natus Dantec Keypoint Focus, Инструкции по эксплуатации оборудования

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Dantec Keypoint Focus
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PC Requirements
Safety
If the PC used is powered by the Keypoint Focus module and is NOT purchased from Natus,
then the following must be observed and fulfilled :
• The Keypoint Focus module fulfills the IEC 60601-1 [Medical Electrical equipment Part 1:
General requirements for safety], and the IEC 60601-1-2 [Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests].
The chosen PC must fulfill the following standards:
• The IEC 60950-1 [Information technology equipment - Safety - Part 1: General
requirements];
and
• The IEC 60601-1-2 [Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests];
and
The whole system must fulfill the requirements in the safety standard: IEC 60601-1
[Medical electrical equipment – Part 1-1: General requirements for safety – Collateral
standard: Safety requirements for medical electrical systems and essential performance], and
especially for the PC leakage current and electromagnetic compatibility, the following must be
fulfilled:
• The maximum enclosure/touch leakage current in accordance with IEC 60601-1 is 0.100
mA in normal condition (and 0.500 mA in single fault condition).
−
The Keypoint Focus module enclosure/touch leakage current without a PC and its
power cord is up to 0.05 mA in normal condition.
−
Thus the enclosure/touch leakage current for the chosen PC, including the power
interface cord must be max. 0.05 mA, in normal condition.
WARNING Failing to comply with these requirements may result in danger to the patient
or the operator.
Performance
For functional performance, the PC must meet the requirements described in the
Keypoint.NET Software Release Note.