Masimo Radical-7 Pulse CO Oximeter with Oxygen Reserve Index User Manual
- June 16, 2024
- MASiMO
Table of Contents
Addendum
Radical-7 ® Pulse CO-Oximeter ®
with Oxygen Reserve index (ORi™)
Radical-7 Pulse CO Oximeter with Oxygen Reserve Index
These operating instructions provide the necessary information for proper
operation of all models of the Radical-7. There may be information provided in
this manual that is not relevant for your system. General knowledge of pulse
oximetry and an understanding of the features and functions of Radical-7 are
prerequisites for its proper use. Do not operate Radical-7 without completely
reading and understanding these instructions. If you encounter any serious
incident with product, please notify the competent authority in your country
and the manufacturer.
Note: Cleared Use Only: The device and related accessories are cleared by
the Food and Drug Administration (FDA) and are CE Marked for noninvasive
patient monitoring and may not be used for any processes, procedures,
experiments, or any other use for which the device is not intended or cleared
by the applicable regulatory authorities, or in any manner inconsistent with
the directions for use or labeling.
Notice: Purchase or possession of this device does not carry any express
or implied license to use with replacement parts which would, alone or in
combination with this device, fall within the scope of one of the relating
patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician. See instructions for use for full prescribing
information, including indications, contraindications, warnings and
precautions.
For professional use. See instructions for use for full prescribing
information, including indications, contraindications, warnings, and
precautions.
Wireless Radio:
Contains: FCC ID: VFK-RAD7A or VFK-RAD7B | FCC Model: Radical-7 | IC ID:
7362A-RAD7A or 7362ARAD7B | IC Model: VFK-RAD7A or VFK-RAD7B
Manufacturer:
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Authorized Brazil Company Representative:
MASIMO IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS LTDA
Alameda Tangará, 80
Salas 402 e 404 Bloco A
Cotia – SP Brazil 06711-020
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005/A1,
CAN/CSA C22.2 No. 60601-1:2014, and applicable Particular (EN/ISO
80601-2-61:2011) and related Collateral (IEC 60601-1- 8:2006/AMD1:2012)
Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents.htm
®, Masimo®, Pulse CO-Oximeter®, Radical-7®, rainbow®, and Root® are federally
registered trademarks of Masimo Corporation.
ORi™ is a trademark of Masimo Corporation. All other trademarks and registered
trademarks are property of their respective owners. © 2023 Masimo Corporation
Addendum, Radical-7 Operator’s Manual: ORi
This addendum provides updates to the following:
Operator’s Manual, Radical-7
301261/LAB-5475 and equivalent translations
This addendum covers the ORi feature of the Radical-7 device. For all other
information, refer to the Operator’s Manual, Radical-7.
Product Description, Features and Indications for Use
The Radical-7 is a noninvasive monitor that measures arterial oxygen
saturation (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth
Variability Index (PVi) along with optional non-invasive measurements of total
hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC),
methemoglobin (SpMet), Acoustic Respiration Rate (RRa), Oxygen Reserve Index
(ORi), and Pleth Respiration Rate (RRp).
The Radical-7 can be used as either a Handheld or a Standalone monitor. The
Radical-7 features a touchscreen that continuously displays numeric values for
all parameters.
The Radical-7 provides graphical displays for plethysmographic waveform,
respiratory waveform, Signal Identification and Quality Indicator (Signal IQ).
The Radical-7 can also be used to interface with a multi-parameter patient
monitor to send Masimo SET pulse oximetry information to that monitor for
display.
The Radical-7 has an embedded 802.11 wireless radio that can be used for
connectivity.
Key Feature Update
The following added feature is available for the Radical-7:Oxygen Reserve
Index (ORi), an index to be used to monitor oxygen saturation of patients on
supplemental oxygen as an adjunct to SpO2.
Indications for Use
The ORi feature is intended to be used in patients undergoing surgery as an
adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin
oxygen saturation levels (e.g., due to administration of supplemental oxygen).
The ORi feature is indicated for the monitoring of hemoglobin oxygen
saturation levels in patients 18 years and older (adults and transitional
adolescents), on supplemental oxygen during no-motion conditions
perioperatively in hospital environments.
Safety Information, Warnings, and Cautions
The following information is an addendum to be used with the content in Safety
information, Warnings and Cautions of the Operator’s Manual, Radical-7 ® Pulse
CO-Oximeter ® .
