Endoscopy systems

PillCam™ COLON 2 system

<p>The PillCam™ COLON 2 system is a colon exam in a capsule. Perform a capsule endoscopy procedure, record images, and interpret the results with this system.</p>

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Indications, Safety, and WarningsIndications

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 informationThe 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.

Features

Incomplete colonoscopies happen, but there’s another option — the PillCam™ COLON 2 system.

Incomplete optical colonoscopies occur in 4–25%⁴ of screening patients, often requiring an out-of-practice referral for CT colonography (CTC).

The PillCam™ COLON 2 capsule provides a potential solution for patients who need another option after an incomplete colonoscopy, allowing a complete examination in up to 97% of patients.⁵

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Minimally invasive
visualization^1,2

Patient-friendly experience
without radiation^3,4

High-diagnostic yield
compared to CTC⁶

Explore the PillCam™ COLON 2 system components.

PillCam™ COLON 2 capsule

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

Indications, Safety, and WarningsIndications

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.

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

PillCam™ recorder 3

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.

Indications, Safety, and WarningsIndications

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.

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

PillCam™ COLON 2 sensor belt

The PillCam™ COLON 2 sensor belt is worn around the patient's waist over a single layer of clothing and can be adjusted to achieve the most comfortable fit.

Indications, Safety, and WarningsIndications

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.

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

PillCam™ COLON 2 sensor array

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

Indications, Safety, and WarningsIndications

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.

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

PillCam™ software v9

PillCam™ software v9 is the advanced capsule endoscopy software suite that helps you review PillCam™ studies efficiently, wherever you are.

Indications, Safety, and WarningsIndications

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.

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

PillCam™ capsule endoscopy software v9

Top 100

See the most clinically relevant study images to help you identify pathologies.

Note: The top 100 features are not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire video.

Image atlas
Compare pathologies for a confident diagnosis.

PillCam™ COLON 2 system is compatible with PillCam™ software generations 8.3 and newer. This allows you to interpret PillCam™ COLON 2 studies using the same interface and tools you’ve become accustomed to with PillCam™ small bowel capsules.

Improved GI map

Improved GI mapping provides a graphical representation of the progress of the capsule through the small bowel and colon. This feature is available with both the PillCam™ sensor array and belt.

PillCam™ capsule endoscopy technology

Optimize tissue coverage with innovative technology.

An adaptive frame rate technology optimizes tissue coverage.
Capsule image rate changes from 4 fps to 35 fps when the system detects a change in the image or when the capsule is in motion.³
Extra wide 172-degree angle of view (344 degrees total) allows for nearly 360-degree coverage of the colon.⁴
The capsule transmits images to a recorder that connects to a belt or sensor array the patient wears, ensuring reliable, accurate data collection.¹

Full reading training is available with the technology.

Did you know?

The PillCam™ COLON 2 capsule has a Category I CPT code established. Ask your account manager about CPT code 91113 for direct visualization of the colonic mucosa.

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Ordering information

Item number	Description	Quantity
FGS-0520	PillCam™ COLON 2 capsule	1
FGS-521	PillCam™ COLON 2 capsule	5
FGS-522	PillCam™ COLON 2 capsule	10
FGS-0667	PillCam™ patency capsule	1
FGS-0668	PillCam™ patency capsule	5
400100102	PillCam™ recorder 3 kit (includes cradle and pouch)	1
FGS-0554	PillCam™ DR3 recorder case	1
FGS-0347	PillCam™ recorder 3 (recorder only)	1
ASM-0355-01	PillCam™ recorder 3 pouch and strap (accessories)	1