IFI_Sensitech FreezeAlert

General description:
The Sensitech FreezeAlert is an electronic Irreversible Freeze Indicator (IFI) with an internal sensor, factory-programmed alarm, and visual display for indicating a freeze event during transport or storage of freeze-sensitive vaccines. The device indicates via a visual alarm when an exposure to temperatures below -0.5°C for longer than 60 minutes has occurred. The device needs to be activated prior to use and once an alarm has been triggered, cannot be re-used.

Product specific description:
Product: FreezeAlert / T3500-02-157
Manufacturer: Sensitech
WHO PQS number: E006/009
Country: The Netherlands

Hardware specifications:
Operating temperature: -20°C to +55°C
Alarm: Visual, display showing either a tick for “OK” or a cross for “Alarm”
User interface: LCD, with start button switch
Resolution: Not Applicable
Accuracy: +/- 0.5°C within the range -6.5°C to +6.5°C
Battery type: Non-replaceable Lithium coin cell battery
Battery shelf life: 48 months from date of manufacture (includes activated life)
Activated life: 36 months (device shipped inactivated from manufacturer)
IP rating: IP64
Sensor: Internal, not replaceable sensor
Memory: Not applicable
Data download: Not available
Mounting: Not applicable
Label colour: White
Unit weight: 14g
Unit Dimensions (LxWxD): 5.15 x 3.5 x 1.0cm

Calibration:
Supplied with a three-point NIST/ILAC or ISO/IEC 17025 standard traceable calibration certificate.

Factory-programmed settings:
Logging interval: 1 minute
Start delay: 0 minutes
Low alarm threshold: Lower than -0.5°C for longer than 60 minutes
User ability to reconfigure, reset or stop: No

Software specifications:
Software for device programming, data download and analysis: Not applicable

User manuals:
Hardware user-instructions: Hard copy user-instructions (in English) included in packaging. Soft copy user-instructions (in English and French) available on manufacturer’s website.
Software user-instructions: Not applicable.

Warranty:
The product is covered by a one-year replacement warranty in the event of any component failure not caused by mechanical damage.