Masimo Radical 7 User manual (2019)

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Radical-7
Operator's Manual
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are marketed outside of the United States (OUS). It is not intended for
use in the United States.
These operating instructions provide the necessary information for proper
operation of all models of the Radical-7® Pulse CO-Oximeter®. 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: Use of this device must follow the order of a physician.
For professional use. See instructions for Use for full prescribing
information, including indications, contraindications, warnings,
precautions, and adverse events.
Wireless Radio
FCC ID: VKF-RAD7CA or VKF-RAD7A or VKF-RAD7B | IC ID: 7362A-
RAD7CA or 7362A-RAD7A or 7362A-RAD7B
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
www.masimo.com 1 Masimo
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EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Authorized Brazil Company Representative:
MEDSTAR IMPORT AND EXPORT EIRELI
R VALENCIO SOARES RODRIGUES, 89- ROOM 1
CEP: 06.730-000
NEIGHBORHOOD: CENTER
MUNICIPALITY: VARGEM GRANDE PAULISTA
UF: SP
Medical electrical equipment
with respect to electric shock, fire and mechanical hazards only
in accordance with
UL 60601-1/CAN/CSA C22.2 No. 601.1
Patents:
Transform, DST, FastSat, FST, Masimo, Pulse CO-Oximeter, PVI, Radical-7,
Root, rainbow, rainbow Acoustic Monitoring, RAM, rainbow Resposable,
RDS, RRa, RRp, SatShare, SedLine, SET, Signal Extraction Technology,
Signal IQ, SpCO, SpHb, and SpMet are federally registered trademarks of
Masimo Corporation.
3D Desat Index Alarm, In Vivo Adjustment, ORI, SpfO2, SpOC and SST are
trademarks of Masimo Corporation. All other trademarks and registered
trademarks are property of their respective owners.
The use of the trademarks PATIENT SAFETYNET and PSN is under license
from University HealthSystem Consortium.
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www.masimo.com/patents.htm
, Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation
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© 20182019 Masimo Corporation
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Contents
About this Manual --------------------------------------------------------- 11
Product Description ------------------------------------------------------- 11
Key Features ------------------------------------------------------------ 12
Indications for Use -------------------------------------------------------- 13
Contraindications ---------------------------------------------------------- 14
Warnings and Cautions ---------------------------------------------------- 15
Safety Warnings and Cautions ------------------------------------------ 15
Performance Warnings and Cautions ----------------------------------- 17
Cleaning and Service Warnings and Cautions -------------------------- 25
Compliance Warnings and Cautions ------------------------------------ 27
Chapter 1: Technology Overview ------------------------------------------ 31
Signal Extraction Technology (SET) ------------------------------------- 31
rainbow Pulse CO-Oximetry Technology® ----------------------------- 34
rainbow Acoustic Monitoring (RAM) Technology ---------------------- 42
Chapter 2: Radical-7 Descriptions ----------------------------------------- 47
General System Description -------------------------------------------- 47
Functionality of the Radical-7------------------------------------------- 47
Handheld ---------------------------------------------------------------- 49
Standalone -------------------------------------------------------------- 53
Monitor Interface With SatShare --------------------------------------- 58
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Radical-7 Contents
Chapter 3: Setup ---------------------------------------------------------- 59
Unpacking and Inspection ---------------------------------------------- 59
Docking Station Power Requirements ---------------------------------- 59
Setting Up the Docking Station ---------------------------------------- 60
Initial Battery Charging ------------------------------------------------- 60
Setting Up for Philips, Agilent, or HP VueLink ------------------------- 61
Setting Up for SpaceLabs Flexport ------------------------------------- 62
Setting Up and Using SatShare ---------------------------------------- 62
Chapter 4: Operation ------------------------------------------------------ 65
Using the Touchscreen and Buttons ----------------------------------- 66
Using Screen Lock ------------------------------------------------------ 67
Using the Home Button ------------------------------------------------ 68
Standby and Power Off ------------------------------------------------- 68
Navigating the Radical-7 ----------------------------------------------- 69
About the Display View ------------------------------------------------ 70
Sensitivity Modes Overview -------------------------------------------- 81
Changing Sensitivity Modes -------------------------------------------- 82
Accessing the Main Menu ---------------------------------------------- 84
Navigating the Main Menu --------------------------------------------- 84
Parameter Settings ----------------------------------------------------- 87
Chapter 5: Profiles -------------------------------------------------------- 145
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Radical-7 Contents
Profiles Overview------------------------------------------------------ 145
Changing Profiles ----------------------------------------------------- 146
Replacing Factory Default Settings for Adult and Neo Profiles ------ 150
Powering Off the Radical-7 ------------------------------------------- 151
Chapter 6: Alarms and Messages --------------------------------------- 153
About Alarms --------------------------------------------------------- 153
Silencing the Alarms -------------------------------------------------- 153
Adaptive Threshold alarm (ATA) Feature ----------------------------- 156
3D Alarms ------------------------------------------------------------- 157
Messages-------------------------------------------------------------- 161
Chapter 7: Troubleshooting --------------------------------------------- 171
Troubleshooting Measurements -------------------------------------- 171
Troubleshooting the Radical-7 ---------------------------------------- 175
Chapter 8: Specifications ------------------------------------------------ 177
Measurement Range -------------------------------------------------- 177
Accuracy (ARMS) ------------------------------------------------------ 178
Resolution ------------------------------------------------------------- 179
Electrical --------------------------------------------------------------- 180
Environmental --------------------------------------------------------- 181
Physical Characteristics ----------------------------------------------- 181
Alarms ----------------------------------------------------------------- 182
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Radical-7 Contents
Display Indicators ------------------------------------------------------ 183
Compliance ------------------------------------------------------------ 183
Output Interface ------------------------------------------------------- 185
Serial Interface Specifications------------------------------------------ 186
Serial Interface Setup -------------------------------------------------- 186
Analog Output and Nurse Call Specifications ------------------------- 188
Symbols ---------------------------------------------------------------- 190
Citations --------------------------------------------------------------- 192
Chapter 9: Service and Maintenance ------------------------------------- 195
Cleaning --------------------------------------------------------------- 195
Battery Operation and Maintenance ---------------------------------- 196
Performance Verification ---------------------------------------------- 200
Repair Policy ----------------------------------------------------------- 203
Return Procedure ------------------------------------------------------ 204
Contacting Masimo ---------------------------------------------------- 204
Appendix ----------------------------------------------------------------- 209
Concepts of Alarm Response Delay ----------------------------------- 209
Guidance and Manufacturer's Declaration- Electromagnetic Emissions
------------------------------------------------------------------------- 210
Manufacturer's Declaration-Electromagnetic Immunity --------------- 212
Recommended Separation Distances---------------------------------- 217
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Radical-7 Contents
Index --------------------------------------------------------------------- 219
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About this Manual

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

Product Description

The Radical-7 is a noninvasive monitor that measures arterial oxygen
saturation (SpO
optional measurements of hemoglobin (SpHb), carboxyhemoglobin
(SpCO®), total oxygen content (SpOC), methemoglobin (SpMet), Pleth
Variability Index (PVI®), Oxygen Reserve Index (ORI™), Acoustic
Respiration Rate (RRa®), and Pleth Respiration Rate (RRp).
), pulse rate (PR), and perfusion index (PI), along with
2
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Radical-7 Product Description
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.
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Radical-7 Indications for Use
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.]
Oxygen Reserve Index (ORI) is an index to measure changes in
oxygen states under hyperoxic conditions.
Respiration rate can be determined by the acoustic (RRa) or
plethysmographic waveform (RRp).
Signal IQ waveform for signal identification and quality indication
during excessive motion and low signal to noise situations.
FastSat® tracks rapid changes in arterial O
.
2
Variable pitch provides tonal variance for every 1% change in
saturation.
SatShare® interface allows transfer of SpO
and pulse rate to an
2
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.
Multi-gesture touchscreen interface.
Detachable portable Handheld for patient transport.
Remote alarm interface.

Indications for Use

The Masimo Radical-7 and accessories are indicated for the continuous
noninvasive monitoring of functional oxygen saturation of arterial
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Radical-7 Contraindications
hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO),
methemoglobin saturation (SpMet®), total hemoglobin concentration
(SpHb), and/or respiratory rate (RRa).
The Masimo Radical-7 and accessories have been validated and 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 and accessories are indicated to
provide the continuous noninvasive monitoring data obtained from the
Masimo rainbow SET® Radical 7 Pulse CO-Oximeter® and accessories of
functional oxygen saturation of arterial hemoglobin (SpO
) and pulse rate
2
(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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Warnings and Cautions

Caution: Radical-7 is to be operated by, or under the supervision of,
qualified personnel only. The manual, accessories, directions for use, all
precautionary information, and specifications should be read before use.

