PillCam™ SB 3 Capsule

Long Description:

A camera inside a capsule that captures images at a frame rate of 2 to 6 frames per second (fps) based on capsule speed as it travels through the small bowel.

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Specifications

Specifications:
Physical Properties

Dimensions

Length: 26.2 mm

Diameter: 11.4 mm

Weight 3.0 g
Material Biocompatible plastic
Optical Properties
Illumination 4 white light emitting diodes on each side
Field of View 156° ISO-8600-3
Effective Visibility

156° (Optical field of view at 4.5 mm from

top cover per ISO-8600-3)

136° (Optical field of view from entrance

pupil per FDA Method)

Min. Detectable Object At least 0.07 mm
Frequency 434.1 MHz
Modulation MSK
ERP [nW] -20
Operational Properties
Frame Rate 2 fps or 2–6 fps
Operating Time  ≥ 8 hours
Chemical Safety Resistant to dissolution in pH=2 to pH=8
Battery Type Silver Oxide batteries, Mercury-free
Operating Temperature 20–40°C
Storage Temperature 0–25°C
Downlink Communications
Operating Frequency 13.6 MHz
Receiver Bandwidth +/- 150 kHz

 

Order Information
Order Code Product Description Ordering Quantity
FGS-0502 PillCam™ SB 3 Capsule 5 pack
FGS-0500 PillCam™ SB 3 Capsule 10 pack
FGS-0498 PillCam™ SB 3-EX Capsule 5 pack
FGS-0499 PillCam™ SB 3-EX Capsule 10 pack

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PillCam™ SB 3 Sensor Belt

Long Description:

Patients undergoing capsule endoscopy with the PillCam™ SB 3 system may wear the sensor belt to receive transmission data from PillCam™ SB 3 capsule.  The belt is worn around the patient’s waist over a single layer of clothing and can be adjusted to achieve the most comfortable fit.

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Specifications

Specifications:
Order Information
Order Code Product Description Ordering Quantity
FGS-0568 PillCam™ Sensor Belt  2 each
FGS-0510 PillCam™ Sensor Belt Disposable Kit 5 pack
FGS-0509 PillCam™ Sensor Belt Cover 1 each

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PillCam™ SB 3 Sensor Array

Long Description:

The PillCam™ SB 3 sensor array features an 8-lead sensor, which is placed on the patient’s body to receive transmission data from the PillCam™ SB 3 capsule.

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Specifications

Specifications:
Reception Antenna
# of Sensor Elements

8 sensors

Sensor Size Diameter: 40 mm
Material  Polyurethane, Teflon
Antennas Wire Material Coax wire
Transmission Antenna
Antenna Structure Loop antenna
Size 1.9 m
Color Black
Material Polyurethane, Teflon

 

Order Information
Order Code Product Description Ordering Quantity
FGS-0569 PillCam™ Sensor Array 2T, DR3 8-lead 1 each
FGS-0453 PillCam™ Sensor Sleeves 10 pack
FGS-0581 6” Disposable Velcro Sleeve 10 pack

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PillCam™ Recorder 3

Long Description:

The PillCam™ recorder 3 is a recording device with a built in real-time viewer, which is worn by the patient during the PillCam™ procedure. Following the procedure, the physician downloads the images from the PillCam™ recorder 3 for interpretation.

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Specifications

Specifications:
Physical Properties
Software Proprietary firmware
Recording Capacity Up to 15 hours @ LCD OFF
Weight 500 g, including battery pack
Operational Power 3.5–4.2 V DC, 0.15–0.5 A
Battery Type

Internal, Li-Ion, 3.8 V typical,

8800 mAH

Operating Temperature 0–40°C
Storage Temperature 0–55°C
Storage and Operating Humidity Up to 85%
Storage and Operating Pressure 790–520 mmHg
Receiver (Rx)
Operating Frequency 434.1 MHz
Transmitter
Operating Frequency 13.6 MHz
Frequency Band ISM
Modulation Type Linear Chirp
Type of Modulated Signal  Digital data
Effective Radiated Power  -27.4 dBm

 

Order Information
Order Code Product Description Ordering Quantity
400100102 PillCam™ Recorder 3 Kit (includes cradle & pouch) 1 each
FGS-0554 PillCam™ DR3 Recorder Case 1 each
FGS-0347 PillCam™ Recorder 3 (recorder only) 1 each
ASM-0355-01 PillCam™ Recorder 3 Pouch & Strap (accessories) 1 each

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RAPID™ Software v8.3

Long Description:

RAPID™ software v8.3 provides advanced software algorithms to support an efficient review of PillCam™ SB, PillCam™ UGI, and PillCam™ COLON 2 studies. It can help reduce the time you need to review and interpret studies, which supports a more timely diagnosis and helps you move patients closer to effective treatment.

