Given Imaging GIVENRECORDER Data Recorder with a connected Sensor Array User Manual RAPID 7 Setup

Given Imaging Limited Data Recorder with a connected Sensor Array RAPID 7 Setup

manual

PillCam® Platform Setup & MaintenanceRAPID® 7DOC-1530-01August 2010Book 1Book 1: Setup & MaintenanceBook 2: Performing Capsule Endoscopy Book 3: Using the RAPID® Software
COPYRIGHTThis manual is the property of Given Imaging Limited and may not be transferred or reproduced in any form without the written permission of Given Imaging Limited. Copyright © 2001-2010 Given Imaging Ltd. TRADEMARKSGIVEN, GIVEN & Design, PILLCAM, PILLCAM & Logo, PILLCAM IMAGING CAPSULE & Design, AGILE, RAPID, RAPID ACCESS, ORDERWIN, ORDER WHEN I NEED, FINGERS HOLDING A CAPSULE & Logo, FINGERS HOLDING PILLCAM CAPSULE & Logo, ICCE, ICCE Logos, International Conference on Capsule Endoscopy, VUESPAN, BRAVO PH SYSTEM, BRAVO, ENDONETICS, VERSAFLEX, GEROFLEX, REPHLUX TRACER, ION, GASTROTRAC, BILITEC, DIGITRAPPER, SLIMLINE, PHERSAFLEX, MANOSCAN, MANOSCAN 360, MANOSCAN Z, MANOSCAN 3D, MANOSCAN HD, MANOSCAN V, MANOSHIELD, MANOSHIELD AR, MANOVIEW, MANOVIEW Z, ACCUTRAC, ACCUTRAC Z, ACCUVIEW, ACCUVIEW Z, SURETEC, ACCUFET, ACCUFET Z, INSERTASSIST, BOLUSVIEW, POLYGRAF ID, RESPSPONSE, ION Z, and GPS are Trademarks and/or Registered Trademarks of Given Imaging Ltd., its subsidiaries, and/or affiliates in the United States and/or other countries. All other company or product names are the trademarks or registered trademarks of their respective holders. All rights not expressly granted are reserved. 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.NoteChanges or modifications not expressly approved by Given Imaging Limited could void authority to operate the PillCam Platform.
Given Imaging Ltd. iTable of ContentsChapter 1Introduction ........... ............................................................................................................ 1Conventions ............................................................................................................................. 1Welcome to the PillCam Platform........................................................................................... 2PillCam Video Capsule ....................................................................................................... 2Handling the PillCam Video Capsule.................................................................................. 3DataRecorders.................................................................................................................... 3DataRecorder 2................................................................................................................... 3DataRecorder 2 Automatic Shutdown.......................................................................................  4DataRecorder 2 LED Indications...............................................................................................  5DataRecorder 2 Cradle .............................................................................................................  6Cradle Connections...................................................................................................................  6DataRecorder 3................................................................................................................... 7Acknowledge Button .................................................................................................................  8Navigation Buttons ....................................................................................................................  8Battery Status............................................................................................................................  8DataRecorder Automatic Shutdown..........................................................................................  8DataRecorder 3 LED Indications...............................................................................................  9DataRecorder 3 Error Message Guide....................................................................................  10DataRecorder 3 Check-in Screen Icons..................................................................................  10DataRecorder 3 Screen Icons.................................................................................................  11Battery and Capsule Icons......................................................................................................  11Navigation Buttons Legends ...................................................................................................  12DataRecorder Cradle ..............................................................................................................  12Cradle Connections.................................................................................................................  13External Power Supply...................................................................................................... 14RecorderPouch................................................................................................................. 14SB SensorBelt................................................................................................................... 14SensorArray...................................................................................................................... 14Given Workstation............................................................................................................. 15RAPID 7 Software............................................................................................................. 16Chapter 2Setting Up the System  .................................................................................................... 17Setup Requirements ............................................................................................................. 17Given Workstation............................................................................................................. 18DataRecorder and Cradle................................................................................................. 18Storage Space for the PillCam Capsule Box .................................................................... 18Main Platform Components .................................................................................................. 18Connecting the Components................................................................................................ 18Connecting the Given Workstation...................................................................................... 20Connecting the DataRecorder Cradle.................................................................................. 21Chapter 3Software Installation   ...................................................................................................... 23RAPID Installation.................................................................................................................. 23Registration....................................................................................................................... 28Wide Screen Compatibility.................................................................................................... 30Chapter 4
PillCam PlatformiiMulti-User Setup  ..............................................................................................................31System Administration .........................................................................................................  31To Define a User ..............................................................................................................  31To Delete User Account ...................................................................................................  32To Set a New Password for a User..................................................................................  32To Change the Password of the Administrator.................................................................  33Change the Given Workstation’s Time and Date .............................................................  33System Logs..........................................................................................................................  33To View the Logs..............................................................................................................  34To Create a Backup of the Logs.......................................................................................  34Chapter 5Technical Description  .....................................................................................................35System Labeling....................................................................................................................  35Capsule Labeling..............................................................................................................  36Essential Performance..........................................................................................................  36PillCam Video Capsules...................................................................................................  36DataRecorder 2 and DataRecorder 3...............................................................................  36Warnings ................................................................................................................................  36Cautions .................................................................................................................................  38System Specifications ..........................................................................................................  38PillCam SB Capsule.........................................................................................................  39PillCam SB 2 Capsule......................................................................................................  40PillCam ESO 2 Capsule ...................................................................................................  41PillCam ESO 3 Capsule ...................................................................................................  42PillCam COLON 2 Capsule..............................................................................................  43SensorArray DataRecorder 2...........................................................................................  44SensorArray DataRecorder 3...........................................................................................  44SB SensorBelt for DataRecorder 2 and DataRecorder 3.................................................  45DataRecorder 2 /2C  ........................................................................................................  45Cradle DataRecorder 2 ....................................................................................................  46DataRecorder 3 ...............................................................................................................  46Cradle DataRecorder 3 ....................................................................................................  47DC Power Supply.............................................................................................................  47DataRecorder 3 Memory Card .........................................................................................  47RAPID Software ...............................................................................................................  48Guidance and Manufacturer's Declarations .......................................................................  48PillCam Capsules (No PillCam COLON 2).......................................................................  48PillCam COLON 2 Capsules ............................................................................................  51DataRecorder 2(C) ..........................................................................................................  55DataRecorder 3 ...............................................................................................................  58Chapter 6Maintenance ................. ....................................................................................................63Charging DataRecorder........................................................................................................  63Disclaimer.........................................................................................................................  63Important Safety Instructions............................................................................................  63Charging the DataRecorder .............................................................................................  63DataRecorder 2................................................................................................................  64Manual Discharge of DataRecorder 2 ..................................................................................... 65
