Accuracy Specifications - Covidien Nellcor Series Gebrauchsanweisung

WARNINGS
1. Use this sensor only with Nellcor OxiMax™ instruments and instruments
containing Nellcor oximetry, or with instruments licensed to use Nellcor
OxiMax sensors (Nellcor-compatible instruments).
2. If the sensor is misapplied with excessive pressure for prolonged periods, a
pressure injury can occur.
3. Do not use the MAXA(L) or other oximetry sensors during MRI scanning.
Conducted current may cause burns. Also, the MAXA(L) may affect the MRI
image, and the MRI unit may affect the accuracy of oximetry measurements.
4. As with all medical equipment, carefully route cables to reduce the
possibility of patient entanglement or strangulation.
CAUTIONS
1. In the event of damage to the sterile packaging, do NOT resterilize. Follow local
governing ordinances and recycling instructions regarding disposal or recycling
of sensors.
2. Do not use a damaged sensor or pulse oximetry cable. Do not use a sensor with
exposed optical components.
3. Do not immerse in water or cleaning solutions. Do not resterilize. Such sterilization
could damage the sensor and may result in sensor malfunction and/or erroneous
oximetry measurements.
4. Failure to apply the MAXA(L) properly may cause incorrect measurements.
5. If the sensor is wrapped too tightly or supplemental tape is applied, venous
pulsations may lead to inaccurate saturation measurements.
6. While the MAXA(L) is designed to reduce the effects of ambient light, excessive
light may cause inaccurate measurements. In such cases, cover the sensor with
opaque material.
7. Circulation distal to the sensor site should be checked routinely. The site must be
inspected every 8 hours to ensure adhesion, application pressure, skin integrity,
and correct optical alignment. If skin integrity changes, move the sensor to
another site. If the sensor is misapplied with excessive pressure, a pressure injury
can occur.
8. Deeply pigmented skin, intravascular dyes or externally applied coloring (such as
nail polish, dye or pigmented cream) may lead to inaccurate measurements.
9. Excessive motion may compromise performance. In such cases, try to keep the
patient still, or change the sensor site to one with less motion.
10. Do not alter or modify the MAXA(L). Alterations or modifications may affect
performance or accuracy.
11. For additional warnings, cautions or contraindications when using this sensor
with Nellcor-compatible instruments, refer to the instrument operator's manual or
contact the manufacturer of the instrument.

Accuracy Specifications

This sensor integrates Nellcor OxiMax technology into its design. When connected
to an OxiMax-enabled instrument, this sensor uses OxiMax technology to provide
additional advanced sensor performance features. Consult individual manufacturers
for features and compatibility of particular instruments and sensor models.
Each Nellcor OxiMax-compatible instrument manufacturer is responsible for
determining optimal compatibility conditions and settings for its instruments
to provide safe and effective use of each Nellcor OxiMax sensor. This includes
specifications and/or warnings, cautions, or contraindications. Refer to each
instrument operator's manual or consult manufacturer for complete instructions,
warnings, cautions, or contraindications on the use of this sensor with their Nellcor
OxiMax compatible instrument.
4