Samsung SONOACE R5 Instrukcja Użytkownika Pobierz pdf (Strona 8)

Safety Requirements

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Classications:

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Type of protection against electrical shock: Class I

■X

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

■X

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.

■X

Mode of operation: Continuous operation

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Electromechanical safety standards met:

■X

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

Performance [IEC 60601-1: 2005]

■X

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]

■X

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

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

■X

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]

■X

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

A1: 1991 and A2: 1995]

■X

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

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

■X

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

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

■X

Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:

Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1: 1999]

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