Masimo Radical-7 User manual

Operator's Manual
Radical-7®Pulse CO-Oximeter®

www.masimo.com 1 Masimo
For Sale in the USA
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.
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.
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
7362A-RAD7B | IC Model: VFK-RAD7A or VFK-RAD7B
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
3149433
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
Radical-7®, ®, Adaptive Probe Off Detection®, APOD®, 3D Alarm®, Discrete Saturation
Transform®, DST®, FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVi®, Root®,
rainbow®, rainbow Resposable®, RRa®, SatShare®, SedLine®, SET®, Signal Extraction
Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet® are federally registered trademarks
of Masimo Corporation.
3D Desat Index Alarm™, rainbow Acoustic Monitoring™, RAM™, RDS™, ORi™, and SST™ are
trademarks of Masimo Corporation. All other trademarks and registered trademarks are
property of their respective owners. The use of the trademark PATIENT SAFETYNET is under
license from University HealthSystem Consortium.
© 2019 Masimo Corporation

www.masimo.com 3 Masimo
Contents
About This Manual-------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use----------------------------------------------- 9
Key Features --------------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------10
Contraindications --------------------------------------------------------------------------------------10
Safety Information, Warnings and Cautions ---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 11
Performance Warnings and Cautions--------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ----------------------------------------------------18
Compliance Warnings and Cautions----------------------------------------------------------------19
Chapter 1: Technology Overview ------------------------------------------------------------------------ 21
Signal Extraction Technology® (SET®)------------------------------------------------------------ 21
rainbow Pulse CO-Oximetry Technology -----------------------------------------------------------24
rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------28
Chapter 2: Description ------------------------------------------------------------------------------------31
General System Description-------------------------------------------------------------------------- 31
Functionality of the Radical-7------------------------------------------------------------------------31
Handheld ----------------------------------------------------------------------------------------------- 33
Docking Station --------------------------------------------------------------------------------------- 35
Root------------------------------------------------------------------------------------------------------ 38
Monitor Interface With SatShare------------------------------------------------------------------- 39
Chapter 3: Setup------------------------------------------------------------------------------------------- 41
Unpacking and Inspection --------------------------------------------------------------------------- 41
Powering Radical-7 On, Standby, and Power Off-------------------------------------------------- 41
Initial Battery Charging -------------------------------------------------------------------------------42
Docking Station Setup --------------------------------------------------------------------------------42
Root Setup ----------------------------------------------------------------------------------------------43
SatShare Setup and Use ------------------------------------------------------------------------------43
Philips, Agilent, or HP VueLink Setup --------------------------------------------------------------44
SpaceLabs Flexport Setup ----------------------------------------------------------------------------44
Chapter 4: Operation-------------------------------------------------------------------------------------- 47

Radical-7 Contents
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Using the Touchscreen and Buttons --------------------------------------------------------------- 47
About the Main Screen ------------------------------------------------------------------------------- 51
Accessing Main Menu Options ----------------------------------------------------------------------65
Parameter Settings------------------------------------------------------------------------------------ 67
Sounds ---------------------------------------------------------------------------------------------------83
Device Settings-----------------------------------------------------------------------------------------84
About-----------------------------------------------------------------------------------------------------92
Trends----------------------------------------------------------------------------------------------------93
Chapter 5: Profiles----------------------------------------------------------------------------------------- 97
Profiles Overview--------------------------------------------------------------------------------------- 97
Changing Profiles -------------------------------------------------------------------------------------- 97
Profiles Settings----------------------------------------------------------------------------------------99
Replacing Factory Default Settings for Adult and Neo Profiles ------------------------------100
Chapter 6: Alarms and Messages--------------------------------------------------------------------- 101
About Alarms ----------------------------------------------------------------------------------------- 101
3D Alarms --------------------------------------------------------------------------------------------- 103
Radical-7 Messages---------------------------------------------------------------------------------- 105
Chapter 7: Troubleshooting----------------------------------------------------------------------------- 111
Troubleshooting Measurements-------------------------------------------------------------------- 111
Troubleshooting the Radical-7 ---------------------------------------------------------------------114
Chapter 8: Specifications -------------------------------------------------------------------------------119
Display Range -----------------------------------------------------------------------------------------119
Accuracy (ARMS*) ------------------------------------------------------------------------------------119
Resolution----------------------------------------------------------------------------------------------121
Electrical------------------------------------------------------------------------------------------------121
Environmental-----------------------------------------------------------------------------------------122
Physical Characteristics -----------------------------------------------------------------------------122
Trending----------------------------------------------------------------------------------------------- 123
Alarms ------------------------------------------------------------------------------------------------- 123
Display Indicators------------------------------------------------------------------------------------ 123
Compliance --------------------------------------------------------------------------------------------124
Output Interface ------------------------------------------------------------------------------------- 125
Wireless Specifications ----------------------------------------------------------------------------- 128