Safety Warnings and Cautions

Warning: Do not use the Radical-7 if it appears or is suspected to be
damaged.
Warning: Do not start or operate Radical-7 unless the setup was verified
to be correct.
Warning: Do not use Radical-7 during magnetic resonance imaging (MRI)
or in an MRI environment.
Warning: Explosion hazard: 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.
Warning: Do not place the Radical-7 or accessories in any position that
might cause it to fall on the patient.
Warning: When positioned on a flat surface, the device should be
secured with a mounting system recommended by Masimo.
Warning: To ensure safety, avoid stacking multiple devices or placing
anything on the device during operation.
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.
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Radical-7 Warnings and Cautions
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.
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: 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: Electric shock hazard: Do not open the Radical-7 cover except to
replace the battery or batteries.
Caution: Electrical shock and flammability hazard: Before cleaning, always
turn off the device and disconnect from any power source.
Caution: To ensure patient electrical isolation, only dock to Masimo
devices that have been designed for Radical-7.
Caution: Use a grounded outlet for proper equipment grounding. A
hospital-grade outlet is required.
Caution: Do not place Radical-7 where the appliance inlet or the AC
power plug cannot be readily disconnected.
Caution: To avoid risk of electrical shock, this equipment must only be
connected to a supply mains with a protective earth connection. Do not
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Radical-7 Warnings and Cautions
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 Analog Output/Nurse Call connector must be IEC-
60950 compliant.
Caution: To ensure patient electrical isolation, all external device
connections to the RS-232 serial port must be IEC-60950 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.

Performance Warnings and Cautions

Warning: Radical-7 is not an apnea monitor.
Warning: Radical-7 should not be used for arrhythmia analysis.
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 defibrillation; however, the
display may require up to 15 seconds to return to normal operation.
Warning: Radical-7 may be used during electrocautery, but this may
affect the accuracy or availability of the parameters and measurements.
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Radical-7 Warnings and Cautions
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: Radical-7 is intended only as an adjunct device in patient
assessment. It should not be used as the sole basis for diagnosis or
therapy decisions. It must be used in conjunction with clinical signs and
symptoms.
Warning: A functional tester cannot be used to assess the accuracy of
the Radical-7.
Warning: Interfering Substances: Dyes, or any substance containing dyes,
that change usual blood pigmentation may cause erroneous readings.
Warning: SpO2, SpCO, SpMet, and SpHb are empirically calibrated in
healthy adult volunteers with normal levels of carboxyhemoglobin (COHb)
and methemoglobin (MetHb).
Warning: Inaccurate SpO2 readings may be caused by:
Improper sensor application.
Elevated levels of COHb or MetHb: High levels of COHb or
MetHb may occur with a seemingly normal SpO2. When elevated
levels of COHb or MetHb are suspected, laboratory analysis (CO-
Oximetry) of a blood sample should be performed.
Intravascular dyes, such as indocyanine green or methylene blue.
Externally applied coloring and texture, such as nail polish, acrylic
nails, glitter, etc.
Elevated levels of bilirubin
Severe anemia
Low arterial perfusion
Motion artifact
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Radical-7 Warnings and Cautions
Warning: Inaccurate SpHb and SpOC 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 PaO2 levels
Elevated levels of bilirubin
Low arterial perfusion
Motion artifact
Low arterial oxygen saturation levels
Elevated carboxyhemoglobin levels
Elevated methemoglobin levels
Hemoglobinopathies and synthesis disorders such as
thalassemias, Hb s, Hb c, sickle cell, etc.
Vasospastic disease such as Raynaud's
Elevated altitude
Peripheral vascular disease
Liver disease
EMI radiation interference
Warning: Inaccurate SpCO and SpMet readings can be caused by:
Improper sensor application
Intravascular dyes such as indocyanine green or methylene blue
Abnormal hemoglobin levels
Low arterial perfusion
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Radical-7 Warnings and Cautions
Low arterial oxygen saturation levels including altitude induced
hypoxemia
Elevated total bilirubin levels
Motion artifact
SpCO readings may not be provided if SpO2 readings are less
than 90%
SpCO readings may not be provided if SpMet readings are
greater than 2%
Warning: SpCO readings may not be provided if there are low arterial
saturation levels or elevated methemoglobin levels.
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: Inaccurate respiration rate measurements may be caused by:
Improper sensor application
Low arterial perfusion
Motion artifact
Low arterial oxygen saturation
Excessive ambient or environmental noise
Warning: Inaccurate ORI 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 levels of bilirubin
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Radical-7 Warnings and Cautions
Low arterial perfusion
Motion artifact
Patient attached to blood pressure cuff
Elevated carboxyhemoglobin levels
Elevated methemoglobin levels
Vasospastic disease such as Raynaud's
Peripheral vascular disease
Hemoglobinopathies and synthesis disorders such as
thalassemias, Hb s, Hb c, sickle cell, etc
Elevated levels of Dyshemoglobin
Patient is under Hypocapnic and Hypercapnic Conditions
EMI radiation interference
Birthmark(s) or skin discolorations in sensor path
Moisture on the skin
Deformed Fingers
Foreign objects in the light path
Excessive ambient light or direct sunlight
Use of incorrect sensor type(size)
Extreme anemia or extremely low total hemoglobin
concentrations
Severe vasoconstriction, or hypothermia
Low ORI SIQ episodes
Warning: ORI is not intended as a replacement for SpO2 monitoring,
PaO2 monitoring, or as a sole indicator of the patient condition.
Caution: ORI measurements are only displayed on Root® when Radical-7
has been configured for ORI and is communicating to Root.
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Radical-7 Warnings and Cautions
Caution: ORI may not indicate additional changes in oxygen states above
200 mmHg of PaO2
Caution: Do not place the Radical-7 on electrical equipment that may
affect the device, preventing it from working properly.
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: Do not place the Radical-7 against a surface that may cause the
alarm to be muffled.
Caution: Ensure the speaker is not covered.
Caution: To ensure that alarm limits are appropriate for the patient being
monitored, check the limits each time the Radical-7 is used.
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: When All Mute or All Mute with Reminder is selected, there will
be no audible alarms.
Caution: Failure to charge Radical-7 promptly after a Low Battery alarm
may result in the device shutting down.
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Radical-7 Warnings and Cautions
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: If using pulse oximetry 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: Variation in hemoglobin measurements may be profound and
may be affected by sampling technique as well as the patient's
physiological conditions. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated and/or supplemented with
additional test data. Blood samples should be analyzed by laboratory
instruments prior to clinical decision making to completely understand
the patient’s condition.
Caution: If SpO2 values indicate hypoxemia, a laboratory blood sample
should be taken to confirm the patient’s condition.
Caution: When using In Vivo Adjustment™, confirm offset values(s)
periodically as the difference between the displayed parameter value and
the laboratory reference value may vary over time.
Caution: Do not use In Vivo Adjustment if the monitor displays a Low
SpHb SIQ message.
Note: Use the Radical-7 in accordance with Environmental Specifications
section in this manual.
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.
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Radical-7 Warnings and Cautions
Note: It is recommended that Radical-7 battery is fully charged prior to
use.
Note: Always charge Radical-7 when it is not in use to ensure that the
Radical-7 battery remains fully charged.
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.
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: 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: The 3D Desat Index™ alarm is intended as an adjunct alarm rather
than in place of the Low SpO2 alarm.
Note: When monitoring acoustic respiration, Masimo recommends
minimally monitoring both oxygenation (SpO2) and respiration (RRa).
Note: High-intensity extreme lights (such as pulsating strobe lights)
directed on the sensor, may not allow the pulse CO-Oximeter® to obtain
vital sign readings.
Warning: Plethysmographic waveforms displayed on multi-parameter
monitors using SatShare should only be used for reference. Only
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Radical-7 Warnings and Cautions
plethysmographic waveforms displayed on the Radical-7 should be used
for monitoring purposes.
Warning: Simultaneous use of SatShare and serial port is not supported.
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.
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.

Cleaning and Service Warnings and Cautions

Warning: Do not adjust, repair, open, disassemble, or modify Radical-7.
Injury to personnel or equipment damage could occur. Return Radical-7
for servicing.
Warning: Electrical Shock Hazard: The battery should be installed and/or
removed from the Radical-7 by qualified personnel only.
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Radical-7 Warnings and Cautions
Warning: Do not use petroleum-based or acetone solutions, or other
harsh solvents, to clean the Radical-7. These substances affect the
device’s materials and device failure can result.
Warning: Do not touch, press, or rub the display panels with abrasive
cleaning compounds, instruments, brushes, rough-surface materials, or
bring them into contact with anything that could scratch the display.
Caution: An operator may only perform maintenance procedures
specifically described in the manual. Refer servicing to qualified service
personnel trained in the repair of this equipment.
Caution: Do not submerge Radical-7 in any cleaning solution or attempt
to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any
other method. This will seriously damage Radical-7.
Note: Changes or modifications not expressly approved by Masimo shall
void the warranty for this equipment.
Note: Excessive cleaning solution can flow into the monitor and cause
damage to internal components.
Warning: Fire Hazard: To protect against fire hazard, replace only with
fuses of same type, current rating, and voltage rating.
Warning: Electrical Shock Hazard: The Docking Station battery should be
installed and/or removed from the Docking Station only by qualified
personnel.
Caution: Electrical Shock Hazard: Carry out periodic tests to verify that
leakage currents of patient-applied circuits and the system are within
acceptable limits as specified by the applicable safety standards. The
summation of leakage currents must be checked and in compliance with
IEC 60601-1 and UL60601-1. The system leakage current must be checked
when connecting external equipment to the system. When an event such
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Radical-7 Warnings and Cautions
as a component drop of approximately 1 meter or greater or a spillage of
blood or other liquids occurs, retest before further use. Injury to
personnel could occur.

