GS corpuls3 - Page 317

User Manual corpuls
3
Appendix
ENG - Version 2.1 – P/N 04130.2 305
• Do not use any damaged oximetry sensors and particularly no oximetry sensors with open
optical components.
• The oximetry sensor must not be placed on the same extremity as a cuff for non-invasive blood
pressure monitoring, a catheter or an intravascular access. The cuff pressure influences pulse
oximetry during all pressure measurements. An object in the vessel (e.g. infusion needle) may
impair perfusion and thereby affect the measurement.
• The oximetry sensor must not be fixed to the body in such a way that it influences perfusion or
injures the skin. Tissue damage may be caused by incorrect use and application when the
oximetry sensor is bound to tightly. Check the sensor surface as described in the instructions for
use, to avoid injuries to the skin surface and to guarantee the correct position and adherence of
the sensor.
• To avoid measuring errors, the sensor must be protected from outside light, particularly in rapidly
changing lighting conditions. This applies especially to open systems in contrast to the finger
sensors.
• The oximeter requires a measurable pulse wave to determine measurement values. If no pulse
or only a weak pulse is detected, incorrect measured values may be calculated.
• The measurement of the pulse is based on the optical detection of the peripheral pulse. Due to
this, certain arrhythmias cannot be detected. The oximeter may not be used as substitute for an
ECG-based device for arrhythmia analysis.
• Very low oxygen saturation levels (SpO
2
) may cause inaccurate readings of SpCO- and SpMet.
• Severe anaemia may cause faulty SpO
2
readings.
• A synthetic modification of the haemoglobin may cause faulty SpHb readings.
• The measured values may likewise be incorrect if pronounced movement artefacts occur.
• The measurement values only lie within the specified range of accuracy (see appendix D,
Technical Specifications , p. 286) when the signal intensity is sufficient.
• Factors which cause unpaired venous returns may likewise result in pulsation.
• The measurement may be impaired by an excessively high proportion of dysfunctional
haemoglobin, such as carboxyhaemoglobin or methaemoglobin. Likewise, colourants and raised
bilirubin levels in the blood may impair the accuracy of the measurement.
• The oximeter or the oximetry sensors must not be used during magnetic resonance tomography
(MRT). Induced currents could possibly cause fires. The MRT image could be negatively affected
by the Masimo Rainbow SET
®
oximeter. The accuracy of the oximetry measurement may be
impaired by the magnetic resonance tomograph.
• The oximeter may be used during defibrillation. Measurements performed subsequently may be
inaccurate for a short time.
• Also read and understand the warnings in the operating instructions accompanying the different
oximetry sensors.
• SpO
2
is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers
with normal levels of carboxyhemoglobin (COHb) and methoglobin (MetHb). An oximeter cannot
measure elevated levels of COHb or MetHb. Increase in either COHb or MetHb will affect the
accuracy of the SpO
2
measurement.
• High-intensity, extreme lights (including pulsating strobe lights) directly on the sensor may
prevent the oximeter from obtaining readings.
• Interfering substances: Carboxyhemoglobin may erroneously increase SpO
2
readings. The level
of increase is approximately equal to the amount of carboxyhemoglobin present. Colourants or
any substance containing colourants that change the usual blood pigmentation may cause
erroneous readings.
• Inaccurate SpO
2
readings can be caused by:
- For increased COHb: COHb levels above normal tend to increase the level SpO
2
. The level
of increase is approximately equal to the amount of COHb that is present. NOTE: High levels
of COHb may occur with a seemingly normal SpO
2
. When elevated levels of COHb are
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
- For increased MetHb: the SpO
2
may be decreased by levels of MetHb of up to approximately
10% to 15%. At higher levels of MetHb, the SpO
2
may tend to read in the low to mid 80s.
When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood