A02_-Items_Requirements.pdf

ITEMS REQUIREMENTS

TITLE: Automated Breathing Metabolic Simulator Supply Contract

1.0 SCOPE

1.1 Background. The US Army Combat Capabilities Development Command Chemical Biological Center (CCDC-CBC) is procuring an Automated Breathing Metabolic Simulator (ABMS). Breathing Simulators are widely used in the respiratory protection field. These systems are used to test open-circuit breathing apparatus. This device provides a satisfactory metabolism simulation that can be adjusted easily to accommodate several different breathing profiles and work rates. The ultimate goal of the testing apparatus is to accurately simulate both breathing and metabolic functions of a human being. The advantages of using a machine instead of human test subjects lie in the ability to quantify metabolic input, repeatability and the elimination of a need to find a wide variety of test subjects, thus reducing the variances among human test subjects.

1.2 Objective. The objective of this contract is to obtain an Automated Breathing Metabolic Simulator (ABMS).

2.0 Requirements.

The contractor shall provide timely delivery of Government requested material to the address provided below unless otherwise specified by the Government. The Government is procuring an Automated Breathing Metabolic Simulators (ABMS), with ancillary equipment as detailed below.

Line

Part Description

Total Quantity

1 Automated Breathing Metabolic Simulator 1 2 Installation / Training 1 3 2 years Maintenance/Support /Updates 1 4 Set-01 Test Headforms, 5 sizes (small, short/wide, medium, long/narrow, large).

a. The Government requires an Automated Breathing Metabolic Simulator (ABMS) capable of evaluating technology used in the design and development of respiratory protective devices. The ABMS simulates human respiratory efforts and approximates respiratory metabolism/behavior which is central to the development of new respiratory products and continued production of quality respiratory devices that will pass the regulatory standards. The ABMS needs to meet the following operational and program requirements:

i. The ABMS should perform accurately, reliably, and consistently in laboratory conditions of: ambient temperature of 25ºC ± 5ºC, relative humidity of 20-80%.

ii. The ABMS shall have a self-check function to verify that it is operating correctly.

iii. The ABMS will be a closed-loop humidified human-like bidirectional flow path with minimal dead space volume.

iv. The ABMS should be capable of variable:

a. Respiratory Frequency (RF): user selectable from 0-50 breaths per minute with a maximum rate of 150 RMV. Discrete values for BPM/RF available from dropdown menu. Various “Standard” rates should be included. Program limits set by the product of BPM and Liters per piston stroke volume; this Respiratory-Minute-Volume (RMV) value cannot exceed 165.

b. Human-like breathing wave forms, with the ability to accept data recorded in a suitable electronic format (.CSV) to replicate manned test conditions with exception of certain patterns (i.e. square patterns).

c. Options to function in a ‘flow’ based mode for current regulatory testing or compliance to accommodate work of breathing (WOB) measurements under various states for future regulatory compliance.

d. Temperature control at the mouth for inhaled/exhaled wet/dry bulb temperatures to meet user defined criteria, controllable between 27-45ºC ± 0.5ºC in a saturated humidity-absolute (relative is not required).

e. Oxygen Consumption (VO2): user selectable from 0-5 liters per minute.

f. Carbon Dioxide Production (VCO2): user selectable from 0-5 liters per minute.

v. The ABMS should monitor/measure:

a. Carbon Dioxide at the mouth from 0.00-15.00% ± 0.02% CO2 with a response ranging from 24-800 milliseconds, or better.

b. Oxygen at the mouth from 0.00-100.00% ± 0.01% O2 with a response time of

800 milliseconds, or better.

c. Breathing pressures during inhalation and exhalation at the mouth.

vi. The ABMS shall have control of:

a. Ventilation rate.

b. Oxygen Consumed per minute.

c. Volume of Carbon Dioxide injected per minute.

d. Respiratory frequency as specified in section.

e. Variation of exhaled breath temperature.

f. A means for the user to input waveforms of their own definition via a (.CSV) format is available.

vii. ABMS should have variability to record and maintain individually selectable test protocols for standard tests, to enhance user friendliness, and expedite initiation of commonly executed tests.

viii. ABMS should be able to record calibration data. Each test shall be recorded electronically in an easily retrievable format. The record should include:

a. The protocol used.

b. Daily barometric pressure.

c. Each stressor value reported as a one-minute average.

d. The range operating average (the average of the one-minute averages to that point) for each stressor.

e. A time mark.

ix. Operational output shall include but not be limited to:

a. Graphical display of the one-minute stressor averages.

b. Running range operating average.

c. Simulator records control values and variables (i.e. temperatures, span values, offsets, etc.)

x. ABMS shall be calibration ready with compliance to ISO 16900 standards;

using, when applicable, NIST Calibration standards.

2.1 Non-Developmental Item. The Automated Breathing Metabolic Simulator (ABMS) should be a non-developmental item to the maximum extent possible.

2.2 Qualification. The Automated Breathing Metabolic Simulator (ABMS) must be qualified and demonstrate compliance to the ISO 16900 standards. Instrumentation used for validating the ABMS function and measurements shall be traceable to the National Institute of Standards and Technology (NIST) and bear current NIST calibration. Proof of qualification should be addressed in the response.

2.3 Installation/Training. Vendor will provide training at time of delivery to no less than three employees as designated by the purchaser. The vendor will provide all documentation for the operation and maintenance of the ABMS including a User’s Manual.

2.4 Maintenance, Inspection and Repair. The Government desires a system with minimal maintenance and inspection requirements at the organizational level. The system should also be easily repairable. CCDC would like the test platform/equipment provided to be maintained in good working order. Such required level of maintenance services will include no less than two years of service including routine repairs and replacement of parts on an as needed basis. Emergency repairs will be made when necessary whenever the equipment becomes unexpectedly inoperable.

2.5 Test Headforms. The vendor will provide one set of test Headforms in the following sizes: small, short/wide, medium, long/narrow and large.

3.0 Delivery/Logistics.

3.1 The contractor shall deliver and set up the equipment to:

U.S. Army CCDC Chemical Biological Center

RDCB-DRP-R

POC: John P. Lloyd 3549 Ricketts Point Road Room 609 410-436-0357

APG, MD 21010

3.2 The hours of operation at CCDC-CBC’s facility are between the hours of 0800 and 1800 on Monday through Friday. Delivery of materials shall be within these contract hours. Inspection and Acceptance of the items will be conducted at destination by authorized CCDC-CBC government personnel. Delivery shall be coordinated with the POC listed above.

4.0 Safety Security Considerations. None

5.0 Security Considerations. None

6.0 Period of Performance/Delivery Date.

The contractor shall provide timely delivery 180 days after receipt of order.