Compliance Warnings and Cautions

Warning: Do not incinerate battery.
Caution: Dispose of used batteries according to required country or
regional instructions.
Caution: Disposal of product - Comply with local laws in the disposal of
the device and/or its accessories.
Caution: To minimize radio interference, other electrical equipment that
emits radio frequency transmissions should not be in close proximity to
Radical-7.
Note: Cleared Use Only: The device and related accessories have
obtained CE Mark 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 instructions for use or
labeling.
Note: This equipment has been tested and found to comply with the
Class B limits for medical devices according to the EN 60601-1-2, Medical
Device Directive 93/42/EEC. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation.
Note: This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
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Radical-7 Warnings and Cautions
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Note: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more
of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for
help.
Note: This Class B digital apparatus complies with Canadian ICES-003.
Note: In accordance with international telecommunication requirements,
the frequency band of 2.4 GHz and 5.15 to 5.25 Ghz is only for indoor
usage to reduce potential for harmful interference to co-channel mobile
satellite systems.
Note: Users are advised that high-power radars are allocated as primary
users (i.e. priority users) of the bands 5.25-5.35 GHz and 5.65-5.85 GHz
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Radical-7 Warnings and Cautions
and that these radars could cause interference and/or damage to LE-LAN
devices.
Note: In accordance with FCC requirements, radio accessories on Radical-
7 cannot be attached directly to the patient using any accessory
containing metal components.
Note: To satisfy RF exposure requirements, this device and its antenna
must operate with a separation distance of at least 20 cm from all
persons and must not be co-located or operating in conjunction with any
other antenna or transmitter.
Caution: External device connections to the SatShare port must be IEC-
60601-1 compliant.
Note: Change or modifications that are not expressly approved by the
manufacturer could void the user’s authority to operate the equipment.
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Page 32
Page 33

Chapter 1: Technology Overview

The following chapter contains general descriptions about parameters,
measurements, and the technology used by Masimo products.

Signal Extraction Technology (SET)

Masimo Signal Extraction Technology's signal processing differs from that
of conventional pulse oximeters. Conventional pulse oximeters assume
that arterial blood is the only blood moving (pulsating) in the
measurement site. During patient motion, however, the venous blood also
moves, causing conventional pulse oximeters to read low values, because
they cannot distinguish between the arterial and venous blood movement
(sometimes referred to as noise).
Masimo SET® pulse oximetry utilizes parallel engines and adaptive
filtering. Adaptive filters are powerful because they are able to adapt to
the varying physiologic signals and/or noise and separate them by
looking at the whole signal and breaking it down to its fundamental
components. The Masimo SET® signal processing algorithm, Discrete
Saturation Transform® (DST®), in parallel with Fast Saturation Transform
®
), reliably identifies the noise, isolates it and, using adaptive filters,
(FST
cancels it. It then reports the true arterial oxygen saturation for display on
the monitor.
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Radical-7 Chapter 1: Technology Overview

Masimo rainbow SET® Parallel Engines

This figure is for conceptual purposes only.

Masimo SET® DST

This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2)

Pulse oximetry is governed by the following principles:
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Radical-7 Chapter 1: Technology Overview
1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-
oxygenated blood) differ in their absorption of red and infrared
light (spectrophotometry).
2. The amount of arterial blood in tissue changes with your pulse
(photoplethysmography). Therefore, the amount of light
absorbed by the varying quantities of arterial blood changes as
well.
Successful Monitoring for SpO2, PR, and PI
Stability of the SpO2 readings may be a good indicator of signal validity.
Although stability is a relative term, experience will provide a good
feeling for changes that are artifactual or physiological and the speed,
timing, and behavior of each.
The stability of the readings over time is affected by the averaging mode
being used. The longer the averaging time, the more stable the readings
tend to become. This is due to a dampened response as the signal is
averaged over a longer period of time than during shorter averaging
times. However, longer averaging times delay the response of the
oximeter and reduce the measured variations of SpO
and pulse rate.
2
Functional Oxygen Saturation (SpO2)
The Radical-7 is calibrated to measure and display functional oxygen
saturation (SpO2): the amount of oxyhemoglobin expressed as a
percentage of the hemoglobin that is available to transport oxygen.
Note: Dyshemoglobins are not capable of transporting oxygen, but are
recognized as oxygenated hemoglobins by conventional pulse oximetry.
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Radical-7 Chapter 1: Technology Overview

General Description for Pulse Rate (PR)

Pulse rate (PR) , measured in beats per minute (BPM) is based on the
optical detection of peripheral flow pulse.

General Description for Perfusion Index (PI)

The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the
non-pulsatile or static blood in peripheral tissue. PI thus represents a
noninvasive measure of peripheral perfusion that can be continuously and
noninvasively obtained from a pulse oximeter.

General Description for Pleth Variability Index (PVI)

The pleth variability index (PVI) is a measure of the dynamic changes in
the perfusion index (PI) that occur during the respiratory cycle. The
calculation is accomplished by measuring changes in PI over a time
interval where one or more complete respiratory cycles have occurred.
PVI is displayed as a percentage (0-100%).
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.

rainbow Pulse CO-Oximetry Technology®

rainbow Pulse CO-Oximetry technology is governed by the following
principles:
1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-
oxygenated blood), carboxyhemoglobin (blood with carbon
monoxide content), methemoglobin (blood with oxidized
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Radical-7 Chapter 1: Technology Overview
hemoglobin) and blood plasma constituents differ in their
absorption of visible and infrared light (using
spectrophotometry).
2. The amount of arterial blood in tissue changes with pulse
(photoplethysmography). Therefore, the amount of light
absorbed by the varying quantities of arterial blood changes as
well.
The Radical-7 uses a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood, blood with carbon monoxide,
oxidized blood and blood plasma.
The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs)
that pass light through the site to a diode (detector). Signal data is
obtained by passing various visible and infrared lights (LEDs, 500 to
1400nm) through a capillary bed (for example, a fingertip, a hand, a foot)
and measuring changes in light absorption during the blood pulsatile
cycle. This information may be useful to clinicians. The maximum radiant
power of the strongest light is rated at ≤ 25 mW. The detector receives
the light, converts it into an electronic signal and sends it to the Radical-7
for calculation.
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Radical-7 Chapter 1: Technology Overview
Light Emitting Diodes
1.
(LEDs)
(7 + wavelengths)
2. Detector
Once the Radical-7 receives the signal from the sensor, it utilizes
proprietary algorithms to calculate the patient’s functional oxygen
saturation (SpO
[%]), blood levels of carboxyhemoglobin (SpCO [%]),
2
methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb
[g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb measurements
rely on a multi-wavelength calibration equation to quantify the
percentage of carbon monoxide and methemoglobin and the
concentration of total hemoglobin in arterial blood. Maximum skin-sensor
interface temperature was tested to be less than 41º C (106º F) in a
minimum ambient temperature of 35º C (95º F). The tests were
conducted with sensors operating at reasonable worst case power.

