Use Instructions
SpiroSphere
®
ECG Instructions for Use
Page 2/136
Version 02.02 • 04AUG2022
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The SpiroSphere is a compact device to measure inspiratory and expiratory lung function
parameters in adults and children aged 4 years and older.
With the option ECG electrocardiographic diagnoses can be made. For this purpose a 12-channel
surface electrocardiogram can be measured and recorded. Automatic interpretation of the ECG is
not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not
intended for intra-cardial use.
The minimum age for ECG application is 4 years.
It can be used by physicians in the ofce or hospital.
Indications for Use
According to "STANDARDIZATION OF SPIROMETRY 2019 UPDATE”
(American Journal of Respiratory and Critical Care Medicine, October 2019)
performing lung function tests can be physically demand for a minority of
patients. The forced expiratory maneuver used in spirometry increases
intrathoracic, intraabdominal, and intracranial pressures. Potential risks of
spirometry are primarily related to maximal pressures generated in the thorax
and their impact on abdominal and thoracic organs, venous return and systemic
blood pressure, and expansion of the chest wall and lung. The physical effort
required can increase myocardial demand. Caution must be used for patients
with medical conditions that could be adversely affected by these physiological
consequences:
Due to increases in myocardial demand or changes in blood pressure
• Acute myocardial infarction within 1 week
• Systemic hypotension or severe hypertension
• Signicant atrial/ventricular arrhythmia
• Noncompensated heart failure
• Uncontrolled pulmonary hypertension
• Acute cor pulmonale
• Clinically unstable pulmonary embolism
• History of syncope related to forced expiration/cough
Contraindications