Masimo Radical 7 User manual (2019)
Radical-7
Operator's Manual
This Operator’s Manual presents Masimo features and/or products that
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
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.
www.masimo.com 2 Masimo
www.masimo.com/patents.htm
, Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation
© 20182019 Masimo Corporation
www.masimo.com 3 Masimo
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
www.masimo.com 9 Masimo
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.
www.masimo.com 15 Masimo
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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