21CFR USB Vaccine Monitoring Kit (EL-21CFR-VAC): 马来西亚的首选 MOBICON-REMOTE ELECTRONIC SDN BHD

详情

Overview

This 21CFR Part 11 compliant, standalone, vaccine monitoring data logger records and displays over 32,000 temperature readings from the supplied high accuracy glycol bottle thermistor probe. The data logger features an LCD and push-button which allow the user to cycle through the most recent, highest and lowest stored readings.

Why buy a 21CFR logger?
The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) give the criteria under which electronic records can be considered by the FDA as equivalent to paper records. If you need to meet these regulations or have enhanced data security requirements then you should choose one of our 21CFR loggers, otherwise our standard loggers will suffice. Learn more about 21 CFR Part 11.
Used in conjunction with Lascar's 21CFR Part 11 software, the logger enjoys all of the core offerings of the original EasyLog software, but with additional 21CFR characteristics including user permissions, encrypted data which cannot be edited, full audit trail and electronic signatures for all activity.
Easily set up the logger and view downloaded data by plugging the unit into a PC’s USB port and using the free 21CFR Part 11 software provided. Supplied with a long life ½ AA lithium battery, wall mount clip, glycol bottle thermistor probe and traceable calibration certificate.

Specification

Measurement range
-40 to 60°C (-40 to 140°F)
Accuracy
±0.1°C (±0.2°F) (typ)
Logging rate
User selectable between 1 second and 12 hours
Operating temperature
-35 to 60°C (-31 to 140°F)
Battery life
2 years
Calibration Certificate
Supplied at 2 and 8°C

Application Info

The EL-21CFR-VAC has been specifically developed to meet the data security required by the FDA's 21CFR part 11 regulations. As such it is suitable for use in applications where the integrity of the data is of the highest importance.

For application stories on our data loggers, visit our case studies section.

Calibration

The EL-21CFR-VAC comes with a calibration certificate issued at 2 and 8°C.
Click here to view a sample certificate.