Performance Warnings and Cautions
WARNING: ORi is intended to be used with SpO2 to provide increased
specificity to elevated oxygen levels (e.g., Supplemental Oxygen). For
clinical conditions where exposure to excessive oxygen can be particularly
harmful, a lower targeted SpO2 value should be used in conjunction with ORi.
WARNING: Optical, pleth-based measurements (e.g. SpO2, PVi, SpHb, SpOC,
SpMet, SpCO, RRp, and ORi) can be affected by the following:
- Improper sensor application or use of incorrect sensor.
- Blood pressure cuff applied to the same arm as the sensor site.
- Intravascular dyes such as indocyanine green or methylene blue.
- Venous congestion.
- Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).
- Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
- Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
- Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or foreign objects in the light path.
- Elevated levels of bilirubin.
- Physiological conditions that can significantly shift the oxygen disassociation curve.
- A physiological condition that may effect vasomotor tone or changes in vasomotor tone.
WARNING: Inaccurate ORi readings may be caused by:
- Low arterial perfusion (<0.2).
- Motion induced artifact.
- Elevated COHb and/or MetHb levels.
- Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (Quantitative defects such as Thalassemias).
- Hypotension, severe vasoconstriction, severe anemia, or hypothermia.
WARNING: ORi is not intended as a replacement for SpO2 monitoring, PaO2
monitoring, or as a sole indicator of the patient’s condition. ORi is to be
used only when patients are receiving supplemental oxygen.
WARNING: ORi trend should be used as an adjunct to SpO2 for patients
under supplemental oxygen. A specific ORi value does not represent a specific
oxygenation level. It provides a reference value in the assessment of the
direction of the oxygenation of hemoglobin.
WARNING: The responsiveness of ORi may vary for each patient and even
within patients depending on the clinical scenario. Therefore, the ORi trend
should not be used as a replacement for other monitoring (e.g., pulse
oximetry/SaO2, ABG/PaO2). It should be used as an adjunct.
WARNING: In the event of a rapid drop in ORi, it is important to check
the oxygen delivery to the patient and other clinical signs of impaired
oxygenation, including changes in patient’s cardiovascular function or
clinical condition.
WARNING: Oxygenation should not be titrated to a maximum ORi value. Not
all patients will reach the same maximum ORi value. PaO2 reference
measurements should be used to verify hyperoxygenation status.
WARNING: An ORi value of 0.7 to 1 does not necessarily correlate with a PaO2
value of >250 mmHg within the same subject or between subjects. This could
lead directly to patient harm of desaturation when the clinician
inappropriately decreases oxygen supply in the intraoperative period in the
cohort of patients where PaO2 is 250 mmHg or lower at ORi of 0.7 to 1.
Concomitant use of SpO2 by pulse oximetry with ORi is critical. Suspected
hypoxemia must include check of the patient cardiopulmonary status and be
verified by arterial blood analysis.
Note: Physiological conditions that result in loss of pulsatile signal
may result in no SpO2, SpHb, SpOC, SpCO, SpMet, RRp, and ORi readings.
Technology Overview
The following information is an addendum to be used with the content in
Technology Overview of the Operator’s Manual, Radical-7 ® Pulse CO-Oximeter ®
.
Masimo rainbow SET® Parallel Engines This figure is for conceptual purposes
only.
General Description for Oxygen Reserve Index (ORi)
ORi is a feature intended to extend monitoring resolution of hemoglobin oxygen
saturation under supplemental oxygen. The feature is intended to be used in
conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature
utilizes the same principles of operation as pulse oximetry, utilizing
hemoglobin wavelength absorption characteristics to determine relative blood
oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen
saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen
disassociation curve, ORi provides visibility to the transition from normoxia
to hyperoxia and within the moderate hyperoxic range (100-250 mmHg PaO2). The
following is the intended benefits of the ORi feature:
Increased monitoring resolution to help increase visibility to oxygenation
under supplemental oxygen. The measurement is taken by a sensor capable of
measuring ORi, on the fingertip of adult patients. The sensor connects
directly to the Pulse CO-Oximeter or with a patient cable. The sensor collects
signal data from the patient and sends it to the device.
Successful Monitoring for ORi
Successful clinical use of ORi requires the use of SpO2 and a clinician’s
assessment of the ORi trend. A specific ORi value is not intended to be
reflective of a specific oxygenation state and will not be characteristically
the same for a patient. It is to be used only when patients are provided with
supplemental oxygen. If the SpO2 value is below 95%, the ORi value will be set
to “0”. When an ORi value is not able to be determined, the ORi will appear as
“—” on the display. Check the sensor application to see that the emitter and
detector are aligned. In the event of a rapid drop in ORi, it is important to
check the oxygen delivery to the patient and other clinical signs of impaired
oxygenation, including changes in patient’s cardiovascular function or
clinical condition.
