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Statement of Work
Hysteroscopy Fluid Management and Tissue Removal System
Southeast Louisiana Veterans Health Care System New Orleans, LA
06/14/2018
| 1. | PURPOSE |
| 1.1 | The overall purpose is to provide and install Hysteroscopy Fluid Management System in the Southeast Louisiana Veterans Health Care System (SLVHCS) Surgery Operating Room at 2400 Canal St, New Orleans, LA 70119. |
| 2. | SCOPE |
| 2.1 | The Contractor shall provide, transport, install, train, and test all listed equipment. All products must meet all salient characteristics defined in this section. |
| 2.2 | All equipment and installation must meet manufacturers and VA specifications. |
| 2.3 | The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the supplies and equipment. |
| 2.4 | The Contractor is responsible for any missing parts and components not included in order to carry out the installation. |
2.5 SALIENT CHARACTERISTICS
| 2.5.1 | Fluid Management System Control Unit | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7210164 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Able to control the flow and suction of fluids during Hysteroscopic and other intrauterine procedures. Unit should be able to provide accurate displays that can be read by providers during cases. Must be able to provide a vacuum pressure of between 150-200mmHg. Possess automatically triggered audible alarms which indicates intrauterine pressure of 200 mmHg has been reached or exceeded or falls below 20 mmHg for more than 5 seconds. The system should be capable of fluid flow between 30-700ml/min. Must be compatible and interface with the Hysteroscopic tissue removal system (2.5.6-2.5.9). Should utilize a bi-directional control to allow the provider to pressurize or depressurize the uterine cavity. Must have default settings of 60mmHg for pressure, a maximum flow rate of 700ml/min, and an alarm to indicate a fluid deficit which reaches 1500ml. |
| 2.5.2 | Fluid Management Stand | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7210165 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| Construction: Stand should arrive pre-assembled. Stand is required to hold all parts of the fluid management and tissue removal system in place during movement; to include: the carrier plate for the control unit, a fluid bag holder, and a fluid bag monitoring unit. Must be able to attach to rolling base (2.5.3) for movement during and between procedures. Stand must be capable of holding four 5-liter fluid bags at once. Must be strong enough to handle a combined weight of fluid bags and collection cannisters of 92 lbs. (42kg). | |
| 2.5.3 | Rolling Base | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7210166 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of attaching to the fluid management stand. Must be significantly robust to handle the load of the entire fluid management and tissue removal system. Rolling system should be capable of allowing 360-degree traverse and easy maneuverability during and between procedures. Must be compatible with and able to securely hold five 3000cc Fluid Canisters at once (2.5.21). Rolling base must consist of the following: roller base, five canister holders, carrier plate, large washer, socket head screw, and two Allen wrenches. |
| 2.5.4 | Vacuum Regulator | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 72203420 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of producing a flow rate of at least 700ml/min. Must be significantly responsive enough to provide immediate suction flexibility as needed. Must be sensitive and powerful enough to ensure intrauterine distension within a physician defined specific number in a range between 35-80mmHg. Vacuum regular must be compatible with fluid management system control unit, stand, and base as well as the entirety of the Hysteroscopic tissue removal system. |
| 2.5.5 | US Country Kit | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 72202710 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of connecting and providing power to both fluid management system and tissue removal system. Must include both US standard power cord and manual. Must be compatible with the rest of the fluid management system. Must be compatible with standard US AC sockets and 120V electric supply. Should be compliant IEC 60601-1. |
| 2.5.6 | Hysteroscopic Tissue Removal Control Unit | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7209808 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of performing hysteroscopic procedures as well as the removal of other intrauterine abnormalities. Must be compatible with fluid management system. Must fit on and be compatible with fluid management system stand. Must use a mechanical system for intrauterine tissue removal. |
| 2.5.7 | Hysteroscopic Tissue Removal System Foot Pedal | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7209820 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of controlling the tissue removal instruments utilizing manual manipulation control from operator’s foot. Must be compatible with the tissue removal control unit. |
| 2.5.8 | Hysteroscopic Tissue Removal System Handpiece | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7209807 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of controlling the tissue removal instruments and suction fluid management at the same time. Must be hand held and controlled utilizing manual manipulation control from operator’s hands. Must be compatible with tissue removal control unit. Must be capable of utilizing both the large and small hysteroscopic scopes (2.5.13 and 2.5.17) and both soft and dense tissue removal instruments (2.5.9-2.5.12). |
