized Yellow : Receiver is not initialized Battery Status Green : Fully charged Yellow : Not charged WARNING DO NOT do begin procedure when receiver units battery indicator is not green. This indicates battery is not fully charge or out of order, and patient data may be lost. 3-5 Chapter 3 Performing Capsule Endoscopy 3.4 Patient Preparation Provide the patient with the following instructions to prepare for the capsule endoscope procedure. 3.4.1 Patient Preparation
One day prior to the capsule endoscope procedure
Lunch: Patient can have a normal mean around noon, followed by a liquid diet as instructed by the physician.
- The patient should fast for at least 12 hours prior to the procedure. Patient may only drink water (no food or other beverages such as milk or coffee).
- The patient should not take any medications two hours before ingesting the capsule endoscope.
- Male patients may need to shave area, as advised by physician or nurse.
- Patient should stop taking iron supplements 1 week before the capsule endoscope procedure, and should not ingest any medicine at least 2 hours prior to the procedure.
- Diabetic patients need to follow any changes to insulin dosage as prescribed by the physician.
- Physician is recommended to prescribe patient a laxative such as PEG or Sodium Phosphate. Patient should ingest laxative 12 hours prior to procedure.
- Physician is recommended to prescribe patient an anti-foaming agent (such as simethicone), to reduce bubbles in the GI tract. This should be ingested after the laxative.
- The patient should abstain from smoking 12 hours before the procedure.
- On the day of the capsule endoscope test, the patient should wear comfortable and loose cloths. One-piece clothing should not be worn.
- Prior to the procedure, do not apply any lotions or perfumes.
On the day of capsule endoscope procedure
- After arriving in a hospital at the appointed time, the patient should submit an examination permission form and check in.
After ingesting capsule endoscope
- The patient should refrain from taking any food or drink two hours after ingesting the MiroCam capsule endoscope. Water is permitted after two hours. 3- 6 Performing Capsule Endoscopy Chapter 3
- The patient can start with light food after 4 hours. When the examination is complete, the patient can start having normal meals. In case of any abdominal pain, nausea or vomiting after ingesting the MiroCam capsule, the patient should contact physician or nurse immediately.
3.5 Sensor Placement & Capsule Ingestion Following is the detailed procedure required to correctly administer the capsule endoscope procedure. 3-7 Chapter 3 Performing Capsule Endoscopy 3.5.1 Connecting Sensor Pads After attaching sensor pads to the data cables, attach the sensor pad correctly to each area as shown below. R 1 5 2 3 4 8 6 7 Xiphoid process Line Pelvic Line 3- 8 Performing Capsule Endoscopy Chapter 3 3.5.2 1 5 4 8 Xiphoid process Line Pelvic Line
Attach sensor pads according to the number on the data cable.
Locate the center between the umbilical and the xiphoid process. From this center point, attach the sensor to the distal point on the right flank of the patients body.
- Place the sensor pad on the xiphoid process line, directly below the right clavicle.
- Place the sensor pad on the xiphoid process line, directly below the left clavicle. Locate the center between the umbilical and the xiphoid process. From this center point, attach the sensor to the distal point on the left flank of the patients body.
- Place the sensor pad on the right pelvic line, 2 cm behind
- Place the sensor on the right inguinal line, 2 cm to the outside of
- Place the sensor on the right inguinal line, 2 cm to the outside of sensor #1. sensor #2. sensor #3. 3-9 Chapter 3 Performing Capsule Endoscopy
- Place the sensor pad on the right pelvic line, 2 cm behind sensor #4.
- Place the sensor directly below the right clavicle. CAUTION The numbering of the data cables and sensor pad must match the specified area. Please follow the numbering sequence appropriately. CAUTION To prevent entanglement of the data cables during procedure, organize cables and place appropriately in cable bag. WARNING Correct image signal may not be obtained if a sensor pad is not in direct, immediate contact with the skin. Ensure the sensor pads are in direct contact with the skin. Shaving may be required for male patients. The pictures below show the sensor pads attached in the correct locations. 3- 10 Performing Capsule Endoscopy Chapter 3 3.5.3 Removing Capsule from Packaging While holding the MiroCam upside down, peel off the sterilized packaging cover. 3.5.4 Removing the Case Turn the package over, the MiroCam case will slip out of the packaging. While holding the MiroCam case, open the lid. 3.5.5 Removing the Capsule Grip capsule with right hand, and remove from cast. Do not touch the dome of the capsule. 3-11 Chapter 3 Performing Capsule Endoscopy
Make sure that the capsule packaging is not damaged in any way. When removed capsule from case, the capsule should be flashing. CAUTION Do not use a capsule endoscope when the packaging or the capsule is damaged.
Check if the front of the capsule is flashing when it is removed from the case
After washing hands, patients should grip the gold section of the capsule between the thumb and the forefinger of the both hands. 3.5.6 Checking Operation of the Receiver and Signal Reception After the patient holds the capsule as detailed above, the signal indicator on the receiver is green and signal indication melody is generated.. If signal indicator is yellow, there is no signal being received from the capsule.
Switch on the receiver.
Check if the battery indicator (BAT) at the top of the receiver shows that the battery is fully charged. The battery indicator on the 3- 12 Performing Capsule Endoscopy Chapter 3 receiver should be green.
Check if the initialize indicator (INI) at the top of the receiver shows that initialization is complete. The INI indicator on the receiver should be green.
Connect the data cable to the MiroCam receiver.
After patient grasps capsule by opposing gold bands (as detailed in picture above, check the SIG indicator on the receiver is green and signal indication melody is generate. CAUTION If the battery indicator on the receiver shows that the battery is not fully charged, do not start the endoscopy procedure. The battery may be depleted during the procedure and images may not be saved properly. 3.5.7 Ingesting the Capsule After checking if the signal indicator on the receiver is green, ingest the capsule with water. CAUTION Do NOT bite the capsule while ingesting. 3-13 Chapter 3 Performing Capsule Endoscopy 3.5.8 Checking and Wearing the Receiver
After ingesting the capsule, make sure that the SIG indicator is green.
Place the receiver in the bag.
Organize the contents of the bag so that the cables are not entangled.
Adjust cables, and place excess in cable bag.
Adjust the bag strap as needed.
Capsule endoscopy procedure will be complete after 11 hours. CAUTION Patient should not touch receiver during the procedure. This may lead to loss of image data. 3- 14 Performing Capsule Endoscopy Chapter 3 3.6 Uploading Images Once the capsule endoscopy procedure is complete, upload image data from the receiver to the workstation and start diagnosis of the data using MiroView. 3.6.1 Transferring and Checking image data
Switch on the workstation.
Click the
When the login window appears, enter the user ID and password, icon on the desktop to launch MiroView. and then click the button.
Connect the smaller end of the USB cable to the receiver.
Connect the other end of the USB cable to the workstation.
Click the button in MiroView.
Click the button in the upper right corner of MiroView.
When the image data in the MiroCam receiver is successfully uploaded, click the MiroView. button in the upper left corner of
Select the patient image data and click the icon to review patient images. WARNING For more information on using MiroView, please refer to Chapter 4, Using MiroView. 3-15 Chapter 3 Performing Capsule Endoscopy 3.7 Receiver Management Post Procedure 3.7.1 Cleaning
Remove data cable from receiver unit.
Capsule and sensor pads should not be reused.
To clean the MiroCam Receiver unit and Workstation, dampen a soft cloth with warm water or with a commercial, nonabrasive cleaner (or a mild soap or detergent solution) and wipe the exterior surface lightly. Do not allow any liquids to come in contact with the power connector, cable connector or switches. Do not allow any liquids to penetrate connectors or openings in the system cover. Cleaning of the system and accessories should be conducted at least once a week. CAUTION Do not immerse the MiroCam capsule endoscope system or its accessories in liquid or clean with caustic or abrasive cleaners. Do not spray or pour any liquid on the system or its accessories. Do not use the organic solvents such as a lacquer, thinner, ethylene and oxide because they can damage the equipment. When cleaning the data cables, do not use the cleaning tools such as brush and sandpaper. 3.7.2 Charging Battery
Battery must be recharged after every procedure.
Battery can be individually recharged or with receiver unit.
Battery must be recharged in battery charger.
in charger, If automatically consecutively charge (not simultaneous). two batteries are inserted the batteries will 3- 16 Performing Capsule Endoscopy Chapter 3
Connect adapter DC cable to battery charger.
Connect AC power code to adaptor.
Connect AC power code to AC consent or multi-tap.
Battery charger indicator lights:
Battery is charging when green light is blinking
Battery is fully charged when light is solid blue
Battery is not-charging if light is yellow
Note: second battery in charger will automatically begin charging once first battery is fully charged. WARNING If the indicator on the battery charger is blinking yellow there is a bad connection. Please disconnect the battery from the battery charger and try again. WARNING Only use batteries provided by IntroMedic. Usage of inappropriate batteries can cause serious damage to the receiver. WARNING Recharge the MiroCam receiver batteries with the adaptor and the battery charger only from IntroMedic. Improper adaptors and battery chargers cause serious damage. 3-17 Chapter 3 Performing Capsule Endoscopy WARNING Try not to contact the metallic terminal board of batteries with conductive objects or human body. It can cause an electric shock or damage and/or breakage of the batteries. WARNING Do not use the batteries with visible surface damage on. Usage of damaged batteries can result in leakage of contents of the batteries. fire. WARNING To avoid the risk of explosion, keep batteries away from WARNING Treat the batteries carefully from serious impact or shock. WARNING Do not expose the batteries to liquids. This can cause This can cause serious damage to the batteries. serious damage. 3- 18 4 Using MiroView Chapter 4 Using MiroView 4- 2 Using MiroView Chapter 4 MiroView is a computer software program that aids in diagnosis of disease of the small bowel via displaying images obtained from the MiroCam capsule. 4. USING MIROVIEW 4.1 Before Using MiroView MiroView will be pre-installed on workstations. Click the corresponding icon on the desktop to launch MiroView. 4.1.1 Starting MiroView
Switch on the workstation.
Click the icon on the desktop to launch MiroView.