A stable ORi reading is associated with correct sensor placement, absence of
motion, small physiological changes during the measurement and acceptable
levels of arterial perfusion at the measurement site. Absence of motion does
not mean that muscles need to be fully relaxed. Physiological changes at the
measurement site are mainly caused by fluctuations in the oxygen saturation,
blood concentration and perfusion. See Safety Information, Warnings and
Cautions and Troubleshooting Measurements.
Operation
The following information is an addendum to be used with the content in
Operation of the Operator’s Manual, Radical-7 ® Pulse CO-Oximeter ® .
Accessing Main Menu Options
To access Main Menu options, press the Main Menu icon in the bottom Right
corner of the touchscreen:
The Main Menu options are:
Parameter Settings
See Parameter Settings.
Parameter Settings
**** The following is an example of the Parameter Settings screen. Only
parameters that have been loaded onto the system will be visible.
To access any of the available parameter setting screens:
- From the Parameter Settings screen, to access the desired parameter, flick the on-screen icons left or right.
- Touch the icon of the desired parameter. For details, see any of the following sections:
• See ORi Settings on page 13.
ORi Settings
From the ORi Settings screen, access the following screens:
ORi Alarms on page 14
ORi Histogram on page 14
Trends on page 15
See About Parameter Information in Operation of the Operator’s Manual,
Radical-7 ® Pulse CO- Oximeter ® .
ORi Alarms
From the Alarms screen, change any of the following options:
Options| Description| Alarm Priority| Factory DefaultSettings| User
Configurable Settings
---|---|---|---|---
High Limit| High Limit is the upper threshold that triggers an alarm.| Medium|
Off| 0.02 to 0.70 or Off in increments of 0.01
ORi Histogram
From the Histogram screen, change any of the following options:
Options| Description| Factory Default Settings| **User
Configurable Settings***
---|---|---|---
Bin 1| Define the range of parameter values to be displayed under respective
Bins in histogram view.| 0.00-0.20| 0.00 to 0.96 in steps of 0.01
Bin 2| 0.21-0.40| 0.01 to 0.97 in steps of 0.01
Bin 3| 0.41-0.60| 0.02 to 0.98 in steps of 0.01
Bin 4| 0.61-0.80| 0.03 to 0.99 in steps of 0.01
Bin 5| 0.81-1.00| 0.04 to 1.00 in steps of 0.01
- If one of the Bin settings is changed, all other Bin settings are effected. For example, if Bin 2 is changed to a span of 0.04 to 0.32, Bin 1 changes to a span of 0.00 to 0.03, and Bin 3 changes to a span of 0.33 to 0.60.
Trends
Trend settings allow the user to configure the Y-axis maximum and Y-axis
minimum for each parameter. The maximum and minimum possible values differ
depending on the selected parameter. See Customizing Trend View in Operation
of the Operator’s Manual, Radical-7 ® Pulse CO-Oximeter ® . for additional
information.
ORi Trends
From the Trends screen, change any of the following options:
Options| Description| Factory Default Settings| User
Configurable Settings
---|---|---|---
Y-Axis Min| The ORi Trend Min, indicating the lowest value that will be
shown.| 0| 0.00 to 0.99 in increments of 0.01
Y-Axis Max| The ORi Trend Max, indicating the highest value that will be
shown.| 1| 0.01 to 1.00 in increments of 0.01
Visualization
When the Radical-7 is docked to Root, the Radical-7 provides a supplemental
visualization of the alarm status for the connected Masimo medical
technologies.
Note: The visualization may not be visible on Radical-7 depending on the
layout settings in Root. Refer to the Operator’s Manual for Root for layout
setting information.
Parameter Visualization Table
Monitoring and alarm status for various parameters and/or measurements are
visualized using the following areas/organs on the screen:
| Parameter or MeasurementORi | Area Displayed on Visualization Screen |
|---|---|
| ORi | Lung |
Messages
The following information is an addendum to be used with the content in Alarms
and Messages of the Operator’s Manual, Radical-7 ® Pulse CO-Oximeter ® .
ORi Messages
The following section lists ORi specific messages, their potential causes, and
next steps.
| Message | Potential Causes | Next Steps |
|---|---|---|
| Low ORi SIQ | • Indicates low signal quality of ORi measurement. | • Ensure |
proper sensor application. Check sensor to see if it
is working properly. If not, replace the sensor. See Successful Monitoring for
ORi.