Table of ContentsiiiDataRecorder 3................................................................................................................. 66SensorBelt Cleaning.............................................................................................................. 67SensorArray Cleaning ........................................................................................................... 67Chapter 7Troubleshooting ......... ..................................................................................................... 69RAPID Video..................................................................................................................... 69Saving and Opening Video ............................................................................................... 69SensorArray...................................................................................................................... 69Printer ............................................................................................................................... 70CD/DVD ............................................................................................................................ 70RAPID Software................................................................................................................ 70Capsule............................................................................................................................. 70Given Workstation............................................................................................................. 70Cradle ............................................................................................................................... 71DataRecorder.................................................................................................................... 71Low Signal ........................................................................................................................ 72Index .................................................................................................................................  73
PillCam Platformiv
Given Imaging Ltd. 1Chapter 1IntroductionConventionsScreen elements, such as text on the screen in messages, or in menus, as well as button names are in bold and italics: e.g. Capture button.Screen names, are in a bold type face: e.g. DataRecorders screen.The footer shows the page number company name or the chapter number.The header shows the equipment name and chapter name.A note is information or remark that receives emphasis and looks as follows:A caution warns you about possible damage to equipment, and looks as follows:A warning warns you about possible harm to people and looks as follows:NoteCaution!Warning
PillCam Platform2Chapter 1Welcome to the PillCam PlatformThe PillCam Platform enables minimally invasive visualization of the gastrointestinal tract. The system consists of:•PillCam video capsules—PillCam SB, PillCam ESO, and PillCam COLON, that acquire pictures of the gastrointestinal tract and transmits them to the DataRecorder•DataRecorder, which stores the images collected during the examination for subsequent video creation with the full RAPID software •RAPID software, which processes and transforms the raw image data into a conveniently viewable RAPID videoPillCam Video CapsulePillCam video capsules are video cameras for imaging the intestinal tract. The capsules, about the size of a large vitamin pill, are equipped with tiny battery, transmitters with antenna, and Light Emitting Diodes (LEDs) for each video camera head, all encapsulated in a biocompatible plastic casing.There are three PillCam video capsule types: •PillCam SB capsules are used for examination of the small bowel.•PillCam ESO capsules are used for examination of the esophagus. •PillCam COLON capsules are used for examination of the colon.PillCam SB capsules contain one video camera while the PillCam ESO and PillCam COLON capsules each contain two video cameras. After activation and ingestion, the PillCam video capsule is propelled by peristalsis through the gastrointestinal tract. The video cameras positioned behind a clear plastic dome acquire images while the PillCam video capsule travels along the patient's gastrointestinal tract. The transmitter sends images to the DataRecorder for storage. For specification and technical parameters of the PillCam video capsules, see System Specifications on page 32. For Indications and Contraindications, see chapter two of Book 2: Peforming Capsule Endoscopy. PillCam SB capsulesPillCam ESO capsulesPillCam COLON capsule
IntroductionChapter 1 3Handling the PillCam Video CapsuleEach PillCam video capsule comes in its own box that enables the handling of the capsule until ingestion. A magnet close to the capsule in the box keeps it inactive until removal from the box. The capsule is active immediately after removal from the box.To ensure the capsule remains inactive, it must be in the box. PillCam video capsules are packed at Given Imaging Ltd. in a controlled process, ensuring the capsule is only activated after removal from its box. Caution!• Removal of a PillCam video capsule from its box activates it.• Keep in the box until use.• Store the capsules only in packaging supplied with the product.• Do not use a PillCam video capsule if packaging is damaged.DataRecordersThe DataRecorder is a compact battery-operated unit worn by the patient during the examination. It receives and stores the image data transmitted by the PillCam capsule. There are two models currently available: DataRecorder 2 and DataRecorder 3.DataRecorder 2The DataRecorder 2 consists of a receiver, a processor module, and a memory device for storing the data transmitted by the PillCam video capsule.The standard DataRecorder 2 Kit includes the following items:•DataRecorder 2•Standard RecorderBelt •Two RecorderBelt extensions•Pouch + suspenders•Li-Ion battery pack •DataRecorder 2 Cradle and adaptor•8-lead and 3-lead SensorArray •DataRecorder 2 Carrying case
PillCam Platform4Chapter 1The battery of the DataRecorder 2 is charged in the cradle either with its adaptor or while inside the DataRecorder 2.The DataRecorder 2 is ready for operation when its battery is charged and the SensorArray is connected. When the DataRecorder 2 is on, it starts recording as soon as a signal is received from any PillCam video capsule. When the capsule LED blinks, the DataRecorder 2 is receiving data. When the signal from the PillCam video capsule is too weak, the LED does not blink.DataRecorder 2 Automatic ShutdownAfter the DataRecorder 2 has been initialized with patient data, it goes into a standby mode when removed from its cradle and starts recording as soon as a signal is received from any PillCam video capsule. If no signal is received, the DataRecorder automatically shuts down after 90 minutes. This feature ensures that the DataRecorder 2 preserves sufficient battery power to record a complete study.Capsule LEDDataRecorder LED
IntroductionChapter 1 5DataRecorder 2 LED IndicationsThe following table describes the LED indicators and their status/color for each of the most common DataRecorder 2 events/status. LEDsDataRecorder 2 StatusDataRecorder is ON but not initialized. DataRecorder does not capture capsule signals.DataRecorder is initialized with patient data and ready to capture capsule signals.DataRecorder shuts down if no capsule signals are received for more than 30, 60, or 90 minutes, depending on the DataRecorder software version.DataRecorder is exchanging status or data with RAPID or RAPID RT.LED blinking rate varies according to the communication flow.DataRecorder is capturing capsule signals.Blinking rate = capsule frame rate.DataRecorder has stopped capturing capsule signals for more than 5 seconds.DataRecorder is detecting a capsule in sleep mode. Blinking rate = every five seconds (in any color).DataRecorder is malfunctioning.<20 secondsDataRecorder is synchronizing with a capsule. This is normal functioning.>20 secondsDataRecorder detects capsule signal, but is not recording it. This is a malfunction.NoteCheck the SensorArray connection or have patient move to a different location.Maximum LevelBattery Charge levelWhen charging, the Battery LEDs do not blink.When DataRecorder is out of the Cradle, the Battery LEDS blink once every 5 seconds.25%Below 10%
PillCam Platform6Chapter 1DataRecorder 2 Cradle The DataRecorder 2 Cradle is used to charge the DataRecorder 2 or to charge a spare battery externally. It is also used to discharge the battery before starting the recharge, when the Cradle detects that the battery needs refreshing (i.e., the battery gauge needs calibration). Thus occasionally, when inserted into the cradle, before charging starts, the Cradle may discharge first the battery and then start recharging.The cradle also connects the DataRecorder 2 to the computer for performing patient check-in and creating a video.The green LED on the cradle indicates that the DataRecorder 2 is charged and ready for use.•The red LED, when lit continuously, indicates a defective battery.•The red LED, when blinking, indicates that there is a problem with the cradle.WarningNever connect the DataRecorder 2 to the SensorArray while the DataRecorder 2 is in its cradle.Cradle ConnectionsThere are four connections on the back panel of the cradle. Only two of them are used with standard operation of the cradle: the power connector and the USB cable connection.NoteWhen connecting more than one DataRecorder 2 to the computer, it is recommended to use a USB-powered hub.The D-type connector and Auxiliary mains socket-outlet are for service use only.Auxiliary mains socketD-type connectorUSB cable Power connector
IntroductionChapter 1 7Warning• The cradle is for indoor use only.• Never charge non-rechargeable batteries.• All cells containing mercury, cadmium, or lead as electrochemical substances are subject to special waste disposal requirements.• This charger is a class A product. In a domestic environment, this charger may cause radio interference.DataRecorder 3The DataRecorder 3 consists of a receiver, a transmitter, and a memory device for storing the data transmitted by the PillCam capsule. The standard DataRecorder 3 Kit includes the following items:•DataRecorder 3•Pouch + shoulder strap•DataRecorder 3 cradle •External power supplySensorArrays are not part of the standard kit, and are supplied separately.The battery of the DataRecorder 3 is charged while the DataRecorder is in its cradle. The DataRecorder is ready for operation when its battery is charged, removed from the cradle, and the SensorArray is connected. When ON, the DataRecorder initiates pairing procedure (see DataRecorder-Capsule Pairing in chapter 4 of the Procedure Manual) as soon as a signal is received from a capsule. When the capsule LED on the DataRecorder blinks in blue, the DataRecorder is receiving data from a paired capsule. ON/OFF Button Acknowledge ButtonCapsule and Message LEDsLine for status iconsProcedure info areaNavigation ButtonsCradleCard ReaderMessage  areaCapsule LED Message LED
PillCam Platform8Chapter 1Acknowledge ButtonThe Acknowledge button is used by the patient in response to DataRecorder messages, including regimen instruction messages during post ingestion regimen (see Post Capsule Ingestion Instructions in Book 2: Performing Capsule Endoscopy) to acknowledge receiving the message.Navigation ButtonsThe Navigation buttons are used:•For manual capsule paring process (see DataRecorder-Capsule Pairing in Book 2: Performing Capsule Endoscopy, Chapter 4)•To interact with the DataRecorder (see Navigation Buttons Legends on page 12)Battery StatusThe battery icon   on the screen indicates the status of the battery in 10% increments.When the battery charge is below 10% the battery icon turns red. When the battery charge is below 5% the DataRecorder shuts down. When the DataRecorder 3 is charging in its cradle, the bottom LED in the cradle is orange. When the DataRecorder is ready for use, the bottom LED in the cradle is green.DataRecorder Automatic ShutdownAfter the DataRecorder has been initialized with patient data, it goes into a standby mode when removed from its cradle and starts recording as soon as a signal is received from a paired capsule. If after 90 minutes no paired signal is received, the DataRecorder automatically shuts down. The DataRecorder 3 also turns off five minutes after End of Procedure .
IntroductionChapter 1 9DataRecorder 3 LED IndicationsThe following table describes the LED indicators and their status/color for each of the most common DataRecorder 3 events/status. LEDs DataRecorder 3 StatusDataRecorder is initialized with patient data and ready to capture capsule signals.DataRecorder shuts down if no capsule signals are received for more than 90 minutes.BlinkingDataRecorder is receiving capsule signals before capsule pairing is achieved.Blinking rate = capsule frame rateBlinkingDataRecorder is receiving paired capsule signals.Blinking rate = capsule frame rate.Blink every 5 secondsDataRecorder has stopped receiving capsule signals for more than 5 seconds.DataRecorder has started downloading.DataRecorder has stopped recording because the memory card is full. BlinkingThere is an instruction on the DataRecorder screen.DataRecorder is malfunctioning.BlinkingDataRecorder detects capsule signal, but is not recording it. This is a malfunction. Check the SensorArray connection or have patient move to a different location.The LEDS on the navigation buttons blink in blue once every 5 seconds when the DataRecorder is on, out of the cradle and the LCD screen is off.Pressing any of the navigation buttons when the LCD screen is OFF will turn the LCD screen ON.
