1. StatSensor® Creatinine Operator Training Program
M Sonar Study

2. Learning Objectives
This training module provides a comprehensive overview of the StatSensor® meter features and operating procedures including:
System Overview
Quality Control
Participant Testing
Cleaning
Troubleshooting Tips and
Support
Welcome to the Nova StatSensor Operator Training Program for the M Sonar Study. This program will provide you with a comprehensive overview of StatSensor’s features and operating procedures including how to analyze Quality Control materials, conduct Patient Testing, clean the meter after use, and troubleshoot problems.

3. System Overview
StatSensor® is a handheld analyzer for whole blood creatinine testing.
Provides an accurate measurement of kidney function by finger stick capillary blood sampling.
StatSensor® calculates glomerular filtration rate (eGFR) using the MDRD equation.
Creatinine with eGFR is a more accurate and sensitive assessment of kidney function than creatinine alone.
You are now looking at the Nova StatSensor. StatSensor is a handheld analyzer for whole blood creatinine testing. It provides an accurate measurement of kidney function using a simple whole blood finger stick sample. StatSensor is also capable of performing whole blood measurements on venous and arterial specimens.
StatSensor is set up to report an estimated glomerular filtration rate, referred to as eGFR. According to the National Kidney Foundation, when used together, creatinine and eGFR is a more accurate and sensitive assessment of kidney function than creatinine alone.

4. System Overview Product Features
Accuracy comparable to hospital laboratory testing.
Results reported in 30 seconds.
Uses only 1.2 uL of sample.
END fill test strip.
Reportable range 0.3 – 12.0 mg/dL (27µmol/L – 1,050 µmol/L).
Color touch screen.
Rechargeable battery.
Barcode scanning for control lot numbers only.
StatSensor is capable of performing measurements on whole blood. Results are reported back to you in 30 seconds on 1.2 microliters of sample.
When performing a test, just touch a whole blood droplet to the end of the test strip and 30 seconds later the results are displayed. The system reports creatinine results up to 12.0 milligrams per deciliter or 1,050 micromoles per liter. Once testing is complete, remember to dock the meter to charge the device battery.
StatSensor has an interactive color touch screen, runs on a rechargeable lithium battery and has a built in laser scanner for reading liquid control bar codes.

5. System Overview The StatSensor® Device
Strip port Screen title Touch screen Keypad Forward Button Back Button OK/Enter button default action Sleep Mode Button Laser Barcode Scanner
At the top end of StatSensor you will find the test strip port for inserting the analytical test strip. At the other end of the meter is the laser bar code scanner. The color touch screen is located in the center of the meter. Each screen has a title located at the top of it. In this example the name of the screen is the “Patient Result” screen.
StatSensor also provides additional buttons below the touchscreen to move forward, backwards, accept the current screen action or put the meter into sleep mode.

6. System Overview Docking Station Battery
When the meter is not in use, place it into the Docking Station.
Enables the meter to stay fully charged.
Battery
Rechargeable Lithium Polymer battery.
Typical life of a fully charged battery is hours or 40 tests (when not docked).
The Docking Station is the home for StatSensor. When StatSensor is placed into the Docking Station, the battery inside the meter will recharge. This will ensure that you always have a fully charged battery when you want to use StatSensor.
On the backside of StatSensor you will find a battery door. Behind the battery door is a rechargeable lithium polymer battery. The typical use life of a fully charged battery is approximately 8 hours or 40 tests if StatSensor is not docked after use.

7. Consumable: Creatinine Test Strip
Always Date Vials Once Opened!
10 strips per vial
Keep tightly closed when not in use.
Store strips in their original vial in the refrigerator at 2 – 8°C (36° – 46°F).
Expiration date is printed on the vial of test strips.
Once opened, test strips are stable for 90 days.
Write the Date Opened and Discard Date on the vial.
The heart of StatSensor technology is the creatinine test strip. Creatinine test strips come in plastic vials containing 10 strips. Two vials are shipped in each test strip box. The inside of each vial contains desiccant to protect the test strips from humidity exposure. To ensure the desiccant is effective, the test strip vial should remain tightly closed when not in use.
When storing the vials prior to opening, test strips should be refrigerated in their original vial. Once a vial is opened, the test strips are stable under refrigeration for 90 days. To ensure your creatinine test strips are not utilized beyond 90 days after opening, remember to record the date opened on the outside of the vial. Then, count forward 90 days and record the discard date on the vial.
Best practice: Remove the number of strips you need for the day and return vial back to refrigerator.

