General warnings, Warnings related to the environment, Warnings related to using the electrocardiograph – Welch Allyn CP 50 Plus 12-lead resting electrocardiograph - User Manual User Manual
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General warnings
Warnings indicate conditions or practices that could lead to illness, injury, or death.
Warnings related to the environment
WARNING To avoid a possible explosion, do not use the
electrocardiograph in the presence of flammable anesthetics: mixtures
containing air, oxygen, or nitrous oxide.
WARNING When transporting the electrocardiograph on a cart, tuck the
patient cable away from the wheels so that it does not present a hazard.
Warnings related to accessories and other equipment
WARNING For operator and patient safety, peripheral equipment and
accessories that can come in direct patient contact must be in compliance
with all appropriate safety, EMC, and regulatory requirements.
WARNING All signal input and output (I/O) connectors are intended for
connection of only devices complying with IEC 60601-1, or other IEC
standards (for example, IEC 60950), as appropriate to the device.
Connecting additional devices to the electrocardiograph might increase
chassis or patient leakage currents. To maintain operator and patient
safety, consider the requirements of IEC 60601-1-1. Measure the leakage
currents to confirm that no electric shock hazard exists. In the case of a
USB printer, the printer (non-medical electrical equipment) shall be situated
outside the patient environment (reference IEC 60601-1-1). The printer
used should be approved to the appropriate safety standard for non-
medical electrical equipment (IEC 60950, or its national variants), and use
of an isolation transformer is recommended. If there is a requirement for
the printer to be situated within the patient environment it is the
responsibility of the user to ensure that the system provides a level of
safety in compliance with IEC 60601-1 and 60601-1-1.
WARNING The electrocardiograph has not been designed for use with
highfrequency (HF) surgical equipment and does not protect against
hazards to the patient.
Warnings related to using the electrocardiograph
WARNING This device captures and presents data reflecting a patient’s
physiological condition. When reviewed by a trained physician or clinician,
this data can be useful in determining a diagnosis. However, the data
should not be used as a sole means for determining a patient’s diagnosis or
prescribing treatment.
8 Introduction
CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph