EKF Diagnostics STAT-Site MHigh Manual do utilizador

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EST

ROCEDURE

The STAT-Site

Hgb

Test procedure is detailed in this

insert and in the STAT-Site

Hgb

Meter User's Guide.

Hgb

Before You Test: Read the STAT-Site

Meter

User's Guide for complete information on meter setup,

maintenance and display messages.

Materials Provided

Hgb

•

STAT-Site

Test Cards

•

CODE Key

Additional Materials Needed

•

Latex Gloves

•

Lancets for capillary blood collection

•

Biohazardous waste container

•

Alcohol swabs and gauze for cleaning puncture site

•

STAT-Site

Hemoglobin Controls, Cat. No. 503000

•

STAT-Site

Hgb

Meter (Catalog #900900).

Display

This is where the Test Results, Symbols and

Codes, and simple Messages that guide you

through the procedure are displayed.

On/Off

Up Button

Button

Used to access

Used to turn the

meter off and on.

memory, and select

options.

Test Card

Platform

Down

Can be removed to

Button

provide access to

battery, CODE Key,

Used to select options.

and to clean.

Test Card

Figure 1

Platform Tab

Test Card Holder

Helps you remove the Test

This is where the STAT-Site

Hgb

Card Platform.

Test Cards are inserted.

Press

to turn on power. To conserve battery

power, the meter will automatically shut off if left

idle for more than 2 minutes.

pg 2

STEP 1. CODE the Meter

If the CODE number on the

display matches the CODE

number of the Test Card that

you are using, GO TO STEP 2

(see Figure 2).

If no CODE number or a CODE

Figure 2

number different from the CODE of the Test Card that

you are using is displayed on the screen, remove the Test

Card Platform by gently pushing up on the tab at the

bottom of the Test Card Platform (see Figure 1).

Insert the appropriate CODE Key in the opening marked

with an arrow (see Figure 4).

When the CODE Key has been correctly inserted, the

meter will display "CODE," the coded TEST NAME

(i.e., Hgb), and the CODE number.

You may leave the CODE Key in place and replace the

Test Card Platform by lining up the top edge (see Figure

3), sliding up, and pressing into place.

STEP 2. Insert the Test Card

The flashing Test Card symbol

indicates that you

should insert the Test Card. Insert a STAT-Site

Hgb

Test Card with a CODE number that matches the CODE

displayed on the screen at power on.

Slide the edges of the Test Card under the Guide tabs on

the Test Card Holder. It is important that you insert

the card fully (see Figure 5) to the back. You will feel

and hear the Test Card "lock" into place.

When the display shows the Test Type (i.e. Hgb), an

unblinking Test Card symbol , and a Flashing Drop

symbol , it is time to apply the sample (see Figure 6).

About Obtaining The Fingerstick Sample

•

Washing hands under warm water greatly increases blood flow and

should help to relax the patient.

•

The fingerstick should provide a free-flowing drop of blood

without squeezing the fingertip.

•

See Page 1 of this insert for additional information on specimen

collection and preparation.

STEP 3. Apply the Sample

Position the drop of blood directly over the center of the

Test Card. Carefully lay the drop of blood on the center

of the Test Card (see Figure 7). If desired, a Transfer

Tube (Catalog #202012) or a device capable of deliver-

ing approximately 12µL of blood can be used to collect

and apply the sample (see Figure 8) (needed if sample is

not a large hanging drop applied directly from a finger-

stick). After applying the sample to the center of the

Test Card, the countdown to test result will begin.

The Test may finish before reaching zero.

CODE THE METER.

Figure3

Figure 4

INSERT THE TEST CARD.

Figure 5

Figure 6

APPLY THE SAMPLE.

Figure 8

Figure 7

(Optional-

see Step 3)

EST

ESULT

When the test is completed, the final result is displayed along

with the test type and appropriate units (g/dL or mmol/L). The

STAT-Site

Hgb

Test provides a direct reading of hemoglobin

concentration in whole blood between 6 and 21 g/dL. Values

below or above this range will be reported as <Lo> or <Hi>

respectively.

Record your result and remove the Test Card. Remove test

card and inspect the bottom of card to confirm even color

development. To remove the Test Card, lift very slightly as you

slide the Test Card out of the meter. Dispose of the Test Card

properly. Note: see meter User's Guide for instructions on

setting up units to display.

SING

EMORY

The meter will shut off automatically after two minutes of

inactivity. To retrieve the last result from meter memory:

Remove the used Test Card.

Press the On/Off button to turn the meter on.

Press and hold the

Up button to display the last result.

Press the On/Off button to turn the meter off.

DISPLAY MESSAGES

(For more information see the meter User's Guide.)

Lo Result is less than (<) 6 mg/dL.

Result is greater than (>) 21 mg/dL.

E-1 Room Temperature is outside of operating range

E-2 Too much sample.

Repeat test with new Card.

E-3 Not enough sample.

Repeat test with new Card.

E-4 Meter Error

Clean meter and retest.

E-5 Card Error

Use new card and try again.

E-6 Calibration Error

Call Technical Service.

E-8 CODE Key Error

Call Technical Service.

UALITY

ONTROL

To assure consistent performance of your STAT-Site

System, it is recommended that control material be assayed

according to the established quality assurance guidelines for

your facility. For this purpose, we recommend STAT-Site

Hemoglobin Controls, Ref. No. 503000. External controls

should be tested with each new lot or shipment of test cards,

once for each test kit, and as otherwise required by your

laboratory's standard GLP quality control procedures.

Process the controls as you would a patient specimen.

Always test control material when you first use your meter or

if you drop your analyzer, or if there is any indication the Test

System is not functioning properly.

Replicate testing is recommended to ensure that good tech-

nique has been achieved. If results with the quality control

material do not fall within the expected range, and the reason

cannot be identified, consult the Technical Assistance section

Hgb

of the STAT-Site

User's Guide before calling Technical

Service.

IMITATIONS

•

For in vitro diagnostic use.

•

Do not use with serum or plasma.

•

Fetal, newborn, or variant hemoglobin samples have not

been evaluated with STAT-Site

Hgb

. Children as young

as 3 weeks old were tested and included in the study.

•

The performance characteristics of arterial blood have not

been determined.

XPECTED

ESULTS

Different blood hemoglobin values have been reported in the

literature

(2,3,4,5)

Adult Males

13-18 g/dL

Adult Females

11-14 g/dL

Infants (postnatal)

10-14 g/dL

Children (2 yrs.-teenage)

Gradual increase from

infant to adult levels.

Due to the wide range of conditions (dietary, geographical,

smoking, exercise, recumbency, etc.) which affect reference

values

(6)

, it is recommended that each laboratory establish its

own expected ranges.

Hgb

pg 3