Reprocessed Masimo Pulse Oximeter Sensor
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Reprocessed Masimo Pulse Oximeter Sensor Description
Reprocessed Low Noise Cabled Sensors (LNCS)
®
Series - Adult, Pediatric, and Infant S
p
O
2
adhesive sensors.
When used with Masimo SET
®
Radical
TM
:
1859 and
2317 Adult
1860
Pediatric
1861
Infant
1862 Adult
2319 and
2328
Infant
2320 and
2329
Adult
> 30 kg
10 - 50 kg
3 - 20 kg
> 40 kg
3 - 20 kg
> 40 kg
Application Site
Finger
Finger or
toe
Thumb or
great toe
Adult finger
or toe
Thumb or
great toe
Adult
finger or
toe
Saturation Accuracy,
No Motion
± 2.3%
± 2.3%
± 2.3%
± 2.3%
± 2%
± 2%
Pulse Rate Accuracy,
No Motion
± 3 bpm
± 3 bpm
± 3 bpm
± 3 bpm
± 3 bpm
± 3 bpm
Indications for Use
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and
pulse rate monitoring.
Contraindications for Use
Reprocessed Masimo Pulse Oximeter sensor should not be used in patients who exhibit allergic reactions to foam rubber
products and/or adhesive tape.
Warnings
•
Prior to use, read and follow these ins
tructions as well as those of the Operator’s Manual for your pulse oximetry system.
•
Do not use if there is any evidence of damage to the package.
•
Inspect the sensor site periodically to ensure correct sensor alignment and adhesion. Skin integrity and circulation distal
to the site should be checked routinely and the sensor relocated to another site if found to be compromised.
•
Incorrect application or duration of use of a sensor can cause tissue damage.
•
During low perfusion, the sensor site needs to be reviewed frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
•
The readings may read lower than core arterial oxygen saturation with very low perfusion at the monitored site.
•
Erroneously low readings may occur if the sensor is applied too tightly.
•
Do not use tape to secure the sensor. This can restrict blood flow and cause inaccurate readings. Additional tape can cause
skin damage or damage the sensor.
•
Inspect the sensor for visible defects. Never use a sensor with exposed electrical circuitry or one that appears to be
damaged.
•
High levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
2
measurements.
•
“Elevated levels of Total Bilirubin may lead to inaccurate
SpO
2
measurements.”
•
High levels of Methemoglobin (MetHb) will lead to inaccurate SpO
2
measurements.
•
Under reading of actual arterial oxygen saturation may be caused by venous congestion. Assure proper venous outflow
from monitored site. The sensor should not be below heart level.
•
Elevated oxygen concentrations may predispose a premature infant to retinopathy. The upper alarm limit for the oxygen
saturation must be carefully selected in accordance with accepted clinical standards.
•
Do not use oximetry sensors during magnetic resonance imaging (MRI), as the conducted current may cause burns. Cross-
interference between the two devices can also cause inaccuracies in the measurements of either system.
•
Do not attempt to repair, modify or clean the sensor. Immersion in water will compromise the device performance.
•
Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual arterial
oxygen saturation
•
Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
•
If using pulse oximetry during full body irradiation, keep the sensor out of the irradiation field. If sensor is exposed to the
irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period.
•
When uncertain about any measure
ment accuracy, check the patient’s vital signs by alternate means, then make sure the
pulse oximeter is working properly.
