Warnings – Philips SPO2 M1191A User Manual

Page 5

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Warnings

• These sensors are for use only with Philips/Agilent/HP instruments.

Before using, verify the combination of instrument/sensor is specified in
the instrument’s user documentation (e.g. Instructions for Use);
otherwise patient injury may result.

• Pulse oximetry measurements are statistically distributed. Two-thirds of

all pulse oximetry measurements can be expected to fall within the
stated accuracy (refer to Specifications later in this IFU for stated sensor

accuracy).

• Connect the sensor only to the SpO

2

connection or the SpO

2

adapter

cable of the oximeter.

• Do not reuse the sensor on a different patient until it has been

disinfected. The sensor can be reused on the same patient for the
patient’s entire stay.

• At elevated ambient temperatures, patient skin could be severely burned

after prolonged sensor application at sites that are not well perfused. To
prevent this condition, be sure to check patient application sites

frequently. All listed sensors operate without risk of exceeding 41

o

C on

the skin if the initial skin temperature does not exceed 35

o

C.

• Be sure to apply the sensor to the patient at the preferred or alternative

application site, while following application instructions provided later
in this document. Failure to do so can cause inaccurate measurements.

• To avoid venous pulsation, obstructed circulation, pressure marks,

pressure necrosis, artifacts and inaccurate measurements, make sure you

are using a sensor of the correct size and that the sensor is not too tight.
If the sensor is too tight, because the application site is too large or
becomes too large due to edema, the excessive pressure applied may

result in venous congestion distal from the application site, leading to
interstitial edema and tissue ischemia.

• If the sensor is applied too loose it may fall off or compromise proper

alignment of sensor optics and result in inaccurate readings.

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