Masimo Radius PPG Mode D'emploi page 3

Radius PPG™
+70 C
Chip and Receiver
-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 Operator's Manual for the device/monitor, The Directions for Use for the sensor,
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
• Radius PPG reusable chip
• Radius PPG adhesive sensor (shipped seperately, see Directions for Use for the Radius PPG Adhesive Sensor)
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
• 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 host (see Wireless Technology Information for details); moving outside
of this range may cause a loss in connection with the host device.
• 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.
INSTRUCTIONS
a) Initial setup
1. Verify you have all components. Refer to Fig. 1.
A. Radius PPG adhesive sensor
2. Turn on the patient monitor.
3. Plug the cable into the patient monitor. Refer to Fig. 2. The light on wireless receiver will be white.
4. Attach the wireless receiver to the side of the patient monitor using the adhesive provided. Refer to Fig. 3.
5. Avoid covering speakers or holes used for mounting when attaching the module. Refer to Fig. 4.
6. Attach the chip holder near the receiver on the patient monitor. Refer to Fig. 5.
7. Verify that the wireless receiver is attached and plugged in to patient monitor. Verify that the chip holder is attached to patient monitor. Refer to Fig. 6.
b) Pairing the reusable transmitter chip with the wireless receiver
1. Ensure the device is powered on. Refer to Fig. 7.
2. Hold the reusable chip to the indent on the wireless receiver until the Bluetooth symbol on the wireless receiver turns green. Refer to Fig. 8.
3. Insert the reusable chip into the sensor attachment strap until there is a tactile or audible click of connection. Refer to Fig. 9.
4. Verify the light on the wireless receiver turns blue. (See LIGHT INDICATOR GUIDE section.)
c) Disconnecting
1. Push down on the tab to release the reusable chip from the sensor. Refer to Fig. 10.
2. After cleaning, store the reusable chip in the chip holder attached to the patient monitor. Refer back to Fig. 6.
3. Discard the adhesive sensor and strap.
CLEANING
WARNING: Before cleaning, make sure the device is off and is not applied to a patient.
Thoroughly clean the Radius PPG reusable chip and wireless receiver before applying to a new patient.
To surface clean the reusable chip and wireless receiver:
1. Remove the sensor from the patient and disconnect the reusable chip.
2. Wipe all surfaces of the reusable chip and wireless receiver 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 wireless receiver to dry thoroughly before using again.
CAUTIONS:
• To avoid permanent damage to the reusable chip and wireless receiver, do not use undiluted bleach (5–5.25% sodium hypochlorite) or any other cleaning
solution not recommended.
• Do not immerse the reusable chip and wireless receiver in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave or ethylene oxide.
D I R E C T I O N S F O R U S E
LATEX
PCX-2108A
02/13
B. Radius PPG wireless bluetooth receiver
Not made with natural rubber latex
C. Radius PPG reusable chip
3
), pulse rate (PR).
2
) and pulse rate (PR) for use with adult,
2
D. Radius PPG reusable chip holder for device
10353C-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%