iMiniPlus PDF Logger User Guide v2.0
- 5 -
5
FDA 21 CFR Part 11 compliance
The PDF report should not be used to provide traceable and auditable data record. The PDF report can be changed
by the user. This is contrary to the FDA 21 CFR Part 11 requirements to data security. In order to produce secure and
traceable record, users have to open LRF with Console Pro and create an LCF file. There is no need to physically
connect logger to PC and download again with Console Pro if logger finished trip. You can just mail LRF and open
it with Console Pro.
6
How iMiniPlus PDF Logger works
iMiniPlus PDF Logger needs to be programmed by Console Pro for logging trip before use.
There is no need to install USB drivers on PC. iMiniPlus PDF Logger is configured as generic USB Mass Storage
Device. All operating systems should install this device automatically using default USB drivers.
iMiniPlus PDF does not require any proprietary software installation to download data from logger after logging
trip is finished.
iMiniPlus normally generates 3 files once connected to USB.
PDF report. This file is used to view logger data. This file is not present if the logger has been configured not
to produce it.
CONTROL.BIN file is used for communication purposes with software
. LRF file is used by Console Pro to create secure. LCF file for traceable data records.
iMiniPlus PDF Logger does not consume battery power when connected to USB and cannot measure or recognize
change in Battery status.
iMiniPlus PDF Logger checks battery status every 15 minutes when not connected to USB and updates Battery
Low icon on LCD.
Console Pro checks battery status of the logger when programming the logger for new trip.
Please note that battery low detect circuit is only accurate when electronics and battery of the is at room
temperatures from 15 °C to 25 °C or from 59 °F to 77 °F. If logger is used in cold environment it may report battery
low prematurely on LCD display. In this case remove logger from cold and check again battery status after 15
minutes or when the temperature of electronics has risen to room temperature range.
7
PDF report contents
You can disable PDF report generation by programming logger with Console Pro software. You can also enable or
disable certain parts of the report as described by the document named “iMiniPlus PDF Logger User guide - working
with Console Pro”.
Accuracy of statistical values displayed in PDF report in Fahrenheit temperature scale is± 0.1 °F.
Accuracy for time out specifications values is ± 1 second.
If first or last reading exceeds specification only half of the log interval is added to the time out of specifications.