Samsung SONOACE R5 Manual do Utilizador Página 8

  • Descarregar
  • Adicionar aos meus manuais
  • Imprimir
  • Página
    / 168
  • Índice
  • MARCADORES
  • Avaliado. / 5. Com base em avaliações de clientes
Vista de página 7
Safety Requirements
Classication:
Type of protection against electrical shock: Class I
Degree of protection against electrical shock (Patient connection): Type BF equipment
Degree of protection against harmful ingress of water: Ordinary equipment
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.
Mode of operation: Continuous operation
Electromechanical safety standards met:
Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance
[IEC 60601-1:2005]
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 60601-1-6:2006]
Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37:2007]
Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with A1:1991
and A2:1995]
Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral Standard: safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
Medical Electrical Equipment, Part 1: General Requirements for Safety - 2 Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]
Medical Electrical Equipment, Part 1: General Requirements for Safety - 4 Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]
Medical Electrical Equipment, Part 2: Particular Requirements for Safety - 37 Ultrasonic Medical
Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with A1:2004, A2:2005]
Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]
Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2
No.601.1-M90:1990, with R2003, with R2005]
Biological Evaluation of Medical Devices [ISO10993 : 2009]
Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC61157:2007]
Vista de página 7
1 2 3 4 5 6 7 8 9 10 11 12 13 ... 167 168

Comentários a estes Manuais

Sem comentários