Environmental Specifications; Battery Life - Masimo Radius PPG Instrucciones De Uso

LIGHT INDICATOR GUIDE
Wireless Transmitter
Color
receiver
No light --
White solid
solid
(2 seconds)
Green
flashing
(30 seconds) (30 seconds)
Blue solid
Purple flashing
Orange flashing
Red flashing
ACCURACY SPECIFICATIONS (A
Oxygen Saturation (SpO )
2
SpO Accuracy, No Motion (70–100%)
1
2
SpO Accuracy, Motion
2
2
SpO Accuracy, Low Perfusion
2
* NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the
rms
device measurements fell within ± A
1 The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark
pigmented skin in induced hypoxia studies in the range of 70–100% SpO
The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented
2
skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at
an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70–100% SpO
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
3
strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
4 The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25–240 bpm in bench top testing against a Biotek Index 2 simulator and Masimo's
simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for the properties of fetal hemoglobin.
5

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
FCC ID are as follows: Chip: VKF-AIRTB01 Receiver: VKF-AIRDG01
IC IDs are as follows: Chip: 7362A-AIRTB01 Receiver: 7362A-AIRDG01
Radius PPG Receiver:
EN 301 489-17 V3.1.1
EN 301 489-3 V2.1.1
WARNING: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
WARNING: The frequency bands of this device (2.4 GHz) are only for indoor use, in accordance with international telecommunication requirements.
CAUTION: Keep the Radius PPG away from electrical equipment that emits radio frequencies to minimize radio interference. Radio interference may result in no
or inaccurate readings.
chip
• Wireless receiver cable is not connected to host
device with power
--
• Chip not connected to sensor with battery
• Wireless receiver is connected to host device with
power ready to initiate pairing with transmitter chip
--
• Paring search period has expired
-- • Chip and receiver are linked
flashing
• Pairing search period
flashing • Successful pairing of receiver and chip
• Battery seal tab has not been removed to activate
battery
flashing
• Battery is obstructed
flashing • Low sensor battery
• Depleted sensor battery
flashing
• Hardware or sensor failure, chip blinking board
failure code
*)
rms
Adults, Pediatrics, Infants
All patient populations
All patient populations
3
of the reference measurements in a controlled study.
rms
-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
EU Radio Equipment Directive (RED 2014/53/EU)
EN 300 328 V2.2.1
EN 300 330 V2.1.0
Description
Neonates
5
against a laboratory co-oximeter.
2
against a laboratory co-oximeter.
2
EN 301 489-17 V3.1.1
EN 300 328 V2.2.1
4
Next steps
• Turn on patient monitor and plug cable into patient
monitor
• See Instructions, section a) for set up
• Hold reusable chip to the indent on the wireless receiver
to initiate pairing
• See Instructions, section b) for pairing
• Insert reusable chip into sensor attachment strap to
complete pairing
• See Instructions, section b) for pairing
• Verify sensor attachment so host device can receive data
• 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 (Refer to Figs. 9 and 10.)
• Consider replacing sensor, do not discard reusable chip
• See Instructions, section c) for disconnecting
• Replace sensor, do not discard reusable chip. If issue
persists, replace reusable chip
• See Instructions, section c) for disconnecting
• Contact Masimo Technical Support, or replace sensor
and chip
Pulse Rate
4
2% All patient populations
3% No Motion
3% Motion
2% Low Perfusion
Radius PPG Chip:
(PR) 25–240 bpm
3 bpm
5 bpm
3 bpm
10353C-eIFU-1219