Contraindications - Masimo RD SET DBI Mode D'emploi

RD SET™ DBI
Reusable Soft Sensors
Reusable
Prior to using this sensor, the user should read and understand the Operator's Manual for the monitor and this Directions for Use.
INDICATIONS
When used with Masimo SET® or Masimo rainbow® SET:
The RD SET™ DBI Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen
saturation of arterial hemoglobin (SpO
conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
When used with Nellcor and Nellcor Compatible Pulse Oximeters or Philips FAST SpO
RD SET DBI Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of
arterial hemoglobin (SpO ) and pulse rate (measured by an SpO
2
type facilities, mobile, and home environments.

CONTRAINDICATIONS

The RD SET DBI Reusable Soft Sensors are contraindicated for use on active 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
The RD SET DBI Reusable Soft Sensors are for use only with devices containing or licensed to use Masimo SET technology. Consult individual
device manufacturer for compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether
their devices are compatible with each sensor model.
RD SET DBI sensors have been verified using Masimo rainbow SET™ technology.
RD SET DBI sensors have been verified on the Nellcor N-200 and N-395 Pulse Oximeter.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to use Masimo sensors.
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 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 readings may be caused by abnormal venous pulsation or venous congestion.
2
• 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.
• 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
analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO
• Elevated levels of total bilirubin may lead to inaccurate SpO
D I R E C T I O N S F O R U S E
LATEX Not made with natural rubber latex
PCX-2108A
02/13
) and pulse rate (measured by an SpO
2
sensor) for use with patients during no motion conditions, in hospitals, hospital-
2
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
2
2
sensor) for use with adult and pediatric patients during no motion
2
Technology:
2
. When elevated levels of COHb or MetHb are suspected, laboratory
2
readings.
2
readings.
2
readings.
3
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
9022B-eIFU-0119