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Safety Instruction
10
03-11-24
1070en01
If, under these prescribed conditions of operation and maintenance, an aberrant
or abnormal result occurs, as defined by the laboratory protocol, laboratory per-
sonnel should first make certain that the system is performing and is being oper-
ated in accordance with the Product Labelling. The laboratory protocol should
than be followed to advise the clinician in case a result appears to have deviated
from the norms established by the laboratory.
Boule products do not make diagnosis on patients. Boule intends its diagnostic
products (systems, software and hardware) to be used to collect data reflecting
the patient's hematological status at a certain point of time. Such data may be used
in conjunction with other diagnostic information and with the attending physi-
cians evaluation of the patients condition to arrive at a diagnosis and a clinical
course of treatment.
1.4
General Warnings
Boule incorporates safety features within the instrument in order to protect the
operator from injury, the instrument from damage and the test results from inac-
curacies.
Electrical hazard
•
Do not spill blood, reagent, drop metal objects such as wire staples or paper
clips into the instrument. This might cause a short circuit.
If this should occur, turn off the power immediately and contact your serv-
ice department.
Note:
The cover should only be opened/removed by authorised service
personnel.
•
Do not touch the electrical circuits inside the cover.
There is a hazard of electrical shock.
Note
: The cover should only be opened/removed by authorised service
personnel.
Potentially biohazardous material
Because no test method can offer complete assurance that HIV, Hepatitis B or C
viruses, or other infectious agents are absent, these products should be handled
at the Biosafety Level 2 as recommended for any infectious human blood speci-
mens in Protection of Laboratory Workers From Infectious Disease Transmitted
by Blood, Body Fluids and Tissues- 2nd Edition, Tentative Guidelines(1991)
Document M29-T2 promulgated by the National Committee for Clinical Lab.
Standards in the U.S.A. (NCCLS)
Contamination hazard
•
Always wear protective gloves and/or goggles when handling infectious or
potentially infectious materials.
•
Handle samples with great care.
There is a risk of infection if contaminated blood splashes.
- If blood splashes, enter your eye or a cut, wash it off with plenty of water.
•
Do not touch the waste liquid when discarding waste or disassembling/as-
sembling the related parts outside the instrument.
Risk of infection from contaminated blood.
-If you should touch the waste liquid inadvertently, wash off with disinfect-
ant first, then wash it off with soap.
Summary of Contents for CA530
Page 2: ......
Page 6: ...6 03 11 24 ...
Page 24: ...Specifications 24 03 11 24 1001en01 ...
Page 38: ...Parameter Flags 38 03 11 24 1002en01 ...
Page 80: ...Warning Displays 80 03 11 24 1008en01 ...
Page 92: ...QC and Blood Controls 92 03 11 24 1156en01 ...
Page 98: ...Maintenance Shut Down Transport 98 03 11 24 1011en01 ...
Page 107: ......