INSTRUCTIONS OLYMPUS CAPSULE ENDOSCOPE SYSTEM CAPSULE ENDOSCOPE SYSTEM SET MAJ-Y0136 MAJ-Y0136 CAPSULE ENDOSCOPE EC-Y0005 Refer to the companion manual, the “WORKSTATION MANUAL” and “Cautions for Capsule Endoscopy Patient” for operating information of the MAJ-Y0134. USA:CAUTION:Investigational device. Limited by Federal (or United State) Law to investigational use.
Contents Labels and Symbols ................................................................................................................................. 1 Symbols................................................................................................................................................... 1 Labels......................................................................................................................................................
Contents 5.3 Disposal .......................................................................................................................................... 93 Chapter 6 Troubleshooting.................................................................................................................... 94 6.1 Troubleshooting .............................................................................................................................. 94 6.2 Returning the system for repair ................
Labels and Symbols Safety-related labels and symbols are attached at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. Symbols The meaning(s) of the symbol(s) shown on the package, the back cover of this instruction manual and/or this equipment are as follows: Caution, refer to instructions. Refer to instructions.
Labels Capsule endoscope Capsule endoscope storage case (Label 1) Product name and model name Sterilization lot number OLYMPUS EC-Y0005 Expiration date Refer to instructions TYPE BF applied part marking Sterilized with ethylene oxide IC : 4763B-ECS10 Single use only FCC ID number Protection against fluid ingress Manufacture details 2 OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL IC number
Antenna unit Unit Label Unit Label FCC marking Model name IC note CSA marking X432262-21 Refer to instructions Manufacturer details OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL 3
Recorder unit Recorder unit (back panel) Label Model Electrical rating / Input power RECORDER OLYMPUS RE-10 MODEL X432262-11 INPUT 3.
Recorder unit cradle Recorder unit cradle (bottom panel) Label Model name Refer to instructions CSA marking Electrical rating / Input power FCC note IC note MODEL X432262-31 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two condtions: (1)This device may not cause harmful interference,and (2)this device must accept any interference received, Including interference that may cause undesired operation.
Battery pack Label Model name Electrical rating / Input power WARNING Refer to instructions Battery pack MODEL X432262-11-12 OUTPUT 3.7V 2860mAh 10.5Wh WARNING: Use this Battery pack only X432262-11 Keep away from heat or frame. Don’t make the battery pack charged, used, or lift under high temperature conditions. Don’t short circuit, disassemble or reconstruct. Don’t drop, avoid physical shock. Don’t make the Battery pack contacted with water, chemical or any other liquid. Keep away from metal objects.
Recorder unit harness Model No.
Antenna harness Model name Label 8 Manufactur OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL
Important Information — Please Read Before Use Intended use The OLYMPUS CAPSULE ENDOSCOPE SYSTEM has been designed to be used for visualization of the small intestine mucosa. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas. Do not use this system for any purpose other than its intended use. Instruction manual This instruction manual contains essential information on using the system safely and effectively.
User qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in capsule endoscopy procedures. This manual, therefore, does not explain or discuss capsule endoscopy procedures.
Signal words The following signal words are used throughout this manual. Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.
Dangers, warnings and cautions Follow the dangers, warnings and cautions given below when handling the system. This information is to be supplemented by the dangers, warnings and cautions given in each chapter. • This system is contraindicated to patients with the following conditions. − Patients with cardiac pacemakers or other implanted electronic devices (e.g., defibrillators) (Cardiac pacemakers or other implanted electronic devices may malfunction due to the RF (radio frequency) interference.
• Instruct of the patient to stay away from equipment that generates strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope. Otherwise, injury within the body cavity may occur. If the excretion of the capsule endoscope has not been confirmed, within 2 weeks after ingestion, attempt to locate the capsule endoscope within the patient’s body by X-ray examination.
• Prior to using the capsule endoscope, the physician should consider performing a contrasted X-ray series in patients with the following conditions. Patients with suspected intestinal strictures, adhesions, diverticulum, obstructions, fistulas that may block the passage of the capsule endoscope, and patients with suspected gastrointestinal tract delay.
• A negative or normal result obtained by the imaging capsule does not exclude the presence of pathology and if symptoms persist, further evaluation should be performed. • The capsule endoscope must be ingested under the supervision of the physician or medical personnel authorized by the physician. • Never install and/or operate this system in locations where: − Concentration of oxygen is high. − Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.
• Do not heat the battery pack or bring it in contact with fire. The insulating material may melt, gas could be released, the safety circuit may be damaged, and electrolytic solution may be ignited, causing excessive heat, release of smoke, explosion, and/or a fire. • Do not use or store the battery pack near flames or a source of high temperature (over 80°C (176°F)) such as a stove.
• If a battery pack is leaking, take care that the liquid does not come in contact with your skin or eyes. If liquid enters the eye, do not rub it; immediately rinse with clean water, then consult a physician. Failure to take appropriate action may result in injury. • If recharging is not completed after the given recharging time, do not continue recharging. Excessive heat, release of smoke, explosion, and/or a fire may result. • Do not place the battery pack in a microwave or a high-pressure cooker.
