Radical-7
Operator's Manual
Medical electrical equipment with respect to electric shock, fire and mechanical
The Radical-7 operating instructions provide the necessary information for proper operation
of all models of the Radical-7 Pulse CO-Oximeter system. 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 the Radical-7 are prerequisites for its
proper use. Do not operate the Radical-7 without completely reading and understanding the
instructions in this manual.
NOTICE:
Purchase or possession of this instrument does not carry any express or implied license to use
this instrument with replacement parts which would, alone or in combination with this
instrument, fall within the scope of one of the patents relating to this instrument.
Caution
Federal law restricts this device to sale by or on the order of a physician.
Wireless Radio
FCC ID: VKF-RAD7A, IC: 7362A-RAD7A
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1
Patents: www.masimo.com/patents.htm
© 2012 Masimo Corporation
®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®,
FastSat®, FST®, Masimo®, Pulse Oximeter®, PVI®, rainbow®, SatShare®, SET®, Signal
Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet® are federally registered
trademarks of Masimo Corporation.
Adaptive Threshold Alarm™, In Vivo Adjustment™, Pleth Variability Index™, Radical-7™,
Rainbow Acoustic Monitoring™, rainbow Resposable™, RDS™, RRa™, RRp™,SafetyNet™, SpOC™
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 1 Masimo
Contents
About this Manual -------------------------------------------------------------------------------------------7
Product Description, Indications for Use, Contraindications, and Features ---------------------- 9
Product Description ------------------------------------------------------------------------------------- 9
Indications for Use ------------------------------------------------------------------------------------- 10
Contraindications -------------------------------------------------------------------------------------- 10
Safety Information, Warnings, and Cautions ---------------------------------------------------------- 11
Parameter Related Safety Information, Warnings, and Cautions ------------------------------ 11
Device Related Safety Information, Warnings, and Cautions----------------------------------- 14
Electrical Safety Information, Warnings, and Cautions ----------------------------------------- 18
Alarm Related Safety Information, Warnings, and Cautions ---------------------------------- 20
Sensor Related Safety Information, Warnings, and Cautions ---------------------------------- 21
Chapter 1: Technology Overview ------------------------------------------------------------------------ 23
Signal Extraction Technology (SET) ---------------------------------------------------------------- 23
rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 25
rainbow Acoustic Monitoring (RAM) Technology ------------------------------------------------- 29
Chapter 2: Radical-7 Descriptions --------------------------------------------------------------------- 33
General System Description ------------------------------------------------------------------------- 33
Functionality of the Radical-7 ------------------------------------------------------------------------ 34
Handheld ----------------------------------------------------------------------------------------------- 35
Standalone ---------------------------------------------------------------------------------------------- 37
Monitor Interface With SatShare ------------------------------------------------------------------- 40
Chapter 3: Setup ------------------------------------------------------------------------------------------- 41
Unpacking and Inspection --------------------------------------------------------------------------- 41
Docking Station Power Requirements -------------------------------------------------------------- 41
Setting Up the Docking Station --------------------------------------------------------------------- 41
Initial Battery Charging ------------------------------------------------------------------------------- 42
Setting Up for Philips, Agilent, or HP VueLink ---------------------------------------------------- 42
Setting Up for SpaceLabs Flexport ------------------------------------------------------------------ 43
Setting Up and Using SatShare --------------------------------------------------------------------- 44
Chapter 4: Operation -------------------------------------------------------------------------------------- 45
Using the Touchscreen and Buttons ---------------------------------------------------------------- 45
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Radical-7 Contents
Using Screen Lock ------------------------------------------------------------------------------------- 46
Using the Home Button ------------------------------------------------------------------------------ 46
Navigating the Radical-7 ----------------------------------------------------------------------------- 47
About the Display View ------------------------------------------------------------------------------- 48
Sensitivity Modes Overview -------------------------------------------------------------------------- 55
Changing Sensitivity Modes ------------------------------------------------------------------------- 56
Accessing the Main Menu ---------------------------------------------------------------------------- 57
Navigating the Main Menu--------------------------------------------------------------------------- 57
Parameter Settings ------------------------------------------------------------------------------------ 59
Sounds --------------------------------------------------------------------------------------------------- 74
Device Settings ----------------------------------------------------------------------------------------- 75
Trends ---------------------------------------------------------------------------------------------------- 81
About ----------------------------------------------------------------------------------------------------- 91
Chapter 5: Profiles ----------------------------------------------------------------------------------------- 93
Profiles Overview --------------------------------------------------------------------------------------- 93
Changing Profiles -------------------------------------------------------------------------------------- 94
Replacing Factory Default Settings for Adult and Neo Profiles -------------------------------- 97
Powering Off the Radical-7 --------------------------------------------------------------------------- 98
Chapter 6: Alarms and Messages ----------------------------------------------------------------------- 99
About Alarms ------------------------------------------------------------------------------------------- 99
Silencing the Alarms ---------------------------------------------------------------------------------- 99
Adaptive Threshold Alarm (ATA) Feature ------------------------------------------------------- 101
3D Alarms --------------------------------------------------------------------------------------------- 102
Messages ---------------------------------------------------------------------------------------------- 104
Chapter 7: Troubleshooting ----------------------------------------------------------------------------- 111
Troubleshooting Measurements-------------------------------------------------------------------- 111
Troubleshooting the Radical-7 --------------------------------------------------------------------- 113
Chapter 8: Specifications ------------------------------------------------------------------------------- 115
Measurement Range --------------------------------------------------------------------------------- 115
Accuracy ------------------------------------------------------------------------------------------------ 115
Resolution ---------------------------------------------------------------------------------------------- 117
Electrical------------------------------------------------------------------------------------------------ 117
Environmental ----------------------------------------------------------------------------------------- 118
Physical Characteristics ----------------------------------------------------------------------------- 118
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Radical-7 Contents
Trending ----------------------------------------------------------------------------------------------- 118
Alarms -------------------------------------------------------------------------------------------------- 119
Display Indicators ------------------------------------------------------------------------------------ 120
Compliance --------------------------------------------------------------------------------------------- 121
Output Interface -------------------------------------------------------------------------------------- 122
Wireless Radio (If Installed) ----------------------------------------------------------------------- 122
Serial Interface Specifications --------------------------------------------------------------------- 122
Serial Interface Setup ------------------------------------------------------------------------------- 123
Analog Output and Nurse Call Specifications --------------------------------------------------- 124
Symbols ------------------------------------------------------------------------------------------------ 126
Country Codes (FCC and EU) ------------------------------------------------------------------------ 127
Citations ----------------------------------------------------------------------------------------------- 129
Chapter 9: Service and Maintenance----------------------------------------------------------------- 131
Cleaning ----------------------------------------------------------------------------------------------- 131
Battery Operation and Maintenance ------------------------------------------------------------- 131
Performance Verification --------------------------------------------------------------------------- 134
Repair Policy ------------------------------------------------------------------------------------------ 136
Return Procedure ------------------------------------------------------------------------------------- 136
Contacting Masimo ---------------------------------------------------------------------------------- 136
Appendix: Best Practices for Comparisons to Reference Measurements ----------------------- 139
Best Practices Checklist for Continuous SpHb Comparisons --------------------------------- 139
Best Practices Checklist for SpCO Comparisons ------------------------------------------------ 142
Best Practices Checklist for Acoustic Respiration Rate Comparisons ----------------------- 144
Index ------------------------------------------------------------------------------------------------------- 149
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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.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse affect, death) to the patient or user. The following is an example of a warning:
Warning
This is a sample of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this instrument or damage to other property. The following is
an example of a caution:
A note is given when additional general information is applicable. The following is an
example of a note:
Note: This is a sample of a note.
Caution
This is a sample of caution statement.
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Product Description, Indications for Use, Contraindications, and Features
The following chapter contains the Radical-7 product description, key features and benefits,
indications for use, contraindications, and safety information, including cautions, warnings,
and notes.