PillCam Platform10 Chapter 1DataRecorder 3 Error Message GuideDataRecorder 3 Check-in Screen IconsPopup Message Popup MessageNo valid approved memory card is detected.Verify approved card is in the DataRecorder.Do not move DataRecorder from cradleMemory card is write-protected SensorArray hardware failure.Consult a technician. Memory card error.Remove + reinsert card. Wrong SensorArray typeInsufficient memory on cardNo USB connection to cradle.Check connection. If connection is OK and error persists, consult a technicianSensorArray not connected.Connect the SensorArray  Wrong software on memory cardCradle error Fatal error.Consult a technician. End of procedureIcon NamePatient NamePatient IDProcedureRegimen
IntroductionChapter 1 11DataRecorder 3 Screen IconsThe following icons appear in the top status line of the DataRecorder screen.Battery and Capsule IconsThe following icons appear in the top status line of the DataRecorder screen.Icon Explanation Icon ExplanationStart pairing procedure  SensorArray not connected Pairing succeeded DataRecorder is initializedData not downloaded DataRecorder is waiting for initializationData downloaded SensorArray failureWrong SensorArray type Small bowel detectionEnd procedure, Memory full Regimen Reminder numbers appear in status line when in Real Time Viewing modeIcon Battery Status Icon Capsule Reception StatusBattery fully charged Signal weak, recording with noiseBattery charge level at 10% intervals Signal strong, recording with noiseBattery empty, DataRecorder shuts down Signal weak, but recording OKSignal strong, and recording OK
PillCam Platform12 Chapter 1Navigation Buttons LegendsDataRecorder Cradle The DataRecorder Cradle is used to charge the DataRecorder. The cradle also connects the DataRecorder to the computer for performing patient check-in and creating a video.•The top LED is orange when the DataRecorder is in the cradle.•The bottom LED is orange when charging the battery.•The bottom LED is green when the DataRecorder is fully charged.WarningNever connect the DataRecorder to the SensorArray while the DataRecorder is in its cradle.Icon Action when pressed Icon Action when pressedConfirm Confirm SB detection and activate instruction #1Scroll up  Activate Real-Time viewing (followed by pressing the left and right buttons)Scroll down Mark frameExit Real-Time viewing Switch video head (in Real-Time viewing mode)
IntroductionChapter 1 13Cradle ConnectionsThere are two connections on the back panel of the cradle: the power connector and the USB  connection to computer.At the front of the cradle is a USB socket for connecting a card reader or USB storage device.NoteConnect only USB storage devices, DataRecorder 3 memory cards (in its reader), or self-powered external hard drives to the DataRecorder 3 cradle. Other USB devices may not function as indicated.Warning• The cradle is for indoor use only.• Never charge non-rechargeable batteries.• All cells containing mercury, cadmium, or lead as electrochemical substances are subject to special waste disposal requirements.• This charger is a class A product. In a domestic environment, this charger may cause radio interference.USB Connection to computer Power connectorUSB connector
PillCam Platform14 Chapter 1External Power SupplyThe Cradle is connected to the mains power through an external power supply.Caution!Use only this power supply.RecorderPouchThe DataRecorder 3 RecorderPouch is a pouch with an adjustable strap to hold the DataRecorder. The patient must wear the DataRecorder at all times while the PillCam video capsule is active inside the patient. Use the waist strap to anchor the DataRecorder and the SensorArray connector to the patient’s body.SB SensorBeltThe SB SensorBelt receives data from the PillCam video capsule and transfers it to the DataRecorder. The sensor is connected to the DataRecorder module by a flexible cable and is worn at the waist of the patient over a thin shirt. The SB SensorBelt is used for PillCam capsule endoscopy of the small bowel.SensorArrayThe SensorArray receives data from the PillCam capsule through the sensors and transfers it to the DataRecorder. Each sensor is connected to the DataRecorder module by a flexible cable. The sensor is built of a flexible printed circuit board (PCB) and is attached to the skin by means of a disposable, medical adhesive sleeve. The SensorArray used in a capsule endoscopy depends on the caspule type and the DataRecorder type: •8-lead SensorArray: used with DataRecorder 2 and PillCam SB and PillCam COLON capsules
IntroductionChapter 1 15•8-lead SensorArray DR3: used with DataRecorder 3 and PillCam SB 2 and PillCam COLON 2 capsules. This SensorArray also transmits control signals to the COLON 2 capsule through the transmitter loop antenna.•3-lead SensorArray: used with DataRecorder 2 and PillCam ESO 2 capsules •3-lead SensorArray DR3: used with DataRecorder 3 and PillCam ESO 3 capsules NoteAll components of the PillCam Platform are Latex free.Given WorkstationThe Given Workstation is a dedicated computer designed for processing, displaying, storing the acquired images, and generating the RAPID videos.To control access to the Given Workstation and to make sure that only authorized personnel may use the relevant files on the Given Workstation, a multi-user configuration is provided, see Multi-User Setup on page 27. NoteWhen RAPID is installed on a personal computer, it functions nearly identically to the Given Workstation. Throughout this manual, references to the workstation apply also to the RAPID computer except where otherwise noted.
PillCam Platform16 Chapter 1RAPID 7 SoftwareRAPID 7 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules. RAPID 7 supports patient check-in/DataRecorder initialization, video creation, viewing of the RAPID video, and generation of a Capsule Endoscopy Report.
Given Imaging Ltd. 17Chapter 2Setting Up the SystemSetup Requirements Set up your office to accomodate the new PillCam Platform.  Review the following Workstation specifications:Four electrical outlets are required to connect the following components: Workstation computer, monitor, printer, and one cradle. Each additional cradle requires an additional outlet. NoteYou may use a Given approved power strip.Caution!Do not connect any component of the PillCam Platform to the same outlet as any appliance or device that has a high power requirement (refrigerators, generators, devices with motors, etc.).   When setting up the system, make sure that the total power requirements for all of the devices connected to a single outlet or circuit do not exceed the rated limit for that circuit.  If you are not sure of the rated limit, please consult your maintenance department or an electrician.Do not use a KVM Switch with the PillCam Platform. The dimensions of the Workstation components are listed below:NoteExtra space is needed for air circulation and cable connectors behind the Workstation.
PillCam Platform18  Chapter 2Given WorkstationThe footprint of the Given Workstation is about 18 cm (W) x 47 cm (D) x 45 cm (H). DataRecorder and CradleThe cradle of any DataRecorder with its cable connections have a footprint of about 8-12 inches (20-30 cm).  The DataRecorder is kept in its cradle when not in use.Storage Space for the PillCam Capsule BoxProvide a storage space that is protected from any powerful electromagnetic source, for stor-ing the PillCam video capsule 1box.   Main Platform ComponentsFollowing is a list of items which you need to connect in order to set up the PillCam Platform:•Given Workstation•Monitor•Keyboard•Mouse •Printer•DataRecorder with CradleConnecting the ComponentsWarningThe Given Workstation has either an automatic or a manual Voltage Select Switch. In case the workstation has a manual switch:• verify that the workstation’s voltage is set according to the local voltage prior to connecting the Given Workstation to the wall outlet.•  If the voltage is not set according to the local voltage, do not connect the system.  Call the Given Customer Support. Caution!Voltage mismatch will damage the Given Workstation.
Chapter 2Chapter 2 19Use the following sketch as an aid in setting up the PillCam Platform:Dell Given WorkstationThe following table lists the items that connect to the Given Workstation back panel:Connection ExplanationPower cord  Connects the Given Workstation to the electric socket.Keyboard Connects the Given Workstation to the keyboard.Mouse Connects the Given Workstation to the MouseMonitor Connects the Given Workstation to the monitor.Parallel Port  Connects to the parallel printer cable that connects the Given Workstation to the printer. USB Port  Connects to the USB cable that connects the Given Workstation to the printer, as an alternative to using Parallel Port.USB 2 Port  The USB 2.0 ports connect to the USB cables that connect the Given Workstation to the DataRecorder Cradle and to the Card reader.Modem Connects to the telephone cable that connects the Given Workstation to a phone line. Don't connect at setup. Connect the modem only if instructed to do so by Given Customer Support.
PillCam Platform20  Chapter 2NoteYou will need the telephone connection only for some maintenance operation on your WorkStation. Connect the modem of the Given Workstation only when instructed to do so by Given Customer Support. To connect, insert the Modem cable into the Modem connector and the other jack phone connector of the Modem cable into the phone outlet.Connecting the Given Workstation1. Connect the Mouse cable to the Mouse connector.  2. Connect the Keyboard cable to the Keyboard connector. 3. Connect the monitor to the Workstation.a. Unpack the monitor.b. Using the provided stencil, apply to the front of the monitor the adhesive black label of the Given logo included in the System Accessory box. c. Connect the DVI-VGA adaptor to the monitor connector at the Workstation’s back panel. d. Connect the monitor cable to the DVI-VGA adaptor at the Workstation’s back panel. 4. Connect the printer to the LPT connector or to the USB connector, depending on the printer’s connection cable.5. If the Workstation’s voltage setting is manual, verify that the Workstation’s voltage matches the local voltage. If it does not, call Given Customer Support.WarningDo not connect the components to the wall electric outlet until you verify the Workstation voltage matches the local voltage.6. After voltage verification, connect the power cable of the Given Workstation to the electric outlet.7. Connect the power cable of the monitor to the wall electric outlet.
