ITC IRMA TruPoint Blood Analysis System - Manual (Page 135)

B.3
Environmental Conditions for Vac - Powered
Equipment
Table B-2
The AC adapter and battery charger are intended for indoor use
and operation. They should be transported and used within the
following conditions.
Temperature Range: 5 - 40 °C (41 - 104°F)
Relative Humidity Range: 0 - 80%
Voltage and frequency
fluctuations: No greater than ±10% of the main
power source
Electromagnetic Emissions and Immunity, continued Table B-3
• CISPR 11 (1997), w/A1: 1999 (Class B Group 1)
• EN 55011 / 1998, w/A1: 1999 & A2: 2002 (Class B Group 1)
• EN 60601-1-2: 2001 - Emission Requirements This equipment has been
tested and found to comply with the limits for medical devices to EN
60601-1-2: 2001. This testing shows that the device provides reasonable
protection against harmful interference in a typical medical installation.
However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference
to other devices or is negatively impacted by other devices, the user is
encouraged to try to correct the interference by one or more of the
following measures:
- reorient or relocate the devices
- increase the separation between the devices
- connect the equipment to an outlet on a different circuit
- consult the manufacturer or field service technician for help
Equipment connected to the serial port must comply with the respective
IEC standards (e.g., IEC 950 for data processing equipment and IEC
601-1 for medical equipment). Furthermore, all configurations shall
comply with the system standard IEC 601-1-1. Anybody who connects
additional equipment to the signal input or output part is considered to be
configuring a medical system, and is therefore responsible for ensuring
that the system complies with the requirements of the system standard
IEC 601-1-1. If in doubt, consult the technical service department or
your local representative.
• IEC 1000-4-2: 1995 / EN 61000-4-2: 1995
• IEC 1000-4-3: 2002 / EN 61000-4-3: 2002
• IEC 1000-4-4: 1995 / EN 61000-4-4: 1995
• IEC 1000-4-5: 1995 / EN 61000-4-5: 1995
• IEC 1000-4-6: 1996 / EN 61000-4-6: 1999
• IEC 1000-4-8: 1993 / EN 61000-4-8: 1994
• IEC 1000-4-11: 1994 / EN 61000-4-11: 1994
• Part 68 FCC Regulations
• Use in aircraft: the use of IRMA TruPoint with an unterminated distal
end of a data transmission cable will result in emissions that exceed FAA
radiative emissions test RTCADO 160C.