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Medtronic / Covidien Products / Capsule Endoscopy / PillCam™ Crohn’s System

PillCam™ Crohn’s Capsule

Product Details

The PillCam™ Crohn’s capsule enables direct visualization of the small bowel and colon with innovative imaging technology. The capsule features allow you to achieve comprehensive coverage for efficient disease management.

Order Information

Order Information
Order Code Description Unit of Measure Quantity
FGS-0661 PillCam™ Crohn’s Capsule Pack 5
FGS-0663 PillCam™ Crohn’s Capsule Pack 10

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
# of Optical Heads 2
Illumination 4 white light emitting diodes on each side
Field of View (per camera) 168° (Optical field of view from entrance pupil)
Effective Visibility Distance: 3cm
Min. Detectable Object At least 0.1 mm
Uplink Communications
Operating Frequency 434.1MHz
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
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
Bandwidth 3.2MHx @ 2.7 Mbps
  9.7MHz @ 8.1 Mbps
Storage Temperature 0-25° C
Downlink Communication
Operating Frequency 13.6 MHz
Receiver Bandwidth ± 150 kHz

PillCam™ Crohn’s and COLON 2 Sensor Belt

Product Details

Patients undergoing capsule endoscopy with the PillCam™ COLON 2 or PillCam™ Crohn’s system may wear the PillCam™ Crohn’s and 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.

Order Information

Order Information
Order Code Description Unit of Measure Quantity
FGS-0443 PillCam™ Crohn’s and COLON 2 Sensor Belt Each 1

Specifications
Front Dimensions
Dimensions 470mm x 100 x 12mm
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 alcohol wipes
Download Loop
Cable Length 1900 +/- 3 mm
Cleaning Method Wipe with alcohol wipes

PillCam™ Sensor Array

Product Details

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

Order Information

Order Information
Order Code Description Unit of Measure Quantity
FGS-0427 PillCam™ Sensor Array 2T, DR3 8-lead Each 1
FGS-0453 PillCam™ Sensor Sleeves Pack 10
FGS-0581 6” Disposable Sleeve Pack 10

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 Polyurethan, Teflon

PillCam™ Recorder 3

Product Details

The PillCam™ recorder 3 is a recording device worn by the patient during the capsule endoscopy procedure. Following the procedure, the physician downloads the images from the PillCam™ recorder 3 for interpretation.

Order Information

Order Information
Order Code Description Unit of Measure Quantity
FGS-0347 PillCam™ Recorder 3 (recorder only) Each 1
FGS-0583  PillCam™ Recorder 3 Cradle Kit Each 1
FGS-0554 PillCam™ DR3 Recorder Case Each 1
ASM-0355-01 PillCam™ Recorder 3 Pouch & Strap (accessories) Each 1

Specifications
Physical Properties
Software Proprietary firmware
Recording Capacity Up to 15 hours @ LCD OFF
Weight 500 g, including battery pack
Operational Power 3V - 4.2V DC, 0.33A - 0.79A
Battery Type Internal, Li-Ion, 3.7 V typical, 8000mAH
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

PillCam™ Patency Capsule

Product Details

The PillCam™ patency capsule is a dissolvable capsule that provides a simple and convenient way to verify adequate patency of the gastrointestinal tract prior to capsule endoscopy. In patients with known or suspected strictures, a PillCam™ patency capsule may be given to help physicians assess if capsule endoscopy is a good option.

Order Information

Order Information
Order Code Description Unit of Measure Quantity
FGS-0110 PillCam™ Patency Capsule Pack 5

Specifications
Physical Properties
Physical Dimensions Length: 26 mm

Diameter: 11 mm
Weight 3.3 gr +/- 0.2 gr
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 35-45◦C
Storage Conditions 0-25◦C, dry and out of direct sunlight

Overview

Visualize. Assess. Track Crohn’s disease over time.

The PillCam™ Crohn’s system is the only product that visualizes the small bowel and colonic mucosa directly and noninvasively — with one procedure.

That may mean greater clinical and economic efficiency for you, your patients, and your practice.

The PillCam™ Crohn's capsule gives you a 336-degree view via two camera heads (168° per head), which helps to visualize both the small bowel and colonic mucosa.([FOOTNOTE=User manual (DOC-2926-01). Page 220. August 2017.],[ANCHOR=],[LINK=])

Technology

Pan-intestinal imaging for a pan-intestinal disease

The PillCam™ Crohn’s system enables you to efficiently assess your patient’s Crohn’s disease and how well it is responding to treatment.

