eResearchTechnology GmbH AM3G01 User Manual
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Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
Valid for all ERT Devices
Additional equipment connected to medical electrical equipment must comply
with the respective EN or ISO standards (e.g. EN 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements for
medical electrical systems. Anybody connecting additional equipment to medical
electrical equipment configures a medical system and is therefore responsible that
the system complies with the requirements for medical electrical systems. Atten-
tion is drawn to the fact that local laws take priority over the above mentioned
requirements. If in doubt, consult your local representative or the ERT Customer
Care.
Additional equipment connected to medical electrical equipment must comply
with the respective EN or ISO standards (e.g. EN 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements for
medical electrical systems. Anybody connecting additional equipment to medical
electrical equipment configures a medical system and is therefore responsible that
the system complies with the requirements for medical electrical systems. Atten-
tion is drawn to the fact that local laws take priority over the above mentioned
requirements. If in doubt, consult your local representative or the ERT Customer
Care.
Radiated Interference
The ERT device meets the regulations according to EN 60601-1-2 regarding
interference radiated and received. The device should not be installed in the vicinity
of high-frequency devices, X-ray equipment, motors or transformers with high
installed power rating, since electric or magnetic interference fields may falsify the
results of measurements or make taking measurements impossible. Due to this,
the vicinity of power lines is to be avoided as well.
Existing environmental interferences may cause deviations of the measuring values
without impairing the device’s function.
Therefore, it is recommended to keep a distance of about 2 meters from possible
error sources when using the device.
If available: More detailed information can be found in the EMC tables of the
Instructions for Use of your device.
The ERT device meets the regulations according to EN 60601-1-2 regarding
interference radiated and received. The device should not be installed in the vicinity
of high-frequency devices, X-ray equipment, motors or transformers with high
installed power rating, since electric or magnetic interference fields may falsify the
results of measurements or make taking measurements impossible. Due to this,
the vicinity of power lines is to be avoided as well.
Existing environmental interferences may cause deviations of the measuring values
without impairing the device’s function.
Therefore, it is recommended to keep a distance of about 2 meters from possible
error sources when using the device.
If available: More detailed information can be found in the EMC tables of the
Instructions for Use of your device.
Ambient Conditions
AM3 must not be operated in rooms or in the presence of flammable anaesthetic
mixture with air or flammable anaesthetic mixture with oxygen or nitrous oxide.
AM3 has to be effectively protected against moisture. Therefore, it is required that
the AM3 is always stored in the black bag. The device corresponds to IP 22 degree
of protection. Measurements in the rain or in the shower are not allowed.
AM3 must not be operated in rooms or in the presence of flammable anaesthetic
mixture with air or flammable anaesthetic mixture with oxygen or nitrous oxide.
AM3 has to be effectively protected against moisture. Therefore, it is required that
the AM3 is always stored in the black bag. The device corresponds to IP 22 degree
of protection. Measurements in the rain or in the shower are not allowed.
Measuring Mode
As the combination with an IEC 60950-1 proofed PC or modem can lead to a
summation of the leakage current, the AM3 must not be connected to a PC or
modem during the measurement.
Should the measuring values of the AM3 be changed after a longer period of use,
a new sensor should be used.
As the combination with an IEC 60950-1 proofed PC or modem can lead to a
summation of the leakage current, the AM3 must not be connected to a PC or
modem during the measurement.
Should the measuring values of the AM3 be changed after a longer period of use,
a new sensor should be used.
Interfaces
The AM3 must only be connected to a PC that corresponds to EN 60950
standards.
If the connection cable is defective, it has to be replaced by a new one. The
physician must not touch the patient and live parts at the same time. The operator
must not touch the Interfaces during measurement.
The AM3 must only be connected to a PC that corresponds to EN 60950
standards.
If the connection cable is defective, it has to be replaced by a new one. The
physician must not touch the patient and live parts at the same time. The operator
must not touch the Interfaces during measurement.
Patient Safety according to EN 60601-1
The subject has to keep a distance of at least 1,5 m from a connected modem or
notebook to avoid any contact with electrical voltage. The physician/operator must
not touch any voltage-carrying parts and the subject at the same time.
The subject has to keep a distance of at least 1,5 m from a connected modem or
notebook to avoid any contact with electrical voltage. The physician/operator must
not touch any voltage-carrying parts and the subject at the same time.