PillCam™ COLON 2 Capsule

Long Description:

PillCam™ COLON 2 capsule is a camera within a capsule that captures images as it travels through the colon.

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Specifications

Specifications:
Physical Properties
Dimensions

Length: 32.3 mm+0.5 mm

Diameter: 11.6 mm

Weight 2.9 g + 0.1 g
Material Biocompatible plastic
Optical Properties
Number of Heads 2
Illumination 4 white light emitting diodes on each side
Field of View 172° ISO-8600-3
Effective visibility Distance: 3 cm
Min. detectable object At least 0.1 mm
Operational Properties
Operating Time  Minimum of 10 hours
Chemical Safety Resistant to dissolution in pH=2 to pH=8
Battery Type Silver Oxide batteries
Operating Temperature 20–40°C
Storage Temperature 0–25°C
Uplink Communications
Operating Frequency 434.1 MHz
Frame Rate 4–35 fps

Data Rate 

 

2.7 Mbps and 8.1 Mbps

Modulation Type 

MSK/Digital data

 

Effective Radiated Power  -44.56 dBm
Downlink Communications
Operating Frequency 13.6 MHz
Receiver Bandwidth +/- 150 kHz

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PillCam™ COLON 2 Sensor Belt

Long Description:

Patients undergoing capsule endoscopy with the PillCam™ COLON 2 system may wear the PillCam™ COLON 2 sensor belt.  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:
Front Sensor
Dimensions

470 mm x 100 x 12 mm

Insert Material PORON (Rogers comp), Kapton (Dupont) and Polypropylene
Number of Sensors 4
Cleaning Method Wipe with alcohol wipes
Back Sensor
Dimensions 254 mm x 178 x 12mm
Insert Material PORON (Rogers comp), Kapton (Dupont)
Number of Sensors 2
Cleaning Method Wipe with alchohol wipes
Download Loop
Cable Length 1900 +/- 3 mm
Cleaning Method
Wipe with alchohol wipes

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PillCam™ COLON 2 Sensor Array

Long Description:

The PillCam™ COLON 2 sensor array features an 8-lead sensor, which is placed on the patient’s body to receive transmision data from the PillCam™ COLON 2 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

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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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Overview:

A Colon Exam in a Capsule

Achieve direct visualization of the colon with the PillCam™ COLON 2 system. This innovative capsule endoscopy solution provides clear images of the colon to support detection of polyps with a noninvasive, patient-friendly device.

With innovative features like adaptive frame rate technology, advanced optics, and an extra-wide angle of view, this system has proven accuracy for detecting colon polyps.([FOOTNOTE=Eliakim R, Yassin K, Niv Y, Metzger J, Lachter J, Gal E, et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy. Endoscopy. 2009 Dec;41(12):1026-31.],[ANCHOR=],[LINK=]),([FOOTNOTE=Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, et al. Second Generation PillCam™ COLON Capsule Compared with Colonoscopy. Gastrointest Endosc. 2011;74(3):581-589.],[ANCHOR=],[LINK=]),([FOOTNOTE=User Manual (DOC-2044-02, March 2013), page 19.],[ANCHOR=],[LINK=])  The PillCam™ COLON 2 system includes everything you need to perform a capsule endoscopy procedure, record images and interpret the results.

Technology:

Optimize Tissue Coverage with Innovative Technology

Adaptive frame rate technology optimizes tissue coverage, giving you greater confidence in the exam.

  • Capsule image rate changes from 4fps to 35fps when the system detects a change in the image, or when the capsule is in motion
  • Increased frame rate flexibility maximizes mucosa coverage and optimizes video length while also conserving battery energy
  • Advanced optics supported by three lenses
  • Extra wide 172° angle of view (344° total) allows for maximum tissue coverage
  • Capsule transmits images to a recorder that the patient wears on a belt, ensuring reliable, accurate data collection

Includes full reading training to facilitate ease-of-use and ensure your proficiency with the technology.

Indications for Use

  • The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.
  • It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.
  • In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Contraindications

  • Patients with known or suspected GI obstruction, strictures or fistulas based on the clinical picture or pre-procedure testing and profile.
  • Patients with cardiac pacemakers or other implanted electro-medical devices.
  • Patients with swallowing disorders.
  • In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use.

Procedure Risk Information

  • The risks of PillCam™ COLON 2 capsule include capsule retention, aspiration and skin irritation.
  • The risks associated with colon preparation are allergies or other known contraindications to any preparation agents or medications used for the PillCam™ COLON 2 regimen, according to laxative medication labeling and per physician discretion.
  • Medical, endoscopic or surgical intervention may be necessary to address any of these complications, should they occur.
  • After ingesting the PillCam™ COLON 2 capsule and until it is excreted, the patient 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.

Software Updates

Download the latest PillCam™ COLON 2 system software by completing the appropriate form on the next page

RAPIDTM READER SOFTWARE v8.3

RAPIDTM READER SOFTWARE v8.0