Page: 1 of 7

Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

General Notes on Optical Calibration:

• Requires downloading of the Optics Utility from TECTA-PDS onto USB drive. Access to this
download file is restricted to TECTA service level 2 technicians.

• Calibration is a tool of last resort on chambers that fail TECTA B16 software Validation QC
criteria (red icon upon validation or red crossed chambers) to regain loss of optical performance.
The first attempt to improve optical performance should be to clean optical path components
using approved methods or replace optical cover(s) and re-validate using TECTA B16 software.

• Minimize risk by not frequently reading and writing to the EEPROM microchip of TECTA B16
instrument.

• Only perform calibration or validation on an instrument where optical components are at room
temperature (18 to 25°C). Significant deviation from room temperature such as 8°C (upon
delivery) or 44.5°C (immediately following a fecal coliform incubation) can have a +/-15% impact
on optical validation results.

• Only Calibrate individual chambers that fail the TECTA software Validation QA criteria after
proper cleaning or inspection.

• Calibrate a quadrant of 4 chambers if an optical cover is exchanged where one or more probe
fails TECTA software Validation QA criteria.

• Calibrate all 16 chambers if the paired Validation Cartridge is exchanged.

• The Optical utility can be used by service level 2 technicians to generate an optical performance
report for all 16 chambers of TECTA B16 instrument in one report file.

Optical Calibration Procedure:

1) Download the Optical Utility

from TECTA-PDS.

Use a dedicated, reliable

USB drive with minimum of
2GB of storage space.

Consider a backup USB

drive or have the download
file accessible when
servicing a remote site.

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consent of Pathogen Detection Systems, Inc.
 Page: 2 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

2) Insert Optics Utility USB

drive into either USB port of
the TECTA B16.

Instrument must be powered

on first before inserting USB
key to be recognized.

3) Press ‘Home’ icon to view

the ‘System’ tab.

4) Press ‘Upgrade Application’.

When prompted, press ‘Yes’

to proceed with upgrade.

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consent of Pathogen Detection Systems, Inc.
 Page: 3 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

5) Type ‘272’ as Pass Key and

press ‘Authorize’ button.

6) Do not press the LCD

touchscreen and do not
remove USB drive while the
Optics Utility is loading.

7) Press ‘Clear All’ button once

the Optics Utility user
interface is displayed.

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consent of Pathogen Detection Systems, Inc.
 Page: 4 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

8) Select ‘Chamber: 1’ by
pressing check box or
‘Select’.

9) Press ‘Unlock’ button to

release lid of a TECTA B16
Rev1 and open the lid of
instrument.

Pressing the ‘Unlock’ button

is unnecessary if servicing a
TECTA B16 Rev2
instrument.

10) Load the Validation Cartridge

into ‘Chamber: 1’ and close
lid.

If servicing a TECTA B16

Rev1, press ‘Lock’ button to
keep lid retained during test.

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consent of Pathogen Detection Systems, Inc.
 Page: 5 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

11) Press ‘Calibrate’ button and

wait a few seconds while
chamber icon is yellow.

12) If the chamber calibration

result is green and the bottom
line reads “SUCCESSFUL
CALIBRATION!”, press the
‘Calibrate to EEPROM’ button.

If the chamber calibration

result is orange and reads
“Out of Bounds!” DO NOT
perform any other actions on
this chamber. Uncheck
chamber and move on to
next chamber requiring
calibration.

13) After the bottom line reads

“SUCCESSFUL WRITE!”
press ‘Validate’ button and
wait a few seconds while
chamber icon is yellow.

Chamber will display % delta

and offset delta and chamber
icon will display green if QA
criteria passed and purple if
QA criteria failed.

Failed chambers should be

re-calibrated until they pass.

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consent of Pathogen Detection Systems, Inc.
 Page: 6 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

14) To move to next chamber

requiring calibration, uncheck
‘Chamber: 1’ by pressing
checkbox or ‘Select’ and
select next chamber by
pressing its checkbox or
‘Select’.

15) Open the lid of the

instrument (press ‘Unlock’ if
Rev1). Load validation
Cartridge into next chamber
to calibrate and close lid
(press ‘Lock’ if Rev1).

16) Repeat Steps 11 through 16

until all chambers requiring
calibration have completed
Calibration and Validation
with the utility.

‘Validate’ only can be

performed on all chambers to
produce a complete
instrument optical report.

Note: Validation QC criteria

for utility is 5% which is
different than TECTA
software at 20%.

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consent of Pathogen Detection Systems, Inc.
 Page: 7 of 7
Date: 18-Dec-16
Title: SI-16-01-Optical Calibration Instructions Doc Number SI-16-00

17) When complete, Press

‘Report’ button to save a
report of all old and new
calibration values and
validation results to a folder
labelled “reports” on the
Optics Utility USB drive

Reporting is complete once

bottom line reads
“SUCCESSFULLY WROTE
optical_XEND######”.

18) Press ‘Quit’ button to exit

optical utility and TECTA B16
instrument will reboot into
TECTA software

Once TECTA B16 splash

screen displayed, it is safe to
remove USB drive from
instrument.

19) Open the lid and remove the

Validation Cartridge.

Return Validation Cartridge

to its original packaging to
protect it from light exposure.

Confidential Information - No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the written
consent of Pathogen Detection Systems, Inc.