StatStrip Ref 554255B Quick Reference Guide Rev 1.86

StatStrip Glucose and ß-Ketone Hospital Meter Table of Contents Intended Use... QR-1 Limitations... QR-2 The StatStrip Glucose and ß-Ketone Hospital Meter... QR-3 Barcode Scanning... QR-4 Quality Control Test... QR-5 Add Comment to a Result (Patient, QC, Linearity)... QR-13 Running a Patient Sample... QR-14 Docking/Charging Station... QR-24 Changing the Battery... QR-25 Cleaning and Disinfecting the Meter... QR-27 Troubleshooting... QR-33

Intended Use The Nova StatStrip Glucose and ß-Ketone Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in fresh capillary, venous, arterial, and neonate whole blood and ß-Ketone in fresh capillary and venous whole blood samples. The Nova StatStrip Glucose and ß-Ketone Meter System is specifically indicated for use in a clinical or ambulatory care setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. It is not for diagnosis of or screening for diabetes.

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Limitations • For Glucose, capillary,venous, arterial and neonate whole blood specimens. • For ß-Ketone, capillary and venous whole blood specimens. • Blood source - Use only whole blood. Do not use serum or plasma. • Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. • Altitudes above 15,000 feet (4572 meters) above sea level have not been evaluated. • Anticoagulants: sodium, lithium, and ammonium heparin • Fluoride and EDTA blood collection devices should not be used for venous specimens. QR-2

The StatStrip Glucose and ß-Ketone Hospital Meter Refer to this Quick Reference Guide only after you have become familiar with all of the instructions in the Instructions for Use Manual. Barcode Scanner Touch Screen

Test Strip Port QR-3

Barcode Scanning A built-in barcode scanner provides automated data entry. Patient ID's and lot numbers may be scanned into the meter. To scan a barcode, hold the barcode label parallel to and approximately 2 to 6 inches from the scanner. Press the scan button. If the information appears on the screen at the top (Screen Title), the barcode has been successfully scanned. Press the OK button.

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Quality Control Test NOTE: The operation overview provided in this section is for hospital settings. The meter configuration and screens may vary depending on your healthcare setting (e.g. Ambulatory Care Settings). The following section explains how to run a Quality Control Test with one of the three StatStrip Glucose and ß-Ketone Control Solutions. Read the StatStrip Glucose and ß-Ketone Solution package insert sheet for complete instructions, indications, precautions, and limitations of the system. 1. From the Patient Test screen, press the QC soft key. If you insert a test strip first, the color bar will turn to either blue for glucose or green for ketone. QR-5

2. The Enter Strip Lot screen displays. Enter the Strip Lot Number or scan the barcode. To scan the barcode, press the Scan soft key. Data Entry Field

Accept Soft Key

Scan Soft Key

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NOTE: If the Strip Lot Number is invalid, the screen displays the invalid number with "is not a valid Strip Lot Try again." 3. Press the Accept soft key if the lot number is correct. 4. The Enter QC Lot screen displays. Enter the QC lot number, select from the QC Lot List screen (press the List soft button), or scan the barcode. To scan the barcode, press the Scan soft key. NOTE: If the QC Lot Number is invalid, the screen displays the invalid number with "is not a valid QC Lot # Try again." 5.Press the Accept soft key if the lot number is correct. QR-7

Enter QC Lot

Op: 8636 13:42

Name: NICU-1

L1 L2 L3 _________________________

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Back

Scan OK

Data Entry Field

Scan Soft Key

Accept Soft Key

Enter QC Lot

Op: 8636 13:42

Name: NICU-1

L1 L2 L3 _________________________ 0207406081

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Accept

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List

6. If a strip has not been inserted, the Insert Strip screen displays. Insert a Test Strip as shown on the screen.

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7. With the test strip correctly inserted, Insert Strip the Apply Sample screen displays. Insert Test Strip in meter Name: NICU-1

Op: 8636 13:42

8. Gently mix the StatStrip Glucose and ß-Ketone Control Solution before each use. 9. Discard the first drop of control solution from the bottle to avoid contamination.

Cancel

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10.Place a drop of control solution from Apply Sample the bottle to the end of the test strip Touch test strip to Level 1 QC drop until the solution is drawn into the well of the test strip. When enough sample has been drawn into the strip, an audible beep is sounded by the meter. Name: NICU-1

11. Recap the control solution. The Testing Sample screen displays. The screen shows a clock with seconds remaining below the clock.