Pulse CO-Oximetry vs. Drawn Whole Blood Measurements

When SpO2, SpCO, SpMet, and SpHb measurements obtained from the
Radical-7 (noninvasive) are compared to drawn whole blood (invasive)
measurements by blood gas and/or laboratory CO-Oximetry methods,
caution should be taken when evaluating and interpreting the results.
The blood gas and/or laboratory CO-Oximetry measurements may differ
from the SpO
Radical-7. Any comparisons should be simultaneous, meaning the
measurement on the device should be noted at the exact time that blood
is drawn.
www.masimo.com 36 Masimo
, SpCO, SpMet, SpHb, and SpOC measurements of the
2
Page 39
Radical-7 Chapter 1: Technology Overview
In the case of SpO2, different results are usually obtained from the arterial
blood gas sample if the calculated measurement is not appropriately
corrected for the effects of variables that shift the relationship between
the partial pressure of oxygen (pO
pH,temperature, the partial pressure of carbon dioxide (pCO
) and saturation, such as:
2
), 2,3-DPG,
2
and fetal hemoglobin.
In the case of SpCO, different results are also expected if concentration of
methemoglobin in the blood gas sample is abnormal (greater than 2% for
methemoglobin concentration).
In the case of SpHb, variation in hemoglobin measurements may be
profound and may be affected by sampling technique as well as the
patient's physiological conditions. Any results exhibiting inconsistency
with the patient's clinical status should be repeated and/or supplemented
with additional test data. As with most hemoglobin tests, a laboratory
blood sample should be analyzed prior to clinical decision making.
High levels of bilirubin may cause erroneous SpO
, SpMet, SpCO, and
2
SpHb readings. As blood samples are usually taken over a period of 20
seconds (the time it takes to draw the blood) a meaningful comparison
can only be achieved if the oxygen saturation, carboxyhemoglobin, and
methemoglobin concentration of the patient are stable and not changing
over the period of time that the blood gas sample is taken. Subsequently,
blood gas and laboratory CO-Oximetry measurements of SpO
, SpCO,
2
SpMet, SpHb, and SpOC may vary with the rapid administration of fluids
and in procedures such as dialysis. Additionally, drawn whole blood
testing can be affected by sample handling methods and time elapsed
between blood draw and sample testing.
Measurements with Low Signal IQ should not be compared to laboratory
measurements.
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General Description for Total Hemoglobin (SpHb)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring
the levels of total hemoglobin (SpHb) in arterial blood. It relies on the
same principles of pulse oximetry to make its SpHb measurement. The
measurement is taken by a sensor capable of measuring SpHb, usually on
the fingertip for adults and pediatric 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. The device displays the calculated data as measurement of total
hemoglobin concentration.
Successful Monitoring for SpHb
A stable SpHb reading is associated with correct sensor placement, small
physiological changes during the measurement and acceptable levels of
arterial perfusion at the measurement site. Physiological changes at the
measurement site are mainly caused by fluctuations in the oxygen
saturation, blood concentration and perfusion. See
Cautions
on page 15 and
Troubleshooting Measurements
Warnings and
on page 171.

General Description for Total Arterial Oxygen Content (CaO2)

Oxygen (O2) is carried in the blood in two forms, either dissolved in
plasma or combined with hemoglobin. The amount of oxygen in the
arterial blood is termed the oxygen content (CaO
units of ml O
/dL blood. One gram of hemoglobin (Hb) can carry 1.34 ml
2
of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3
ml of oxygen*. The oxygen content is determined mathematically as:
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) and is measured in
2
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Radical-7 Chapter 1: Technology Overview
CaO2 = 1.34 (ml O2/g) x Hb (g/dL) x HbO2 + PaO2 (mmHg) x 0.003 (ml
/dL/mmHg)
O
2
Where HbO
is the fractional arterial oxygen saturation and PaO2 is the
2
partial pressure of arterial oxygen.
For typical PaO
approximately 0.3 ml O
values, the second part of the above equation is
2
/dL based on PaO2 being approximately 100
2
mmHg. Furthermore, for typical carboxyhemoglobin and methemoglobin
levels, the functional saturation (SpO
) as measured by a pulse oximeter
2
is given by:
SpO2 = 1.02 x HbO
When calculating oxygen content (SpOC), the Radical-7 will use SpfO
available instead of SpO
. SpfO2 is the measured fractional arterial
2
2
™ if
2
oxygen saturation.
*Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood
Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999.
General Description for SpOC
The above approximations result in the following reduced equation for
oxygen content via the Pulse CO-Oximeter:
SpOC (ml/dL*) = 1.31 (ml O2/g) x SpHb (g/dL) x SpO2 + 0.3 (ml O2/dL)
*When ml O
/g Hb is multiplied by g/dL of SpHb, the gram unit in the
2
denominator of ml/g cancels the gram unit in the numerator of g/dL
resulting in ml/dL (ml of oxygen in one dL of blood) as the unit of
measure for SpOC. See
Warnings and Cautions
on page 15.
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General Description for Carboxyhemoglobin (SpCO)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring
the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It
relies on the same basic principles of pulse oximetry (spectrophotometry)
to make its SpCO measurement.
The measurement is obtained by placing a sensor on a patient, usually on
the fingertip for adults and the hand or foot for infants. The sensor
connects either directly to the Pulse CO-Oximetry device or through an
device patient cable.
The sensor collects signal data from the patient and sends it to the
device. The device displays the calculated data as percentage value for
the SpCO, which reflect blood levels of carbon monoxide bound to
hemoglobin.
Successful Monitoring for SpCO
A stable SpCO reading is associated with correct sensor placement, small
physiological changes during the measurement and acceptable levels of
arterial perfusion in the patient's fingertip (measurement site).
Physiological changes at the measurement site are mainly caused by
fluctuations in the oxygen saturation, blood concentration and perfusion.

General Description for Methemoglobin (SpMet)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring
the levels of methemoglobin concentration (SpMet) in arterial blood. It
relies on the same basic principles of pulse oximetry (spectrophotometry)
to make its SpMet measurement.
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Radical-7 Chapter 1: Technology Overview
The measurement is obtained by placing a sensor on a patient, usually on
the fingertip for adults and the hand or foot for infants. The sensor
connects either directly to the Pulse CO-Oximetry device or through a
patient cable.
The sensor collects signal data from the patient and sends it to the
device. The device displays the calculated data as percentage value for
the SpMet.
Successful Monitoring for SpMet
A stable SpMet reading is associated with correct sensor placement, small
physiological changes during the measurement and acceptable levels of
arterial perfusion in the patient’s fingertip (measurement site).
Physiological changes at the measurement site are mainly caused by
fluctuations in the oxygen saturation, blood concentration and perfusion.
Warnings and Cautions
See
on page 15.

General Description for Oxygen Reserve Index (ORI)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring
changes in oxygen states in hyperoxic conditions. It relies on the same
principles of pulse oximetry to make its ORi* measurement.
The measurement is taken by a sensor capable of measuring ORi, usually
on the fingertip for adult or pediatric 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. The
device displays the processed data as an indicator of changes in oxygen
states in hyperoxic conditions.
*Available only on Root display
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Radical-7 Chapter 1: Technology Overview
Successful Monitoring for ORI
A stable ORi* reading is associated with correct sensor placement, small
physiological changes during the measurement and acceptable levels of
arterial perfusion at the measurement site. Physiological changes at the
measurement site are mainly caused by fluctuations in the oxygen
saturation, blood concentration and perfusion. See
Cautions
*Available only on Root display
on page 15 and
Troubleshooting Measurements
Warnings and
on page 171.

SpCO, SpMet, and SpHb Measurements During Patient Motion

The Radical-7 displays measurements of SpCO, SpMet, and SpHb during
patient motion. However, because of the changes in the physiological
parameters such as blood volume, arterial-venous coupling, etc. that
occur during patient motion, the accuracy of such measurements may not
be reliable during excessive motion. In this case, the measurement value
for SpCO, SpMet, or SpHb displays as dashes (---) and a message (
,
SpCO SIQ
clinician that the device does not have confidence in the value due to
poor signal quality caused by excessive motion or other signal
interference.
Low SpMet SIQ
, or
Low SpHb SIQ
) displays to alert the
Low

rainbow Acoustic Monitoring (RAM) Technology

rainbow Acoustic Monitoring™ (RAM) continuously measures a patient’s
respiration rate based on airflow sounds generated in the upper airway.
The Acoustic Sensor, which is applied on the patient's neck, translates
airflow sounds generated in the upper airway to an electrical signal that
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Radical-7 Chapter 1: Technology Overview
can be processed to produce a respiration rate, measured as breaths per
minute.
Respiratory sounds include sounds related to respiration such as breath
sounds (during inspiration and expiration), adventitious sounds, cough
sounds, snoring sounds, sneezing sounds, and sounds from the
respiratory muscles [1].
These respiratory sounds often have different characteristics depending
on the location of recording [2] and they originate in the large airways
where air velocity and air turbulence induce vibration in the airway wall.
These vibrations are transmitted, for example, through the lung tissue,
thoracic wall and trachea to the surface where they may be heard with
the aid of a stethoscope, a microphone or more sophisticated devices.