• Keep the capsule endoscope away from permanent magnets or electromagnets. Magnets can turn the capsule endoscope ON, resulting in the consumption of battery power. • Keep the capsule activator away from implant devices, such as cardiac pacemakers, defibrillators, nerve stimulators, and other equipment that may be affected by DC magnetic fields. • Before use, ensure that there are no rough or sharp edges and/or projections on the surface of the capsule endoscope.
• If more than one capsule endoscope is ingested at the same time, image recording may fail because of radio interference. Before use, the physician has to ensure that the patient has not swallowed any other capsule endoscope. Do not use the capsule endoscope with any other swallowable diagnostic devices because the safety of concomitant use has not been verified. • Do not turn ON a capsule endoscope near another patient already undergoing an examination with an ingested capsule endoscope.
• This system is used to examine the small intestine by the patient’s ingestion of a capsule endoscope, that continuously takes pictures as it moves down the gastrointestinal tract by peristalsis. The captured images are radio transmitted to the recorder unit, and are observed using the workstation. After the examination, the capsule endoscope is excreted naturally. • Have a spare capsule endoscope ready for use in case the primary device is determined to be unusable prior to patient ingestion.
Danger, warning and cautions for patients Provide the following information to the patients at least one day before the examination, so that the examination may be performed properly. Failure to follow these instructions may result in injury to the patient and/or may interfere with the examination. Please provide the patient with the separate “Caution for Capsule Endoscopy Patient” packed with the capsule endoscope (EC-Y0005).
• Patients who are currently taking medication must not take any medication during the period beginning two hours before and ending two hours after the beginning of the examination. If the medication must be taken on a set schedule, instruct the patient to consult the prescribing physician about shifting the schedule. Failure to follow instructions may interfere with the examination.
Expiration date of the capsule endoscope The battery inside the capsule endoscope gradually loses life during long term storage. A storage environment with temperatures over 25°C (77°F) may cause the capsule’s battery to deplete rapidly. Loss of battery life may shorten the operation time (continuously recording and transmitting the images) of the capsule endoscope.
Color Tone of the Capsule Endoscope Image Images photographed by the CMOS incorporated in the capsule endoscope (EC-Y0005) are wirelessly transmitted to the antenna harness attached to the patient and then recorded on the recorder unit . The images stored in the recorder unit can be played on the workstation for observation. Once the capsule endoscope is dispensed to the patient, it cannot be controlled from outside of the patient.
• Since the capsule endoscope transmits images by radio, noise may appear in the recorded images depending on the surrounding electromagnetic environment (see Figure 3 (an example of the noise is indicated by the arrow)). If an image with noise is displayed, observe the image carefully. Figure 3 • Some debris in the small intestine may look like bleeding in color and shape (see Figure 4 (in the circle)).
• Do not change the color setting of Windows® installed in the workstation. Doing so may change the color tone of the image. • Connect the LCD monitor and the workstation hardware securely. If the connection is loose, the images may not be displayed properly. • Use monitors designated by Olympus for observation of the capsule endoscopic images. Non-designated monitors may display the images in different color tones.
EMC (Electromagnetic Compatibility) • In order to provide the intended functionality, the system emits RF (Radio Frequency) energy while in operation. This may affect electrical devices in the vicinity. • The system is equipped with a function for device identification via radio transmission, and is thus subject to electromagnetic interference from other equipment in the vicinity.
Chapter 1 Checking the Package Contents Match all items in the package with the components shown in this chapter. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the system; immediately contact Olympus.
1.
1.
The product model of each item and its content are as follows: Product name Model Capsule endoscope system set MAJ-Y0136 MAJ-Y0136 Capsule endoscope Capsule activator Recorder unit Antenna unit Recorder unit cradle EC-Y0005 MAJ-1478 X432262-11 X432262-21 X432262-31 Antenna harness Recorder unit harness X432252-51 X432251-40 Comments Recorder unit, antenna unit, battery pack, recorder unit harness, recorder unit cradle, antenna harness, AC adapter, AC cable ,USB cable, capsule activator 1 pc. 1 pc.
Chapter 2 Nomenclature and Functions 2.
1. Capsule endoscope (EC-Y0005) Takes endoscopic pictures of the gastrointestinal tract and transmits the image data by radio transmission. 2. Antenna unit (X432262-21) Receives transmissions from the capsule endoscope, and transfers the image data to the recorder unit. 3. Recorder unit (X432262-11) Records the image data transmitted by the capsule endoscope via the antenna unit. 4. Battery pack (X432262-11-12) The power supply for the recorder unit. 5.
2.2 Capsule endoscope (EC-Y0005) Capsule endoscope (EC-Y0005) 1. Exterior package Exterior package of the capsule endoscope. 2. Top cover A transparent observation port covering the objective lens and illumination light emitting diode (LED). 3. Objective lens Lens for endoscopic observation. 4. Illumination LED Illuminates the area being observed. 5. Battery Internal battery for operating the capsule endoscope.
