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Out-of-hospital Transport - Standards Compliance - Philips M8102A Instructions For Use Manual

Patient monitor.
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24 Specifications
can be used in a transport environment such as a road ambulance, airplane or helicopter. For this
purpose the monitor fulfils the following additional mechanical, EMC and environmental
requirements:
• Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN
60068-2-27 (peak acceleration up to 100 g).
• Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/
EN 60068-2-64 (RMS acceleration 5 g).
• Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to
IEC/EN 60068-2-6 (acceleration up to amplitude 2 g).
• Bump Test according to IEC/EN60068-2-29 (peak acceleration 15 g, 1000 bumps).
• Free Fall Test according to EN1789 (covers also IEC TR 60721-4-7 and Class 7M3). Test
procedure according to EN 60068-2-32 (height 0.75 m).
• Specification for degrees of protection provided by enclosures according to IEC/EN 60529: IP 32
• EN 1789 +A1:2003 Medical vehicles and their equipment - Road ambulances (chapter 6 - Medical
Devices).
• Radiated susceptibility 20 V/m according to EN ISO 9919 (SpO
• Altitude Range from -500 to 3000 m operating and -500 to 4600 m storage and transportation.
• Extended radiated susceptibility tests
The MP2 patient monitor with its out-of-hospital parameter set provides a general immunity level of
20 V/m with only few restrictions. Details are as listed below:
– GSM 900: Immunity at 900 MHz (uplink mobile phone), 20 V/m (ECG:10V/m), duty cycle
1:8
– GSM 1800: Immunity at 1800 MHz (uplink mobile phone), 20 V/m, duty cycle 1:8.
– DECT: Immunity at 1800 MHz (digital cordless phone), 20 V/m, duty cycle 1:24
– AM: 1 kHz Immunity from 80 MHz to 1.0 GHz (any radio communication unit, broadcasting
and TV transmitter), 20 V/m, modulation factor 80%. (ECG: 20 V/m except 600-950 MHz
where it is 10 V/m and Temperature which holds 3 V/m over the full range).
Temperature measurement accuracy may be compromised in the presence of strong electromagnetic
CAUTION
fields (>3 V/m) in certain small frequency bands.
• Magnetic Field emission according to MIL STD 461E, Chapter RE101: Radiated emissions,
magnetic field, 30 Hz to 100 kHz. Limit class: Army.
• Magnetic Field susceptibility: Radiated susceptibility, magnetic field, 50, 60 and 400 Hz,
18 μT(15 A/m)
• Operating ambient temperature testing over the range from 0 to 40°C (32 to 100°F).
• Operating ambient humidity testing up to 95% RH at 40°C (100°F), non condensing.
Additional requirements can be necessary for transport situations in air, on water or in difficult terrain
N O T E
in certain countries, e.g. EU.
248

Out-Of-Hospital Transport - Standards Compliance

) and EN ISO 21647 (CO
2
).
2

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