Summary of Contents for Given Imaging PillCam RAPID 7
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PillCam Platform ® Setup & Maintenance ® RAPID DOC-1530-01 August 2010 Book 1 Book 1: Setup & Maintenance Book 2: Performing Capsule Endoscopy ® Book 3: Using the RAPID Software...
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.
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PillCam Platform Multi-User Setup ......................31 System Administration ......................31 To Define a User ......................31 To Delete User Account ....................32 To Set a New Password for a User .................. 32 To Change the Password of the Administrator..............33 Change the Given Workstation’s Time and Date ............. 33 System Logs ..........................
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 •...
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.
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.
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.
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.
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.
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: •...
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.
PillCam Platform DataRecorder 3 Error Message Guide Popup Message Popup Message No valid approved memory card is detected. Do not move DataRecorder from Verify approved card is in the cradle DataRecorder. SensorArray hardware failure. Memory card is write-protected Consult a technician. Memory card error.
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 DataRecorder is waiting for Data not downloaded initialization Data downloaded SensorArray failure...
PillCam Platform Navigation Buttons Legends Icon Action when pressed Icon Action when pressed Confirm SB detection and activate Confirm instruction #1 Activate Real-Time viewing Scroll up (followed by pressing the left and right buttons) Scroll down Mark frame Switch video head (in Real-Time Exit Real-Time viewing viewing mode) DataRecorder Cradle...
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 Power connector to computer 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...
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.
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 •...
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. Chapter 1...
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.
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).
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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: Connection Explanation Power cord Connects the Given Workstation to the electric socket. Keyboard Connects the Given Workstation to the keyboard.
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.
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.
Before installing any new application, close all other applications currently running on the computer. RAPID Installation Insert the RAPID 7 Installation disc into the DVD drive. The RAPID 7 installation menu screen appears. Install RAPID Access v. 7 Click . The following screens appear. Given Imaging Ltd.
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PillCam Platform If you have a valid licensed copy of the Operating System, click The following screen appears. Click . The following screen appears. Chapter 3...
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RAPID Installation Click . The InstallShield Wizard for the RAPID Atlas appears. Next Click . The following screen appears. Chapter 3...
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PillCam Platform Browse Click if you wish to install in a different location. To continue with the installation, Next click . The following screen appears. Finish Click . As soon as the progress bar is full, the License Agreement screen appears. Chapter 3...
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RAPID Installation Yes. To continue the installation and accept the license agreement, click If you wish to Print print the license agreement before reading it, click . The following screen appears. Next Click . The following screen appears. Browse Click if you wish to install in a different location.
PillCam Platform 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 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.
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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.
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: •...
Log On to Windows installation, the Windows screen appears. User In the 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 Given Imaging Ltd.
PillCam Platform Given Workstation Manager Wait for the screen to appear. Add New User Add New User Click . The screen appears. User name Password Type in a new 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.
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. Set Password Click xxx’s Password was changed successfully The message appears. To Change the Password of the Administrator Change Admin Password Click Change Rapidadmin Password...
PillCam Platform To View the Logs View Logs Log Viewer To view the logs, click . The screen appears. To view more details about one of the events, select and double click the relevant line and the Event Properties screen of that specific action appears. To Create a Backup of the 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.
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 Given Imaging Ltd.
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 Lot Number Expiration Date Essential Performance PillCam Video Capsules ON-Mode Data transmitting to DataRecorder is considered to be essential performance of the PillCam...
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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 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.
Technical Description PillCam SB Capsule Properties Physical Dimensions Length: 26 mm Diameter: 11 mm Weight 3.30 gr Material Biocompatible plastic Optical Illumination 6 white light emitting diodes # of imaging heads Field of view 140° ISO-8600-3 Effective visibility Distance: 3 cm Magnification Min.
PillCam Platform PillCam SB 2 Capsule Properties Physical Dimensions Length: 26 mm Diameter: 11 mm Weight 2.89gr. Material Biocompatible plastic Optical Illumination 4 white light emitting diodes # of imaging heads Field of view 156° ISO-8600-3 Effective visibility Distance: 3 cm Min.
Technical Description PillCam ESO 2 Capsule Properties Physical Dimensions Length: 26 mm Diameter: 11 mm Weight 2.89 gr Material Biocompatible plastic Optical Illumination 4 white light emitting diodes for each head # of imaging heads Field of view ISO-8600-3 for each head °...
PillCam Platform PillCam ESO 3 Capsule Properties Length: 31.5 mm Physical Dimensions Diameter: 11.6 mm Weight 2.9 gr Material Biocompatible plastic Optical 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.
Technical Description PillCam COLON 2 Capsule Properties Physical Dimensions Length: 31.5 mm Diameter: 11.6 mm Weight 2.9 g Material Biocompatible plastic Optical # of optical heads Illumination 4 white light emitting diodes on each side Field of view 172° ISO-8600-3 Effective visibility Distance: 0–30 mm Min.
PillCam Platform SensorArray DataRecorder 2 Versions: SB, COLON, ESO Sensor size Diameter 40 mm Color black Material plastic SB = COLON 8 sensor elements SensorArray 3 sensor elements SensorArray SensorArray DataRecorder 3 Properties Reception antenna # of sensor elements 3 or 8 sensors Sensor size Diameter: 40 mm Color...
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...
PillCam Platform Cradle DataRecorder 2 Properties Weight 890 g Size (without 14[D] x 165[W] x 97[H]mm battery inserter Color black Mains power 1x male power cable plug connections power mains 100 to 240V range DataRecorder 3 Properties Physical Software Proprietary firmware Recording capacity Up to 15 hours @ LCD OFF Weight...
Technical Description Cradle DataRecorder 3 Properties Weight 250 g Operating temp 0–45 ° Color White & Black Mains power 1x male power cable plug connections Input Voltage: Maximum 5.25V, Min 4.75V power mains range Input Current: Maximum 4A, Min 100 mA DC Power Supply Properties Weight...
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.
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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. IEC 60601 test Compliance Electromagnetic...
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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. IEC 60601 tes t Compliance Electromagnetic environment -...
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.
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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.
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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.
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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.
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 Electromagnetic environment - guidance...
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PillCam Platform Guidance and manufacturer’s declaration - electronic emissions <5 % U <5 % U (>95 % dip in U (>95 % dip in U Mains power quality should be for 0.5 cycle for 0.5 cycle that of a typical commercial or Voltage dips, hospital environment.
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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).
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 Electromagnetic environment - guidance...
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Technical Description Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment and systems <5 % U (>95 % dip in U Mains power quality should be for 0.5 cycle that of a typical commercial or Voltage dips, hospital environment. If the 40 % U short interruptions user of the DataRecorder 3...
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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. IEC 60601 tes t Compliance Electromagnetic environment -...
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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.
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.
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.
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.
PillCam Platform DataRecorder Info • in the bottom left corner of the screen DataRecorders • in the DataRecorder 2 bar in the screen • the orange LED on the cradle blinks To return to other RAPID functions, click Close If you need to stop the discharge (also for automatic discharge) while it is in progress, return DataRecorder Info to the screen and click...
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%).
RAPID Software • Contact Customer Support SensorArray Problem Cause Action Connector is damaged Sensor is torn from its wire • Mishandling Contact Customer Support • End of Life Insulation of the sensor wire is damaged Given Imaging Ltd.
XML corruption Contact Customer Support Capsule Problem Cause Action 1 Send capsule to Given Imaging Ltd. DOA (Dead On Arrival): Capsule failure 2 Open another capsule LEDs do not light up 3 If second capsule from 10-pak is when capsule is removed...
Customer Support activated successful 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.
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.
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