- i) Patient and operator safety and system performance should not be adversely affected by fluid spills.
- ii) If the unit is affected, it should fail safely.
- c) Overcurrent Protection
- i) Loss of power to other equipment on the same branch circuit due to internal equipment faults should be
prevented by using fuses or circuit breakers which are clearly labeled and easy to replace or reset.
- ii) If fuses are used, a spare fuse should be provided in a labeled holder located next to the main fuse holder.
Permanent markings near each fuse holder must indicate fuse ratings.
- d) Line Voltage Variation
- i) The unit should operate satisfactorily at line voltages from -12.5% to +8%
of the nominal line voltage of 220Volts.
- ii) The unit should not be damaged by voltages from -21% to +12.5% of the nominal line voltage of 220Volts.
- e) Electromagnetic Interference (EMI)
- i) The unit’s performance should not be affected by EMI radiated or conducted through the power lines from another
device.
- ii) If the unit is affected, it should fail safely.