Product Description
The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2),
pulse rate (PR), and perfusion index (PI), along with optional measurements of hemoglobin
(SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet),
Pleth Variability Index (PVI), Acoustic Respiration Rate (RRa), and Pleth Respiration Rate
(RRp).
The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7
features a touchscreen Liquid Crystal Display (LCD) 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 is clinically proven to satisfy all sensitivity and specificity
requirements for pulse oximeter technology.
• Rainbow technology uses 7+ wavelengths of light to continuously and
noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet), and
total hemoglobin (SpHb), as well as providing a more reliable probe-off detection.
• Total oxygen content (SpOC) provides a calculated measurement of the amount of
oxygen in arterial blood, which may provide useful information about oxygen both
dissolved in plasma and combined with hemoglobin.
• Perfusion Index (PI) with trending capability indicates arterial pulse signal
strength and may be used as a diagnostic tool during low perfusion.
• Pleth Variability Index (PVI) may show changes that reflect physiologic factors
such as vascular tone, circulating blood volume, and intrathoracic pressure
excursions. [The utility of PVI is unknown at this time and requires further clinical
studies. Technical factors that may affect PVI include probe malposition and
patient motion.]
• Respiration rate can be determined by the acoustic (RRa) or plethysmographic
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waveform (RRp).
Radical-7 Product Description, Indications for Use, Contraindications, and Features
• Signal IQ waveform for signal identification and quality indication during
excessive motion and low signal to noise situations.
• FastSat tracks rapid changes in arterial O2.
• Variable pitch provides tonal variance for every 1% change in saturation.
• SatShare interface allows transfer of SpO2 and pulse rate to an existing
multi-parameter monitor and allows for the reading of SpCO, SpMet, SpHb, and
SpOC on adjacent Radical-7 monitor.
• Automatic screen rotation provides upright display for vertical or horizontal
monitor positioning.
• 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 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 (SpO2)
and pulse rate (PR) to multi-parameter devices for the display of those devices.
Contraindications
The Radical-7 is not intended for use as an apnea monitor.
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7 test results should be scrutinized in
Safety Information, Warnings, and Cautions
The following section lists warnings, caution, notes, and safety information.
The Radical-7 is designed to minimize the possibility of hazards from errors in the software
program by following sound Engineering Design Processes, Risk Analysis and Software
Validation.
The Radical-7 is to be operated by qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be read before use.
Always use the Radical-7 precisely in accordance with the directions in this manual,
including finger selection, finger alignment in the sensor, and subject behavior during
testing. Failure to follow all of the directions in this manual could lead to inaccurate
measurements.
Caution
For SpHb, the Radical-7 should be considered an early warning device. Blood
samples should be analyzed by laboratory instruments prior to clinical
decision making to completely understand the patient’s condition.
Caution
Variation in hemoglobin measurements may be profound and may be affected
by sample type, body positioning, as well as other physiological conditions.
As with most hemoglobin tests, Radicallight of a specific patient’s condition. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated and/or supplemented
with additional test data.
Parameter Related Safety Information, Warnings, and Cautions
This section contains parameter related safety information.
Warning
Interfering Substances: Dyes, or any substance containing dyes, that change
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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).
Radical-7 Safety Information, Warnings, and Cautions
may be decreased by levels of MetHb
hen elevated levels of
Warning
The Radical-7 cannot measure elevated levels of COHb or MetHb.
Warning
Inaccurate SpO2 readings may be caused by:
• Elevated levels of COHb and MetHb
• For increased COHb: COHb levels above normal tend to increase
the level of SpO2. The level of increase is approximately equal
to the amount of COHb that is present.
• Note: High levels of COHb may occur with a seemingly normal
SpO2. When elevated levels of COHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
• For increased MetHb: the SpO2
of up to approximately 10% to 15%. At higher levels of MetHb, the
SpO2 may tend to read in the low to mid 80s. W
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 Safety Information, Warnings, and Cautions
Warning
Inaccurate SpHb and SpOC readings may be caused by:
• 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
• Low arterial perfusion
• Motion artifact
• Low arterial oxygen saturation levels
• Elevated carboxyhemoglobin levels
• Elevated methemoglobin levels
• Difference between patient's finger skin and finger core temperature
• Hemoglobin synthesis disorders
• 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:
• Intravascular dyes such as indocyanine green or methylene blue
• Abnormal hemoglobin levels
• Low arterial perfusion
• 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%
Inaccurate SpCO readings can be caused by:
• Levels of methemoglobin approximately 1.5% or above
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Radical-7 Safety Information, Warnings, and Cautions
Warning
Inaccurate respiration rate measurements may be caused by:
• Low arterial perfusion
• Motion artifact
• Low arterial oxygen saturation
• Excessive ambient or environmental noise
• Improper sensor placement
Caution
If patient hypoxemia is indicated, blood samples should be analyzed by
laboratory devices to completely understand the patient’s condition.
Caution
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.
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
Changing the SpHb Cal, the date and time of the system clock, or the trend
period clears the data in the trend memory.
Caution
Excessive ambient noise may affect the accuracy of the respiration rate reading
from the Acoustic Respiration Sensor.
When monitoring acoustic respiration, Masimo recommends minimally monitoring both
oxygenation (SpO2) and respiration (RRa).
Device Related Safety Information, Warnings, and Cautions
This section contains device related safety information.
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Radical-7 Safety Information, Warnings, and Cautions
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 use the Radical-7 or sensor during magnetic resonance imaging (MRI)
scanning.
Warning
Do not place the Radical-7 or accessories in any position that might cause it to
fall on the patient.
Warning
During SatShare operation, do not use the plethysmographic waveform display
on the multi-parameter monitor for diagnostic purposes. Instead, use the
plethysmographic waveform displayed on the Radical-7 screen.
Warning
Pulse rate measurement is based on the optical detection of a peripheral flow
pulse and therefore may not detect certain arrhythmias. The Radical-7 should
not be used as a replacement or substitute for ECG-based arrhythmia analysis.
Warning
The Radical-7 can be used during defibrillation, but the readings may be
inaccurate for up to 20 seconds.
Warning
Do not place containers with liquids on or near the Radical-7. Liquids spilled on
the instrument may cause it to perform inaccurately or fail.
Warning
EMI radiation interference such as computer displays and/or LCD/plasma TVs
can cause error or incorrect measurements on the Radical-7.
Warning
If the Radical-7 fails any part of the setup procedures or leakage spot check,
remove the instrument from operation until qualified service personnel have
corrected the situation.
Warning
A functional tester cannot be used to assess the accuracy of the Radical-7.
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Radical-7 Safety Information, Warnings, and Cautions
parameter patient monitor decodes these
Warning
Do not autoclave, pressure sterilize, or gas sterilize the Radical-7.
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 panel.
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
instrument failure can result.
Warning
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.
Warning
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 multisignals into saturation and pulse rate values.
Warning
Simultaneous use of SatShare and serial port is not supported.
Caution
Do not place the Radical-7 where the controls can be changed by the patient.
Caution
Disposal of product - Comply with local laws in the disposal of the instrument
and/or its accessories.
Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with Flexport.
If the Radical Docking Station is compatible with SafetyNet, Vuelink is not supported.
Use the Radical-7 in accordance with Environmental Specifications section in of this manual.
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Radical-7 Safety Information, Warnings, and Cautions
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) 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 FDA, or in any manner inconsistent with the instructions for use or labeling.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
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.
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.
In order to maintain compliance with FCC regulations, shielded cables must be used with this
equipment. Operation with non-approved equipment or unshielded cables is likely to result in
interference to radio and TV reception. The user is cautioned that changes and modifications
made to the equipment without the approval of manufacturer could void the user's authority
to operate this equipment.
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.
This equipment has been tested and found to comply with the limits for medical devices to
the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation.
