Salient Characteristics.pdf
PDF 177 KB Posted
- Attached to
- PillCam DR3 Capsule Endoscopy System
- Solicitation number
- 36C26126Q0877
About this file
This document is a Brand Name Only ("Salient Characteristics") specification for a medical device procurement, specifically for the PillCam DR3 capsule endoscopy system manufactured by Medtronic.
The specification establishes essential and significant physical, functional, and performance characteristics required for the capsule endoscopy device. Key requirements include compatibility with National VA standards for capsule endoscopy systems and associated data recorders, workstations, and accessories. The device must weigh 500 grams including battery pack and provide up to 15 hours of recording capacity with the LCD display off. Technical specifications include operational power of 3V–4.2V DC at 0.33A–0.79A, an internal Li-ion battery rated at 3.7V typical with 8,000 mAh capacity, and operating temperature range of 0–40°C with storage temperature range of 0–55°C. Additional environmental specifications include storage and operating humidity up to 85%, storage and operating pressure of 790–520 mmHg, receiver operating frequency of 434.1 MHz with 10 MHz bandwidth, transmitter operating frequency of 13.6 MHz (ISM Band), Linear Chirp modulation type, and effective radiated power of -27.4 dBm. The device is intended to provide a non-invasive solution for visualizing the gastrointestinal tract to enable detection, diagnosis, and monitoring of GI conditions including Crohn's disease, polyps, bleeding, and other abnormalities without requiring sedation or traditional endoscopic procedures.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| 36C26126Q0877.pdf | ||
| P03 JOFOC Brand Name Only Redacted.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Brand Name Only (“Salient Characteristics”)
Brand Name Only Item: PillCam DR3
1) Medtronic
2) Essential/significant physical, functional, or performance characteristics.
a) Compatibility – The product is compatible with National VA standards for capsule endoscopy systems, including associated data recorders, workstations, and accessories.
b) Dimensions-Not in IFU
c) Weight – 500g including battery pack
d) Industry Standard – The industry standard should include the following characteristics for Endoscopy:
i) Recording Capacity: Up to 15 hours @ LCD OFF
ii) Operational Power: 3V – 4.2V DC, 0.33A – 0.79A
iii) Battery Type: Internal, Li-ion, 3.7V typical, 8,000 mAh
iv) Operating Temperature: 0–40°C
v) Storage Temperature: 0–55°C
vi) Storage & Operating Humidity: Up to 85%
vii) Storage & Operating Pressure: 790–520 mmHg
viii) Receiver Operating Frequency: 434.1 MHz
ix) Receiver Bandwidth: 10 MHz
x) Transmitter Operating Frequency: 13.6 MHz (ISM Band)
xi) Modulation Type: Linear Chirp (Digital data)
i) Effective Radiated Power: -27.4 dBm
b) Purpose – To provide a non-invasive capsule endoscopy solution for visualizing the gastrointestinal tract, enabling the detection, diagnosis, and monitoring of GI conditions and diseases, including Crohn's disease, polyps, bleeding, and other abnormalities, without the need for sedation or traditional endoscopic procedures..
c) Governing Body or Organization –N/A
Complete generic identification – Generic cautery unit identification:
i) Recording Capacity: Up to 15 hours @ LCD OFF
ii) Operational Power: 3V – 4.2V DC, 0.33A – 0.79A
iii) Battery Type: Internal, Li-ion, 3.7V typical, 8,000 mAh
iv) Operating Temperature: 0–40°C
v) Storage Temperature: 0–55°C
vi) Storage & Operating Humidity: Up to 85%
vii) Storage & Operating Pressure: 790–520 mmHg
viii) Receiver Operating Frequency: 434.1 MHz
ix) Receiver Bandwidth: 10 MHz
x) Transmitter Operating Frequency: 13.6 MHz (ISM Band)
xi) Modulation Type: Linear Chirp (Digital data)
xii) Effective Radiated Power: -27.4 dBm
Brand Name Only (“Salient Characteristics”)
2) Applicable model/make/catalog number – PillCam DR3
3) Manufacturer name – Medtronic
File details come from the government source that posted it. Updated .