Covidien Nellcor MAXN, Инструкция по эксплуатации

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Enclosed adhesive “dots” are provided for reapplication. Place a transparent dot over each
window as shown, then remove the protective paper that covers each dot. The sensor is now
ready to be reapplied to the same patient. 4
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 MAXN or other oximetry sensors during MRI scanning. Conducted
current may cause burns. Also, the MAXN 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 the sensor 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 MAXN 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 MAXN 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 MAXN. 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.
Note: High oxygen levels may predispose a premature infant to develop retinopathy.
Therefore, the upper alarm limit for oxygen saturation must be carefully selected in
accordance with accepted clinical standards and considering the accuracy range of the
oximeter being used.
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.