2.3 Antenna unit (X432262-21) 1. Antenna sheet 3. Connection unit 4. hole 2. Antenna cable 5. Antenna unit eject button 1. Antenna sheet Receives signals from the capsule endoscope. 2. Antenna cable Transfers the received signals to the connection unit. 3. Connection unit Connects to the recorder unit. 4. Hole Use it for alining the antenna sheet. 5. Antenna unit eject button Slide the button located on the backside of the recorder unit to disconnect the antenna unit.
2.4 Recorder unit (X432262-11) 2. Power lamp 1. Indicator lamp 7. Power switch 3. Display panel 4. Battery cover 5. Battery pack case 9.Hole 6. Antenna unit connector 8. Eject button 1. Indicator lamp Indicates the reception/communication status with the capsule endoscope and the workstation. 2.
Illuminates green when the recorder unit is turned ON. 3. Display panel Displays patient ID, battery pack level, etc. 4. Battery cover Covers the battery pack and holds the battery pack in place. 5. Battery pack case Insert the battery pack here. 6. Antenna unit connector Attach the antenna unit here. Connect to the recorder unit cradle. 7. Power switch Turn the recorder unit ON by holding down the switch for 1 second or more. Turn the recorder unit OFF by holding down the switch for 2 seconds or more. 8.
2.5 Recorder unit cradle (X432262-31) 2. USB cable 3. Recorder unit connector 6.Charge completion lamp 7.Charge lamp 1. AC adapter 5. USB connector 4. Power connector 1. AC adapter Connects to an AC power supply. 2. USB cable Connects between the USB connector and the workstation. 3. Recorder unit connector Connect to the recorder unit. 4. Power connector Connect to the AC adapter. 5. USB connector Connect to USB cable. 6.Charge completion lamp Show the status that battery is charged completely.. 7.
2.6 Recorder unit harness (X432251-40) 1. Suspender 3. Pouch cover 2. Pouch 1. Suspender Adjusts the length according to the patient’s physique. 2. Pouch Stores the recorder unit during the examination. 3. Pouch cover Secures the recorder unit and the antenna cables to the pouch.
2.7 Antenna harness (X432252-51) 6. Belt coupler 7. Short belt 5. Hook and loop fastener 8. Long belt 2. Fastener 1. Antenna pouch 3.Alignment hole 4. Belt ring 1.Antenna pouch Housing the antenna sheet.. 2. Fastener Zip up to fix the antenna sheet.. 3. Alignment hole Adjust this hole to the umbilical position. 4. Belt ring Through a belt, and fix the hook and loop fastener.. 5. Hook and loop fastener Connect the both ends of the belt. 6.
2.8 Capsule activator (MAJ-1478) 1. Capsule endoscope insertion hole To turn ON the capsule endoscope, insert it into this hole. 2. Boss Projected portion that indicates direction of the activator. It is like a guide when inserting the activator. 2.9 Battery pack (X432262-11-12) 1.Terminal 2.Clawe 1. Terminal Connects to the connector in the battery case of the recorder unit. 2. Clawe Insert this nail into the hole of the recorder unit when inserting the battery pack into the battery pack case. 2.
Chapter 3 Installation and Connection 3.1 Preparation The following items are required for the capsule endoscope examination. Inspect them the day before the examination as described in this chapter.
3.2 Exterior Do not use if the equipment exterior is abnormal.It may result in failure of the examination. Inspect the equipment as described in Table 3.2 below. Equipment Description Antenna unit Check that the unit is free of cracks, deterioration, deformation, And other damage. Recorder unit Check that the unit is free of cracks, deterioration, deformation, And other damage. Recorder unit cradle Check that the unit is free of cracks, deterioration, deformation, and other damage.
3.4 Preparation of the recorder unit Attaching the battery pack 1. Open the battery cover by pressing the battery cover eject button. Hole Figure 3.1 Figure 3.2 2. Align the two claws on the battery pack with the hole in the battery pack case, and insert the battery pack to the battery pack case. figure 3.3 44 Figure 3.
3. Close the battery cover by pressing it down over the battery pack until the battery cover is locked. (Refer Figure 3.5) Figure 3.5 Don’t use the recorder unit if there are cracks, deterioration, deformation, and other damage. It may interfere with the examination. • The battery pack is not charged when it is shipped. Charge it before use. • To remove the battery pack, remove the battery cover for reference ‘1’ of “Attaching the Battery pack” of the previous page.
3.5 Preparation of the recorder unit cradle 1. Connect the AC adapter to the power connector. Figure 3.7 2. Connect the USB cable to the USB connector. Figure 3.
3. Connect the AC cable to the AC Adapter. Figure 3.9 4. Connect the AC cable to the AC power supply. 5. Connect the USB cable to the USB connector on the workstation. Refer to “Workstation manual”.
