Exhibit I BACTEC MGIT Instrument Quick Ref Guide.pdf

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Icons Reference Daily QC/Maintenance Routine Operations Error Codes Error Station Resolution

Before using this Guide, it is important that all users review the BD BACTEC™ MGIT™ Instrument User’s Manual for comprehensive operating instructions, including important warnings relating to operator safety.

Becton, Dickinson and Company 7 Loveton Circle

Sparks, Maryland 21152 USA

Becton Dickinson Ireland Ltd.

Donore Road, Drogheda

Co. Louth, A92 YW26 Ireland

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Route de Crassier 17 1262 Eysins, Switzerland

Australian and New Zealand Sponsors:

Becton Dickinson Pty Ltd.

66 Waterloo Road Macquarie Park NSW 2113, Australia

Becton Dickinson Limited 14B George Bourke Drive

Mt. Wellington Auckland 1060, New Zealand

BACTEC™ MGIT™

Instrument

Quick Reference Guide (BD BACTEC™ MGIT™ 960 and BD BACTEC™ MGIT™ 320)

BD, the BD Logo, BACTEC, EpiCenter, and MGIT are trademarks of Becton, Dickinson and Company or its affiliates. © 2022 BD. All rights reserved.

441743

445870 http://www.bd.com/e-labeling http://www.bd.com/e-labeling http://www.bd.com/e-labeling

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Station Statuses Drawer Statuses Configuration Instrument Statuses

Positive Drawer (A, B, C) loading software

Set audible alert volume Current date

Negative Drawer (A, B, C) normal

Set instrument number (960) Current time

Available Drawer (A, B, C) offline

Set instrument number (320) Main Status Screen

Ongoing Drawer (A, B, C) testing Set report language Configuration

Anonymous Configuration Accession barcoding enable/disable Maintenance

Error Set protocol length AST set (2 tubes, 3, 4, etc.) System alerts

Blocked Set time Make default AST set Print reports

AST Ongoing set Set date AST Set Position 1 Temperature readings

AST Complete set Set time/date format AST Set Position 2, etc.

Icons

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Maintenance Alerts / Notification Actions / Navigation

Block / Unblock stations System alert

Ok; confirm selection or operation; activity complete

Scan barcode

Block station Activity error or instrument full

Cancel selection or operation

Force station available

Unblock station

Problem with storage media or no storage media is inserted

Increase value or scroll up

Force set available

Copy data to storage media

Insert storage media

Decrease value or scroll down Disable

Update software Power was removed at this time

Move to other field Enable

Replace calibrators;

replace single calibrator

Power was restored at this time

Perform action Value can be adjusted up/down

Replace all calibrators Exit

(Other maintenance icons on p. 5)

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Operations Operations Reports Reports

Remove ongoing tubes Isolate number Unloaded Positive

Tubes

Confirm that Unloaded Tube Report did not print correctly

Identify anonymous tubes

Remove completed AST set

Unloaded Negative Tubes

Resolve station errors

(Other operations icons shown on

p. 6 – 7)

Unloaded Ongoing Tubes

AST operations Unloaded AST Sets

AST set entry 1 From Main Status screen, select the print reports soft key.

2 Select the desired report soft key.

For Unloaded Tubes reports, you must select a soft key to confirm that the report did or did not print okay.

For Instrument Inventory Report, select a soft key for the desired drawer.

Instrument Inventory (+ AST Set Inventory if enabled)

Error/Alert

Default AST set is shown Quality Control Negative Tube

Change AST set definition

Confirm that Unloaded Tube Report printed correctly

Positive Tube / Completed AST Set

Printing Reports Drawer Indicators

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Maintenance

Check indictor lamps

1 Make sure all drawers are closed. Select the maintenance soft key.

2 Select the test indicators soft key.

3 Select the test drawer indicators soft key. All three external lamps on all drawers should light, as well as the instrument alarm indicator.

4 Open drawer A. Soft key definitions now change to allow testing station status LEDs.

5 Select the test green LEDs soft key. All the green LEDs at all the stations should light. If any does not, block those station(s). Select the test green LEDs soft key again to extinguish the green LEDs.

6 Select the test red LEDs soft key. All the red LEDs at all the stations should light. If any does not, block those station(s). Select the test red LEDs soft key again to extinguish the red LEDs.

7 Repeat the tests of red and green station status LEDs for drawers B and C (MGIT 960 only).

Check printer paper

• Add paper if needed.

Check temperatures

• Check the thermometer reading of the Temperature QC tube. If your manual readings are within +1.0/-2.0 °C of 37 °C, the controller and heaters are operating within the expected range. From the main status screen, select the temperature soft key to access drawer temperature readings. Verify that the temperature is currently within 1.5 °C of the manual reading for each of the drawers.

Print QC Report

• Select the print reports soft key, then select the QC Report soft key.

Monthly: Clean / Replace air filters (refer to User’s Manual Section 6.2.2.1)

Maintenance

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Entering new MGIT tubes 1 Take the new MGIT tubes to the instrument. Open the desired drawer. Select the tube entry soft key (left).

2 Scan the tube’s barcode label.

If Accession Barcoding is enabled, first the leftmost icon at left appears. Scan the tube barcode sequence number. Next, the middle icon at left appears. Scan the accession barcode. If an accession barcode is not available, select the accession barcode not available soft key (rightmost icon at left).

