Masimo Radius PPG Instrucciones De Uso página 2

Radius PPG™ and Masimo SafetyNet™
Supplement
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
Reusable
Prior to using this product the user should read and understand the Directions for Use for the sensor, and this Directions for Use.
WARNINGS, CAUTIONS AND NOTES
• Do not self-diagnose or self-medicate on the basis of the measurements. Always consult your doctor.
• Do not leave the sensor components unattended around children. Small items may become choking hazards.
• To ensure continued monitoring, routinely verify the wireless connection.
• When using multiple Radius PPG sensors, repeat pairing before monitoring to ensure proper wireless connection.
• When using Radius PPG, keep it within the recommended range from the connected device (see Wireless Technology Information for details);
moving outside of this range may cause a loss in connection with the smart device/mobile application.
• When using Radius PPG, relocate the devices away from sources that may interfere with the Bluetooth connection. The presence of other
devices that may create radio frequency interference (RFI) may result in loss of Quality of Service (see Specifications for details) of the Bluetooth
connection. Devices that may cause RFI include but are not limited to the following: electrocautery equipment, diathermy equipment, other
cellular telephones, wireless PC and tablets, pagers, RFID devices, MRI, and electromagnetic security systems.
LIGHT INDICATOR GUIDE
The reusable chip includes a light to indicate battery and pairing status. Refer to the table for a description of the color of the flashing light, and next
steps.
Color Description
Green • Successful insertion of chip into sensor
• Successful pairing of chip to mobile device
Blue
and app
• Battery seal tab has not been removed to
Purple activate battery
• Battery is obstructed
Orange • Low sensor battery
• Depleted sensor battery
Red
• Hardware or sensor failure, chip blinking
board failure code
CLEANING
WARNING: Before cleaning, make sure the device is off and is not applied to a patient.
Thoroughly clean the Radius PPG reusable chip before applying to a new patient.
To surface clean the reusable chip:
1. Remove the sensor from the patient and disconnect the reusable chip.
2. Wipe all surfaces of the reusable chip with one of the following:
a. 70% Isopropyl alcohol
b. 10% (1:10) chlorine bleach to water solution
c. Quaternary ammonium chloride solution
3. Allow the reusable chip and receiver to dry thoroughly before using again.
CAUTIONS:
• To avoid permanent damage to the reusable chip, do not use undiluted bleach (5–5.25% sodium hypochlorite) or any other cleaning solution not
recommended.
• Do not immerse the reusable chip in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave or ethylene oxide.
ENVIRONMENTAL SPECIFICATIONS
Storage/Transport Temperature
Operating Temperature
Storage/Transport Humidity
Operating Humidity
Atmospheric Pressure
BATTERY LIFE
Battery Life
WIRELESS TECHNOLOGY INFORMATION
Modulation Type
Max. Output Power
Frequency Range
Antenna Peak Gain
Recommended Range
Quality of Service (QoS)
Security
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
• Follow app instructions for pairing
• Verify data is displayed on app
• Remove tab to activate battery
• Refer to Directions for Use for the Radius PPG Adhesive Sensor
• Disconnect reusable chip from sensor, wait 30 seconds, insert
chip into sensor
• Consider replacing sensor, do not discard reusable chip
• Replace sensor, do not discard reusable chip. If issue persists,
replace reusable chip
• Contact Masimo Technical Support, or replace sensor and chip
-40 – +70°C @ ambient humidity
0–40°C @ ambient humidity
5–95% non-condensing
5–95% non-condensing
540 to 1060 mBar @ ambient temperature and humidity
96 hours in typical continuous usage
Bluetooth LE Wireless Technology Information
GFSK
+8 dBm
2402–2480 MHz
1 dBi
100 ft (~30 meters) line-of-sight
Delay < 30 seconds
Proprietary binary protocol
Next steps
2
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%
10693B-eIFU-0420