Specifications
The following information is an addendum to be used with the content in
Specifications of the Operator’s Manual, Radical-7 ® Pulse CO-Oximeter ® .
Display Range and Display Resolution
| Measurement | Display Range | Resolution |
|---|---|---|
| ORi (Oxygen Reserve index) | 0.00 to 1.00 (Graphical) | 0.01 |
| 0.00 to 1.00 (Numeric) | 0.01 |
ORi Specifications
Oxygen Reserve Index (ORi )
| Application Site | 18 years and older | Fingertip |
|---|---|---|
| Response Range | 18 years and older | 100-250 mmHg PaO2 |
| Predictability of Hyperoxia (AUC of ROC | 18 years and older | ≥ 0.8 |
ORi Performance Summary
The performance of the ORi was evaluated using clinical data collected from a
combination of 206 healthy volunteers and patients undergoing surgery from
three datasets. One dataset included prospectively collected data from 52
healthy volunteers that underwent controlled hyperoxygenation using different
supplemental oxygen levels (FiO2). One dataset included prospectively
collected data from 31 surgery patients that underwent a pre-intubation
hyperoxygenation protocol. The third dataset included retrospectively analyzed
convenience data collected from 133 surgical patients under supplemental
oxygenation. Each dataset included PaO2 values determined by a blood draw as a
reference for the classification of hyperoxia. ORi, SpO2, and PaO2 data
pairing was done time synchronized and PaO2 data was captured independently.
The combined dataset was analyzed for the performance of the ORi in its
ability to add resolution to changes in oxygenation in the moderate hyperoxia
range of 100-250 mmHg PaO2 as compared to SpO2. The below Receiver Operator
Curves (ROC) from the clinical study data shows the comparative oxygen
responsiveness of ORi in predicting hyperoxia based upon a hyperoxia threshold
of 150 mmHg PaO2 on a mix of healthy and hospitalized subjects.
The study found ORi had a higher positive predictive value (PPV), greater area-under-the-curve (AUC) and enhanced incremental resolution than SpO2 for the detection of hyperoxia. See the comparison of ORi and SpO2 at 4 levels of PaO2.
Hyperoxia Pa02 threshold (mm Hg)| ORI PPV (%)| Sp02 PPV (%)|
ORi AUC| Sp02 AUC| ORi Threshold| Sp02 Threshold
---|---|---|---|---|---|---
105| 98| 95| 0.95| 0.93| 0.1| 98
120| 97| 94| 0.96| 0.90| 0.2| 99
150| 88| 81| 0.92| 0.84| 0.3| 99
200| 62| 49| 0.88| 0.78| 0.45| 99
250| 38| 36| 0.84| 0.75| 0.55| 100
Hyperoxia Pa02 Threshold (mmHg)
| ORi 00.01)| Sp02 (a96%)
---|---|---
Sensitivity| Specificity| Sensitivity|
Specificity
105| 95 +/- 1| 86 +/- 4| 100 +/- 0| 37 +/- 5
120| 98 +/- 1| 73 +/- 4| 100 +/- 0| 26 +/- 4
150| 100 +/- 0| 48 +/- 3| 100 +/- 0| 16 +/- 2
200| 100 +/- 0| 29 +/- 2| 100 +/- 0| 10 +/- 2
250| 100 +/- 0| 24 +/- 2| 100 +/- 0| 8 +/- 1
The study data supported the primary endpoints of a AUC ≥ 0.8 and the improved
detection as compared to SpO2 based upon AUC and PPV.
The data also supported the secondary endpoint of ORi providing additional
incremental resolution from SpO2. See table below that shows the increased ORi
range.
| Hyperoxia PaO2 Threshold (mm Hg) | ORi Threshold | SpO2 Threshold |
|---|---|---|
| 105 | 0.1 | 98 |
| 120 | 0.2 | 99 |
| 150 | 0.3 | 99 |
| 200 | 0.45 | 99 |
| 250 | 0.55 | 100 |
| % of Range | 64.30% | 2% |
www.masimo.com
304918/LAB-12187A-1123
Documents / Resources
|
Masimo Radical-7 Pulse CO Oximeter with Oxygen Reserve
Index
[pdf] User Manual
Radical-7 Pulse CO Oximeter with Oxygen Reserve Index, Radical-7, Pulse CO
Oximeter with Oxygen Reserve Index, CO Oximeter with Oxygen Reserve Index,
Oximeter with Oxygen Reserve Index, Oxygen Reserve Index, Reserve Index
---|---