GNATUS Autoclave Bioclave 12L, Owner'S Manual

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9
TECHNICAL SPECIFICATIONS
Standards
This equipment was designed, manufactured and tested in compliance with the following standards:
NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança;
EN 980:2003 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
ISO 14971 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 - Dental equipment - graphical symbols;
ISO 7494 - Norma dental units;
ISO 13485-2 - Quality systems - medical devices;
ISO 780 - Packaging - pictorial marking for handling goods;
ISO 11144 - Norma dental equipment - connections for suply and waste lines;
EN 60601-1 (1990);
Amendment 1 EN 60601-1 (1992);
Amendment 2 EN 60601-1 (1995);
Amendment13 EN 60601-1 (1995);
EN 60601-1-2 (2001);
NBR IEC 601-1 (1994);
Emenda 1 NBR IEC 601-1 (1994);
CISPR 11, edição 3.1 (ago/1999);
IEC 61000-4-2 (1999);
IEC 61000-4-3 (1998);
IEC 61000-4-4 (1995);
IEC 61000-4-5 (1995);
IEC 61000-4-6 (1996);
IEC 61000-4-11 (1996);
Special precautions and installation conditions
- Install the autoclave on a firm and leveled surface, approximately at 80 cm. from the floor. Leave
enough space for handling the materials to be sterilized.
- Check that the electricity network is compatible with the equipment’s specification.
- Before turning your autoclave on, install the fuses included with the equipment.
- Check if the grounding conductor is correctly connected.
- Never use cord extensions, connectors or voltage transformers.
NOTE: This information are also contained in the Installation and maintenance manual owned by
the GNATUS authorized technician.
• Tension of Feeding
127V~
220V~
• Frequency
50/60Hz
•
Power
1600VA
• Sterilization pressure
1,7 kgf/cm
2
± 0,4 (1,3 to 2,1kgf/cm
2
)
• Operation temperature
128ºC ±5 (123 to 133ºC)
• Sterilization time
16 minutos
• Volume
12 Liters
• Protection fuses
F1 = 0,5A
F2 and F3 = 15A
F4 = 08A
• Diameter of the chamber
214 mm
• Chamber’s depth
318 mm
• Water consumption
150 - 200ml
• Net Weight
23 Kg
• Gross Weight
26 Kg
• Degree of protection
Tipo BF
• Water leak protection
IPX0
•
Complete cycle
60 minutes
These values are approximate,
they may change depending on
the material’s type and volume,
energy oscillation, etc.
• Manometer’s tolerance
variation
Divide the manometer’s scale
by three equal parts. For the
first part, the tolerance is 3%,
for the second part is 2%, and
for the third is 3%.
+20%
-20%
+20%
-10%