rainbow Acoustic Monitoring Architecture

The following figure illustrates how a respiratory sound produced by a
patient can be turned into a numerical measurement that corresponds to
a respiratory parameter.
Patient
Respiratory airflow to
sound
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Sensor
Sound to
electrical
signal
Acquisition
System
Electrical signal
to digital signal
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Radical-7 Chapter 1: Technology Overview
Signal
Processing
Digital signal to
Envelope
Detection
RRa Estimation
respiratory
measurement
Patient
The generation of respiratory sounds is primarily related to turbulent
respiratory airflow in upper airways. Sound pressure waves within the
airway gas and airway wall motion contribute to the vibrations that reach
the body surface and are recorded as respiratory sounds.
Although the spectral shape of respiratory sounds varies widely from
person to person, it is often reproducible within the same person, likely
reflecting the strong influence of individual airway anatomy [2-6].
Sensor
The sensor captures respiratory sounds (and other biological sounds)
much like a microphone does. When subjected to a mechanical strain,
(e.g., surface vibrations generated during breathing), the sensor becomes
electrically polarized.
The degree of polarization is proportional to the applied strain. The
output of the sensor is an electric signal that includes a sound signal that
is modulated by inspiratory and expiratory phases of the respiratory cycle.
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Radical-7 Chapter 1: Technology Overview
Acquisition System
The acquisition system converts the electric signal provided by the sensor
into a digital signal. This format allows the signal to be processed by a
computing device.
Signal Processing
The digital signal produced by the acquisition system is converted into a
measurement that corresponds to the respiratory parameter of interest.
As shown in the previous figure, this can be performed by, for example,
determining the digital signal envelope or outline which in turn may be
utilized to determine the respiratory rate. In this way, a real-time,
continuous breath rate parameter can be obtained and displayed on a
monitor which, in many cases, may be real-time and continuous.
The respiratory cycle envelope signal processing principle is similar to
methods that sample airway gasses and subsequently determine a
respiratory rate.
[1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G.
Righini, S.A.T. Stoneman. Definition of terms for applications of respiratory
sounds. Eur Respir Rev 2000; 10:77, 597-610.
[2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis
lectures on biomedical engineering #8. Morgan & Claypool Publishers,
2006.
[3] Olsen, et al. Mechanisms of lung sound generation. Semin Respir Med
1985; 6: 171-179.
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Radical-7 Chapter 1: Technology Overview
[4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds –
Advances beyond the stethoscope. Am J Respir Crit Care Med 1977; 156:
974-987.
[5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral
content of normal breath sounds. J Appl Physiol 1996; 80: 5-13.
[6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath
sounds. J Appl Physiol 1981; 50: 307-314.
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Page 49

Chapter 2: Radical-7 Descriptions

The following chapter contains the Radical-7 descriptions, including
descriptions of the Handheld monitor , the Standalone monitor, and the
optional SatShare monitor interface.

General System Description

The Radical-7 system includes the following:
1. Device
2. Patient Cable
3. Sensor
For a list of compatible sensors and cables, visit http://www.masimo.com.

Functionality of the Radical-7

The Radical-7 provides the functionality of three devices in one:
Handheld Pulse CO-Oximeter
The Radical-7 is a fully featured Handheld.
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Radical-7 Chapter 2: Radical-7 Descriptions
The Handheld contains the majority of the device
features. All measurements and device status datum
are displayed on the touchscreen. All user input is
performed through the touchscreen and control
buttons. The sensor cable connector is located on
the Handheld.
Standalone Pulse Oximeter
The Radical-7 is a fully featured Standalone Pulse-Oximeter, and Acoustic
Monitor.
The Handheld snaps into the
Docking Station to provide a fully
featured standalone monitor. The
Docking Station connects to AC
power for standalone operation or
charging of the Handheld. An
optional Docking Station battery is
available. The Standalone features
Nurse Call, analog output, and
serial output.
Monitor Interface
The Radical-7 interfaces to the SpO
patient monitors to upgrade conventional pulse oximetry technology on
input module of multi-parameter
2
the multi-parameter monitor to Masimo SET® technology.
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Radical-7 Chapter 2: Radical-7 Descriptions
Utilizing a SatShare cable, the
standalone Radical-7 also interfaces
with the SpO
input of a validated
2
multi-parameter patient monitor,
instantly upgrading the
conventional pulse oximetry to
Masimo SET® pulse oximetry. The
SatShare cable attaches to the back
of the Radical Docking Station, and
SatShare cables are available to
interface with most multi-parameter
patient monitors.

Handheld

All user input and displays are controlled by this component. The patient
cable connects into the connector on the Handheld device. The Handheld
is battery powered and can be used either as a transport monitor or as a
Handheld Pulse CO-Oximeter for spot checks.

Handheld Front Panel

The following figure numbers and corresponding table describes the
hardware features of the Radical-7.
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Radical-7 Chapter 2: Radical-7 Descriptions
Changing the Size
of Parameter Values
Chapter 5: Profiles
button for two (2) seconds. To turn off,
1. Handheld Release button
Press down the Handheld Release
Button to pull the Handheld off the
Docking Station.
2. Touchscreen Display
The Touchscreen Display refers to the
interactive area on the Handheld.
There are different Display Views that
can appear in this area. For more
about using the Touchscreen and
Display Views, see
on page 73.
3. Profile button
The Profile button provides instant
access to the Profile Screen. See
on page 145.
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4. Power button
To turn on the Radical-7, press the
Power button. To place Radical-7 in
standby, press and hold the Power
press and hold the button for eight (8)
seconds.
5. Home button
The Home button provides instant
access to the Display View screen.
6. Alarm Silence Button
The Alarm Silence button temporarily
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Radical-7 Chapter 2: Radical-7 Descriptions
Silencing the
Alarms
silences alarms. See
on page 153.
7. Speaker
The speaker indicates audio alarms.
Care should be taken not to cover the
speaker and muffle the audible alarm
volume.
8. Patient Cable Connector
Connect a patient cable or a direct
cable sensor into the Radical-7.
Caution: Refer to the Directions for
Use for the sensor before applying it
on patients.

Handheld Back Panel

The Handheld back panel features the connection to the Docking Station,
an accessory mount for the pole clamp accessory, and access to the
Handheld battery pack.
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Radical-7 Chapter 2: Radical-7 Descriptions
Battery Operation
and Maintenance
Item and Description
1. Connector
The Handheld interfaces with the Docking Station through this
connector.
2. Pole Clamp
The optional Pole Clamp accessory attaches to this holder. See the
directions for use of the Pole Clamp accessory for attachment
instructions.
3. Battery Compartment
The Handheld is powered by a lithium ion battery located in this
compartment. For battery care and replacement, see
on page 196.
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Standalone

When the Handheld is placed into the Docking Station, they become a
full-featured standalone system. In this manual, when the Handheld and
the Docking Station are connected, they are referred to
Standalone
Standalone acts as a battery charger for the Handheld and has AC power
connection capabilities. If the AC power from the wall outlet is
temporarily interrupted, then the battery in the Handheld allows for
continuous operation. The Standalone can also interface with serial
devices, Nurse Call or analog output devices, and multi-parameter patient
monitors through a SatShare cable.
There are several models of compatible Docking Stations available: RDS-1,
RDS-2, and RDS-3. The RDS-1 and RDS-3 are optionally available with
SafetyNet capability. The following table lists which features are available
for each model of Docking Station.
. The
Docking Station Features RDS-1 RDS-2 RDS-
3
AC Power Input
SatShare Interface
Serial RS-232 interface
Nurse Call/Analog Output interface
10-Hour Extended Battery
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Radical-7 Chapter 2: Radical-7 Descriptions
Docking Station Features RDS-1 RDS-2 RDS-
3
Automatic Display Rotation Support (Gravity
Detector)
Docking Station Battery Charging indicator
Handheld Battery Charging indicator
Visual Alarm indicator
AC Power indicator
Docking indicator

Standalone Front Panel

The following figure and corresponding text review the features of the
Radical-7 Standalone. Note that when the Standalone is turned on, all
indicator LEDs initially turn on and off at start up.
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Radical-7 Chapter 2: Radical-7 Descriptions
Item and Description
1. Docking Station Battery Charging Indicator
The Docking Station Battery Charging indicator is illuminated
when the Docking Station battery is charging. The indicator
blinks just prior to charging. The Charging Indicator does not
illuminate when the battery is fully charged or when the
battery is not present.
2. Handheld Battery Charging indicator
The Handheld Battery Charging indicator is illuminated when
the Handheld battery is charging. The indicator blinks just
prior to charging. The Charging Indicator does not illuminate
when the battery is fully charged or when the battery is not
present.
3. Visual Alarm Indicator
The Visual Alarm indicator is illuminated when an alarm
condition is active and the Alarm Status Indicator is shown.
4. AC Power Indicator
The AC Power indicator is illuminated when the Radical-7
Docking Station is plugged into AC line power.
5. Docking Indicator
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Radical-7 Chapter 2: Radical-7 Descriptions
Item and Description
The Docking indicator is illuminated when the Handheld
device is turned on and is properly interfaced to a Docking
Station.

