sat801+ Pulse Oximeter
Safety
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2 Safety
This section gives an overview of all important safety aspects for optimal prediction of humans as
well as for the safe and trouble-free operation of the unit.
Additionally, the individual chapters contain precise safety notices (designated by symbols) for
the prevention of imminent danger. Furthermore, existing pictograms, signs, and inscriptions on
the unit must be observed and are to be maintained in well readable condition.
2.1 Intended use
The unit is used for the continuous monitoring of functional oxygen saturation and pulse
frequency. It has an alarming function in case of deviations from the set alarm limits.
The unit is suitable for monitoring newborns, pediatric and adult patients. Only the certified
Masimo sensor may be used for the respective patient type.
Due to its structure and its configuration, the unit can be used domestically, in the clinical setting
and in the sleep laboratory stationary and mobile, inside and outside of these areas.
The pulse oximeter is considered to be an early warning system. If a possible undersupply of a
patient's oxygen is indicated, a more exact investigation is immediately necessary.
ATTENTION!
Each use of the unit beyond that recommended by law and or misuse is forbidden and is
considered to be in violation of the law.
Claims of any kind against the manufacturer and/or its authorized personnel on account of
damage from improper use of the unit are forbidden.
The user of the unit is solely responsible for all damages resulting from improper use.
Proper adherence to these operating conditions, as well as the data and the instructions are
considered to be proper use.
The unit may not be opened or altered except for changing the battery.
Parts other than those pertaining to the supply scope may be used only after release by the
company, Bitmos GmbH.
2.1.1 Possible misapplications
WARNING! Fire Hazard!
The pulse oximeter may not be used during nuclear magnetic resonance imaging
tests. The electrical current induced there can cause burns.
– The pulse oximeter may not be used to monitor breathing. This may take place only with
special respiratory monitoring equipment.
– A pulse oximeter shall not be used as an apnea monitor.
– A pulse oximeter should be considered an early warning device. As a trend towards patient
hypoxemia is indicated, blood samples should be analyzed by a laboratory co-oximeter to
completely understand the patient’s condition.
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