Radical-7 Contents
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Guidance and Manufacturer's Declaration-Electromagnetic Emissions-------------------- 131
Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication
Equipment--------------------------------------------------------------------------------------------- 132
Manufacturer's Declaration-Electromagnetic Immunity -------------------------------------- 134
Recommended Separation Distances ------------------------------------------------------------ 136
Symbols------------------------------------------------------------------------------------------------ 137
Citations ----------------------------------------------------------------------------------------------- 139
Chapter 9: Service and Maintenance------------------------------------------------------------------141
Cleaning ------------------------------------------------------------------------------------------------141
Battery Operation and Maintenance --------------------------------------------------------------141
Replacing the Fuses --------------------------------------------------------------------------------- 143
Performance Verification --------------------------------------------------------------------------- 143
Repair Policy ------------------------------------------------------------------------------------------ 146
Return Procedure------------------------------------------------------------------------------------- 146
Contacting Masimo ---------------------------------------------------------------------------------- 146
Appendix: Concepts of Alarm Response Delay------------------------------------------------------ 149
Concepts of Alarm Response Delay --------------------------------------------------------------- 149
Index ------------------------------------------------------------------------------------------------------- 151

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About This Manual
This manual explains how to set up and use Radical-7® Pulse CO-Oximeter®. Important
safety information relating to general use of Radical-7 appears in this manual. Read and
follow any warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.

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Product Description, Features and
Indications for Use
The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse
rate (PR), and perfusion index (Pi), along with optional measurements of hemoglobin (SpHb),
carboxyhemoglobin (SpCO®), total oxygen content (SpOC), methemoglobin (SpMet), Pleth
Variability Index (PVi®), and Acoustic Respiration Rate (RRa®).
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 Features
The following features are available for the Radical-7. Some features are optional:
•Masimo SET® technology is clinically proven to satisfy all sensitivity and
specificity requirements for pulse oximetry.
•Masimo rainbow® technology uses 7+ wavelengths of light to continuously and
noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet), and
total hemoglobin (SpHb), as well as providing a more reliable probe-off detection.
•Total oxygen content (SpOC) provides a calculated measurement of the amount of
oxygen in arterial blood, which may provide useful information about oxygen both
dissolved in plasma and combined with hemoglobin.
•Perfusion Index (Pi) with trending capability indicates arterial pulse signal
strength and may be used as a diagnostic tool during low perfusion.
•Pleth Variability Index (PVi) may show changes that reflect physiologic factors
such as vascular tone, circulating blood volume, and intrathoracic pressure
excursions. [The utility of PVi is unknown at this time and requires further clinical
studies. Technical factors that may affect PVi include probe malposition and
patient motion.]
•Respiration rate can be determined by the acoustic (RRa) waveform.
•Signal IQ waveform for signal identification and quality indication during
excessive motion and low signal to noise situations.
•FastSat tracks rapid changes in arterial O2.
•Variable pitch provides tonal variance for every 1% change in saturation.
•SatShare interface allows transfer of SpO2and pulse rate to an existing
multi-parameter monitor and allows for the reading of SpCO, SpMet, SpHb, and
SpOC on adjacent Radical-7 monitor.
•Automatic screen rotation provides upright display for vertical or horizontal
monitor positioning.

Radical-7 Product Description, Features and Indications for Use
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•Multi-gesture touchscreen interface.
•Detachable portable Handheld for patient transport.
•Remote alarm interface.
•Ability to display data on a secondary display.
Indications for Use
The Masimo Radical-7® Pulse CO-Oximeter® and Accessories are indicated for the
continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation
(SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
The Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated for use with adult,
pediatric, and neonatal patients during both no motion and motion conditions, and for
patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and
home environments.
In addition, the Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated to
provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7®
Pulse CO-Oximeter® and accessories of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate (PR) to multi-parameter devices for the display of those devices.
Contraindications
Radical-7 is not intended for use as an apnea monitor.

