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
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| Date Submitted | 2010-12-20 00:00:00 |
| Date Available | 2010-12-20 00:00:00 |
| Creation Date | 2010-09-07 11:54:21 |
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| Document Title | RAPID 7 Setup.book |
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| Document Author: | belindaf |
PillCam® Platform Setup & Maintenance RAPID® 7 DOC-1530-01 August 2010 Book 1 Book 1: Setup & Maintenance Book 2: Performing Capsule Endoscopy Book 3: Using the RAPID® Software COPYRIGHT This 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. TRADEMARKS GIVEN, 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. Note Changes or modifications not expressly approved by Given Imaging Limited could void authority to operate the PillCam Platform. Table of Contents Chapter 1 Introduction ........... ............................................................................................................ 1 Conventions ............................................................................................................................. 1 Welcome to the PillCam Platform........................................................................................... PillCam Video Capsule ....................................................................................................... Handling the PillCam Video Capsule .................................................................................. DataRecorders.................................................................................................................... DataRecorder 2................................................................................................................... DataRecorder 2 Automatic Shutdown....................................................................................... DataRecorder 2 LED Indications............................................................................................... DataRecorder 2 Cradle ............................................................................................................. Cradle Connections................................................................................................................... DataRecorder 3................................................................................................................... 7 Acknowledge Button ................................................................................................................. 8 Navigation Buttons .................................................................................................................... 8 Battery Status............................................................................................................................ 8 DataRecorder Automatic Shutdown.......................................................................................... 8 DataRecorder 3 LED Indications............................................................................................... 9 DataRecorder 3 Error Message Guide.................................................................................... 10 DataRecorder 3 Check-in Screen Icons.................................................................................. 10 DataRecorder 3 Screen Icons................................................................................................. 11 Battery and Capsule Icons ...................................................................................................... 11 Navigation Buttons Legends ................................................................................................... 12 DataRecorder Cradle .............................................................................................................. 12 Cradle Connections................................................................................................................. 13 External Power Supply...................................................................................................... RecorderPouch ................................................................................................................. SB SensorBelt................................................................................................................... SensorArray ...................................................................................................................... Given Workstation............................................................................................................. RAPID 7 Software............................................................................................................. 14 14 14 14 15 16 Chapter 2 Setting Up the System .................................................................................................... 17 Setup Requirements ............................................................................................................. Given Workstation............................................................................................................. DataRecorder and Cradle ................................................................................................. Storage Space for the PillCam Capsule Box .................................................................... 17 18 18 18 Main Platform Components .................................................................................................. 18 Connecting the Components................................................................................................ 18 Connecting the Given Workstation ...................................................................................... 20 Connecting the DataRecorder Cradle .................................................................................. 21 Chapter 3 Software Installation ...................................................................................................... 23 RAPID Installation.................................................................................................................. 23 Registration....................................................................................................................... 28 Wide Screen Compatibility.................................................................................................... 30 Chapter 4 Given Imaging Ltd. PillCam Platform Multi-User Setup ..............................................................................................................31 System Administration ......................................................................................................... To Define a User .............................................................................................................. To Delete User Account ................................................................................................... To Set a New Password for a User .................................................................................. To Change the Password of the Administrator................................................................. Change the Given Workstation’s Time and Date ............................................................. 