biosystems A15 - System Requirements and Compliance

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MINIMUM COMPUTER REQUIREMENTS
Pentium IV processor or higher
Windows 98 or higher
256 Mb RAM
50 Mb free hard disk space
CD-ROM
VGA Monitor, minimum resolution of 640x480
Mouse
RS-232 serial channel or USB connector
The insulation level of the communications channel of the A15 analyzer is reinforced (the insulation of the communi-
cations channel of the computer must also be reinforced)
(1)
POWER REQUIREMENTS
Input voltage 125-230 Vac, 50/60 Hz
Power 150 VA
Electrical installation category (overvoltage category) II
The power point must be ofcially approved, earthed and the cable must have a minimum cross-section of 1.5 mm
2.
ATMOSPHERIC CONDITIONS
Interior use
Height < 2500 m
Temperature 10°C - 35°C
Relative humidity < 75%
Contamination level 2
(1)
Reinforced insulation is that which ensures protection equal to or higher than double that provided by the main
insulation.
The main insulation is that whose failure could lead to a risk of electric shock (EN 61010-1).
COMPLIANCE WITH DIRECTIVES AND APPLIED STANDARDS
Directive 98/79/CEE regarding sanitary products for in vitro diagnostic use
• EN 61010-2 -10:2002 “Safety requirements for electrical equipment for measurement, control and laboratory use.
: EN61010-2-101:2004»Particular requirements for vitro diagnostics(IVD) medical equipment”
• UNE EN 61326:1999+A1:2000+A2:2003+A3:2005+ERR:2002 “Electromagnetic equipment for measurement,
control and laboratory use –ECM requirements.
• UNE-EN 55022:2000+A1:2002+CORR:2002- Radiated emissions class B-continuous interference class B”.
• UNE -EN 61000-3-2:2002 «Harmonic current»
• UNE -EN 61000-3-3:1997+Corr:1999+A1:2002-»Flickers»
• UNE -EN 61000-4-2:1997+A1:1999+A2:2001
• UNE -EN 61000-4-3:2003+A1:2004-»Radiated immunity»
• UNE -EN 61000-4-4:1997+A1:2001+A2:2002-»Fast transient /Burst»
• UNE -EN 61000-4-5:1997+A1:2001-»Surge transients»
• UNE -EN 61000-4-6:1998+A1:2001-»Conducted immunity»
• UNE -EN 61000-4-11:1997+A1:2001-»Voltage disp short interruptions and voltage variations immunity»
• UNE EN 22233-02. Test packaging.
• UNE EN 24180-2.Complete and full shipment packaging.
• UNE EN 22247-03(ISO 2247-2000). Fixed low frequency vibration test.
• UNE EN 22248-94. Freefall vertical shock test.