Salient Characteristics -.docx
DOCX document 26 KB Posted
- Attached to
- SiteRite 9 Ultrasound System with Accessories
- Solicitation number
- 36C26126Q1262
About this file
This document is a Salient Characteristics specification for a medical equipment procurement. The Fresno VA Medical Center's PACU department requires the SiteRite 9 Ultrasound System (Part # 9770800) manufactured by BD/Becton, Dickinson and Company to replace an end-of-life cardiovascular access ultrasound system. The procurement includes the ultrasound system, SiteRite 9 Ultrasound Cue Magnetizer (9770811), SiteRite 9 Ultrasound System Cue Linear Probe (9770803), Sherlock 3CG Tip Confirmation Sensor (9770358), and Medical Equipment Roll Stand (9770206). The system must be fully compatible with the facility's existing Sherlock 3CG Tip Confirmation System workflow and capable of providing real-time imaging for accurate PICC line and central catheter placement at the bedside.
The salient characteristics emphasize that the equipment must maintain compatibility with BD/Bard proprietary systems and components, feature a 15.6-inch touchscreen console, meet FDA Class II medical device approval standards, comply with ISO quality management processes, and adhere to OSHA and Joint Commission guidelines. The primary purpose is to enable clinicians to safely visualize veins during catheter placement while the magnetic tracking system confirms proper catheter tip positioning near the heart, thereby improving accuracy, reducing complications, and minimizing the need for follow-up X-rays. The certification confirms these salient characteristics are essential to government requirements and the restrictions will not limit acquisition to a single manufacturer.
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Other files
| File | Type | Posted |
|---|---|---|
| RFQ-36C26126Q1262.pdf | ||
| P03_LSJ PART 12 SSJ-AP 4480_CO Signed_Redacted.pdf |
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Text version
Product Salient Characteristics or Equal To 9/4/2026
Model /Part No.: SiteRite™ 9 Ultrasound System (9770800) Manufacturers: BD/Bard Becton, Dickinson and Company Essential/significant physical, functional, or performance characteristics.
a) Compatibility – The Sherlock 3CG system is designed to work only with specific equipment made by the same manufacturer, BD/Bard. It is fully compatible with the SiteRite Ultrasound system, which provides the imaging needed during catheter placement. The Sherlock 3CG technology also works with the required magnetizer and linear ultrasound probe, which allow the system to track the tip of the catheter in real time. These components are all designed to function together as one integrated system. Because the Sherlock 3CG uses proprietary software and sensors, it is not compatible with other brands of ultrasound machines or third‑party accessories, and only BD/Bard‑approved components will operate correctly with the system.
b) Dimensions - The console features a 15.6‑inch touchscreen, making the device about 15.6 inches wide. The overall unit is designed to be slim and portable, with its width closely matching the screen size (~15½″), and a depth likely around 2–3 inches.
| c) | Industry Standard - Industry standards for this type of medical equipment include the basic expectations that all hospitals and clinics follow when purchasing and using ultrasound‑based vascular access systems. These standards generally require the equipment to be FDA‑approved as a medical device, manufactured under recognized quality‑control systems such as ISO‑certified processes, and safe to use in clinical environments that follow OSHA and Joint Commission guidelines. The equipment must also meet normal healthcare expectations for accuracy, reliability, and compatibility with established vascular access procedures. In short, the Sherlock 3CG system and SiteRite ultrasound meet the standard performance, safety, and regulatory requirements that are commonly accepted across the healthcare industry. |
| d) | Purpose - The purpose of this equipment is to help medical staff safely and accurately place PICC lines and other central catheters at the bedside. The SiteRite 9 ultrasound provides real‑time imaging so clinicians can see the patient’s vein during the procedure. The Sherlock 3CG system tracks the catheter tip as it moves through the vein and confirms that it reaches the correct location near the heart, which improves safety and reduces the need for X‑rays. The magnetizer and linear probe are accessories that allow the system to detect and guide the catheter tip accurately. Together, this equipment improves the accuracy of catheter placement, reduces complications, and supports safer care for Veterans at the Fresno VA Medical Center. |
| e) | Governing Body or Organization - The governing bodies and organizations for this type of medical equipment include the U.S. Food and Drug Administration (FDA), which regulates the safety and performance of the devices as Class II medical devices. In addition, industry standards commonly follow OSHA requirements for workplace safety, ISO quality‑management standards for medical manufacturing, and The Joint Commission guidelines for safe clinical use in hospitals. These organizations collectively help ensure the equipment is produced, handled, and used according to nationally recognized safety and quality standards. |
1) Complete generic identification - The complete generic identification for this equipment is an ultrasound‑based catheter tip confirmation system with integrated real‑time imaging and magnetic tracking capabilities, used for placing PICC lines and other central venous catheters. This includes a portable medical ultrasound unit, a catheter tip tracking system, and the required accessories such as a linear ultrasound probe and magnetizer.
2) Applicable model/make/catalog number - SiteRite™ 9 Ultrasound System (9770800) & SiteRite™ 9 Ultrasound Cue™ Magnetizer (9770811) & SiteRite™ 9 Ultrasound System Cue™ Linear Probe (9770803) & Sherlock 3CG™ Tip Confirmation Sensor (9770358) & Medical Equipment Roll Stand (MER) (9770206)
3) Manufacturer name – BD , Becton Dickinson and Company
Per VAAR 811.104 and 811.105, I certify the following regarding the above information:
· The salient characteristics listed above are essential to the Government’s requirements.
· To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.
File details come from the government source that posted it. Updated .