3 The assigned station is shown in the main body of the display. In addition, the station LEDs of the assigned station illuminates GREEN. Carefully insert the tube into the station.

4 Repeat Steps 2–3 for each of the new cultures you want to enter.

Entering new AST tubes 1 Take the AST tube sets to the instrument using the AST tube rack. Open the desired drawer. Select the tube entry soft key.

2 Scan the AST carrier’s barcode label.

If Accession Barcoding is enabled, the system expects an accession barcode to be scanned after the AST carrier barcode. Scan the accession barcode if it is available. If it is not available, select the accession barcode not available soft key.

3 To change the AST set definition, select the change AST set definition soft key. Use the ▲ or ▼ key to scroll through the available definitions for the scanned carrier size. (As you scroll, the default set is indicated by a check mark in the main body of the display.)

4 To change the isolate number, select the isolate number soft key. Use the ▲ key to increase or the ▼ key to decrease the isolate number.

5 The assigned stations of the set are shown in the main body of the display. In addition, the station LEDs of all the assigned stations for the set illuminate GREEN. Carefully insert the tube set into the indicated stations. Make sure the Growth Control tube is leftmost of the tube set.

6 Repeat Steps 2–5 for each of the AST sets you want to enter.

Entering new MGIT / AST tubes

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Removing Tubes

To remove positive tubes:

1 Open the desired drawer. Select the remove positive tubes soft key (left).

2 All the positive stations illuminate with FLASHING GREEN, FLASHING RED indicators. Remove one of the positive tubes and scan its barcode label. The LEDs at this station extinguish. Repeat to remove additional positive tubes.

To remove negative tubes:

1 Open the desired drawer. Select the remove negative tubes soft key (left).

2 All the final negative stations illuminate with FLASHING GREEN indicators.

3 To remove all negative tubes (batch removal), select the remove negatives – batch soft key (left). Remove all the tubes in the indicated stations. The barcode scanner turns off, so you cannot scan any of the tube barcode labels. Do not close the drawer until you have removed all the tubes in the FLASHING GREEN stations. When all negative tubes are removed, select the OK soft key.

To remove negative tubes one at a time, remove the desired tubes and scan their barcode labels. Continue to remove and scan all the desired individual negative tubes.

To remove completed AST sets:

1 Open the desired drawer. Select the remove completed AST sets soft key.

2 The first completed AST set stations illuminate with FLASHING GREEN indicators. Remove the carrier and scan its barcode label. The LEDs at this station extinguish. Repeat to remove additional AST sets.

Removing +/–/AST Tubes

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Code Meaning Corrective Action (If the recommended actions do not correct the situation, refer to the User’s Manual or contact BD)

E01 Positivity Algorithms Reset Error occurs as a result of another error condition that went uncorrected.

E02 Temperature alarm Check current incubator temperature, room temperature, and thermometer tube. Keep drawers closed. Clean/ replace air filters. Remove instrument from direct sunlight/heat source.

E04 Flash cache error System encountered a software error. Save data to storage media and call BD.

E05 Calibration error A calibrator reading is out of tolerance. Check for debris/spilled media in instrument. If error recurs, replace calibrator.

E06 Detector error Check for/remove object impeding motion of detector assembly. Reboot instrument and call BD.

E07 Power supplies high/low Contact your local BD representative for assistance. Do not reboot the instrument.

E08 Drawer voltage high/low Check line voltage. Clean/replace air filters. Reboot instrument. If error recurs, note any error sub-codes.

E09 No tests in over 4 hours Determine why tests have not occurred (e.g., power off, drawer openings interrupted testing, etc.). If none of the above events happened, save data to storage media and call BD.

E10 Database corruption Database checksum test failed. Save data to storage media and call BD.

E11 Printer error Check printer paper (jammed or out), cable connections, power on, and online indicator.

E12 Station error Check that tubes are seated in stations. Determine why tube is missing from station. If the tube cannot be located, select the force station available soft key.

E13 Power Failure Note power failure and restore times in instrument log (or print screen).

E30 Unexpected tube was scanned Locate the missing tube or press “force station available” soft key.

E31 Storage media error Insert blank, formatted storage media.

E32 Drawer full No available stations. Remove final negatives.

E33 Moved tube with no error Refer to User’s Manual.

E34 Update error Repeat software update.

Error Codes E01 – E34

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E35 Incorrect drawer Tube just scanned belongs in another drawer. Open next drawer and scan tube barcode. Repeat until error does not recur.

E37 Barcode scan order incorrect System expected a barcode sequence number and an accession barcode was scanned (or vice versa). Be sure to scan the type of barcode the system expects.

E38 No storage media in drive Insert blank, formatted, write-enabled storage media in the storage media drive to save data to storage media.

E39 Storage media full, insert another Insert blank, formatted, write-enabled storage media in the storage media drive to complete the save data to storage media function.

E40 Network error Start BD EpiCenter™ system.

E43 LIS parameter changed:

instrument must be restarted. Select OK soft key to implement changes or select not OK soft key to cancel changes.

E45 Drawer error A drawer is not fully closed. Close drawer.

E50 Internal software error System encountered a software error. Save data to storage media and call BD.

E92 AST Set Error Main error code for any station error in an AST set. Refer to User’s Manual for additional information.

Code Meaning Corrective Action (If the recommended actions do not correct the situation, refer to the User’s Manual or contact BD)

Error Codes E35 – E92

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Resolving Errors