Lascar 21CFR WiFi Thermistor Vaccine Monitoring Kit
- Measure and Record Temperature Using External Thermistor
- Permission-Based Use, Authority Level-Sign-Off and Full System Audits Ensure 21CFR Part 11 Standards Met
- -40°C to 125°C Temperature Measurement Range with ±0.5°C Accuracy
- Requires a Paid WiFi 21CFR Cloud Service Subscriptions Starting at $179 per Year (Purchased during Setup Process)
- Logs up to 1 Million Readings onto Internal Memory if Wireless Network Not Available
- Includes a NIST Traceable Calibration Certificate, Compliant to ISO/IEC 17025:2017
- Unless otherwise stated by the customer the calibration interval will default to the manufacturers recommendation of 1-Year
- Data Loggers are Calibrated for Both Fridge (5°C) and Freezer (-15°C) Use
- Can Be Used as Either Primary or Backup Data Logger
- Meets CDC & VFC (Vaccines for Children) Program Recommendations for Safe Vaccine Storage & Handling
Includes NIST Traceable Calibration Certificate, 3 Meter Thermistor Probe with Attached Glycol Bottle, Rechargeable Lithium Battery, Micro USB Cable and Wall Bracket. PC Software (For Setup and Local Storage) Available as A Download.
Overview of the Lascar EL-WIFI-21CFR-VAC 21CFR Compliant Vaccine Monitoring Digital Data Logger
The Lascar EL-WIFI-21CFR-VAC is 21CFR part 11 compliant, WIFI enabled data logger designed for monitoring vaccines refrigerators and freezers. Included with the logger is an external sensor with a glycol filled buffer bottle that can monitor temperatures ranging from -40°C to +60°C (-40°F to +140°F) with an accuracy of +/-0.2°C. The EL-WIFI-21CFR-VAC works with your existing WIFI network, enabling it to stream recorded data wirelessly to the EasyLog 21CFR Cloud (paid service). The kit comes with the logger, sensor with glycol buffer bottle, 1-year ISO/IEC 17025:2017 calibration certificate, and mounting accessories.
Why purchase a 21 CFR compliant data logger?
The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) provide criteria under which electronic records can be considered by the FDA as equivalent to paper records. If you are required to meet these regulations or have internal data security requirements, then choosing a 21 CFR compliant data logger makes sense. If you don’t need to meet these requirements, we suggest looking at the EL-WIFI-VACX instead.
When used with the Lascar 21CFR Part 11 software, the logger has all the same core offerings as the original EasyLog software, but includes additional functionality that includes user permissions, data encryption that can’t be edited, full audit trail, and electronic signatures for all activity.
Lascar WiFi Vaccine Monitoring Kit Specifications
Temperature | Sensor Type: Removable Thermistor Probe Measurement Range: -40°C to 125°C (-40°F to 257°F) Resolution: 0.01 (Measurement and Display) Accuracy: ±0.5°C |
Thermistor Probe (Included) |
304 Stainless Steel End Cap, High Temp Flexible Cable w/ Tight Bend Radius Length: 50cm |
Data Storage Options | Local: Store Recorded Readings on Local Computer/Server for Analysis Using EasyLog 21CFR WiFi PC Software Remote: Store All Recorded Readings in the EasyLog 21CFR WiFi Cloud for Access from Any Device Any Time and Analysis. EasyLog 21CFR WiFi PC Software is used only for the initial Setup. |
Data Storage Capacity | On Device: 1,000,000 Temperature Readings Note: If WiFi Connectivity is Not Available. Once Restored, Data is Wirelessly Transmitted to PC or Cloud, Depending on Setup and Configuration |
Sampling Rate | 10 Second to 12 Hours |
Transmission Rate | 1 Minute to 24 Hours (User-Configurable) How often Data is Transmitted Back to the PC Using Existing WiFi Network |
Operating Range | Temperature: -20°C to 60°C (-4°F to 140°F) |
Power Source | Rechargeable Lithium Polymer |
Battery Life | Typically 6 Months (Dependant on Sampling Rate and Environment) |
21CFR Complaince | Permissions Based Use and Access, Authority Based Action Sign-Off, Data Records Cannot Be Edited or Deleted and Complete System Audit Trail |
OS Compatibility | Desktop PC: Windows 11, 10 and 7 (64-bit and 32-Bit Versions) NOTE: EasyLog 21CFR Wi-Fi PC Software for Initial Setup or Local Storage of Data Mobile/Tablet: Android (Available on Google Play) and iOS (Available on App Store) |
Display Functions | Current, Min and Max Readings, Battery Life, Wireless Signal Strength, Alarm Event Status, Probe Connection Status, Maximum Logged Temperature Minimum Logged Temperature |
Alarm | Visual - Blinking LED |
Standards Compliance | Unit: IP55, 21CFR Probe: IP67 |
Dimensions | Logger: 26.36mm x 97.3mm x 71.3 mm Probe Cable Length: 3 Meters Probe: 75mm |