03-11-24 9
1 Safety Instruction
1.1 Intended Use
CA620/530 and CA620-CellGuard
The CA620/530 is a fully automated hematology analyser used for in vitro diag-
nostic testing of whole blood specimens under laboratory conditions. The user
must have basic skills in laboratory practice and must be aware of the guidelines
in “Good Laboratory Practice”.
The CA620-CellGuard is intended to be used especially in blood banks as pre do-
nor screening as well as a quality control tool for PLT concentrates in a blood
bank production facility.
During the installation and set-up, the CA620-CellGuard can be configured either
for pre-donor screening, in which the instrument is fully identical to the CA620,
or for quality control to measure PLT concentrates.
1.2 Counter Indications
• Do not use the instrument outdoors.
Usage outside the specified temperature and humidity range might result in
instrument malfunction or short circuit.
- Turn off the power immediately and contact your service department.
• Do not modify the instrument.
Modification without written instructions from the manufacturer might
cause erroneous results or risk for electrical shock.
• Do not remove the cover. Only authorized service personnel is allowed to
open the instrument.
• Do not use the instrument for other purposes then as indicated in this man-
ual.
1.3 Warranty Limitations
• Service and instrument maintenance must be performed by Boule Medical
AB or authorized service personnel. (Referred to hereafter in this manual as
Boule).
• Use only original spare parts and by Boule authorized reagents, blood, cali-
brators and cleaners.
Boule has designed the Medonic instruments as systems for optimal per-
formance. Substituting reagents, calibrators, controls, and components not
recommended by Boule may adversely affect the performance of the instru-
ment. If the substituted products are defective or adversely affect the per-
formance of the instrument it may void your warranty. Each Boule system
is tested at the factory using our recommended reagents, calibrators and
controls, all performance claims are generated as part of this complete sys-
tem.
• System operators and laboratory supervisors are responsible that Boule
products are operated and maintained in accordance to the procedures de-
scribed in the Product Labelling (manuals, package inserts and bulletins of
any kind). They are also responsible for determining that product perform-
ance conforms to the applicable claims.
1070en01
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