Chapter 4 Operation 4.1 Preparation and Inspection before examination Before starting an examination, be sure to read and clearly understand the information in this instruction manual. Instruct the patient to stay away from equipment that generates strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope. Otherwise, injury within the body cavity may occur.
• On rare occasions, interference may result in the need to repeat the capsule endoscope procedure. In this case, the physician should advise the patient to stay within the premises of the medical facility during the examination to prevent this problem from reoccurring. • The capsule endoscope contains a radio transmitter; therefore, the patient cannot fly in an airplane until the examination is over. •The life span of a battery pack is approximately 1 year from the date of purchase.
Recharging Fully recharge the battery packs to prevent low battery charge, which could cause the examination to end prematurely. In preparation for the examination, recharge the battery packs on the previous day. The battery pack can not be recharged at temperatures below 0℃. 1. Check that the recorder unit is off and the display panel is blank. 2. Suppress the recorder unit cradle by hand, and insert the recorder unit to the recorder unit cradle as shown in Figure 4.1.
3. Wait a few seconds, and check that the charge lamp illuminates and Battery charge screen as shown in Figure 4.4 is displayed on the display panel. The recharging time is approximately 2 hours. Battery charging screen Charge lamp Figure 4.3 Figure 4.4 4. When recharging is complete, the charge lamp goes off, the charge completion lamp illuminates and Battery full screen as shown in Figure 4.6 is displayed on the display panel. Battery full screen Charge completion lamp Figure 4.
Initial setup of the recorder unit Before initializing, to complete the connection and setup of the Workstation, refer to the “WORKSTATION MANUAL”. The recorder unit is connected to the workstation via the recorder unit cradle. While setting up the recorder unit, do not remove the recorder unit from the recorder unit cradle or remove the USB cable and/or AC adapter. Doing so may result in failure of the examination.
2. When initialization is completed, patient ID and the patient’s name are displayed on the Battery full screen as shown in Figure 4.8 on the display panel and the recorder unit’s indicator lamp change green. None Figure 4.8 3. While holding the recorder unit cradle with one hand, lift the recorder unit up with your other hand to remove it from the recorder unit cradle. The recorder unit is turned OFF automatically.
4.2 Attaching the equipment to the patient Patient confirmation Before attaching the antenna unit to the patient, confirm the patient’s identity. Also confirm that the patient has not eaten or drunk for at least 8 hours before the examination. Inserting the antenna sheet •When inserting the antenna sheet to the antenna harness, take care not to bend the antenna sheet.
Preparation of antenna unit harness Select the appropriate belt to fit the body form of the patient. If it is necessary, connect two belts in the following procedures. (Refer to figure 4.10, figure 4.11) 1. Turn down a belt in a belt coupler of the short belt. And close a hook and loop fastener. Figure 4.10 2. Figure 4.11 Put the end of the long belt through the belt coupler of the short belt like figure 4.12. Figure 4.12 3. Close the hook and loop fastener of the long belt. (Refer to figure 4.
Attaching the antenna unit • Refer to the following information to attach the antenna unit to the patent’s body. Otherwise, noise may appear in the images or the images may not be transmitted properly. • Allow only a thin clothing of natural materials to be placed between the body and the antenna harness. • Do not tuck metals, such as buckle of belt, between the antenna unit and surfaces of the body. Otherwise, noise may appear in the images or the images may not be transmitted properly.
3. Let the other end of the belt into a belt ring. Pull out the both ends of the belt in right and left to attach antenna harness to the patient. (Refer to figure 4.16) Figure 4.15 Figure 4.16 4. Adjust the position of the antenna harness so that the alignment hole of the antenna harness to the umbilical position of the patient.(Refer to figure 4.17) Figure 4.17 5. Reattach the antenna harness in the case such as follows when the patient walks and/or sits down. - A patient feels unpleasantness.
・Instruct the patient to be careful so that the antenna harness does not move from the attached position and so that the antenna harness is not separated from the surface of the patient’s body. Otherwise, noise may appear in the images, or the images may not be transmitted properly. ･ Instruct the patient to be careful so that the antenna cable is not caught on things such as knob of doors.
Connecting the recorder unit and the antenna unit 1. Connect the antenna unit to the recorder unit by inserting the connection unit into the recorder unit until they click (Refer to Figure 4.19). Figure 4.19 2. Hold down the recorder unit’s power switch for at least 1 second to turn ON the recorder unit (Refer to 4.20). The starting screen is displayed as shown in Figure 4.21 on the display panel. 3.
Starting screen Figure 4.21 4. Confirm the patient’s identity with the patient ID and the patient’s name displayed on the recorder unit (Refer to Fig 4.22). Battery icon ID View screen Patient ID Patient Name Recording time Figure 4.
• If the Battery icon is orange, the battery may run out before 12 hour. Recharge the battery pack, or replace with a fully-charged battery pack. • Start the examination immediately after turning the recorder unit ON. Failure to do so may result in premature termination of the examination due to an empty or low battery. • If any of error messages are appeared on the display panel, refer to “Troubleshooting”. • The recording time is displayed at the lower left of the display panel.
