Precautions; Application Of The Product And Intended Use - GERATHERM oxy control Gebrauchsanweisung

PRECAUTIONS

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1. Do not use the pulse oximeter in an MRI or CT environment.
2. The pulse oximeter must be kept out of reach of children. Small
parts can be detached from the device. These can be swallo-
wed by children or cause suffocation by inhalation of the parts.
3. Operating Geratherm oxy control can be influenced by the use
of an electrosurgical unit (ESU).
4. Do not use the pulse oximeter in situations where alarms are
required. The device has no alarm. It is not suitable for con-
tinuous monitoring. Explosion Hazard: Do not use the pulse
oximeter in an explosive atmosphere.
5. Do not use the device if it has damaged partsExplosion hazard:
Do not use the pulse oximeter in an explosive atmosphere.
6. The pulse oximeter is provided only as an aid for patient dia-
gnosis. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
7. Prolonged use or the patient's condition may require changing
the sensor site periodically. Change the sensor site and check
skin integrity, circulatory status, and correct alignment every
4 hours.
8. Inaccurate measurements by autoclaving, sterilizing with ethyl
oxide or immersing the sensors in liquid may cause inaccurate
readings.
9. Keep the oximeter in a dry environment.
10. The following factors can affect the SpO2 measurements and
lead to inaccurate values:
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APPLICATION OF THE PRODUCT AND INTENDED USE

Geratherm
intended for spot-checking of oxygen saturation of arterial he-
moglobin (SpO
in hospitals, hospital-type facilities, and home environments. It is
not for continuous monitoring.
y BA.indd 17
Significant levels of dysfunctional hemoglobin (such as
carboplatin hemoglobin or methemoglobin)
Intravascular dyes such as indocyanine green or methy-
lene blue
High ambient light (the sensor area protected from direct
sunlight)
Excessive patient movement
Venous pulsations
Placement of a sensor on an extremity with a blood pres-
sure cuff, an arterial catheter or intravascular line
Patient has hypotension, severe vasoconstriction, severe
anemia, or hypothermia
Patient has a cardiac arrest or is in shock
Nail polish or artificial fingernails
Too cold or dirty fingers
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pulse oximeter is a portable non-invasive device
) and pulse rate of adult and pediatric patients
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