8. Consumable: Quality Control Solutions
Always Date Vials Once Opened!
IMPORTANT: Daily routine when conducting patient testing:
Conduct two levels of Quality Control testing (requires 2 strips) once the patient visit is confirmed for that day.
Patient testing is valid for 24 hours following Quality Control.
Repeat Quality Control on next confirmed patient visit day.
Store controls refrigerated at 2° – 8°C (36° – 46°F).
Keep the vials tightly closed when not in use.
Expiration date is printed on the control vials.
Once opened, Quality Control is stable for 90 days.
Write the Discard Date on the vial.
Tho levels of Quality Control material will be used for the study. Control materials are routinely tested to ensure your StatSensor is working correctly. Control materials are available in both normal and abnormal creatinine levels.
StatSensor control materials are packaged in screw top vials. They should be stored refrigerated. Remember to keep the vial tightly closed. Just like the test strips, once opened, control materials are stable for 90 days under refrigerated conditions. Don’t forget, when opening a new vial write the discard date on the vial.
Lot number

9. Conducting Quality Control
Press the “OK” button on the device to power on.
Press “OK” again to log in.
Enter “Operator ID”:
Enter your 5-digit RIC number
Press “OK”
The screen which follows is shown:
4. Press “QC”
Once the device is powered on and the 5-digit RIC number has been entered, you will see the Patient Test screen. The screen indicates the meter is ready to perform patient or Quality Control testing. Upon receiving the device and consumables, you will need to conduct a Quality Control test and send the results to Blinded Diagnostics for site confirmation.

10. Conducting Quality Control
At the “Enter QC Lot” screen.
You will have two options:
Scan the liquid quality control bottle to capture the lot number. (Best practice) OR
Enter lot number manually using keypad.
Press the Accept Soft Key.
“Enter QC Lot” screen is displayed.
Scan the lot number barcode on the outside of the Quality Control vial as a best practice. Once the Quality Control lot has been successfully scanned, press the Accept Soft Key. Quality control lot number can be entered manually should a problem with the scanner occur.
Accept Soft Key

11. Conducting Quality Control
Lay the Statsensor® on a flat surface
The Insert Strip screen displays.
Insert a Test Strip as shown on the screen.
Once inserted, the Apply Sample screen displays.
Gently mix the QC control vial before each use.
Place a drop of QC at the end of the test strip until the solution is drawn into the test strip.
When enough sample has been drawn into the strip, the analysis countdown begins.
Once you accept the Quality Control lot number, the “Insert Strip” screen is displayed. Insert the gold end of the test strip into StatSensor as shown making sure that the Nova label is facing upwards. When the test strip is inserted correctly, the “Apply Sample” screen is displayed.
Make sure you gently mix the Quality Control vial before use. When ready, place a drop of Quality Control material at the end of the test strip and allow the solution to be drawn into the test strip by capillary action. When enough sample has been drawn into the test strip, the analysis countdown automatically begins.

12. Conducting Quality Control
Quality Control Analysis
The Testing Sample screen displays during QC.
The QC result will display in 30 seconds with a “Creat” value.
Confirm that the QC result is acceptable by comparing with range on QC vial.
For example, QC vial shows , range is
To accept the result, Press the Accept Soft Key.
The analysis will count down from 30 seconds to 0. Once the analysis is complete, the Quality Control result is displayed. Compare your value to the acceptable range found on the QC vial. Upon completion of the 1st QC, log on to to report results. You will receive an confirming that the information was successfully transferred. Subsequent QC testing WILL NOT be captured via the web portal.
Accept Soft Key

13. Complete the QC Confirmation Step
Go to
Enter your Information on the form
Submit
You will receive an confirmation
You will only have to complete this form once!

14. Quality Control Tips Quality Control Analysis
Always hold the meter level or pointed slightly downward with the test strip when dosing.
Proper orientation prevents control solution from running down the strip into the meter.
Allowing liquid to run into the meter may damage the meter!
Lets review a few key points.
When applying Quality Control to the test strip, always make sure you hold the meter level or pointed slightly downward.
Never stand the meter straight up when applying Quality Control material to the test strip. Ensuring that the meter is properly oriented helps prevent the control solution from possibly running down the strip into the meter.

15. Insert Conducting Quality Control Video

16. Conducting A Test Press the “OK” button on the device to power on.
Press “OK” again to log in.
Enter “Operator ID”:
Enter your 5-digit RIC number
Press “OK”
IMPORTANT: Press GFR button, then press “OK”
To get both Creatinine and GFR values, both boxes must be black.
If you forget to press GFR, the device will report a Creatinine value only. Site staff will have to manually determine GFR via the MDRD equation (located on
Enter the appropriate patient information using the touch screen keypad and press Accept.
Patient Age
Male/Female
African American OR All Other Races
Notice that the Creatinine test is already highlighted? You want to also run GFR, touch the GFR button on the touchscreen and then press Accept.
StatSensor will then prompt you to enter some patient information to assist with the GFR calculation. When complete, press Accept.