When the login screen appears, enter your user ID and password and press the button to access MiroView. CAUTION Before starting the system, check the power rating for the NOTE If you have forgotten your password, contact your system workstation. administrator or local IntroMedic representative. 4-3 Chapter 4 Using MiroView 4.1.2 MiroView Icons Symbol Description Symbol Description Connect to the receiver and open receiver control screen. Open the patient data screen of the MiroCam system. Open screen to review for a specific patient Select and save an image being reviewed. Move to the previous image. Move to the previous captured image. Play images in sequential order. Stop playback of images. Show images in a single screen. Show images in the quad screen. Open the report screen to create a patient capsule endoscopy report. Open screen to export
(save externally) selected image data for a specific patient. Open screen to backup image data for a specific patient. Place a landmark in an image being reviewed. Move to the next image. Move to the next captured image. Play images in reverse order. Show images in full screen Show images in the dual screen. Play all images. 4- 4 Using MiroView Chapter 4 Symbol Description Symbol Description View images via Quick Mode function. Show images in the Capture Box by group. When editing the captured image in the report mode, add a circle on the captured image. Erase the circle or arrow displayed in an image when a report is created. Cancel the last action applied to an image when a report is created. Indicate that a report for the selected patient is being created. Indicate that image data for the selected patient has been exported. User logs out from MiroView. SGIB - Play the images captured via Suspected GI Bleeding function. Show all images in the Capture Box. When editing the captured image in the report mode, add an arrow on the captured image. Select a color to use in an image when a report is created. Re-apply the cancelled changes when a report is created. Indicate that a report for the selected patient has been created. Indicate that image data for the selected patient has been backed up. Show the complete list of patients 4-5 Chapter 4 Using MiroView 4.1.3 MiroView Menus File Menu changes Save comments etc.) to Database
(captured images, Backup patient information and image data file (complete file) Restore patient information and image data file into MiroView (from backup file) Save captured images, videos and/or patient report to a designated storage space (USB etc.) Export patient information and image data file for MiroView Express Import patient information and image data file from MiroView Express Preview of printing image Print current patient report Convert the report to a PDF file Print system and/or patient check list Printer settings Close MiroView Software Save Backup Restore Export Export for MiroView Express Import for MiroView Express Preview Print Report Save as PDF File Print check list Printer options Close 4- 6 Using MiroView Chapter 4 Tools Menu Settings Setting MiroView Software View history of changes View history of changes View personal info Display patient information Delete Reload Play mode Delete the selected file from the list Refresh the list of patient files Change the play mode Show compare window Show comparison window Show position window Show positioning window 4-7 Chapter 4 Using MiroView 4.1.4 MiroView Keyboard shortcuts List Screen
<<F5>>
or Mouse Wheel
<<Enter>>
<<Home>>
<<END>>
<< PGUP>>
<<PGDN>>
<<CTRL>> + << PGUP>>
<<CTRL>> + <<PGDN>>
Refresh List Move the cursor up / down the list Select a file from the list to review Go to first page of patient files Go to last page of patient files Move 1 page in direction of older files Move 1 page in direction of newer files Move 10 pages in direction of older files Move 10 pages in direction of newer files Review Screen
<<Space>>
(While Playing)
Mouse Wheel
<<CTRL>>
<<PGUP/PGDN>>
<<CTRL>> +
<<direction arrows>> or
<<CTRL>>+ mouse wheel
<<LShift>> + /
(LShift+ wheel up/dn)
<<CTRL>>+<<+>>
<<CTRL>>+<<->>
4- 8 Start / Pause video while in play mode Increase Frame-rate Decrease Frame-rate Move forward / backward frame by frame Skip forward / backward to next ten captured images. Move to previous / next captured image Move to the previous/next sub-captured image Expand images. Hide all sub-captured images. to display all sub-captured Using MiroView Chapter 4 Delete a selected arrow or circle Drawing Tool
(Used in Comparison Window & Report Mode)
<<Delete>>
(After selecting a or more diagram)
<<CTRL>> + <<Delete>>
<<CTRL>> + <<z>>
<<CTRL>> + <<LSHIFT>>
+<<z>>
Delete all arrows / circles Undo Redo 4-9 Chapter 4 Using MiroView 4.1.5 Basic Screen Layout
4- 10
Receiver
List
Review
Report
Export
Backup
Whole List
Active Item to the the patient data screen of Connect to the receiver and switch to the control screen. Switch MiroCam system. Switch to the screen where images for the selected patient can be reviewed. Switch to the screen where a report for the selected patient can be created. Switch to the screen where image data for the selected patient can be exported. Switch to the screen where image data for the selected patient can be backed up. Show the complete list of patients contained on the workstation. In the complete list of patients, the patients in yellow are the ones being diagnosed and the items in grey are the ones deleted. NOTE In the complete list of patients screen, use the review, report or backup function by clicking the right mouse button. Using MiroView Chapter 4
Review View
Report View 4-11 Chapter 4 Using MiroView 4.1.6 Basic Procedure
In the patient list, select a desired patient and press the to review data for the selected patient. button
Press the
Press the
Press the
Press the button to play the images. button to stop playback of the images. button to save the current image in the Capture Box. button to create and print a report for the patient being diagnosed.
Press the button to upload the data from the receiver or to initialize the receiver. 4.2 Administering and Initializing Patients Before performing capsule endoscopy, run MiroView to check in
(administer) and initialize the receiver for a patient. 4.2.1 Sequence of Operation
Initialize the receiver unit button.
- Press the
- Connect the receivers USB cable to the receiver. 4- 12 Using MiroView Chapter 4
- Press the button to continue.
- The initialization screen will appear.
- Click the Yes button to initialize.
- When the progress bar is full and the complete message appears, the initialization is complete.
- Click the the patient. button and enter basic information for 4-13 Chapter 4 Using MiroView
- Complete all fields and click ready for use.
Upload image data for patient
- Press the button. button. Receiver is
- Connect the receivers USB cable to the receiver.
- Press the appears. 4- 14 button, and wait until the following screen Using MiroView Chapter 4
- When the progress bar is full and the complete message appears, the upload is complete.
Play and diagnose image data for a patient
- Select the desired patient from the patient list.
- Press the
- Press the button. button to play and diagnose image data.
Printing Patient Report
- Press the
- Create a report.
- Print the report button. CAUTION The installation and initial operation of the system should be performed by authorized service personnel from IntroMedic. Follow the steps in the Service Manual. CAUTION Before starting the procedure, ensure the environmental conditions are suitable, as described in the User Manual. , 4-15 Chapter 4 Using MiroView 4.2.2 MiroView Setting
Settings Menu is selected from Tools Menu
- Name of hospital: Input the hospital name
- DB server: IP address for using a DB (PostGreSql server). Consult with IT staff to properly use this option. Language: Select preferred language.
- Measurement units: Choose preferred measurement units.
User Option Tab within Settings Menu
- User Name: Change the name of doctor which appears in the top right of the MiroView program.
- Number of sub-capture images: Select the number of sub-
captured images (from 0 to 9).
- Export option: Select type of report files to be exported: avi +
4- 16 Using MiroView Chapter 4 jpeg, avi only, jpeg only, avi + jpeg. Selecting All includes all files (both included and not-included in report).
- View Style: Select preferred viewing style.
Miscellaneous Tab within Setting Menu
- New User: Create a new ID. Only the master user can use this function.
- Current User: Change the password of the current user.
- Select Image: Save a logo image to insert into the report. Appropriate image file size should be used.
- Delete Image: Delete logo image. NOTE To apply the changes from the Settings menu, the user must close and re-start the MiroView program. 4-17 Chapter 4 Using MiroView 4.3 Viewing Setting
Single view
- Click the
- The Single View screen will appear, allowing viewing of a icon in the upper right corner of MiroView. single image.
Dual view
- Click the
- The Dual View screen will appear, allowing viewing of two icon in the upper right corner of MiroView. images at a time. In this screen, images are displayed alternately in each pane.
4- 18 Using MiroView Chapter 4
Quad view
- Click the
- The Quad View screen will appear, allowing viewing of four icon in the upper right corner of MiroView. images at a time. In this screen, images are displayed alternately in each pane.
CAUTION Because the playback speed varies depending on the view type, use the view that is most comfortable and appropriate for diagnosis. Do not be confused due to odd image on the center. The S/W distorts center of an image to fill out. Zoom
- Click the
- The Zoom screen will appear, allowing viewing of zooming icon in the upper right corner of MiroView. image at a time
4-19 Chapter 4 Using MiroView 4.3.1 Viewing Mode Setting
Click the icon in the upper right corner of MiroView to view images in normal playback mode, in which all images are displayed.
Click the icon in the upper right corner of MiroView to view images in brief playback mode, in which the selected images are displayed based on their similarities. This mode will skip images which are the same. CAUTION Quick View mode does not display all images, so it is not intended for diagnosis. Use normal playback mode for diagnosis.
Click the icon in the upper right corner of MiroView to use the SGIB (Suspected GI Bleeding) function to view images containing suspected bleeding. CAUTION Because SGIB mode only display images selected by software, it is possible that there are some images or areas of GI bleeding not detected by the software.
Use the image playback speed bar in the center of the MiroView screen to adjust the playback speed for images. The playback speed is measured in the number of images displayed per second.
Use the control icon in the center of the MiroView screen to specify how images are displayed. Image displayed by following capsule progress. Image displayed by reverse capsule progress. Stop image display. Display next frame image Display previous frame image Display next captured image Display previous captured image 4- 20 Using MiroView Chapter 4 4.3.2 Setting and Using Capture Box
Save data in capture box Clicking the button in the upper right corner of MiroView displays the area corresponding to the current image in the time bar and saves the image group for the area in the Capture Box. Use the capture (
displayed in the Capture Box.
) button to save images. Images will be 4-21 Chapter 4 Using MiroView
Save data in capture box Click the icon in the center of the MiroView screen to specify the start point of each area of the GI tract. Images for each area of the GI tract are displayed in the time bar and are saved in the Capture Box.
Specify playback position Drag and drop the position control bar in the time bar to place an image to display in the center of the screen. 4- 22 Using MiroView Chapter 4
View saved images The captured images group and landmarked images can be viewed in the Capture Box. Captured images cannot be viewed in the Quad View screen. Use the left or right arrow to view the saved images from start to finish. Previous Next Image NOTE Using the Mouse Wheel When paused, move the mouse wheel down to view the
'next image and move it up to view the previous image. During playback, you can display the previous or next images by using the mouse wheel. Click the + icon to display the all captured images in the group. A group consists of between 2 to 9 neighboring images before and after a captured image. Use the SGIB (Suspected GI Bleeding) detection bar at the top of the time bar to retrieve images with suspected bleeding. 4-23 Chapter 4 Using MiroView 4.3.3 Setting and Using Tracking Function
Click the screen. button in the lower center of the
The route taken by a capsule will be displayed in 2D based on actual human anatomy. 4- 24 Using MiroView Chapter 4 4.3.4 Setting and Using Comparison Window in The current image can be compared with existing images of other patients identify disease pathologies or abmormalities. the Compare window to readily
Click the button in the right side of the screen.
Click the button in the Compare window.
Image data that will be displayed in the Compare window can be selected and sorted. 4-25 Chapter 4 Using MiroView
The function can be used in the Compare window.
In the Compare window, circle or arrow marks can be placed or removed to highlight a specific area. 4- 26 Using MiroView Chapter 4 4.4 Creating a Report After reviewing images, a diagnostic report can be created for the patient. Access via the icon. 4.4.1 Editing Report
Click
Enter patient icon in the upper left corner of MiroView. information, and procedure the appropriate text boxes; choose a desired text box from the tab. The tab is editable. Click the icon to add and name a text box onto the tab. findings in
A specific image can be selected, and related comments entered in the text box. Double-click the left mouse button to select desired image. If needed, place a mark on disease pathology in the captured image.
Add circle mark Add arrow mark Delete added mark Change marker color Undo last action Redo last undo action 4-27 Chapter 4 Using MiroView
Check the Final Approval option in the lower right corner.
Press the
Press the button to save the created report. button to print a report for the selected patient. CAUTION If Final Approval is not checked, a report cannot be used as a medical examination certificate. However, if it is checked, the report becomes a finalized medical examination certificate that is not editable. 4- 28 Using MiroView Chapter 4 4.4.2 Settings
Press the button to change settings.
Press the right-mouse button to see the pop-up menu. 4-29 Chapter 4 Using MiroView
Press the right-mouse button on the desired text line to edit. Pop-up menu will appear and select Edit Caption to change text.
Add images or logos to report:
o Click Add Image on the pop-up menu. 4- 30 Using MiroView Chapter 4 o Rectangular area appears. o Click the right-mouse button on the rectangular area. Click Select Image. 4-31 Chapter 4 Using MiroView o Select the desired image or logo to insert. o Image box can be resized and moved to the desired location. 4- 32 Using MiroView Chapter 4 4.5 Atlas For reference, the MiroCam Image Atlas provides an extensive image library of disease pathology and normal anatomy. Users can access the Atlas DB via Atlas function on the Help menu. 4.5.1 Accessing Atlas
Execute Atlas from the Help menu
Select image from categories in the bottom left. 4-33 Chapter 4 Using MiroView
Click on an image from the Image Atlas to add to the Comparison Window in Review Mode CAUTION My Atlas DB is not available in MiroView Express but only in MiroView. 4- 34 Using MiroView Chapter 4 4.6 Backing up Patient Data 4.6.1 Backing up Image Data
The entire image data for the selected patient can be backed up onto a DVD, an external HDD or a USB flash memory.
Select a patient to back up from the patient list in MiroView and click the icon.
