RFI Attachment 3_Flexible Bronchoscopes Device Specification.xlsx
XLSX spreadsheet 34 KB Posted
- Attached to
- Request for Information Fiber Bronchoscope
- Solicitation number
- W81K0425Q1935
- Issued by
-
Department of the Army Medical Command
About this file
This file is a device specification template for flexible bronchoscopes, attached to a Request for Information (RFI) from the Department of the Army Medical Command. The specification template covers three categories of bronchoscopes: Flexible Fiberoptic (reusable), Flexible Video (reusable), and Single-Use Video bronchoscopes.
The template requests detailed technical specifications including FDA clearance information, TAA compliance, patient population, insertion tube dimensions, working channel specifications, optical characteristics, tip deflection ranges, compatibility with cameras and light sources, reprocessing requirements, and humidity operating ranges. Vendors are required to provide pricing information including list price, government/ECAT pricing, and warranty terms. While this is primarily a data collection template, it indicates the Army Medical Command's interest in procuring bronchoscopes that meet specific clinical and technical requirements, with emphasis on regulatory compliance and equipment compatibility.
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Text version
Fiber Optic-Bronchoscopes Flexible Fiberoptic Bronchoscopes (Reusable)
| Manufacturer | |
| Model | |
| WHERE MARKETED | |
| COUNTRY OF ORIGIN | |
| Website | |
| Point of Contact (Name, Address, Email, Phone) | |
| FDA CLEARANCE | |
| CE MARK | |
| TAA Compliant | |
| FDA - Pre Market 510(k) | |
| FDA Regulation Number | |
| FDA Product Code | |
| Patient Population | |
| Scope Type | |
| Technology / Visualization Type | |
| INSERTION TUBE | |
| Working Length, mm |
ECRI.Infrastructure.Services.HPCS: The length of the insertion tube from the distal tip to the proximal housing.
| Outer diameter, mm | |
| Graduation marks, cm | |
| WORKING CHANNELS | |
| Diameter, mm (min. 2 mm) | |
| OPTICS | |
| High-Definition Image | |
| Field of view, degrees | |
| Depth of field, mm | |
| TIP DEFLECTION RANGE, degrees |
ECRI.Infrastructure.Services.HPCS: The range of angulation of the distal tip of the bronchoscope. Maximum deflection angle can be used for viewing or photography; however, some biopsy instruments cannot be inserted during full tip deflection due to the tight instrument channel curvature.
| DISTAL TIP | |
| Diameter, mm | |
| UMBILICAL CORD | |
| Length, mm |
ECRI.Infrastructure.Services.HPCS: The length of the cable assembly leading from the bronchoscope to the light source.
| Aspiration | |
| COMPATIBLE EQUIPMENT | |
| Compatible cameras |
ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
Compatible light sources ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
| Light source Power |
| Compatible video processors |
ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
| IMMERSIBLE |
| RECOMMENDED REPROCESSING |
ECRI.Infrastructure.Services.HPCS: The instrument cleaning method recommended by the manufacturer. Endoscopes that can be reprocessed easily and quickly using various methods are preferred over endoscopes that are restricted to only one method.
| ECRI.Infrastructure.Services.HPCS: The range of angulation of the distal tip of the bronchoscope. Maximum deflection angle can be used for viewing or photography; however, some biopsy instruments cannot be inserted during full tip deflection due to the tight instrument channel curvature. | RELATIVE HUMIDITY RANGE | |
| Operation | ||
| Storage | ||
| PURCHASE INFORMATION | ||
| List price |
ECRI.Infrastructure.Services.HPCS: Indicates the list price or price range of the model. List prices do not reflect customization, group purchasing or other manufacturer agreements, or other discounts. ECRI believes that although list prices enhance equipment planning projects, they should not be the sole consideration when making a purchase decision.