Chapter 2Chapter 2 21Connecting the DataRecorder CradleYou can connect the cradle only to the USB2 ports that are side by side in a separate slot on the back panel of the Workstation. If you are not using a Given Workstation, use a USB hub for connecting more than one cradle to your computer.NoteIf you use more than one cradle, make sure each one is connected to a different power outlet.
PillCam Platform22  Chapter 2
Given Imaging Ltd. 23Chapter 3Software Installation Before installing any new application, close all other applications currently running on the computer. RAPID Installation1. Insert the RAPID 7 Installation disc into the DVD drive. The RAPID 7 installation menu screen appears.2. Click Install RAPID Access v. 7. The following screens appear.
PillCam Platform24 Chapter 33. If you have a valid licensed copy of the Operating System, click Yes. The following screen appears. 4. Click Yes. The following screen appears.
RAPID InstallationChapter 3 255. Click Yes. The InstallShield Wizard for the RAPID Atlas appears.6. Click Next. The following screen appears.
PillCam Platform26 Chapter 37. Click Browse if you wish to install in a different location. To continue with the installation, click Next. The following screen appears. 8. Click Finish. As soon as the progress bar is full, the License Agreement screen appears.
RAPID InstallationChapter 3 279. To continue the installation and accept the license agreement, click Yes. If you wish to print the license agreement before reading it, click Print. The following screen appears.10. Click Next. The following screen appears. 11. Click Browse if you wish to install in a different location. To continue with the installation, click Next. The Please Wait screen appears and the installation starts. Depending on the computer configuration, this stage takes at least several minutes. If the installation fails, the following message appears: RAPID installation has failed. In that case, restore the previous version of the RAPID Software.To restore:a. Insert RAPID 7 Installation CD.b. Click Install RAPID and follow the instructions on the screen.
PillCam Platform28 Chapter 312. Just before the end of the installation, the following screen appears.This refers to an exported System Wide Settings xml file. If you wish to import such a file, click Yes and browse for the file location. A message warns you that the imported file will overwrite an existing settings file and asks whether you wish to continue. 13. Click Yes. If RAPID installation continues uninterrupted, the following screen appears as soon as all the stages are completed. 14. To complete the installation, click Finish. The following screen appears.RegistrationUnrestricted use of RAPID requires registration via the Given registration center. You must supply requested information to obtain the Registration Key.
RAPID InstallationChapter 3 29The registration screen appears at the end of the installation process:NoteKeep the registration window open until you finish the registration. Each time you open the registration window, a new System Key appears and any Registration Key based on a previous System Key will not be accepted. If you click Exit, you can open and use the RAPID software, but after seven uses without registering, you must first perform registration in order to use RAPID.15. Obtain a Registration Key via the Given registration center online or by phone: • online: https://portal.givenimaging.com/RapidRegistration• by phone: call your local Given customer support center16. Be ready to provide the Given registration center with the following information: • System ID (from the registration screen)• System Key (from the registration screen)• RAPID DVD serial number (supplied with the DVD)• Your customer ID17. Enter the Registration Key received from the Given registration center.NoteThe registration process uses ONLY lower case letters and numbers.18. Click OK.NoteIf you do not register during installation, the next six times you open RAPID, it will ask you to register. After seven uses without registering, you cannot use RAPID without first performing registration.
PillCam Platform30 Chapter 3Wide Screen CompatibilityIn order to get optimal image and reduce risk of getting blurred or distorted images and fonts, the user should set his display resolution according to his screen manufactures' recommendations with these restriction in mind:•RAPID's minimal supported horizontal resolution is 1024.•RAPID's minimal supported vertical resolution is 768.For example here some recommended resolutions for different screens:      Aspect Ratio Minimum Resolution4:3 1024 x 76816:9 1360 x 76816:10 1280 x 800
Given Imaging Ltd. 31Chapter 4Multi-User SetupSystem Administration Different users in the RAPID may be defined. The settings values set by each user are saved so that each time that user logs in to the system, the relevant settings are in effect. Thus, different users may set different use profiles for themselves. Each user needs to log in with his or her username and password. The default password of the user rapid is blank (no need for password), the default password of the user rapidadmin is rapidadmin (case sensitive). The password for rapidadmin can be changed by the rapidadmin user.The user rapidadmin is meant to be used by a site-assigned system administrator to define additional users as required.To Define a User1. When Windows (re)starts (on a computer installed with RAPID) after completing RAPID installation, the Windows Log On to Windows screen appears.2. In the User field type rapidadmin (not case sensitive). In the password field type in your password (if you haven't changed it since installation, it is still rapidadmin). Click OK.
PillCam Platform32 Chapter 43. Wait for the Given Workstation Manager screen to appear.4. Click Add New User. The Add New User screen appears.5. Type in a new User name and Password for the new user.NoteThe password you type in at this stage is a temporary password. The user is requested to change it when he logs on for the first time.6. Click Add User. The message User xxx was added successfully appears.7. Repeat steps 4–6 for each new user.To Delete User Account1. Click Delete User Account. The Delete User Account screen appears.2. From the list, select which user you want to delete and click Delete User.The message You chose to delete xxx User. Are you sure? appears.3. Click Yes. The message xxx Account was deleted successfully appears.To Set a New Password for a UserIf a user has forgotten his password, you can create a new one.1. Click Set New Password For User. 2. From the list, select the relevant user.3. Type the new password in the New Password field, and in the Confirm New Password field.
Multi-User SetupChapter 4 33NoteThis new password will again be a temporary one, to be changed when the user logs on for the first time with this password.4. Click Set Password. The message xxx’s Password was changed successfully appears.To Change the Password of the Administrator1. Click Change Admin Password. The Change Rapidadmin Password screen appears.2. Type in your current password in the Old (Current) Password field.3. Type in your new password in the fields New Password and Confirm new Password.4. Click Change my Password. The message RAPID Administrator Password was changed successfully appears.NoteFor security reasons, all users should change their default passwords to a chosen password.Change the Given Workstation’s Time and DateAccess to the standard Date/Time properties screen of Windows is disabled on a Workstation with RAPID 7 installed. Only the administrator can change the time and date of the system.1. Click Change System Date/Time. The Date/Time properties screen appears. 2. Make the desired changes and click OK.3. Log off as Rapidadmin user.System LogsSystem Logs are all the actions performed on the Workstation.The following items are recorded into the system log files: • the physician (username) who performed the action• the time and date of the action• what action was performed (log on, log off, all actions such as adding, deleting and printing data)The Given Workstation Manager screen allows you to view the logs and to create a backup of the logs.
PillCam Platform34 Chapter 4To View the LogsTo view the logs, click View Logs. The Log Viewer screen appears. To view more details about one of the events, select and double click the relevant line and the Event Properties screen of that specific action appears.To Create a Backup of the LogsCreating a backup of the logs involves saving the data to a removable storage device (such as CD, Disk-On-Key, or USB Mass Storage Device) and deleting this data from the Workstation.1. Connect your storage device or media to the Workstation.2. Click Backup Logs. The Logs Backup screen appears.3. Select the relevant removable disk from the list and click Backup. Both the Security Events and the System Events are backed up through this command. The following message appears:4. Click OK. The system will delete these files once they are backed up successfully onto a removable device. To check this, click View Logs again on the Given Workstation Manager screen. The system log will be empty and the security log shows that the logs were backed up.5. Click Log Off  in the Given Workstation Manager window.6. Click Yes to confirm exit.
Given Imaging Ltd. 35Chapter 5Technical DescriptionSystem LabelingThe following table lists the labels attached to various components of the PillCam Platform:Labeling ExplanationThe PillCam video capsule should not be stored and used near any powerful magnetic fields such as the one created by an MRI.The PillCam video capsule is intended for single use only. Attention! Consult the documentation provided with the PillCam Platform.Temperature limits Non-ionizing radiationType BF equipment RoHsFCC compliance Capsule IDCE mark Ingress protectionC-Tick mark Do not IronCSA mark Latex freeExpiration date Machine wash - warmRecycle Do not tumble dryLot number Do not dry cleanIndoor use only Do not use bleach!
PillCam Platform36 Chapter 5Capsule LabelingEach box has a label at the bottom as shown below. Each capsule is marked with the expiration date, lot number, and a unique Capsule ID code. Essential PerformancePillCam Video Capsules ON-ModeData transmitting to DataRecorder is considered to be essential performance of the PillCam capsules. The PillCam capsules shall transmit data continuously monitored by on-line image display as received by DataRecorder.OFF-ModeNo unintentional transmissions are allowed.DataRecorder 2 and DataRecorder 3Data receiving by DataRecorder is considered to be essential performance of the DataRecorder 2 and DataRecorder 3. Warnings•PillCam Platform and its components need special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying documents. •Portable and mobile RF communications equipment can affect the PillCam video capsule and the DataRecorder.Lot NumberExpiration DateCapsule ID Code
Technical DescriptionChapter 5 37•PillCam video capsules and DataRecorder should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.•PillCam video capsules and DataRecorder may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.•Do not disassemble or modify the battery pack. The battery pack is equipped with built-in safety/protection features. Should these features be disabled, the battery pack can leak acid, overheat, emit smoke, burst and/or ignite.•Do not use or leave the battery pack of the DataRecorder near a heat source such as a fire or a heater (+80°C or higher). If the resin separator should be damaged owing to overheating, internal short-circuiting may occur to the battery pack, possibly leading to acid leakage, smoke emission, bursting and/or ignition of the battery pack.•Do not immerse the battery pack in water or seawater and do not allow it to get wet. Otherwise, the protective features in it can be damaged, it can be charged with extremely high current and voltage, abnormal chemical reactions may occur in it, possibly leading to acid leakage, smoke emission, bursting and/or ignition.•Do not recharge the battery pack near fire or in extremely hot weather. Otherwise, hot temperatures can trigger its built-in protective features, inhibiting recharging, or can damage the built-in protective features, causing it to be charged with an extremely high current and voltage and, as a result, abnormal chemical reactions can occur in it, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition.•To recharge the battery pack, use the DataRecorder cradle and observe the recharging conditions. A recharging operation under non-conforming recharging conditions (higher temperature and larger voltage/current than specified, modified battery charger, etc.) can cause the battery pack to be overcharged, or charged with extremely high current, abnormal chemical reaction can occur in it, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition.•Do not pierce the battery pack with a nail or other sharp objects, strike it with a hammer, or step on it. Otherwise, the battery pack will become damaged and deformed, internal short-circuiting can occur, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition.•Do not strike or throw the battery pack. The impact might cause leakage, overheating, smoke emission, bursting and/or ignition. Also, if the protective feature in it becomes damaged, it could become charged with an extremely high current and voltage, abnormal chemical reactions can occur, which can lead to acid leakage, overheating smoke emission, bursting and/or ignition.•Do not use an apparently damaged or deformed battery pack. Otherwise, acid leakage, overheating, smoke emission, bursting and/or ignition of the battery pack may occur.•If the battery pack leaks and the electrolyte gets into the eyes, do not rub them. Instead, rinse the eyes with clean running water and immediately seek medical attention. Otherwise, eye injury may result.•If recharging operation fails to complete even when a specified recharging time has elapsed, immediately stop further recharging. Otherwise, acid leakage, overheating, smoke emission, bursting and/or ignition can occur.•Do not put the battery pack into a microwave oven or pressurized container. Rapid heating or disrupted sealing can lead to acid leakage, overheating, smoke emission, bursting and/or ignition.
PillCam Platform38 Chapter 5•If the battery pack leaks or gives off a bad odor, remove it from any exposed flame. Otherwise, the leaking electrolyte may catch fire and the battery pack may emit smoke, burst or ignite.•If the battery pack gives off an odor, generates heat, becomes discolored or deformed, or in any way appears abnormal during use, recharging or storage, immediately remove it from the equipment or cradle and stop using it. Otherwise, the problematic battery pack can develop acid leakage, overheating, smoke emission, bursting and/or ignition.•The use of accessories, transducers and cables other than those supplied or approved by Given Imaging as replacement parts for internal DataRecorder components, may result in increased emissions or decreased immunity of the PillCam Platform.Cautions•Do not use or subject the battery pack to intense sunlight or hot temperatures such as in a car in hot weather. Otherwise, acid leakage, overheating and/or smoke emission can occur. Also, its guaranteed performance will be lost and/or its service life will be shortened.•The battery pack incorporates built-in safety devices. Do not use it in a location where static electricity (greater than the manufacturer’s guarantee) may be present. Otherwise, the safety devices can be damaged, possibly leading to acid leakage, overheating, smoke emission, bursting and/or ignition.•The guaranteed recharging temperature range is 0°C to +45°C. A recharging operation outside this temperature range can lead to acid leakage and/or overheating of the battery pack and may cause damage to it.•If acid leaking from the battery pack comes into contact with your skin or clothing, immediately wash it away with running water. Otherwise, skin inflammation can occur.•For recharging procedures, refer to DataRecorder 3 on page 66.•If you find rust, a bad odor, overheating and/or other irregularities when using the battery pack for the first time, return it to your supplier or vendor.System SpecificationsNoteSpecifications are subject to change without prior notice and without any obligation to users on the part of the manufacturer.
Technical DescriptionChapter 5 39PillCam SB CapsulePropertiesPhysical Dimensions Length: 26 mmDiameter: 11 mmWeight 3.30 grMaterial Biocompatible plasticOptical Illumination 6 white light emitting diodes# of imaging heads 1Field of view 140° ISO-8600-3Effective visibility Distance: 3 cmMagnification 1:8Min. detectable object  Less than 0.1 mmOperational Frame rate 2 fpsOperating time 7 ± 1 hoursChemical safety Resistant to dissolution in pH=2 to pH=8Battery type Silver Oxide batteriesOperating temperature 20–45°CStorage temperature 0–50°C
PillCam Platform40 Chapter 5PillCam SB 2 CapsulePropertiesPhysical Dimensions Length: 26 mmDiameter: 11 mmWeight 2.89gr.Material Biocompatible plasticOptical Illumination 4 white light emitting diodes# of imaging heads 1Field of view 156° ISO-8600-3Effective visibility Distance: 3 cmMin. detectable object  Less than 0.1 mmOperational Frame rate either 2 or 4 fpsOperating time > 8 hoursChemical safety Resistant to dissolution in pH=2 to pH=8Battery type Silver Oxide batteries (3V)Operating temperature 20–45°CStorage temperature 0–40°C
Technical DescriptionChapter 5 41PillCam ESO 2 CapsulePropertiesPhysical Dimensions Length: 26 mmDiameter: 11 mmWeight 2.89 grMaterial Biocompatible plasticOptical Illumination 4 white light emitting diodes for each head# of imaging heads 2Field of view 169° ISO-8600-3 for each headEffective visibility Distance: 3 cmMin. detectable object  Less than 0.06 mmOperational Frame rate up to 9 fps per headOperating time 30 minutes Chemical safety Resistant to dissolution in pH=2 to pH=8Battery type Silver Oxide batteriesOperating temperature 20–45°CStorage temperature 0–50°C
PillCam Platform42 Chapter 5PillCam ESO 3 CapsulePropertiesPhysical Dimensions Length: 31.5 mmDiameter: 11.6 mmWeight 2.9 grMaterial Biocompatible plasticOptical Illumination 4 white light emitting diodes for each head# of optical heads 2Field of view 172° ISO-8600-3 for each headEffective visibility Distance: 0–30 mmMin. detectable object  0.09 mmOperational Frame rate 35 fps per headOperating time 30 minutes Chemical safety Resistant to dissolution in pH=2 to pH=8Battery type Silver Oxide batteriesOperating temperature 20–45°CStorage temperature 0–40°C
Technical DescriptionChapter 5 43PillCam COLON 2 CapsulePropertiesPhysical Dimensions Length: 31.5 mmDiameter: 11.6 mmWeight 2.9 gMaterial Biocompatible plasticOptical # of optical heads 2Illumination 4 white light emitting diodes on each sideField of view 172° ISO-8600-3Effective visibility Distance: 0–30 mmMin. detectable object  0.09 mmOperational Operating time Total: 10 hours:Chemical safety Resistant to dissolution in pH=2 to pH=8Battery type Silver Oxide batteries Operating temperature 20–45°CStorage temperature 0–30°CUplink communication Operating frequency 434.1 MHz Frame rate 4–35 fpsData rate 2.7 Mbps and 8.1 MbpsModulation type MSK/Digital dataFrequency band standards FCC CFR 47 part 15 section 15.209ERC 70-03 Annex 1 band F1Effective radiated power -48.8 dBm (measured in 120 kHz bandwidth)Downlink communication Operating frequency 13.56 MHzReceiver Bandwidth + 150 KHzFrequency band standards FCC CFR 47 part 15 section 15.225ERC 70-03 Annex 9 band F
PillCam Platform44 Chapter 5SensorArray DataRecorder 2SensorArray DataRecorder 3Versions: SB, COLON, ESOSensor size Diameter 40 mm Color blackMaterial plasticSB = COLON SensorArray 8 sensor elementsESO SensorArray 3 sensor elementsPropertiesReception antenna # of sensor elements 3 or 8 sensorsSensor size Diameter: 40 mmColor BlackMaterial Polyurethane, Teflon Antennas wire material Coax wireTransmission antenna Antenna structure Loop antennaSize 1.90 mColor BlackMaterial Polyurethane, Teflon
Technical DescriptionChapter 5 45SB SensorBelt for DataRecorder 2 and DataRecorder 3DataRecorder 2 /2C SensorBelt InsertDimensions 365 mm x 90 mmInsert material PolypropyleneNumber of sensors 4Sensor dimensions Diameter 40 mm Cable length 550 mmCleaning method Wipe with medical alcohol wipesExpected life 500 proceduresSensorBelt Cover and StrapsCover dimensions 385 mm x 125 mmCover and strap material 100% polyesterFits abdomen size 60 - 130 cmWashing instructions Machine wash, warm, Use mild detergentHang dryDo not dry clean, Do not use bleachExpected life 40 wash cyclesSoftware Proprietary firmwareRecording capacity DataRecorder 2: @2fps for 10 hours DataRecorder 2C: @4fps for 10 hoursWeight 500 gr., including battery pack.Operational Power  6–8 VDC, 0.1–0.3 A Battery type Internal, Li-Ion, 7.2 V, 4400 mAHBattery Pack weight 200 gr.Operating temp. 0–40°CStorage temp. 0–55°CShielding Shieldex Supra, from Less EMF Inc.Classification • internally powered (complies with requirements for Class I equipment while connected to supply mains through charger)• Type BF applied part• Ordinary equipment
PillCam Platform46 Chapter 5Cradle DataRecorder 2DataRecorder 3 PropertiesWeight 890 gSize (without battery inserter 14[D] x 165[W] x 97[H]mmColor blackMains power connections 1x male power cable plugpower mains range 100 to 240VPropertiesPhysical Software Proprietary firmwareRecording capacity Up to 15 hours @ LCD OFFWeight 500 g., including battery pack.Operational Power   3.5–4.2 VDC, 0.15–0.5 A Battery type Internal, Li-Ion, 3.8 V typical, 8800 mAHOperating temp. 0–40°CStorage temp. 0–55°CShielding No belt shieldingClassification • internally powered (complies with requirements for Class I equipment while connected to supply mains through charger)• Type BF applied part• Ordinary equipmentReceiver (Rx) Operating frequency   434.1 MHzBandwidth of the receiving section in this band 10 MHzTransmitter Operating frequency 13.56 MHzFrequency band ISMModulation type Linear ChirpType of modulated signal Digital dataFrequency of modulating signal 20.25 dBmEffective radiated power -27.4 dBm
Technical DescriptionChapter 5 47Cradle DataRecorder 3DC Power SupplyDataRecorder 3 Memory CardPropertiesWeight 250 gOperating temp  0–45°CColor White & BlackMains power connections 1x male power cable plugpower mains range Input Voltage: Maximum 5.25V, Min 4.75VInput Current:   Maximum 4A, Min 100 mAPropertiesWeight 300 gInput connector  3 pole AC inlet IEC320-C14CInput Voltage 90 - 246 VACOutput voltage 5V DC, 5 AmpProtections Short circuit/ Over load/ Over voltage/ Over temp.PropertiesDimensions 24mm x 32mm x 2.1mmWeight 2.5 gCapacity >16GBRating Class 6: 40X or higher, 6 MB/sec minimum data transfer rate Storage temperature -40°C–85°CSecurity Built-in write-protect switch prevents accidental data loss Compatibility SDHC host devices; not compatible with standard SD-enabled devices/readers File format FAT 32
PillCam Platform48 Chapter 5RAPID SoftwareGuidance and Manufacturer's DeclarationsPillCam Capsules (No PillCam COLON 2) Software RAPID proprietary, version 7Languages English/French/German/Italian/Spanish/Portuguese/Dutch/Swedish/Finnish/Danish/Chinese-Mandarin/Korean/Russian/Greek Data export JPEG Images, (AVI) Video clips, grml (Given proprietary) files, HTML Reports, generic XML-format Capsule Endoscopy report data. Displayed data Single and multi images, Timebar, Colorbar with region specific color and other diagnostic data.Event marker Annotated thumbnailsViewing rate 5–80 fpsViewing Modes SingleView, DualView, QuadView, Mosaic View, Double-Head View (ESO and COLON)Run Modes Normal, QuickView, SBI Guidance and manufacturer’s declaration - electronic emissionsThe PillCam capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam capsules capsule should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11 Group 1The PillCam capsules use 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 equipmentRF emissionsCISPR 11 Class B The PillCam capsules are suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2 Not applicableVoltage fluctuations/flicker emissionsIEC 61000-3-3 Not applicable
Technical DescriptionChapter 5 49Guidance and manufacturer’s declaration - electronic emissionsThe PillCam capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam capsules should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.Electrical fast transient / burstIEC 61000-4-4±2 kV for power supply lines±1 kV for input/output linesNot applicable Not applicableSurge,IEC 61000-4-5±1 kV line(s) to line(s)±2 kV line(s) to earth Not applicable Not applicableVoltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 secNot applicable Not applicablePower frequency (50/60 Hz) magnetic field, IEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT   is the AC mains voltage prior to application of the test level.
PillCam Platform50 Chapter 5Guidance and manufacturer’s declaration - electronic emissionsThe PillCam capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam capsules should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of a PillCam capsule, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanceConducted RFIEC 61000-4-63 VRMS150 kHz to80 MHzNot applicable Not applicableRadiated RFIEC 61000-4-33 V/m80 MHz to2.5 GHz3 V/m d = 1.2 P   80 MHz to 800 MHzd = 2.3 P   800 MHz to 2.5 GHzNOTE 1: At 80 MHz and 800 MHz, 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.NOTE 3: 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). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.NOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol: 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 PillCam capsules are used exceeds the applicable RF compliance level above, the PillCam capsules should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PillCam capsules.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Technical DescriptionChapter 5 51PillCam COLON 2 Capsules Recommended separation distances between portable and mobile RF communications equipment and the PillCam capsulesThe PillCam capsules are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PillCam capsules can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PillCam capsules as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter [W]Separation distance according to frequency of transmitter [m]150 kHz to 80 MHzd = 1.2 P80 MHz to 800 MHzd = 1.2 P800 MHz to 2,5 GHzd = 2.3 P0.01 Not applicable 0.12 0.230.1 Not applicable 0.38 0.731 Not applicable 1.2 2.310 Not applicable 3.8 7.3100 Not applicable 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 80 MHz and 800 MHz, 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.Guidance and manufacturer’s declaration - electromagnetic emissionsThe PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam COLON 2 capsules capsule should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11 Group 1The PillCam COLON 2 capsules use 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 equipmentRF emissionsCISPR 11 Class B The PillCam capsules are suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2 Not applicableVoltage fluctuations/flicker emissionsIEC 61000-3-3 Not applicable
PillCam Platform52 Chapter 5Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systemsThe PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam COLON 2 capsules should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.Electrical fast transient / burstIEC 61000-4-4±2 kV for power supply lines±1 kV for input/output linesNot applicable Mains power quality should be that of a typical commercial or hospital environment.Surge,IEC 61000-4-5±1 kV line(s) to line(s)±2 kV line(s) to earth Not applicable Mains power quality should be that of a typical commercial or hospital environment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 secNot applicableMains power quality should be that of a typical commercial or hospital environment. If the user of the equipment requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic field, IEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT   is the AC mains voltage prior to application of the test level.
Technical DescriptionChapter 5 53Guidance and manufacturer’s declaration - electromagnetic immunityThe PillCam COLON 2 capsules are intended for use in the electromagnetic environment specified below. The customer or the user of the PillCam capsules should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of a PillCam capsule, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Conducted RFIEC 61000-4-63 Vrms150 kHz to80 MHzNot applicable Recommended separation distance: d= 1.2 PRadiated RFIEC 61000-4-33 V/m80 MHz to2.5 GHz3 V/m d = 1.2 P   80 MHz to 800 MHzMHz ranged = 2.3 P   800 MHz to 2500 MHzNOTE 1: At 80 MHz and 800 MHz, 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.NOTE 3: 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). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.NOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol: 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 PillCam capsules are used exceeds the applicable RF compliance level above, the PillCam capsules should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PillCam capsules.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
PillCam Platform54 Chapter 5Recommended separation distances between portable and mobile RF communications equipment and the PillCam COLON 2 capsulesThe PillCam COLON 2 capsules are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PillCam COLON 2 capsules can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PillCam COLON 2 capsules as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter [W]Separation distance according to frequency of transmitter [m]150 kHz to 80 MHzd = 1.2 P80 MHz to 800 MHzd = 1.2 P800 MHz to 2,5 GHzd = 2.3 P0.01 0.12 0.12 0.230.1 0.38 0.38 0.7311.2 1.2 2.310 3.8 3.8 7.3100121223For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 80 MHz and 800 MHz, 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.
Technical DescriptionChapter 5 55DataRecorder 2(C) Guidance and manufacturer’s declaration - electronic emissionsThe DataRecorder 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 2 should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11 Group 1The DataRecorder 2 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 equipmentRF emissionsCISPR 11 Class B The DataRecorder 2 is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2 Class AVoltage fluctuations/flicker emissionsIEC 61000-3-3 CompliesGuidance and manufacturer’s declaration - electronic emissionsThe DataRecorder 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 2 should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient / burstIEC 61000-4-4±2 kV for power supply lines±1 kV for input/output lines±2 kV for power supply lines±1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.Surge,IEC 61000-4-5±1 kV line(s) to line(s)±2 kV line(s) to earth±1 kV line(s) to line(s)±2 kV line(s) to earthMains power quality should be that of a typical commercial or hospital environment.