31 31 32 32 33 33 System Logs .......................................................................................................................... 33 To View the Logs.............................................................................................................. 34 To Create a Backup of the Logs....................................................................................... 34 Chapter 5 Technical Description .....................................................................................................35 System Labeling.................................................................................................................... 35 Capsule Labeling.............................................................................................................. 36 Essential Performance.......................................................................................................... 36 PillCam Video Capsules................................................................................................... 36 DataRecorder 2 and DataRecorder 3............................................................................... 36 Warnings ................................................................................................................................ 36 Cautions ................................................................................................................................. 38 System Specifications .......................................................................................................... PillCam SB Capsule ......................................................................................................... PillCam SB 2 Capsule ...................................................................................................... PillCam ESO 2 Capsule ................................................................................................... PillCam ESO 3 Capsule ................................................................................................... PillCam COLON 2 Capsule .............................................................................................. SensorArray DataRecorder 2 ........................................................................................... SensorArray DataRecorder 3 ........................................................................................... SB SensorBelt for DataRecorder 2 and DataRecorder 3 ................................................. DataRecorder 2 /2C ........................................................................................................ Cradle DataRecorder 2 .................................................................................................... DataRecorder 3 ............................................................................................................... Cradle DataRecorder 3 .................................................................................................... DC Power Supply ............................................................................................................. DataRecorder 3 Memory Card ......................................................................................... RAPID Software ............................................................................................................... 38 39 40 41 42 43 44 44 45 45 46 46 47 47 47 48 Guidance and Manufacturer's Declarations ....................................................................... PillCam Capsules (No PillCam COLON 2)....................................................................... PillCam COLON 2 Capsules ............................................................................................ DataRecorder 2(C) .......................................................................................................... DataRecorder 3 ............................................................................................................... 48 48 51 55 58 Chapter 6 Maintenance ................. ....................................................................................................63 Charging DataRecorder ........................................................................................................ Disclaimer......................................................................................................................... Important Safety Instructions............................................................................................ Charging the DataRecorder ............................................................................................. DataRecorder 2 ................................................................................................................ 63 63 63 63 64 Manual Discharge of DataRecorder 2 ..................................................................................... 65 ii Table of Contents DataRecorder 3................................................................................................................. 66 SensorBelt Cleaning.............................................................................................................. 67 SensorArray Cleaning ........................................................................................................... 67 Chapter 7 Troubleshooting ......... ..................................................................................................... 69 RAPID Video..................................................................................................................... Saving and Opening Video ............................................................................................... SensorArray ...................................................................................................................... Printer ............................................................................................................................... CD/DVD ............................................................................................................................ RAPID Software................................................................................................................ Capsule............................................................................................................................. Given Workstation............................................................................................................. Cradle ............................................................................................................................... DataRecorder.................................................................................................................... Low Signal ........................................................................................................................ 