Philips Avalon FM20 - Essential Performance

2 Site Preparation
19
Safety Requirements (Customer or Philips)
The monitor is an electrical Class II device in which the protection against electric shock does not rely
on basic insulation and a protective earth conductor, but on double and/or reinforced insulation.
WARNING
• Always use the supplied power cord with the earthed mains plug to connect the monitor to an
earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed
AC mains socket.
• The protective earth conductor is required for EMC purposes. It has no protective function
against electric shock! The protection against electric shock in this device is provided by double
and/or reinforced insulation.
• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple
portable socket-outlet without an approved separating transformer is used, the interruption of its
protective earthing may result in equipment leakage currents equal to the sum of the individual
earth leakage currents, so exceeding allowable limits.
Electrical Requirements (Customer or Philips)
Line Voltage Connection
• The FM20/FM30 monitor uses supply voltage 100V — 240V (0.7A — 0.4A).
• The M8023A External Power Supply uses supply voltage 100V — 240V (1.3 — 0.7A)
• The FM20/FM30 monitor and the M8023A External power supply may be operated with supply
frequency range of 50 Hz to 60 Hz.
Essential Performance
This section defines the essential performance for Avalon fetal monitors in combination with the
specified wired transducers and sensors, and also with the cableless measurements (Avalon CL, Avalon
CTS).
Under normal and single fault conditions either at least the performance/functionality listed in the
tables below is provided, or failure to provide this performance/functionality is readily identifiable by
the user (e.g. technical alarm, no waves and/or numeric values, complete failure of the monitor, readily
identifiable distorted signals, etc.).
Measurement Essential Performance
General No interruption or cessation of current operating mode (e.g. no
reboot, display OK).
No spontaneous operation of controls (e.g. no activation of touch
screen without user interaction).
ECG (Monitoring) Measurement of the fetal and maternal heart rate over the
specified measurement range and with an accuracy of ± 5 bpm.
Alarming on heart rate limit violation within specified delay time.