Click the icon and then move and save image data onto a DVD. If needed, insert an additional DVD and continue to save the data. CAUTION The number of DVDs required for backup is displayed. Check the number of DVDs available and click the icon. NOTE A 4.7G DVD is recommended for optimal backup results. 4-35 Chapter 4 Using MiroView 4.6.2 Exporting Image Data
Selected images and report files for a patient can be exported to a CD/DVD, an external HDD or a USB flash memory.
Select a patient to back up from the patient list in MiroView and click the icon.
Click the Burn icon and then move and save the image data onto a
DVD. If needed, insert an additional DVD or CD and continue to save the data. CAUTION The number of DVDs or CDs required for exporting is displayed. Check the number of DVDs or CDs available and click the CAUTION The same type of CD or DVD should be used for a backup. If backup fails, it should be started again from the beginning. icon. 4- 36 Using MiroView Chapter 4 4.6.3 Exporting Image Data for MiroView Express
MiroView Express Overview MiroView Express software is a light version of the MiroView software, which can be installed on laptops or a PC (at home or the office), and is designed to enable Physicians to more readily review patient files. To view a patient file with MiroView Express, it is necessary to export the desired patient file from the MiroView workstation (via the Export for Express function). The file can be exported to external storage devices, including USB flash memory or USB external hard drive. Before using the Export to MiroView Express function, insert or connect the external storage device (external hard disk or USB flash memory). The storage device must have a minimum of 4GB free space to export a file for MiroView Express (exact requirement will vary).
Select Export for MiroView Express from the File tab in MiroView. 4-37 Chapter 4 Using MiroView
Select the location of the storage device and complete the File name field.
A progress bar will appear.
When complete, the following message Exporting has been completed. will appear. 4- 38 Using MiroView Chapter 4 4.6.4 Importing Image Data for MiroView Express After reviewing the patient file with MiroView Express, the changed data (i.e. saved images, comments, reports etc.) can be synchronized with the patient file in the MiroView workstation via the Import from MiroView Express function.
Select Import from MiroView Express from the File tab in MiroView.
Select the patient file to import (from the external storage device with the patient file). 4-39 Chapter 4 Using MiroView
Confirm file by click Button.
A progress bar will appear.
When import is complete, following message Import from MiroView Express is complete. will appear. CAUTION For further information about MiroView Express, please refer to the MiroView Express User Guide included with the installation CD, and/or contact your local IntroMedic Representative for assistance. 4- 40 Using MiroView RTV 5 Chapter 5 Using MiroView RTV 5- 2 Using MiroView RTV Chapter 5 5. USING MIROVIEW RTV MiroView RTV, the application software for the MiroCam System Real-
time Viewer, consist of a data transmission module that directly receives the image data from the receiver and an output module for image display. 5.1 Overview MiroView RTV will be pre-installed on UMPC(Ultra-Mobile PC) that provided by IntroMedic. Click the corresponding icon on the desktop to launch the MiroView RTV. 5.1.1 Basic Screen Layout
Name / ID / Gender / Age
Start / Pause / Resume
Main Display
Time Display Display patient name, ID, gender and age Change MiroView RTV operation status between start, pause and resume.
Patient Information
Operation
Main Display Display captured image.
Time Display Button Indicates procedure time. the MiroCam capsule endoscope 5-3 Chapter 5 Using MiroView RTV 5.1.2 Basic UMPC Layout
USB Port
DC-Jack
Power Switch UMPC Power on switch. USB Port for connect with MiroCam Receiver Connector for UMPC Charger WARNING Only use UMPC provided by IntroMedic. Usage of inappropriate UMPC can cause serious harm to the patient. WARNING Only recharge the UMPC batteries with the adaptor from IntroMedic. Use of the improper adaptor can cause serious damage to patient and UMPC. WARNING For safe use of UMPC, please refer to UMPC User Manual.
5- 4 Using MiroView RTV Chapter 5 5.2 Using MiroView RTV with MiroCam Receiver MR1000 5.2.1 Before Using MiroView RTV
The MiroView RTV software is pre-install on UMPC provided by IntroMedic. WARNING Do not use MiroView RTV software and UMPC before upgrading the MiroCam receiver. WARNING Do not upgrade MiroCam receiver during the MiroCam capsule endoscopy procedure, it may result in loss if image data .
Connect the data cable for the Real-time Viewer to the MiroCam receiver. NOTE The data cable for MiroView RTV has no cover for the USB port on the receiver.
Fallow the MiroCam capsule endoscopy procedure. NOTE For more information on the MiroCam capsule endoscope procedure, please refer to Chapter 3, Performing Capsule Endoscopy. 5-5 Chapter 5 Using MiroView RTV 5.2.2 Starting MiroView RTV
Switch on the UMPC.
Click the
Connect the small side of the USB cable to the receiver. icon on the desktop to launch MiroView RTV.
Connect the large side of the USB cable to the UMPC.
Click the
Click the
Click the
Click the button to start image display button to stop image display button to restart image display button on the top-right to close the MiroView RTV. NOTE Start, Pause, and Resume use the same button. The function (Start, Pause or Resume) changes based upon the status of MiroView RTV software. CAUTION MiroView RTV is not software for to be used for diagnostic purposes. Use the MiroView software for viewing the patient images for diagnostic purposes. CAUTION Do not disconnect the receiver while the RTV is in use. If the receiver is disconnected during use, the software may need to be restarted. NOTE If an error message appears while using MiroView RTV, reconnect the USB cable between MiroCam receiver and UMPC 5- 6 Using MiroView RTV Chapter 5 5.2.3 After Using MiroView RTV
Disconnect USB cable from MiroCam Receiver and UMPC.
Charge the UMPC by using the adaptor provided by IntroMedic.
Continue MiroCam capsule endoscope procedure. 5.3 Using MiroView RTV with MiroCam Receiver MR2000 5.3.1 Before Using MiroView RTV
The MiroView RTV software is pre-install on UMPC provided by IntroMedic. Fallow the MiroCam capsule endoscopy procedure. NOTE For more information on the MiroCam capsule endoscope procedure, please refer to Chapter 3, Performing Capsule Endoscopy. 5-7 Chapter 5 Using MiroView RTV 5.3.2 Starting MiroView RTV
Switch on the UMPC.
Click the
Connect the small side of the USB cable to the receiver. icon on the desktop to launch MiroView RTV.
Connect the large side of the USB cable to the UMPC.
Click the
Click the
Click the
Click the button to start image display button to stop image display button to restart image display button on the top-right to close the MiroView RTV. NOTE Start, Pause, and Resume use the same button. The function (Start, Pause or Resume) changes based upon the status of MiroView RTV software. CAUTION MiroView RTV is not software for to be used for diagnostic purposes. Use the MiroView software for viewing the patient images for diagnostic purposes. CAUTION Do not disconnect the receiver while the RTV is in use. If the receiver is disconnected during use, the software may need to be restarted. NOTE If an error message appears while using MiroView RTV, reconnect the USB cable between MiroCam receiver and UMPC 5- 8 Using MiroView RTV Chapter 5 5.3.3 After Using MiroView RTV
Disconnect USB cable from MiroCam Receiver and UMPC.
Charge the UMPC by using the adaptor provided by IntroMedic.
Continue MiroCam capsule endoscope procedure. 5-9 Chapter 5 Using MiroView RTV 5- 10 A Appendix Case Form Report A- 2 Case Form Report Trial ID :
Version No. : 1.0 : 30/07/2007 CASE REPORT FORM Subject No.:
Subject Initials :
Center No.:
Principal Investigator Center Name Address Telephone No. Fax No. E-mail CONFIDENTIAL A-3 Trial ID :
Case Form Report Version No. : 1.0 :
30/07/2007 Screening Subject No.:
Subject Initials :
Center No.:
Date of Informed consent signed D M M Y Y Y Y Inclusion Criteria Yes No N/A 1. Informed consent form voluntarily signed 2. Male / Female subject of age 19 years~70 years. If there is one or more mark of No, you shall be contradicted for this clinical test. CONFIDENTIAL A- 4 Case Form Report Trial ID :
Version No. : 1.0 : 30/07/2007 Screening Subject No.:
Subject Initials :
Center No.:
Date of visit :
D M M Y Y Y Y Exclusion Criteria Yes No N/A 1. Do you have a gastrointestinal disorder
(suspected malignantlesions or gastrointestinal obstructive disorders, perforation, stenosis or fistula)?
2. Do you have a cardiovascular disorder (dysrhythemia, trouble with cardiac conduction system, hypertension(high blood pressure) or ischemic heart disease)?
3. Have you been diagnosed of cardiac insufficiency, angina pectoris or cardiac arrest (heart attack) in recent 6 months?
bearing potential?
pacemaker or defibrillator?
4. Are you with (or implanted) medical devices such as cardiac 8. Are you an infant or epileptic? Are you easily affected by 5. Do you have a swallowing disorder?
6. Do you have delayed gastric emptying or serious gastric disorder?
7. Are you a pregnant or nursing woman, or a woman of child 9. Do you have several small bowel diverticulums ?
10. Did you fail to obtain a voluntary agreement?
11. Are you judged unqualified for this test by doctors or nurses?
If there is one or more mark of Yes, you shall be contradicted for this clinical test. CONFIDENTIAL electronic waves?