  • Exclusive Adaptive Frame Rate (AFR) technology, which adjusts the rate of image capture to 4 or 35 FPS, depending on the movement speed
  • The PillCam™ Crohn's capsule gives you a 336-degree view via two camera heads (168° per head), which helps to visualize both the small bowel and colonic mucosa
  • A predicate PillCam™ CE device has shown the ability to detect subtle mucosal lesions ([FOOTNOTE=Dionisio et al. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn’s disease: a meta-analysis. Am J Gastroenterol. 2010;105(6):1240-1248.
    ],[ANCHOR=],[LINK=])    ,([FOOTNOTE=Leighton et al. Capsule endoscopy is superior to small-bowel follow-through and equivalent to ileocolonoscopy in suspected Crohn’s disease. Clin Gastroenterol Hepatol. 2014;12(4):609-615.],[ANCHOR=],[LINK=]),([FOOTNOTE=Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Diagnostic Accuracy of Capsule Endoscopy for Small Bowel Crohn’s Disease is Superior to that of MR Enterography or CT Enterography. Clinical Gastroenterology and Hepatology. 2011;9:124-129.],[ANCHOR=],[LINK=])  and high diagnostic yield compared to SBFT,1,2 MRE in the proximal SB,3,([FOOTNOTE=Kopylov U, Yung DE, Engel T, Vijayan S, Har-Noy O, Katz L, et al. Diagnostic yield of capsule endoscopy versus magnetic resonance enterography and small bowel contrast ultrasound in the evaluation of small bowel Crohn’s disease: systematic review and meta-analysis. Dig Liver Dis. 2017 Aug;49(8):854-863.],[ANCHOR=],[LINK=]), ([FOOTNOTE=Greener T, Klangb E, Yablecovitcha D, et al. on behalf of the Israeli IBD Research Nucleus. The Impact of Magnetic Resonance Enterography and Capsule Endoscopy on the Re-classification of Disease in Patients with Known Crohn’s Disease: A Prospective Israeli IBD Research Nucleus (IIRN) Study. J Crohns Colitis. 2016 May;10(5):525-31.],[ANCHOR=],[LINK=]), ([FOOTNOTE=Böcker U, Dinter D, Litterer C, Hummel F, Knebel P, Franke A, Weiss C, Singer MV, Löhr JM. Comparison of magnetic resonance imaging and video capsule enteroscopy in diagnosing small-bowel pathology: localization-dependent diagnostic yield. Scand J Gastroenterol. 2010 Apr;45(4):490-500.],[ANCHOR=],[LINK=])  and CTE.1,3
  • Noninvasive procedure is well tolerated by patients([FOOTNOTE=Wiarda B, Stolk M, Heine D, Mensink P, Thieme M, Kuipers E, and Stoker J. Patient burden and patient preference: comparing MR enteroclysis, capsule endoscopy and balloon-assisted enteroscopy. Journal of Gastroenterology and Hepatology. 2012;1-30.],[ANCHOR=],[LINK=])
  • No sedation or radiation required
  • The PillCam™ Crohn’s system may reduce the number of invasive procedures, which may help to increase your patients’ satisfaction

Indications

Get indications, contraindications, and procedure risk information for the PillCam™ Crohn's capsule.

Learn More

Software Updates

Efficient Assessment of Disease Activity

Since disease activity doesn’t always correlate to how your patient feels,([FOOTNOTE=Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, et al. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn’s disease. Gastroenterol. 2010 Feb;138(2):463.468.
],[ANCHOR=],[LINK=]),([FOOTNOTE=Allez M, Lemann M, Bonnet J, Cattan P, Jian R, Modigliani R. Long term outcome of patients with active Crohn’s disease exhibiting extensive and deep ulcerations at colonoscopy. Am J Gastroenterol. 2002 Apr;97(4):947-953.],[ANCHOR=],[LINK=]) it’s important to directly visualize the disease progression or healing. The PillCam™ Crohn’s system enables you to efficiently assess your patient’s Crohn’s disease and how well it is responding to treatment. Here’s how:

  • Compare images and disease progression over time
  • Catalog prescriptions
  • See severity by location
  • Tailor your approach according to your patient’s specific disease state
  • Assess mucosal healing — a hallmark of Crohn’s disease remission

Available Software

Download the latest PillCam™ Crohn's system software

Click on a software version below for more details.

PillCam™ Software v9

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