RFI Attachment 1 CODS Dermatome Portable.pdf
PDF 169 KB Posted
- Attached to
- Request For Information Portable Dermatome
- Solicitation number
- W81K0425Q1993
- Issued by
-
Department of the Army Medical Command
About this file
This is a Critical Operational Device Specification (CODS) document for a portable dermatome device, issued by the Department of the Army Medical Command. The specification outlines minimum and desired requirements for a medical device used in skin grafting procedures.
The key technical requirements include: FDA clearance as either a Class I or II medical device, operating pressure of at least 100 psi, maximum oscillating speed of 6,500 cycles/minute, cutting width of 1-4 inches, cutting thickness range of 0.00-0.76mm in 0.1-0.5mm increments, and dual voltage capability (110-120 VAC/60Hz and 220-240 VAC/50Hz). Logistical requirements specify a minimum 1-year warranty (3 years desired), provision of repair parts documentation, physical and digital manuals, Trade Agreements Act compliance, and both in-person and video training. Additional desired features include a medical-grade stainless steel instrument case for steam sterilization. The device must not exceed 0.20 cubic feet in volume and 6.3 pounds in weight.
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Other files
| File | Type | Posted |
|---|---|---|
| RFI _Dermatome .pdf | ||
| Attachment 2 Company and Product Information.pdf |
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
1. Critical Specifications: The below are critical specifications and the minimum must be met for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
2. Instructions: Indicate “yes” or “no” under both minimum and desired columns below. Additional comments may be added.
3. Critical Operational Device Specifications
Operational Characteristic Minimum Required
Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Food and Drug Administration (FDA) Regulatory Oversight
The Dermatome 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.
Minimum Requirement
N/A
2 Core Function The system shall be used in skin grafting, producing thin slices of skin at precise thickness from a donor area to use them for making skin grafts.
Minimum Requirement
3 Operating Pressure, psi
The dermatome shall have an operating pressure no less than100 psi.
Minimum Requirement
4 Max Oscillating Speed, cycles / min
The dermatome shall have a max oscillating speed, cycles/ mins of 6,500
Minimum Requirement N/A
5 Cutting Width, in
The Dermatome shall have a cutting width of 1- 4 in
Minimum Requirement N/A
6 Cutting Thickness, mm
The Dermatome shall have cutting ranges from 0.000” – 0.030” (0.00mm – 0.76mm)
Minimum Requirement
7 Cutting Thickness Increments, mm
The Dermatome shall cut in thicknesses of 0.1-0.5mm Minimum Requirement N/A
8 Power The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz.
The system must include auto-detection and simultaneous switching capability between both voltage ranges.
Additionally, if battery charging is necessary, the device must support charging for both voltage ranges
Minimum Requirement
9 Operational Cube and Weight
The system shall be no larger than 0.20 cu ft, 6.3lbs Minimum Requirement N/A
4. Critical Logistic Specifications
Operational Characteristic Minimum Required
Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Repair Parts
Support
Contractor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.
Minimum
2 Warranty The contractor shall provide a warranty for at least
(1) year. This warranty shall include all parts, In-
House labor, and technical support during the warranty period
Desired the contractor provides a warranty for at least 3 years.
This warranty shall include all parts, In-house labor, and technical support during the warranty period.
3 Manuals The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system
Minimum Requirement
Trade Agreements Act (TAA) Compliance
The Dermatome system shall be compliant with TAA regulations.
Minimum Requirement
N/A
5 Training The vendor shall provide in person training as well video training on the use of the dermatome.
Minimum
3. ADDITIONAL PERFORMANCE PARAMETERS
These are desired Additional Performance Parameters (APPs) but are not essential.
Number Additional Performance
Parameters (APPs) Minimum Requirement 1 Medical grade stainless steel instrument case The desired system comes with medical grade stainless steel instrument case, used for steam sterilization system.
***End of CODS***
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