Welch Allyn CP 50 Directions For Use Manual page 13

12-lead resting electrocardiograph
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Directions for use
Warnings related to using the electrocardiograph
WARNING All signal input and output (SIP/SOP) connectors should not be
contacted by the patient directly or indirectly through the user during
operation.
WARNING Use only parts and accessories, including thermal paper, that
were supplied with the device and available through Welch Allyn. The use
of accessories other than those specified may result in degraded
performance or unsafe use of this device, including compromised
defibrillator protection, increased electromagnetic emissions or decreased
electromagnetic immunity.
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.
WARNING To avoid serious injury or death, take these precautions during
patient defibrillation:
Avoid contact with the electrocardiograph, patient cable, and patient.
Verify that the patient leads are properly connected.
Place defibrillator paddles properly in relation to electrodes.
After defibrillation, pull each patient lead out of the patient cable and inspect
the tips for charring (black carbon marks). If there is any charring, the patient
cable and individual leads must be replaced. If there is no charring, fully
reinsert the leads into the patient cable. (Charring can occur only if a lead is
not fully inserted into the patient cable before defibrillation.)
WARNING To prevent the spread of infection, take these precautions:
Dispose of single-use components (for example, electrodes) after using
them once.
Regularly clean all components that come in contact with patients.
Avoid ECG testing for patients with open, infectious sores.
WARNING Avoid positioning any leads or cables so that they could easily
trip someone or become wrapped around a patient's neck.
WARNING To ensure safe use of the device, follow the documented
maintenance procedures.
WARNING Only qualified service personnel should attempt to repair the
electrocardiograph. In case of a malfunction, call Technical Support.
WARNING Do not perform ST segment analysis on the ECG screen
display, since these ECG representations are scaled. Make manual
measurements of ECG intervals and magnitudes on printed ECG reports
only.
WARNING To maintain diagnostic accuracy and to comply with IEC
60601-02-51, do not scale (re size) when sending a saved ECG to an
external printer.
Introduction 9

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