PillCam Platform56 Chapter 5Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 sec<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 secMains power quality should be that of a typical commercial or hospital environment. If the user of the DataRecorder 2 requires continued operation during power mains interruptions, it is recommended that the DataRecorder 2 be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic field, IEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT   is the AC mains voltage prior to application of the test level.Guidance and manufacturer’s declaration - electronic emissionsThe DataRecorder 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 2 should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of DataRecorder 2, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanceConducted RFIEC 61000-4-63 VRMS150 kHz to80 MHz3Vmsd = 1.2 PRadiated RFIEC 61000-4-33 V/m80 MHz to2.5 GHz3 V/m d = 1.2 P   80 MHz to 800 MHz ranged = 2.3 P   800 MHz to 2.5 GHz rangeGuidance and manufacturer’s declaration - electronic emissions
Technical DescriptionChapter 5 57NOTE 1: At 80 MHz and 800 MHz, 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.NOTE 3: 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). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.NOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol:  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 DataRecorder 2 is used exceeds the applicable RF compliance level above, the DataRecorder 2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DataRecorder 2.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Recommended separation distances between portable and mobile RF communications equipment and the PillCam ESO capsuleThe DataRecorder 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DataRecorder 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DataRecorder 2 as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter [W]Separation distance according to frequency of transmitter [m]150 kHz to 80 MHzd = 1.2 P80 MHz to 800 MHzd = 1.2 P800 MHz to 2,5 GHzd = 2.3 P0.01 Not applicable 0.12 0.230.1 Not applicable 0.38 0.731 Not applicable 1.2 2.310 Not applicable 3.8 7.3100 Not applicable 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 80 MHz and 800 MHz, 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.Guidance and manufacturer’s declaration - electronic emissions
PillCam Platform58 Chapter 5DataRecorder 3 Guidance and manufacturer’s declaration - electromagnetic emissionsThe DataRecorder 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 3 should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11 Group 1The Data Recorder 3 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 equipmentRF emissionsCISPR 11 Class B The Data Recorder 3 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2 N/AVoltage fluctuations/flicker emissionsIEC 61000-3-3 N/AGuidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systemsThe DataRecorder 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 3 should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-26 kV contact8 kV air6 kV contact8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.Electrical fast transient / burstIEC 61000-4-42 kV for power supply lines1 kV for input/output lines N/A Mains power quality should be that of a typical commercial or hospital environment.Surge,IEC 61000-4-51 kV line to line2 kV line to earth N/A Mains power quality should be that of a typical commercial or hospital environment.
Technical DescriptionChapter 5 59Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5 % UT (>95 % dip in UT)for 0.5 cycle40 % UT (60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT (>95 % dip in UT)for 5 secN/AMains power quality should be that of a typical commercial or hospital environment. If the user of the DataRecorder 3 requires continued operation during power mains interruptions, it is recommended that the DataRecorder 3 be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic field, IEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: UT   is the AC mains voltage prior to application of the test level.Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems
PillCam Platform60 Chapter 5Guidance and manufacturer’s declaration - electromagnetic immunityThe DataRecorder 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the DataRecorder 3 should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of DataRecorder 3, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Conducted RF,IEC 61000-4-63Vrms150 kHz to80 MHz3Vrms150 kHz to80 MHzRecommended separation distance:d = 1.2 PRadiated RF,IEC 61000-4-33 V/m80 MHz to2.5 GHz[E1] = 3 V/m Recommended separation distance:d = 1.2 P   80 MHz to 800 MHz ranged = 2.3 P   800 MHz to 2500 MHz rangeNOTE 1: At 80 MHz and 800 MHz, 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.NOTE 3: 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). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.NOTE 5: Interference may occur in the vicinity of equipment marked with the following symbol:  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 DataRecorder 3 is used exceeds the applicable RF compliance level above, the DataRecorder 3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DataRecorder 3.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Technical DescriptionChapter 5 61Recommended separation distances between portable and mobile RF communications equipment and the DataRecorder 3The DataRecorder 3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DataRecorder 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DataRecorder 3 as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter [W]Separation distance according to frequency of transmitter [m]150 kHz to 80 MHzd = 1.2 P80 MHz to 800 MHzd = 1.2 P800 MHz to 2,5 GHzd = 2.3 P0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 80 MHz and 800 MHz, 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.
PillCam Platform62 Chapter 5
Given Imaging Ltd. 63Chapter 6MaintenanceCharging DataRecorder DisclaimerThe DataRecorder cradle is a non-medical device, used for charging the DataRecorder from Given Imaging Ltd.Important Safety InstructionsNoteBefore using the DataRecorder Cradle, read all instructions on cautionary markings on the Cradle, on the Battery and on the DataRecorder. Caution!Use only the provided power cable for the DataRecorder Cradle. Charge the DataRecorder in its dedicated Cradle only.WarningChanges or modifications to this equipment not expressly approved by the party responsible for compliance (Given Imaging Ltd.) could void the user’s authority to operate the equipment.Use only a fully charged DataRecorder. In general, including first time use, charging the DataRecorder is an overnight process and should not be performed in the vicinity of the patient. When you receive the DataRecorder after an examination, charge it immediately until the green LED is lit, and leave it in its cradle. NoteThis equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular
PillCam Platform64 Chapter 6installation. If this equipment does cause harmful interference to radio or television reception, 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.• Consult the dealer or an experienced radio/TV technician for help.DataRecorder 2The following table lists and explains the LEDs (from left to right) of the DataRecorder 2 Cradle and their meaning:To Charge the DataRecorder 21. First plug the power cable into the cradle and plug the power cable into the wall outlet.All three LEDs turn on for a self-test that takes 5 seconds. After 5 seconds all LEDs turn off, and the cradle is idle and ready for use.If after the self-test the red LED blinks, the battery pack is faulty. Contact Given Imaging Customer Support.2. Insert the DataRecorder 2 or the DataRecorder 2 Li-Ion battery with its adaptor into the cradle.All three LEDS of the cradle blink for 4 seconds, before the charging process starts (orange LED is on).NoteIf the Cradle detects that the battery needs refreshing (i.e., the battery gauge needs recalibration), it will automatically discharge the battery before recharging it. The orange LED on the cradle blinks during discharging. LED Status ExplanationGreen  On Battery Pack is ready for useOrange On Battery Pack is chargingBlinking Battery Pack is dischargingRed On Battery Pack is faultyDataRecorder 2 with Batteryor AdaptorGreen, Orange and Red LEDs
MaintenanceChapter 6 65We recommend manually discharging the DataRecorder 2 battery once every three months, even if the DataRecorder 2 is not used. This will prevent the DataRecorder 2 from discharging automatically at an inconvenient time, since the discharge is an overnight process that may take up to 12 hours.3. As soon as the DataRecorder 2 or its Battery Pack are fully charged, the green LED turns on, and the Orange LED turns off. Leave the DataRecorder 2 in its Cradle until the next examination.NoteYou can check the status of the DataRecorder 2 by pushing the button on the back of the DataRecorder 2 momentarily. All 4 LEDs must be lit before an examination.Manual Discharge of DataRecorder 2 If the Cradle detects that the battery needs refreshing (i.e., the battery gauge needs recalibration), it will automatically discharge the battery before recharging it. The orange LED on the cradle blinks during discharging.We recommend manually discharging the DataRecorder 2 battery once every three months, even if the DataRecorder 2 is not used. This will prevent the DataRecorder 2 from discharging automatically at an inconvenient time, since the discharge is an overnight process that may take up to 12 hours.To discharge the DataRecorder 2 Battery1. Make sure the appropriate battery is inside the DataRecorder 2.2. Insert the DataRecorder 2 into its cradle.3. From the Procedures screen, select the relevant DataRecorder 2 by clicking the DataRecorder 2 bar.The buttons on the right side of the screen become available.4. Click   to open the DataRecorder Info screen.5. At the bottom of the screen, click Start Discharge.A message appears: Discharge may take up to 12 hours. Are you sure you want to start discharge?6. Click OK.While the battery is being discharged, its battery status indicates Discharging:Push buttonLEDs on theDataRecorder 2(at the back)
PillCam Platform66 Chapter 6• in the bottom left corner of the DataRecorder Info screen• in the DataRecorder 2 bar in the DataRecorders screen• the orange LED on the cradle blinks7. To return to other RAPID functions, click Close.8. If you need to stop the discharge (also for automatic discharge) while it is in progress, return to the DataRecorder Info screen and click Stop Discharge.If you stop the automatic discharge process in the middle, the battery LEDs may not indicate the correct battery status.NoteDo not charge the battery in the vicinity of the patient.For more information on charging the DataRecorder 2, see Charging DataRecorder on page 63.Make sure the DataRecorder is fully charged for SB and Colon Capsule Endoscopy, and that at least two of the four battery LEDs light up for an ESO Capsule Endoscopy.DataRecorder 3The following table lists and explains the LEDs of the DataRecorder 3 Cradle and their meaning:To Charge the DataRecorder 1. First plug the power cable into the cradle and plug the power cable into the wall outlet.2. Insert the DataRecorder into the cradle. The bottom LED is orange when charging the battery.3. As soon as the DataRecorder is fully charged, the bottom LED turns green. Leave the DataRecorder in its cradle until the next examination.LED Status ExplanationGreen  On Battery Pack is ready for useYellow On Battery Pack is chargingBlinking Battery Pack is charging
MaintenanceChapter 6 67SensorBelt CleaningThe SensorBelt may be machine washed after removal of the SensorBelt Insert. Follow instructions on the care label and use a mild detergent.The surface of the SensorBelt may be wiped with any commonly used disinfectant.The SensortBelt Insert may be wiped gently with alcohol (up to 70%). SensorArray CleaningFor mild cleaning (dirt, sweat), wipe the sensors gently with alcohol (up to 70%). The alcohol will not remove the adhesive. Since alcohol is a polar solvent, do not use lavishly, and allow to dry for 20 minutes.To remove adhesive from the SensorArray (not from the human body), use White Benzene. NoteWhite Benzene MUST be used in a ventilated area with all precautions defined in the manufacturer’s instructions.Alternatively, use one of the following medical adhesive removers to remove adhesive:• B-508 Secure Solvent• B-202 Hollister Solvent• B-206 Detachol Adhesive RemoverUse all precautions as defined by the manufacturer.