Standalone Back Panel

The following figure and corresponding text review the features of the
Radical-7 Standalone.
Item and Description
1. Serial Output connector
Use the Serial Output connector with a ferrite bead installed to connect
a serial device, including a serial printer, a monitoring system or PC to
the Radical-7. The data is provided in standard RS-232C format. All
external device connections to the Serial Output connector must be IEC-
60950 compliant.
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Radical-7 Chapter 2: Radical-7 Descriptions
Serial Interface Specifications
www.masimo.com
Item and Description
2. Analog Output/Nurse Call connector
Use the Analog Output connector with a ferrite bead installed to
interface with an analog output device, such as a chart recorder or
Nurse Call system. All external device connections to the Analog
Output/Nurse Call connector must be IEC-60950 compliant.
See
on page 186.
3. SatShare Cable connector
Use the SatShare Cable connector to connect a SatShare cable to the
SpO
input connector of a multi-parameter patient monitor. All external
2
device connections to the SatShare Cable Connector must be IEC-
60601-1-1 compliant. SatShare cables are available to interface with
most major multi-parameter patient monitors. Check the label on the
SatShare cable and the SatShare Directions for Use to ensure that the
correct cable is used for each type of patient monitor.
Visit
for the latest SatShare cables and validated
devices.
4. Power Entry module
The Power Entry module contains the input connector for AC power
and two fuses. The AC input provides power to the system from the AC
line. Always connect the Radical-7 to the mains power for continuous
operation and/ or battery recharging. Note: Use the power cord as the
means to disconnect the device from the mains power supply.
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Radical-7 Chapter 2: Radical-7 Descriptions
Item and Description
5. Equipotential Ground connector
Use the Equipotential Ground connector for grounding.

Monitor Interface With SatShare

The Radical-7 has a unique SatShare interface that links to most existing
multi-parameter patient monitors through a SatShare cable.
Upgrades any approved and validated monitor to Masimo SET®
performance by using the calculated SpO
and pulse rate
2
determined by Radical-7 to simulate an ideal plethysmograph
waveform, which is sent to the validated multi-parameter patient
monitor.
Connects into the SpO
patient cable or SpO2 input connector of
2
the multi-parameter patient monitor.
See
Setting Up and Using SatShare
on page 62.
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Page 61

Chapter 3: Setup

The following chapter contains information about setting up the Radical-7
before use.

Unpacking and Inspection

To unpack and inspect the device
1. Remove the device from the shipping carton and examine it for
signs of shipping damage.
2. Check all materials against the packing list. Save all packing
materials, invoice and bill of lading. These may be required to
process a claim with the carrier.
3. If anything is missing or damaged, contact the Technical Service
Department. See
Return Procedure

Docking Station Power Requirements

on page 204.
Always use a hospital-grade, AC power cable to connect the
Docking Station to an AC power source.
Do not connect the Docking Station to an AC outlet that is
controlled by a switch because the power to the Docking Station
may be inadvertently switched off.
Verify the AC power voltage and line frequency before use.
Verify that the power source can provide an adequate power
rating as indicated on the rear panel of the Docking Station.
The Radical-7 is designed to operate on 100 to 240VAC, 47-63
Hz.
The Radical-7 is rated at 55 VA max.
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Radical-7 Chapter 3: Setup
Connect a hospital-grade power cable (IEC-320 connector type
at the device) to the Power Entry module on the Docking
Station.
Connect the power cable to an AC power source.
Ensure that the device is adequately powered by verifying that
the AC power indicator on the Docking Station is illuminated.
Warnings and Cautions
See
on page 15.

Setting Up the Docking Station

Place the Docking Station on a stable hard flat surface near the patient.
Always place the Radical-7 on a dry surface. Maintain a minimum of 3 cm
(1 inch) free space around the Radical-7. Make sure that the Radical-7
speaker is not covered to avoid a muffled alarm sound.
The Radical-7 Handheld, Docking Station or Standalone should not be
operated outside the environmental conditions listed in the specifications
section
Environmental
on page 181.

Initial Battery Charging

Before use, the Radical-7 Handheld battery and the Docking Station
battery must be charged completely.
To charge the Handheld and Docking Station for the first time
1. Attach the Handheld to the Docking Station.
2. Plug in the AC power cord to power entry module. Make sure it
is securely plugged in.
3. Plug the AC power cord into an AC power source.
4. Verify that the batteries are charging.
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Radical-7 Chapter 3: Setup
The Battery Charging indicators on the Docking Station flash
prior to charging and remain illuminated while the batteries
are charging.
See
Standalone Front Panel
Maintenance
on page 196.
on page 54 and
Battery Operation and

Setting Up for Philips, Agilent, or HP VueLink

To set up for use with VueLink compatible monitors (Philips, Agilent, or HP)
1. On the Radical-7, on the
device output
screen, for the
option, select Hp VueLink.
2. Connect one end of the VueLink cable to the Serial Output
connector on the Docking Station.
3. Connect the other end of the VueLink cable to the VueLink
module and insert the module into the VueLink compatible
monitor rack.
The SpO
and pulse rate values appear on the VueLink
2
compatible monitor.
4. In order for the plethysmographic waveform to be displayed on
the VueLink compatible monitor, and for the VueLink monitor to
convey alarm conditions measured by the Radical-7, the VueLink
compatible monitor must be properly configured.
5. See instructions for use provided with the VueLink compatible
monitor and the VueLink module. See
Serial Interface Specifications
and
Compliance
on page 186.
on page 183
serial
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Radical-7 Chapter 3: Setup

Setting Up for SpaceLabs Flexport

To set up for use with SpaceLabs Flexport
1. On the Radical-7, on the
device output
screen, for the
serial
option, select SpaceLabs Flexport.
2. Connect one end of the Spacelabs Flexport cable to the Serial
Output connector on the Docking Station.
3. Connect the other end of the Spacelabs Flexport cable to the
Spacelabs Universal Flexport connector.
The SpO
and pulse rate values appear on the Spacelabs screen.
2
4. In order for the plethysmographic waveform to be displayed on
the Spacelabs screen, and for the Spacelabs monitor to convey
alarm conditions measured by the Radical-7, the Spacelabs
monitor must be properly configured.
5. See instructions for use provided with the Spacelabs monitor.
Compliance
See
Specifications
on page 183 and
on page 186.
Serial Interface

Setting Up and Using SatShare

Parameter values from the Radical-7 can be displayed on a multi-
parameter monitor through the SatShare feature. The SatShare feature
provides an ideal, simulated plethysmographic waveform that
corresponds to the parameter values determined the by Radical-7. This
waveform may be used to display these values on multi-parameter
monitors through the multi-parameter oximetry sensor or input
connector.
It is recommended that the Radical-7 be positioned near the multi-
parameter monitor, with the Radical-7 screen displaying the
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Radical-7 Chapter 3: Setup
plethysmographic waveform and the parameter values. Refer to the
instructions for use provided with the multi-parameter monitor. See
Compliance
To set up for use with SatShare interface
1. Select the SatShare cable that is appropriate for the multi-
2. Connect the labeled end of the SatShare cable to the SatShare
3. Connect the other end of the SatShare cable to one of the
on page 183.
parameter monitor. For the latest list of available SatShare cables
and validated devices, see
Cable connector on the Docking Station. See
Panel
on page 56. For a secure connection, tighten the cable
connector screws.
following:
Sensor connector of the multi-parameter monitor cable
Directly to the multi-parameter monitor
www.masimo.com
.
Standalone Back
4. Verify that the multi-parameter monitor recognizes the SatShare
cable.
5. As appropriate, configure alarm limits on the multi-parameter
monitor.
6. Set the averaging time for the multi-parameter monitor to its
lowest setting (or fastest response). The ideal waveform for the
Radical-7 requires additional averaging by the monitor. If the
averaging time of the multi-parameter monitor is not changed,
the time to display physiological changes in saturation on the
monitor is increased with SatShare. However, the delay can be
minimized by reducing the averaging time on the multi-
parameter monitor.
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Radical-7 Chapter 3: Setup
7. While in the SatShare mode, if there are any significant
discrepancies between the readings from Radical-7 and those on
the monitor displaying the values obtained from SatShare, the
values reported by the Radical-7 are to be considered the correct
values.
8. It is possible to use the Radical-7 with SatShare while the
Radical-7 is not connected to AC power. However, in this
configuration, battery run time is reduced. See
Operation and Maintenance
on page 196.
Battery
9. On the Radical-7, turn on the
Device Output
10. If displaying the simulated waveform is not desirable, it is
recommended to turn off the plethysmographic waveform
display of the multi-parameter patient monitor. See
on page 126.
Interface Specifications
Satshare Numbers
on page 186.
option. See
Serial
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Page 67

Chapter 4: Operation

The following chapter contains information about using the Radical-7.
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Radical-7 Chapter 4: Operation
About the Display
View
Chapter 5: Profiles
Silencing the Alarms

Using the Touchscreen and Buttons

1. Display View
To access other screens,
touch a value on the Display
View. See
on page 70.
2. Profiles button
To the access the
Profiles
screen, press Profiles. See
on page
145.
3. Alarm Silence button
To temporarily silence audible
alarms, press Alarm Silence.
See
on
page 153.
4. Home button
To return to the
Display View
press Home.
5. Power button
To turn on the Radical-7,
press the Power button. To
turn off, press and hold the
button for more than 2
seconds
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,
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Radical-7 Chapter 4: Operation

Using Screen Lock

When turned on, the
interaction with
Screen Lock
Display View
feature may prevent unintentional
.
Using the Screen Lock feature
1. When turned on, any interaction with the
the Screen Lock feature.
2. To bypass
Screen Lock
when it appears, press and hold the Lock
icon until it unlocks.
3. To turn on or turn off
117.
Screen Lock
Display View
, see
Access Control
triggers
on page
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Radical-7 Chapter 4: Operation

Using the Home Button

One option to return to
Display View
is by using the Home button.
To return to Display View using the Home button
From any screen, press Home.

