Transcript NOVA StatStrip power point

CLINITEK Status Plus UACR Operator
Training Program
®
M11-352
Sonar Study
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
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)
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
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
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.
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
Getting Started Video
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.
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
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
Initial Setup Video
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.
Consumable: Quality Control Solutions
•
•
Two levels of Quality Control: Level 1 and Level 2
IMPORTANT: Daily routine when conducting patient testing:
1. Conduct two levels of Quality Control testing (requires 2
strips) once the patient visit is confirmed for that day.
2. Patient testing is valid for 24 hours following Quality
Control.
3. 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.
Conducting Quality Control
1.
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
2.
Touch Strip Test on the main <Select> screen.
3.
Select “Quick Test”
•
The Analyzer will proceed to the <Prepare Test> Screen
4.
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
Step 1
Step 2
NOTE: DO NOT lay the pads on the paper towel or cover the pads with the paper towel
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.
5. At the conclusion of the testing countdown, <Results> will be displayed on the screen.
• Select Print to print the results.
6. Click Done to return to the main <Select> screen and remove used urinalysis strip and
discard in a biohazard container.
7. Repeat steps two (2) through six (6) for Level 2 Quality Control testing.
8. Confirm that the QC results are acceptable by comparing with range on QC vials.
Complete the QC Confirmation Step
• Go to http://mytrial.info
• Enter your Information on the
form
• Submit
• You will receive an email
confirmation
• You will only have to
complete this form once!
Conducting Patient Test
1.
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
2.
Touch Strip Test on the main <Select> screen.
3.
Select “Quick Test”
•
The Analyzer will proceed to the <Prepare Test> Screen
4.
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
Step 1
Step 2
NOTE: DO NOT lay the pads on the paper towel or cover the pads with the paper towel
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.
5. At the conclusion of the testing countdown, <Results> will be displayed on the screen.
• Select Print to print the results.
6. Click Done to return to the main <Select> screen and remove used urinalysis strip and
discard in a biohazard container.
7. Record patient results per protocol.
Conducting A Test Video
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
Questions?
Thank You for Your Participation!