This Class B digital apparatus complies with Canadian ICES-003.
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Radical-7 Safety Information, Warnings, and Cautions
replace only with fuses of same type,
Electrical Safety Information, Warnings, and Cautions
This section contains electrical related safety information.
Warning
Fire Hazard: To protect against fire hazard,
current rating, and voltage rating.
Caution
Do not place the Radical-7 on electrical equipment that may affect the
instrument, preventing it from working properly.
Caution
Dispose of used batteries according to required country or regional instructions.
Caution
Risk of explosion if battery is replaced with an incorrect type. Replace with
Masimo supplied parts only.
Caution
At Low Battery, connect the Radical-7 to AC power to prevent loss of power.
Caution
Do not incinerate battery.
Caution
Electric shock hazard: Do not open the Radical-7 cover except to replace the
battery or batteries.
Caution
To protect against injury from electric shock, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Use cleaning solutions sparingly.
Caution
Electrical shock and flammability hazard: Before cleaning the Radical-7, always
turn it off and disconnect the power cord from the AC power supply.
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Radical-7 Safety Information, Warnings, and Cautions
Caution
Do not under any circumstances remove the grounding conductor from the
power plug.
Caution
Do not use extension cords or adapters of any type. The power cord and plug
must be intact and undamaged.
Caution
To ensure patient electrical isolation, connect only to other equipment with
electrically isolated circuits.
Caution
Do not connect to an electrical outlet controlled by a wall switch or dimmer.
All external instrument connections to the Analog Output/Nurse Call connector must be
IEC-60950 compliant.
It is recommended that the Radical-7 Handheld is docked to the Docking Station that is
attached to an AC power source when it is not in use to ensure that the battery remains fully
charged.
External instrument connections to the SatShare port must be IEC-60601-1 compliant.
Only use a SatShare cable that has a ferrite bead installed.
Use the power cord as the means to disconnect the instrument from the main power supply.
If the Radical-7 Handheld has not been used or charged within seven (7) days or more, then
recharge the battery prior to use.
The instrument must be configured to match your local power line frequency to allow for the
cancelation of noise introduced by fluorescent lights and other sources.
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.
To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt
to sterilize by irradiation, steam, autoclave or any method other than ethylene oxide as
indicated.
Only SpO2 and pulse rate can be displayed on the multi-parameter monitor with SatShare.
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Radical-7 Safety Information, Warnings, and Cautions
The battery should be installed and/or removed from the Radical-7 by qualified personnel
only.
All batteries lose capacity with age, thus the amount of run time at Low Battery will vary
depending upon the age of the battery.
All external device connections to the RS-232 serial port must be IEC-60950 compliant.
The Docking Station battery should be installed and/or removed from the Docking Station
only by qualified personnel.
To conserve battery power, keep the frequency of the audible alarms to a minimum and the
volume to a minimum.
To conserve battery power, keep the back-lit LCD screen at minimum illumination.
When using the SatShare feature, to conserve battery power, always keep the Radical-7 on AC
line power.
Alarm Related Safety Information, Warnings, and Cautions
This section contains alarm related safety information.
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
Do not place the Radical-7 against a surface that may cause the alarm to be
muffled.
Caution
To ensure that alarm limits are appropriate for the patient being monitored,
check the limits each time the Radical-7 is used.
Caution
The Nurse Call feature is disabled when the Audible Alarms are silenced and
Nurse Call setting is set to Alarms.
Caution
When the Radical-7 is placed in All Mute, the patient alarms will not audibly
sound on the Radical-7 or the SafetyNet. The SafetyNet View will display a visual
alarm.
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Radical-7 Safety Information, Warnings, and Cautions
Caution
During SatShare operation, the audible alarms may be muted on the Radical-7.
When the audible alarm is muted (indicated by a bell with a slash through it) on
the Radical-7, use the multi-parameter monitor for audible alarm indication.
Caution
If an alarm condition occurs while the Alarm Silence period is set to All Mute, the
only alarm indications will be visual display and symbols related to alarm
condition. No alarm will sound.
The Desat Index alarm is intended as an adjunct rather than in place of the Low Saturation
alarm.
Sensor Related Safety Information, Warnings, and Cautions
This section contains sensor related safety information.
Warning
As with all medical equipment, carefully route patient cabling to reduce the
Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage
the sensor cable.
Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
Failure to apply the sensor properly may lead to incorrect measurements.
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).
possibility of patient entanglement or strangulation.
Warning
Always remove the sensor from the patient and completely disconnect the
patient from the Radical-7 before bathing the patient.
Caution
If using the Radical-7 during full body irradiation, keep the sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be
inaccurate or the instrument might read zero for the duration of the active
irradiation period.
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Radical-7 Safety Information, Warnings, and Cautions
Do not expose the Masimo sensors used with Radical-7 to moisture, liquids or a humid
environment, as this may make the sensor perform inaccurately or fail.
High-intensity extreme lights (including pulsating strobe lights and direct sunlight) directed
on the sensor, may not allow the Radical-7 to obtain readings.
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.
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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 digital 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 (FST®), reliably identifies the
noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen
saturation for display on the monitor.
Masimo rainbow SET Parallel Engines
This figure is for conceptual purposes only.
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Radical-7 Chapter 1: Technology Overview
Masimo SET DST
This figure is for conceptual purposes only.
General Description for Oxygen Saturation (SpO2)
Pulse oximetry is governed by the following principles:
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.
3. As a plethysmographic waveform
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 SpO2 and pulse rate.
Functional Oxygen Saturation
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 that carboxyhemoglobin is not capable of transporting oxygen, but is recognized as
oxygenated hemoglobin 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 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.
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Radical-7 Chapter 1: Technology Overview
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.
1. Light Emitting Diodes (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 (SpO2 [%]), blood levels of
carboxyhemoglobin (SpCO [%]), 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. In an ambient
temperature of 35º C the maximum skin surface temperature has been measured at less than
106º F (41º C), verified by Masimo sensor skin temperature test procedure.
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 SpO2, SpCO,
SpMet, SpHb, and SpOC measurements of the Radical-7. Any comparisons should be
simultaneous, meaning the measurement on the device should be noted at the exact time
that blood is drawn.
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 (PCO2), 2,3-DPG, 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).
High levels of bilirubin may cause erroneous SpO2, SpMet, SpCO, and SpHb readings. As
blood samples are usually taken over a period of 20 seconds (the time it takes to draw the
www.masimo.com 26 Masimo
) and saturation, such as:
2
Radical-7 Chapter 1: Technology Overview
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 SpO2, SpCO, 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.
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 adult 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 instrument. The instrument 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 Safety
Information, Warnings, and Cautions on page 11 and Troubleshooting Measurements on
page 111.
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 (CaO2)
and is measured in units of ml O2/dL blood. One gram of hemoglobin (Hb) can carry 1.34 ml
of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen*. The
oxygen content is determined mathematically as:
CaO2 = 1.34 (ml O2/g Hb) x Hb (g/dL) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/100 mm Hg/dL)
Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of
arterial oxygen.
For typical PaO2 values, the second part of the above equation (PaO2 [mm Hg] x [0.3 ml O2/
100 mm Hg/dL]) is approximately 0.3 ml/dL. Furthermore, for typical carboxyhemoglobin
and methemoglobin levels, the functional saturation (SpO2) as measured by a pulse oximeter
is given by:
SpO2 = 1.02 x HbO2
*Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second
Edition. New York: Lippincott Williams & Wilkins, 1999.
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Radical-7 Chapter 1: Technology Overview
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 Hb) x SpHb (g/dL) x SpO2 + 0.3 ml/dL
*When ml O2/g Hb is multiplied by g/dL of SpHb, the gram unit in the 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 Safety Information, Warnings, and Cautions on
page 11.
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 instrument or through an instrument patient cable.
