A02 Att 1 MECs MMCIP - SAM.pdf
PDF 94 KB Posted
- Attached to
- Miniaturized Large Volume Infusion System
- Solicitation number
- HT9425-25-RFI-MMCIP
- Issued by
-
Defense Health Agency
About this file
This is a Minimum Essential Characteristics (MEC) attachment to RFI No. HT9425-25-MMCIP that outlines required and desired specifications for a large volume infusion system.
The document details 13 essential characteristics with both minimum requirements and desired specifications. Key minimum requirements include: FDA clearance/approval, simultaneous delivery of three products, size no larger than 0.1 cubic feet, weight under 7 lbs with accessories, 6-hour battery operation, 6-hour recharge time while operating, position-independent pumping capability, secondary infusion functionality for each channel, universal mounting mechanisms, visual and auditory alarms meeting IEC standards, 110~240VAC 50/60Hz power compatibility, and ability to disable Wi-Fi/Bluetooth if included. Enhanced desired specifications include capability for 4-product delivery through a single control interface, smaller size (0.057 cubic feet), lighter weight (4 lbs), longer battery life (8 hours), faster recharge time (4 hours), and expanded power compatibility (50/60/400Hz).
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Other files
| File | Type | Posted |
|---|---|---|
| A02 RFI Att 2 - Vendor Info MMCIP - SAM.pdf | ||
| A02-RFI for SAM MMCIP.pdf |
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Text version
Attachment 1 RFI No. HT9425-25-MMCIP
MINIMUM ESSENTIAL CHARACTERISTICS (MEC)
ESSENTIAL CHARACTERISTICS: The below are essential characteristics for a large volume Infusion system.
They are separated by “minimum” and “desired” columns.
Instructions: Indicate if current system meets the minimum and/or desired characteristics. If proposed system does NOT currently meet the minimum characteristic, please include a brief statement/proposed plan how minimum characteristic(s) will be met.
No.
Essential Characteristic
Minimum Characteristic
Required
Desired Characteristics
Meets MINIMUM or DESIRED characteristic
(indicate “minimum” or
“desired” below)
Discuss plan to meet minimum characteristic, if not already met.
Food and Drug Administration
(FDA)
FDA Cleared or FDA Approved
Minimum Requirement
Simultaneous Product Delivery
System must be capable of simultaneous delivery of three
(3) products.
System will be capable of simultaneous delivery of three
(3) to four (4) products with the ability to control all channels through a single screen/control interface.
Size and portability
System must be no larger than 0.1
cu. ft.
System will be no larger than 0.057
cu. ft.
Weight The system with accessories must weigh no more than 7 lbs.
The system with accessories will weigh no more than 4 lbs.
Battery power The system must operate for 6 hours on battery power when not plugged in to a direct power source.
The system must operate for 8 hours on battery power when not plugged in to a direct power source.
Battery rechargeability
Battery must be rechargeable in less than 6 hours while in operation.
Battery rechargeable in less than 4 hours while in operation.
Pump Position System must be able to pump fluid regardless of position in relation to patient.
Secondary infusion capability
Each channel must have a secondary infusion function and include the option to program and administer a secondary infusion through an existing primary line (i.e., a “piggyback,” infusion).
Securing and mounting specifications
System must have a universally adaptable vertical and horizontal mounting mechanism.
Visual alarm System must have a visual alarm that meets International Electrotechnical Commission
(IEC) 60601-1-8
requirements with option for blackout ops.
Reference:
https://webstore.i ec.ch/en/publicati on/59648
Auditory alarm System must have an adjustable audible alarm that https://webstore.iec.ch/en/publication/59648 meets IEC 60601-2-24 requirements.
Reference:
https://webstore.i ec.ch/en/publicati on/2635
Power source System must use
110~240VAC,
50/60Hz power.
System will use
110~240VAC,
50/60/400Hz power.
Network connectivity
The system must be capable of turning off Wi-Fi and Bluetooth, if included.
(end of Attachment 1 - MEC) https://webstore.iec.ch/en/publication/2635
File details come from the government source that posted it. Updated .