Welch Allyn CP 100 Update To Directions For Use page 20

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"Intended use" statement expanded
CP 100, CP 200
The Welch Allyn electrocardiograph and spirometry products (subject devices) are
intended for use by trained operators in health facilities. The subject devices provide the
following diagnostic functions:
• Acquiring, viewing (CP 200), storing (CP 200), and printing ECG waveforms using ECG
front end modules (patient cables) and associated accessories that provide signal
acquisition for up to twelve (12) leads of patient ECG waveforms through surface
electrodes adhered to the body.
• Using optional algorithms to generate measurements, data presentations, graphical
presentations and interpretative statements on an advisory basis. These are
presented for review and interpretation by the clinician based upon knowledge of the
patient, the result of physical examination, the ECG tracings and other clinical
findings.
• Using the optional CP 200 spirometry module and associated accessories to acquire,
view, store and print measures and waveforms of pulmonary function including, but
not limited to, maximal volume and flow of air that can be moved in and out of the
patient's lungs. These measures are used in the diagnosis and monitoring of lung
diseases and interventions for the treatment of certain lung diseases. The spirometer
should only be used with patients able to understand the instructions for performing
the test.
"Indications for use" statement expanded
CP 100, CP 200
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and
monitor patient cardiac function.
The 12-lead ECG interpretive algorithm provides a computer-generated analysis of
potential patient cardiac abnormalities which must be confirmed by a physician with other
relevant clinical information.
The optional CP 200 spirometry module is indicated for use in clinical situations to assess
a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory
test results.
Spirometry is indicated for use in various common clinical situations:
• Assessing health status before a patient begins strenuous physical activity.
• Evaluating the following symptoms, signs, or abnormal laboratory tests:
Symptoms — dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain
Signs — diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest
deformity, unexplained crackles, shortness of breath
Abnormal laboratory tests — hypoxemia, hypercapnia, polycythemia, abnormal chest
radiographs
Welch Allyn CP Series Electrocardiographs