Samsung SONOACE R3 Instrukcja Użytkownika Pobierz pdf (Strona 9)

Safety Requirements

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Classication:

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Type of protection against electrical shock: Class I

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Degree of protection against electrical shock (Patient connection): Type BF applied part

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Degree of protection against harmful ingress of water: Ordinary equipment

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Degree of safety of application in the presence of a ammable anesthetic material with air or with

oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable anesthetic

mixture with air or with oxygen or nitrous oxide.

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Mode of operation: Continuous operation

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Electromechanical safety standards met:

 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential

Performance [IEC 60601-1:2005/A1:2012]

 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential

Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

[IEC 60601-1-2:2007]

 Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential

Performance- Collateral Standard: Usability [IEC 60601-1-6:2010]

 Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential

Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007]

 Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with

A1:1991 and A2:1995]

 Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: Safety

Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]

 Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:

Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]

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Samsung SONOACE R3 Instrukcja Użytkownika Strona 9