Appendix C –Accessories 72
1Introduction, General Warnings and Cautions.
The O2matic PRO 100 is a medical device with the ability to assist medical
staff in hospitals and respiratory clinics with oxygen supplementation to
secure a stable oxygenation of the blood. The O2matic PRO 100 device will
do this by continuously adjusting the flow of oxygen to the patient based on
the actual oxygen saturation in the blood, which is measured by standard
pulse oximetry.
The O2matic PRO 100 device is suitable for use in hospitals except near
active HF surgical equipment and the RF shielded room of a medical
electrical system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
NOTE: The emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
To avoid adverse events to the patient due to electromagnetic disturbances,
the patient shall be assessed by medical staff at regular intervals,
determined based on the condition of the patient.
1.1 Intended purpose
O2matic PRO 100 is an electro/mechanical medical device, intended for
oxygen therapy optimization at all hospital departments and units that
administer oxygen therapy. O2matic PRO 100 is for short term continuous
use at hospital for not more than 30 days. The regulation of oxygen is
managed by a software algorithm.
1.2 Contraindications
a) Do not use in an explosive atmosphere or in the presence of
flammable anesthetics or gases.
b) Do not use on multiple patients simultaneously
