MODIFICATION
65 -- The United States Government wishes to assess the capability of patient monitors in performing to the objectives described within this RFI in order to meet the specifications for use within a wide variety of clinical and environmental conditions.
- Notice Date
- 9/28/2012
- Notice Type
- Modification/Amendment
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- RFI-12-0001
- Point of Contact
- Paul J. Ferrante, Phone: 215-737-2845, Maciej Okulicz-Kozaryn, Phone: 215-737-4201
- E-Mail Address
-
Paul.Ferrante@dla.mil, Maciej.Okulicz-Kozaryn@dla.mil
(Paul.Ferrante@dla.mil, Maciej.Okulicz-Kozaryn@dla.mil)
- Small Business Set-Aside
- N/A
- Description
- The following questions were submitted regarding RFI-12-0001 and the Government's response is as below: EC 1. Food and Drug Administration (FDA) Approved (KPP) Threshold: Monitor shall be FDA cleared. Question: For our response to this RFI are we limited to essential monitoring characteristics that are FDA approved or may we include additional features pending FDA approval? Government Response: The monitor, as a whole, must be FDA cleared. If we add other features, they also have to be FDA cleared for that monitor according to the FDA. Vendors may submit features pending FDA approval as a separate informational submission. EC 14. The Device shall have defibrillator overload protection. Threshold: Conformance IAW IEC 60601-1-8, Medical Electrical Equipment - General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. The Device shall have defibrillator overload protection. Question: 60601-1-8 is an alarm system standard and does not cover defibrillator overload protection. The correct particular standard for ECG monitors is IEC 60601-2-27 should it be referenced here because it does address defibrillator overload protection? Government Response: Yes, that is correct. IEC 60601-2-27 replaces 60601-1-8. EC 15. The Device shall be protected from and suppress electrical signal interference during surgical electrocautery use. Threshold: Conformance IAW IEC 60601-1-8, Medical Electrical Equipment - General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Question: 60601-1-8 is an alarm system standard and does not cover ESU protection. The correct particular standard for ECG monitors is IEC 60601-2-27. Should it be referenced here because it does address ESU protection? Government Response: Yes, that is correct. IEC 60601-2-27 replaces 60601-1-8. EC 19. The Device shall have Shipping and Storage temperature ranges within allowable limits for cold and hot storage and operational environments per MIL-STD-810G requirements. Threshold: Conforms to MIL-STD-810G requirements Question: MIL STD 810G does not set specific limits for testing. 810G states that temperature limits are determined by the LCEP (Life Cycle Environmental Profile), which must be developed for each test item. So, each product could actually have different temperature limits and still pass 810G. Should manufacturers comply with Joint Enroute Care Equipment Test Standard (JECETS) which specifies temperature limits and specifies using the test methods in 810G for Tactical-Standby to Operational environmental Tests? Government Response: Yes. EC23. Startup package Threshold: Device shall be provided with but not limited to the following accessories: two each 5-lead ECG patient cables, 10 feet minimum length. Three each pre-gelled electrodes. One each power adapter 100-240 volt, AC, 50/60 Hz, and IEC power cord for specified country. One each CO2 sensor and airway adapter set. One each 8-foot (2.4 meter) extension cable. Two each disposable pulse oximetry sensors to fit child and adult. Question: What is the one 8 foot extension cable? Also as temperature, NIBP, 12-lead and invasive pressures are essential threshold parameters should the required cables and initial consumables be included in startup package? Government Response : Both the invasive and 12-lead capability should be included. The 8' extension cord is for the sensors and must be compatible with the monitor.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/RFI-12-0001/listing.html)
- Record
- SN02904360-W 20120930/120929001237-3ef2adcb68db24dc32830c9edc10faa4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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