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Safety Information, Warnings and
Cautions
CAUTION: Radical-7 is to be operated by, or under the supervision of, qualified personnel
only. Read the manual, accessories directions for use, all precautionary information, and
specifications before use. Refer to Operator’s Manuals of Root, Patient SafetyNet and Kite for
additional safety information, warnings, and cautions.
Safety Warnings and Cautions
WARNING: Do not use the Radical-7 if it appears or is suspected to be damaged. Damage to
the device can result in exposed electrical circuits that may cause patient harm.
WARNING: Do not adjust, repair, open, disassemble, or modify the Radical-7. Damage to the
device may result in degraded performance and/or patient injury.
WARNING: Do not start or operate Radical-7 unless the setup was verified to be correct.
Improper set-up of this device may result in degraded performance and/or patient injury.
WARNING: Do not place the Radical-7 or accessories in any position that might cause it to
fall on the patient.
WARNING: Only use Masimo authorized devices with Radical-7. Using unauthorized devices
with Radical-7 may result in damage to the device and/or patient injury.
WARNING: All sensors and cables are designed for use with specific devices. Verify the
compatibility of the device, cable, and sensor before use; otherwise degraded performance
and/or patient injury can result.
WARNING: Do not use the Radical-7 in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous
oxide to avoid risk of explosion.
WARNING: Do not use Radical-7 during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Radical-7 may be used during defibrillation. However, to reduce the risk of electric
shock, the operator should not touch the Radical-7 during defibrillation.
WARNING: When positioned on a flat surface, the device should be secured with a mounting
system recommended by Masimo.
WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts.
WARNING: To protect against injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Do not attempt to sterilize the device.
• Use cleaning solutions only as instructed in this Operator's Manual.
• Do not attempt to clean Radical-7 while monitoring patient.
WARNING: To protect from electric shock, always remove the sensor and completely
disconnect Radical-7 before bathing the patient.

Radical-7 Safety Information, Warnings and Cautions
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WARNING: To ensure safety, avoid placing anything on the device during operation.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
CAUTION: Do not place the Radical-7 where the controls can be changed by the patient.
CAUTION: Electric shock hazard: Do not open the Radical-7 cover except to replace the
battery or batteries.
CAUTION: To ensure patient electrical isolation, only dock to Masimo devices that have been
designed for Radical-7.
CAUTION: Do not place Radical-7 where the appliance inlet or the AC power plug cannot be
readily disconnected.
CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is
required.
CAUTION: To avoid risk of electrical shock, this equipment must only be connected to a
supply mains with a protective earth connection. Do not under any circumstances remove the
grounding conductor from the power plug.
CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable
could cause damage to Radical Docking Station. Check the power cord and plug to ensure that
it is intact and undamaged.
CAUTION: To ensure patient electrical isolation, all external device connections to the Data
Output/Nurse Call connectors must be IEC 60950-1, IEC 60601-1, or UL1069 compliant.
Note: If there is any doubt about the integrity of the protective earth conductor arrangement,
operate the Radical-7 on internal battery power until the AC power supply protective
conductor is fully functional.
Note: Disconnect the device from AC mains by removing the AC power cord connector from
the appliance inlet.
Note: Do not monitor more than a single patient at a time on Radical-7.
Note: Use and store the Radical-7 in accordance with specifications. See the Specifications
chapter in this manual.
Kite
WARNING: Do not adjust, repair, open, disassemble, or physically modify the Kite host
device. Injury to personnel or equipment damage could occur. Return the Kite host device for
servicing.
Performance Warnings and Cautions
WARNING: Radical-7 should not be used as the sole basis for medical decisions. It must be
used in conjunction with clinical signs and symptoms.
WARNING: The Radical-7 and Accessories are not intended to be used as the sole basis for
making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it
is intended to be used in conjunction with additional methods of assessing clinical signs and
symptoms.

Radical-7 Safety Information, Warnings and Cautions
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WARNING: If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Radical-7 for proper functioning.
WARNING: Variation in hemoglobin measurements may be profound and may be affected by
sample type, body positioning, as well as other physiological conditions. As with most
hemoglobin data, Radical-7 trend data should be scrutinized in light of a specific patient
condition. Any results exhibiting inconsistency with the patient's clinical status should be
repeated and/or supplemented with additional data.
WARNING: Do not use Radical-7 as an apnea monitor. Radical-7 does not have alarms to alert
you when you are not breathing properly.
WARNING: Radical-7 should not be used used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING: Radical-7 may be used during defibrillation; however, the display may require up
to 15 seconds to return to normal operation.
WARNING: Radical-7 may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
WARNING: Radical-7 may be used during electrocautery, but this may affect the accuracy or
availability of the parameters and measurements.
WARNING: Avoid placing Radical-7 against a surface that may cause the alarm to be muffled.
This may result in the inability to detect the audible alarms.
WARNING: Radical-7 may not fully charge in a high ambient temperature environment.
WARNING: Do not place containers with liquids on or near Radical-7. Liquids spilled on
Radical-7 may cause it to perform inaccurately or fail.
WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor
or sensors that become partially dislodged may cause no or incorrect readings.
WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site
may result in no or incorrect readings.
WARNING: Do not use Radical-7 on patients that have been injected with dyes or any
substance containing dyes, the change usual blood pigmentation may cause no or incorrect
readings.
WARNING: Display parameter may not be accurate when a low SIQ message is provided.
Clinicians should consider additional information to supplement values to completely
understand the patient’s condition.
WARNING: If SpO2values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
WARNING: SpO2is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: Optical, pleth-based measurements (e.g. SpO2, SpHb, SpOC, SpMet, and SpCO)
can be affected by the following:
•Improper sensor application or use of 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.