The sensor collects signal data from the patient and sends it to the instrument. The
instrument 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.
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 instrument or through a patient cable.
The sensor collects signal data from the patient and sends it to the instrument. The
instrument displays the calculated data as percentage value for the SpMet.
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Radical-7 Chapter 1: Technology Overview
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. See Safety Information, Warnings,
and Cautions on page 11.
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 (Low SpCO SIQ, Low
SpMet SIQ, or Low SpHb SIQ) displays to alert the clinician that the instrument does not have
confidence in the value due to poor signal quality caused by excessive motion or other signal
interference.
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 translates airflow
sounds generated in the upper airway to an electrical signal that 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
Radical-7 Chapter 1: Technology Overview
Signal
Processing
Envelope
Detection
RRa Estimation
Digital signal to
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.
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.
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Radical-7 Chapter 1: Technology Overview
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.
[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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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. Instrument
2. Patient Cable
3. Sensor
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Radical-7 Chapter 2: Radical-7 Descriptions
touchscreen. All user input is performed through the touchscreen and
Functionality of the Radical-7
The Radical-7 provides the functionality of three instruments in one:
Handheld Pulse CO-Oximeter
The Radical-7 is a fully featured Handheld.
The Handheld contains the majority of the device features. All
measurements and instrument status datum are displayed on the
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 SpO2 input module of multi-parameter patient monitors to
upgrade conventional pulse oximetry technology on the multi-parameter monitor to Masimo
SET technology.
Utilizing a SatShare cable, the standalone
Radical-7 also interfaces with the SpO2 input of a
validated 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.
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Radical-7 Chapter 2: Radical-7 Descriptions
Handheld
All user input and displays are controlled by this component. The patient cable connects into
the connector on the Handheld instrument. 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.
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
Changing the Size of Parameter Values on page
50.
3 Profile button
The Profile button provides instant access to the
Profile Screen. See Chapter 5: Profiles on page 93.
4 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.
5 Home button
The Home button provides instant access to the
Display View screen.
6 Alarm Silence Button
The Alarm Silence button temporarily silences
alarms. See Silencing the Alarms on page 99.
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
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Radical-7 Chapter 2: Radical-7 Descriptions
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.
Item Description
1 The Handheld interfaces with the Docking Station through this connector.
2 The optional Pole Clamp accessory attaches to this holder. See the directions
for use of the Pole Clamp accessory for attachment instructions.
3 The Handheld is powered by a lithium ion battery located in this compartment.
For battery care and replacement, see Battery Operation and Maintenance on
page 131.
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Radical-7 Chapter 2: Radical-7 Descriptions
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. The 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 instruments, Nurse Call or analog output
instruments, 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.
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
Automatic Display Rotation Support (Gravity
Detector)
Docking Station Battery Charging indicator
Handheld Battery Charging indicator
Visual Alarm indicator
AC Power indicator
Docking indicator
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Radical-7 Chapter 2: Radical-7 Descriptions
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.
Item 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
4
5
Visual Alarm
Indicator
AC Power
Indicator
Docking
Indicator
The Visual Alarm indicator is illuminated
when an alarm condition is active and the
Alarm Status Indicator is shown.
The AC Power indicator is illuminated
when the Radical-7 Docking Station is
plugged into AC line power.
The Docking indicator is illuminated
when the Handheld instrument is turned
on and is properly interfaced to a Docking
Station.
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Radical-7 Chapter 2: Radical-7 Descriptions
7.
such as a chart recorder or Nurse Call system. All external
Directions for Use to ensure that the correct cable is used
Standalone Back Panel
The following figure and corresponding text review the features of the Radical-7 Standalone.
Item Connector Description
1 Serial Output
connector
2 Analog
Output/Nurse Call
connector
3 SatShare Cable
connector
Use the Serial Output connector with a ferrite bead
installed to connect a serial instrument, including a
serial printer, a monitoring system or PC to the RadicalThe data is provided in standard RS-232C format. All
external instrument connections to the Serial Output
connector must be IEC-60950 compliant.
Use the Analog Output connector with a ferrite bead
installed to interface with an analog output instrument,
instrument connections to the Analog Output/Nurse Call
connector must be IEC-60950 compliant.
See Serial Interface Specifications on page 122.
Use the SatShare Cable connector to connect a SatShare
cable to the SpO2 input connector of a multi-parameter
patient monitor. All external instrument 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
for each type of patient monitor.
Visit www.masimo.com for the latest SatShare cables
and validated instruments.
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Radical-7 Chapter 2: Radical-7 Descriptions
The Power Entry module contains the input connector for
Item Connector Description
4 Power Entry module
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 instrument from the mains
power supply.
5 Equipotential
Use the Equipotential Ground connector for grounding.
Ground connector
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 SpO2 and pulse rate determined by Radical-7 to simulate an
ideal plethysmograph waveform, which is sent to the validated multi-parameter
patient monitor.
• Connects into the SpO2 patient cable or SpO2 input connector of the
multi-parameter patient monitor.
See Setting Up and Using SatShare on page 44.
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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 instrument 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
Docking Station Power Requirements
See Safety Information, Warnings, and Cautions on page 11.
Return Procedure on page 136.
• 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.
• Connect a hospital-grade power cable (IEC-320 connector type at the instrument)
to the Power Entry module on the Docking Station.
• Connect the power cable to an AC power source.
• Ensure that the instrument is adequately powered by verifying that the AC power
indicator on the Docking Station is illuminated.
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 118.
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Radical-7 Chapter 3: Setup
Initial Battery Charging
Before use, the Radical-7 Handheld battery and the Docking Station battery must be charged
completely. See Electrical Safety Information, Warnings, and Cautions on page 18.
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.
• The Battery Charging indicators on the Docking Station flash prior to
charging and remain illuminated while the batteries are charging.
See Standalone Front Panel on page 38 and Battery Operation and Maintenance on page
131.
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 serial 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 SpO2 and pulse rate values appear on the VueLink 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 Device Related Safety Information, Warnings, and Cautions
on page 14 and Serial Interface Specifications on page 122.
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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 SpO2 and pulse rate values appear on the Spacelabs screen.
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. See Device Related
Safety Information, Warnings, and Cautions on page 14 and Serial Interface
Specifications on page 122.
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Radical-7 Chapter 3: Setup
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 plethysmographic waveform and the parameter values.
Refer to the instructions for use provided with the multi-parameter monitor. See Device
Related Safety Information, Warnings, and Cautions on page 14.
To set up for use with SatShare interface
1. Select the SatShare cable that is appropriate for the multi-parameter monitor. For
the latest list of available SatShare cables and validated instruments, see
www.masimo.com.
2. Connect the labeled end of the SatShare cable to the SatShare Cable connector on
the Docking Station. See Standalone Back Panel on page 39. For a secure
connection, tighten the cable connector screws.
3. Connect the other end of the SatShare cable to one of the following:
• Sensor connector of the multi-parameter monitor cable
• Directly to the multi-parameter monitor
4. Verify that the Radical-7 recognizes the SatShare cable. If functional, the name of
the SatShare cable displays on the Radical-7 screen.
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.
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 Battery Operation and Maintenance on page 131.
9. On the Radical-7, turn on the Satshare Numbers option. See Device Output on
page 80.
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 Serial Interface Specifications on page 122.
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Chapter 4: Operation
The following chapter contains information about using the Radical-7.
Using the Touchscreen and Buttons
1. Display View
To access other screens,
touch a value on the Display
View. See About the Display
View on page 48.
2. Profiles button
To the access the Profiles
screen, press Profiles. See
Chapter 5: Profiles on page
93.
3. Alarm Silence button
To temporarily silence
audible alarms, press Alarm
Silence. See Silencing the
Alarms on page 99.
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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Radical-7 Chapter 4: Operation
Using Screen Lock
When turned on, the Screen Lock feature may prevent unintentional interaction with Display
View.
