Masimo Radius-7 Operator's Manual
Radius-7
®
Wearable Pulse
CO-Oximeter
Operator's Manual
®
For Sale in the USA
These operating instructions provide the necessary information for proper operation of all
models of the Radius-7. There may be information provided in this manual that is not
relevant for your system. General knowledge of pulse oximetry and an understanding of the
features and functions of Radius-7 are prerequisites for its proper use. Do not operate
Radius-7 without completely reading and understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to
use with replacement parts which would, alone or in combination with this device, fall within
the scope of one of the relating patents.
Note: 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 applicable regulatory authorities, or in any manner inconsistent with the
directions for use or labeling.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See
instructions for use for full prescribing information, including indications, contraindications,
warnings and precautions.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Wireless Radio:
Contains: FCC ID: VKF-MWM1 | Model: Radius-7 | Contains: IC: 7362A-MWM1 | IC Model:
MWM1
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Patents: www.masimo.com/patents.htm
APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, PVi®, rainbow®, rainbow
Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®,
SpMet® are federally registered trademarks of Masimo Corporation.
www.masimo.com 1 Masimo
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
E357969
®, Masimo®, Pulse CO-Oximeter®, Radius-7®, Root®, Adaptive Probe Off Detection®,
related Collateral (ANSI/AAMI/IEC 60601-1-8:2006) Standards for which the
MEDICAL ELECTRICAL EQUIPMENT
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. 60601-1:2008, and
applicable Particular (IEC 60601-2-49:2011, EN/ISO 80601-2-61:2011) and
product has been found to comply by UL.
rainbow Acoustic Monitoring™, RAM™, SpOC™, and X-Cal™ are trademarks of Masimo
Corporation. All other trademarks and registered trademarks are property of their respective
owners.
The use of the trademark Patient SafetyNet™ is under license from University HealthSystem
Consortium.
© 2017 Masimo Corporation
www.masimo.com 2 Masimo
Contents
About this Manual -------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use ----------------------------------------------- 9
Product Description ------------------------------------------------------------------------------------- 9
Indications for Use -------------------------------------------------------------------------------------- 9
Contraindications --------------------------------------------------------------------------------------- 9
Safety Information, Warnings and Cautions ---------------------------------------------------------- 11
Safety Warnings and Cautions ----------------------------------------------------------------------- 11
Performance Warnings and Cautions --------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 17
Compliance Warnings and Cautions ---------------------------------------------------------------- 17
Chapter 1: Technology Overview ------------------------------------------------------------------------ 19
Signal Extraction Technology® (SET®) ------------------------------------------------------------ 19
rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 22
rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------ 26
Chapter 2: System Components ------------------------------------------------------------------------- 29
General System Description -------------------------------------------------------------------------- 29
Radius-7 Instrument Module ------------------------------------------------------------------------ 30
Radius-7 Battery Module ------------------------------------------------------------------------------ 31
Radius-7 Armband ------------------------------------------------------------------------------------- 32
Radius-7 Battery Charging Adapter ---------------------------------------------------------------- 33
Chapter 3: Setting Up------------------------------------------------------------------------------------ 35
Unpacking and Inspection -------------------------------------------------------------------------- 35
Preparation for Use ----------------------------------------------------------------------------------- 35
Charging the Radius-7 Battery Module ------------------------------------------------------------ 36
Connecting Radius-7 to Root via Bluetooth ------------------------------------------------------ 36
Connecting Radius-7 to Patient SafetyNet -------------------------------------------------------- 37
Securing Radius-7 to Patient ------------------------------------------------------------------------- 37
Removing Radius-7 from Patient ------------------------------------------------------------------- 40
Chapter 4: Operation -------------------------------------------------------------------------------------- 41
Using the Touchpad ----------------------------------------------------------------------------------- 41
About the Main Screen -------------------------------------------------------------------------------- 42
www.masimo.com 3 Masimo
Radius-7 Contents
Navigating Radius-7 Main Menu -------------------------------------------------------------------- 42
Navigating Radius-7 Settings on Root ------------------------------------------------------------- 43
Parameter Settings ------------------------------------------------------------------------------------ 46
Trends ---------------------------------------------------------------------------------------------------- 61
Chapter 5: Alarms and Messages ----------------------------------------------------------------------- 63
About Alarms ------------------------------------------------------------------------------------------- 63
3D Alarms ----------------------------------------------------------------------------------------------- 64
Messages ------------------------------------------------------------------------------------------------ 66
Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 71
Troubleshooting Measurements--------------------------------------------------------------------- 71
Troubleshooting Radius-7 ---------------------------------------------------------------------------- 73
Radius-7 Error Codes ---------------------------------------------------------------------------------- 74
Chapter 7: Specifications --------------------------------------------------------------------------------- 75
Measurement Range ---------------------------------------------------------------------------------- 75
Accuracy (ARMS*) ------------------------------------------------------------------------------------- 75
ARMS Performance Specifications ------------------------------------------------------------------ 77
Resolution ---------------------------------------------------------------------------------------------- 80
Electrical------------------------------------------------------------------------------------------------- 81
Environmental ------------------------------------------------------------------------------------------ 81
Physical Characteristics ------------------------------------------------------------------------------ 82
Alarms --------------------------------------------------------------------------------------------------- 82
Display Indicators -------------------------------------------------------------------------------------- 83
EMC Compliance --------------------------------------------------------------------------------------- 83
Safety Standards Compliance ----------------------------------------------------------------------- 83
Wireless Specifications ------------------------------------------------------------------------------- 84
Guidance and Manufacturer's Declaration- Electromagnetic Emissions --------------------- 86
Guidance and Manufacturer's Declaration- Electromagnetic Immunity --------------------- 87
Recommended Separation Distances -------------------------------------------------------------- 89
Symbols------------------------------------------------------------------------------------------------- 90
Citations ------------------------------------------------------------------------------------------------- 92
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 95
Cleaning ------------------------------------------------------------------------------------------------- 95
Battery Operation and Maintenance --------------------------------------------------------------- 95
www.masimo.com 4 Masimo
Radius-7 Contents
Safety Checks ------------------------------------------------------------------------------------------ 96
Repair Policy -------------------------------------------------------------------------------------------- 97
Return Procedure --------------------------------------------------------------------------------------- 97
Contacting Masimo ----------------------------------------------------------------------------------- 98
Appendix: Concepts of Alarm Response Delay ------------------------------------------------------ 101
Concepts of Alarm Response Delay --------------------------------------------------------------- 101
Index ------------------------------------------------------------------------------------------------------- 103
www.masimo.com 5 Masimo
About this Manual
This manual explains how to set up and use the Radius-7® Wearable Pulse CO-Oximeter®.
