Preface
Destination of use
Giotto is an automatic stainer specifically for the staining of slides.
Giotto is ideal for the automated production of histological, cytological and histochemistry staining procedures.
It is to be used in Anatomic Pathology labs and wherever the staining of histological sections or cytological specimens on slides are
conducted.
The instrument should be used, accordingly to all instructions present in this manual, only by well-trained, authorized staff.
Any improper use of the instrument must be considered as a “not-allowed” operation.
It is possible to configure the instrument, assign reagents to the reservoirs and create or modify staining procedures that foresee the
placement of racks into the reservoirs for a specific length of time.
In order to prevent dangerous situations and for the correct use of the instrument, this manual should be kept and read.
The operators must be adequately trained in its use and must respect all safety rules and its use limits.
Instrument maintenance, due to trouble or malfunction, should only be performed by trained, authorized Diapath S.p.A. staff.
The instrument 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, perform an analysis of electromagnetic interferences.
Do not use the device near sources of strong electromagnetic radiations, such as radiofrequency wave generators. In this case the
radiations may interfere with 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 the following rules:
• 2007/47/CEE Directive 93/42/EEC concerning the updating of Directives 98/79/EEC on medical devices and medical devices in
vitro, which came into force on 21/03/2010 by Legislative Decree 25/2010.
• Legislative Decree 27
th
January 2010, n. 17 implementing Directive 2006/42/EC on machinery and amending Directive
95/16/EC relating to lifts.
• ISO 9001(*): quality management system requirements.
• ISO 13485(*): quality management system requirements for medical devices. Requirements for regulatory purposes and
specific requirements of the application of ISO 9001(*)
• UNI CEI EN ISO 14971(*): application of risks management to medical devices
• EN 61326-1(*): Electrical equipment for measurement, control and laboratory use - EMC requirements Part 1: General
requirements.
• 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).
• EN 61000-3-2(*): Electromagnetic compatibility (EMC) Part 3-2: Limits - Limits for harmonic current emissions. (Equipment
with input current <= 16A per phase).
• 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.
• EN 61010-1(*): Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1: General
requirements.
• EN 61010-2-101(*): Safety requirements for electrical equipment for measurements, control and laboratory use. Part 2-101:
Particular requirements for medical equipment for in-vitro diagnostics.
• The LED light according to standard EN62471 and classified in 1 Risk Group Category.
(*)
In the applicable edition
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