1. CLINITEK Status® Plus UACR Operator Training Program
M Sonar Study

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

3. System Overview
Microalbumin product is useful to test for microalbuminuria in patients with diabetes or hypertension in order to detect early kidney disease.
Albumin, creatinine, and albumin-to-creatinine ratio results to help identify clinically relevant microalbuminuria.
Results reported in 60 seconds
Reportable range: Microalbuminuria is indicated at a ratio result of 30–300 mg/g
Touch screen
A/C Power or Rechargeable battery (Sonar study will use A/C power only)
Clinitek is capable of performing measurements on urine. Results are reported back to you in 60 seconds.

4. System Overview The CLINITEK Status® Plus Device 1. Analyzer
2. Power supply adaptor and AC power cord (Figure shows US
version)
3. Test table with calibration bar
4 . Test table insert
5 . Paper roll
This illustration shows all materials needed to set up the Clinitek device.
Review the “Unpacking Guide” contents and remove the component’s wrappings to ensure all components are intact
b) Operator’s Guide
c) Documentation CD
d) Clinitek Status+ Analyzer
e) Test Table: DO NOT touch the white calibration bar
f) Test Table Insert (may already be located in the Test Table)
i) Test Table Insert is comprised of two (2) sides
i) One (1) side has a clear strip center for use with TEST STRIPS
g) Power Supply
h) Paper Roll

5. Getting Started LOCATION:
The Analyzer should be on a level work surface in a temperature and humidity controlled environment.
Ideal temperature: 22-26oC (72-79oF).
POWER SUPPLY:
Connect the power supply to the power inlet located on the back left hand side of the Analyzer and connect the other end into an AC electrical wall outlet.
Country specific adapter not included, available separately

6. Getting Started INSERT TEST STRIP TABLE:
i) Hold table by the end opposite of the white calibration bar. DO NOT TOUCH the white calibration strip.
ii) Insert with the white bar facing UP into the port on the front.
iii) Push into analyzer JUST OVER HALF-WAY. DO NOT PUSH TABLE FULLY INTO ANALYZER.
INSERT TEST TABLE INSERT:
Place appropriate side of insert into strip table.

7. Getting Started PRINTER PAPER: i) Turn analyzer to back.
ii) Open the printer compartment. This reveals the paper feeder.
iii) Pull up on the grey lever on the LEFT side of the printer compartment.
iv) Push down on the grey tab to expose the paper holder.
v) Place the paper into the grey paper holder so the paper is fed out the bottom of the roll, and away from you. (Paper should be up the back wall of compartment).
vi) Feed the paper through to expose about 4 inches.
vii) Push the grey lever on the left down.
viii) Feed the paper though the printer compartment door and close the printer compartment door making sure it clicks back into place
1 Paper holding arm
2 Printer paper

8. Getting Started Video

9. Initial Setup POWERING ON:
Press the Power button located on the front of the Analyzer to turn on your Analyzer. The Analyzer will perform a System Test each time it is turned on
a) During the initial start-up, the Analyzer will prompt you to select a language. Select the language and press Next
b) This will bring you to the Start-up Wizard. This screen will show you what the Wizard will help you set up. Click Next to begin the Set-up
c)Select proper
Date: Day/Month/Year
Time: 24 hours
Preferred Test Sequence: Select Quick Test
Type of Strip Select “Multistix 10 SG”
Results Format: Select Standard International (SI)
Done will bring you to a Confirmation Screen where you can verify your selections.
Quick test: will allow the user to complete a test without the option to enter Operator ID/Name or Patient/Sample information.
Type of Strip: Clinitek Microalbumin 2 will not appear on the screen, but will be identified automatically using the ID band system.
d) Press Next and it will bring you to your main <Select> screen where QC/Patient tests can be run, system settings can be accessed, and results can be recalled

10. Initial Setup Regular Start up: For all future startup…
a) The Analyzer will perform a system test each time it is powered up
b) Upon successful start-up, the analyzer will take you directly to the main screen. Title Bar will say <Select> & Ready along with a Time/Date Stamp.
c) The main <Select> screen displays with options:
i) Instrument Setup
ii) Recall Results
iii) Cassette Test (Not applicable for Sonar Study)
iv) Strip Test: Select this option to run Liquid QC and UACR tests
Clinitek Status+ does not require calibration prior to use; it performs a system test each time it is turned on and each time a test is run.