69 69 69 70 70 70 70 70 71 71 72 Index ................................................................................................................................. 73 iii PillCam Platform iv Chapter 1 Introduction Conventions Screen 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: Note A caution warns you about possible damage to equipment, and looks as follows: Caution A warning warns you about possible harm to people and looks as follows: Warning Given Imaging Ltd. PillCam Platform Welcome to the PillCam Platform The 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 video PillCam Video Capsule PillCam 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 PillCam ESO capsules PillCam COLON capsule 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. Chapter 1 Introduction Handling the PillCam Video Capsule Each 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. DataRecorders The 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 2 The 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 Chapter 1 PillCam Platform The 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. Capsule LED DataRecorder LED DataRecorder 2 Automatic Shutdown After 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. Chapter 1 Introduction DataRecorder 2 LED Indications The following table describes the LED indicators and their status/color for each of the most common DataRecorder 2 events/status. LEDs DataRecorder 2 Status DataRecorder 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. DataRecorder is synchronizing with a capsule. This is normal functioning. <20 seconds DataRecorder detects capsule signal, but is not recording it. This is a malfunction. Note >20 seconds Check the SensorArray connection or have patient move to a different location. Maximum Level 25% Battery Charge level When charging, the Battery LEDs do not blink. When DataRecorder is out of the Cradle, the Battery LEDS blink once every 5 seconds. Below 10% Chapter 1 PillCam Platform DataRecorder 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. Warning Never connect the DataRecorder 2 to the SensorArray while the DataRecorder 2 is in its cradle. Cradle Connections There 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. Note When connecting more than one DataRecorder 2 to the computer, it is recommended to use a USB-powered hub. USB cable Power connector D-type connector Auxiliary mains socket The D-type connector and Auxiliary mains socket-outlet are for service use only. Chapter 1 Introduction 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. DataRecorder 3 The 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 supply • • • • SensorArrays 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. Capsule and Message LEDs ON/OFF Button Acknowledge Button Line for status icons Navigation Buttons Procedure info area Message area Cradle Card Reader 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. Message LED Capsule LED Chapter 1 PillCam Platform Acknowledge Button The 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 Buttons The 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 Status The 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 Shutdown After 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 . Chapter 1 Introduction DataRecorder 3 LED Indications The following table describes the LED indicators and their status/color for each of the most common DataRecorder 3 events/status. LEDs DataRecorder 3 Status DataRecorder 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. Blinking Blinking DataRecorder is receiving capsule signals before capsule pairing is achieved. Blinking rate = capsule frame rate DataRecorder is receiving paired capsule signals. Blinking rate = capsule frame rate. DataRecorder has stopped receiving capsule signals for more than 5 seconds. Blink every 5 seconds DataRecorder has started downloading. DataRecorder has stopped recording because the memory card is full. There is an instruction on the DataRecorder screen. Blinking DataRecorder is malfunctioning. Blinking DataRecorder 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. Chapter 1 PillCam Platform DataRecorder 3 Error Message Guide Popup Message Popup Message No valid approved memory card is detected. Verify approved card is in the DataRecorder. Do not move DataRecorder from cradle Memory card is write-protected SensorArray hardware failure. Consult a technician. Memory card error. Remove + reinsert card. Wrong SensorArray type Insufficient memory on card No USB connection to cradle. Check connection. If connection is OK and error persists, consult a technician SensorArray not connected. Connect the SensorArray Wrong software on memory card Fatal error. Consult a technician. Cradle error End of procedure DataRecorder 3 Check-in Screen Icons Icon Name Patient Name Patient ID Procedure Regimen 10 Chapter 1 Introduction DataRecorder 3 Screen Icons The following icons appear in the top status line of the DataRecorder screen. Icon Explanation Icon Explanation Start pairing procedure SensorArray not connected Pairing succeeded DataRecorder is initialized Data not downloaded DataRecorder is waiting for initialization Data downloaded SensorArray failure Wrong SensorArray type Small bowel detection End procedure, Memory full Regimen Reminder numbers appear in status line when in Real Time Viewing mode Battery and Capsule Icons The following icons appear in the top status line of the DataRecorder screen. Icon Battery Status Icon Capsule Reception Status Battery fully charged Signal weak, recording with noise Battery charge level at 10% intervals Signal strong, recording with noise Battery empty, DataRecorder shuts down Signal weak, but recording OK Signal strong, and recording OK Chapter 1 11 PillCam Platform Navigation Buttons Legends Icon Action when pressed Icon Action when pressed Confirm Confirm SB detection and activate instruction #1 Scroll up Activate Real-Time viewing (followed by pressing the left and right buttons) Scroll down Mark frame Exit Real-Time viewing Switch video head (in Real-Time viewing mode) DataRecorder 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. Warning Never connect the DataRecorder to the SensorArray while the DataRecorder is in its cradle. 12 Chapter 1 Introduction Cradle Connections There are two connections on the back panel of the cradle: the power connector and the USB connection to computer. USB Connection to computer Power connector At the front of the cradle is a USB socket for connecting a card reader or USB storage device. USB connector Note Connect 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 Chapter 1 • 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. 