P09_SOW_Fresenius Hemodialysis Machines.docx

Statement of Work Hemo Dyalysis Machines Eastern Colorado Health Care System Aurora, CO

1. PURPOSE

1.1. The purpose of this requirement is to deliver Fresenius Medical Care 2008T Bluestar with CDX and BiBag Hemodialysis Machines at VA Eastern Colorado Health Care System, located at 1700 N. Wheeling Street, Aurora, CO 80045.

2. SCOPE

2.1. The Contractor shall deliver all items listed in section 2.5.

2.2. All items must meet all salient characteristics defined in section 2.5.

2.3. Installation must meet manufacturer specifications.

· Features

1. Floor space: Approximately 54 cm wide by 63 cm deep

2. Height: 149 cm

3. Total Weight: Approximately 90kg

· Electrical

1. Power Supply-Main: AC 117 V ±10% 60 Hz ±3 Hz

2. Power Consuption: Does not exceed 12.6 amps @ 117 VAC

3. External Connections: Isolated RS232 and Ethernet ports; leakage current isolation per UL 60601-1 between the machine and external computer

· Water

1. Ingress Rating: IPX1 (Vertical drip-proof protection)

2. Back Flow Prevention: Integral back flow prevention provided by external vent to atmosphere in water inlet circuit

3. Pressure: Min 20 psi; Max 105 psi

4. Temperature: Min 50°F (10°C); Max 77°F (25°C)

5. Quality: ANSI/AAMI 13959:2014, Water for hemodialysis and related therapies

6. Drain: 3 feet maximum height. Must comply with local codes and must maintain a free fall air gap between drain hose and building drain

7. Rinsing: Temperature 37°C. Flow rate 620 mL/min. Time between 10 and 60 minutes (internally selectable)

· Blood Circulation

1. Blood Pump: Display of blood flow rate Internal diameter of blood pump segment: 6–600 mL/min 2.6 to 10 mm (0.1” to 0.4”)

2. Heparin Pump: Type of Syringe Administration Rate: 10–12 mL disposable syringe

3. 0 to 9.9 mL/hr

4. Arterial Pressure Monitor: -300 to +500 mmHg

5. Venous Pressure Monitor: -80 to +500 mmHg

6. TMP Monitor: +60 to -520 mmHg

7. Level Detector: Ultrasonic impulses detect fluid level in the drip chamber

8. Blood Leak Detector: Two-color light source transmitter/sensor with a resolution of: minor ≥ 0.35 mL/min of blood (hematocrit = 25%)

9. Access Flow (Qa) requires OLC: Maximum Qa: 2000 mL/min

· User Interface

1. Language: The operating screens may be set to either French (Canadian), Spanish (Mexico), or English (U.S.)

· Blood Pressure Module

1. Cuff Inflation: Typically 5–10 seconds from 0-250 mmHg

2. Interval Settings: Interval times: 5–60 minutes in increments of 5 minutes

· Optional Features

1. PatientCard System, Sustained Low-Efficiency Dialysis (SLED)

· Dialyzing Fluid

1. Dialysate Flow: Dialysate Flow button

2. Dialysate Flow Adjustment Range:

Accuracy: ±5% Sequential (0)/100*/150*/200*/300/400/500/600/700/800 mL/min, selectable in the “Home” screen; Additionally, 1.5X or 2.0X dialysate flow rate based on the Blood Pump rate (Qb):

Note: All flow rates are approximate. Dialysate flow will not adjust unless the blood pump is adjusted at least 15–20 mL/min SLED*: 100/150/200/300 mL/min

* Requires “Allow Slow Flow” Service Mode option † If Auto Flow Minimum 300 Qd is set in Service Mode ‡ If Auto Flow Minimum 500 Qd is set in Service Mode

3. Concentrate Pressure: Max suction height 3 feet Max supplied pressure 2 psi, 10 psi with bibag kit installed

4. Sodium Adjustment Range: 130 to 155 mEq/L Na+

5. Bicarbonate Adjustment Range: 20 to 40 mEq/L Bicarbonate (post-reaction, after mixing with the acid and purified water)

6. Conductivity Range of Display: 10.0 to 17.0 mS/cm at 25°C. Alarm limits will not go below 12.5 or above 16.0 mS/cm

7. Dialysate Temperature: 35 to 39°C, selectable in 0.1°C steps

8. Sodium Variation System (SVS): Three preset profiles (step, linear, and exponential)

9. Online Clearance (OLC): Dialysate Flow rate: 300–800 mL/min # of Tests: 1–6 during each treatment

· Ultrafiltration Control

1. UF Pump Volume Accuracy: ±1% (for Pdi > -500 mbar) where Pdi = dialysate pressure on inlet side of the dialyzer

2. Fluid removal rate from Patient: 0–4000 mL/hr

3. UF Profiles: Eight UF profiles are available for the removal of fluid from the patient Four are preset and four may be defined by the user

· Heat Disinfection

1. Temperature: 83 ± 8°C at NTC 3

2. Flow Rate: 600 mL/min

3. Time: Between 10 and 60 minutes (internally selectable)

· Chemical Disinfection

1. Temperature: 37°C (set point applicable)

2. Flow Rate: 620 mL/min

3. Time: Between 10 and 60 minutes (internally selectable)

2.6 DELIVERY AND INSTALLATION

2.6.1. DELIVERY

2.6.1.1. Delivery Timeframe: within 30 days of award unless specified differently within scope of contract.

2.6.1.2. Delivery Location: Contractor shall deliver all equipment to the Eastern Colorado Health Care System, 1700 N. Wheeling Street, Aurora, CO 80045

2.6.1.3. Delivery Markings: Contractor shall deliver items in manufacturer's original sealed containers with manufactures’s name marked thereon. Deliveries shall be marked with the PO and contract number.

2.6.1.4. Delivery and Installation will be coordinated through the On-Site Point of Contact (POC). POCs for delivery and install are:

Services POCs: Samantha Yuk 720-723-3192 samantha.yul@va.gov

2.7. OPERATION AND MAINTENANCE MANUALS

2.7.1. Binders - Quantity (2) each for items identified in section 2.5

2.7.2. Digital Copies - Quantity (1) each for items identified in section 2.5.

2.7.3. Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to On-Site Point of Contact upon completion of installation.

3.1. SECURITY REQUIREMENTS

3.1.1. Security background checks are not required.

3.2. WARRANTY

3.2.1. The contractor shall provide all manufacturer(s) warranties on all parts and labor at time of delivery.

3.2.2. The warranties shall include all travel and shipping costs associated with any warranty repair.