Masimo rainbow DCI Mode D'emploi page 3

rainbow® DC Series
Reusable SpCO®, SpMet® & SpO
LATEX
Reusable
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
rainbow® DCI® and DCI-P 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
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and 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
rainbow DCI and DCI-P 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
rainbow DCI and DCI-P 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 rainbow DCI and DCI-P 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.
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DIRECTIONS FOR USE
Not made with natural rubber latex
Sensors
readings (e.g. tricuspid value regurgitation, Trendelenburg position).
2
3
Non-sterile
en
> 10 kg
4869K-eIFU-0818