13 PillCam Platform External Power Supply The Cradle is connected to the mains power through an external power supply. Caution Use only this power supply. RecorderPouch The 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 SensorBelt The 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. SensorArray The 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 14 Chapter 1 Introduction • 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 Note All components of the PillCam Platform are Latex free. Given Workstation The 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. Note When 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. Chapter 1 15 PillCam Platform RAPID 7 Software RAPID 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. 16 Chapter 1 Chapter 2 Setting Up the System Setup 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. Note You 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: Note Extra space is needed for air circulation and cable connectors behind the Workstation. Given Imaging Ltd. 17 PillCam Platform Given Workstation The footprint of the Given Workstation is about 18 cm (W) x 47 cm (D) x 45 cm (H). DataRecorder and Cradle The 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 Box Provide a storage space that is protected from any powerful electromagnetic source, for storing the PillCam video capsule 1box. Main Platform Components Following 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 Cradle Connecting the Components Warning The 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. 18 Caution Voltage mismatch will damage the Given Workstation. Chapter 2 Chapter 2 Use the following sketch as an aid in setting up the PillCam Platform: Dell Given Workstation The following table lists the items that connect to the Given Workstation back panel: Chapter 2 Connection Explanation Power cord Connects the Given Workstation to the electric socket. Keyboard Connects the Given Workstation to the keyboard. Mouse Connects the Given Workstation to the Mouse Monitor 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. 19 PillCam Platform Note You 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 Workstation 1. 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. Warning Do not connect the components to the wall electric outlet until you verify the Workstation voltage matches the local voltage. 20 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 2 Chapter 2 Connecting the DataRecorder Cradle You 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. Note If you use more than one cradle, make sure each one is connected to a different power outlet. Chapter 2 21 PillCam Platform 22 Chapter 2 Chapter 3 Software Installation Before installing any new application, close all other applications currently running on the computer. RAPID Installation 1. 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. Given Imaging Ltd. 23 PillCam Platform 24 3. If you have a valid licensed copy of the Operating System, click Yes. The following screen appears. 4. Click Yes. The following screen appears. Chapter 3 RAPID Installation Chapter 3 5. Click Yes. The InstallShield Wizard for the RAPID Atlas appears. 6. Click Next. The following screen appears. 25 PillCam Platform 26 7. 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. Chapter 3 RAPID Installation 9. 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: Chapter 3 a. Insert RAPID 7 Installation CD. b. Click Install RAPID and follow the instructions on the screen. 27 PillCam Platform 12. 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. Registration Unrestricted use of RAPID requires registration via the Given registration center. You must supply requested information to obtain the Registration Key. 28 Chapter 3 RAPID Installation The registration screen appears at the end of the installation process: Note Keep 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 center 16. 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 ID 17. Enter the Registration Key received from the Given registration center. Note The registration process uses ONLY lower case letters and numbers. 18. Click OK. Note If 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. Chapter 3 29 PillCam Platform Wide Screen Compatibility In 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: 30 Aspect Ratio Minimum Resolution 4:3 1024 x 768 16:9 1360 x 768 16:10 1280 x 800 Chapter 3 Chapter 4 Multi-User Setup System 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 User 1. 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. Given Imaging Ltd. 31 PillCam Platform 3. 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. Note The 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 Account 1. 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 User If a user has forgotten his password, you can create a new one. 32 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. Chapter 4 Multi-User Setup Note This 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 Administrator 1. 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. Note For security reasons, all users should change their default passwords to a chosen password. Change the Given Workstation’s Time and Date Access 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 Logs System 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. Chapter 4 33 PillCam Platform To View the Logs To 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 of that specific action appears. Event Properties screen To Create a Backup of the Logs Creating 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. 34 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. Chapter 4 Chapter 5 Technical Description System Labeling The following table lists the labels attached to various components of the PillCam Platform: Labeling Explanation The 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. Given Imaging Ltd. Attention! Consult the documentation provided with the PillCam Platform. Temperature limits Non-ionizing radiation Type BF equipment RoHs FCC compliance Capsule ID CE mark Ingress protection C-Tick mark Do not Iron CSA mark Latex free Expiration date Machine wash - warm Recycle Do not tumble dry Lot number Do not dry clean Indoor use only Do not use bleach 35 PillCam Platform Capsule Labeling Each 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. Capsule ID Code Expiration Date Lot Number Essential Performance PillCam Video Capsules ON-Mode Data 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-Mode No unintentional transmissions are allowed. DataRecorder 2 and DataRecorder 3 Data 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. 