SON Hologic Fluent System.docx

Philadelphia VA Medical Center

Background:

The Hologic Fluent Fluid Management System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Fluent Fluid Management System and Disposable Pack is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators.

Scope of Work:

The Philadelphia VA Medical Center (PHIVAMC) has a Brand Name Only requirement for a Hologic Fluent Fluid Management System. The system includes one (1) FLT-100 Fluent System, one (1) Omni Instrument Tray and one (1) Omni Hysteroscopy Standard Set. This shall include training of all equipment.

Salient Characteristics of the brand name required Hologic Fluent Fluid Management System:

The Hologic Fluent Fluid Management System removal device is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures including use with the MyoSure Tissue Removal Device. The Omni Hysteroscope system includes a base scope with compatible sheaths of varying working channel size. The removable outflow channels are intended to be used to provide a fluid outflow lumen for use with Omni 5.5mm and 6mm Operative Sheaths.

The removable outflow channel includes a sealed entry port to permit the introduction of instrumentation. The reusable rod lens hysteroscope utilizes rod lenses for visualization and fibers for illumination. The hysteroscope includes Omni 5.5mm and 6mm Operative Sheaths to accommodate the respective MyoSure Tissue Removal Device. The operative hysteroscopy system can be combined with a hysteroscopic fluid management system to provide continuous flow hysteroscopy capability.

Salient Characteristics of the brand name required The Omni™ Hysteroscope Standard Set:

60-201 – Omni 3.7mm Diagnostic Sheath 60-200 – Omni Hysteroscope 60-202 – Omni 5.5mm Operative Sheath 40-201 – Omni 5.5mm Outflow Channel 50-201XL – Omni 6mm Outflow Channel 60-203 – Omni 6mm Operative Sheath

Salient Characteristics of the brand name required Hologic Fluent System:

• Dual peristaltic pump technology with integrated suction

• Deficit accuracy within +/- 50mL

• Preset deficits per AAGL guidelines

• System won’t leave setup screen until all components are in place

• System starts warning users at 75% of set deficit limit

• System warns users when supply bag is low and waste bag is full

• Can hang a bag while the system is running

• Deficit set from 100ml-2,500Ml in 50ml increments

• Pressure can be set from 40-120mmHg in 5mmHg increments

• Fluent Disposable Pack (6-Pack) Delivery:

Delivery shall be within thirty (30) days from the time of award. The Hologic Fluent Fluid Management System, one (1) FLT-100 Fluent System, one (1) Omni Instrument Tray and one (1) Omni Hysteroscopy Standard Set and accessories shall be delivered to the Philadelphia VAMC located at 3900 Woodland Avenue, Philadelphia, PA 19104; Attn; Warehouse. BioMedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. Placement in the PHIVAMC clinic shall be coordinated through the Point of Contact.