Passport® - Mindray

Appendix Safety Designations
Dielectric Strength
Complies with the requirements of IEC 60601-1: 1997, clause 20.
AC power to earth(A-a1): 1500VRMS, 1min/5mA
AC power to applied part (B-a): 4000VRMS, 1min/5mA
Applied part to earth(B-d): 1500VRMS, 1min/5mA
Between applied parts(B-b): 1500VRMS, 1min/5mA
Earthing Impedance
Complies with the requirements of IEC 60601-1: 1997, clause 18.
The impedance between the protective earth terminal of the power input connector and
any tangible metal part (such as screw and equipotential stud) that is protectively earthed
shall not exceed 0.1 ohms.
Protective Earthing and Potential Equalization
Complies with the requirements of IEC 60601-1: 1997, clause 58.
The protective earth terminal cannot be used for mechanical connections between different
parts of the equipment or for fixing any component irrelevant to protective or functional
earthing.
Anti-power Interference
After interference from ESU/defibrillation/electrostatic discharge
The equipment returns to normal operation mode within 10 seconds. The display is able to
show physiological parameters and waveforms normally. For example, the ECG waveform
data stored are not lost.
Protection Against Power Failure
Requirements of ISO21647: 2005: provides the device to prevent AC power from
disconnection and tension of 10 Kg.
If the power supply is restored after interrupted, saved presets, user settings, and patient data
previous to power failure are retained or can be restored with a DPM storage device.
The monitor stores up to 96 hours of trend information (approximately 6000 trend items)
when powered off. The interval for trend data is 1 minute.
Power Input
Complies with the requirements of IEC60601-1: 1997, clause 7.1.
Limitation of Voltage and (or) Energy
Complies with the requirements of IEC60601-1: 1997, clause 1.5.
Defibrillation-proof Applied Part
Complies with the requirements of IEC60601-1: 1997, clause 17.h.
Passport V Operating Instructions 0070-10-0704-02 19 - 33