IInserting the Recorder Unit in the Recorder Unit Harness • Attach the antenna unit and the recorder unit so that antenna cable is not caught on things such as a knob of a door. Otherwise it may damage the antenna unit and/or the recorder unit and may result in failure of the examination. • Attach the antenna unit and the recorder unit so that antenna cable is not laid on or near the antenna sheet. It may prevent the proper reception of images. 1.
Turning the power ON 1. Check the expiration date. 2. Slowly remove the sealing paper and take care that the capsule endoscope does not fall out of the container. Figure 4.24 3. Hold the sterile container, taking care not to squeeze it. Adjust the direction of the activator’s boss to the closest groove to the handle of the inner lid of the sterile container. Insert the capsule activator straight along with the groove. The capsule endoscope will turn ON (see Figure 4.25).
• The capsule activator is not sterilized. Do not allow the capsule endoscope to touch the activator. • Keep the capsule endoscope away from DC magnetic fields such as magnets. Magnets can turn the capsule endoscope ON, resulting in the consumption of battery power. • Do not look directly at the capsule endoscope’s LED for a prolonged duration. You may feel dizzy due to the afterimage. Inserting the capsule activator again will turn the capsule endoscope OFF.
Confirming Operation Confirm the operation of the capsule endoscope according to the following steps. 1. Bring the capsule endoscope in the sterile container close to the antenna sheet (the patient’s abdomen). 2. Confirm that the receiving lamp of the recorder unit blinks green.
Confirming image You can confirm if the image transmitted from capsule endoscope by Image View screen. 1. Push the “MENU” button to display the Menu screen. 2.Choose the “Image View” by pushing “Cursor” button, and push “OK” button.(Refer to Figure 4.26) The capsule endoscope image is displayed on the Image View screen. (Refer to Figure 4.27) “Image View” MENU screen “OK” button “MENU” button Cursor button “ ”, “ ”, “⊳” , “ ” Fig 4.
When the ID View screen with Image View icon (Refer to Figure 4.28) is displayed, Image View screen can be displayed with the pushing “OK” button. ID View screen ID View icon Figure 4.28 • When approximately two minutes pass, the display panel of the recorder unit turn off. • When “MENU” button is pushed, the MENU screen is displayed. • When “Back” button is pushed, the previous screen is displayed. • You can capture a displaying image with the pushing the “OK” button.
Confirming the recorded image You can display recorded images on Playback mode of the Image View screen. 1. Push the “MENU” button to display the Menu screen. Choose the “Image View” by pushing “Cursor” button, and push “OK” button. The capsule endoscope image is displayed by Image View screen. 2. Push the ”⊳” on Image View screen shown below. (See Figure 4.29) As shown figure 4.30, a stored image is displayed by playback screen. Image View screen Cursor button “ ”, “ ”, “⊳” , “ ” Fig 4.29 3.
• Expansion and the reduction of the average color bar are possible by pushing “ ”or ” ”. The average color bar can display three following conditions. ― All mode displays the average color bar of all images which are stored. ― 1hour mode displays 30 minutes before and after an image chosen. (Displays average color bar of 1 hour.) ― 10 minutes mode displays 5 minutes before and after an image chosen. (Displays average color bar of 10 minutes.
Capture of the image During Image View screen is displayed, you can capture the image shown on the screen. 1. Push “OK” button when the image to be captured is displayed. Such screen as in the Figure 4.31 is displayed. Set icon and Cancel icon are displayed in the screen. number of images already captured / max number of images to be captured Selection image time A position of the captured image on average color bar Set icon Cancel icon “OK” button Figure 4.31 2. Push “OK” button to capture images.
･When number of the capture image exceeds 15, Figure 4.32 is displayed. Choose “Capture cancel” to stop capturing image or “Erase others” to capture more image by ”⊳”,” ” and “OK” button. ･When you choose “Erase others”, Capture list is displayed. Please refer to cancellation method “capture for the later operation.” Figure 4.32 • Do not touch the display panel with Image View screen. You may not operate the recorder unit normally.
Confirming capture image You can confirm the image which is captured by following operation from Capture list. 1. Push “MENU” button to display Menu screen. 2. Choose “Capture View” and push “OK” button on MENU screen. “Capture View” “OK” button “MENU” button Cursor button “ ”, “ ”, “⊳” , “ ” Figure 4.33 3. The images which are captured are displayed. The chosen image is surrounded in a blue line.(Refer to Figure 4.34) Choose an image using Cursor button. Capture List Selection image Figure 4.
4. The image which you choose is displayed when push “OK” button. (Refer to Figure4.35) You can display previous and following images by pushing a “⊳”, ” ”. number of the capture image/ capture possibility number of sheets Figure 4.35 ･ The display panel of the recorder unit turn off approximately two minutes after the last operation. ･When “MENU” button is pushed, the MENU screen is displayed. ･When “Back” button is pushed, the previous screen is displayed.