36 Chapter 5 Technical Description • 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 shortcircuiting 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. Chapter 5 37 PillCam Platform • 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 Specifications Note Specifications are subject to change without prior notice and without any obligation to users on the part of the manufacturer. 38 Chapter 5 Technical Description PillCam SB Capsule Properties Physical Optical Operational Chapter 5 Dimensions Length: 26 mm Diameter: 11 mm Weight 3.30 gr Material Biocompatible plastic Illumination 6 white light emitting diodes # of imaging heads Field of view 140° ISO-8600-3 Effective visibility Distance: 3 cm Magnification 1:8 Min. detectable object Less than 0.1 mm Frame rate 2 fps Operating time 7 ± 1 hours Chemical safety Resistant to dissolution in pH=2 to pH=8 Battery type Silver Oxide batteries Operating temperature 20–45°C Storage temperature 0–50°C 39 PillCam Platform PillCam SB 2 Capsule Properties Physical Optical Operational 40 Dimensions Length: 26 mm Diameter: 11 mm Weight 2.89gr. Material Biocompatible plastic Illumination 4 white light emitting diodes # of imaging heads Field of view 156° ISO-8600-3 Effective visibility Distance: 3 cm Min. detectable object Less than 0.1 mm Frame rate either 2 or 4 fps Operating time > 8 hours Chemical safety Resistant to dissolution in pH=2 to pH=8 Battery type Silver Oxide batteries (3V) Operating temperature 20–45°C Storage temperature 0–40°C Chapter 5 Technical Description PillCam ESO 2 Capsule Properties Physical Optical Operational Chapter 5 Dimensions Length: 26 mm Diameter: 11 mm Weight 2.89 gr Material Biocompatible plastic Illumination 4 white light emitting diodes for each head # of imaging heads Field of view 169° ISO-8600-3 for each head Effective visibility Distance: 3 cm Min. detectable object Less than 0.06 mm Frame rate up to 9 fps per head Operating time 30 minutes Chemical safety Resistant to dissolution in pH=2 to pH=8 Battery type Silver Oxide batteries Operating temperature 20–45°C Storage temperature 0–50°C 41 PillCam Platform PillCam ESO 3 Capsule Properties Physical Optical Operational 42 Dimensions Length: 31.5 mm Diameter: 11.6 mm Weight 2.9 gr Material Biocompatible plastic Illumination 4 white light emitting diodes for each head # of optical heads Field of view 172° ISO-8600-3 for each head Effective visibility Distance: 0–30 mm Min. detectable object 0.09 mm Frame rate 35 fps per head Operating time 30 minutes Chemical safety Resistant to dissolution in pH=2 to pH=8 Battery type Silver Oxide batteries Operating temperature 20–45°C Storage temperature 0–40°C Chapter 5 Technical Description PillCam COLON 2 Capsule Properties Physical Optical Operational Uplink communication Downlink communication Chapter 5 Dimensions Length: 31.5 mm Diameter: 11.6 mm Weight 2.9 g Material Biocompatible plastic # of optical heads Illumination 4 white light emitting diodes on each side Field of view 172° ISO-8600-3 Effective visibility Min. detectable object Operating time Distance: 0–30 mm 0.09 mm Total: 10 hours: Chemical safety Resistant to dissolution in pH=2 to pH=8 Battery type Silver Oxide batteries Operating temperature Storage temperature 20–45°C Operating frequency 434.1 MHz Frame rate 4–35 fps Data rate 2.7 Mbps and 8.1 Mbps Modulation type MSK/Digital data Frequency band standards Effective radiated power Operating frequency FCC CFR 47 part 15 section 15.209 ERC 70-03 Annex 1 band F1 -48.8 dBm (measured in 120 kHz bandwidth) 13.56 MHz Receiver Bandwidth + 150 KHz Frequency band standards FCC CFR 47 part 15 section 15.225 ERC 70-03 Annex 9 band F 0–30°C 43 PillCam Platform SensorArray DataRecorder 2 Versions: SB, COLON, ESO Sensor size Diameter 40 mm Color black Material SB = COLON SensorArray plastic ESO SensorArray 3 sensor elements 8 sensor elements SensorArray DataRecorder 3 Properties Reception antenna Transmission antenna 44 # of sensor elements 3 or 8 sensors Sensor size Diameter: 40 mm Color Black Material Polyurethane, Teflon Antennas wire material Coax wire Antenna structure Loop antenna Size 1.90 m Color Black Material Polyurethane, Teflon Chapter 5 Technical Description SB SensorBelt for DataRecorder 2 and DataRecorder 3 SensorBelt Insert Dimensions 365 mm x 90 mm Insert material Polypropylene Number of sensors Sensor dimensions Diameter 40 mm Cable length 550 mm Cleaning method Wipe with medical alcohol wipes Expected life 500 procedures SensorBelt Cover and Straps Cover dimensions 385 mm x 125 mm Cover and strap material 100% polyester Fits abdomen size 60 - 130 cm Washing instructions Machine wash, warm, Use mild detergent Hang dry Do not dry clean, Do not use bleach Expected life 40 wash cycles DataRecorder 2 /2C Chapter 5 Software Proprietary firmware Recording capacity DataRecorder 2: @2fps for 10 hours DataRecorder 2C: @4fps for 10 hours Weight 500 gr., including battery pack. Operational Power 6–8 VDC, 0.1–0.3 A Battery type Internal, Li-Ion, 7.2 V, 4400 mAH Battery Pack weight 200 gr. Operating temp. 0–40°C Storage temp. 0–55°C Shielding 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 45 PillCam Platform Cradle DataRecorder 2 Properties Weight 890 g Size (without battery inserter Color Mains power connections black power mains range 100 to 240V 14[D] x 165[W] x 97[H]mm 1x male power cable plug DataRecorder 3 Properties Physical Software Proprietary firmware Recording capacity Up to 15 hours @ LCD OFF Weight 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 mAH Operating temp. 0–40°C Storage temp. 0–55°C Shielding No belt shielding Classification • • • Receiver (Rx) Transmitter 46 internally powered (complies with requirements for Class I equipment while connected to supply mains through charger) Type BF applied part Ordinary equipment Operating frequency 434.1 MHz Bandwidth of the receiving section in this band 10 MHz Operating frequency 13.56 MHz Frequency band ISM Modulation type Linear Chirp Type of modulated signal Digital data Frequency of modulating signal 20.25 dBm Effective radiated power -27.4 dBm Chapter 5 Technical Description Cradle DataRecorder 3 Properties Weight 250 g Operating temp 0–45°C Color Mains power connections White & Black power mains range Input Voltage: Maximum 5.25V, Min 4.75V Input Current: Maximum 4A, Min 100 mA 1x male power cable plug DC Power Supply Properties Weight 300 g Input connector 3 pole AC inlet IEC320-C14C Input Voltage 90 - 246 VAC Output voltage 5V DC, 5 Amp Protections Short circuit/ Over load/ Over voltage/ Over temp. DataRecorder 3 Memory Card Properties Dimensions 24mm x 32mm x 2.1mm Weight 2.5 g Capacity >16GB Rating Class 6: 40X or higher, 6 MB/sec minimum data transfer rate Storage temperature -40°C–85°C Security Compatibility File format Chapter 5 Built-in write-protect switch prevents accidental data loss SDHC host devices; not compatible with standard SD-enabled devices/readers FAT 32 47 PillCam