A-5 Case Form Report A- 6 EC Representative NanoMedical Largo do Sequeira 7 G3 P.E. 1100-587 Lisboa Portugal Key Contact: Nuno Nicola Covacich Office: +351-21-884-3140 Mobile: +351964468482 or +351961300259 Email: nuno.nicola@nano-medical.org IntroMedic Co.,Ltd. Suite 1104, E&C Venture Dream Tower 6-Cha 197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719 Tel : +82-2-801-9300 Fax : +82-2-801-9330 http://www.intromedic.com e-mail : help@intromedic.com Disposal of Old Electrical &
Electronic Equipment Applicable in the European Union and other European countries with separate collection systems 0843
| 1 | User Manual 2 | Users Manual | 4.47 MiB | May 05 2009 |
Service Manual Copyright 2007 IntroMedic Co., Ltd. MM1100-0807 Version 1.22 Date : 2008-07-01 Warranty Trademarks MiroCam, MiroView, IntroMedic, and the associated logos are the registered trademarks or trademarks of IntroMedic Co., Ltd. IntroMedic Co., Ltd. July 2007. Except as required by applicable copyright laws; any use of the IntroMedic trademarks, or any reprinting, reproduction, modification, referencing and translations of the User Manual, without the prior written approval of IntroMedic Co., Ltd. is strictly prohibited. Warranty Every effort has been made to ensure the information contained in this Service Manual is accurate, and is believed to be correct at time of printing. IntroMedic reserves the right to change any content contained with this Service Manual without prior notice. IntroMedic Co., Ltd. warrants the product against defects in material and workmanship for a period of twelve (12) months from the date of sale, unless different local regulations apply. IntroMedic Co., Ltd. will repair or replace products that are ascertained by IntroMedic to have defects during the warranty period. IntroMedic Co., Ltd. is not liable for the defects occurred by misuse, careless handling, unauthorized modifications or erroneous use, or any use that is non-compliant with instructions detailed within this Service Manual. This includes use of the product in non-appropriate locations or conditions. Any other warranties are neither represented here nor recognized by implication. To validate the warranty, please complete product registration with the local authorized IntroMedic distributor. Page 3 Warranty Exclusive warranty service The warranty service provided hereby is applicable exclusively to the purchaser of the product. IntroMedic will only warranty the product for purposes and usage as defined in this Service Manual. Any usage not heeding the warnings, cautions and recommended usages as defined in this manual will nullify the warranty. Support For warranty or repair service please contact the local authorized IntroMedic distributor. For customer service or support please contact your point of purchase or IntroMedic Co., Ltd. Service agreements are only applicable to products of IntroMedic Co., Ltd. IntroMedic Customer Service TEL: 82-2-801-9300 FAX: 82-2-801-9330 http://www.intromedic.com E-mail: helpdesk@intromedic.com Safety Non-compliance with the users manual, unauthorized modifications of the product or replacement of parts, and/or opening of the product casing is prohibited and may be hazardous. Page 4 Contents Contents 1. SYSTEM OVERVIEW ................................... 3 1.1 Warnings ............................................................. 3 1.2 Symbols for Safety ............................................... 4 1.3 Function Symbols ................................................ 5 1.4 Remarks for Safe Use .......................................... 8 2. SYSTEM OVERVIEW ................................. 19 2.1 MiroCam Overview .......................................... 19 2.2 MiroCam System Main Components ................... 20 2.3 MiroCam Method of Action .............................. 21 2.4 System Configuration......................................... 23 2.5 Product Specifications....................................... 27 2.6 Component List.................................................. 37 3. PRODUCT INSTALLATION ....................... 41 3.1 Component Check List....................................... 41 3.2 Packaging Specifications ................................... 42 3.3 Installation Diagram ........................................... 45 3.4 System Installation & Connection....................... 46 3.5 MiroView Installation....................................... 50 4. TECHNICAL DATA..................................... 93 4.1 Overview............................................................ 93 4.2 Hardware........................................................... 93 4.3 Software ............................................................ 96 4.4 Compliance / Approvals ..................................... 98 Page 5 Contents 5. Storage & Transportation .................. 103 5.1 Safe Storage Conditions ...................................103 5.2 Safety Transportion Conditions.........................103 6. TROUBLESHOOTING.............................. 107 6.1 Introduction ......................................................107 6.2 Who should perform repairs..............................107 6.3 Obtain replacement parts .................................107 6.4 Troubleshooting Guide......................................108 7. PACKING FOR SHIPMENT...................... 115 7.1 General Introduction.........................................115 7.2 Repacking in Original Packing Box ....................115 7.3 Repacking in Different Packing Box...................121 8. EMC INFORMATION................................ 125 Page 6 Safety Information 1 Safety Information Chapter 1 Page 2 Chapter 1 Safety Information 1. SYSTEM OVERVIEW 1.1 Warnings together with IEC 60601-1, the Collateral Standard MiroCam has been manufactured to conform with the International Standard for Medical Electrical Equipment: General Requirements for Safety for Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2. MiroCam has been manufactured to conform to the electric shock, fire and mechanical hazard standards as defined in CAN/CSA C22.2 NO.601.1. Based on request of the buyer, IntroMedic will provide the labeling, such as ID labels, and the User & Service Manual in the national language(s) of European countries. Translated documents will be evaluated by a local language expert, and will be confirmed by a native speaker of the respective national language. Safety Symbols: The User & Service Manual incorporates various safety symbols to ensure safe and correct use of the product and to prevent any personal injury or property damage. These symbols are defined in the following table:
WARNING WARNING indicates a potential hazard that, if not avoided, could result in serious personal injury or damage to the product. CAUTION CAUTION indicates a potential hazard that, if not avoided, could result in minor personal injury or damage to the product. NOTE NOTE does not indicate potential hazards as in Caution or Warning, but contains the installation, operation or maintenance of the product. information regarding important Page 3 Safety Information Chapter 1 1.2 Symbols for Safety This section describes a set of symbols that IEC (The International Electrotechnical Commission) has established for medical electronic equipment to classify a connection or warning of any potential hazards. IEC 348: Notice for the user to pay special attention to the following details IEC 878-02-03: Indicates that this is classified into Type BF equipment EN 980: Denotes Date of Manufacture EN 980: Denotes Address of Manufacture IEC60601, ANNEX D: Denotes ON status of main power switch IEC60601, ANNEX D: Denotes OFF status of main power switch 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 Denote Herz, the unit of Frequency IEC 417-5021: Denotes potential equalization terminal Single Use Only Use by date SN A V Hz Page 4 Chapter 1 Safety Information 1.3 Function Symbols 1.3.1 Application Function Symbols table describes symbols or icons used in the following The MiroView software. Symbol Description Symbol Description Connect to the receiver and open receiver control screen. Open the patient data screen of the MiroCam system. Opens screen to view MiroCam for a specific patient. Select and save an image being reviewed. Move to the previous image. Move to the previous captured image. Play images in sequential order. Stop playback of images. Show images in a single screen. Open the report screen to create a patient capsule endoscopy report. Open screen to export
(save externally) selected image data for a specific patient. Open screen to backup image data for a specific patient. Place a landmark in an image being reviewed. Move to the next image. Move to the next captured image. Play images in reverse order. Zoom images. Show images in the dual screen. Page 5 Safety Information Chapter 1 Symbol Description Symbol Description Show images in the quad screen. Play the selected images only. View images via Quick Mode function. Show images in the Capture Box by group. When editing the captured image in the report mode, add a circle on the captured image. Erase the circle or arrow displayed in an image when a report is created. Cancel the last action applied to an image when a report is created. Indicate that a report for the selected patient is being created. Indicate that image data for the selected patient has been exported. Play all images. SGIB - Play the images captured via Suspected GI Bleeding function. Show all images in the Capture Box. When editing the captured image in the report mode, add an arrow on the captured image. Select a color to use in an image when a report is created. Re-apply the cancelled changes when a report is created. Indicate that a report for the selected patient has been created. Indicate that image data for the selected patient has been backed up. User logs out from MiroView. Show the complete list of patients Page 6 Chapter 1 Safety Information 1.3.2 Receiver Function Symbols Symbol Description SIG INI BAT Indicates status of signal from capsule Green: Signal is being received from capsule Yellow: Signal is not being received from capsule Initialization status of Receiver Unit Green: Receiver is initialized Yellow: Receiver is not initialized Battery Status Green: Fully charged Yellow: Not charged Page 7 Safety Information Chapter 1 1.4 Remarks for Safe Use n n n Follow the safety instructions included in this Service Manual and clinical precautions advised by medical professionals. The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device and/or product. IntroMedic Co., Ltd. for physical harm or equipment problems caused by the users careless operation or mismanagement of the device and/or product. is NOT responsible n Users MUST have read and understood the User Manual. ONLY trained and qualified medical professionals or authorized representatives of IntroMedic Co., Ltd. may operate the system. n User Manual must ALWAYS be with the equipment. This is the USERS RESPONSIBILITY. n CAUTION: The equipment should not be exposed or come in contact with foreign substances including water, cleaning fluids, disinfecting cleanser; as such substances may harm the equipment n ONLY authorized personnel may perform repairs. Never attempt to open covers, panels or casings. n DO NOT crease, bend, fold or twist the data cables. Take care to n guard them against mechanical stress (e.g. wheels or heels)!
The sensor pads, receiver, data cables, and capsules must not be exposed to mechanical shock (e.g. by dropping). Any damage caused will void the product warranty. n CAUTION: Damage/injuries to the sensor pad or data cable may cause a safety hazard. Damaged items MUST be repaired IMMEDIATELY. n DO NOT handle fluids in the vicinity of the system. n When using a cart, ensure the brake or latch guard is in use to prevent the cart from rolling. n DO NOT USE in moist or damp places. Page 8 Chapter 1 Safety Information n DO NOT operate the equipment with wet hands. n Avoid using environments. the equipment in extreme temperatures or humid n DO NOT keep the equipment or carry out the procedure in places such as areas exposed to direct sunlight, vicinity of heaters, vicinity of chemical materials or gases, areas moist/damp or dusty, or poorly ventilated areas. n DO NOT disassemble or open the equipment without permission. This will invalidate the warranty. n DO NOT carry out the procedure in areas with high vibrations or in environments where high electro-magnetic waves are generated. n DO NOT pull out the power cord by grabbing the cable. When disconnecting the power cord, grasp the plug, and pull out. This prevents short-circuits, disconnection, or cord damage. n CAUTION: Verify that the power voltage supplied from the power receptacle matches with the voltage the system requires. Check Voltage and Frequency on the AC/DC adaptor. n CAUTION: Verify that all connection terminals are securely connected to the system. n CAUTION: Turn off the power switch on the receiver before connecting the sensor pads. n DO NOT discard cables and connectors with general waste. Discard separately as industrial or medical waste. n CAUTION: Discard the battery according to the regulations of industrial n waste. DO NOT discard with general waste. The capsule and sensor pads are medical waste, and should be disposed of according to local regulations or WEEE directive on waste disposal. n DO NOT carry out the procedure simultaneously with other procedures using medical products or equipment. Page 9 Safety Information Chapter 1 n DO NOT use for purposes other than medical treatment. n DO NOT connect the USB cable to the receiver while the receivers data cable and sensor pads are still connected. Page 10 Chapter 1 Safety Information n DO NOT charge the receiver while the receivers data cable and sensor pads are still connected. n Connect USB cable to receiver only after mounting it on charger. n DO NOT install any other programs onto the workstation utilized for review and diagnosis of patient image data (i.e computers with the MiroView software). The capsule is disposable and should not be reused. In the medical environment condition, only use the capsule, receiver, data cable and sensor pads. n n n All products connected with the MiroCam Endoscope system must be compliant with requirements of IEC60950-1 or UL certifications. Page 11 Safety Information Chapter 1 1.4.1 Environmental Condition for Operation n Temperature n Relative humidity n Atmospheric pressure
: +10 - +40
: 45% - 75%
: 700hPa to 1060hPa WARNING DO NOT operate power the equipment in stations, X-ray the vicinity of generators, devices, and broadcasting stations where high levels of electro-magnetic waves are generated. The electro-magnetic waves can cause equipment malfunctions. If from a cold environment (stock room, airfreight) into a warm room, initial activation should take place after a few hours, to allow temperature adjustment and balance and evaporation of condensed humidity. the equipment has been brought for in CAUTION WARNING DO NOT operate the equipment in the vicinity of heat sources, strong electric or magnetic fields (close to a transformer), or near instruments generating high-
frequency signals. WARNING Do not use MiroCam alongside or together with medical devices or procedures involving electrical currents. Do not use MiroCam with h.f. surgical equipment. It may result in burns at the site of the electrodes and possible damage to the capsule and receiver. Do not use the unit in close radius (within 1 m) of short wave or microwave therapy equipment. It may produce instability in the captured image. WARNING This device is a Class B device according to EN60601-1-2 standards. This equipment can cause radio interference in residential areas. In this case, the owner (or operator) can be held responsible to take appropriate measures or take proper measures for compensation. Page 12 Chapter 1 Safety Information 1.4.2 Safety Precaution
- Make sure the environment is without interference from CAUTION electromagnetic fields.
- Make sure the environment is without noise and
- DO NOT carry out the procedure while using other equipments, devices or products.
- The instruction for use of the sensor pads MUST be vibration. observed.
- DO NOT use on patients with pacemakers or defibrillators. CAUTION DO NOT use the capsule if the package is unsealed. n DO NOT reuse capsules. n To prevent unexpected accidents like fire or explosion, do not use any product near or in the presence of inflammable or ignitable substances. n DO NOT disassemble the equipment case nor open the cover. In case service is required, please contact IntroMedic customer support or local point of sale immediately. n Only the accessories authorized and designed by IntroMedic Co., Ltd. should be used with this equipment. Faults resulting from the usage of unapproved or inappropriate accessories are not guaranteed against. This equipment may have an effect on other products or be effected by other products. Follow the Doctors instructions and abide by the guidelines in the User Manual. n n n DO NOT try to upload the data while the data cables are still connected to the receiver. n DO NOT charge the rechargeable battery in the receiver while the data cable and sensor pads are still connected to the receiver. Page 13 Safety Information Chapter 1 n Stay away from high frequency radiation sites (such as high voltage, radar, installation power plants, MRI, CT or electric blankets etc.) during your capsule endoscope procedure. (It may result in serious side effects requiring emergency treatment.) In case of any symptoms of abdominal pain, vomiting, fever, heart trouble, dizziness or seizure during or after the capsule endoscope procedure, the patient should immediately notify the physician in charge. n n Always check the connection between the receiver and the data cable. n Always check that the battery in the receiver is fully charged before use. n DO NOT use the capsule if the package is unsealed. n After ingesting the capsule, ask patient to check whether the capsule has been excreted. n n Prior to undergoing the capsule endoscopy procedure, patients with diabetes must be informed via a medical professional regarding appropriate medication & dosage. For more accurate data and better analysis, follow the Patient Preparation as recommended in the Users Manual. Tell Patient not to bite the capsule before ingesting. n n Patient should avoid excessive physical activity during the capsule endoscope procedure. n When undergoing the capsule endoscope procedure, DO NOT make physical contact with another person undergoing the same procedure. n During operation of the receiver, DO NOT touch the receiver, or get the receiver wet. n Only use the provided batteries, and never remove the battery from the receiver during the procedure. n During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB. This may damage the patients data. Page 14 Chapter 1 Safety Information n Always confirm that the USB is connected by checking the Receiver screen on the MiroView software. n Always check the AC Power range before use the workstation. n DO NOT touch AC Power code with wet hands. n DO NOT open the receiver bag or touch receiver outside of the hospital. This device is intended for the patients over the age of 18. n WARNING The Capsule takes images for 11 hours and gets naturally excreted in about 24 hours under normal conditions. If the capsule has not been excreted from the patient within 72 hours, patient should contact the physician. After examining, the physician may need to perform a surgical operation or treatment to remove the capsule. WARNING Before moving the system, always make sure to disconnect the monitor from the main system, and then safely move the main system and monitor separately. Connect the main system and monitor only after the hardware is fully installed, secure and stable. Page 15 Safety Information Chapter 1 1.4.3 Cleaning and Maintenance n System and accessories
- All products should be cleanly maintained. For cleaning, rub lightly with a soft cloth wet with warm water at least once a week. Do not use organic solvents such as lacquer, thinner, ethylene and oxide because they can damage the equipment. Be careful that foreign substances do not enter the main system when cleaning.
- ALWAYS operate the equipment under sanitary environmental conditions. DO NOT use heat or gas for disinfection of the capsule. n Service Document If required, or upon request, the local IntroMedic Distributor (authorized IntroMedic Representative) may provide block diagrams, lists of spare parts, descriptions, adjustment instructions or other related information which may help qualified technical personnel in repairing specified parts of the equipment which have been defined repairable by IntroMedic Co., Ltd. n Moving the Equipment
- CAUTION when moving equipment.
- WARNING: Excessive impact/shock causes internal damage.
If wiring is connected/disconnected when moving, check the wiring status after moving. If damage to the equipment is discovered after moving, immediately contact IntroMedic or local Distributor.
Page 16 System Overview 2 System Overview Chapter 2 Page 18 Chapter 2 System Overview 2. SYSTEM OVERVIEW 2.1 MiroCam Overview MiroCam is an orally ingested capsule endoscope designed to capture images of the small intestine lining. Captured images are viewed via the MiroCam software for diagnosis of diseases related to the small intestine. Generally, the capsule endoscope has been developed to provide a means to view the entire small bowel, with much higher diagnostic sensitivity than other radiological techniques. Further, the capsule endoscope avoids a great deal of discomfort associated with traditional endoscopy, while allowing the patient to maintain a normal schedule. Additional methods for screening of the small bowel primarily include barium x-rays and enteroscopy, but the diagnostic value of these tests for a wide variety of specific lesions is low. Following is further description of the methods. Enteroscopy is a method to perform direct visual inspection of the small bowel mucosa beyond the reach of standard upper endoscopes. The procedure can be accomplished of the small by examination with either push or sonde type endoscopes, or operative enteroscopy. Enteroscopy of the small intestine is difficult, requires a lengthy examination time, can only partially visualize the small intestine, is extremely uncomfortable, and is not performed on a widespread basis. Barium X-rays of the small bowel are currently the primary radiographic means of diagnosing a small bowel neoplasm, and the best way to locate small bowel lesions. However, the procedure has limited sensitivity. Page 19 System Overview Chapter 2 Sensitivity to diagnose small bowel neoplasms can be doubled by enteroclysis, which is extremely inconvenient for the patient and must be done only in a hospital set up by an expert. The sensitivity and specificity of the diagnosis of mucosal lesion (like AVM, for example) is close to zero. Computed tomography (CT) of the abdomen is sometimes helpful in diagnosing and localizing of small bowel abnormalities, but it is unable to determine small intraluminal or mucosal lesions. It is widely accepted that the aforementioned methods for diagnosing small bowel diseases and disorders are limited. Capsule Endoscopy is a great advancement, providing a much more thorough diagnostic method. IntroMedics MiroCam Capsule Endoscope System is designed to aid the gastroenterologist in visualizing and diagnosing disease of the small bowel in an efficient, cost effective, and comfortable manner. 2.2 MiroCam System Main Components Capsule:The MiroCam Capsule moves slowly through the small intestine tract, capturing images of the entire small intestine at 3 frames/sec. Receiver:The MiroCam Receiver provides 9 receiving channels through which signals can be received. The pair of channels which have the best signal characteristics are selected and used for the receipt of the of image signals. The receive also connects to MiroView software to upload images taken of the patients GI tract. MiroView Software: MiroView enables the gastorenterologist to perform a diagnostic reiview of the patients small bowel, and Page 20 Chapter 2 System Overview document the results in a printable report. 2.3 MiroCam Method of Action The following image displays the key components of the MiroCam capsule endoscope system. MiroView To enable physicians to diagnose images of a patients small bowel, the MiroCam method of action includes the following steps. Step 1. Image Capturing: The MiroCam capsule uses a CMOS Image sensor built in the capsule to take the pictures through the front of the optical dome. The LED light flashes each time the picture is taken to brighten the dark digestive organ. The capsule captures 3 pictures per second and sends the images to the receiver immediately. For transmission, the images taken from the capsule are transformed to data that is possible to transmit to the receiver through the human body. Page 21 System Overview Chapter 2 Step 2. Data transmission: The MiroCam capsule transmits the data from the capsule via E-Field Propagation. This communication method uses the human body as the medium to transmit signals from internally within the body (from the capsule) to external sensors (data cable sensor pads). Step 3. Data Reception and Storage: To retrieve the signal emitted from the capsule, the MiroCam system needs to attach reception poles
(sensors attached to data cables) on the exterior of the human body to retrieve the signal. The signal is then changed into a data format that is feasible for image processing, and stored onto the memory of the receiver. Step 4. Data Upload: The image data is uploaded from the receiver to the MiroView software (software on a PC workstation) via a standard USB data cable. This data is uploaded after the patient has completed the procedure (i.e. sensor pads / data cables are not attached to patient). Step 5. Image Restoration & Display: After all stored image data in the receiver has been transferred to the image processing software
(MiroView), the software changes the transferred image data by using an image reconstruction algorithm to a RGB signal. The reconstructed image data is saved along with patient information, and viewed by the physician to diagnose diseases of the small bowel. MiroView can recall the saved data anytime, as the user desires to perform a diagnostic review of the patient images. Page 22 Chapter 2 System Overview 2.4 System Configuration The MiroCam System consists of an imaging capsule, signal receiver, and the MiroView software for image viewing. The overall system configuration is as follows:
MiroCam System Block Diagram Capsule Receiver Image Sensor System Interface Software Data Communication Data Storage Image Processing Data Transmiter Data Recover Image Display Page 23 System Overview Chapter 2 2.4.1 Capsule The capsule consists of an optical dome, LED module, imaging &
communication module, battery, power supply module, cage pin and cage. The capsule can operate inside a human body for more than 11 hours. This mechanical device is enclosed in a harmless plastic capsule. The dome and the capsule body are bonded with a medical grade adhesive. The surface of the plastic body is gold-plated for signal transmission. LED module Dome Lenz module PCB sensor Battery Power supply
<Capsule Structure>
CMOS Image Sensor Specifications Image size : 320 * 320 pixel Operation voltage : 3V Operation Frequency :12MHz Image Frame : 3 Frame / sec 2.4.2 Receiver The MiroCam Receiver consists of the data cable, signal input block, analog block, digital control block, data storage block and USB communication block. Following is some more information about the Page 24 Chapter 2 System Overview individual components. u Signal input block includes 9 channel connectors and a multiplexer u Analog block has an amplifier and filter for analog to digital conversion. This converts the image data transmitted by the capsule. u Digital control block includes a digital image processing unit and demodulation unit. This block also saves the data. u All image data is saved to flash memory and transferred to image processing workstation by USB channel u The receiver is divided into a restoration part that restores the actual data, and a transmitter part that transmits the image data to MiroView. More specifically, the receiver can be divided into the receiving block, signal input block, analog block, digital block, storage block and USB transmission block. After processing the converted signals, the digital block demodulates image data and saves it. The saved data is then transferred to MiroView software (on a PC) via the USB transmission module. Receiver Power Source: The MiroCam receiver operates via a battery, completely independent of any other power sources. The receiver of the MiroCam capsule endoscope system includes amplifier and filter components, which convert the image data transmitted by the capsule. The receiver is divided into a restoration part that restores the actual data, and a transmitter part that transmits the image data to MiroView. More specifically, the receiver can be divided into the receiving block, signal input block, analog block, digital block, storage block and USB transmission Page 25 System Overview Chapter 2 block. The signal input block is implemented with 9 signal lines and connectors while the analog block amplifies, filters and performs AD conversion. After processing the converted signals, the digital block demodulates image data and saves it. The saved data is then transferred the USB transmission module. to MiroView software (on a PC) via 2.4.3 MiroView (Software) MiroView, the application software for the MiroCam capsule endoscope system, consists of an image-processing module that restores the received image data to actual images, and an output module for image output. The recorded images can be viewed via a conventional PC or Notebook using IntroMedics proprietary software. MiroView is compatible with Windows operating systems. Selected images can be edited and saved in a CD or DVD. The software includes a number of features and functions to assist in the efficiency and sensitivity of the diagnosis. Page 26 Chapter 2 System Overview 2.5 Product Specifications 2.5.1 Capsule Capsule consists of the optical dome, lens, led lighting module, gold-band, battery, power module, case pin and case. The capsule operates for about 11 hours in the human body. The electrical components are enclosed by a plastic cage that is safe and does not harm the human body. n Dimensions Size(mm) 10.8(L1) x 24(L2) x 19(L3) x 5(L4) x6(L5) Weight(g) 3.25 Page 27 System Overview Chapter 2 n Description Function
- Main Device of MiroCam MC1000
- This transmits light from the outside of Capsule and its transparency is over 98%.
- Made from COC.
- This transmits light source of image from the LED of inside of capsule.
- Gold coating that transmits the image data from the capsule to the human body.
- The lens concentrates the light emitted by the LEDs, and focuses the image for the CMOS image sensor.
- Protects the interior capsule components.
- Prevents entry of foreign materials into capsule.
- Cage is composed of an FDA certified safe material, harmless to the human body.
- LED illuminates the dark spaces inside the human body GI tract.
- The illumination enables images to be captured. Title No. 1 Main Body 2 Optical Dome 3 Gold-Band 4 5 Lens Cage 6 White LED Page 28 Chapter 2 System Overview n Specifications
- Size : 10.8 X 24mm
- Weight : 3.25g
- Material : Human Compliance Plastic
Light : 6 white LED
- View Angle : 150(In image)
- View Depth : 3 cm
- Enlargement Ratio : 1:8
- Detectable Range : under 0.1mm
- Sampling Ratio : 2.9 fps
- Operating time : 11 hours
- Mechanical Safety : Compatible ISO60601-1-1
- Biocompatibility Safety : Compatible ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11
- Chemical Safety : Safe in pH=2 ~ pH=8
- Battery Type : Silver Oxide Cell
- Operation Temperature : 20 ~ 40
- Storage Temperature : 0 ~ 50 Page 29 System Overview Chapter 2 2.5.2 Receiver Receiver consists of the data cable, signal input block, analog block, digital control block, data storage block and USB communication block. Signal input block has 9 channel connectors and a multiplexer. Analog block has an amplifier and filter for analog to digital conversion. Digital control block has a digital image processing unit and demodulation unit. All image data are saved to flash memory and transferred to image processing workstation by USB channel. n Dimensions H W L Size(mm) 140(H) x 85(W) x 40(L) Weight(g) 350 Page 30 Chapter 2 System Overview n Description No. Title Main Body 9-Channel Connector LED Display USB Connector Power Switch Battery Function
- Main Device of MiroCam MR1000.
