2016-Q-65205_Technical_Requirements.docx

Minimally, the proposed system must be able to do the following:

· Electronically record temperatures by accurately monitoring two (2) low and two (2) high preprogrammed threshold temperatures (between -30°C and +50°C), and will indicate time and duration of a temperature breach (up to 6 days).

· 8 Parameter Settings total: (2) Low Temp, (2) High Temp, (1) Excursion time up to 6 days (measured in days, hours, minutes), (1) Excursion time low up to 6 days (same measurement), (1) delay start-up 30 minutes, (1) Sampling interval 1 minutes.

· Accurate within ±0.5°C between -20°C and +30°C

· Must be programmed at Manufacture to SNS provided specifications in Celsius

· Data recorded on temperature monitor devise must be tamper proof and permanent

· Weight ≤ 9 ounces

· Dimensions: ≤ 1.75" x 2.5" x 0.5" (W x H x Thickness)

· Resolution: ±0.1°C

· Battery Shelf Life ≥ 2 years (from time of programming)

· Expire date indicated on unit (defined by end of Month and Year)

· Must visually display an out of temperature notification (or an icon symbol) if the temperature exceeded the programmed parameters such as an “Ok” and/or an “Alarm”

· Must display out of time excursion defined in days, hours, minutes for both high and low settings

· Simple one or two button end user operation of monitor

· Must provide easy to follow, short and simple direction cards or sheets for end user to operate monitor and interpret results.

· Must provide end user operation instructions card or sheet for each unit purchased

· Must provide web site and phone contact information for end user for help assistance.

· With short DSNS notice, the Manufacture must provide knowledgeable operator help assistance 24/7 for the period of 2 weeks minimum to support end user questions. Minimum of 12 operator lines.

· Must include statement on end user directions for safe disposal and any associated material risks by end user

· No Chemical indicator devices accepted

· Single use, disposable

· Must describe their QA/QC Validation Approach per industry standard and traceable to NIST standards

· Must describe their General Qualification Acceptance Criteria

· Must describe their testing philosophy approach and methodology (Software and Hardware, Factory Acceptance Testing)

· Must provide Qualification verification letter for all units sold

· Units must be serialized or Lot # controlled (defined on Quality Acceptance Verification letter)

· Must provide Five reference sites where the monitors has been successfully implemented for a minimum of two years

· Must indicate the varying service level agreements and associated fees

· Must define how future upgrades affect other listed requirements