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Specifications

Specifications:
General Characteristics
Software

RAPID™ software, version 8.3

Languages

English/French/German/Italian/Spanish/Portuguese/Dutch/Swedish/

Finnish/Danish/Chinese-Mandarin/Korean/Russian/Greek

Data Export

JPEG Images, (MPEG) Video clips, grml (Given proprietary) files,

PDF 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

Single, Dual, Quad, Mosaic, and Collage view, dual-head view 

(ESO/UGI and COLON)

Run Modes

View, Automatic, QuickView, SBI

 

Order Information

Order Code Product Description Ordering Quantity
400100117 RAPID™ Software Kit, v8.3 1 item

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PillCam™ Patency Capsule

Long Description:

Device used to verify an unobstructed small bowel prior to capsule endoscopy.

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Specifications

Specifications:
Physical Properties

Physical Dimensions

Length: 26 mm

Diameter: 11 mm

Weight 3.3gr +/- 0.2gr
Material Biocompatible, food grade (mostly dissolving) components:
Coating Parylene C
Body

Lactose anhydrous

Barium sulphate

Magnesium Stearate

Citric acid

Sodium bicarbonate

Plug

Lactose anhydrous

Avicel PH 200

Compritol 888

PVP K-90

Operating Time (period) ≤ 4 days
Shelf Life 12 months
Operating Temperature

35-45C

Storage Conditions 0-25C, dry and out of direct sunlight

 

Order Information
Order Code Product Description Ordering Quantity
FGS-0110 PillCam™ Patency Capsule 5 pack

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PillCam™ SB 3 Small Sensor Array

Long Description:

A smaller version of the sensor array, which is ideal for pediatric or smaller patients.

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Specifications

Specifications:
Physical Properties
Software Proprietary firmware
Recording Capacity Up to 15 hours @ LCD OFF
Weight 500 g, including battery pack
Operational Power 3.5–4.2 V DC, 0.15–0.5 A
Battery Type

Internal, Li-Ion, 3.8 V typical,

8800 mAH

Operating Temperature 0–40°C
Storage Temperature 0–55°C
Storage and Operating Humidity Up to 85%
Storage and Operating Pressure 790–520 mmHg
Receiver (Rx)
Operating Frequency 434.1 MHz

Bandwidth of the

Receiving Section in this Band

10 MHz
Transmitter
Operating Frequency 13.6 MHz
Frequency Band ISM
Modulation Type Linear chirp
Type of Modulated Signal Digital data
Effective Radiated Power -27.4 dBm

 

Order Information
Order Code Product Description Ordering Quantity
FGS-0567 PillCam™ Pediatric Sensor Array, 8-Lead 1 each
FGS-0453 PillCam™ Sensor Sleeves 10 pack
FGS-0581 6” Disposable Velcro Sleeve 10 pack

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Overview:

More Detail. More Efficiency. More Confidence to Treat Your Patients.*([FOOTNOTE=Indications for use in the RAPID™ Software v8.3 user manual, pages 227-228.],[ANCHOR=],[LINK=]),([FOOTNOTE=RD-30 PillCam™ SB 3 system. Data on file, January 15, 2013.],[ANCHOR=],[LINK=]),([FOOTNOTE=RD-304 Clinical Validation Study comparing PillCam™ SB 3 system to PillCam™ SB 2 system, 2012. Data on file, January 24, 2013.],[ANCHOR=],[LINK=])

The PillCam™ SB 3 system allows for direct visualization of the small bowel, supporting greater confidence when monitoring lesions3 that may be related to Crohn’s disease, obscure bleeding, or iron deficiency anemia. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa.

This system includes innovative features like adaptive frame rate technology, which supports image acquisition that is uniquely suited to each patient's motility, as well as the tools you need to record and interpret study results. The software contains our most advanced algorithms, providing you with the tools you need to efficiently read and interpret study results.

Technology:

Adaptive Frame Rate Technology

The PillCam™ SB 3 system optimizes tissue coverage with the most advanced capsule endoscopy technology.

  • Capture image rate changes from 2 to 6 fps when the system determines the capsule is moving more quickly.
  • Increased frame rate flexibility maximizes mucosa coverage and supports tissue acquisition that is uniquely suited to each patient’s motility.
  • High-quality imaging supports greater diagnostic confidence—In one survey, 100% of GIs ranked the image sharpness, natural tissue colors, balanced illumination, and overall image quality provided by the PillCam™ SB 3 system higher than that of the previous generation.3
  • Proprietary software algorithms enable smarter video compilation that is 40% more efficient than the PillCam™ SB 2 system.2

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PillCam™ SB 3 Indications for Use

  • The PillCam™ SB 3 capsule is intended for visualization of the small bowel mucosa and:
    • May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
    • May be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
    • May be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
  • The PillCam™ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
  • The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Contraindications

  • Contraindications for PillCam™  SB 3 capsule include:
    • Patients with known or suspected GI obstructions, strictures or fistulas based on the clinical picture or pre-procedure testing and profile.
    • Patients with cardiac pacemakers or other implanted electromedical devices.
    • Patients with swallowing disorders.

