Attachment 2 - Statement of Need Letter PFT System with Bicycle - 8 Apr 25.pdf

Statement of Need for

60 SGCS/SGCSP

PULMONARY FUNCTION DEPARTMENT

Description: The Pulmonary Function Department requires the Analyzer Vyntus One PFT PC system with an ergonomic bicycle or equivalent to perform pulmonary function testing from simple spirometry to advanced lung analysis. The Vyntus One PFT PC System has the capabilities of Spirometry (FVC, SVC, MVV), Lung subdivisions (FRC-N2, RV, TLC), Real- Time DLCO (both single breath and intrabreath), MIP/MEP, pre/post bronchodilator, and a Body Diffusion System which includes: 1110L body plethysmograph with 551 pound patient bench and 25” telescoping arm, breathing circuit (including ultrasonic sensor, flow path valve, and demand valve), SentrySuite Software, 3-L manual syringe, and DLCO pressure regulator. This system also allows for wheelchair access which is required. This is a “brand name or equal” request.

POC: SSgt Rachel Pardue

Contractor shall deliver the following:

1. Training for 4 participants plus additional days.

1.1. Post-Training Follow-up Call with the Clinical Educator

2. PFT Windows 10 PC.

2.1. Pre-formatted reports and reference sets with design tools for modification

2.2. Automated interpretation algorithms

3. BODY BOX + Diffusion System

3.1. Up to 1110L body plethysmograph with 551-pound patient bench

3.2. Wheel-chair accessible

3.3. DLCO pressure regulator

3.4. GAS .3% CO .3% CH4 21% 02 BAL N2

3.5. GAS 99.00% OXYGEN

3.6. GAS 16% O2 5% CO2 0.3% CO/CH4/BAL N2 E CYLINDER

4. Electromagnetically braked bicycle ergometer with a user weight limit max of 308 lbs.

4.1 Electrical requirements 90-264V

4.2 Integrated non-invasive blood pressure monitor, initiated via software or manually from display unit head

4.3 Load of 20-999 watts, revolution range 30-130 rpm, and integrate isolation transformer

4.4 Manual adjustment of saddle height from 120-210 cm and adjustable handlebar

4.5 Bike weight 134.5 lbs

4.6 Includes BP and Cuffs

5. PFT system

5.1. Must display data at all times to provide easy access and adjust parameters for efficient customization

5.2. Must use Ultrasonic Flow sensing device with an accuracy of 1% or 50mL

5.3. Must have 25-inch telescoping arm

5.4. Must include an ergometer with built in BP monitoring and work range from 6-999 watts

5.5. Plethysmograph must have a fixed handle specifically designed to assist patients in entering and exiting

5.6. Plethysmograph floor must not be more than 3 inches from the floor

5.7. Must include a hygiene manual verified by 3rd party testing

5.8. Must have the ability to be a standalone machine with adjustable height

5.10 Must have Global Lung Index (GLI) reference value equations

5.11 Must be capable of performing all of the following tests in a single device:

5.11.1 Cardiopulmonary Stress Testing

5.11.2 Spirometry (Pre/Post)

5.11.3 Lung Volume via Plethysmography

5.11.4 Airways Resistance

5.11.5 Diffusion Capacity

5.11.6 Bronchoprovocation Studies

5.12 Factory calibrated ultrasonic flow sensor

5.13 Must have a flexible telescoping arm reaching at least 24” outside the body box

5.14 Must have capability of linking its program/system to other PFT machines

5.15 Must have required certificates like a MEDCOI or similar to the DOD/DHA requirements that allows the machine to connect to MHS Genesis

5.16 Software must have Authorization to Operate (ATO)

5.17 Must have connectivity and setup for DOD/DHA network to allow patient data or patient studies transfers and upload to the patient’s electronic record

5.18 Must have these dimensions 145 cm W × 118 cm D × 175 cm H (57.1" × 46.5" × 68.9")

5.19 Weight must not exceed 83 kg

6 Compatible with Cardiosoft ECG 6.10Bandwidth 0.05–150 Hz digital 6.11Must have wireless Bluetooth connection from ECG to PC

7 Include additional breathing circuits with adapter, shutter, and silicone valves

8 Ambient Conditions 8.10Temperature - +10 °C to +34 °C (+50 °F to 93.2 °F) 8.11Relative humidity - 20 to 80 % RH, non-condensing

8.12Ambient pressure anywhere from 700 to 1060 hPa (600 to 795 mmHg 8.13Altitude IP 20

9 Must have ability to send reports electronically and be wheelchair accessible

10 The following items or equal must be included:

10.1 Additional breathing circuit for Vyntus body (2ea)

10.2 Ambu Bluesensor (1ea)

10.3 Vyntus One PC System for PFT and CPET testing (1ea)

10.4 Vyntus body diff sadd system (1ea)

10.5 Gas – 99.00% Oxygen (USP) (1ea)

10.6 Gas .3%CO .3%CH4 21%O2 BAL N2 (ED) (2ea)

10.7 Gas 6%O2 5%CO2 .3%CO/CH4/BAL N2 E Cyl (1ea)

10.8 Service VYN-PFT Fundamentals Training-3 Days-Cust Hosted (1ea)

10.9 Vyntus One Sample Line (2ea)

10.10 Service VYN-CPET Fundamentals Training-3 Days-Cust Hosted (1ea)

10.11 DVT Volume Sensor, Complete, Vyntus CPX (1ea)

10.12 ITGV Simulator (1ea)

10.13 Power Cord Hospital Grade (1ea)

10.14 Vyntus ECG (1ea)

10.15 Carrying Bag for Vyntus ECG (1ea)

10.16 Bicycle ergometer with BP and Cuffs (1ea)

10.17 SES Standalone Device (1ea)

10.18 Additional Breathing Circuit for Vyntus One (1ea)

10.19 Laser Printer Kit, Color, Vyntus (1ea)

11 Must include equipment installation & set-up

12 Must include at least 12 months warranty

13 Must include shipping

14 Delivery: 60 Days after receipt of order.

15 Point of Contact after the contract is awarded:

10.1 Coordinate with Mr. Paul B. Plamenco at DGMC at 707-423-7506.

16 Qualifications/Certifications: N/A.