Criticare Systems, Inc.
VitalCare
TM
506N3 Series Service Manual
Page 1-19
Section 1 —Introduction
Software Error Related
Hazard Mediation
Criticare Systems, Inc., has quality control practices and procedures
in place to review potential hazards as they relate to software.
The monitor is Year 2000 Compliant and utilizes a 4 digit year for all
date, time, and leap year calculations.
Potential Interference
This device has been successfully tested to IEC 60101-1-2 specified
levels for emissions of and resistance to electromagnetic energy
fields. External disturbances which exceed these levels may cause
operational issues with this device. Other devices which are sensitive
to a lower level of emissions than those allowed by IEC 60101-1-2
may experience operational issues when used in proximity to this
device.
MAGNETIC FIELDS
Use of the monitor in an MRI environment may interfere with MRI
image quality. Use of MRI may interfere with the monitor.
RADIO FREQUENCY INTERFERENCE
The monitor conforms with IEC 1000-4-3 for radio frequency
interference, and will operate with negligible adverse effects.
CONDUCTED TRANSIENTS
The monitor conforms with IEC 61000-4-4, and IEC 61000-4-5 for
conducted transients, and will operate with negligible adverse effects.
X-RAY
The monitor will operate with negligible adverse effects in an x-ray
environment. However, the monitor should not be placed directly in
the x-ray beam, which could damage the internal electronics of the
monitor.
OTHER INTERFERENCE
There is a negligible adverse effect to the monitor from
electrocautery, electrosurgery, infrared energy, pacemakers, or
defibrillation.
Leakage Current
The monitor complies with leakage current limits required by medical
safety standards for patient-connected devices. Standards include
the International Electrotechnical Commission (IEC) 60101-1, 1st
edition, 2003 Part 1. A hazard caused by the summation of leakage
currents is possible, when several pieces of equipment are
interconnected.
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