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8994B-eIFU-0318
en
RD SET™ DCI® & DCI-P Series
Adult & Pediatric Reusable Finger Clip Sensors
D I R E C T I O N S F O R U S E
Reusable
LATEX
PCX-2108A
02/13
Not made with natural rubber latex
NON
STERILE
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Non-sterile
INDICATIONS
The RD SET DCI® and DCI-P reusable sensors are indicated for either “spot check” or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO
2
) and pulse rate (measured by an SpO
2
sensor) for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or
poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET DCI and DCI-P sensors are contraindicated for use on mobile patients or for prolonged periods of use. They are not intended for long-term monitoring. They must
be removed and repositioned to a different monitoring site at least every four (4) hours. Because individual skin conditions and perfusion levels affect the ability of the site to
tolerate sensor placement, it may be necessary to move the sensor more frequently. If extended monitoring is required, use of an RD SET disposable sensor is recommended.
DESCRIPTION
The RD SET DCI and DCI-P reusable sensors are for use only with devices containing Masimo SET® oximetry or licensed to use RD SET DCI and DCI-P sensors. Consult individual
device manufacturer for compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether its device is compatible with
each sensor model.
The RD SET DCI and DCI-P sensors have been verified with Masimo SET Oximetry Technology.
WARNING:
Masimo sensors and cables are designed for use with instruments containing Masimo SET® oximetry or licensed to use Masimo sensors.
WARNINGS
• 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 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.
• The site must be checked frequently or per clinical protocol to ensure adequate circulation, skin integrity and correct optical alignment.
• Exercise extreme caution; skin erosion, tissue ischemia, and/or pressure necrosis can be caused when the sensor is not frequently moved, applied too tightly, or
becomes too tight due to edema. Assess site as frequently as every (1) hour and move the sensor if there are signs of loss of skin integrity and/or loss of circulation or
perfusion.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of tape can cause skin damage, and/or pressure necrosis
or damage the sensor.
• Carefully route sensor and patient cable to reduce the possibility of patient entanglement or strangulation.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect readings.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• Inaccurate SpO
2
readings may be caused by abnormal venous pulsation or venous congestion.
• 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).
• Venous pulsations may cause erroneous low SpO
2
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
• The pulsations from intra-aortic balloon support can affect the pulse rate displayed on the oximeter. Verify patient’s pulse rate against the ECG heart rate.
• 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
not provided for the duration of the active radiation.
• 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 as it may result in physical harm.
• 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.
• To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this
precaution in high ambient light conditions may result in inaccurate measurements.
• Inaccurate readings may be caused by EMI radiation interference.
• Abnormal fingers, Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
may lead to inaccurate or no readings.
• High levels of COHb or MetHb may occur with a seemingly normal SpO
2
. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a
blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
2
readings.
• Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO
2
readings.
• Elevated levels of total bilirubin may lead to inaccurate SpO
2
readings.
• Inaccurate SpO
2
readings may be caused by severe anemia, very low arterial perfusion, or extreme motion artifact.
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. may cause inaccurate SpO
2
readings.
• Inaccurate SpO
2
readings may be caused by vasospastic disease such as Raynaud’s, and peripheral vascular disease.
• Inaccurate SpO
2
readings may be caused by elevated levels of dyshemoglobin, hypocapnic or hypercapnic conditions and severe vasoconstriction or hypothermia.
• SpO
2
readings may be affected under very low perfusion conditions at the monitored site.
• Readings provided with a low signal confidence indicator may not be accurate.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Clean the sensors prior to reuse on multiple patients.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide as it will damage the sensor.
• Do not attempt to reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical components, potentially leading to
patient harm.
• Caution:
Replace the sensor when a replace sensor or a persistent low SIQ message is displayed when the patient monitoring time is exhausted.
• Note:
The sensor is provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. The sensor will provide 8,760
hours of patient monitoring time. Replace the sensor when the patient monitoring time is exhausted.
INSTRUCTIONS
A. Site Selection
• Choose a site that is well perfused and least restricts a conscious patient’s movements. The ring finger of the non-dominant hand is preferred.
Alternatively, the other digits on the non-dominant hand may be used.
• Always choose a site that will completely cover the sensor’s detector window. The great toe or long toe (next to the great toe) may be used on restrained
patients or patients whose hands are unavailable.
• Site should be cleaned of debris prior to sensor placement.
CAUTION:
Before using the sensor, ensure that the sensor is physically intact, with no broken or frayed wires or damaged parts.