11. Initial Setup Video

12. Consumable: Microalbumin 2 Test Strip
25 strips per vial
Expiration date is printed on the vial of test strips.
Store strips in their original vial at room temperature between 15°–30°C (59°–86°F).
Keep tightly closed when not in use.
Do not use product after expiration date.
Do not store the bottle in direct sunlight.
Remove each strip from the bottle immediately before it is to be used for testing. Replace cap
immediately and tightly after removing reagent strip.
Do not touch test areas of the reagent strip. Dip test areas in urine completely, but briefly, to
avoid dissolving out the reagents.

13. Consumable: Quality Control Solutions
Two levels of Quality Control: Level 1 and Level 2
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.
18-month shelf life & open vial stability from date of manufacture when stored at 2 – 8º C
Keep the vials tightly closed when not in use.
Expiration date is printed on the control vials.
Two levels of Quality Control material will be used for the study. Control materials are routinely tested to ensure your Clinitek is working correctly. Control materials are available in both normal and abnormal levels.
Urinalysis Strip Testing
i) Positive and Negative Controls should be used with
(1) each new lot of reagent strips opened
(2) each new bottle of reagent strips opened
(3) each new shipment of reagent strips
(4) monthly for reagent strips that are stored for >30days

14. Conducting Quality Control
Collect materials needed to conduct Quality Control
Two (2) Test strips (1 for each control level)
Level 1 and Level 2 Quality Control solutions (Take out of refrigerator 15 minutes before use)
Paper towel for blotting
Touch Strip Test on the main <Select> screen.
Select “Quick Test”
The Analyzer will proceed to the <Prepare Test> Screen
Click Start on the <Prepare Test> screen. The Analyzer begins an eight (8) second countdown for you to:
Apply Level 1 Quality Control solution to the strip pads
Blot excess liquid from strip
Insert strip on tray with test pads facing up
NOTE: DO NOT lay the pads on the paper towel or cover the pads with the paper towel
Upon receiving the device and consumables, you will need to conduct a Quality Control test and enter the information at
Step 1
Step 2

15. Conducting Quality Control
The test table and strip will automatically be pulled into the analyzer at the end of the 8 second countdown .
<Analyzing in progress> screen will automatically begin at the end of calibration and a countdown until result will be displayed.
At the conclusion of the testing countdown, <Results> will be displayed on the screen.
Select Print to print the results.
Click Done to return to the main <Select> screen and remove used urinalysis strip and discard in a biohazard container.
Repeat steps two (2) through six (6) for Level 2 Quality Control testing.
Confirm that the QC results are acceptable by comparing with range on QC vials.
If a sample is not applied within the 8 second window the analyzer will begin the calibration and test, but “Alert: Tests Stopped Misplaced Strip” along with instructions to restart the test will appear on the screen
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.

16. 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!
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.

17. Conducting Patient Test
Collect materials needed to conduct Quality Control
Test strip
Patient urine sample
Collect specimen in a dry, covered container free of detergents or contaminating substances and urine should be at least 3 inches in depth.
Specimen should be well mixed and un-centrifuged.
Paper towel for blotting
Touch Strip Test on the main <Select> screen.
Select “Quick Test”
The Analyzer will proceed to the <Prepare Test> Screen
Click Start on the <Prepare Test> screen. The Analyzer begins an eight (8) second countdown for you to:
Dip the reagent strip into the urine sample making sure to wet all the pads.
Blot excess liquid from strip
Insert strip on tray with test pads facing up
NOTE: DO NOT lay the pads on the paper towel or cover the pads with the paper towel
Upon receiving the device and consumables, you will need to conduct a Quality Control test and enter the information at
Step 1
Step 2

18. Conducting Patient Test
The test table and strip will automatically be pulled into the analyzer at the end of the 8 second countdown .
<Analyzing in progress> screen will automatically begin at the end of calibration and a countdown until result will be displayed.
At the conclusion of the testing countdown, <Results> will be displayed on the screen.
Select Print to print the results.
Click Done to return to the main <Select> screen and remove used urinalysis strip and discard in a biohazard container.
Record patient results per protocol.
If a sample is not applied within the 8 second window the analyzer will begin the calibration and test, but “Alert: Tests Stopped Misplaced Strip” along with instructions to restart the test will appear on the screen
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.

19. Conducting A Test Video

20. Cleaning Clean the meter on a routine basis:
Cleaning Test Table Insert:
a) Remove the Test Table Insert and rinse both sides under running water
b) Dry and replace insert
Cleaning Exterior of device
a) Turn Analyzer off by pressing on on/off button for 2 seconds
b) Wipe the outside of the unit with a cloth dampened (not wet) with a mild detergent
c) Allow unit to air dry and turn on
Please review this manufacturer’s recommendation in the Operator’s Manual 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.

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