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Chapter 1
Safety Guidance
This unit is internally powered equipment and the degree of shock protection
is type CF applied part . Type CF protection means that these patient
connections will comply with permitted leakage currents, dielectric strengths
of IEC 60601-1.
WARNING
and
CAUTION
messages must be observed. To avoid the possibility
of injury, observe the following precautions during the operation of the device.
WARNING
: This device is not explosion-proof and can not be used in the
presence of flammable anaesthetics.
WARNING
: Do not throw batteries in fire as this may cause them
to explode.
WARNING
: Do not attempt to recharge normal dry-cell batteries, they may
leak, and may cause a fire or even explode.
WARNING
: Don’t touch signal input or output connector and the patient
simultaneously.
WARNING
: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (e.g. IEC
950 for data processing equipment and IEC60601-1 for medical equipment).
Furthermore all configurations shall comply with the valid version of the system
standard IEC60601-1-1. Everybody who connects additional equipment to the
signal input connector or signal output connector configures a medical system,
and is therefore responsible that the system complies with the requirements
of the valid version of the system standard IEC 60601-1-1. If in doubt, consult
our technical service department or your local distributor.
WARNING
: Pocket Fetal Doppler is a tool to aid the healthcare professional
and should not be used in place of normal fetal monitoring.
WARNING
: Replacing battery shall only be done outside the patient
environment (1.5m away from the patient).
CAUTION
: The device must be serviced only by authorized and qualified
personnel.
CAUTION
: The main unit is designed for continuous operation and is
‘ordinary’. Do not immerse in any liquid (i.e. not drip or splash-proof).
CAUTION
: Keep the device clean. Avoid vibration.
CAUTION
: Do not use high temperature sterilizing process and E-beam
or gamma radiation sterilization.
CAUTION
: Electromagnetic Interference-Ensure that the environment
in which the device is operated is not subject to any sources of strong
electromagnetic interference, such as radio transmitters, mobile telephones, etc.
ENGLISH