Standby and Power Off

To put Radical-7 in Standby Mode or to Power Off, follow these steps:
State Description
Press and hold the Power Button for two (2) seconds until a
Standby
Mode
single audible tone sounds.
Standby Mode conserves power while enabling a quicker
startup sequence.
Press and hold the Power Button for eight (8) seconds, until
two (2) audible tones sound. The Home Button will flash on
Power Off
and off, and the Power Button will flash orange.
Power Off completely shuts down Root and results in a
longer startup sequence.
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Radical-7 Chapter 4: Operation

Navigating the Radical-7

Navigate the Radical-7 screens via the
Display View
or the
Main Menu
.
Display View
The following is the primary interactive screen that the user views.
To access the Main Menu screen
Touch the gear icon at the lower right corner of the display.
Main Menu
The following is the
Main Menu
screen where users can access additional
screens and information. Users can swipe the screen left or right to pan
the Menu Icons. Users can touch the arrow icon to return to the
. See
View
Accessing the Main Menu
on page 84.
Display
Display Timeout
When no user interaction occurs within one minute, the display times out
and returns to the
Display View
.
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Radical-7 Chapter 4: Operation

About the Display View

The
Display View
consists of different areas:
Status Bar. See
Parameter Display. See
page 73.
About the Status Bar
on page 72.
Changing the Size of Parameter Values
on
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Radical-7 Chapter 4: Operation
Trend Field. See
Waveform and Trend Views
Small Parameter View. See
on page 76.
Accessing the Main Menu
on page 84.
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Radical-7 Chapter 4: Operation

About the Status Bar

The Status Bar is visible on the top portion of the
Display View
.
Status Bar
Access additional screens, more information, or toggle features by
touching directly on any of the following indicators in the Status Bar.
Sensitivity Modes. See
Profiles. See
Messages
WiFi
on page 124.
Profiles Overview
on page 161.
Sensitivity Modes Overview
on page 145.
on page 81.
Battery
Sounds
Time settings. See
on page 125.
on page 113.
Localization
on page 121.
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Radical-7 Chapter 4: Operation

Changing the Size of Parameter Values

To change the size of parameter values on the Display View
1. On the
parameters, as shown above.
2. When the parameter value dims, shakes, and grows in size, drag
and drop that parameter above the
3. The parameter value appears on the screen in a larger font. The
device automatically configures the screen for optimal display of
the parameter values.
4. To remove parameter values from the larger font display, press
and hold the larger parameter value. Then drag and drop the
parameter value back to the
Small Parameter v
iew, touch and hold any one of the

Trend Field

Small Parameter
.
view.
Trend Field
The
Trend Field
Trends
on page 127.
To access trend, waveform, or customize the views on the Display View screen
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allows users to access various customizable views. See
Page 76
Radical-7 Chapter 4: Operation
1. Touch the Trend Field, as shown below.
2. The following screen appears.
3. Swipe up or swipe down the available options.
4. Touch on the desired option.
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Radical-7 Chapter 4: Operation
5. The
Trend Field
displays trend data specific to the option that
was selected.
Pulse Bar
The
Pulse Bar
the Signal IQ (SIQ) displayed on each individual pulsation. The height of
the bars provides an assessment of the confidence in the measurement
displayed. See
is a visual indicator that conveys the detection of pulse and
Signal IQ Indicators
on page 77.
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Radical-7 Chapter 4: Operation

Waveform and Trend Views

The following section contain information about trends and waveforms
available from the
Trend Field
on the
Display View
screen. The following
are examples of some of the views that are available.
Pleth + Sig IQ + Acoustic View
Shows the parameter values on the top of the screen. The waveform is
located below the parameter values. The
Small Parameter
along the bottom of the screen. This view contains the Pleth waveform,
signal quality indications, and acoustic waveform.
view is located
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Radical-7 Chapter 4: Operation
Signal IQ Indicators
The Signal IQ (SIQ), displayed on each individual pulsation, is conveyed
by vertical bars, as shown below. The height of the bar provides an
assessment of the confidence in the measurement displayed.
Acoustic Waveform View
Shows the parameter values on the top of the screen. The RRa waveform
is located below the parameter values. The
Small Parameter
located along the bottom of the screen. Acoustic Respiratory Rate (RRa)
must be available for this feature to be shown. This view contains
acoustic respiratory rate waveform only.
view is
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Radical-7 Chapter 4: Operation
Pleth + Sig IQ + Acoustic View
Shows the parameter values on the top of the screen. The waveform is
located below the parameter values. The
along the bottom of the screen. This view contains the Pleth waveform,
signal quality indications, and acoustic waveform.
Small Parameter
view is located
Parameter Quick Trend View
This view displays the quick trend of the selected parameter over an
adjustable period of time. The default is 1 hour. Enlarge the quick trend
to the full trend view by touching the expand icon of the waveform
display.
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Radical-7 Chapter 4: Operation
With a pinch gesture, using two fingers, the user can zoom in and out of
the quick trend data within the
Trend Field
.
About Events Feature
The Events feature provides graphical display of parameter or
measurement alarms and non-clinical exception messages. This feature is
only viewable in the Full Trend screen; however, it is available at all times
for all parameters and measurements. For more information about these
alarms and exceptions, see Chapter 6: Alarms and Messages.
Events appear as color-coded circles along the trend of a parameter or
measurement.
Color of
Event
Circle
Red
Visibility Description
Parameter or
measurement
alarm.
Example
Messages
SpO2 low
SpCO high
PR low
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Radical-7 Chapter 4: Operation
Yellow
Specific to parameters
and measurements
shown in Full Trend
screen.
Whenever in Full Trend
screen.
Change in In
Vivo offset.
Non-clinical
exception.
SpO2 In Vivo
offset
changed: -1.9
Replace
sensor
Low battery
No cable
connected
In the example below showing two (2) Events, the yellow circle represents
a system exception and the red circle represents a parameter alarm
related to the patient’s SpO
level.
2
If there are two (2) parameters and/or measurements displayed in the Full
Trend screen, then only Events related to those parameters and/or
measurements will be visible.
Using the same example, tapping on the red circle reveals a message box
displaying the alarm (
Start SpO2 Low
), the reading (
SpO2 87
), as well as
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Radical-7 Chapter 4: Operation
its timestamp (
11:34:56 AM
), which correlates with the position of the
vertical blue line.
To view time and reading information about a specific parameter or
measurement, tap anywhere along the trend.
Using the same example, tapping on the trend somewhere towards the
right reveals a message box displaying the parameter reading (
and its timestamp (
12:11:32 PM
).
SpO2 96
)

Sensitivity Modes Overview

Three sensitivity levels enable a clinician to tailor the response of the
Radical-7 to the needs of the particular patient situation. Access the
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Radical-7 Chapter 4: Operation
menu by touching on the indicator in the upper left corner of the
. The sensitivity levels are as follows:
View
NORM (Normal Sensitivity)
NORM is the recommended sensitivity mode for patients who
are experiencing some compromise in blood flow or perfusion. It
is advisable for care areas where patients are observed
frequently, such as an intensive care unit (ICU).
APOD® (Adaptive Probe Off Detection® Sensitivity)
APOD is the recommended sensitivity mode where there is a
high probability of the sensor becoming detached. It is also the
suggested mode for care areas where patients are not visually
monitored continuously. This mode delivers enhanced protection
against erroneous pulse rate and arterial oxygen saturation
readings when a sensor becomes inadvertently detached from a
patient due to excessive movement.
MAX (Maximum Sensitivity)
MAX is recommended sensitivity mode for patients with low
perfusion or when a
low perfusion
message displays in APOD or
NORM mode. MAX mode is not recommended for care areas
where patients are not monitored visually, such as general wards.
It is designed to interpret and display data at the measuring site
when the signal may be weak due to decreased perfusion. When
a sensor becomes detached from a patient, it will have
compromised protection against erroneous pulse rate and
arterial saturation readings.
Display

Changing Sensitivity Modes

There are two ways to change the sensitivity modes.
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Radical-7 Chapter 4: Operation
1. Press the indication on the top left of the
2. Alternatively, from the
the
Profiles
screen, select the desired mode by scrolling up or
Main Menu
, touch the
down. Then select OK.
Display View
Profiles
.
icon. From
Note that the device will revert to APOD mode after a power
cycle.
Changing Profiles
See
on page 146.
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Radical-7 Chapter 4: Operation

Accessing the Main Menu

To access
bottom right corner of the
Main Menu
from the
Small Parameter View

Navigating the Main Menu

Display View
, touch the gear icon on the
.
From the
Main Menu
screen, touch the icons for any of the
following screens:
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Radical-7 Chapter 4: Operation
Device Settings
Parameter Settings
Changing Profiles
3D Alarms
Trends
Trend Field
Sounds
Device Settings
See
on page 116.
Parameter Settings
See
Profiles
See
3D Alarms
See
on page 157.
Trends
on page 87.
on page 146.
www.masimo.com 85 Masimo
See
page 73.
Sound
See
on page 127 and
on page 113.
on
Page 88
Radical-7 Chapter 4: Operation
About
About
See
on page 141.
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Radical-7 Chapter 4: Operation

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
1. From the
Parameter Settings
screen, to access the desired
parameter, flick the on-screen icons left or right.
2. Touch the icon of the desired parameter. For details, see any of
the following sections.
SpO2 Settings
SpHb Settings
on page 91.
on page 94.
PVI Settings
PR Settings
on page 106.
on page 98.
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Radical-7 Chapter 4: Operation
Perfusion Index (PI) Settings
SpCO Settings
SpMet Settings
SpOC Settings
Respiration Rate (RR)
on page 108.
on page 109.
on page 111.
on page 101
on page 99.

