Technical Specifications
Item Description
Atmospheric Pressure 70 to 106kPa
Transport/Storage Conditions
Temperature -20ºC to +60ºC (–4° F to 140° F)
Relative Humidity (RH) 15% to 95% (non-condensing)
Atmospheric Pressure 50kPa to 106kPa
Safety Specifications
Table 126: Safety Specifications
Item Description
Certification marks
The medical device has a lifetime of 7 years with respect to the
Council Regulation EU 2017/745 Annex I, Requirement 6.
Certification CAN/CSA-C22.2 No. 60601-1,
ES60601-1
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-25
IEC 60601-2-51
Type of Protection Against
Electrical Shock
Class 1, internally powered
Degree of Protection Against
Ingress of Liquids
IP 20
Patient Mode of Operation Continuous
Patient Leakage Current <10 μA Normal Condition (NC), <50 μA Single Fault Condition (SFC)
Degree of Protection Against
Electrical Shock
Type CF defibrillation-proof applied part
5864335-001-1  MAC
â„¢
5 A4/MAC
â„¢
5 A5/MAC
â„¢
5 Lite 337
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