Arkray Lab 004 Operating Instructions Manual

Premise
Thank you for purchasing our compact biochemical analyzer, The Lab
004.
This operating manual contains important information on the functions of
The Lab 004.
This operating manual is issued by ARKRAY, Inc.
Read carefully prior to starting up the unit.
It is recommended to retain this operating manual for future use.
The Lab 004 (DB-3910) instrument is intended for the quantitative and
automated measurement of several physiological markers in serum and
plasma. This instrument is intended for use with The Lab 004 reagent
strips. For information about the analyte, the function and the target
disease/condition as well as the intended use population, please refer to
the reagent instructions for use. For in vitro diagnostic use and
professional use only.
This product conforms to the EMC Standard IEC61326-2-6:2012
(EN61326-2-6:2013).
Class of emission: CISPR 11 Class A
This instrument is an IVD medical instrument.
This product conforms to Regulation (EU) 2017/746.
This instrument generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the operating manual,
may cause harmful interference to radio communications. Operation of
this instrument in a residential area is likely to cause harmful
interference in which case the user will be required to correct the
interference at his own expense.
The electromagnetic environment should be evaluated prior to operation
of the device. Do not use this device in close proximity to sources of
strong electromagnetic radiation, as these may interfere with proper
operation.
Introduction
Read this operating manual thoroughly before using the instrument. This
operating manual gives an overview of the instrument and the proper
procedures for operation and maintenance. Follow the instructions in
this operating manual in order not to defeat the purpose of the protective
features of the instrument.
If you have had or could have had any serious incident related to the
device, please report it directly to the manufacturer or through the
authorised representative and to your local regulatory authority.
For the purchase of reagents, consumables or other optional items,
contact your distributor.
© 2019 ARKRAY, Inc.
84-08673
• TAKE THE UTMOST CARE WHEN HANDLING BLOOD. This
instrument uses blood as sample. Blood may be contaminated
with pathogenic microorganisms that can cause infectious
diseases. Improper handling of blood may cause infection to
the user or other individuals by pathogenic microorganisms.
• This product is intended for professional use only and hence
the system is to be operated by qualified persons only. A
qualified person is one having adequate knowledge of clinical
testing and the disposal of infectious waste. Thoroughly read
this operating manual before use.
• Never touch the strip tray or other parts where the sample may
adhere with your bare hands. During cleaning or maintenance
of these parts, wear disposable gloves to prevent exposure to
pathogenic microorganisms.
• Dispose of used samples, tips, reagent strips, parts and
instrument in accordance with local regulations for
biohazardous waste.
For a description of the performance characteristics, reference
intervals, warnings and limitations specific to the reagent, refer
to the reagent product insert.
NOTE:
This product is a precision instrument. Handle the instrument with care.
Do not subject the instrument to strong impact or vibration
• It is strictly prohibited to copy any part of this operating manual without the
expressed consent of ARKRAY, Inc.
• The information in this operating manual is subject to change without notice.
• ARKRAY, Inc. has made every effort to prepare this operating manual.
Should you discover anything strange, incorrect or missing, please contact
your distributor.
Symbols
The following symbols are used in this operating manual to call your
attention to specific items.
■ For your safety
Follow the instructions given here to prevent exposure to
pathogenic microorganisms.
Follow the instructions given here to prevent injury and property
damage.
■ For optimal performance
IMPORTANT:
Follow the instructions given here to obtain accurate measurement
results.
NOTE:
Information useful for preventing damage to the instrument or parts,
and other important information you should keep in mind.
REFERENCE:
Additional explanations that help you make the best use of the instrument
and information on related functions.