About Parameter Information

Additional information about each parameter is available.
To access additional information about parameters
1. From the parameter settings screen, touch the About icon. The
following is an example for SpHb.
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Radical-7 Chapter 4: Operation
2. An
About
screen appears for the selected parameter.

In Vivo Adjustment Overview

The In Vivo Adjustment feature lets clinicians manually adjust one or
more clinical parameters to match that of a corresponding laboratory
reference for continuous trending. To remind clinicians that the feature is
active, an offset value displays alongside the adjusted parameter value.
The In Vivo Adjustment feature for a parameter can be turned on by
accessing the In Vivo screen in the settings menu of that parameter. After
enabling the feature, set an offset value. Once the feature is enabled, a
positive or a negative offset value appears, as shown in the following
illustration.
The In Vivo offset is set to zero for any of the following:
Cable or sensor is disconnected from device.
Sensor goes off patient causing a sensor initialization to occur.
Eight hours has elapsed since the In Vivo value was activated.
Restore of factory defaults.
The user turns off In Vivo.
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Radical-7 Chapter 4: Operation
Offset Value
When In Vivo Adjustment is activated for a specific parameter, the offset
value appears beneath that specific parameter. A positive value means
that the displayed parameter value has been increased (according to a
laboratory reference value as entered by a clinician) and a negative value
means the displayed parameter value has been decreased (according to a
laboratory reference value as entered by a clinician).
In the example below, the displayed SpO
value of 95 takes into account
2
an offset of -1.0, and the displayed SpHb value of 13.8 takes into account
an offset of +0.4.
The In Vivo Adjustment feature can be set to
Off
default setting is
. If set to On, the parameter value is adjusted and an
On
or
Off
. the factory
offset value appears. The offset value is set by the user.
The feature applies to any of the following parameters:
In Vivo for SpO2
In Vivo for SpHb
on page 94.
on page 98.
In Vivo for SpCO
In Vivo for SpMet
on page 108.
on page 110.
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Radical-7 Chapter 4: Operation
Low Limit is the lower threshold

SpO2 Settings

Access any of the following options:
Alarms for SpO2
on page 91.
Additional Settings for SpO2
About Parameter Information
Alarms for SpO2
From the
Options Description
High Limit
Alarms
screen, change any of the following options:
The High Limit is upper
threshold that triggers an
alarm.
on page 92.
on page 88.
Factory
Default
Settings
Off
Configurable
Options
2% to 99% in
steps of 1%,
or Off
When set to
Off, alarm is
disabled
Low Limit
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that triggers an alarm.
88%
1% to 98% in
steps of 1%
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Radical-7 Chapter 4: Operation
Adaptive Threshold alarm
(ATA) Feature
Options Description
Sets the Rapid Desat limit
threshold to the selected
amount below the Low Alarm
Rapid
Desat
Limit. When SpO
below rapid desat limit the
audio and visual alarm are
immediately triggered without
respect to the alarm delay.
Alarm
Delay
When an alarm condition is
met, this feature delays the
audible part of an alarm.
ATA establishes patient-specific
Adaptive
Threshold
Alarm
(ATA)
limit thresholds based upon the
baseline value of the
parameter.
See
value falls
2
on page 156.
Factory
Default
Settings
-10%
5
seconds
Configurable
Options
Off, -5%, or -
10%
0, 5, 10, or 15
seconds
Off Off or On
Additional Settings for SpO2
From the
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Additional Settings
screen, change any of the following options:
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Radical-7 Chapter 4: Operation
User Configurable
FastSat Overview
Options Description Factory
Default
Settings
Settings
Averaging
Time
The length of time over
which the system
calculates the average of
8 seconds 2-4, 4-6, 8, 10,
12, 14, or 16
seconds
all data points.
FastSat
See
on
Off On or Off
page 93.
FastSat Overview
FastSat enables rapid tracking of arterial oxygen saturation changes.
Arterial oxygen saturation data is averaged using pulse oximeter
averaging algorithms to smooth the trend.
On
When the Radical-7 is set to FastSat
evaluates all the saturation values providing an averaged saturation value
that is a better representation of the patient’s current oxygenation status.
With FastSat, the averaging time is dependent on the input signal.
, the averaging algorithm
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Radical-7 Chapter 4: Operation
In Vivo
Adjustment Overview
In Vivo
Adjustment Overview
Adjust difference of ±
In Vivo for SpO2
From the
In Vivo
screen, change any of the following options:
Options Description Factory
Default
Settings
Enabled See
Off On or Off
on page 89.
Offset
Amount
See
0 when
turned on
on page 89.

SpHb Settings

From the
SpHb Alarms
Additional Settings for SpHb
SpHb Settings
on page 94.
screen, access any of the following screens:
on page 96.
User Configurable
Settings
6%, in steps of 0.1%
About Parameter Information
SpHb Alarms
From the
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Alarms
on page 88.
screen, change any of the following options:
Page 97
Radical-7 Chapter 4: Operation
Options Description Factory
Default
Settings
High
Limit
The High Limit is
upper threshold that
triggers an alarm.
17.0 g/dL
(170 g/L)
(11.0
mmol/L)
User Configurable
Settings
2.0 g/dL to 24.5 g/dL in
steps of 0.1 g/dL, or Off
(2 g/L to 249 g/L in
steps of 1 g/L, or Off)
(2.0 mmol/L to 15.0
mmol/L in steps of 0.1
mmol/L, or Off)
When SpHb Precision is
set to 1.0, the values are
rounded down.
When set to Off, alarm is
disabled.
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Radical-7 Chapter 4: Operation
Options Description Factory
Default
Settings
Low
Limit
The Low Limit is
lower threshold that
7.0 g/dL
(70 g/L)
triggers an alarm.
(4.0
mmol/L)
User Configurable
Settings
Off, or 1.0 g/dL to 23.5
g/dL in steps of 0.1 g/dL
(Off, or 1 g/L to 248 g/L
in steps of 1 g/L)
(Off, or 1.0 mmol/L to
14.5 mmol/L, in steps of
0.1 mmol/L)
When SpHb Precision is
set to 1.0, values are
rounded down.
When set to Off, alarm is
disabled.
Additional Settings for SpHb
From the
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Additional Settings
screen, change any of the following options:
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Radical-7 Chapter 4: Operation
Options Description Factory
Default
Settings
Averaging
Time
The length of time over which
the system calculates the
Medium Short,
average of all data points.
Calibration Provides an arterial or venous
Venous Arterial or
value that displays on the main
screen.
Precision Allows the user to set the
0.1 0.1, 0.5, or 1.0
decimal for SpHb.
Unit of
Measure*
Displays total hemoglobin
(SpHb) as g/dL (grams per
g/dL g/dL, g/L, or
deciliter), g/L (grams per liter),
or mmol/L (milimoles per liter).
Unit of Measure can not be
changed during active
monitoring.
User
Configurable
Settings
Medium, or
Long
Venous
(whole
numbers)
mmol/L,
*Changing Unit of Measure will delete all prior trend data for all
parameters.
www.masimo.com 97 Masimo
Page 100
Radical-7 Chapter 4: Operation
In Vivo
Adjustment
Overview
In Vivo
Adjustment
Overview
In Vivo for SpHb
From the
In Vivo
screen, change any of the following options:
Options Description Factory
Default
Settings
In Vivo
See
Off On or Off
Calibration
on page 89.
In Vivo
See
0
Calibration
Offset
on page 89.

PR Settings

From the
PR Setting
s screen, change any of the following options:
User Configurable
Settings
± 3 g/dL in steps
of ± 0.1 g/dL
PR Alarms
About Parameter Information
PR Alarms
From the
www.masimo.com 98 Masimo
on page 98.
PR Alarms
screen, change any of the following options:
on page 88.
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