Masimo Radius PPG Mode D'emploi page 4

Radius PPG™
Wireless SpO
2
Single patient use only
Prior to using this product the user should read and understand the Operator's Manual for the device/monitor, the Directions for Use for the Radius PPG
chip and receiver, and this Directions for Use.
INDICATIONS
Masimo Radius PPG™ is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO
Masimo Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO
pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities
and home environments.
Devices with Masimo technology are only to be used with Masimo sensors and cables.
CONTRAINDICATIONS
The Radius PPG is contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.
DESCRIPTION
Radius PPG consists of three parts:
• Radius PPG wireless receiver
(shipped seperately, see Directions for Use for the Radius PPG
chip and receiver)
Radius PPG is a wireless sensor for use with devices containing Masimo technology MX Version 7.14.8.x. or higher. Consult individual device manufacturers for
compatibility of particular device and sensor models. Each device manufacturer is responsible for determining whether their device is compatible with each
sensor model.
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 adhesion, circulation, skin integrity and correct optical alignment.
• Do not leave the sensor components unattended around children. Small items may become choking hazards.
• 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.
• Circulation distal to the sensor site should be checked routinely.
• The sensor attachment strap site must be checked frequently or per clinical protocol to ensure adequate securement, circulation and skin integrity.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis.
• With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
• 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.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• Misapplications due to wrong sensor types can cause inaccurate or no 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 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.
• Carefully route the sensor cable reduce the possibility of patient entanglement or strangulation.
• 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 period.
• Do not use the sensor during MRI scanning or in a MRI environment.
• 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.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• High levels of COHb or MetHb may occur with a seemingly normal SpO
(CO-Oximetry) of a blood sample should be performed.
• 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 SpO
• Inaccurate SpO readings may be caused by severe anemia, low arterial perfusion, motion artifact, hypocapnic or hypercapnic conditions, EMI radiation
2
interference.
• When using multiple Radius PPG sensors, repeat pairing before monitoring to ensure proper wireless connection.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical
components, potentially leading to patient harm.
• 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.
• 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. After
single-patient use, discard sensor.
Sensors
D I R E C T I O N S F O R U S E
PCX-2108A
02/13
• Radius PPG reusable chip
readings (e.g. tricuspid value regurgitation).
2
measurements.
2
measurements.
2
LATEX Not made with natural rubber latex
(shipped seperately, see Directions for Use for
the Radius PPG chip and receiver)
measurements.
2
measurements.
2
. When elevated levels of COHb or MetHb are suspected, laboratory analysis
2
4
), pulse rate (PR).
2
) and pulse rate (PR) for use with adult,
2
• Radius PPG adhesive sensor
10352C-eIFU-1219
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%