Masimo RD SET Série Mode D'emploi page 5

RD SET™ Cabled Sensor Series
Adt, Pdt, Inf, Neo, and NeoPt SpO
Single patient use only
Prior to using this sensor, the user should read and understand the Operator's Manual for the device and this Directions for Use.
INDICATIONS
The RD SET™ Cabled Sensor Series disposable sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate (measured by an SpO
patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET Cabled sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.
DESCRIPTION
The RD SET Cabled sensors are for use with devices containing Masimo SET oximetry or licensed to use RD SET Cabled sensors. Consult individual device
manufacturer for compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether its devices are compatible
with each sensor model.
WARNING: Masimo sensors and cables are designed for use with devices 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 adhesion, circulation, skin integrity and correct optical alignment.
• Exercise 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.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• 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
• 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.
• 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 not provided 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.
• 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.
• High levels of COHb or MetHb may occur with a seemingly normal SpO
(CO-Oximetry) of a blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• 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 SpO
• Inaccurate SpO readings may be caused by severe anemia, low arterial perfusion or motion artifact.
2
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performace and/or accuracy.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the
electrical components, potentially leading to patient harm.
• High oxygen concentrations may predispose a premature infant to retinopathy. Therefore, the upper alarm limit for the oxygen saturation must be
carefully selected in accordance with accepted clinical standards.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently displayed after completing the low
SIQ troubleshooting steps identified in the monitoring device operator's manual.
• 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 up to 168 hours of patient monitoring time or up to 336 hours for sensors with a replaceable tape. After single-patient use, discard sensor.
INSTRUCTIONS
A) Site Selection
• Always choose a site that is well perfused and will completely cover the sensor's detector window.
• Site should be cleaned of debris and dry prior to sensor placement.
RD SET Cabled Adt: Adult Sensor
> 30 kg The preferred site is the middle or ring finger of non-dominant hand.
RD SET Cabled Pdt: Pediatric Sensor
10-50 kg The preferred site is middle or ring finger of non-dominant hand.
RD SET Cabled Inf: Infant Sensor
3-10 kg The preferred site is the great toe. Alternatively, the toe next to the great toe, or the thumb can be used.
10 - 20 kg The preferred site is the middle or ring finger of the non-dominant hand. Alternatively, the toe can be used.
RD SET Cabled Neo: Neonatal/Adult Sensor
< 3 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
> 40 kg The preferred site is the middle or ring finger of non-dominant hand.
D I R E C T I O N S F O R U S E
LATEX
PCX-2108A
02/13
sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for
2
readings (e.g. tricuspid value regurgitation).
2
measurements.
2
measurements.
2
Disposable Sensors
2
Not made with natural rubber latex
. When elevated levels of COHb or MetHb are suspected, laboratory analysis
2
measurements.
2
5
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%
9884C-eIFU-0319