Cancellation of the captured image By the following operation, cancellation of the capture is possible. 1. Choose an image to erase from Capture list and push "OK" button. 2. Push ” ” when the captured image which you choose is displayed on the screen. “OK” button “MENU” button Cursor button “ ”, “ ”, “⊳” , “ ” Fig 4.36 3. Choose "Yes" and push "OK" button on the following screen. (Refer to Figure 4.37) Figure 4.
･ The display panel of the recorder unit turn off approximately two minutes after the last operation. ･When “MENU” button is pushed, the MENU screen is displayed. ･When “Back” button is pushed, the previous screen is displayed.
Confirming the guidance The recorder unit gives guidance to a patient during the examination by registering patient and examination data in Workstation. By the following operation, guidance to a patient is displayed. 1. Push “MENU” button to display MENU screen. 2. Choose the “Guidance List” by the Cursor button, and push “OK” button. (Refer to Figure 4.38) “Guidance List” “OK” button “MENU” button Cursor button “ ”, “ ”, “⊳” , “ ” Figure 4.
3. Guidance List is displayed. (Refer to Figure 4.39) 09:00 Please call a nurse. 10:00 Please come back to the p 12:00 You can take a light meal. 16:00 Please Come back to the h The latest guidance Please come back to the procedure room． Figure 4.39 ･If the guidance has already been given, the icon shown beside the time green from white. ･The latest guidance is displayed in the lower part of the screen. （Refer to Figure 4.39） ･When “MENU” button is pushed, the MENU screen is displayed.
Handling the recorder unit when guidance is given ･Instuct the patient not to operate the recorder unit other than guidance occurs and to stop beep and vibration. ･Instruct a flow of the examination to the patient to patient cope even if a patient does not notice guidance. 1. Instruct a patient how to stop beep and vibration of guidance by pushing “OK” button when guidance is given. 2. ID View screen is displayed when guidance is given.
Confirmation of the memo You can confirm the memo which is inputted in the recorder unit. 1. Push the “MENU” button. 2. Choose “Memo” by the Cursor button and push “OK” button. (Refer to Figure 4.41) “MEMO” “OK” button “MENU” button Cursor button “ ”, “ ”, “⊳” , “ ” Figure 4.41 3. Such screen as figure 4.42 is displayed so that you can read the memo. Figure 4.
･ The display panel of the recorder unit turn off approximately two minutes after the last operation. ･When “MENU” button is pushed, the MENU screen is displayed. ･When “Back” button is pushed, the previous screen is displayed.
Editing of the memo You can edit the memo into a recorder unit. 1. Choose the inputting position on the Memo screen by Cursor button. 2. Input a letter by touching it with a keyboard displayed on the screen. Figure 4.43 Button ⊳ OK BACK MENU Function Press to move cursor up in input. Press to move cursor down in input. Press to move cursor left in input. Press to move cursor right in input. Save and Exit to Menu screen. Exit to Menu screen, Memo not saved. Exit to Menu screen, Memo not saved.
4.4 Starting the examination Even when the guidance function is used, explain the patient how the examination is performed, so that the examination can proceed if the patient fails to be aware of the guidance. Ingesting capsule endoscope ･The capsule endoscope should only be ingested with water. Use of other liquids may interfere with the examination. ･Avoid touching the top cover (LED side) of the capsule endoscope. Do not wipe with gauze or other cloths. 1. Prepare a glass of water 2.
4.5 During the examination Familiarize the patient with the following warnings and cautions. Instruct the patient to stay away from equipment that generates strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope. Otherwise, injury within the body cavity may occur.
• Since the capsule endoscope is a radio-transmitting device, it could interfere/ or experience interference with other radio-transmitting devices (e.g., telemetry, keyless entry devices). • On rare occasions, interference may result in the need to repeat the capsule endoscope procedure. In this case, the physician should advise the patient to stay within the premises of the medical facility during the examination to prevent this problem from reoccurring.
4.6 Ending the examination Removing equipment 1. About 8 hours after the start of the examination, check that the recorder unit’s indicator lamp has stopped blinking, and end the examination. If the indicator lamp is blinking, confirm the image view screen and determine whether to continue or stop the examination. 2. Take the recorder unit out of the pouch of the recorder unit harness.
3. Hold down the recorder unit’s power switch for 2 seconds or more to turn OFF the recorder unit (see Figure4.44), then disconnect the antenna unit. Slide the antenna unit eject button on the backside of the recorder unit, and disconnect the connection unit by sliding it in the direction of the arrow (Refer to Figure4.45). Figure 4.44 Figure 4.45 4. Remove the recorder unit harness from the patient. 5. Remove the antenna unit from the patient.
Downloading image data Download the image data from the recorder unit to the workstation according to the following procedure: • While downloading, do not remove the recorder unit from the recorder unit cradle or turn OFF the workstation. Doing so may result in loss of image data. • While downloading, do not unplug the power cable. Doing so may result in loss of image data. • While downloading, do not turn OFF the recorder unit.
