A02 - Attachment 2 - MECs for Microscope Surgical - KO review.docx
DOCX document 36 KB Posted
- Attached to
- SURGICAL MICROSCOPE
- Solicitation number
- HT942524RFIPDM1SURGICALMICROSCOPE
- Issued by
-
Defense Health Agency
About this file
This document is an Attachment 2 - Minimum Essential Characteristics (MECs) for a Request for Information (RFI)/Sources Sought for a Surgical Microscope requirement. The U.S. Army Medical Material Development Activity (USAMMDA) has a requirement for three (3) commercial surgical microscopes to conduct environmental and operational testing to evaluate the devices' ability to function successfully in austere environments.
The MECs outline the essential characteristics the surgical microscope must meet, including FDA clearance, mounting on a wheeled base, magnification range, lighting/illumination features, motorization, foot pedal controls, assistant view, weight, packaging, software support, power requirements, warranty, and training. The document also lists additional performance parameters that are desired but not required, such as compatibility with image-guided surgery, augmented/virtual reality, connectivity, and image stabilization. The related federal contract opportunity is an RFI/Sources Sought with the intent to determine which vendors can meet the stated MECs. Responses are due but no solicitation or award is guaranteed at this time.
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Other files
| File | Type | Posted |
|---|---|---|
| A02 RFI for Surgical Microscope RFI-Sources-Sought - KO review.docx | DOCX document | |
| A02 - Attachment 1 - Company Information - KO review.docx | DOCX document |
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Attachment 2
RFI/Sources Sought No. HT9425-24-RFI-PDM1
MINIMUM ESSENTIAL CHARACTERISTICS (MECs)
Title: SURGICAL MICROSCOPE Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA) Medical Field Systems, (MFS), Program Management Office (PMO)
1. PURPOSE:
The Government has a requirement for three (3) commercial Surgical Microscopes. The government’s intent is to procure three (3) different make and model surgical microscopes for test articles to carry out environmental and operational testing. The purpose of this testing is to evaluate each device’s ability to function successfully in austere environment.
2. ESSENTIAL CHARACTERISTICS:
These are essential characteristics and must meet at least meet the “Minium Required” in order for the device to be considered acceptable. Desired characteristics are not mandatory, in order to be considered acceptable.
| Number |
| Essential Characteristic (EC) |
| Minium Requirement |
| Desired Characteristics |
| Meets Minimum Required |
(yes/no)
1.
| Food and Drug Administration (FDA) Regulatory Oversight |
| The system shall be cleared by the FDA with a 510(k) approval, if it is a Class II medical device. |
If the system is a Class I medical device, it shall be registered with the FDA for human use.
Minium Required
| 2. |
| Mounting and Base |
| The surgical microscope shall be mounted on a wheeled base to allow for movement within an Army Tactical Expandable Shelter in a manner that doesn’t hit the ceiling or ceiling beams. |
| The surgical microscope should be is mounted on a wheeled base to allow for movement over rugged terrain such as packed stone, packed dirt, and within the temper tents. |
| 3. |
| Magnification Range |
The automatic magnification of the device shall include a 10X eyepiece capable of range from 2.2x to 14; and a 15.5x eyepiece capable of range from 2.5 to 20
The automatic magnification of the device should include a 10X eyepiece capable of range from 1x to 17; and a 15.5x eyepiece capable of range from 2.5 to 25
| 4. |
| Illumination |
The surgical microscope shall support the following lighting and illumination features:
- High brightness illumination via xenon or LED light sources
- Blue and Ultraviolet blocking capabilities - Adjustable illumination intensity - Adjustable brightness - Adjustable angle of illumination In addition, the surgical microscope the vendor can include an emergency backup illumination of the same level as the primary illumination being used.
| 5 |
| Motorization |
| The microscope shall have a motorized base plate, allowing motorized movement in the X-Y plane that supports zoom magnification and power focusing. |
| Minium Required |
| 6 |
| Foot Pedal |
| The microscope shall be supported by a foot pedal that allows hands-free zoom magnification and focusing. |
| Minium Required |
| 7 |
| Assistant View |
The microscope shall have an assistant view scope.
The assistant view can be through a digital display instead of binocular or monocular tubes.
| 8 |
| Weight, Deployed |
| The system in its floor stand configuration shall weigh no more than 975 lbs. |
| The system in its floor stand configuration weigh should not be more than 750 lbs. |
| 9 |
| Packaging |
The microscope shall be securely packaged with light weight foam inserts for transport in a non-expanded Army Tactical Expandable Shelter that meets MILSTD-810H and doesn’t exceed 1500 lbs, which Subject matter experts (SMEs) has determine an appropriate weight.
The microscope should be securely packaged for transport in a non-expanded Army Tactical Expandable Shelter that meets MIL-STD-810H that doesn’t exceed 1200 lbs.
| 10 |
| Software, Updates |
| The vendor shall provide software support, including software patches, interface control documents, and mandatory updates |
| The vendor should provide software support, including software patches, interface control documents, and mandatory updates for the life of the device. |
| 11 |
| Power |
| The microscope shall run on 110 VAC, 60 Hz, and shall come with a hospital-grade adapter plug. |
| The microscope can run on 110/220 VAC, 50/60 Hz, and shall come with a hospital-grade adapter plug. |
| 12 |
| Warranty |
| The vendor shall offer a one (1) year manufacturer warranty on all equipment purchased by the government. All terms and coverage of the warranty are to be standard to the manufacturer. |
Minium Required
| 13 |
| User, Training, and Service Manuals/ Materials |
| The vendor shall provide digital and hardcopy versions of all User, Training, and Service |
Manuals/ Materials applicable to the system Minium Required
| 14 |
| Training |
| The vendor shall offer one group (up to 6 participants) user and one group (up to 6 participants) maintainer training event over the period of performance. The training event will be conducted at CONUS locations to be determined, and the vendor shall be notified of training requests no earlier than 30 days from the time of the training event. The vendor shall provide all necessary consumable and disposable items unique to the Microscope Surgical System for each training at no additional cost to the government. The vendor shall also provide updated digital and hard copy versions of all training, user, and service materials applicable to the system. |
Minium Required
| 15 |
| Trade Act Agreement (TAA) compliant |
| The system and accessories shall be compliant with TAA regulations |
| Minium Required |
| 16 |
| Required Delivery Date |
| The vendor shall deliver the microscope surgical 45 days after order is complete |
| Minium Required |
3. ADDITIONAL PERFORMANCE PARAMETERS:
These characteristics are not essential and reflect desired capabilities above and beyond the minimum threshold.
| Number |
| Additional Performance Parameters (APPs) |
| Desired Characteristics |
| Able to meet desired Characteristic(s) |
(yes/no)
| 1 |
| Image Guided Surgery |
The microscope shall be compatible with an Image-guided surgery system.
| 2 |
| Augmented/Virtual Reality Compatible |
The system shall have the option to allow surgery through augmented/virtual reality, or “4D”, and shall come provisioned with the necessary equipment.
| 3 |
| Connectivity |
The microscope components, including foot-pedal and any visual support equipment such as headgear, shall have the capacity to be wired to the microscope for power and data transmission purposes. No essential function of the microscope shall require WiFi, Bluetooth, or other connectivity.
| 4 |
| Image Stabilization |
| The microscope shall have the ability or mechanical devices to compensate and stabilize images during use on a non-cement floor (Government-provided ISO) |
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