Radical-7 Safety Information, Warnings and Cautions
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•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.
•Externally applied coloring and texture, such as nail polish, acrylic nails, glitter,
etc.
WARNING: No or inaccurate SpO2readings may be caused by:
•Improper sensor application.
•Blood pressure cuff applied to the same arm as the sensor site.
•Arterial catheter
•Elevated levels of COHb and/or MetHb. Note: High levels of COHb or MetHb may
occur with a seemingly normal SpO2.
•Intravascular dyes such as indocyanine green or methylene blue.
•Venous congestion.
•Excessive venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg
position).
•Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
•Moisture, birthmarks, skin discoloration, or foreign objects in the light path.
•Elevated levels of bilirubin.
•Severe anemia.
•Very low arterial perfusion.
•Hypocapnic or Hypercapnic conditions.
•Excessive motion.
•Vasospastic disease such as Raynaud's.
•Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
•Peripheral vascular disease.
•EMI radiation interference.
WARNING: Inaccurate SpHb and SpOC readings may be caused by:
•Intravascular dyes, such as indocyanine green or methylene blue.

Radical-7 Safety Information, Warnings and Cautions
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•Excessive venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg
position).
•Elevated PaO2levels.
•Elevated levels of bilirubin.
•Low arterial perfusion.
•Motion artifact.
•Low arterial oxygen saturation levels.
•Elevated COHb and/or MetHb levels.
•Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
•Vasospastic disease such as Raynaud's.
•Peripheral vascular disease.
•Liver disease.
•EMI radiation interference.
WARNING: Inaccurate SpCO and SpMet readings may be caused by:
•Improper sensor application.
•Intravascular dyes such as indocyanine green or methylene blue.
•Externally applied coloring and texture, such as nail polish, acrylic nails, glitter,
etc.
•Elevated PaO2levels.
•Elevated methemoglobin levels.
•Abnormal hemoglobin levels.
•Low arterial perfusion.
•Low arterial oxygen saturation levels including altitude induced hypoxemia.
•Elevated total bilirubin levels.
•Motion artifact.
•Vasospastic disease such as Raynaud's.
•Peripheral vascular disease.
•Liver disease.
•EMI radiation interference.
WARNING: SpCO readings may not be provided if there are Low arterial oxygen saturation
levels or elevated methemoglobin levels.
WARNING: Inaccurate respiration rate measurements may be caused by:
•Improper sensor application.
•Low arterial perfusion.
•Motion artifact.

Radical-7 Safety Information, Warnings and Cautions
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•Low arterial oxygen saturation.
•Excessive ambient or environmental noise.
•Improper sensor placement.
WARNING: Wireless communication of alarms to a secondary monitoring station should not
be relied upon as a primary alarm.
WARNING: A functional tester cannot be used to assess the accuracy of the Radical-7.
CAUTION: If using Radical-7 during full body irradiation, keep the sensor out of the radiation
field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device
might read zero for the duration of the active irradiation period.
CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to
light sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy.
CAUTION: The device must be configured to match your local power line frequency to allow
for the cancelation of noise introduced by fluorescent lights and other sources.
CAUTION: 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.
CAUTION: 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.
CAUTION: For home use, ensure that the Radical-7 alarm can be heard from other rooms in
the house, especially when noisy appliances such as vacuum cleaners, dishwashers, clothes
dryers, televisions, or radios are operating.
CAUTION: When Silence Duration is set to All Mute or All Mute with Reminder on Radical-7,
there will be no audible alarms on Radical-7 or Patient SafetyNet; however, there will be
visual alarms displayed on Radical-7 and Patient SafetyNet view.
CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused
monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status
through other means.
CAUTION: To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to Radical-7.
CAUTION: Do not place the Radical-7 on electrical equipment that may affect the device,
preventing it from working properly.
CAUTION: Failure to charge Radical-7 promptly after a Low Battery alarm may result in the
device shutting down.
CAUTION: To minimize electromagnetic interference, only use a SatShare cable that has a
ferrite bead installed.
CAUTION: During SatShare operation, alarms may be muted on the Radical-7. Use the
multi-parameter monitor for audible alarms during SatShare operation.
CAUTION: Ensure Radical Docking Station is connected to AC power source when charging
Radical-7.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer.

