5
PREFACE
Destination of use
Galileo Series 2 is a semi-automatic rotary microtome for creating thin sections of paraffin embedded specimens. Suitable for specimens
of different hardness.
The instrument may be operated by trained and qualified staff only.
It is possible to set up all process parameters, such as: specimen coarse feed, cutting speed, cutting and trimming thickness.
The reading of this manual and the maintenance are essential to use the equipment avoiding any dangerous situation.
The operators must be adequately trained in its use and respect all safety rules and its use limits.
Trained and authorized Diapath S.p.A. staff will perform instrument maintenance, in case of failure or malfunction.
The microtome complies with CISPR 11 Class A rules: in case of domestic use, it may cause radio interferences. In this case a
measurement and mitigation of such interference is necessary.
Before installing the instrument, an analysis of electromagnetic interferences must be performed.
Do not use the device near sources of strong electromagnetic radiations, such as radiofrequency wave generators. In this case, the
radiations may interfere with the normal functioning of the instrument.
The Instrument has been designed according to the legislative decree 332/00 of 08th September 2000 “Accomplishment of 98/79/CE
directive of 27th October 1998 concerning in-vitro diagnostic medical devices” respecting electromagnetic compatibility rules:
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ISO 9001(*) quality management system. Requirements
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ISO 13485(*) quality management system requirements for medical devices. Requirements for regulatory purposes and
specific requirements of the application of ISO 9001 (*)
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UNI CEI EN ISO 14971(*) application of risks management to medical devices
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UNI EN ISO 18113-3(*) In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3: In
vitro diagnostic instruments for professional use
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UNI CEI EN ISO 15223-1(*) Symbols to be used with medical device labels, labelling and information to be supplied. Part 1:
General requirements
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EN 61326-1(*) Electrical equipment for measurement, control and laboratory use - EMC requirements Part 1: General
requirements
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EN 61326-2-6(*) Electrical equipment for measurement, control and laboratory use - EMC requirements. Part 2-6: Particular
requirements - In vitro diagnostic medical devices (IVD)
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EN 61000-3-2(*) Electromagnetic compatibility (EMC) Part 3-2: Limits - Limits for harmonic current emissions. (equipment
with input current <= 16A per phase)
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EN 61000-3-3(*) + A1(*)+ A2(*) Electromagnetic compatibility (EMC) Part 3-3: Limits - Limitation of voltage fluctuations and
of flicker in low voltage supply systems for equipment with rated current <= 16A and not subject to conditional connection
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EN 61010-1(*) Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General
requirements
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EN 61010-2-101(*) Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101:
Particular requirements for medical equipment for in-vitro diagnostics
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The LED light according to standard EN62471 and classified in 1 Risk Group Category
(*)
In the applicable edition
