Incorrect Use; Standards And Safety Regulations - Thermo Scientific Safe 2020 Operating Instructions Manual

Safety cabinets
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1.
General notes
Model Maxisafe 2020:
The safety cabinet also meets the requirements from DIN 12980 / 2005-06 and
can be used for the production of cytostatic agents.
For cytostatic agent applications, use the lowered one-piece working plate only.
Prior to the initial operation of the cabinet, the operator must perform an
installation test. The test result must be documented by a test report. The
cabinet must only be released for operation if it is in compliance with the
operating parameters specified by Thermo Electron LED GmbH.
After any changes to the installation conditions or after any modification to the
technical system, a repeat test must be performed and the test result must be
documented by a test report that shows that all operating parameters are in
compliance with those specified by Thermo Electron LED GmbH.
1.4.2

Incorrect use:

The safety cabinet must not be used in laboratories that do not comply with the
requirements of safety levels 1, 2, or 3.
The unit must not be operated as a Class II safety cabinet, if:
no repeat test is performed after changes to the installation conditions or after
modifications to the technical system,
the alarm system of the device has issued a failure message and the
cause for the failure has not been repaired.
The alarm system must not be tampered with or disabled. If alarm system
components heve been removed or disabled for service or repairs, the unit must
only be released for operation if all alarm system components are functioning
again properly.
The filters installed in the device are not capable of separating gaseous
substances. Therefore, do not work with or store substances in the device:
which in quantity or concentration are toxic,
if a reaction with other substances may result in hazardous toxic concentrations
or formation of toxic gases,
that may form combustible or explosive mixtures in combination with air.
1.5

Standards and safety regulations

The device complies with the safety requirements of the following standards and
guidelines:
IEC 61010-1 / EN 61010-1
EN 12469 / 2000
DIN 12980 / 2005-06 (model Maxisafe 2020 only)
Low Voltage Directive
EMC Directive
Operating Instructions Safety Cabinet Safe 2020 / Maxisafe 2020
9

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