Attachment 01_SON_MEC_Checklist_HT942523R0053.xlsx
XLSX spreadsheet 12 KB Posted
- Attached to
- ULTRASONIC UNIT, BLOOD FLOW DETECTION Federal contract opportunity
- Solicitation number
- HT942523R0053
- Issued by
- Defense Health Agency
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| File | Type | Posted |
|---|---|---|
| RFQ-HT942523R0053.pdf |
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Text version
MEC Checklist
| Attachment 01 - SON&MEC Checklist | |||||||
| RFP #: | HT9425-23-R-0053 | ||||||
| Number | Document | Essential Characteristic (EC) / Section | Threshold (T) / Description | Objective (O) | Product Meets Threshold & Objective Y/N? | Offeror Confirms the SON Section Can be Met | Comments (if not, please explain why, or explain how product exceeds Essential Characteristics/SON) |
| 1 | MEC | Food and Drug Administration (FDA) Regulatory Oversight | The system 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. | T=O | |||||
| 2 | MEC | Intended Uses | The device shall be capable of use on sterile sites in intraoperative environments and on non-sterile sites such as intact skin. | T=O | ||
| 3 | MEC | Directionality | The device shall be a non-directional Doppler. | The device shall be a bi-directional Doppler. | ||
| 4 | MEC | Probe Frequency | The device shall support a probe frequency of 8 MHz. | T=O | ||
| 5 | MEC | Probe Shape | The probe shall be pencil-style shaped. | T=O | ||
| 6 | MEC | Probe Type | The probes shall be a durable probe compatible with sterile technique. | The device shall support the use of durable probes with sterile technique and disposable probes. | ||
| 7 | MEC | Output | The device shall contain a speaker for detection of audio output. | The device shall have a display screen as well as a speaker. | ||
| 8 | MEC | Power Source | The device shall be capable of operating on battery power or plugged into external power. | The device shall be capable of operating with a battery, rechargeable if possible. | ||
| 9 | MEC | Power Specifications | The device shall be able to operate using 110-120 VAC/60 Hz. | The device shall be able to operate using both of the following voltages: | ||
| 10 | MEC | Weight, Device | The device shall weigh no more than 8 lbs. in its operational configuration. | The device shall weigh no more than 5 lbs. in its operational configuration. | ||
| 11 | MEC | Packaging | The supplier shall provide the system with all its components and accessories packed safely and securely in a self-contained harden case (e.g. Harding Pelican, ECS Case, and/or equivalent). The case shall have approved marked data plates with the following information: |
a. National Stock Number(s) – Actual NSN(s) to be provided after award.
b. Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013).
c. Inserts shall be of closed cell foam or similar insulating and protective material capable of sustaining the system throughout transport and environmental conditions. The supplier shall provide the system with all its components and accessories packed safely and securely in a self-contained harden case with a pressure-equalization valve (e.g. Harding Pelican, ECS Case, and/or equivalent). The case shall have approved marked data plates with the following information:
a. National Stock Number(s) – Actual NSN(s) to be provided after award.
b. Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013).
c. Inserts shall be of closed cell foam or similar insulating and protective material capable of sustaining the system throughout transport and environmental conditions.
d. Shall include a waterproof list of case contents with picture showing location and position of item in the case.
| 12 | MEC | TAA Compliance | The system shall be compliant with Trade Agreements Act (TAA) regulations. | T=O |
| 13 | MEC | Weight, Packaged | The system and all accessories shall come in one hardened transport case weighing no more than 15 lbs. | The system and all accessories shall come in one hardened transport case weighing no more than 10 lbs. |
| 14 | MEC | Authority to Operate (ATO) | If applicable, the system shall be able to obtain an Authority to Operate from the Defense Health Agency (DHA) that will be supported for the length of the contract. | T=O |
| 15 | SON | Section 3.1 | Parts and Accessories Support | N/A |
| 16 | SON | Section 3.2 | Packaging, Storage, and Transportation | N/A |
| 17 | SON | Section 3.3 | Warranty and Maintenance | N/A |
| 18 | SON | Section 3.4 | Software | N/A |
| 19 | SON | Section 3.5 | Training | N/A |
| 20 | SON | Section 3.6 | Documents | N/A |
| 21 | SON | Section 3.7 | Cybersecurity | N/A |
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