1. CLINITEK Status® Plus UACR Operator Training Program

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
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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)
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4. The CLINITEK Status® Plus Device
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
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5. Getting Started LOCATION
The Analyzer should be on a level work surface in a temperature and humidity controlled environment
Ideal temperature: 22o–26oC (72o–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
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6. Getting Started INSERT TEST STRIP TABLE
Hold table by the end opposite of the white calibration bar. DO NOT TOUCH the white calibration strip
Insert with the white bar facing UP into the port on the front
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
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7. Getting Started PRINTER PAPER Turn analyzer to back
Open the printer compartment. This reveals the paper feeder.
Pull up on the grey lever on the LEFT side of the printer compartment
Push down on the grey tab to expose the paper holder
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).
Feed the paper through to expose about 4 inches
Push the grey lever on the left down
Feed the paper though the printer compartment door and close the printer compartment door making sure it clicks back into place
Paper holding arm
Printer paper
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8. Getting Started Video
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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.
During the initial start-up, the Analyzer will prompt you to select a language. Select the language and press Next.
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.
Select proper
Date: Day/Month/Year
Time: 24 hours
Preferred Test Sequence: Select Quick Test
Type of Strip Select “Multistix 10 SG”
Results Format: Conventional
Done will bring you to a Confirmation Screen where you can verify your selections
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
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10. Initial Setup Regular Start up: For all future startup…
The Analyzer will perform a system test each time it is powered up
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.
The main <Select> screen displays with options:
Instrument Setup
Recall Results
Cassette Test (Not applicable for Sonar Study)
Strip Test: Select this option to run Liquid QC and UACR tests
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11. Initial Setup Video
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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 15o–30oC (59o–86oF)
Keep tightly closed when not in use
Do not use product after expiration date
Do not store the bottle in direct sunlight
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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 and open vial stability from date of manufacture when stored at 2o– 8oC
Keep the vials tightly closed when not in use
Expiration date is printed on the control vials
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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
Step 1
Step 2
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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
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16. 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
Step 1
Step 2
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17. 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
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18. Conducting a Test Video
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19. Cleaning Clean the meter on a routine basis Cleaning Test Table Insert
Remove the Test Table Insert and rinse both sides under running water
Dry and replace insert
Cleaning Exterior of device
Turn Analyzer off by pressing on on/off button for 2 seconds
Wipe the outside of the unit with a cloth dampened (not wet) with a mild detergent
Allow unit to air dry and turn on
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20. 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!
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21. Questions Thank You for Your Participation!
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