| ECRI.Infrastructure.Services.HPCS: The length of the cable assembly leading from the bronchoscope to the light source. | GOVT/ECAT Price | |
| Warranty |
Video-Bronchoscope Flexible Video Bronchoscopes (Reusable)
| Manufacturer | |
| Model | |
| WHERE MARKETED | |
| COUNTRY OF ORIGIN | |
| Website | |
| Point of Contact (Name, Address, Email, Phone) | |
| FDA CLEARANCE | |
| CE MARK | |
| TAA Compliant | |
| FDA - Pre Market 510(k) | |
| FDA Regulation Number | |
| FDA Product Code | |
| Patient Population | |
| Scope Type | |
| Technology / visualization type | |
| INSERTION TUBE | |
| Length, mm |
ECRI.Infrastructure.Services.HPCS: The length of the insertion tube from the distal tip to the proximal housing.
| Outer diameter, mm | |
| Graduation marks, cm | |
| WORKING CHANNELS | |
| Diameter, mm | |
| OPTICS | |
| Enhancements | |
| Field of view, degrees | |
| Depth of field, mm | |
| TIP DEFLECTION RANGE, degrees |
ECRI.Infrastructure.Services.HPCS: The range of angulation of the distal tip of the bronchoscope. Maximum deflection angle can be used for viewing or photography; however, some biopsy instruments cannot be inserted during full tip deflection due to the tight instrument channel curvature.
| DISTAL TIP | |
| Diameter, mm | |
| UMBILICAL CORD | |
| Length, mm |
ECRI.Infrastructure.Services.HPCS: The length of the cable assembly leading from the bronchoscope to the light source.
| Aspiration | |
| COMPATIBLE EQUIPMENT | |
| Compatible Cameras |
ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
| Image Enhancements |
| Compatible light sources |
ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
Compatible video processors ECRI.Infrastructure.Services.HPCS: Not all bronchoscopes are compatible with every light source or camera system. In order to avoid the need to purchase new equipment or adaptors, ECRI recommends that facilities confirm compatibility before purchase.
| IMMERSIBLE |
| RECOMMENDED REPROCESSING |
ECRI.Infrastructure.Services.HPCS: The instrument cleaning method recommended by the manufacturer. Endoscopes that can be reprocessed easily and quickly using various methods are preferred over endoscopes that are restricted to only one method.
| ECRI.Infrastructure.Services.HPCS: The range of angulation of the distal tip of the bronchoscope. Maximum deflection angle can be used for viewing or photography; however, some biopsy instruments cannot be inserted during full tip deflection due to the tight instrument channel curvature. | RELATIVE HUMIDITY RANGE | |
| Operation | ||
| Storage | ||
| PURCHASE INFORMATION | ||
| List price |
ECRI.Infrastructure.Services.HPCS: Indicates the list price or price range of the model. List prices do not reflect customization, group purchasing or other manufacturer agreements, or other discounts. ECRI believes that although list prices enhance equipment planning projects, they should not be the sole consideration when making a purchase decision.
| ECRI.Infrastructure.Services.HPCS: The length of the cable assembly leading from the bronchoscope to the light source. | GOVT/ECAT Price | |
| Warranty | ||
| OTHER SPECIFICATIONS |
Single Use Video-Bronchoscope
| Single-Use Bronchoscopes with Video Display |
| Manufacturer |
| Model |
| Website |
| Country of Origin |
| Manufacturing Origin |
| Point of Contact (Name, Address, Email, Phone) |
| TAA Compliant |
| FDA 510(k) Clearance |
| FDA - Pre Market 510(k) |
| FDA Regulation Number |
| FDA Product Code |
| Patient Population |
| Scope Type |
| Technology/Visualization Type |
| High-Definition Image |
| Angle of View, degrees |
| Field of View, degrees |
| Focal Range, mm |
| Insertion Tube Diameter, mm |
| Working Length, mm |
| Working Channels |
| Working Channel Diameter, mm |
| Distal Tip Diameter, mm |
| Deflection Up/Down, degrees |
| Image Enhancement Features |
| Compatible Video Processors |
| Method of Sterilization |
| IMMERSIBLE |
| Packaging Unit |
| List price |
| GOVT/ECAT Price |
| Warranty |
| Shelf Life |
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