Chapter I - The BAX® System X5 Instrument
10
BAX® System X5 User Guide
Biological Safety
Samples analyzed with this instrument may contain potentially bio-hazardous material such as bacterial, fungal
or viral agents. As with all potentially biohazardous specimens, universal safety precautions should be taken when
handling and processing samples.
The BAX® System method includes sample preparation enrichment procedures that nourish the growth of
potential pathogens to detectable levels. Because pathogens can cause human illness, appropriate safety
precautions must be taken when handling samples, media, reagents, glassware and other supplies and equipment
that could be contaminated with potentially pathogenic bacteria. In particular, individuals who are pregnant or
immunocompromised should avoid any potential contact with
Listeria
monocytogenes
.
Reagents used with the BAX® System assays should pose no hazards when used as directed. Before using this
product, please review the Safety Data Sheets (SDS), available on the web at www.Hygiena.com. Refer to your site
practices for safe handling of materials at extreme temperatures.
Wear protection gloves and clothing.
Never eat, drink, or smoke in the laboratory.
Wash your hands before and after working.
Safety and Electromagnetic Capability (EMC) Standards
U.S. and
Canadian Safety
Standards
This instrument has been tested to and complies with standard UL 3101-1,
“Safety Requirements for Electrical Equipment for Laboratory Use, Part 1:
General Requirements
This instrument has been tested to and complies with standard CSA 1010.1,
“Safety Requirements for Electrical Equipment for Measurement, Control, and
L
aboratory Use, Part 1: General Requirements.”
Canada EMC
Standard
This instrument has been tested to and complies with ICES-001, Issue 3:
Industrial, Scientific, and Medical Radio Frequency Generators
European Safety
and EMC
Standards
Safety
This instrument meets European requirements for safety (Low Voltage Directive
73/23/EEC). This instrument has been tested to and complies with standards EN
61010-
1:2001, “Safety Requirements for Electrical Equipment for Measurement,
Control and Laboratory Use,
Part 1: General Requirements,” and EN 61010-2-
010, “Particular Requirements for Laboratory Equipment for the Heating of
Materials.”
EMC
This instrument meets European requirements for emission and immunity (EMC
Directive 89/336/EEC). This instrument has been tested to and complies with
standard EN 61326 (Group 1, Class B), “Electrical Equipment for Measurement,
Control and Laboratory Use
– EMC Requirements.”
Australian EMC
Standards
This instrument has been tested to and complies with standard AS/NZS 2064,
“Limits and Methods Measurement of Electromagnetic Disturbance
Characteristics of Industrial, Scientific, and Medical (ISM) Radio-frequency
Equipment.”