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5 years ago

Operation - Mindray

Operation - Mindray

Patient Parameter

Patient Parameter Specifications Appendix Electromagnetic Compatibility The Rosebud meets the requirements of IEC 60601-1-2:2001/EN 60601-1-2:2001. NOTE: The Rosebud needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. NOTE: Portable and mobile RF communications equipment can affect the Rosebud. See TABLE 5-1 through TABLE 5-4. TABLE 5-1 ELECTROMAGNETIC EMISSIONS The Rosebud is intended for use in the electromagnetic environment specified below. The customer or the user of the Rosebud should assure that it is used in such an environment. EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ Flicker emissions IEC 61000-3-3 TABLE 5-2 Group 1 The Rosebud uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class A The Rosebud is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply Class A network that supplies buildings used for domestic purposes Complies ELECTROMAGNETIC IMMUNITY The Rosebud is intended for use in the electromagnetic environment specified below. The customer or the user of the Rosebud should assure that it is used in such an environment. IMMUNITY TEST Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 IEC 60601 TEST LEVEL ±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/ output lines ±1 kV differential mode ±2 kV common mode COMPLIANCE LEVEL ±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/ output lines ±1 kV differential mode ±2 kV common mode ELECTROMAGNETIC ENVIRONMENT - GUIDANCE Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 5 - 10 0070-10-0603-60 Rosebud® Operating Instructions

Appendix Patient Parameter Specifications TABLE 5-2 ELECTROMAGNETIC IMMUNITY The Rosebud is intended for use in the electromagnetic environment specified below. The customer or the user of the Rosebud should assure that it is used in such an environment. IMMUNITY TEST Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 TEST LEVEL 95% dip in U T ) for 0.5 cycle 40% U T (60% dip in U T ) for 5 cycles 70% U T (30% dip in U T ) for 25 cycles 95% dip in U T ) for 5 sec. COMPLIANCE LEVEL 95% dip in U T ) for 0.5 cycle 40% U T (60% dip in U T ) for 5 cycles 70% U T (30% dip in U T ) for 25 cycles 95% dip in U T ) for 5 sec. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Rosebud requires continued operation during power mains interruptions, it is recommended that the Rosebud be powered from an uninterruptible power supply or a battery. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. U T is the A.C. mains voltage prior to application of the test level. ELECTROMAGNETIC ENVIRONMENT - GUIDANCE Rosebud® Operating Instructions 0070-10-0603-60 5 - 11

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