Using the Screen Lock feature
1. When turned on, any interaction with the Display View triggers 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 Screen Lock, see Access Control on page 76.
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.
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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 Display View. See Accessing the Main Menu on page 57.
Display Timeout
When no user interaction occurs within 1 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 About the Status Bar on page 49.
Parameter Display. See Changing the Size of Parameter Values on page 50.
Trend Field. See Waveform and Trend Views on page 52.
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Radical-7 Chapter 4: Operation
Small Parameter View. See Accessing the Main Menu on page 57.
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 Sensitivity Modes Overview on page 55.
• Profiles. See Profiles Overview on page 93.
• Messages on page 104. (read only)
• WiFi on page 79.
• Battery on page 80.
• Sounds on page 74.
• Time settings. See Localization on page 78.
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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 Small Parameter view, touch and hold any one of the parameters, as shown
above.
2. When the parameter value dims, shakes, and grows in size, drag and drop that
parameter above the Trend Field.
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 view.
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Radical-7 Chapter 4: Operation
Trend Field
The Trend Field allows users to access various customizable views. See Trends on page 81.
To access trend, waveform, or customize the views on the Display View screen
1. Touch the Trend Field, as shown below.
2. The following screen appears.
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Radical-7 Chapter 4: Operation
3. Swipe up or swipe down the available options.
4. Touch on the desired option.
5. The Trend Field displays trend data specific to the option that was selected.
Pulse Bar
The Pulse Bar is a visual indicator that conveys the detection of pulse and 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 Signal IQ Indicators on page 53.
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.
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Radical-7 Chapter 4: Operation
Pleth + Sig IQ View
Shows the parameter values on the top of the screen. The waveform is located below the
parameter values. The Small Parameter view is located along the bottom of the screen. This
view contains the Pleth Waveform with signal quality indications only.
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.
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Radical-7 Chapter 4: Operation
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 view is 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.
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 view is located along the bottom of the screen. This
view contains the Pleth waveform, signal quality indications, and acoustic waveform.
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Radical-7 Chapter 4: Operation
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.
With a pinch gesture, using two fingers, the user can zoom in and out of the quick trend data
within the Trend Field.
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 menu by touching on the indicator in the upper
left corner of the Display View. The sensitivity levels are as follows:
• 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.
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Radical-7 Chapter 4: Operation
Changing Sensitivity Modes
There are two ways to change the sensitivity modes.
1. Press the indication on the top left of the Display View.
2. Alternatively, from the Main Menu, touch the Profiles icon. From the Profiles
screen, select the desired mode by scrolling up or down. Then select OK.
Note that the device will revert to APOD mode after a power cycle.
See Changing Profiles on page 94.
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Radical-7 Chapter 4: Operation
Accessing the Main Menu
To access Main Menu from the Display View, touch the gear icon on the bottom right corner of
the Small Parameter View.
Navigating the Main Menu
• From the Main Menu screen, touch the icons for any of the following screens:
Device Settings
See Device Settings on page 75.
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Radical-7 Chapter 4: Operation
Parameter Settings
See Parameter Settings on page 59.
Profiles
See Changing Profiles on page 94.
3D Alarms
See 3D Alarms on page 102.
Trends
See Trends on page 81 and Trend Field on page 51.
Sound
See Sounds on page 74.
About
See About on page 91.
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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 on page 62.
SpHb Settings on page 63.
PVI Settings on page 70.
PR Settings on page 65.
Perfusion Index (PI) Settings on page 66.
SpCO Settings on page 71.
SpMet Settings on page 72.
SpOC Alarms on page 73.
Respiration Rate (RR) on page 67.
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Radical-7 Chapter 4: Operation
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.
2. An About screen appears for the selected parameter.
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Radical-7 Chapter 4: Operation
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.
When the In Vivo Adjustment is set to On, the feature is active (turned on) and 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 disconnect from instrument.
• 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.
Offset value
The offset value appears and indicates that In Vivo Adjustment is active. A positive value
means that the value is increased (according to a laboratory reference value as entered by a
clinician) and a negative value means the value is decreased (according to a laboratory
reference value as entered by a clinician).
In the example below, the SpO2 value is offset (highlighted) by -1.0 and SpHb is offset by
+0.4.
The In Vivo Adjustment feature can be set to On or Off. the factory default setting is Off. If set
to On, the parameter value is adjusted and an offset value appears. The offset value is set by
the user.
The feature applies to any of the following parameters:
In Vivo for SpO2 on page 63.
In Vivo for SpHb on page 65.
In Vivo for SpCO on page 72.
In Vivo for SpMet on page 73.
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Radical-7 Chapter 4: Operation
SpO2 Settings
Access any of the following options:
Alarms for SpO2.
Additional Settings for SpO2 on page 63.
About Parameter Information on page 60.
Alarms for SpO2
From the Alarms screen, change any of the following options:
Options Description
High Limit is the upper
High Limit
threshold that triggers an
alarm.
Low Limit is the lower
Low Limit
threshold that triggers an
alarm.
Sets the Rapid Desat limit
threshold to the selected
amount below the Low
Alarm Limit. When SpO2
Rapid Desat
value falls below rapid desat
limit the audio and visual
alarm are immediately
triggered without respect to
the alarm delay.
When an alarm condition is
Alarm Delay
met, this feature delays the
audible part of an alarm.
ATA establishes
patient-specific limit
Adaptive
Threshold
Alarm (ATA)
thresholds based upon the
baseline value of the
parameter.
See Adaptive Threshold
Alarm (ATA) Feature on
page 101.
Factory Default
Settings
Configurable Options
2% to 99% in steps of
Off
1%, or Off
When set to Off, alarm
is disabled
88%
1% to 98% in steps of
1%
-10% Off, -5%, or -10%
5 seconds 0, 5, 10, or 15 seconds
Off Off or On
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Radical-7 Chapter 4: Operation
Additional Settings for SpO2
From the Additional Settings screen, change any of the following options:
Options Description Factory Default
Settings
Averaging Time The length of time over which the
8 seconds 2-4, 4-6, 8, 10, 12,
system calculates the average of
User Configurable
Settings
14, or 16 seconds
all data points.
FastSat See FastSat Overview on page
Off On or Off
63.
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.
When the Radical-7 is set to FastSat On, the averaging algorithm 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.
In Vivo for SpO2
From the In Vivo screen, change any of the following options:
Options Description Factory Default
Settings
User Configurable
Settings
Enabled See In Vivo Adjustment
Overview on page 61.
Offset Amount See In Vivo Adjustment
Overview on page 61.
Off On or Off
0 when turned
on
Adjust difference of ±
6%, in steps of 0.1%
SpHb Settings
From the SpHb Settings screen, access any of the following screens:
SpHb Alarms on page 64.
Additional Settings for SpHb on page 64.
About Parameter Information on page 60.
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Radical-7 Chapter 4: Operation
calculates the average of all
SpHb Alarms
From the Alarms screen, change any of the following options:
Options Description Factory Default
User Configurable Settings
Settings
High Limit The High Limit is
upper threshold
that triggers an
alarm.
17.0 g/dL
(11.0 mmol/L)
2.0 g/dL to 24.5 g/dL in steps
of 0.1 g/dL, 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.
Low Limit The Low Limit is
lower threshold
that triggers an
alarm.
7.0 g/dL
(4.0 mmol/L)
Off, or 1.0 g/dL to 23.5 g/dL in
steps of 0.1 g/dL
(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 Additional Settings screen, change any of the following options:
Options Description Factory Default
Averaging Time The length of time over
Calibration Provides an arterial or
Precision Allows the user to set the
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which the system
data points.
venous value that displays
on the main screen.
decimal for SpHb.
