Masimo DBI Serie Mode D'emploi page 3

DBI Series
Reusable Soft Sensors
Reusable
Prior to using this sensor, the user should read and understand the Operator's Manual for the device or monitor and this Directions for Use.
INDICATIONS
When used with Masimo SET® or Masimo rainbow® SET:
DBI Series 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
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
LNCS 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
mobile, and home environments.
CONTRAINDICATIONS
DBI Series 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 DBI Reusable Sensor is a soft-bodied reusable finger sensor for use with systems incorporating Masimo-compatible or Masimo-approved pulse oximetry
technology. Masimo SET performance specifications are met when the DBI sensor is used with Masimo patient cables and systems incorporating Masimo SET
Pulse Oximetry technology. The LNCS DBI sensor may also be used on Nellcor 395 systems and below.
DBI Series sensors have been verified using Masimo rainbow SET™ technology.
The LNCS® 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.
• Circulation distal to the sensor site should be checked routinely.
• 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.
• 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 inaccurate 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
(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
• Inaccurate SpO readings may be caused by severe anemia, very low arterial perfusion, or extreme motion artifact.
2
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. may cause inaccurate SpO
• Inaccurate SpO readings may be caused by vasospastic disease such as Raynaud's, and peripheral vascular disease.
2
• Inaccurate SpO readings may be caused by elevated levels of dyshemoglobin, hypocapnic or hypercapnic conditions and severe vasoconstriction
2
or hypothermia.
• SpO readings may be affected under very low perfusion conditions at the monitored site.
2
• 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 remanufacture, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical components,
potentially leading to patient harm.
LNCS® and Direct Connect
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
sensor) for use with adult and pediatric patients during no motion conditions, and for patients who
2
sensor) for use with patients during no motion conditions, in hospitals, hospital-type facilities,
2
readings.
2
Technology:
2
. When elevated levels of COHb or MetHb are suspected, laboratory analysis
2
readings.
2
readings.
2
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
readings.
2
6684C-eIFU-0518