Platform RAPID Software Software RAPID proprietary, version 7 Languages 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 thumbnails Viewing rate 5–80 fps Viewing Modes SingleView, DualView, QuadView, Mosaic View, Double-Head View (ESO and COLON) Run Modes Normal, QuickView, SBI Guidance and Manufacturer's Declarations PillCam Capsules (No PillCam COLON 2) Guidance and manufacturer’s declaration - electronic emissions The 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 48 Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Electromagnetic environment - guidance The 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 equipment 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. Chapter 5 Technical Description Guidance and manufacturer’s declaration - electronic emissions The 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 level Electrostatic discharge ±6 kV contact (ESD) IEC 61000-4-2 ±8 kV air ±2 kV for power supply Electrical fast transient lines / burst IEC 61000-4-4 ±1 kV for input/output lines Surge, ±1 kV line(s) to line(s) IEC 61000-4-5 ±2 kV line(s) to earth Compliance level ±6 kV contact ±8 kV air Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. <5 % UT (>95 % dip in UT) for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Power frequency (50/ 60 Hz) magnetic field, IEC 61000-4-8 3 A/m NOTE: UT is the AC mains voltage prior to application of the test level. Chapter 5 49 PillCam Platform Guidance and manufacturer’s declaration - electronic emissions The 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 Compliance Electromagnetic environment level level guidance Portable 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 distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 VRMS 150 kHz to 80 MHz Not applicable 3 V/m 80 MHz to 2.5 GHz Not applicable d = 1.2 P 80 MHz to 800 MHz 3 V/m d = 2.3 P 800 MHz to 2.5 GHz NOTE 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. 50 Chapter 5 Technical Description Recommended separation distances between portable and mobile RF communications equipment and the PillCam capsules The 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 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 Not applicable 0.12 0.23 0.1 Not applicable 0.38 0.73 Not applicable 1.2 2.3 10 Not applicable 3.8 7.3 100 Not applicable 12 23 For 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 COLON 2 Capsules Guidance and manufacturer’s declaration - electromagnetic emissions The 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 RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Chapter 5 Electromagnetic environment - guidance The 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 equipment 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. 51 PillCam Platform Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems The 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 level Electrostatic discharge ±6 kV contact (ESD) IEC 61000-4-2 ±8 kV air ±2 kV for power supply Electrical fast transient lines / burst IEC 61000-4-4 ±1 kV for input/output lines Surge, ±1 kV line(s) to line(s) IEC 61000-4-5 ±2 kV line(s) to earth Compliance level ±6 kV contact ±8 kV air IEC 61000-4-11 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles Mains power quality should be that of a typical commercial or hospital environment. Not applicable Mains power quality should be that of a typical commercial or hospital environment. Not applicable Mains 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. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. <5 % UT (>95 % dip in UT) for 5 sec Power frequency (50/ 60 Hz) magnetic field, IEC 61000-4-8 3 A/m Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Not applicable <5 % UT (>95 % dip in UT) for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply input lines Electromagnetic environment - guidance NOTE: UT is the AC mains voltage prior to application of the test level. 52 Chapter 5 Technical Description Guidance and manufacturer’s declaration - electromagnetic immunity The 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 Compliance Electromagnetic environment level level guidance Portable 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 RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz Not applicable 3 V/m 80 MHz to 2.5 GHz 3 V/m Recommended separation distance: d= 1.2 P d = 1.2 P 80 MHz to 800 MHz MHz range d = 2.3 P 800 MHz to 2500 MHz NOTE 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. Chapter 5 53 PillCam Platform Recommended separation distances between portable and mobile RF communications equipment and the PillCam COLON 2 capsules The 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 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For 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. 54 Chapter 5 Technical Description DataRecorder 2(C) Guidance and manufacturer’s declaration - electronic emissions The 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 RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Electromagnetic environment - guidance The 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 equipment 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. Guidance and manufacturer’s declaration - electronic emissions The 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 Electrostatic ±6 kV contact discharge (ESD) Compliance level ±6 kV contact ±8 kV air ±8 kV air Electrical fast transient / burst ±2 kV for power supply lines ±2 kV for power supply lines IEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines Surge, ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth IEC 61000-4-2 Chapter 5 Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 55 PillCam Platform Guidance and manufacturer’s declaration - electronic emissions Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 5 sec Power frequency (50/60 Hz) magnetic field, 3 A/m Mains 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 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 3 A/m IEC 61000-4-8 NOTE: UT is the AC mains voltage prior to application of the test level. Guidance and manufacturer’s declaration - electronic emissions The 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 Compliance Electromagnetic environment level level guidance Portable 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 distance 56 Conducted RF 3 VRMS IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 3Vms d = 1.2 P 3 V/m d = 1.2 P 80 MHz to 800 MHz range d = 2.3 P 800 MHz to 2.5 GHz range Chapter 5 Technical Description Guidance and manufacturer’s declaration - electronic emissions NOTE 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 capsule The 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 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 Not applicable 0.12 0.23 0.1 Not applicable 0.38 0.73 Not applicable 1.2 2.3 10 Not applicable 3.8 7.3 100 Not applicable 12 23 For 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. Chapter 5 57 PillCam Platform DataRecorder 3 Guidance and manufacturer’s declaration - electromagnetic emissions The 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 RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 N/A Voltage fluctuations/ flicker emissions IEC 61000-3-3 N/A Electromagnetic environment - guidance The 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 equipment 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. Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems The 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 Electrostatic 6 kV contact discharge (ESD) IEC 61000-4-2 Electrical fast transient / burst IEC 61000-4-4 Surge, IEC 61000-4-5 58 8 kV air Compliance level 6 kV contact 8 kV air 2 kV for power supply lines Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. N/A Mains power quality should be that of a typical commercial or hospital environment. N/A Mains power quality should be that of a typical commercial or hospital environment. 1 kV for input/output lines 1 kV line to line 2 kV line to earth Electromagnetic environment guidance Chapter 5 Technical Description Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles N/A Mains 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. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. <5 % UT (>95 % dip in UT) for 5 sec Power frequency (50/60 Hz) magnetic field, 3 A/m IEC 61000-4-8 NOTE: UT is the AC mains voltage prior to application of the test level. Chapter 5 59 PillCam Platform Guidance and manufacturer’s declaration - electromagnetic immunity The 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 Compliance Electromagnetic environment level level guidance Portable 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, 3Vrms 3Vrms IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz d = 1.2 P Radiated RF, 3 V/m [E1] = 3 V/m Recommended separation distance: IEC 61000-4-3 80 MHz to 2.5 GHz Recommended separation distance: d = 1.2 P 80 MHz to 800 MHz range d = 2.3 P 800 MHz to 2500 MHz range NOTE 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. 60 Chapter 5 Technical Description Recommended separation distances between portable and mobile RF communications equipment and the DataRecorder 3 The 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 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For 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. Chapter 5 61 PillCam Platform 62 Chapter 5 Chapter 6 Maintenance Charging DataRecorder Disclaimer The DataRecorder cradle is a non-medical device, used for charging the DataRecorder from Given Imaging Ltd. Important Safety Instructions Note Before 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. Warning Changes 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. Note This 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 Given Imaging Ltd. 63 PillCam Platform installation. 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 2 DataRecorder 2 or Adaptor with Battery Green, Orange and Red LEDs The following table lists and explains the LEDs (from left to right) of the DataRecorder 2 Cradle and their meaning: LED Green Orange Red Status On On Blinking On Explanation Battery Pack is ready for use Battery Pack is charging Battery Pack is discharging Battery Pack is faulty To Charge the DataRecorder 2 1. 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). Note 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. 64 Chapter 6 Maintenance 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. 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. Note You 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. Push button (at the back) LEDs on the DataRecorder 2 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 Battery 1. 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. to open the DataRecorder Info screen. 4. Click 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: Chapter 6 65 PillCam Platform • 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 blinks 7. 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. Note Do 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 3 The following table lists and explains the LEDs of the DataRecorder 3 Cradle and their meaning: LED Green Yellow Status On On Blinking Explanation Battery Pack is ready for use Battery Pack is charging Battery Pack is charging To Charge the DataRecorder 1. 2. 3. 66 First plug the power cable into the cradle and plug the power cable into the wall outlet. Insert the DataRecorder into the cradle. The bottom LED is orange when charging the battery. As soon as the DataRecorder is fully charged, the bottom LED turns green. Leave the DataRecorder in its cradle until the next examination. Chapter 6 Maintenance SensorBelt Cleaning The 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 Cleaning For 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. Note White 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 Remover Use all precautions as defined by the manufacturer. Chapter 6 67 PillCam Platform 68 Chapter 6 Chapter 7 Troubleshooting RAPID Video Problem Short Video Gaps Bad image quality Video shorter than capsule operating time without either ingestion phase images or body exit images No Localization Cause • Capsule • DataRecorder Battery • DataRecorder Mishandling • Capsule • Interference • Mishandling • Physiological • Stripes in video • Pixilation/confetti • Dark/red/orange image • Capsule • DataRecorder Battery • Interference Action • Contact Customer Support • Send video on CD/DVD • Inform Capsule Lot # • Do not use the same DataRecorder Malfunction of the SensorArray Contact Customer Support • • Send video on CD/DVD Contact Customer Support Saving and Opening Video Problem Cannot locate video Cannot locate findings Cause • Video was not saved in E:\Videos • Incorrect patient’s name • Findings were not saved under patient’s folder • Findings were saved with the wrong name Action Contact Customer Support • • See Saving Your Findings in chapter four of Book 3: Using the RAPID Software Contact Customer Support SensorArray Problem Connector is damaged Sensor is torn from its wire Insulation of the sensor wire is damaged Given Imaging Ltd. Cause Action • • Contact Customer Support Mishandling End of Life 69 PillCam Platform Printer Problem Cannot print report Cause Printer is turned off Printer is not set as default printer Action Turn printer on Set printer to Default Printer Printer has a malfunction Contact Customer Support Cause CD/DVD is not blank or compatible with CD/DVD ROM Wrong Burning procedure A video on the disc is open Action Contact Customer Support Cause Software or Hardware corruption Atlas installation is incomplete or incorrect Action Contact Customer Support • Reinstall Atlas • Contact Customer Support Contact Customer Support CD/DVD Problem Cannot burn