Settings
Settings
Medium Short, Medium, or Long
Venous Arterial or Venous
0.1 0.1, 0.5, or 1.0 (whole
numbers)
User Configurable
Radical-7 Chapter 4: Operation
Unit of Measure Displays total hemoglobin
g/dL mmol/L or g/dL
(SpHb) as g/dL (grams per
deciliter) or mmol/L
(milimoles per liter).
In Vivo for SpHb
From the In Vivo screen, change any of the following options:
Options Description Factory Default
Settings
In Vivo
Calibration
In Vivo
Calibration
See In Vivo Adjustment
Overview on page 61.
See In Vivo Adjustment
Overview on page 61.
Off On or Off
0 ± 3 g/dL in steps of ±
Offset
PR Settings
From the PR Settings screen, change any of the following options:
PR Alarms on page 65.
About Parameter Information on page 60.
PR Alarms
From the PR Alarms screen, change any of the following options:
Options Description Factory Default
High Limit The High Limit is upper
threshold that triggers an
alarm.
Settings
140 bpm
User Configurable
Settings
0.1 g/dL
Options
35 bpm to 235 bpm, in
steps of 5 bpm
Low Limit The Low Limit is lower
threshold that triggers an
50 bpm 30 bpm to 230 bpm, in
steps of 5 bpm
alarm.
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Radical-7 Chapter 4: Operation
Perfusion Index (PI) Settings
From the PI Settings screen, access any of the following screens:
PI Alarms on page 66.
Additional Settings for PI on page 66.
About Parameter Information on page 60.
PI Alarms
From the Alarms screen, change any of the following options:
Options Description Factory
User Configurable Settings
Default
Settings
High Limit The High Limit is upper
threshold that triggers an
alarm.
Off Step size:
0.04 to 0.09 in steps of
0.01
0.10 to 0.90 in steps of
0.10
1 to 19 in steps of 1, or Off
Low Limit The Low Limit is lower
threshold that triggers an
alarm.
Off Step size:
Off, or 0.03 to 0.09 in
steps of 0.01
0.10 to 0.90 in steps of
0.10
1 to 18 in steps of 1
Additional Settings for PI
From the Additional Settings screen, change any of the following options:
Options Description Factory
Default
Settings
User Configurable
Settings
Averaging
Time
The length of time over which
the system calculates the
Long Short or Long
average of all data points.
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Radical-7 Chapter 4: Operation
Respiration Rate (RR)
The Radical-7 can determine respiration rate (RR) either by the acoustic signal (RRa) or by
the plethysmographic waveform (RRp).
RRp Settings
When using a pulse oximetry or pulse CO-Oximetry sensor with the Radical-7, respiration rate
can be determined by the plethysmographic waveform (RRp). This method measures a
patient's respiratory rate based on plethysmographic amplitude changes that correspond to
the respiratory cycle. When using a pulse oximetry or pulse CO-Oximetry sensor, RRp alarms
and RRp settings are active and the Display View conveys respiratory rate as RRp, as shown
below.
Note that the Radical-7 can monitor RRa or RRp but not both simultaneously. RRp is active
under the following conditions:
• RRp is installed on the Radical-7.
• Dual Rainbow cable is disconnected.
• Pulse oximetry or pulse CO-Oximetry sensor is connected.
• Acoustic sensor is not connected.
When using an acoustic sensor, respiration rate (RR) is determined by the acoustic (RRa)
signal. See rainbow Acoustic Monitoring (RAM) Technology on page 29. When the
respiratory rate is determined by the acoustic signal, the Display View conveys respiratory
rate as RRa, as shown below.
From the RR Settings screen, access any of the following screens:
RRp Alarms on page 67.
Additional Settings for RRp on page 68.
RRp Alarms
From the Alarms screen, change any of the following options:
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Radical-7 Chapter 4: Operation
Options Description Factory Default Configurable Options
High Limit The High Limit is
upper threshold that
30 breaths per
minute
6 breaths per minute to 69
breaths per minute, or Off
triggers an alarm.
Low Limit The Low Limit is lower
threshold that
6 breaths per
minute
5 breaths per minute to 68
breaths per minute, or Off
triggers an alarm.
Alarm Delay When an alarm
30 second 0, 10, 15, 30, 60 seconds
condition is met, this
feature delays the
audible part of an
alarm.
Additional Settings for RRp
From the Additional Settings screen, change any of the following options:
Options Description Factory Default
Settings
Averaging
Time
The length of time
over which the system
Slow No, Fast, Medium, Slow,
calculates the average
of all data points.
Freshness The duration of time
5 minutes 0, 1, 5, 10, 15 minutes
that, during
interference, the
system displays the
last valid reading.
User Configurable Settings
Trending
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Radical-7 Chapter 4: Operation
RRa Settings
RRa is active under the following conditions:
• RRa is installed on the Radical-7.
• Dual Rainbow cable is connected.
• Acoustic sensor is connected.
From the RR Settings screen, access any of the following screens:
RRa Alarms on page 69.
Additional Settings for RRa on page 70.
About Parameter Information on page 60.
RRa Alarms
From the Alarms screen, change any of the following options:
Options Description Factory
Default
Settings
High Limit The High Limit is upper
threshold that triggers
30 breaths
per minute
an alarm.
Low Limit The Low Limit is lower
threshold that triggers
6 breaths per
minute
an alarm.
Respiratory
Pause
The duration of time
that triggers an alarm if
30 seconds 20, 25, 30, 35, 40, or 15
no breaths are
detected.
Alarm Delay When a High or Low
30 seconds 60, 0, 10, 15, or 30 seconds
alarm condition occurs,
this feature delays the
audible part of an
alarm.
Configurable Options
6 to 69 breaths per minute in
steps of 1 breaths per minute,
or Off
5 to 68 breaths per minute in
steps of 1 breaths per minute
seconds
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Radical-7 Chapter 4: Operation
Additional Settings for RRa
From the Additional Settings screen, change any of the following options:
Options Description Factory
User Configurable Settings
Default
Settings
Averaging Time The length of time
over which the system
Slow Trending, No, Fast, Medium, or
Slow
calculates the average
of all data points.
Freshness The duration of time
5 minutes 10, 15, 0, 1, or 5 minutes
that, during
interference, the
system displays the
last valid reading.
PVI Settings
From the PVI Settings screen, access any of the following options:
PVI Alarms on page 70.
Additional Settings for PVI on page 71.
About Parameter Information on page 60
PVI Alarms
From the Additional Settings screen, change any of the following options:
Options Description Factory
User Configurable Settings
Default
Settings
High Limit The High Limit is upper
threshold that triggers an
alarm.
Low Limit The Low Limit is lower
threshold that triggers an
alarm.
Off 2 to 99, in steps of 1, or Off
When set to Off, alarms are
disabled.
Off Off, 1 to 98 in steps of 1
When set to Off, alarms are
disabled.
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Radical-7 Chapter 4: Operation
Additional Settings for PVI
From the Additional Settings screen, change any of the following options:
Options Description Factory
User Configurable Settings
Default
Settings
Averaging
Time
The length of time
over which the system
Long Short or Long
calculates the average
of all data points.
SpCO Settings
From the SpCO Settings screen, access the following screens:
SpCO Alarms on page 71.
About Parameter Information on page 60.
SpCO Alarms
From the SpCO Settings screen, access the following screens:
Options Description Factory
High Limit The High Limit is the upper
threshold that triggers an
alarm.
Default
Settings
10 2% to 98%, in steps of 1%, or
User Configurable Settings
Off
When set to Off, alarm is
disabled
Low Limit The Low Limit is the lower
threshold that triggers an
alarm.
Off Off, 1% to 97%, in steps of 1%
When set to Off, alarm is
disabled
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Radical-7 Chapter 4: Operation
In Vivo for SpCO
From the In Vivo screen, access the following screens:
Options Description Factory
Default
Settings
Enabled See In Vivo Adjustment
Off On or Off
Overview on page 61.
Offset Amount See In Vivo Adjustment
0 ± 9% in steps of 0.1%
Overview on page 61.