| 2.5.9 | Dense Tissue Removal Device | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 72204064 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be compatible with Hysteroscopic Tissue Removal System Handpiece (2.5.8). Must be able to cut tissue and aspirate at the same time as allowing suction and irrigation during intrauterine procedures. Must possess a minimum of a 10mm cutting window. Must have a minimum of 5mm distal markings to allow accurate depth measurement. Must have a minimum resection speed of 357 bites per minute. |
2.5.10 Dense Tissue Removal Device
| Suggested Manufacturer Brand Name: Smith and Nephew 72203012 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be compatible with Hysteroscopic Tissue Removal System Handpiece (2.5.8). Must be able to cut tissue and aspirate at the same time as allowing suction and irrigation during intrauterine procedures. Must possess a minimum of a 10mm cutting window. Must have a minimum of 5mm distal markings to allow accurate depth measurement. Must have a minimum resection speed of 357 bites per minute. Must utilize a hook configuration to enable procedures on fundal tissue. |
2.5.11 Soft Tissue Removal Device
| Suggested Manufacturer Brand Name: Smith and Nephew 72202536 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be compatible with Hysteroscopic Tissue Removal System Handpiece (2.5.8). Must be able to cut tissue and aspirate at the same time as allowing suction and irrigation during intrauterine procedures while allowing an unhindered visual access into the uterine cavity. Must utilize a rotary cutting window. Must have a minimum of 5mm distal markings to allow accurate depth measurement. |
2.5.12 Soft Tissue Removal Device
| Suggested Manufacturer Brand Name: Smith and Nephew 7209509 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be compatible with Hysteroscopic Tissue Removal System Handpiece (2.5.8). Must be able to cut tissue and aspirate at the same time as allowing suction and irrigation during intrauterine procedures while allowing an unhindered visual access into the uterine cavity. Must utilize a rotary cutting window. Must have a minimum of 5mm distal markings to allow accurate depth measurement. |
2.5.13 Large Hysteroscope
| Suggested Manufacturer Brand Name: Smith and Nephew 7209208 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be compatible with both the Soft Tissue Removal Device (2.5.12) and the Dense Tissue Removal Device (2.5.10). Must utilize a large working opening to facilitate the deployment of various hysteroscopy instruments. Device must be straight and sufficiently inflexible to allow diagnostic and GYN surgical procedures inside of both the uterine cavity and cervical canal. Must be compatible with the fluid management system and not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must fit inside the Large Hysteroscopic Obturator (2.5.15). Must be capable of using the Large Hysteroscopic Sheath (2.5.14). |
| 2.5.14 Large Hysteroscope | Sheath | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7209383 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be compatible with the Large Hysteroscope (2.5.13). Must be capable of introduction into the uterine cavity. Must be compatible with both the Soft Tissue Removal Device (2.5.12) and the Dense Tissue Removal Device (2.5.10). Must be compatible with the fluid management system and not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must be compatible with the Large Hysteroscopic Obturator (2.5.15). |
| 2.5.15 Large Hysteroscope | Obturator | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 7209384 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be compatible with the Large Hysteroscope (2.5.13). Must be capable of introduction into the uterine cavity. Must be compatible with both the Soft Tissue Removal Device (2.5.12) and the Dense Tissue Removal Device (2.5.10). Must be compatible with the fluid management system and not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must be compatible with the Large Hysteroscopic Sheath (2.5.14). |
| 2.5.16 Large Hysteroscope | Calibration Insert | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 72203606 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be capable of calibrating the Fluid Management System (2.5.1-2.5.4) thru the Large Hysteroscope (2.5.13) to ensure proper pressure and irrigation is available during cases. Must be compatible with the Fluid Management System (2.5.1-2.5.4). Must not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must be compatible with the Large Hysteroscopic Obturator (2.5.15). Must be compatible with the Large Hysteroscopic Sheath (2.5.14). |
2.5.17 Small Hysteroscope
| Suggested Manufacturer Brand Name: Smith and Nephew 72204752 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be no larger in diameter than 5mm as well as have a length of no more than 5.7mm. Must be capable of being used in patients with a stenotic cervix. Must be compatible with both the Soft Tissue Removal Device (2.5.12) and the Dense Tissue Removal Device (2.5.10). Must utilize an opening to facilitate the deployment of various hysteroscopy instruments. Device must be straight and sufficiently inflexible to allow diagnostic and GYN surgical procedures inside of both the uterine cavity and cervical canal. Must be compatible with the fluid management system and not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must be capable of using the Small Hysteroscopic Sheath (2.5.18). |
