Alere Cholestech LDX Короткий довідник - Сторінка 2

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Setup

Take the time to examine and familiarize yourself with the contents of the Alere Cholestech LDX

Connecting the Alere

Cholestech LDX

Analyzer

to the Printer

Before starting to test, press and hold

STOP to enter the Configuration Menu

and select options for language, units,

sample type, printer, risk assessment,

date and time.

Plug the printer power

Plug the power supply

supply

into the printer

into the Alere Cholestech

The DATA button allows you to

and the wall or power

LDX

Analyzer and the wall

select choices for each of the menu

strip. Connect the end

or power strip. Insert the

items in the Configuration Menu. The

end of the white printer

RUN button enters your choices and

of the printer cable B,

advances you to the next menu item.

labeled 'To Printer' to the

cable D, labeled 'To

printer.

Cholestech LDX

," into

the analyzer. Loop through

the cable support.

Optics Check

Running Controls

Run the Optics Check Cassette

Alere™ Level 1 and 2 Controls

Press the RUN button.

Controls must be run

The drawer will open.

following manufacturer's

Place the Optics Check

recommendations. Controls

Cassette into the cassette

must be at room temperature

before testing. Verify that the

drawer. Press the RUN

lot number on the control vial

button again to close the

and the assay sheet are the

drawer.

same. Mix each vial by gently

inverting at least 7 times immediately before

Record Results

use. Store controls in the refrigerator when

not in use.

Check to see that the

four numbers are within

the acceptable range

Testing QC Material

printed on the Optics

Check Cassette. Record

Use the MiniPet

the results on the

tips to measure and dispense

Optics Check Log. If the

the control sample into the

numbers are outside the

cassette. Place the cassette

in the drawer immediately

range, the analyzer will

be temporarily disabled until another optics

and press RUN. Record

check is run that falls within range.

results on a Quality Control

The Optics Check Cassette is used to check

Log. Results must be within

the optical system of the analyzer. Run the

established ranges before patient samples

Optics Check Casette: once each day before

can be tested.

patient samples are tested and after the

Alere Cholestech LDX

Analyzer has been

moved or serviced.

Test Procedure

System.

Open the Drawer

Configuration Menu

Press the RUN button on the analyzer. The

cassette drawer will open, and the screen

will display:

Load cassette

and press RUN

Insert the Cassette

Immediately place the cassette into the

analyzer drawer with the black reaction

bar toward the analyzer and the brown

magnetic stripe on the right.

FAQ

Pipette and

Frequently asked questions about the use of the Alere Cholestech LDX

How do I get a CLIA Certificate of Waiver?

Even though the Alere Cholestech LDX

site using the Alere Cholestech LDX

To obtain a Certificate of Waiver, call your state department of health or Alere (1.877.441.7440) for an

application (form CMS-116). Alere can give you the phone number of your state department of health and

assist you in filling out the application.

Remember:

The Alere Cholestech LDX

Perform a Fingerstick

After cleaning the selected site with alcohol

and drying it thoroughly, firmly prick the site

with a lancet. Gently squeeze the finger to

obtain a large drop of blood. Wipe off the

first large drop of blood.

Begin the Test

Press RUN. The drawer will close. When the test

is finished, the analyzer will beep and the drawer

will open. Put everything that touched the

blood sample into a biohazardous waste

container.

System.

System is a "CLIA-waived" test system, each laboratory or testing

System must have a CLIA Certificate of Waiver before starting testing.

System is only waived for fingerstick or venous whole blood.

Collect the Sample

Dispense the Sample

Squeeze the finger gently again until a large

Place the end of the capillary tube into the

drop of blood forms. Hold the capillary tube

sample well and dispense the sample by pushing

horizontally by the end with the plunger. Touch

down on the plunger. Keep the cassette level

it to the drop of blood without touching the skin.

after the sample has been applied.

Fill the capillary tube within 10 seconds.

Do not allow any bubbles to enter the

capillary tube.

View the Results

Print the Results

Press the DATA button on the analyzer once or

The results will print when the test is finished.

twice (depending on the test cassette) to view

remaining results.

This reference guide provides a brief summary of the testing procedure. For more information, see the

test cassette and control package insert or the Alere Cholestech LDX

How often do I have to run the controls?

Controls should be tested:

•

With each new lot of cassettes;

•

With every new shipment of cassettes, even if the lot has been received previously;

•

When reagents may have been stored or handled in a way that can degrade their performance;

•

As otherwise required by your laboratory's standard quality control procedures;

•

As otherwise required by federal, state and local guidelines.

How should I store my cassettes?

When stored refrigerated at 36–46°F (2–8°C), the cassettes are stable until the expiration date printed

on the cassette pouch and box. Cassettes can be stored at room temperature for 30 days. Do not use a

cassette past the expiration date. Do not return cassettes to the refrigerator once they have been stored

at room temperature.

System User Manual.