User'S Guide: Hematology Calibrator Mek-Cal

USER’S GUIDE Hematology Calibrator
0604-021476D First Edition: 13 Jun 2007 Fifth Edition: 04 Mar 2016 MEK-CAL
The MEK-CAL hematology calibrator contains human erythrocytes,
simulated leukocytes, and mammalian platelets in a plasma-like fluid.
The hematology calibrator is for in vitro diagnostic use.
To achieve optimum performance and safety, thoroughly read this
guide and the hematology analyzer operator’s manual before using the
hematology calibrator.
Instructions for Use

The CE mark is a protected conformity mark of the European NOTE
Community. Products marked with this symbol comply with the
• Dark red supernatant fluid, discoloration of the product or
requirements of the In vitro Diagnostic Medical Device Directive
unacceptable results may indicate deterioration. Do not use the
98/79/EC.
hematology calibrator if deterioration is suspected.
• Confirm that the lot number of the product matches the lot number
General Handling Precautions on the assay sheet.
WARNING 1. Take the hematology calibrator out of the medical refrigerator and
• Dispose of the hematology calibrator by following your local allow it to warm to temperatures between 18 and 30°C (64 and
laws for disposing of infectious medical waste. Otherwise, it 86°F) for 15 minutes before mixing.
may affect the environment.
2. Invert and mix the hematology calibrator.
• Do not swallow the hematology calibrator. It may be infectious.
• Mix the hematology calibrator until the red cells
• When handling the hematology calibrator, wear rubber gloves
are completely suspended.
to protect yourself from infection.
• Immediately before measuring the hematology
calibrator, gently turn it upside down 8 to 10 times.
NOTE
• This hematology calibrator is potential biohazardous material.
NOTE
The MEK-CAL hematology calibrator is intended solely for in vitro • Do not mix the hematology calibrator roughly.
diagnostic use by trained personnel. The hematology calibrator • Do not mix the hematology calibrator using a mixer.
contains human-sourced and/or potentially infectious components. • Incomplete mixing of the hematology calibrator affects the
Components from human donors used in preparation of the measurement result.
hematology calibrator were tested by FDA approved methods for
the presence of the antibodies to human immunodeficiency virus 3. Calibrate the hematology analyzer using the hematology calibrator
(HIV-1/HIV-2) and Hepatitis C virus (HCV) as well as for Hepatitis B as instructed in the hematology analyzer operator’s manual.
virus surface antigen and found to be negative.
• Do not use the hematology calibrator after the expiration date. The 4. Return the hematology calibrator to the medical refrigerator within
measurement data may be inaccurate. 30 minutes of use.
• Store the hematology calibrator in a medical refrigerator.
• Store the hematology calibrator at temperatures between 2 and Expected Results
8°C (36 and 46°F). Do not freeze the hematology calibrator. For calibration values, refer to the assay sheet.
• Allow the hematology calibrator to warm to temperatures between
18 and 30°C (64 and 86°F) and then invert and mix the hematology
Storage
calibrator. Otherwise the contents may leak from the cap.
Store at 2 to 8°C (36 to 46°F).
• If the cap of the hematology calibrator becomes dirty, wipe with a
non-woven towel such as Kimwipes. NOTE
• Platelet cannot be measured by precipitation or centrifuge. Do not freeze the hematology calibrator.
General Expiration Date

The expiration date is shown on the container label.
The MEK-CAL hematology calibrator is for calibration of Nihon
Kohden hematology analyzers. For calibration, refer to the provided
assay table for specific instrument models and the operator’s manual of Expiration Date After Opening the Package
the hematology analyzer. Opened hematology calibrator should be used within 7 days.
NOTE
The MEK-CAL hematology calibrator is designed for Nihon Kohden Copyright Notice
hematology analyzers. Do not use with any other instrument. The entire contents of this manual are copyrighted by Nihon Kohden.
All rights are reserved.
Manufacturer European Representative

NIHON KOHDEN CORPORATION NIHON KOHDEN EUROPE GmbH NIHON KOHDEN SINGAPORE PTE LTD NIHON KOHDEN AMERICA, INC.
1-31-4 Nishiochiai, Shinjuku-ku, Tokyo 161-8560, Japan Raiffeisenstrasse 10, D-61191 Rosbach, Germany 1 Maritime Square, #10-34 HarbourFront Centre 15353 Barranca Parkway, Irvine, CA 92618, U.S.A.
Phone +81 (3) 5996-8036 Fax +81 (3) 5996-8100 Phone +49 6003 827-0 Fax +49 6003 827-599 Singapore 099253 Toll-free +1-800-325-0283
Phone +65 6376-2210 Fax +65 6376-2264 Phone +1 949-580-1555 Fax +1 949-580-1550

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USER’S GUIDE Hematology Calibrator

Instructions for Use

General Expiration Date

Manufacturer European Representative

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