CLINITEK STATUS® PLUS UACR OPERATOR TRAINING PROGRAM.

CLINITEK STATUS® PLUS UACR OPERATOR TRAINING PROGRAM

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

2M11-352 Investigator Training | 06.14.13 | Company Confidential © 2013

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

M11-352 Investigator Training | 06.14.13 | Company Confidential © 2013 4

1. Analyzer2. Power supply adaptor and AC power cord (Figure shows US version)3. Test table with calibration bar4. Test table insert5. Paper roll

The CLINITEK Status® Plus DeviceThe CLINITEK Status® Plus Device

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


Getting Started

INSERT TEST STRIP TABLE

1.Hold table by the end opposite of the white calibration bar. DO NOT TOUCH the white calibration strip

2.Insert with the white bar facing UP into the port on the front

3.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 PAPER1.Turn analyzer to back2.Open the printer compartment. This reveals the paper feeder.3.Pull up on the grey lever on the LEFT side of the printer compartment 4.Push down on the grey tab to expose the paper holder5.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).6.Feed the paper through to expose about 4 inches7.Push the grey lever on the left down 8.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 ONPress 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: Conventional

Done will bring you to a Confirmation Screen where you can verify your selectionsd)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 themain screen. Title Bar will say <Select> & Ready along with a Time/Date Stamp.

c)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


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 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


Consumable – Quality Control Solutions

• Two levels of Quality Control: Level 1 and Level 2

• IMPORTANT: Daily routine when conducting patient testing1. 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 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


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> screen3. Select “Quick Test”

� The Analyzer will proceed to the <Prepare Test> Screen4. 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

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


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 blotting2. Touch Strip Test on the main <Select> screen3. Select “Quick Test”

� The Analyzer will proceed to the <Prepare Test> Screen4. 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

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�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


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!


Questions

Thank You for Your Participation!


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CLINITEK STATUS® PLUS UACR OPERATOR TRAINING PROGRAM.

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