17. Conducting A Test The Insert Strip screen displays.
Insert a test strip as shown on the screen.
Clean the patient’s finger by washing or with alcohol swab.
Dry thoroughly.
Perform a finger stick using the provided lancet.
“Insert Strip” screen is displayed.
Insert the gold end of the test strip into StatSensor as shown making sure that the Nova label is facing upwards. When the test strip is inserted correctly, the “Apply Sample” screen is displayed.
Clean and dry the patient’s finger according to your hospital fingerstick protocol, then perform a fingerstick again following local protocol.

18. Conducting A Test Lay the device on a flat surface as pictured.
The Apply Sample screen displays.
When the blood drop appears, touch the end of the test strip to the blood drop.
The test strip is full when the countdown begins.
Results appear in 30 seconds.
From the “Apply Sample” screen, touch the end of the test strip to the blood drop. Allow the blood to be drawn up into the test strip by capillary action. When enough sample has been drawn into the test strip, the analysis countdown automatically begins. The analysis will count down from 30 seconds.

19. Conducting A Test When the patient result appears:
Record results per protocol.
Press the Accept Soft Key or OK.
Immediately remove and discard strip in biohazard container
Once the analysis is complete, the Patient result is displayed. Record results per protocol.

20. Testing Tips
The test strip must fill completely upon touching the blood drop.
Do not touch the strip to the blood drop a second time. Discard the test strip and repeat the test with a new strip.
Testing will not begin until enough blood has been added to the strip.
Do not let blood run down into the meter.
Do not apply sample to the top of the strip. Sample is applied to the edge of the strip
Blood fills the strip from the end by capillary action.
Always lay device down on a flat surface.
Lets take a moment to review a few key points.
When applying blood to the test strip, always make sure the test strip fills completely the first time. If for some reason the test strip does not fill the first time, do not touch the strip to the blood drop a second time. Instead, discard the test strip and repeat the test with a new strip.
Once again, make sure that you hold the meter level or pointed slightly downward. Never stand the meter straight up when applying blood to the test strip. Ensuring the meter is properly oriented helps to prevent blood from running down the strip into the meter.
Finally, make sure you do not smear or drop the blood onto the top of the test strip. Remember, the test strip fills by capillary action from the end.

21. Insert Conducting A Test Video

22. Cleaning and Disinfecting
To avoid transmission of infectious diseases, clean and disinfect device after every use
Cleaning:
Use a fresh germicidal wipe and clean the external surface of the meter
Properly discard the soiled wipe into an appropriate biohazard container.
Disinfecting:
1. Use a fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally and 3 times vertically.
IMPORTANT: Avoid the meter’s port, bar code scanner, and electrical connector.
Gently wipe the surface area of the test strip port making sure that no fluid enters the port.
Ensure the meter surface stays wet for 1 minute and then is allowed to air dry for an additional 1 minute. Note: To wet the meter surface again, use a new, fresh germicidal wipe. Never re-use a previously soiled wipe.
Dispose of any used wipes and gloves in an appropriate biohazard container.
Wash your hands thoroughly with soap and water.
For further cleaning and disinfecting directions, please go to
Nova provides a standard recommendation for cleaning the surface of the device which can be found on Please review this manufacturer’s recommendation and make sure it is consistent with your institute’s infection control policy.
Once you have disinfected the surface of the meter, immediately clean the surface of the meter with a damp cloth to remove any cleaning residue. Once complete, dry the surface of the meter with a soft cloth or lint-free tissue.
When cleaning StatSensor, please avoid the following common mistakes.
Do not immerse or hold StatSensor under running water.
Do not spray the surface of StatSensor with a disinfectant solution.
In both cases, fluid could get inside the meter and damage the electronics.

23. Troubleshooting Analysis Errors
The test strip was removed or lost electrical contact with the meter before completing the test.
Insert a new test strip and repeat the test.
StatSensor has an error detection system to ensure high quality results are reported. When StatSensor detects a problem, it displays an error on the touchscreen. The next few slides will briefly review common errors you may encounter.
The first error you may encounter is an Analysis Error during Quality Control or Patient testing. In most cases, the error is due to the test strip contact dislodging from the meter in the middle of the test. If this error occurs, remove the test strip, insert a new test strip and repeat the test.

24. Troubleshooting Flow Error Insufficient sample
Sample was applied incorrectly to the
test strip.
Do not pull the test strip away from the
finger until the countdown begins.
During testing you may also encounter a Flow Error. In most cases, this error is due to insufficient sample. Other possibilities include incorrect application of the blood to the test strip or accidentally pulling the strip away from the blood before the countdown begins.
Again, if this error occurs, remove the test strip, insert a new test strip and repeat the test.

25. Troubleshooting Battery Low Place the meter into the Docking Station.
When testing with StatSensor, you may encounter a low battery icon. This is an indication that the rechargeable battery is running low on power and needs to be placed back into the Docking Station.

26. Thank You for Your Participation!
Questions?
Thank You for Your Participation!