Procedure Risk Information

  • The risks of PillCam™ SB 3 capsule include capsule retention, aspiration, and skin irritation.
  • Endoscopic placement may present additional risks.
  • Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
  • After ingesting the PillCam™ SB 3 capsule, and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.
  • Please refer to the product user manual for detailed information.

 

PillCam™ Patency Capsule Indications for Use

  • The PillCam™ patency capsule is an accessory to the PillCam™ capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ capsule in patients with known or suspected strictures.

Contraindications

  • Contraindications for the PillCam™ patency capsule include:
    • Patients with swallowing disorders.

Procedure Risk Information

  • The risks of the PillCam™ patency capsule include capsule retention and aspiration.
  • Endoscopic placement may present additional risks.
  • Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
  • After ingesting the PillCam™ patency capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.
  • Passage of an intact patency capsule does not preclude the presence of an intestinal stricture or other pathology.
  • Please refer to the product user manual for detailed information.

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Software Updates

Download the latest PillCam™ system software by completing the appropriate form from the link below:

RAPIDTM READER SOFTWARE v8.3

RAPIDTM READER SOFTWARE v8.0

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Resources

PillCam™ SB 3 Product Brochure

A detailed summary of PillCam™ SB 3.

View Brochure

RAPID™ Software v8.3 User Manual

Learn how to use RAPID™ Software v8.3.

View Manual

RAPID™ Software v8.3 IT Guide

Learn more about RAPID™ Software v8.3 IT specifications and details.

View Guide

RAPID™ Software Reader Help & Document Disc

The document disc includes all of the resources from the original disc when the software was purchased including print-ready patient instructions. This executible file is for v8.3 & v8.

Download File

Reading a PillCam™ SB 3 Study in RAPID™ Software: Quick Reference Guide   

Highlights for reading a PillCam™ SB 3 study in RAPID™ software.

View Guide

Patient Instructions for Your PillCam™ SB 3 Procedure with Sensor Belt

Detailed information about the PillCam™ SB 3 procedure with sensor belt.

View Guide

Patient Instructions for Your PillCam™ SB 3 Procedure with Sensor Array

Detailed information about the PillCam™ SB 3 procedure with sensor array.

View Guide

Upgrading RAPID™ Software

Designed to familiarize users of RAPID™ for PillCam™ software versions 6 and 7 with the differences in version 8. The video covers the new layout and additional functions of the upgraded software.

Watch Video

RAPID™ Software Overview

A general overview for new users of RAPID™ software v8. 

Watch Video

Patient Check-in for PillCam™ SB 3 System Procedure

The video demonstrates how to check-in a patient for a PillCam™ SB 3 procedure using RAPID™ software v8 prior to the patient ingesting the PillCam™ capsule. 

Watch Video

Downloading & Creating a PillCam™ Video

The video describes three different options to download a study from the PillCam™ recorder, including single-step, transferring the raw data, and compiling the study at a later time, and compiling a study from a removable storage device.

Watch Video

Managing PillCam™ Studies

Learn the functionality for managing studies in RAPID™ software v8. 

Watch Video

Previewing & Reviewing a PillCam™ SB 3 System Study

View the recommended procedure for you to preview and review a PillCam™ SB 3 system study. The video walks you through the process of previewing, including setting landmarks and capturing thumbnails. Additionally, the video demonstrates the different review modes and how to create thumbnails, comments, and annotations for inclusion in a report.

Watch Video

RAPID™ Software Settings

Learn how to configure the settings for RAPID™ software v8. The video provides all the information needed to configure RAPID™ software for your organization prior to first use, and for making changes to settings in general. Settings allow you to change your logo and organization name for reports, default directories, languages, templates and physician names, and enable or disable features.

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Creating a Report in RAPID™ Software

Learn how to create a report using RAPID™ software v8, after previewing and reviewing the study. The video demonstrates how to select and annotate thumbnails, use the Atlas, and create a Lewis Score. It then shows the different ways a report can be created and sent to others.

Watch Video

Creating and Annotating Thumbnails in RAPID™ Software

This video teaches RAPID™ software v8 users how to capture thumbnails and add comments, markings and annotations. In addition, the video trains the user to use the thumbnail functions and shows the main options available when using this software feature in View and Report modes.

Watch Video

RAPID™ Software v8.0 User Manual

Learn how to use RAPID™ Software v8.0

View Manual

RAPID™ Software v8.0 IT Guide

Learn more about RAPID™ Software v8.0 IT specifications and details

View Guide

PillCam™ Recorder DR3 Simulator

The interactive PillCam™ recorder DR3 simulator allows you to train your patients on how to use the recorder before they leave your office. The simulator is a tool that can assist the healthcare provider in instructing the patient on how to interact with alerts and messages from the recorder.

View Simulator