Product Manual

ManualsBrandsBeckman Coulter ManualsLab & PhlebotomyCOULTER HmX PAK Reagent Kit

For In Vitro Diagnostic Use

INTENDED USE

For use on COULTER HmX hematology analyzers to lyse

erythrocytes and preserve leukocytes. Use with only

ISOTON

III or ISOTON 4 diluent. Refer to your instrument

product manuals.

SUMMARY

An erythrolytic reagent and a leukocyte preservative

produce a sample for performing a five-part WBC

differential analysis using VCS technology.

PRINCIPLES

WBC differential analysis begins by diluting a whole-blood

sample with a lytic solution of formic acid that rapidly lyses

the erythrocytes (red blood cells) and reduces the cellular

debris to an insignificant level without altering the

leukocytes (white blood cells). The leukocyte preservative,

consisting of an aqueous solution containing soluble salts,

is added to stop and/or neutralize the lytic activity and

restore the ionic balance to the blood, thus preserving the

leukocytes in their near-native state for differentiation into

five subpopulations (neutrophils, lymphocytes, monocytes,

eosinophils, and basophils) using impedance, radio

frequency, and laser light scatter measurements (VCS

technology).

REACTIVE INGREDIENTS

The COULTER HmX PAK Reagent Kit contains the

following:

PAK LYSE - COULTER Erythrolyse™

II Reagent

Wetting Agent............................................ 0.3-1.5 g/L

Formic Acid ............................................... 1.2 mL/L

PAK PRESERVE - COULTER StabiLyse™

Reagent

Sodium Carbonate .................................... 6.0 g/L

Sodium Chloride...................................... 14.5 g/L

Sodium Sulfate ........................................ 31.3 g/L

WARNINGS

 Product contains <0.5% Formic Acid.

 Do not inhale and/or ingest.

 Avoid eye and skin contact. In case of eye or skin

contact, flush affected area with copious amounts of

water for at least 15 minutes.

 DO NOT REUSE CONTAINERS.

STORAGE, STABILITY, AND DISPOSAL

 Store COULTER HmX PAK Reagent Kit at 2-25°C.

 Do not use product past expiration date.

 Use product at temperatures stated in the instrument

product manuals.

 Opened containers are stable for 60 days when stored

as recommended.

 Dispose of waste product, unused product, and

contaminated packaging in compliance with federal,

state, and local regulations.

PREPARATION

Reagents in the COULTER HmX PAK Reagent Kit are

ready to use. Replace the reagent kit as directed in your

instrument product manuals.

IMPORTANT: If product has been partially or completely

frozen, allow product to warm to room temperature. Mix

product by gentle inversion prior to placement on the

instrument. Install and prime the reagent kit as directed in

your instrument product manuals. Verify background counts

are acceptable before analyzing patient samples.

PRODUCT AVAILABLITY

COULTER HmX PAK Reagent Kit

8547166

(Contains 1 x 1300 mL PAK LYSE and

1 x 350 mL PAK PRESERVE)

TRADEMARKS

Beckman Coulter Logo, COULTER, Erythrolyse, ISOTON,

and StabiLyse

are trademarks of Beckman Coulter, Inc.

U.S. Patent Document Number 5,155,044

For additional information or if damaged product is

received, call Beckman Coulter Customer Service at

800-526-7694 (USA or Canada) or contact your local

Beckman Coulter Representative.

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea, CA 92821

www.beckmancoulter.com

Printed in USA

Made in USA

SSCOULTERP

HmX PAK

Reagent Kit

8547166

PN 772246-AA

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