| 2.5.18 Small Hysteroscope | Sheath | |
| | Suggested Manufacturer Brand Name: Smith and Nephew 72204753 OR EQUIVALENT as listed below: |
| | Specifications/Salient Characteristics: |
| | Must be large enough in diameter to accommodate a 5mm Hysteroscope with a length no greater than 5.7mm. Must be compatible with the Small Hysteroscope (2.5.17). Must be capable of introduction into the uterine cavity. Must be compatible with both the Soft Tissue Removal Device (2.5.12) and the Dense Tissue Removal Device (2.5.10). Must be compatible with the fluid management system and not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. |
2.5.19 Small Hysteroscope Calibration Insert
| Suggested Manufacturer Brand Name: Smith and Nephew 72203506 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be capable of calibrating the Small Hysteroscope (2.5.17). Must be compatible with the Fluid Management System (2.5.1-2.5.4). Must not interfere with the flow of fluids. Device and components must be capable of being sterilized through an autoclave. Must be compatible with the Small Hysteroscopic Sheath (2.5.18). |
2.5.20 Hysteroscopic Procedure Kit
| Suggested Manufacturer Brand Name: Smith and Nephew 7209827 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must consist of the following: an inflow tube set, 4 jumpers, and a Bemis tissue trap. Must be compatible with the Fluid Management System (2.5.1-2.5.4). |
2.5.21 3000cc Canisters
| Suggested Manufacturer Brand Name: Smith and Nephew 72200024 OR EQUIVALENT as listed below: |
| Specifications/Salient Characteristics: |
| Must be compatible with the Fluid Management System’s Rolling Base (2.5.3). Must be able to hold 3000cc’s of fluid. |
| 2.6 | DELIVERY AND | INSTALLATION |
| 2.6.1 | DELIVERY | |
| 2.6.1.1 | Contractor shall deliver all equipment to the Southeast Louisiana Veterans Health Care System (SLVHCS) Surgery Operating Rooms at 2400 Canal St, New Orleans, LA 70119 on September 17, 2018. | |
| 2.6.1.2 | Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon. | |
| 2.6.1.3 | Package to prevent damage or deterioration during shipment, handling, storage and installation. Maintain protective covering in place and in good repair until removal is necessary. | |
| 2.6.1.4 | Deliver specified items only when the site is ready for installation work to proceed. | |
| 2.6.1.5 | Store products in dry condition inside enclosed facilities. | |
| 2.6.1.6 | Any government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the Government. | |
| 2.6.1.7 | A pre-delivery meeting will be conducted 60 days prior to initial award delivery date for verification of delivery and installation dates. | |
| 2.6.1.8 | Delivery and Installation will be coordinated through the COR. | |
| 2.6.2 | INSTALLATION | |
| 2.6.2.1 | All equipment shall be floor mounted by contractor upon delivery unless otherwise noted above. | |
| 2.6.2.2 | Install all equipment to manufacturer’s specifications maintaining Federal, and Local safety standards | |
| 2.6.2.3 | Installation must be completed by September 17, 2018. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday – Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site. | |
| 2.6.2.4 | If there is an operational conflict with installation, night or weekend installation may be required. Government will provide a 72 hours' notice of change of installation hours. | |
| 2.6.2.5 | The contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR. | |
| 2.6.2.6 | The Contractor shall remove all related shipping debris and cleanup any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the SLVHCS premises. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect. | |
| 2.7 | SITE CONDITIONS |
| 2.7.1 | There shall be no smoking, eating, or drinking inside the hospital at any time. |
| 3. | INSPECTION AND ACCEPTANCE: |
| 3.1 | The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. |
| 3.2 | Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). |
| 3.3 | The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. |
| 4. | DELIVERABLES |
| 4.1 | Operation and Maintenance Manuals |
| 4.1.1 | Binders - Quantity (2) each for items 2.5.1 – 2.5.12 |
| 4.1.2 | Digital Copies- Quantity (1) each for items 2.5.1 – 2.5.12 |
| 4.2 | Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to COR upon completion of installation. |
| 5. | TRAINING: |
| 5.1 | Contractor shall provide On-site training of the equipment to the Users. Scheduling of operator training shall be coordinated with the SLVHCS COR after installation is complete. |
| 5.2 | The contractor shall provide a training program to the Biomedical Engineering technicians and in-house clinical personnel. Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system. |
| 6. | PROTECTION OF PROPERTY |
| 6.1 | Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor. |
| 6.2 | The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work. To insure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work. |
| 6.3 | The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion. |
| 6.4 | Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels. |
| 7. | SECURITY REQUIREMENTS |
| 7.1 | The Certification & Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required. See Attachment 1 for Security Requirements. |
| 8. | WARRANTY | |
| 8.1 | The contractor shall provide a one year manufacturer’s warranty on all parts and labor. |
| 8.2 | The warranty shall include all travel and shipping costs associated with any warranty repair. |