Atellica® HEMA Diluent

Current Revision and Date Rev. 03, 2022-06

Product Name Atellica HEMA Diluent 10L 11374304

Atellica HEMA Diluent 20L 11374303

Abbreviated Product Name HEMA Diluent

Systems Atellica HEMA 570

Atellica HEMA 580

Intended Use
Atellica® HEMA Diluent is a buffered isotonic solution intended for in vitro diagnostic use and
designed for sheathing and diluting leukocytes (WBC), and for the determination and
differentiation of blood cells, and the measurement of hematocrit on Atellica HEMA Analyzers.

Principles of the Procedure

Atellica HEMA Diluent is a saline and buffered electrolytic solution which allows the dilution
and the preparation of blood samples for analysis. The presence of non-ionic surfactant
ensures an optimal dynamic of flow in the whole hydraulic systems of the instrument. The
electrolytic action supports the counting of the cells by impedance.
The reagent is also used to stop the chemical reactions of some other reagents. This reagent is
also used in rinsing and cleaning cycles of the hydraulic systems of the instrument.

Reagents
Material Description Storage Stability

Atellica HEMA Diluent Unopened: 18–25°C Until expiration date on product

Composition: Onboard 4 months

Organic Buffer: < 5% Do not freeze.
Preservative (Sodium azide): < 0.1%
Surfactant: < 0.1%
Description: Limpid and colorless aqueous
solution.

Warnings and Precautions

For in vitro diagnostic use.
For Professional Use.

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For Prescription Use Only.

CAUTION
Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare
professional.

Safety data sheets (SDS) available on siemens-healthineers.com.

This reagent is designed for use with Atellica HEMA Analyzers specified above.
Siemens Healthcare Diagnostics cannot guarantee the correct functioning of this reagent with
instruments other than those specified above, or with instruments not manufactured by
Siemens Healthcare Diagnostics.
Contains sodium azide as a preservative. Sodium azide can react with copper or lead plumbing
to form explosive metal azides. On disposal, flush reagents with a large volume of water to
prevent buildup of azides. Disposal into drain systems must be in compliance with prevailing
regulatory requirements.
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution. Discard all materials in a safe and acceptable manner and in compliance with
prevailing regulatory requirements.

Storage and Stability

Store all reagents in an upright position, away from light and heat. Do not use products
beyond the expiration date printed on the product labeling.
For information about product storage and stability, refer to Reagents.

Preparing Reagents
Atellica HEMA Diluent is ready to use.

Procedure
Materials Provided
The following materials are provided:

Contents Volume

11374304 Atellica HEMA Diluent 10L 1 x 10 L

11374303 Atellica HEMA Diluent 20L 1 x 20 L

Materials Required but Not Provided

The following materials are required to perform this assay, but are not provided:

Description

Atellica HEMA Analyzer

Control: refer to the user manual for the specific control used with your instrument.

Test Procedure
1. Refer to the user manual to identify Atellica HEMA Diluent using the barcode reader or
manually.
2. Uncap the new reagent bottle.
3. Insert the stopper assembly straw into the container.

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4. Tighten the stopper assembly to ensure adequate seal.

5. Install the Atellica HEMA Diluent container below the instrument as described in the user
manual.
Follow instructions displayed on your instrument software.
Refer to the system online help for detailed analysis and control procedures.

Performing Quality Control

Atellica HEMA controls must be used to periodically assess the integrity of the reagents and
the instrument in the specified ranges.
Additional quality control material can be used at the discretion of the laboratory. Use the
quality control material in accordance with the quality control instructions for use.
In addition, perform quality control:
• Following a valid calibration
• With use of a new lot of reagent
• When troubleshooting test results that do not match clinical conditions or symptoms
Follow government regulations or accreditation requirements for quality control frequency.
Individual laboratory quality control programs and procedures may require more frequent
quality control testing.

Taking Corrective Action

If the quality control results do not fall within the expected control interval, do not report
results. Perform corrective actions in accordance with established laboratory protocol. For
suggested protocol, refer to the system online help.

Results
Refer to the instrument user manual for calculation and interpretation of analytical results.

Limitations
Packaging Damage
In case of protective packaging damage, do not use product. Damages to the product might
have an effect on the product performance.

Signs of Deterioration
In the event of any signs of physical or chemical deterioration (turbidity, change in color, etc.)
Atellica HEMA Diluent should be replaced.

Temperature Limits
Do not use product if it has been frozen or kept at excessive heat.
Before using, make sure the product has reached the operating temperature conditions as
described in the system online help.

Performance Characteristics
Refer to the user manual for the performance characteristics of the instrument and the
limitations of the analyses on instrument parameters.

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Technical Assistance
According to EU regulation 2017/746, any serious incident that has occurred in relation to the
device shall be reported to the manufacturer and the competent authority of the EU Member
State in which the user and/or patient is established.
For customer support, contact your local technical support provider or distributor.
siemens-healthineers.com

Definition of Symbols
The following symbols may appear on the product labeling:

Symbol Symbol Title Source Symbol Symbol Title Source

Manufacturer 5.1.1a Authorized representative 5.1.2a

in the European
Community

Use-by date 5.1.4a Authorized representative Proprietary

in Switzerland

Catalog number 5.1.6a Batch code 5.1.5a

Consult Instructions for 5.4.3a Contains sufficient for <n> 5.5.5a

Use tests

Internet URL address to Proprietary Version of Instructions for Proprietary

access the electronic Use
instructions for use

In vitro diagnostic medical 5.5.1a Revision Proprietary

device

Prescription device (US FDAb Unique Device Identifier 5.7.10c

only)

CE Marking with Notified EU IVDRd CE Marking EU IVDRd

Body

Temperature limit 5.3.7a Keep away from sunlight 5.3.2a

Upper limit of tempera- 5.3.6a Lower limit of tempera- 5.3.5a

ture ture

Do not re-use 5.4.2a Do not freeze Proprietary

Recycle 1135e This way up 0623e

Biological risks 5.4.1a Caution 5.4.4a

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Symbol Symbol Title Source Symbol Symbol Title Source

YYYY-MM-DD Date format (year-month- N/A YYYY-MM Date format (year-month) N/A
day)

Target Proprietary Interval Proprietary

a International Standard Organization (ISO). ISO 15223-1 Medical Devices- Symbols to be used with medical
device labels, labelling and information to be supplied.
b Federal Register. Vol. 81, No 115. Wednesday, June 15, 2016. Rules and Regulations: 38911.
c ISO 15223-1:2020-04
d IVDR REGULATION (EU) 2017/746
e International Standard Organization (ISO). ISO 7000 Graphical symbols for use on equipment.

Legal Information
Atellica is a trademark of Siemens Healthineers.
© 2021–2022 Siemens Healthineers. All rights reserved.

Siemens Healthcare Diagnostics Inc.

511 Benedict Avenue
Tarrytown, NY 10591 USA

Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestraße 127
91052 Erlangen
Germany
Phone: +49 9131 84-0
siemens-healthineers.com

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