Samsung SONOACE R5 Uživatelský manuál Strana 8

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Safety Requirements
Classications:
X
Type of protection against electrical shock: Class I
X
Degree of protection against electrical shock (Patient connection): Type BF applied part
X
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
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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