CD/DVD Cannot eject CD/DVD Contact Customer Support Close the video and retry RAPID Software Problem Cannot open RAPID Cannot open RAPID Atlas XML corruption Capsule Problem DOA (Dead On Arrival): LEDs do not light up when capsule is removed from its box Cause Capsule failure Action 1 Send capsule to Given Imaging Ltd. 2 Open another capsule 3 If second capsule from 10-pak is DOA, contact Customer Support Given Workstation 70 Problem Blue screen Cause Hardware malfunction Given Workstation does not boot up Given Workstation DOA Hardware malfunction Action 1 Send RAPID and Given Workstation log files 2 Contact Customer Support. Contact Customer Support Transportation mishandling Contact Customer Support Chapter 7 Troubleshooting Problem Given Workstation does not recognize USB storage device Cause USB storage device is not compatible Malfunction of the USB connection on Given Workstation USB storage device malfunction Malfunction of the USB connection on Given Workstation Printer malfunction Printer driver is missing Given Workstation does not recognize printer Action Contact Customer Support 1 Change USB port 2 Contact Customer Support Contact Customer Support 1 Change USB port 2 Contact Customer Support Contact Customer Support Contact Customer Support Cradle Problem All LEDs are flashing red Cause All LEDs are flashing red DataRecorder cannot be placed in cradle Hardware malfunction Action 1 Disconnect cradle for mains power 2 Reconnect cradle to mains power 3 If problem persists, contact Customer Support Contact Customer Support DataRecorder Problem Cannot initialize DataRecorder Cause Computer does not recognize DataRecorder Cannot create video Error message is displayed Not enough space... Capsule LED does not blink in blue when capsule is activated message is displayed Workstation freezes during video creation • No pairing performed, or pairing was not successful Action 1 Check USB and power connection 2 Contact Customer Support Send error message to Customer Support Delete PRRs from hard drive Contact Customer Support 1 perform Capsule pairing 2 If problem persists, contact Customer Support 3 Send malfunctioned capsules to Given Imaging Ltd. Note For 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. Chapter 7 71 PillCam Platform Low Signal If 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 malfunction If this message is displayed, Contact Customer Support. Click OK to close the message. 72 Chapter 7 Index Acknowledge Button .............................. 8 Automatic Shutdown DataRecorder .............................. 4, 8 back pannel connectors ......................... 19 Backup Logs. ....................................... 34 Backup, create ...................................... 34 Battery and Capsule Icons ..................... 11 Battery Status ......................................... 8 Capsule storage space .................................. 18 Troubleshooting ............................. 70 Capsule ID ........................................... 35 CD/DVD Troubleshooting ............................. 70 CE mark .............................................. 35 connecting the RAPID Booster .............. 18 connecting the RAPID Workstation ....... 20 connectors of back pannel ..................... 19 Cradle ...................................... 6, 12, 18 LED indications ........................ 6, 12 Troubleshooting ............................. 71 Cradle Connections .......................... 6, 13 CSA mark ............................................ 35 DataRecorder ................................ 11, 18 DataRecorder 2 Manual Discharge ........................... 65 DataRecorder 2 Kit ................................. 3 DataRecorder 3 Troubleshooting ............................. 71 DataRecorder 3 Kit ................................. 7 DataRecorder 3 LED Indications ............. 9 DataRecorder 3 Memory Card ............... 47 DataRecorder 3 Screen Icons ................. 11 DataRecorder 2 ...................................... 3 DataRecorder 3 ...................................... 7 Expiration date .................................... 35 Gastrointestinal tract .............................. 2 Given Workstation ............................... 18 connecting ..................................... 18 Controlling access .......................... 15 voltage .......................................... 18 installing RAPID C2 ............................ 23 KVM Switch ....................................... 17 Lot number .......................................... 35 Low Signal .......................................... 72 Main screen RAPID C2 Installation CD ............. 23 Navigation Buttons ................................ 8 Navigation Buttons Legends ................. 12 Non-ionizing radiation ......................... 35 outlet ................................................... 17 Password ............................................. Password, change ................................. password, new ..................................... PillCam ESO 2 Capsule ........................ PillCam Platform ................................. before it arrives .............................. Pillcam Platform required space ................................ 32 33 32 41 17 17 17 73 PillCam SB 2 Capsule .......................... 40 PillCam SB Capsule ............................. 39 Printer Troubleshooting ............................. 70 Workstation Manager ........................... 32 RAPID Troubleshooting ............................. RAPID C2 Installation CD ................... RAPID Video Troubleshooting ............................. RAPID Workstation connecting ..................................... RecorderPouch .................................... registration .......................................... RoHs ................................................... 70 23 69 20 14 28 35 SB SensorBelt ...................................... SensorArray .................................. 14, Cleaning ........................................ Troubleshooting ............................. SensorBelt Cleaning ........................................ setting the voltage of APID Workstation sketch Dell Minitower .............................. System Administration ......................... System Log ......................................... 14 67 67 69 67 18 19 31 33 Temperature limits ............................... 35 Type BF equipment .............................. 35 User Account, delete ............................ 32 User, add new ...................................... 32 User, define a ....................................... 31 voltage Given Workstation ......................... 18 Voltage Select Switch .......................... 18 Wide Screen Compatibility ................... 30 Workstation Troubleshooting ............................. 70 74
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