SpMet Settings
From the SpMet Settings screen, access the following screens:
SpMet Alarms on page 72.
About Parameter Information on page 60.
SpMet Alarms
From the Alarms screen, change any of the following options:
Options Description Factory
Default
Settings
High Limit The High Alarm Limit
3.0 1% to 2% in steps of 0.1%
is upper threshold
that triggers an alarm.
User Configurable Settings
2.5% to 99.5% in steps of 0.5%, or
Off
User Configurable Settings
Low Limit The Low Alarm Limit
is lower threshold that
triggers an alarm.
Off Off, 0.1% to 2.0% in steps of 0.1%
2.5% to 99%, in steps of 0.5%
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Radical-7 Chapter 4: Operation
In Vivo for SpMet
From the In Vivo screen, access the following screens:
Options Description Factory
Default
Settings
Enabled Match the corresponding
Off On or Off
laboratory reference for
continuous trending.
Offset Amount Helps offset individual
0 ±3% in steps of 0.1%
patient bias that is expected
when comparing a
noninvasive measurement
to a laboratory reference.
SpOC Settings
From the SpOC Settings screen, access the following screens:
SpOC Alarms on page 73.
About Parameter Information on page 60.
SpOC Alarms
From the SpOC Alarms screen, access the following screens:
Options Description Factory
Default
Settings
User Configurable Settings
User Configurable Settings
High Limit The High Limit is the upper
threshold that triggers an
Off 2% to 34% in steps of 1%, or
Off
alarm.
Low Limit The Low Limit is the lower
threshold that triggers an
Off Off, or 1% to 33% in steps of
1%
alarm.
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Radical-7 Chapter 4: Operation
Sounds
From the Sounds screen, change any of the following options:
Options Description Factory
Default
Settings
Alarm Volume Sets the alarm
Level 4 Level 1 to 4
volume and provides
a sample of the alarm
volume.
Pulse Tone
Volume
Sets the volume of
the tone that conveys
Level 3 Off, Level 1 to 4
the pulse rate.
Silence
Duration
Length of time that
the audible alarm
120
seconds
remains muted.
User Configurable Settings
30, 60, 90, or 120 seconds
If All Mute is set to On (see Access
Control on page 76), then the
following additional settings
become available:
All Mute
If selected, then no alarms will
sound. Only visual elements are
enabled. The following icon appears
on the Display View.
All Mute with Reminder
If selected, then no alarms will
sound. Only visual elements are
enabled A tone sounds every 3
minutes as a reminder. The
following icon appears on the
Display View.
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Radical-7 Chapter 4: Operation
Device Settings
The following is an example of the Device Settings screen.
From the Device Settings screen, access any of the following options:
Screen Orientation on page 79.
Localization on page 78.
WiFi on page 79.
Battery on page 80.
Brightness on page 80.
Access Control on page 76.
Device Output on page 80.
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Radical-7 Chapter 4: Operation
Access Control
The Access Control screen is protected by a Password screen.
Password Screen
Using the Password screen
1. On the Password screen, enter the following numbers: 6 2 7 4
No numbers will be displayed, only asterisks (****).
2. Touch Enter.
3. To undo numbers, touch Backspace.
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Radical-7 Chapter 4: Operation
Access Control Screen
From the Access Control screen, change any of the following options:
Options Description Factory
Default
Settings
All Mute All patient alarm
Disabled Enabled or disabled
conditions are
silenced. Only
system alarms will
be indicated by an
audible alarm.
Lock Alarm
Volume
When set to 3 or 4, 3
or 4 shows dimly lit
Off 3, 4, or Off
in the Alarm Volume
section of the
Alarms Menu screen
and cannot be
changed.
SpO2 Low %
Limit
Threshold at which
SpO2 Low Alarm
Off 1% to 98% in steps of 1, or Off
Limit cannot be
reduced.
Lock Layout Prevents the user
N/A On or Off
from making
changes to the
parameter layout.
Screen Lock Prevents
On On or Off
unintentional
interaction with
Display View.
User Configurable Settings
If enabled, All Mute and All Mute
with Reminder become available
settings from the Silence Duration
option on the Sounds screen. See
Sounds on page 74.
Legacy Mode Changes the Display
Color Mono or Color
View from color to
monochrome.
Save as Adult Saves
pre-configured
profiles for adult
N/A Press Save to load all device
configuration settings to adult
profile.
patients.
Save as Neo Saves
pre-configured
profiles for neonatal
N/A Press Save to load all device
configuration settings to neonatal
profile.
patients
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Radical-7 Chapter 4: Operation
date if Auto Set Date/Time is
Factory
Defaults
Options are restored
to factory values.
N/A Press Restore to return to factory
default values.
Localization
From the Localization screen, change any of the following options:
Options Description Factory Default
Settings
User Configurable
Settings
Current Date Date N/A N/A
Current Time Time N/A N/A
Language Language in which the
screens display.
Time Zone Setting based on
Coordinated Universal Time
English Choose from available
languages.
A (UTC+1hr) Choose local time zone
settings.
(UTC).
Date Format Set the format of the date
display on the Display View.
Time Format Set the format of the time
MM/DD/YYYY MM/DD/YYYY
DD/MM/YYYY
12 hour 24 hour or 12 hour
display as it will be shown on
the Display View.
Line
Frequency
Set to match regional power
line frequency to allow for
60 Hz 50 Hz or 60 Hz
cancelation of noise
introduced by fluorescent
lights and other sources.
Date Manually set the numerical
MM/DD/YYYY Choose month, date,
and year.
Off.
Time Manually set the hour and
minute, AM or PM, if Auto Set
Date/Time is Off.
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12-hour format Choose hour and
minute.
Radical-7 Chapter 4: Operation
Factory Default
Screen Orientation
From the Screen Orientation screen, change any of the following options:
Options Description
Auto Orientation Allows the device to
automatically adjust the
Display screens depending
on orientation.
Orientation Rotates the viewing
screens depending on
device orientation.
Settings
User Configurable Settings
On Off or On
Landscape Landscape: rotates the screen
to horizontal viewing
position
Inverted Landscape: rotates
the screen to (180 degree)
viewing position
Portrait: rotates the screen to
vertical viewing position
Inverted Portrait: rotates the
screen to vertical (180
degree) viewing position
WiFi
When the Radical-7 is connected to a WiFi network, the Wifi icon located on the Status Bar
conveys the strength of the Wifi connection. See About the Status Bar on page 49.
From the Wifi screen, change any of the following options:
Options Description Factory
Default
Settings
WiFi Enables or disables the wireless
Off On or Off
connection
Additional fields in the Wifi screen provide information about WiFi connection. These
additional fields are read only and not configurable.
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User Configurable
Settings
Radical-7 Chapter 4: Operation
Battery
From the Battery screen, view the following information:
• Battery icon that conveys remaining battery charge as a green color.
• Battery icon that conveys that battery charging status. See About the Status Bar
on page 49.
See Battery Operation and Maintenance on page 131.
Brightness
From the Brightness screen, change any of the following options:
Options Description Factory
Default
Settings
Brightness The slider option adjusts the
4 Level 1 to 4
brightness level of the display
and provides a sample of the
brightness level.
Device Output
From the Device Output screen, change any of the following options:
Options Description Factory
Default
Settings
Serial Output to serial devices from
ASCII 1 ASCII 1, IAP, HP Vuelink,
the Serial Output connector is
RS-232 based. See
Standalone Back Panel on
page 39.
Analog 1 An interface with various
N/A SpO2 50% to 100%, Pulse
analog recording instruments
and/or strip chart recorders
through connector located on
Docking Station.
User Configurable Settings
SpaceLabs Flexport, or Data
Collection
rate, Pleth, SIG, 0V Output,
1V Output, SpO2 0% to 100%
User Configurable
Settings
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Radical-7 Chapter 4: Operation
Depending on the
activated based on Low Signal
Analog 2
configuration, the following
parameters are output
continuously on the Analog 1
and Analog 2.