- Durable connector to deliver the signal from the data cables to the receiver.
- Display status of Receiver.
- Signal display to indicate normal operation, including battery, initialization status and signal reception.
- USB Communication connector for image data transmission to Image processing workstation.
- Turn Main power of Receiver on or off.
- Rechargeable battery for MiroCam Receiver unit.
- Output voltage : 3.7Vdc
- Output Current : 8.8A Page 31 System Overview Chapter 2 n Specifications
- Operation System : Firmware
- Recording Time : 12 Hours
- Weight : 350g, include battery
- Operation Voltage : 3.7V, 0.45A
- Battery Type: Lithium Ion Battery (3.7V, 8.8A)
- Battery Weight : 215g
- Operation Temperature : 0 ~ 40
- Storage Temperature : 0 ~ 55
- Category : Type BF Page 32 Chapter 2 System Overview 2.5.3 MiroView Image processing workstation consists of image processing software (MiroView) and hardware workstation. MiroView operates on windows XP, enabling viewing and saving of image data. n Software Version : MiroView Version 1.00 n Operating System : Windows XP Professional n Language : English n Data Export : JPEG Image, AVI Video Clip, PDF Data Report n Data Display : Single or Multi Image, Time Bar, Diagnosis Data n Event Marker : Small Image and comments n Display Ratio : 5 ~ 30 fps n Display Mode : Single View, Dual View, Quad View n Running Mode : Normal View, Quick View, Blood View 2.5.4 Recommended Workstation Specifications n Operating System : Windows XP Professional n CPU : Core 2 Duo E6300(1.86GHz/2M) n Memory : DDR II 1GByte(667MHz) n Display Adaptor : Geforce 7600GT 256MB n Hard Disk : SATA II 160GB, SATA II 320GB n ODD : DVD-RW n Monitor Resolution : 1280 X 1024 n Monitor Contrast : 700 : 1 n Printer Resolution : 4800 X 1200 dpi n Printer Paper : A4 Page 33 System Overview Chapter 2 2.5.5 Accessories n Data Cable L1 L2 L3 Part No. MR1000-D Description Image data receiving cable Size(mm) 700(L1) 110(L3) x 90(L2) x Weight(g) 155 n Sensor Pads Description Image data receiving sensors Size(mm) 60 Weight(g) 5 Part No. MR1000-S Page 34 Chapter 2 System Overview n USB Cable Part No. MR1000-U Description Image data uploading cable Size(mm) 1500 Weight(g) 50 n Battery Charger L H W Part No. MR1000-C Receiver Battery Description Charger Size(mm) 135(H) x 105(L) x 150(W) Weight(g) 350
Input Specification : 9Vdc, 3A
- Output Specification : 4.2Vdc, 4A Page 35 System Overview Chapter 2 n Adaptor L H D W Description Part No. MR1000-T Receiver Battery Charging Adaptor Size(mm) 95(W) x 55(L) x 30(H) x 750(D) Weight(g) 240
Input Specification : 110~220Vac, 50~60/Hz
- Output Specification : 9Vdc, 3A
- Compliance with requirements of IEC601-1 Page 36 Chapter 2 System Overview 2.6 Component List The components of the MiroCam System are as follows:
No. 1 Qty 1 ea Model Name Description Capsule for imaging MC1000 Product Name Capsule Endoscope MR1000-R Receiver Battery Pack MR1000-B Receiver Bag MR1000-G Data Cable MR1000-D MR1000-C Battery Charger Adapter USB Cable MR1000-T MW1000-U 2 3 4 5 6 7 8 1 ea 2 ea 1 ea 1 ea 1 ea 1 ea 1 ea 1 ea Receiver for data storage Batteries for receiver Portable receiver bag Data cable Battery Charger Adaptor for charging Communication cable workstation for 9 Measuring MR1000-M Tape Sensor Pad Software 10 11 12 User Manual 13 Service Manual MR1000-S 1 pk MW1000-SV1.0 1 ea 1 ea MM1000 MM1100 1 ea Signal-receiving pad Software for image diagnosis Instruction for use Instruction for service
<Table 1> List of Component Page 37 Note System Overview Chapter 2 Page 38 Product Installation 3 Product Installation Chapter 3 Page 40 Chapter 3 Product Installation 3. PRODUCT INSTALLATION Installation and initial operation of the system should be performed by authorized IntroMedic service personnel. The following component list should be rechecked prior to product installation. 3.1 Component Check List No. 1 2 3 4 5 6 7 8 Model Name MC1000 Product Name Capsule Endoscope MR1000-R Receiver Battery Pack MR1000-B Receiver Bag MR1000-G Data Cable MR1000-D MR1000-C Battery Charger Adapter USB Cable MR1000-T MW1000-U 9 Measuring MR1000-M Qty 1 ea Description Capsule for imaging 1 ea 2 ea 1 ea 1 ea 1 ea 1 ea 1 ea 1 ea Receiver for data storage Batteries for receiver Portable receiver bag Data cable Battery Charger Adaptor for charging Communication cable workstation for Tape Sensor Pad Software 10 11 12 User Manual 13 Service Manual MR1000-S 1 pk MW1000-SV1.0 1 ea MM1000 1 ea 1 ea MM1100 Signal-receiving pad Software for image diagnosis Instruction for use Instruction for service Note Page 41 Product Installation Chapter 3 3.2 Packaging Specifications 3.2.1 Capsule Endoscope Receiver set Box : 485 X 120 X 400 mm Page 42 Chapter 3 Product Installation 3.2.2 Capsule Endoscope Box : 210 X 206 X 95 mm Page 43 Product Installation Chapter 3 3.2.3 Accessory Box : 352 X 396 X 78 mm Page 44 Chapter 3 Product Installation 3.3 Installation Diagram The recommended configuration of the MiroCam Capsule Endoscope System is as follows:
Note: configuration may change. Charger Charger Arm Monitor Keyboard Printer Mouse Product Table Page 45 Product Installation Chapter 3 3.4 System Installation & Connection 3.4.1 Connect data cable n Check the data cables direction. n Hold green cover of data cable and insert into the receiver. 3.4.2 Connect USB cable n Hold small side of USB cable and insert into the receiver. Page 46 Chapter 3 Product Installation n Hold large side of USB cable and insert into the workstation. WARNING DO NOT connect the USB cable to the receiver while the receivers sensor pads and data cable are still connected. WARNING Connect USB cable to receiver only after mounting it on charger. 3.4.3 Connect battery charger n Battery charger connection diagram. Page 47 Product Installation Chapter 3 n Insert dc-jack of adaptor into battery charger. Page 48 Chapter 3 Product Installation n Insert power-jack of power cord into adaptor. n Connect power plug of power cord into AC consent. WARNING Always check the AC Power range before connect power plug into AC consent. WARNING DO NOT touch AC power code with wet hand. Page 49 Product Installation Chapter 3 3.5 MiroView Installation For installation and operation of MiroView application software, the workstation must be prepared. Recommended workstation specifications are provided to the local IntroMedic Representative, who will install the system and software. 3.5.1 Preparation(Prior to Installing MiroView Software) n Setup hard disk drive
- This process should be done by the hardware vendor
- HDD must have three partitions : C, D and E drive
- C drive should have larger space than 150GB for database
- D drive should have larger space than 50GB for MiroView
- E drive should have larger space than 250GB for patient data. Page 50 Chapter 3 Product Installation n Setup graphic resolution
- Click mouse right button.
- Click properties in command list.
In display properties window click settings tab. Page 51 Product Installation Chapter 3
- Setting screen resolution by 1280 * 1024 and color quality by Highest(32 bit).
- Click button.
- Confirm monitor setting by clicking button. Page 52 Chapter 3 Product Installation n Setup windows account
- Click button and select Control Panel.
- Select User Account. Page 53 Product Installation Chapter 3
- Select Admin account. NOTE If you cant see admin account, create admin account by select Create a new account.
- Select Create a password. Page 54 Chapter 3 Product Installation
- Enter new password miro06 and click button
- Select Create a new account. Page 55 Product Installation Chapter 3
- Enter new account name miro and click button
- Check account type by limited and click button. Page 56 Chapter 3 Product Installation
- Select miro account
- Select Create a password. Page 57 Product Installation Chapter 3
- Enter new password miro06 and click button
- Click
- Select Create a new account. button Page 58 Chapter 3 Product Installation
- Enter new account name MiroCam and click button
- Check account type by Computer administrator and click button. Page 59 Product Installation Chapter 3 n Autonomous log-on for the user
- Select Change the way users log on or off
- Uncheck Use the Welcome screen and click button. Page 60 Chapter 3 Product Installation
- Click button and select Run.
- Enter control userpasswords2 and click button Page 61 Product Installation Chapter 3
- Uncheck User must enter user name and password to use this computer and click button
- Change User name to MiroCam instead of Administrator and click button.
Log-off and Log-on with using MiroCam account. Page 62 Chapter 3 Product Installation n Setup wallpaper
- Copy IPW Installation Ver 1.0.1.x (2007.x.x) from the IPW installation CD to desktop.
- Copy Logo.jpg file to C:\logo.jpg
<Copy>
<Paste>
- Double click logo.jpg file to execute Windows Fixture and Fax Viewer.
- Move the mouse pointer to center of the picture and click the Set as Desktop the mouse and click right button on Background Page 63 Product Installation Chapter 3 3.5.2 Database setup n Open 1. DB Setup (postgresql-8.2.3-1) folder. n Double click postgresql-8.2.smi file to execute. n Check English/English and click button. Page 64 Chapter 3 Product Installation n Click button. n Click button. n Click button. Page 65 Product Installation Chapter 3 n Change Account name to miro and enter miro06 for Account password and Verify password. Click button. WARNING There is a default value for the Account Domain. This should NOT be changed, although it may be different than detailed in the image above. n Click button. n Click button. Page 66 Chapter 3 Product Installation n Enter miro for Superuser name and enter miro06 for Password and Password (again). Click button. n Check PL/pgsql and click button. Page 67 Product Installation Chapter 3 n Check Adminpack and click button. n Click button. Page 68 Chapter 3 Product Installation n Click button. Page 69 Product Installation Chapter 3 3.5.3 Software installation n MiroView application software installation.
- Open Installshield folder and double click 1. MiroViewSetup
- Click button Page 70 Chapter 3 Product Installation
- Click button.
- Check No more query and click button. Page 71 Product Installation Chapter 3
- Click button.
- Click button.
- Click button. Page 72 Chapter 3 Product Installation
- Click button.
- Uncheck No more query and click button,
- Click button. Page 73 Product Installation Chapter 3 n Codec Installation.
- Open Install shield folder and double click 2. Codec Install
If this window appear, click button
- Click button Page 74 Chapter 3 Product Installation n Registry Installation.
- Open Install shield folder and double click 3. RGB Table(0814).
- Click button.
