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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.   

 

 

 
 

Summary of Contents for iMiniPlus PDF

Page 1: ...iMiniPlus PDF User Guide Version 2 0...

Page 2: ...6 9 3 1 Specification and Alarm 17 9 3 2 LCD Display 18 9 4 Checking the time clock 19 9 5 Setting the Start Stop and logging duration 19 9 5 1 Duration of trip at least 19 9 5 2 Interval between each...

Page 3: ...ning logger data to make a decision on accepting or rejecting the shipment 3 Logger profile The iMiniPlus PDF Logger is available in two models Both have the same temperature range of sensor D range 4...

Page 4: ...your distributor for a replacement When replacing the battery align one triangular mark on the battery cover against similar shaped mark on the logger base to avoid damaging plastic lock feature of th...

Page 5: ...r 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 an...

Page 6: ...r of the logger Hardware version this is actually firmware version Description string programmed to the logger by Console Pro Battery status last measured by the logger before it has been connected to...

Page 7: ...d on readings retrieved from logger memory and result may be different Lowest temperature reading for the current trip High Alarm status Low Alarm status Both High and Low Alarm can have the following...

Page 8: ...t to 20 C Note that the graph contains coloured dashed lines for primary alarm limits and solid coloured lines for catastrophe alarm limits Note that the numerical values of the alarm limits are not s...

Page 9: ...trip This part of the report can be disabled when programming You can change date display format to display month first by programming logger Date and Time is displayed along the X axis Temperature v...

Page 10: ...be read as Logger has spent 49 minutes and 40 seconds between 25 C and 25 9 C in this case the value of 1 degree per report line is configured by programmable parameter named Increment Note if Fahrenh...

Page 11: ...ways has two columns This part of the report can be disabled when programming You can change date display format to display month first by programming logger Marked readings are displayed with asteris...

Page 12: ...r The cable has two different ends The smaller one is type Mini B and the bigger one is type A Connect USB cable with Mini B smaller connector to the logger and A size to PC or laptop computer as illu...

Page 13: ...to use Console Pro Professional version 2 12 07 or later to program the logger Check this check box and click on Program and Configure button on the toolbar Program Wizard should start Then click Next...

Page 14: ...report that can be several pages long depending on the number of readings If you uncheck Create PDF file checkbox the logger will not generate PDF report at all You may need this option to prevent unw...

Page 15: ...year format by choosing one option from drop down box on this tab as shown below 9 2 Programming password The iMiniPlus PDF Logger supports a password option that when enabled results in users being...

Page 16: ...to add a password for the first time you can do this here Protect program settings Tick this option if you want to protect your programming settings for the current logger Protect retrieval of reading...

Page 17: ...eturn inside alarm limits the consecutive alarm is reset Total number of out of specification readings cumulative the alarm is triggered if the total number of out of spec readings equals or exceeds t...

Page 18: ...N 4 19 OFF 0 OFF 2 OFF 4 ALARM ON 5 21 OFF 1 OFF 3 OFF 5 ALARM ON 6 22 OFF 2 OFF 4 OFF 7 ALARM ON 7 24 OFF 3 OFF 5 ALARM ON 11 ALARM ON 8 22 OFF 4 ALARM ON 6 ALARM ON 13 ALARM ON 9 21 ALARM ON 5 ALARM...

Page 19: ...ent for instance you have the option of setting up the parameters yourself or let the Console Pro software calculate these automatically for you Thesoftware takes thetotal memory available 8048 readin...

Page 20: ...iMiniPlus PDF Logger User Guide v2 0 20...

Page 21: ...on the LCD You can also enable the STOP button on the logger This is disabled by default because in most applications it is better to take too many readings than too few Downloading the logger readin...

Page 22: ...utton If the upload has failed either select the Cancel button to close the software and start again or select the Restart button to start the sequence again If the iMiniPlus PDF Logger still fails to...

Page 23: ...ve the data from an iMiniPlus PDF Logger both of which will achieve the same result 1 Click the Download Information icon on the toolbar 2 Click the Download Information item located under the Action...

Page 24: ...application Otherwise leave the Logger option at its default setting Do not upload any new start conditions to the logger s Click on the Finish button Readings and Summary is displayed Download Wizard...

Page 25: ...d to communicate with the logger In other words you can email LRF files and Console Pro will create an LCF file from the LRF file Then you will be able to add digital signatures to the LCF file view d...

Page 26: ...n menu The following dialog should be displayed Please ensure that file name is unique By default Console Pro assigns the logger s serial number and trip number to the name of the file Navigate to the...

Page 27: ...and date Real time clock accurate to 1minute per month Sampling frequency 5 seconds 18hours Power source User replaceable 3V lithium coin cell Typical battery life 1 2 years operating life from a user...

Page 28: ...our website www cryopak com http www cryopak com en verification products Mailing Address PO Box 309 Buchanan VA 24066 Office 120 Parkway Drive Buchanan VA 24066 Phone 1 540 254 1433 1 732 346 9200 Ex...

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