PillCam Platform68 Chapter 6
Given Imaging Ltd. 69Chapter 7TroubleshootingRAPID VideoSaving and Opening VideoSensorArrayProblem  Cause ActionShort Video • Capsule• DataRecorder Battery• DataRecorder Mishandling• Contact Customer Support• Send video on CD/DVD• Inform Capsule Lot #• Do not use the same DataRecorderGaps • Capsule• Interference• Mishandling• PhysiologicalBad image quality • Stripes in video• Pixilation/confetti• Dark/red/orange imageVideo shorter than capsule operating time without either ingestion phase images or body exit images•Capsule• DataRecorder Battery• Interference• Send video on CD/DVD• Contact Customer SupportNo Localization Malfunction of the SensorArray Contact Customer SupportProblem  Cause ActionCannot locate video • Video was not saved in E:\Videos• Incorrect patient’s nameContact Customer SupportCannot locate findings • Findings were not saved under patient’s folder• Findings were saved with the wrong name•See Saving Your Findings in chapter four of Book 3: Using the RAPID Software • Contact Customer SupportProblem  Cause ActionConnector is damaged• Mishandling• End of Life Contact Customer SupportSensor is torn from its wireInsulation of the sensor wire is damaged
PillCam Platform70 Chapter 7PrinterCD/DVDRAPID SoftwareCapsuleGiven WorkstationProblem  Cause ActionCannot print report Printer is turned off Turn printer onPrinter is not set as default printer Set printer to Default PrinterPrinter has a malfunction Contact Customer SupportProblem  Cause ActionCannot burn CD/DVD CD/DVD is not blank or compatible with CD/DVD ROM Contact Customer SupportWrong Burning procedure Contact Customer SupportCannot eject CD/DVD A video on the disc is open Close the video and retryProblem  Cause ActionCannot open RAPID Software or Hardware corruption Contact Customer SupportCannot open RAPID Atlas Atlas installation is incomplete or incorrect • Reinstall Atlas• Contact Customer SupportXML corruption Contact Customer SupportProblem  Cause ActionDOA (Dead On Arrival): LEDs do not light up when capsule is removed from its boxCapsule failure 1 Send capsule to Given Imaging Ltd.2 Open another capsule3 If second capsule from 10-pak is DOA, contact Customer SupportProblem  Cause ActionBlue screen Hardware malfunction 1 Send RAPID and Given Workstation log files2 Contact Customer Support.Given Workstation does not boot up Hardware malfunction Contact Customer SupportGiven Workstation DOA  Transportation mishandling Contact Customer Support
TroubleshootingChapter 7 71CradleDataRecorderNoteFor LED behavior see DataRecorder 3 LED Indications on page 9, and Error messages displayed on the DataRecorder screen, see DataRecorder 3 Error Message Guide on page 10.Given Workstation does not recognize USB storage deviceUSB storage device is not compatible Contact Customer SupportMalfunction of the USB connection on Given Workstation1 Change USB port2 Contact Customer SupportUSB storage device malfunction Contact Customer SupportGiven Workstation does not recognize printer Malfunction of the USB connection on Given Workstation1 Change USB port2 Contact Customer SupportPrinter malfunction Contact Customer SupportPrinter driver is missing Contact Customer SupportProblem  Cause ActionAll LEDs are flashing red All LEDs are flashing red1 Disconnect cradle for mains power2 Reconnect cradle to mains power3 If problem persists, contact Customer Support DataRecorder cannot be placed in cradle Hardware malfunction Contact Customer SupportProblem  Cause ActionCannot initialize DataRecorder Computer does not recognize DataRecorder 1 Check USB and power connection2 Contact Customer SupportCannot create video Error message is displayed Send error message to Customer SupportNot enough space... message is displayed Delete PRRs from hard driveWorkstation freezes during video creation Contact Customer SupportCapsule LED does not blink in blue when capsule is activated • No pairing performed, or pairing was not successful1 perform Capsule pairing2 If problem persists, contact Customer Support3 Send malfunctioned capsules to Given Imaging Ltd.Problem  Cause Action
PillCam Platform72 Chapter 7Low SignalIf a low signal is detected during the examination, the following message appears. A low signal detected during the examination may be due to:•Improper use of the SensorArray•A defective SensorArray•A DataRecorder malfunctionIf this message is displayed, Contact Customer Support.Click OK to close the message.
73IndexAAcknowledge Button .............................. 8Automatic ShutdownDataRecorder .............................. 4,  8Bback pannel connectors ......................... 19Backup Logs. ....................................... 34Backup, create ...................................... 34Battery and Capsule Icons ..................... 11Battery Status ......................................... 8CCapsulestorage space .................................. 18Troubleshooting ............................. 70Capsule ID ........................................... 35CD/DVDTroubleshooting ............................. 70CE mark .............................................. 35connecting the RAPID Booster .............. 18connecting the RAPID Workstation ....... 20connectors of back pannel ..................... 19Cradle ...................................... 6,  12,  18LED indications ........................ 6,  12Troubleshooting ............................. 71Cradle Connections .......................... 6,  13CSA mark ............................................ 35DDataRecorder ................................ 11,  18DataRecorder 2Manual Discharge ........................... 65DataRecorder 2 Kit ................................. 3DataRecorder 3Troubleshooting ............................. 71DataRecorder 3 Kit ................................. 7DataRecorder 3 LED Indications ............. 9DataRecorder 3 Memory Card ............... 47DataRecorder 3 Screen Icons ................. 11DataRecorder 2 ...................................... 3DataRecorder 3 ...................................... 7EExpiration date ....................................  35GGastrointestinal tract ..............................  2Given Workstation ...............................  18connecting .....................................  18Controlling access ..........................  15voltage ..........................................  18Iinstalling RAPID C2 ............................  23KKVM Switch .......................................  17LLot number ..........................................  35Low Signal ..........................................  72MMain screenRAPID C2 Installation CD .............  23NNavigation Buttons ................................  8Navigation Buttons Legends .................  12Non-ionizing radiation .........................  35Ooutlet ...................................................  17PPassword .............................................  32Password, change .................................  33password, new .....................................  32PillCam ESO 2 Capsule ........................  41PillCam Platform .................................  17before it arrives ..............................  17Pillcam Platformrequired space ................................  17
74PillCam SB 2 Capsule .......................... 40PillCam SB Capsule ............................. 39PrinterTroubleshooting ............................. 70RRAPIDTroubleshooting ............................. 70RAPID C2 Installation CD ................... 23RAPID VideoTroubleshooting ............................. 69RAPID Workstationconnecting ..................................... 20RecorderPouch .................................... 14registration .......................................... 28RoHs ................................................... 35SSB SensorBelt ...................................... 14SensorArray ..................................  14,  67Cleaning ........................................ 67Troubleshooting ............................. 69SensorBeltCleaning ........................................ 67setting the voltage of APID Workstation  18sketchDell Minitower .............................. 19System Administration ......................... 31System Log ......................................... 33TTemperature limits ...............................  35Type BF equipment .............................. 35UUser Account, delete ............................ 32User, add new ...................................... 32User, define a ....................................... 31VvoltageGiven Workstation ......................... 18Voltage Select Switch .......................... 18WWide Screen Compatibility ...................  30WorkstationTroubleshooting ............................. 70Workstation Manager ...........................  32

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