- Click button. Page 75 Product Installation Chapter 3 3.5.4 Device driver installation n Connect a receiver with the PC via USB port n Check Yes, now and every time I connect a device and click button. n Check Install from list or specific location (Advanced) and click button. Page 76 Chapter 3 Product Installation n Click button. n Select C:\USB Driver folder and click button. n Click button. Page 77 Product Installation Chapter 3 n Click button. NOTE USB driver installation process should be undergone for every USB port to to be used for uploading the receiver data. If you connect the receiver via a different USB port from the one with the installed the driver with, then the driver must be set up again. Page 78 Chapter 3 Product Installation 3.5.5 Make the tables on the database n Click n Select pgAdmin III button and select All program postgreSQL 8.2. n Double click PostgreSQL Database Server 8.2 (Localhost : 5432) Page 79 Product Installation Chapter 3 n Enter miro06. n Select postgres and click the right button on the mouse and run Restore in the pop-up menu. n Click button and look for miro.backup in the installation folder on desktop. Page 80 Chapter 3 Product Installation n Click button. n Click button. n If you see done button, the restoration is successfully complete. Click done button. Page 81 Product Installation Chapter 3 3.5.6 Finalize n Execute MiroView Software by double-clicking icon. If the form for registration appears, setting up the MiroView is successfully complete. n n Move this folder with pushing the left button on the mouse and dragging to the desktop. Page 82 Chapter 3 Product Installation n Cut two folders; IPW Installation... and Postgres. n Paste to the E drive. n Log off and log on whit admin account. Page 83 Product Installation Chapter 3 n Cut two folders; IPW Installation... and Postgres from E drive. n Paste to the desktop. Page 84 Chapter 3 Product Installation n Click button and select Run and type gpedit.msc into the form and Enter. n Select User Configuration Administrative Template Windows Components Windows Explorer on the left side of the window and double click Hide these specified drives in My Computer. Page 85 Product Installation Chapter 3 n If a form appears like below, check on Enabled and select Restrict A, B and C drives only and OK. n Double clicked the specified items like below and get them to Enabled. Page 86 Chapter 3 Product Installation
- Enabled item list Line Description 2 3 4 5 6 7 Remove the folder Options menu item from the Tools manu Remove File menu from the Windows Explorer Remove Map Network Drive and Disconnect Network Drive Remove search button from Windows Explorer Remove Windows Explorers default context menu Hide the Manage item on the Windows Explorer context memu 10 Hide these specified drives in My Computer 12 Remove Hardware tab 13 Remove DFS tab 14 Remove Security tab 17 No Computer Near Me in my Network Places 18 No Entire Network in My Network Places 23 Do not move deleted files to the Recycled bin 26 Remove Shared Documents from My Computer Page 87 Product Installation Chapter 3 n Select User Configuration Administrative Template Start Menu and Taskbar on the left side of the window and set items to Enabled like below.
- Enabled item list Line Description 1 2 3 4 5 6 7 8 Remove users folders from the Start Menu Remove links and access to Windows Update Remove common program groups from Start Menu. Remove My Document icon from Start Menu Remove programs on Setting menu Remove Network Connections from start menu Remove Favorites menu from Start menu Remove Search menu from Start menu Page 88 Chapter 3 Product Installation Line Description 9 Remove Help menu from Start menu 10 Remove Run menu from Start menu 11 Remove My Pictures icon from Start menu 12 Remove My Music icon from Start menu 13 Remove My Network Places icon from Start menu 17 Remove Drag-and-drop context menus on the Start menu 18 Prevent changes to taskbar and Start Menu Settings 19 Remove access to the context menus for the taskbar 20 Do not keep history of recently opened documents 21 Clear history of recently opened documents on exit 22 Turn off personalized menus 28 Prevent grouping of taskbar items 30 Lock the Taskbar 34 Remove frequent programs list from the Start menu 36 Remove the Unlock PC button from the Start menu 37 Remove user name from Start menu Page 89 Product Installation Chapter 3 n Select User Configuration Administrative Template Control Panel on the left side of the window and set Prohibit access to the Control Panel to Enabled like below. n Installation is finished. Page 90 Technical Data 4 Technical Data Chapter 4 Page 92 Chapter 4 Technical Data 4. TECHNICAL DATA 4.1 Overview n Product Name: MiroCam Capsule Endoscope System n Model Name: MiroCam n Serial Number: Refer to the label which is attaching in the reverse side of the product. n Manufacturer: IntroMedic. Co., Ltd. n Manufacturer Address Suite 1104, E&C Venture Dream Tower 6-Cha 197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719 Tel : +82-2-801-9300 Fax : +82-2-801-9330 http://www.intromedic.com e-mail : help@intromedic.com 4.2 Classification of Equipment 4.2.1 According to the type of protection against electric shock 4.2.2 According to the degree of protection against electric shock 4.2.3 According to the degree of protection against ingress of water
: Internally Powered Equipment
: Type BF Applied Part
: IPX0 4.2.4 According to the method of sterilization or disinfection
: Equipment not usable sterilization & disinfection 4.2.5 According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
: Equipment not suitable for use in the presence of a Page 93 Technical Data Chapter 4 FLAMMABLE ANAESTHETIC MIXYURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE 4.2.6 According to the mode of operation
: Continuous Operation with Short-Time Loading Equipment 4.3 Hardware 4.3.1 Capsule (Model: MC1000-C) Light: 6 white LED n Size: 10.8 X 24mm n Weight: 3.25g n Material: Human Compliance Plastic n n View Angle: 150(In image) n View Depth: 3 cm n Enlargement Ratio: 1:8 n Detectable Range: under 0.1mm n Sampling Ratio: 2.9 fps n Working time: 11 hours n Mechanical Safety: Compatible ISO60601-1-1 n Biocompatibility Safety: Compatible ISO10993-4, ISO10993-10, ISO10993-11 n Chemical Safety: Safe in pH=2 ~ pH=8 n Battery Type: Silver Oxide Cell n Operation Temperature: 20 ~ 40 n Storage Temperature: 0 ~ 50 n Recommended Maximum Storage Time: 1 Year 4.3.2 Receiver(Model: MR1000-R, MR2000-R) Page 94 ISO10993-5, Chapter 4 Technical Data n Operation System: Firmware n Recording Time: 12 Hours n Weight: 350g, include battery n Operation Voltage: 3.7V, 0.45A n Battery Type:
l MR1000: Lithium Ion Battery (3.7V, 8.8A) l MR2000: Lithium Ion Battery (3.7V, 10.4A) n Battery Weight: 215g n Operation Temperature: 0 ~ 40 n Storage Temperature: 0 ~ 55 n Category: Type BF n Life Time: 4.62 Year 4.3.3 Battery Charger(MR1000-C) Input Current: 3A Input Voltage: 9VDC n n n Output Voltage: 4.2VDC n Output Current: 4A n Operation Display: LED Display n Adaptor Manufacturer: BridgePower Corporation(JEC Korea) n Adaptor Model: JMW128XA0902F02 4.3.4 Recommended Image Workstation n Operating System: Windows XP Professional n CPU: Core 2 Duo E6300(1.86GHz/2M) n Memory: DDR II 1GByte(667MHz) Page 95 Technical Data Chapter 4 n Display Adaptor: Geforce 7600GT 256MB n Hard Disk: SATA II 160GB, SATA II 320GB n ODD: DVD-RW n Monitor Resolution: 1280 X 1024 n Monitor Contrast: 700 : 1 n Printer Resolution: 4800 X 1200 dpi n Printer Paper: A4 4.4 Software 4.4.1 Version n MiroView Version 1.1.5 4.4.2 Specification Language: English n Monitor Contrast: 700 : 1 n n Data Export: JPEG Image, AVI Video Clip, PDF Data Report n Data Display: Single or Multi Image, Time Bar, Diagnosis Data n Event Marker: Small Image with Explanation n Display Ratio: 5 ~ 30 fps n Display Mode: Single View, Dual View, Quad View n Running Mode: Normal View, Quick View, Blood View n Error Ratio: Under 100 image continuously 4.4.3 Feature n Language: English Page 96 Chapter 4 Technical Data n Color status Display n User Friendly software feature n Automated detection of GI tract bleeding n Color of images are virtually natural Page 97 Technical Data Chapter 4 4.5 Compliance / Approvals The MiroCam capsule endoscope system and accessories complies with the Medical Device Directive 93/42/EEC (CE0843). In addition, the product complies with Medical Electrical Equipment, Part 1 :
General requirement for safety
: Medical Medical Electrical Equipment, Part 1 :
General requirement for safety Collateral Standard Electrical System Medical Electrical Equipment, Part 1 :
General requirement for safety Collateral Standard : Electromagnetic compatibility Medical Electrical Equipment, Part 1 :
General requirement for safety Collateral Standard : Programmable Electrical Medical System Medical Electrical Equipment, Part 2 :
Particular requirement for the safety of endoscope equipment Biological evaluation of medical devices, Part 1: Evaluation and Testing Third Edition IEC 60601-1:1988 +
A1:1991 + A2:1995
(EN 60601-1:1990 +
A1:1992 + A2:1995) EN 60601-1-1:2001 EN 60601-1-2:2001 EN 60601-1-4:1998 EN60601-2-18:1996 EN 10993-1:2003 Page 98 Chapter 4 Technical Data 4.5.1 FCC Statement n This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause this device must accept any harmful interference received, interference that may cause undesired operation. interference, and (2) including n CAUTION: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. in a residential n NOTE: This equipment has been tested and found to comply with the limit for a Cass B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Page 99 Technical Data Chapter 4 Page 100 Storage & Transportation 5 Storage & Transportation Chapter 5 Page 102 Chapter 5 Storage & Transportation 5. Storage & Transportation 5.1 Safe Storage Conditions n Environmental condition for storage
- Temperature
: -10 - +70
- Relative humidity
: 10% - 80%
- Atmospheric pressure
: 700hPa to 1060hPa n Keep in the place that is not in contact with water n Keep in the place out of direct light n Keep away from hazardous materials for the human body. n Keep away from children. n Do not store with chemicals. n For cleaning, only use gauze with water. Other liquid like alcohol should not be used. n Use the provided battery charger for charging. n If product is not used for an extensive period of time, please separate the battery from the receiver unit. 5.2 Safety Transportion Conditions
- Temperature
: -10 - +70
- Relative humidity
: 10% - 80%
- Atmospheric pressure
: 700hPa to 1060hPa
- Product MUST be handled with care, and not dropped. Page 103 Storage & Transportation Chapter 5 Page 104 Troubleshooting 6 Troubleshooting Chapter 6 Page 106 Chapter 6 Troubleshooting 6. TROUBLESHOOTING 6.1 Introduction This chapter explains how to troubleshoot the MiroCam capsule endoscope system if problems arise. Tables are supplied that list possible difficulties, probable cause, and recommended actions to correct. 6.2 Who should perform repairs Only qualified service personnel should open the MiroCam Capsule Endoscope System housing, remove and replace components, or make adjustments. 6.3 Obtain replacement parts IntroMedic Technical Service provides technical assistance information and replacement parts. To obtain replacement parts, contact IntroMedic Co., Ltd. or your local representative. Refer to part names and part numbers listed on Chapter 2.6, Component List. Page 107 Troubleshooting Chapter 6 6.4 Troubleshooting Guide Condition Recommended Action The MiroCam capsule endoscope system workstation fails to power-up when the I/O power switch is on. The MiroCam capsule endoscope system receiver unit fails to power-up when the I/O power switch is on. 1. Ensure that the MiroCam capsule endoscope workstation main system is plugged into an operational AC outlet in accordance with the input specification rated on the side panel of the workstation main system. 2. If the condition persists, contact IntroMedic Co., Ltd. or local representative. 1. Recharge battery of receiver unit. 2. Replace battery of receiver unit. 3. If the condition persists, contact IntroMedic Co., Ltd or local representative. Capsule is not 1. DO NOT use the capsule. Use an alternate capsule. 2. Contact IntroMedic Co., Ltd. for replacement of capsule. 1. Initialize receiver unit via MiroView software. 2. If the condition persists, contact IntroMedic Co., Ltd. 1. Recharge battery of receiver unit. 2. Replace battery of receiver unit. 3. If the condition persists, contact IntroMedic Co., Ltd. blinking when taken out of the case. INI LED on receiver unit is yellow, and does not turn green when held appropriately by patient. BAT LED, on receiver unit is yellow. Page 108 Chapter 6 Troubleshooting If you see following message when you use MiroView software, check possible cause and action before contacting IntroMedic. 