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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
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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 ma y cause undesired operat ion.
Changes or modifications not expressly approved by Given Imaging Limited
could void authority to operate the PillCam Platform.
Low Signal ........................................................................................................................ 72
Index ................................................................................................................................. 73
iii
PillCam Platform
iv
Conventions
Note
Caution
!
Warning
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.
Chapter 1
Introduction
Capture button.
Screen names, are in a bold type face: e.g.
The footer shows the page number company name or the chapter number.
The header shows the equipment name and chapter name.
A note is information or remark that receives emphasis and looks as follows:
A caution warns you about possible damage to equipment, and looks as follows:
A warning warns you about possible harm to people and looks as follows:
DataRecorders screen.
Given Imaging Ltd.1
PillCam Platform
PillCam SB capsules
PillCam ESO capsules
PillCam COLON capsule
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 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.
2Chapter 1
Handling the PillCam Video Capsule
Caution
!
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.
T o 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.
•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
Introduction
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 13
PillCam Platform
Capsule LED
DataRecorder LED
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.
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.
4Chapter 1
Introduction
Note
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 3 0, 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.
<20 seconds
>20 seconds
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.
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.
Maximum Level
Battery Charge level
25%
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 15
PillCam Platform
Warning
Note
Auxiliary mains socketD-type connector
USB cable
Power connector
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.
Never connect the DataRecorder 2 to the SensorArr ay while th e Dat aRe corder
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.
When connecting more than one DataRecorder 2 to the computer, it is
recommended to use a USB-powered hub.
The D-type connector and Auxiliary mains socket-outlet are for service use only.
6Chapter 1
Warning
•The cradle is for indoor use only.
ON/OFF Button
Acknowledge Button
Capsule and Message
LEDs
Line for status icons
Procedure info area
Navigation Buttons
Cradle
Card Reader
Message area
Capsule LED
Message LED
•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
Introduction
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.
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.
Chapter 17
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 .
8Chapter 1
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.
LEDsDataRecorder 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.
DataRecorder is receiving capsule signals before capsule pairing is achieved.
Blinking
Blinking
Blink every 5 seconds
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.
Introduction
Blinking
Blinking
DataRecorder has started downloading.
DataRecorder has stopped recording because the memory card is full.
There is an instruction on the DataRecorder screen.
DataRecorder is malfunctioning.
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 LC D
screen ON.
Chapter 19
PillCam Platform
DataRecorder 3 Error Message Guide
PopupMessagePopupMessage
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
Memory card error.
Remove + reinsert card.
Insufficient memory on card
SensorArray not connected.
Connect the SensorArray
Cradle error
SensorArray hardware failure.
Consult a technician.
Wrong SensorArray type
No USB connection to cradle.
Check connection. If connection is
OK and error persists, consult a
technician
Wrong software on memory card
Fatal error.
Consult a technician.
End of procedure
DataRecorder 3 Check-in Screen Icons
IconName
Patient Name
Patient ID
Procedure
Regimen
10Chapter 1
DataRecorder 3 Screen Icons
The following icons appear in the top status line of the DataRecorder screen.
IconExplanationIconExplanation
Start pairing procedure SensorArray not connected
Pairing succeededDataRecorder is initialized
Introduction
Data not downloaded
Data downloadedSensorArray failure
Wrong SensorArray typeSmall bowel detection
End procedure, Memory full
DataRecorder is waiting for
initialization
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.
IconBattery StatusIconCapsule Reception Status
Battery fully chargedSignal weak, recording with noise
Battery charge level at 10%
intervals
Battery empty, DataRecorder
shuts down
Chapter 111
Signal strong, recording with
noise
Signal weak, but recording OK
Signal strong, and recording OK
PillCam Platform
Warning
Navigation Buttons Legends
IconAction when pressedIconAction when pressed
Confirm
Confirm SB detection and activate
instruction #1
Activate Real-Time viewing
Scroll up
(followed by pressing the left and
right buttons)
Scroll downMark 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.
Never connect the DataRecorder to the SensorArray while the DataRecorder is
in its cradle.
12Chapter 1
Introduction
Note
Warning
USB Connection
to computer
Power connector
USB connector
Cradle Connections
There are two connections on the back panel of the cradle: the power connector and the USB
connection to computer.
At the front of the cradle is a USB socket for connecting a card reader or USB storage device.
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.
•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.
Chapter 113
PillCam Platform
Caution
!
External Power Supply
The Cradle is connected to the mains power through an external power supply.
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
14Chapter 1
Introduction
Note
Note
• 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
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.
T o 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.
When RAPID is installed on a persona l computer , it functions nearly identically
to the Given Workstation. Throughout this manual, references to the
workstation apply also to the RAPID compu ter except whe re oth erwise note d.
Chapter 115
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.
16Chapter 1
Setup Requirements
Note
Caution
!
Note
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.
Chapter 2
Setting Up the System
You may use a Given approved power strip.
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 connecte d to a single
outlet or circuit do not exceed the rated limit for that circuit. If you are n ot 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:
Extra space is needed for air circulation and cable connectors behind the
Workstation.
Given Imaging Ltd.17
PillCam Platform
Warning
Caution
!
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
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 volt age, do no t connect the system .
Call the Given
Voltage mismatch will damage the Given Workstation.
Customer Support.
18Chapter 2
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