The AVS150-5 is a complete system used to perform autoclave validations. The AVS150-5 consists of five N.I.S.T. traceable HiTemp150 data loggers, five IP68 extended range thermal shields, an IFC200 USB cable package and MadgeTechs FDA 21 CFR Part 11 Secure Software. For smaller size autoclaves or mapping projects, the AVS150, includes one HiTemp150 and one thermal shield.

The HiTemp15

The Motor101A measures and records on and off status changes for motors or other equipment drawing up to 200 Amps. The state change occurs when the current switch exceeds the 150mA set point. This allows for most basic equipment to be monitored.

The current switch monitors whether there is current passing through a wire around which it is clamped. When the current exceeds 150mA’s, the output changes and provides a voltage for the Motor101A to measure. The device can hold up to 406,323 state changes, but memory will only be used if the status has changed. The device can be programmed to check for status changes 4 times per second up to once every 24 hours.

The Motor101A includes a data logger, current switch and an IFC200 interface cable.

STATE

GENERAL

0 is completely submersible and can measure temperatures up to 150°C. The 2" rigid probe provides a fast response time and can record readings as fast as once per second. The HiTemp150 can be used in each autoclave cycle for verification and to provide data for validation. When used with the thermal shield the device can withstand up to 250°C (time dependent).

MadgeTechs Secure Software provides data in graphical and tabular form, and provides a summary and statistical report of the data. The software also features sterilization calculations to determine the F0 value. Furthermore the software allows for different user levels and logins, electronic signatures, an audit trail and a secure data file to stand up to auditors.

Please note, the AVS150-5 is not compatible with 64 bit operating systems.

TEMPERATURE

GENERAL