Revision B SEER Light Ambulatory Recorder/Controller 1-11
2019818-008
Introduction: Responsibility of the Manufacturer
Information Technology Equipment
The hardware components supplied by GE for the MARS
®
Holter
analysis workstation, on which the SEER Light Connect application
runs, are considered to be Information Technology Equipment (ITE).
These individual components have been found to comply with the
standard for Safety of Information Technology Equipment, including
Electrical Business Equipment EN60950 (UL 60950).
The software used in the MARS
®
Holter analysis workstation
is
considered as medical software. The software has been designed and
manufactured to the appropriate medical regulations and controls.
In order for the MARS
®
Holter analysis workstation to comply with
medical equipment standard leakage current requirements, a medical
grade uninterruptible power supply (UPS) must be used (UL 60601-1,
CSA 22.2 No. 60601-1, EN 60601-1) to power all non-medical equipment.
In addition, non-medical electrical equipment must comply with IEC and
ISO safety standards that are relevant to that equipment (i.e., IEC
60950, Safety of Information Technology Equipment.)
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