A02 Binocular Microscope MEC SAM.pdf

MATERIEL MODERNIZATION_MINIMUM ESSENTIAL CHARACTERISTICS (MECS)_27MAY2020 |

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Title: MICROSCOPE OPTICAL BINOCULAR

Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA)

Program Name: Medical Field Systems (MFS) Program Management Office (PMO)

1. PURPOSE

The MFSPMO within USAMMDA requires six (6) Microscope Optical Binoculars for test articles, which will be used for blood and bodily fluid analysis, manual urinalysis crystals and sediments identification, and microscopic identification of pathogens and microorganisms.

2. ESSENTIAL CHARACTERISTICS & SERVICES

These characteristics are essential, and the minimum must be met in order for the Microscope Optical Binocular to be considered acceptable.

Numb er

Essential Characteristic

(EC)

Minimum Desired Item Meets Minimum Characteristics

(Yes/ No)

FDA Food and Drug

Administration (FDA) Regulatory

Oversight

The microscope shall be cleared by the FDA with a 510(k) approval for human use if it is a

Class II medical device.

If the system is Class I medical device, it shall be registered with the FDA for human use.

Minimum Required

2 Lighting Type

The microscope shall be equipped with an LED lighting system that is capable of being adjusted by the user.

The microscope LED lighting system is replaceable at the field maintenance level, and does not require specialized facilities or tools.

3 Microscopy Techniques

The microscope shall support bright-field, phase contrast, simple polarizing, sensitive polarization, darkfield, and epi-fluorescence microscopy techniques.

Minimum Required

4 Microscope Head

The head of the microscope shall be able to tilt to accommodate the ergonomic preferences

Minimum Required of the user.

5 Binocular Adjustment

The microscope shall allow adjustment of the Inter-pupillary Distance (IPD) to accommodate the ergonomic preferences of the user.

Minimum Required

6 Height Adjustment

The microscope shall support height adjustment to accommodate the ergonomic preferences of the user.

The microscope height adjustment is non-motorized.

7 Transportation and Weight

Each microscope shall come in a hardened transport case with closed cell foam inserts. The case shall have no fewer than two handles. The case with all accessories shall weigh no more than 74 lbs.

The microscope in its hardened transport case with all accessories weigh no more than 60 lbs. The transport case has wheels, a telescopic handle, and a valve to allow for safe high-altitude transport of the contents.

8 Magnification Levels

The microscope shall support magnification levels of: 4x, 10x, 40x, 100x, and oil immersion. The system configuration shall include all necessary lenses and accessories to support these levels of magnification.

The microscope has 20x magnification as well as a turret condenser for improved lighting.

9 Power Requirements

The microscope shall be able to support 110 or 120 VAC and 60

HZ.

The system has dual-voltage 110-

220 VAC and 50-60 HZ with auto-switching, either natively or with an adapter plug provided by the vendor.

10 Connectivity

The microscope shall have no means to connect to a network, including through WiFi, Bluetooth, or tethered means. If network connectivity is native to the system, it shall be removed or permanently disabled by the manufacturer.

11 Trade Agreement Act compliant

The microscope optical binocular and repair parts- shall be Trade Agreement Act compliant

Minimum Required

12 Parts and Accessories

All necessary accessories and parts for the function, service, maintenance, and transportation of the microscope binocular shall be included:

- Ancillary items, such as tools or devices for calibration or other routine maintenance

13 Operational & Service Manuals

Each microscope shall include:

hardcopy & electronic copies of operator/service manuals

Minimum Required

1-year

Manufacture Warranty

This warranty shall include 1-year Manufacture Warranty

3. Additional Performance Parameters: These are NOT essential characteristics, but rather only desired.

Num ber

Additional Performance Parameters

Minimum Item Meets Minimum Characteristics

(Yes/ No)

1 Operating Temperatures

The system shall remain operational at temperatures as high as 40 ° Celsius and as low as 0° Celsius.

2 Storage Temperatures

The system shall endure high storage temperatures as high as 60 °Celsius, and low storage temperatures as low as -20

°Celsius.

3 Operating Humidity The system shall endure up to 75% humidity during operation.

4. DELIVERY LOCATION:

US Army Medical Material Activity (USAMMDA) 1430 Veterans Drive Fort Detrick, MD 21702

5. DELIVERY DATE: 30 days after date of award

6. SHIPPING TYPE: Freight on Board (FOB)

7. SHIPPING INSTRUCTIONS: Each Microscope Optical Binocular shall include its components and accessories and be packed safely and securely in one self-contained case. The case shall have the approved, marked data plates in accordance with DFARS 252.211-7003 “Item Unique Identification and Valuation.”