Attachment 1 - Essential Characteristics (Liquid Nitrogen Generator).pdf

Essential Characteristics

Requirement Title: Liquid Nitrogen Generator

Has this requirement been submitted into LOGICOLE?

Provide the applicable NER number from the LOGICOLE system: TDAFCLLPSHSTNN

Department: Patient Centered Medical Home, USNH Guantanamo Bay

1. Background/Acquisition History of the item(s) required.

New requirement

2. Name/Nomenclature of item and quantity required: Freezer, Laboratory, Cryogenic, Electromechanical, Qty: 1

a. Briefly describe the functionality of the equipment

• Functionality Overview:

o Produces 6–10 liters of liquid nitrogen per day o Stores up to 35 liters in an integrated Dewar tank o Delivers liquid nitrogen at 98% purity o Built in Air Compressor o Electrical input (110-240V/50–60Hz) o Power supply connection type: NEMA 5-15P o Touch screen controls

• Medical and Research Use:

o Dermatologic procedures in the primary care setting

• Compliance and Safety Standards:

o Meets general safety and electrical regulations under CE and ISO standards o Designed for operation in ambient humidity of 20–95%, suitable for a variety of clinical and lab environments o Noise output limited to 55 dB, compliant with occupational hearing safety limits under OSHA

b. List any requirements for this equipment to be compatible with any existing equipment. PCMH has the accessories required such as face shield, thick lined gloves for handling cold equipment, and re-fillable canister for liquid nitrogen. The room has the required power outlets 110V needed.

b. List specific delivery, transportation, and installation requirements. The equipment will be installed in USNH Guantanamo Bay.

The shipping address is:

DDNV Medical Mission, ATTN: TCN/Requestion # Guantanamo Bay 1933 Cold Storage Road, BLDG CEP 156, Norfolk, VA23511

For Heavy or hazardous materials, the shipping address is:

Portus Warehouse, ATTN: TCN/Requestion # USNH Guantanamo Bay MATMAN DEPT 8998 Blount Island Blvd, Jacksonville, FL 32226

c. List any unique facility specifications/accommodations required for the equipment to be operational within your facility. SDS and markings posted for safety. The room/facility has the required power needed for the machine. No ventilation is required. It is built into the machine. It does not need any water hookup or drainage. The machine only requires 110V for power.

d. For equipment that is required to be stationary or affixed, provide the dimensions of the available space. The available space is 3 feet 5 inches (L) X 4 feet (W) X 6 feet (H)

e. List any environmental factors regarding the equipment that should be taken into consideration? N/A

f. Annotate the voltage and electrical requirements for the equipment. Electrical input

(110V/50-60Hz); Power supply connection type: NEMA 5-15P

g. Annotate whether the equipment has a need to be from an Original Equipment

Manufacturer authorized dealer/distributor/seller for any service, software, warranty, or maintenance requirements. Request warranty and will be serviced by local Biomed Team.

h. List any training requirement for initial training on the use or maintenance of the equipment. Specify the desired format for training (online, on-site, in-person, etc.). The training can be given by a supervisor or a Biomed Technician at our facility, with a complete hands-on approach to the machine for training. Individuals who use the machine will need to read the to-go by manual and be signed off by a supervisor for competency before use.

3. List any Cybersecurity requirements for this equipment. N/A

a. List any specifications for Authorization to Operate (ATO) approvals for this equipment. N/A