PillCam Platform Setup and Maintenance Book 1 Aug 2010

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... 2 PillCam Video Capsule ... 2 Handling the PillCam Video Capsule ... 3 DataRecorders... 3 DataRecorder 2... 3 DataRecorder 2 Automatic Shutdown... 4 DataRecorder 2 LED Indications... 5 DataRecorder 2 Cradle ... 6 Cradle Connections... 6

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... 14 RecorderPouch ... 14 SB SensorBelt... 14 SensorArray ... 14 Given Workstation... 15 RAPID 7 Software... 16 Chapter 2

Setting Up the System ... 17 Setup Requirements ... 17 Given Workstation... 18 DataRecorder and Cradle ... 18 Storage Space for the PillCam Capsule Box ... 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.

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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 ... 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 ... 38 PillCam SB Capsule ... 39 PillCam SB 2 Capsule ... 40 PillCam ESO 2 Capsule ... 41 PillCam ESO 3 Capsule ... 42 PillCam COLON 2 Capsule ... 43 SensorArray DataRecorder 2 ... 44 SensorArray DataRecorder 3 ... 44 SB SensorBelt for DataRecorder 2 and DataRecorder 3 ... 45 DataRecorder 2 /2C ... 45 Cradle DataRecorder 2 ... 46 DataRecorder 3 ... 46 Cradle DataRecorder 3 ... 47 DC Power Supply ... 47 DataRecorder 3 Memory Card ... 47 RAPID Software ... 48 Guidance and Manufacturer's Declarations ... 48 PillCam Capsules (No PillCam COLON 2)... 48 PillCam COLON 2 Capsules ... 51 DataRecorder 2(C) ... 55 DataRecorder 3 ... 58 Chapter 6

Maintenance ... ...63 Charging DataRecorder ... 63 Disclaimer... 63 Important Safety Instructions... 63 Charging the DataRecorder ... 63 DataRecorder 2 ... 64 Manual Discharge of DataRecorder 2 ... 65 ii

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DataRecorder 3... 66 SensorBelt Cleaning... 67 SensorArray Cleaning ... 67 Chapter 7

Troubleshooting ... ... 69 RAPID Video... 69 Saving and Opening Video ... 69 SensorArray ... 69 Printer ... 70 CD/DVD ... 70 RAPID Software... 70 Capsule... 70 Given Workstation... 70 Cradle ... 71 DataRecorder... 71 Low Signal ... 72

Index ... 73

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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.

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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.

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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

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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.

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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%

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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.

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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

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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 .

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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.

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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

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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

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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.

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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.

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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

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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.

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