Masimo rainbow R1 Serie Manuel De L'utilisateur page 4

rainbow® R1 Series
SpO , SpMet®, SpHb® Adhesive Sensors
2
Single patient use only
Prior to using the Sensor the user should read and understand the Operator's Manual for the Device or Monitor and
this Directions for Use.
INDICATIONS
The rainbow® adhesive sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO
The rainbow adhesive sensors are indicated for use with adult, pediatric and neonatal 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 rainbow sensors are contraindicated for patients who exhibit allergic reactions to adhesive tape.
DESCRIPTION
rainbow adhesive sensors are for use with devices containing Masimo rainbow® SET® technology (Version 7.4 or higher) 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.
rainbow adhesive sensors have been verified using Masimo rainbow SET technology.
NOTE: Though this sensor is capable of reading all parameters, it is limited by the parameters on the device.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to use
Masimo sensors.
WARNINGS
• Laboratory diagnostic tests using blood samples should be conducted prior to clinical decision making to completely
understand the patient's condition.
• Comparisons between SpHb measurements and laboratory diagnostic hemoglobin measurements may be affected by
sample type, collection technique, physiological, and other factors.
• 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.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• 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.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure
necrosis.
• 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.
• 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.
• 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.
• 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 readings may be caused when values are provided with a low signal confidence indicator.
• 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.
• Inaccurate readings may be caused by birthmark(s), tattoos, or skin discolorations in sensor path, moisture on the skin,
deformed fingers, misaligned sensor emitter and detector, EMC interference from other sensors attached to the patient,
and objects blocking the light path.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• 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).
D IREC TIO N S FO R US E
PCX-2108A
02/13
), pulse rate, methemoglobin saturation (SpMet®), and/or total hemoglobin concentration (SpHb®).
2
LATEX
Not made with natural rubber latex
4
en
Non-sterile
7532E-eIFU-0218