Masimo Rainbow RAS-45 Instrucciones De Uso página 3

rainbow® RAS-45
Acoustic Respiration Sensor
Do not re-use
Prior to using this sensor, the user should read and understand the Operator's Manual for the device, monitor and
this Directions for Use.
INDICATIONS
The rainbow® Acoustic Monitoring™ sensors and cables are indicated for continuous, noninvasive monitoring of respiratory rate (RRa®) for adult
and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The rainbow® Acoustic Monitoring™ sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/or
adhesive tape.
DESCRIPTION
Sensor Type
Body Weight
Application site
Breaths per Minute, Accuracy Range*
* Respiration rate accuracy for the rainbow Acoustic Monitoring sensor and device has been validated for the range of 4 to 70 breaths per minute
in bench top testing. Clinical validation was performed with the rainbow acoustic sensors and monitoring device for up to 30 breaths per minute
in adult subjects (>30kg) and up to 50 breaths per minute in pediatric subjects (>10kg). See Respiration Rate Accuracy section below.
WARNINGS, CAUTIONS, AND NOTES
• Always refer to the operator's manual for the connected monitor along with these instructions for use for complete instructions.
• 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.
• Do not use sensors that appear to be damaged or discolored, otherwise degraded performance and/or patient injury can result.
• Do not use sensors during magnetic resonance imaging (MRI) or in an MRI environment.
• Carefully route all patient cables to reduce the risk of patient entanglement or strangulation.
• Do not place the sensor where it may cover the patient's nose or mouth.
• Avoid exposing sensors to liquids during use to avoid possible patient harm.
• Only use the adhesive film provided on the sensor to the secure it to the patient. Excessive pressure can cause skin damage.
• Periodically check the sensor site (every 8 hours) to ensure skin integrity and to avoid damage or irritation to the skin .
• Periodically check the sensor site for proper adhesion to minimize the risk of inaccurate or no readings
• Ensure that the placement of the Anchor pad does not tightly stretch the cable to prevent accidental detachment of the sensor due to
patient movement.
• Do not cover or apply additional adhesives to the sensor, this may result in inaccurate or no readings.
• The Anchor pad needs to be attached directly to the patient's skin in order to ensure correct readings.
• Properly apply/place the sensor. Incorrect application or placement may result in inaccurate or no readings.
• Avoid placing sensor on patients exposed to environments with excessive noise. This may result in inaccurate or no readings.
• Properly connect the sensor or the oximeter module to the cable to avoid intermittent readings, inaccurate results, or no reading.
• To prevent damage, do not soak or immerse the sensor or cable in any liquid solution. Do not attempt to sterilize the cable or sensor.
• Do not attempt to reuse, reprocess, recondition or recycle Masimo sensors as this may damage the electrical components, potentially
leading to patient harm.
• 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 120 hours of patient monitoring time. After single-patient use, discard sensor.
INSTRUCTIONS
Note: If the sensor has been stored in a cold environment, it will need to be brought to room temperature before application to ensure correct
readings.
A) Site Selection
Refer to Fig. 1. Select an application site to either side of the larynx.
Note: The sensor may not adhere well on extremely diaphoretic patients.
Note: Site should be hair-free, cleaned of debris and dry.
B) Applying the rainbow RAS-45 Sensor
1. Clean the application site and ensure it is free from any debris prior to applying the sensor onto the patient.
2. Refer to Fig. 2. Hold the sensor so that the "Masimo" label is facing up.
3. Refer to Fig. 3. Gently pull the small tab away from the liner to expose the sensor adhesive.
Note: Avoid contact with the exposed sensor adhesive and sensor pad.
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
Adult, Pediatric > 10 kg
4 to 70 ± 1 breath per minute
3
RAS-45
Neck
en
Non-sterile
8995D-eIFU-0318