Fukuda CardiMax 2, Service Manual

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Chapter 10 Appendix Combination Example of Medical and Non-Medical Equipments
Chapter 10 Appendix
Combination Example of Medical and Non-Medical Equipments
The general description of possible combination of different equipments in different medical environment as
specified in IEC 60601-1 "Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance" is described below.
The system must provide the level of safety equal to that of medical electrical equipments that comply with IEC
60601-1 in the patient environment. The system must be as safe as non-medical electrical equipments that comply
with other IEC or ISO safety standards outside the patient environment. IEC 60601-1 specifies that the level of safety
offered by non-medical electrical equipments used outside the patient environment is acceptable if it conforms to the
technical standards established in the applicable IEC or the safety equivalent to those is ensured. (*1)
To construct a medical electrical system, install Equipment B as shown below assuming that ECG is Equipment A.
bl5895
Patient Environment
Outside
Patient Environment
Room used for other
purposes than diagnosis