Masimo LNCS-II rainbow DCI 8l SpCO Serie Instrucciones De Uso página 3

LNCS-II™ rainbow® DCI & DCIP
8λ SpCO Series
Reusable SpCO®, SpMet® & SpO
LATEX
Reusable Not made with natural rubber latex
Prior to using this sensor, the user should read and understand the Operator's Manual for the device and
this Directions for Use.
INDICATIONS
PCX-2108A
02/13
LNCS-II™ rainbow® DCI® and DCIP 8λ SpCO reusable sensors are indicated for spot check or continuous non-invasive monitoring of
arterial saturation (SpO ), arterial carboxyhemoglobin saturation (SpCO®), arterial methemoglobin (SpMet®), and pulse rate. SpCO and
2
SpMet accuracies were not validated under motion or low perfusion conditions.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to use Masimo
sensors.
CONTRAINDICATIONS
LNCS-II rainbow® DCI and DCIP 8λ SpCO reusable sensors are contraindicated for use on mobile patients or for prolonged periods
of use. The sensor site must be inspected at least every four (4) hours or sooner; and if the circulatory condition or skin integrity is
compromised, the sensor should be applied to a different site.
DESCRIPTION
LNCS-II rainbow® DCI and DCIP 8λ SpCO reusable sensors are for use only with devices containing Masimo rainbow SET® technology
Version 7.1 or higher, devices containing Masimo SET technology or licensed to use rainbow compatible sensors. Consult individual
oximetry system manufacturers for compatibility of particular devices and sensor models. Each device manufacturer is responsible for
determining whether their devices are compatible with each sensor model.
NOTE: Though this sensor is capable of reading all parameters, it is limited by the parameters on the device.
The LNCS-II rainbow® DCI and DCIP 8λ SpCO reusable sensors have been validated on the Radical-7® Pulse CO-Oximeter® containing
Masimo rainbow SET technology.
WARNINGS, CAUTIONS AND NOTES
• All sensors and cables are designed for use with specific monitors. Verify the compatibility of the monitor, cable and sensor before
use, otherwise degraded performance and/or patient injury can result.
• The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and correct
optical alignment.
• Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not
frequently moved. Assess site as frequently as every (1) hour with poorly perfused patients and move the sensor if there are signs
of tissue ischemia.
• Circulation distal to the sensor site should be checked routinely.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure
necrosis.
• With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of additional tape
can cause skin damage, and/or pressure necrosis or damage the sensor.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from
monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor,
Trendelenburg position).
• Venous pulsations may cause erroneous low SpO
• The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display. Verify
patient's pulse rate against the ECG heart rate.
• The sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged, discontinue use.
Never use a damaged sensor or one with exposed electrical circuitry.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation,
the reading might be inaccurate or the unit might read zero for the duration of the active radiation period.
• Do not use the sensor during MRI scanning or in a MRI environment.
• High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights,
infrared heating lamps, and direct sunlight can interfere with the performance of the sensor.
• High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pulse CO-Oximeter to
obtain vital sign readings.
Sensors
2
DIRECTIONS FOR USE
readings (e.g. tricuspid value regurgitation, Trendelenburg position).
2
3
Non-sterile
en
> 10 kg
10572A-eIFU-0220