4. The patient’s ID and name are displayed on the recorder unit’s display panel. Figure 4.46 If an error is detected on the recorder unit, the indicator lamp will blink yellow. To troubleshoot, refer to Chapter 6, “Troubleshooting”. 5. The workstation is used to download image data. For specific information on downloading image data, refer to the “WORKSTATION MANUAL”. • While downloading the image data, the indicator lamp on the recorder unit turns from green to yellow and blinks once every second.
Figure 4.
Confirming excretion of the capsule endoscope Familiarize the patient with the following danger. Instruct the patient to stay away from equipment that generates strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope. Otherwise, injury within the body cavity may occur. If the excretion of the capsule endoscope has not been confirmed within 2 weeks after ingestion, attempt to locate the capsule endoscope within the patient’s body by X-ray examination.
Chapter 5 Care, Storage and Disposal 5.1 Care After using the system, immediately perform the following cleaning procedure. • After wiping with a piece of moistened gauze, dry this system thoroughly before using it again. If it is used while still wet, there is the risk of an electric shock.
･Do not iron or dry clean and do not use a bleach for the recorder unit harness and antenna harness. Doing so will damage the surface. Note that machine-washing may cause the recorder unit harness to shrink slightly. 3. If the recorder unit harness becomes wet, be sure to dry it completely. 5.2 Storage After cleaning the equipment according to the procedure given in Section 4.1, “Care”, be sure to dry it off thoroughly.
5.3 Disposal When disposing of any item, follow all applicable national and local laws and guidelines. The capsule endoscope is excreted naturally through the patient’s feces.
Chapter 6 Troubleshooting If, during the inspections described in Chapter3, “Installation and connection” and Chapter4 “Operation, the system or any of its components appears to have problems,refer to Section 6.1, “Troubleshooting” to correct the problem.If the problem persists, stop using the system, and refer to Section 6.2,“Returning the system for repair” to correct the situation. If the problem cannot be resolved by these countermeasures, contact Olympus.
Irregularity Images from the capsule endoscope are not displayed by the Image View screen. Possible cause The recorder unit is broken. The capsule endoscope is broken. The antenna cable is broken. Solution Contact Olympus. Use a new capsule endoscope. Connect the antenna unit to the recorder unit properly. The recorder unit fails to turn OFF. Display layout is out of place. The antenna unit is not connected to the recorder unit. The antenna unit is too far from the capsule endoscope.
Recorder unit error messages Error code on recorder Unit’s display panel 96 Possible cause Solution System error 1. Restart the system. 2. If the error persists, contact Olympus. Internal memory error Contact Olympus. RTC error 1. Connect the recorder unit to the workstation, and perform initialization. 2. If error persists after initialization, contact Olympus. Communication error with the battery pack 1. 2.
Error code on recorder Unit’s display panel Possible cause Time to replace battery pack∗1 Solution Order a new battery pack from Olympus, and replace it after the new battery pack arrives. The recorder unit may not be able to operate for 12 hours Antenna unit disconnected Connect the antenna unit to the recorder unit. ∗1 The expiration of a battery pack is approximately 1 year from the date of purchase When the battery pack approaches its end-of-life, the recorder unit will prompt for replacement.
6.2 Returning the system for repair Olympus is not liable for any injury or damage occurring as a result of repairs attempted by non-Olympus personnel. Before sending the system for repair, contact Olympus. With the system, include a description of malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem. Refer to Labels Section in Chapter 1 to easily locate the model name and serial number when sending equipment to Olympus for repair.
Appendix Transportation, storage, and operation environment Capsule endoscope Transportation and storage environment Operation environment Ambient temperature 0 – 25°C (32 – 77°F)∗1 Relative humidity 30 – 85%∗2 Barometric pressure Ambient temperature 700 – 1060 hPa (10.2 – 15.4 psia) 10 – 40°C (50 – 104°F) Relative humidity N/A Barometric pressure 700 – 1060 hPa (10.2 – 15.4 psia) ∗1 Storage outside the storage environment range may cause condensation and/or deterioration of the battery.
Recorder unit Transportation and storage environment Operation environment Ambient temperature –20 to +70°C (–4 to +158°F) Relative humidity 10 – 95%∗1 Barometric pressure Ambient temperature 700 – 1060 hPa (10.2 – 15.4 psia) 0 – 50°C (32 – 122°F) Relative humidity 30 – 90%∗1 Barometric pressure 700 – 1060 hPa (10.2 – 15.
Battery pack Transportation and storage environment Operation environment Ambient temperature 0 – 50°C (32 – 122°F) Avoid prolonged storage at temperatures exceeding 40°C (104°F). Relative humidity 10 – 95%∗1 Barometric pressure 700 – 1060 hPa (10.2 – 15.4 psia) 0 – 50°C (32 – 122°F) Recharging: 0 – 40°C (32 – 104°F) Discharging: 0 to +50°C (32 to +122°F) 30 – 90%∗1 Ambient temperature Relative humidity Barometric pressure 700 – 1060 hPa (10.2 – 15.
Recorder unit harness Transportation and storage environment Operation environment Ambient temperature –20 to +70°C (–4 to +158°F) Relative humidity 10 – 95% Barometric pressure Ambient temperature 700 – 1060 hPa (10.2 – 15.4 psia) 0 – 50°C (32 – 122°F) Relative humidity 30 – 90% Barometric pressure 700 – 1060 hPa (10.2 – 15.
Specifications System chart Capsule endoscope ( EC-Y0005) Capsule endoscope system set MAJ-Y0136 (MAJ-Y0136) Capsule activator (MAJ-1478) Battery pack (X432262-11-12) Antenna unit （X432262-21) Antenna harness (X432252-51) Recorder unit （X432262-11） Recorder unit harness (X432251-40) AC cable AC adapter Recorder unit cradle (X432262-31) USB cable Workstation (MAJ-Y0134) LCD monitor Printer USB HDD OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL 103
The system (components within the bold dotted line) is IEC 60601-1 certified in a configuration that includes the capsule endoscope, antenna unit, and recorder unit. The recorder unit cradle, and USB cable, are IEC 60950-1 certified. • In order to provide the intended functionality, the system emits RF energy while in operation. This may affect electrical devices in the vicinity. The patient should keep a distance from such devices.
Capsule endoscope Product name Optics Field of view (maximum) 160° Depth of field 0 – 20 mm Sampling rate Power supply Capsule endoscope (EC-Y0005) 2 fps Power source Battery life Internal battery 12 hours Size Dimensions ø 11 (diameter) × 26 (length) mm Classification as medical electrical equipment Type of protection against electric shock Degree of protection against electric shock Degree of protection against explosion Internal power supply Protection against fluid ingress EMC Applied
106 OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL
Recorder unit Product name Power supply Power source Battery pack (X432262-11-12) Voltage 3.7 V Current 500 mA Battery life Size Classification as medical electrical equipment Year of manufacture EMC Recorder unit (X432262-11) 12 hours or longer Weight 282 g Dimensions 83 (W) × 151 (H) × 32 (D) mm Type of protection against electric shock Degree of protection against explosion 1712345 Internal power supply Applied standard; IEC 60601-1-2:2001 Use under combustible atmosphere prohibited.
Recorder unit cradle Product name Power supply Voltage DC 5V Current 3A Weight Main body: 345 g Dimensions 133 (W) × 79 (H) × 84 (D) mm Classification as medical electrical equipment Year of manufacture Type of protection against electric shock Degree of protection against explosion Class Ⅰ EMC Applied standard; IEC 60950-1:2005 Size 108 Recorder unit cradle (X432262-31) 1712345 (AC Adapter: 175 g) Use under combustible atmosphere prohibited.
Battery pack Product name Battery pack (X432262-11-12) Type Capacity Lithium-Ion storage cell 2860 mAh Voltage 3.7 V Recharging time Size Approx. 2 hours Weight 70 g Dimensions 70.4 (W) × 10.2 (H) × 55.
Antenna unit Product name Size Classification as medical electrical equipment EMC 110 Antenna unit (X432262-21) Weight 140 g Dimensions 83 (W) × 50 (H) × 13 (D) mm The number of antennas Degree of protection against electric shock Degree of protection against explosion Applied standards; IEC 60601-1-2: 2001 8 TYPE BF Use under combustible atmosphere prohibited. This instrument complies with the standards listed in the left column.
Recorder unit harness Product name Size Recorder unit harness (X432251-40) Weight 70 g Dimensions 100 (W) × 160 (H) × 37 (D) mm Antenna harness Product name Size Antenna harness (X432252-51) Weight 180 g Dimensions pouch 350(W)×160(H)mm Long belt 90(W)×50(H)mm Short belt 60(W)×50(H)mm OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL 111
EMC information 〇 Magnetic emission compliance information and recommended electromagnetic environments The system (components within the bold dotted line of “System chart” on page 103) is designed for use under the following electromagnetic environment. Emission standard Compliance Guidance RF emissions CISPR 11 Group 1 This instrument uses RF (Radio Frequency) energy only for its internal function.
〇 Electromagnetic immunity compliance information and recommended electromagnetic environments The system (components within the bold dotted solid line of “System chart” on page 103) is designed for use under the following electromagnetic environment.
〇 Cautions and recommended electromagnetic environment regarding portable and mobile RF communications equipment such as cellular phones • 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). • This instrument complies with the requirements of IEC 60601-1-2: 2001.
○ Recommended separation distance between portable and mobile RF communications equipment and this instrument Rated maximum output power of transmitter P (W) Separation distance according to frequency of transmitter (m) (calculated as V1=3 and E1=3) 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz d= 1.2√P d= 1.2√P d= 2.3√P 0.01 0.1 1 10 0.12 0.38 1.2 3.8 0.12 0.38 1.2 3.8 0.23 0.73 2.3 7.3 100 12 12 23 The guidance may not apply in some situations.
FCC notice This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IC notice This device complies with Industry Canada licence-exempt RSS standard(s).
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