1 Error Message Possible cause Action The selected drive does not support CD/DVD burning. The CD/DVD drive does not support CD/DVD burning. Exchange the CD/DVD drive for DVD multi or DVD writable drive. Select the DVD writable drive and try again. Wait until the process has stopped and try again. Contact to IntroMedic. Contact to IntroMedic. User selected wrong drive. The user executed BACKUP or EXPORT function while the burning process is operating. MiroView software installation problem. MiroView software installation problem. MiroView software installation problem. Contact to IntroMedic. Page 109 2 The selected drive does not support CD/DVD burning. 3 BACKUP or EXPORT is not yet complete. Wait for process to finish and try again. The selected capture cannot be added. The selected landmark cannot be added. Failed to save. 4 5 6 Troubleshooting Chapter 6 7 8 9 An error arose while trying to export. Please try again. An error arose while trying to export. Please try again. There is no data to export. Improper export destination selected. MiroView software installation problem. There is no data to export. Check the drive to export. Check if the drive has sufficient space. Contact IntroMedic. If you did not capture any image, then this is not an error. If persists, contact IntroMedic. Contact IntroMedic MiroView software Installation problem The system resources are not sufficient to support MiroView The system resources are not sufficient to support MiroView. Reboot. Reboot. 10 Failed to make a video file because Microsoft MPEG4-V2 codec does not exist. 11 Not enough memory. 12 The file buffer size is over the limit. Page 110 Chapter 6 Troubleshooting 13 Failed to create the file. The disk space is not enough. 14 Not enough storage space. The disk space is not enough. Synchronization error between files and list File version error. Failed to access the DB server. A printer driver (MM PDF Maker) is not installed. Cannot create the report PDF file because PDF converting module is not installed. Cannot continue to upload because receiver has become disconnected. Improper connection between the receiver and the PC 15 Failed to find the file. 16 The file type does not match. 17 Database error 18 The printer driver is not installed. 19 The PDF converting module is not installed. 20 Receiver is disconnected while uploading 21 Cannot upload because receiver is not connected. Delete data (patient files) from the List Mode. Delete data (patient files) from the List Mode.. Contact IntroMedic Contact IntroMedic Reboot. Contact IntroMedic Contact IntroMedic Check the connection between the receiver and the PC. Check the connection between the receiver and the PC Page 111 Troubleshooting Chapter 6 22 Cannot upload because receiver is not connected. 23 Fill out all the required fields. 24 Failed to upload data from receiver. 25 Failed to complete restoration. 26 Failed to complete restoration due to some missing files. 27 Please insert disk number ##. 28 Wrong disk. Please insert a disk of the same original file. 29 The backup disk info is incorrect. The receiver is turned off. Turn on the receiver and try again. There are the fields which you did not enter the contents into. Connection error between the receiver and the PC MiroView software installation problem. Backup error The user inserted wrong disk while restoring the data The user inserted wrong disk while restoring the data Backup error Make sure all require fields are filled. Check the connection between the receiver and the PC Contact to IntroMedic Back up the data and restore again Insert disk with number ##. Insert the disk of the same original file. Back up the data and restore again Warnning If the problem arises again, contact to IntroMedic Service center. Page 112 Packing for shipment 7 Packing for shipment Chapter 7 Page 114 Chapter 7 Packing for shipment 7. PACKING FOR SHIPMENT To ship the MiroCam Capsule Endoscope System for any reason, follow the instructions in this chapter. 7.1 General Introduction Pack the MiroCam capsule endoscope system carefully. Failure to follow the instructions in this chapter may result in loss or damage not covered by the IntroMedic Co., Ltd. warranty. If the original shipping box is not available, use another suitable box. Return the product with a detailed, written description of the problem. 7.2 Repacking in Original Packing Box If available, use the original packing box and packing materials as illustrated figures in below. Page 115 Packing for shipment Chapter 7 n Repacking MiroCam capsule
Insert capsule storage case into capsule box.
- Close capsule box. Page 116 Chapter 7 Packing for shipment n Repacking MiroCam receiver unit
Insert receiver unit into system carry case.
Insert system carry case into receiver unit box. Page 117 Packing for shipment Chapter 7
- Close receiver unit box. Page 118 Chapter 7 Packing for shipment n Repacking MiroCam capsule endoscope system.
- System repacking diagram. Upper Case shield Capsule box Middle case shield Receiver unit box Lower case shield System box Page 119 Packing for shipment Chapter 7
- System repacking procedure. Page 120 Chapter 7 Packing for shipment 7.3 Repacking in Different Packing Box If the original packing box is not available:
n Place the MiroCam capsule endoscope system in a plastic n bag. Locate a corrugated cardboard shipping box with at least 200 pounds per square inch (psi) bursting strength. n Fill the bottom of the box with at least 2 inches of packing material. n Place the bagged unit on the layer of packing material and fill the box completely with packing material. n Seal the packaging box with packing tape. n Label packing box with shipping address, return address, and the written description. Page 121 Packing for shipment Chapter 7 Page 122 EMC Information 8 EMC Information Chapter 8 Page 124 Chapter 8 EMC Information 8. EMC INFORMATION 8.1 Guidance and manufacturers declaration
electromagnetic emissions The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Compliance Group 1 Class B Class A Complies RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
Flicker emissions IEC 61000-3-3 Electromagnetic environment -
guidance The EUT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The EUT is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Page 125 EMC Information Chapter 8 8.2 Guidance and manufacturers declaration
electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601 Test level 6kV Contact 8kV air 2kV for power supply lines 1kV for input/output lines 1kV differential mode 2kV common mode
<5% U
(>95% dip in U) for 0.5cycle 40% U
(60% dip in U ) for 5 cycle 70% U
(30% dip in U) for 25 cycle
<5% U
(<95% dip in U ) for 5 s 3 A/m Power frequency
(50/60Hz) magnetic field IEC 61000-4-8 Compliance Electromagnetic environment -
level 6kV Contact 8kV air 2kV for power supply lines 1kV for input/output lines 1kV differential mode 2kV common mode
<5% U
(>95% dip in U) for 0.5cycle 40% U
(60% dip in U ) for 5 cycle 70% U
(30% dip in U) for 25 cycle
<5% U
(<95% dip in U ) for 5 s 3 A/m guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the EUT image intensifier requires continued operation during power mains interruptions, it is recommended that the EUT image intensifier be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to application of the test level. Guidance and manufacturers declaration - electromagnetic immunity Page 126 Chapter 8 EMC Information 8.3 Guidance and manufacturers declaration
electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 test Compliance level kHz 3 Vrms 150 80MHz 3 V/m 80 MHz 2.5GHz Level 3 Vrms 150 kHz to 80MHz 3 V/m 80MHz to 2.5GHz to to Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the EUT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800MHz 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site Page 127 EMC Information Chapter 8 survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol :
NOTE 1 ) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. Page 128 Chapter 8 EMC Information 8.4 Recommended separation distances between portable and mobile RF communications equipment and the EUT Intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EUT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EUT as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter
[W]
0.01 0.1 1 10 100 Separation distance according to frequency of transmitter[m]
150kHz to 80MHz V1=3Vrms 0.116 0.368 1.166 3.687 11.660 80MHz to 800MHz E1=3V/m 0.1166 0.3687 1.1660 3.6872 11.6600 800MHz to 2.5GHz E1=3V/m 0.2333 0.7378 2.3333 7.3785 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Page 129 EMC Information Chapter 8 8.5 Immunity and Compliance Level IEC 60601 Test Actual Immunity Compliance Level Level 3Vrms 3Vrms 3V/m 3V/m Immunity test Conducted RF Level 3Vrms IEC 61000-4-6 150kHz to 80MHz Radiated RF 3Vrms IEC 61000-4-3 80MHz to 2.5GHz Page 130 Chapter 8 EMC Information 8.6 Guidance and manufacturers declaration
electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an electromagnetic environment. Immunity test Conducted RF IEC 60601 test level 3 Vrms Compliance level Electromagnetic environment - guidance 3 Vrms The EUT must be used only in a shielded location with a IEC61000-4-6 150 kHz to 150 kHz to minimum RF shielding effectiveness and, for each cable 80MHz 80MHz that enters the shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location Radiated RF 3 V/m 3 V/m Field strengths outside the shielded location from fixed IEC61000-4-3 80 MHz to 80MHz to RF transmitters, as determined by an electromagnetic 2.5GHz 2.5GHz site survey, should be less than 3V/m.a Interference may occur in the vicinity of equipment marked with the following symbol:
Page 131 EMC Information Chapter 8 NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation. Page 132 EC Representative NanoMedical Largo do Sequeira 7 G3 P.E. 1100-587 Lisboa Portugal Key Contact: Nuno Nicola Covacich Office: +351-21-884-3140 Mobile: +351964468482 or +351961300259 Email: nuno.nicola@nano-medical.org IntroMedic Co.,Ltd. Suite 1104, E&C Venture Dream Tower 6-Cha 197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719 Tel : +82-2-801-9300 Fax : +82-2-801-9330 http://www.intromedic.com e-mail : help@intromedic.com Disposal of Old Electrical &
Electronic Equipment Applicable in the European Union and other European countries with separate collection systems 0843
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2009-05-05 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2009-05-05
|
||||
| 1 | Applicant's complete, legal business name |
Intromedic Co., Ltd.
|
||||
| 1 | FCC Registration Number (FRN) |
0016453136
|
||||
| 1 | Physical Address |
Suite 1104, E&C Venture Dream Tower 6-Cha, 197-28
|
||||
| 1 |
Seoul, N/A
|
|||||
| 1 |
South Korea
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
M******@us.ul.com
|
||||
| 1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
| app s | FCC ID | |||||
| 1 | Grantee Code |
VAX
|
||||
| 1 | Equipment Product Code |
INTROMEDIC2
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
J**** L********
|
||||
| 1 | Title |
Manager
|
||||
| 1 | Telephone Number |
82-2-********
|
||||
| 1 | Fax Number |
82-2-********
|
||||
| 1 |
j******@intromedic.com
|
|||||
| app s | Technical Contact | |||||
| 1 | Firm Name |
IntroMedic Co
|
||||
| 1 | Name |
S****** K******
|
||||
| 1 | Physical Address |
28 Guro-Dong, Guro-Gu
|
||||
| 1 |
Seoul, 152-719
|
|||||
| 1 |
South Korea
|
|||||
| 1 | Telephone Number |
82-2-********
|
||||
| 1 | Fax Number |
82-2-********
|
||||
| 1 |
s******@intromedic.com
|
|||||
| app s | Non Technical Contact | |||||
| 1 | Firm Name |
Intromedic Co
|
||||
| 1 | Name |
C**** M****
|
||||
| 1 | Physical Address |
E&C Venture Dream Tower 6-Cha
|
||||
| 1 |
Seoul, 152-719
|
|||||
| 1 |
South Korea
|
|||||
| 1 | Telephone Number |
82-2-********
|
||||
| 1 | Fax Number |
82-2-********
|
||||
| 1 |
c******@intromedic.com
|
|||||
| app s | Confidentiality (long or short term) | |||||
| 1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | DSS - Part 15 Spread Spectrum Transmitter | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Capsule Endoscope & Receiver | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 | Grant Comments | Power listed is conducted. The antenna of this device must not be co-located or used in conjunction with any other antenna or transmitter. | ||||
| 1 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 | Firm Name |
ESTECH Co., Ltd.
|
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| 1 | Name |
Y******** J****
|
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| 1 | Telephone Number |
82-31********
|
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| 1 | Fax Number |
82-31********
|
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| 1 |
j******@estech.co.kr
|
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| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0018000 | ||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC