Safety Specifications - GE MAC 5 A4 Operator's Manual

Item
Atmospheric Pressure
Transport/Storage Conditions
Temperature
Relative Humidity (RH)
Atmospheric Pressure

Safety Specifications

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