N/A Pleth, SIQ, 0V Output, 1V
Output, SpO2 0% to 100%,
SpO2 50% to 100%, or Pulse
rate
Nurse Call
Trigger
The nurse call output will be
activated based on the alarm
N/A Alarms + SIQ, SIQ, Alarms
events. The nurse call with be
or Alarm and Low Signal IQ
events.
Nurse Call
Polarity
Can be inverted to
accommodate various nurse
N/A Normal or Inverted
call station requirements.
Trends
The following sections describe Trend Views and how to adjust trend settings.
About Trend Views
There are different ways to view trend information. The following is an example of trend
information for SpO2 as it appears within the Display View screen.
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Radical-7 Chapter 4: Operation
The following is an example of trend information for SpO2 as it appears in the Full Trend
screen.
Changing Between Trend Views
To toggle between Display View and Full Trend
From the Display View, in the Trend Field, touch the icon as shown below.
From the Full Trend screen, touch the icon as shown below.
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Radical-7 Chapter 4: Operation
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Radical-7 Chapter 4: Operation
Manipulating Trend Data
To manipulate the view of trend data
On the Full Trend screen, with a pinch gesture, using two fingers, the user can zoom in and out
of the trend time scale.
The user can add parameters to the Trend view by dragging and dropping parameters from
the Small Parameter view. To add a parameter to the Trend view, press and hold any of the
parameters inside the Small Parameter view, as shown below. When the parameter dims,
shakes, and grows in size, drag and drop the parameter into the Trend view.
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Radical-7 Chapter 4: Operation
To view past patient trend data, swipe the trend display to the left or to the right.
To exit a Trend view, press the Home button.
Changing the Time Interval of Trend Data
Users can change the time interval of trend data. The time options that can be selected are
10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, or 24 hours.
To change the time interval of trend data
1. From the Display View, in the Trend Field, or from the the Full Trend screen, touch
the Time Interval icon.
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Radical-7 Chapter 4: Operation
2. Scroll up or down to select a time interval.
Using the Histogram Feature
Users can view trend data using the Histogram feature. When turned on, the Histogram
feature displays trend data as a histogram.
To turn on the Histogram feature
1. Navigate to a Full Trend screen. See Changing Between Trend Views on page 82.
2. The Histogram icon appears along the top of the Trend Field, as shown in the
following example for SpO2.
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Radical-7 Chapter 4: Operation
3. Touch the Histogram icon.
4. Trend data displays as a histogram.
To turn off the Histogram feature
• Touch the Trends icon, as shown.
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Radical-7 Chapter 4: Operation
Changing Trend Settings
There are several ways to access and then change the maximum value and the minimum
value of the Y axis for any of the available parameters.
To access the trend settings for any of the available parameters
1. From the Main Menu screen, touch the Trends icon.
2. From the Trends screen, touch any of the available parameters.
Alternatively, from any Parameter Settings screen, touch the Trends icon.
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Radical-7 Chapter 4: Operation
Alternatively, from the Display View or from the Full Trend view, touch the Y axis
range on the left side of the screen as shown. When viewing trends for an
additional parameter, the Y axis range appears on the right side of the screen.
To change the trend settings for any of the available parameters
1. Touch the slider for the Y-axis maximum or the Y-axis minimum.The following is
an example of the SpO2 Trend screen.
2. Select the desired setting by scrolling up or down.
3. When finished, select OK.
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Radical-7 Chapter 4: Operation
Deleting Trend Data
The user can delete patient trend data that has been stored on the Radical-7.
To delete patient trend data
1. From the Trends screen, touch the Trend Settings icon.
2. From the Trend Settings screen, touch Clear, and then touch OK. This deletes all
stored trend data.
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Radical-7 Chapter 4: Operation
About
For information about parameters, see About Parameter Information on page 60.
From the About screen, view any of the following options:
Options Description
Serial Number Displays the serial number of the Handheld.
MCU Displays the version number of the instrument board software.
MX Board Displays the version number of the technology level software.
Processor Displays the version number of the system level software.
Docking
If docked, displays the current software version of the Docking Station.
Station
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Chapter 5: Profiles
The Radical-7 can be configured for various patient types.
Profiles Overview
The Radical-7 contains a Profiles screen, which lets the user customize different settings for
different patient populations:
• Adult
Adult profile is the factory default profile. Displays in the Status bar as ADULT and
the color of the Profile button turns blue.
• Neonatal
Displays in the Status bar as NEO and the color of the Profile button turns pink.
• Custom
Displays in the Status bar as CUSTOM and the Profile button is not illuminated
and appears gray.
If no changes are made to settings, then after a power cycle, the Radical-7 automatically
resets to the Adult profile because Adult is the factory default profile.
If the Profile setting is changed to NEO or CUSTOM, then after a power cycle, the Radical-7
remembers the previously selected Profile setting.
The active profile displays in the Status Bar. In the following example, the Adult profile is
active.
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Radical-7 Chapter 5: Profiles
The Radical-7 conveys the active profile by changing the color of the Profiles button.
To restore all Radical-7 settings to factory default settings, see Access Control on page 76.
Changing Profiles
Changing Profiles is done in the Profiles Settings screen. There are different ways to access
the Profiles Settings screen.
• The first way is by the touching the Profiles shortcut in the Status Bar, as show
below.
• Another way to access the Profiles Settings screen is by pressing the Profile button,
as shown below.
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Radical-7 Chapter 5: Profiles
• Alternatively, from the Main Menu screen, touch the Profiles icon.
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Radical-7 Chapter 5: Profiles
To change Patient Type
1. From the Profile screen, touch the Patient Type field.
2. Select the desired Patient Type by scrolling up or down.
3. When finished, touch OK. To confirm selection, check the Status Bar.
From the Profiles screen, change any of the following options:
Options Description Factory
Default
User Configurable
Settings
Settings
Patient Type Defines the patient population
for which the device will operate.
Adult Neonatal, Adult,
Custom, or Custom 1
to 5
Sensitivity
Modes
Defines the sensitivity level for
which the device will operate.
APOD MAX, APOD, or
NORM
See Sensitivity Modes Overview
on page 55.
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Radical-7 Chapter 5: Profiles
Silence
Duration
The amount of time for which the
audible part of an alarm will be
120 30, 60, 90, 120
seconds
silenced. See Silencing the
Alarms on page 99.
Smart Tone Allows the audible pulse to
Off On or Off
continue to beep when the pleth
graph shows signs of motion.
Replacing Factory Default Settings for Adult and Neo Profiles
The Adult profile and the Neonatal profile can be modified to meet specific requirements and
then they can replace the factory default settings for Adult and Neonatal profiles. As such,
after a power cycle, the Radical-7 remembers the preferred settings for Adult and Neonatal
instead of the factory default settings. When preferred settings for Adult and Neonatal are
saved instead of the factory default settings, the Profile button changes to same blue or pink
color. See Profiles Overview on page 93.
A user can also load preferred profile configurations into the Radical-7 using a separate tool.
To change the factory default settings for Adult or Neonatal profile settings
1. Make the preferred changes to any of the Radical-7 settings.
2. Navigate to the Access Control screen. See Access Control on page 76.
3. For either Adult or Neonatal, touch Save.
4. Touch Ok.
5. Alternatively, the user can restore all Profile settings to their factory default values
by touching Restore, and then touching Ok.
6. Confirm the changes by powering off and powering on the Radical-7 and then
verifying settings.
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Radical-7 Chapter 5: Profiles
Powering Off the Radical-7
When turning off the Radical-7, the device remembers the preferred settings.
To turn off the Radical-7
1. Press and hold the button for more than 2 seconds.
2. To confirm the shutdown process, the following screen appears.
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