Contraindications - Masimo rainbow RAS-45 Inf/Neo Bedienungsanleitung

rainbow® RAS-45 Inf/Neo
Acoustic Respiration Sensor for Infants and Neonates
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 Masimo® Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory
rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in
hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

CONTRAINDICATIONS

The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is contraindicated for patients who exhibit allergic reactions to foam
rubber products and/or adhesive tape.
DESCRIPTION
The RAS-45 Inf/Neo sensor is for use only with devices containing Masimo rainbow SET™ technology.
RAS-45 Inf/Neo Sensors are compatible with Masimo rainbow technology V7.14.6.0 and above.
WARNINGS, CAUTIONS AND NOTES
• Always refer to the operator's manual for the connected monitor, along with these instructions for use for complete
instructions.
• When monitoring acoustic respiration (RRa), monitoring oxygenation (functional oxygen saturation of arterial
hemoglobin, SpO ) is required.
2
• 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 cover the sensor or apply additional adhesives to the sensor, this may result in inaccurate or no readings.
• 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.
• Do not use tape to secure the sensor to the site; this can cause inaccurate readings. Use of additional tape can cause skin
damage, and/or pressure necrosis or damage the sensor.
• Only use the adhesive film provided on the sensor to the secure it to the patient. Excessive pressure can cause skin
damage or patient discomfort.
• Check the sensor site (every 8 hours) to ensure skin integrity and to avoid damage or irritation to the skin.
• The site must be checked frequently or per clinical protocol to ensure adequate circulation, skin integrity and correct
alignment.
• 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.
• 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.
• Ensure that the cable is not tightly stretched, to prevent accidental detachment of the sensor due to patient movement.
• 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 in any liquid solution. Do not attempt to sterilize the sensor.
• Do not attempt to reuse, reprocess, recondition or recycle Masimo sensors as this may damage the electrical
components, potentially leading to patient harm.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
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
3
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%
10075D-eIFU-1119