Radical-7 Safety Information, Warnings and Cautions
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CAUTION: In order to establish and maintain Radical-7’s minimum Quality of Service, the
following network specifications should be met before and after installation:
•Wired Network Connection
During Ping Test, passing result if:
a. At least 98% of packets have latency ≤ 30 milliseconds, and
b. No more than 2 % packets loss.
•Wireless Network Connection
During Ping Test, passing result if:
a. At least 98% of packets have latency ≤ 100 milliseconds,
b. No more than 2 % packets loss, and
c. Primary access point signal strength at least -67 dBm.
CAUTION: The wireless quality of services may be influenced by the presence of other devices
that may create radio frequency interference (RFI). Some RFI devices to consider are as
follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID,
MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices,
consideration should be taken to maximize separation distances and to observe for any
potential signs of interference such as loss of communication or reduced Wi-Fi signal
strength.
CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time the Radical-7 is used.
CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing the low SIQ
troubleshooting steps listed in the troubleshooting section.
Note: Cables and sensors are provided with X-Cal® technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or
Sensor DFU for the specified duration of patient monitoring time.
Note: If the Radical-7 stops communicating with Root, parameters and measurements will
not show on the Root display; however, this will not affect Radical-7's ability to monitor the
patient.
Note: It is recommended that Radical-7 battery is fully charged prior to use.
Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
Note: Additional information specific to the Masimo sensors compatible with Radical-7,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).
Note: Physiological conditions that result in loss of pulsatile signal may result in no PaO2,
SpHb, SpOC, SpCO, and SpMet readings.
Note: Radical-7 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi
communication.
Note: Radical-7’s alarm capabilities have been designed to be independent of the Wi-Fi
communication feature in order to preserve Radical-7’s primary alarms.
Note: Always charge Radical-7 when it is not in use to ensure that the Radical-7 battery
remains fully charged.

Radical-7 Safety Information, Warnings and Cautions
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Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will
vary depending upon the age of the Battery Module.
Note: The 3D Desat Index™ alarm is intended as an adjunct alarm rather than in place of the
Low SpO2alarm.
Note: When monitoring acoustic respiration, Masimo recommends minimally monitoring
both oxygenation (SpO2) and respiration (RRa).
Note: When using the Maximum Sensitivity setting, performance of the "Sensor Off"
detection may be compromised. If the Radical-7 is in this setting and the sensor becomes
dislodged from the patient, the potential for false readings may occur due to environmental
"noise" such as light, vibration, and excessive air movement.
Note: SatShare signals are ideal simulated waveforms corresponding to the calculated
saturation and pulse rate values and do contain all of the information contained in
physiological waveforms. The multi-parameter patient monitor decodes these signals into
saturation and pulse rate values.
Kite
WARNING: Kite does not generate or manage alarms. The connected device's alarms, used in
conjunction with clinical signs and symptoms, are the primary sources for determining that
an alarm condition exists.
CAUTION: Kite is not a primary display. Medical decisions should be made using data from
the primary display of a device in conjunction with clinical signs and symptoms.
CAUTION: Kite is intended to operate across the facility's network. Unanticipated failure or
alteration of network components (including but not limited to: disconnection or
malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of
connectivity of Kite to other hospital systems. Altering or making changes to the hospital
network should be done with proper knowledge.
Patient SafetyNet
Note: The wireless communication status between Radical-7 and Patient SafetyNet is
displayed by Patient SafetyNet.
Cleaning and Service Warnings and Cautions
WARNING: Do not attempt to remanufacture, recondition or recycle the Radical-7 as these
processes may damage the electrical components, potentially leading to patient harm.
WARNING: To avoid electric shock, always turn off the Radical-7 and physically disconnect
the AC power and all patient connections before cleaning.
WARNING: Electrical Shock Hazard: The battery should be installed and/or removed from the
Radical-7 by qualified personnel only.
WARNING: Do not incinerate the Radical-7 Battery. The battery should be properly disposed
according to local laws and regulations.