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EDAN H50 - Chapter 1 Safety Guidance; Intended Use and Indications; Safety Warnings and Cautions

EDAN H50
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H50/H51 Hematology Analyzer User Manual Safety Guidance
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Chapter 1 Safety Guidance
1.1 Indications for Use/Intended Use
H50/H51 Hematology Analyzer is intended to qualitatively and quantitatively measure blood
cells and provide measurement results. It is intended for some routine blood tests or physical
examination in outpatient department or ward of a hospital. H50/H51 Hematology Analyzer
supports to test whole blood samples. Human body fluid, human serum or plasma, and animal
blood are not tested by the analyzer.
The sample must be collected in a tube with K
2
EDTA.
H50/H51 Hematology Analyzer should be operated by trained and qualified medical personnel.
1.2 Warnings and Cautions
1.2.1 Safety Warnings
NOTE:
The reliability of the analyzer and the safety of operators are considered during product
design and production. The following safety and preventive measures should be carried
out:
WARNING
Safety Warnings
1. The analyzer is not intended for treatment.
2. The analyzer is not intended for home use.
3. Do not use the analyzer if it is damaged or defective.
4. The analyzer should be installed by a qualified service engineer. Do not try to
access into the interior of the analyzer. Only authorized service personnel are
authorized to disassemble or maintain the analyzer.
5. To avoid electrical shock, never modify the analyzer’s AC power circuits.
6. The analyzer is intended for use only by trained technologists, nurses, physicians
and therapists. Operators should be familiar with the contents of this user manual
before operation.
7. The results given by the system should be examined based on the overall clinical
condition of the patient, and should not be a substitute for regular checking and
examination.
8. To ensure grounding reliability, only connect the system to a hospital-grade power
receptacle.

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