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Op: 8636 13:42

Remove test strip to cancel test

12.When the meter completes the test, the QC Result screen displays the ß-ketone or glucose result. QC Result

Op: 8636 13:42

Name: NICU-1

QC Result

Op: 8636 13:42

Name: NICU-1

QC Lot: 0213806081 Level: 1 Strip Lot: 0206806099 07/19 06:19 QC Pending

QC Lot: 0213806081 Level: 1 Strip Lot: 0206806099 07/19 06:19 QC Pending

Ket

Glu

0.6

PASS mmol/L

4.4

PASS mmol/L Range 4.0-4.8

Range 0.0-0.6

Ket Result mmol/L Accept Soft Key

OK

Accept

Glu Result mmol/L OK

Comment

Accept

Comment

Comment Soft Key QR-11

13.Remove the strip manually or use the ejector button on the back of the meter to eject the strip directly into a biohazard container. NOTE: Result is displayed with either PASS or FAIL; or only PASS or FAIL is displayed without the result. WARNING: Do not test patient sample until a control solution test result is within expected range. 14.To add a comment to the result, press the Comment soft key. 15.To accept the results, press the Accept soft button. QR-12

Add Comment to a Result (Patient, QC, Linearity) To add a comment to a Data result, press the Comment Free Text Comment _________________ NOTIFIED DR SMITH Entry soft key on the Result DEF ABC /+-.!, Field screen. 3 2 1 The Free Text Comment MNO JKL GHI 6 5 4 screen displays. Add a WXYZ TUV PQRS comment to this screen, 9 8 7 e.g., Notified Dr. Smith or List Soft space Chart Flag 0 press the List soft key for Key List Accept Clear list of comments. OK To add the comment to the Accept Soft Key result and have it become part of the record, press the Accept soft key. Op: 8636

Name: NICU-1

13:42

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Running a Patient Sample NOTE: Theoperationoverviewprovided Patient Test in this section is for hospital settings. The Glu Ket meter configuration and screens may varydependingonyourhealthcaresetting (e.g. Ambulatory Care Settings). Read the Test Strip package insert sheet for complete QC MENU Manual instructions, indications, Accept Ac cept Review Logout precautions, and limitations OK OK of the system. 1. From the Patient Test screen, press the Accept soft key. Or, just insert the glucose or ß-ketone test strip, and the meter will adjust to that test. The header will turn from Grey to Blue for Glucose or Green for Ketone. Op: 8636

Name: NICU-1

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2. The Enter Strip Lot screen displays. Enter or scan the strip lot number. 3. Once the Lot Number has been added, press the Accept soft key. Data Entry Field

Accept Soft Key Scan Soft Key QR-15

4. If the Physician's ID is enabled, the Enter Phys ID screen displays next. Enter the Physician's ID: from Phys ID List screen (press List soft key), by pressing numeric/ alphanumeric soft keys (press the ABC... soft key), or by scanning the barcode ID. 5. If the diagnosis code is enabled, the Enter Diagnosis Code screen displays next. Enter the code: from Diagnosis Code List screen (press List soft key), by pressing numeric/alphanumeric soft keys (press the ABC... soft key), or by scanning the barcode ID. 6. Depending on what is enabled to the meter, one of 3 screens will display: Enter Patient ID, Enter Accn Num, or Sample ID Type. QR-16

7. If Sample ID Type is enabled, select (soft keys) Enter Accn Num (Accession Number) or Enter Patient ID: either the Enter Accn Num screen or the Enter Patient ID screen will display. 8. From the Enter Patient ID screen, enter the Patient ID: from Patient ID List screen (press List soft key), by pressing numeric/alphanumeric soft keys (press the ABC... soft key), or scanning the barcode ID. 9. From the Enter Accn Num screen, enter the Accession Number: by pressing numeric/alphanumeric soft keys (press the ABC... soft key), or by scanning the barcode ID.

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Enter Patient ID

Op: 8636 13:42

Name: NICU-1

_________________________

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Data Entry Field ABC... Accept Soft Key Soft Key Scan Soft Key List Soft Key

Enter Accn Num

Op: 8636 13:42

Name: NICU-1

_________________________ 54821

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Accept

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NOTE: To scan the Patient ID, press the Scan soft key on the screen. Then scan the patient's barcode ID with the top of the meter. QR-18