Important safety information relating to general use of the Radius-7
appears in this manual.
Read and follow any warnings, cautions, and notes presented throughout this manual. The
following are explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
www.masimo.com 7 Masimo
Product Description, Features and Indications for Use
Product Description
The Radius-7® Wearable Pulse CO-Oximeter® is a noninvasive device that measures arterial
oxygen saturation (SpO
(PVi®) along with optional measurements of hemoglobin (SpHb®), carboxyhemoglobin
, pulse rate (PR), perfusion index (Pi), and Pleth Variability Index
2)
(SpCO®), total oxygen content (SpOC™), methemoglobin (SpMet®), and Acoustic Respiration
Rate (RRa®).
The following key features are available for the Radius-7:
• Patient wearable device for continuous monitoring when the patient is
ambulatory.
• Bluetooth radio for transfer of parameter data to the Root patient monitoring and
connectivity platform.
• Optional Wi-Fi for direct communication throughout the hospital to the Patient
SafetyNet™ remote monitoring system.
• Masimo SET® and rainbow® SET technology performance.
• SpO
and pulse rate monitoring in motion and low perfusion environments.
2
• Continuous and noninvasive monitoring of carboxyhemoglobin (SpCO),
methemoglobin (SpMet), and total hemoglobin (SpHb).
• Respiration Rate (RR) is measured by acoustic signal (RRa).
Indications for Use
The Masimo Radius-7® Wearable Pulse CO-Oximeter® and Accessories are indicated for the
continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation
(SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo
Radius-7® Wearable Pulse CO-Oximeter® and accessories are indicated for use with adult
and pediatric patients during both no motion and motion conditions, and for patients who
are well or poorly perfused in hospitals and hospital-type facilities.
Contraindications
There are no contraindications.
www.masimo.com 9 Masimo
Safety Information, Warnings and Cautions
CAUTION: Radius-7 is to be operated by, or under the supervision of, qualified personnel only.
Read the manual, accessories, directions for use, all precautionary information, and
specifications should be read before use. Refer to the Operator’s Manual for Root for
additional safety information, warnings, and cautions.
Safety Warnings and Cautions
WARNING: Do not use Radius-7 if it appears or is suspected to be damaged.
WARNING: Always use Radius-7 in conjunction with Root. Do not use parts from other
systems. Injury to personnel or equipment damage could occur.
WARNING: Do not adjust, repair, open, disassemble, or modify the Radius-7. Damage to the
device may result in degraded performance and/or patient injury.
WARNING: Do not start or operate the Radius-7 unless the setup was verified to be correct.
Improper set-up of this device may result in degraded performance and/or patient injury.
WARNING: Only use Masimo authorized devices with Radius-7. Using unauthorized devices
with Radius-7 may result in damage to the device and/or patient injury.
WARNING: All sensors and cables are designed for use with specific devices. Verify the
compatibility of the device, cable, and sensor before use; otherwise degraded performance
and/or patient injury can result.
WARNING: Do not use the Radius-7 in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous
oxide to avoid risk of explosion.
WARNING: Do not use the Radius-7 during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Radius-7 may be used during defibrillation. However, to reduce the risk of electric
shock, the operator should not touch the Radius-7 during defibrillation.
WARNING: Electrical Shock Hazard: To protect against injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Do not attempt to sterilize the device.
• Use cleaning solutions only as instructed in this Operator's Manual.
• Do not attempt to clean the Radius-7 while monitoring patient.
WARNING: To ensure safety, avoid placing anything on the device during operation.
WARNING: As with all medical equipment, carefully route patient cables to reduce the
possibility of patient entanglement or strangulation.
WARNING: The Armband site must be checked frequently or per clinical protocol to ensure
adequate securement, circulation and skin integrity.
www.masimo.com 11 Masimo
Radius-7 Safety Information, Warnings and Cautions
WARNING: Armbands applied too tightly or that become tight due to edema will cause
inaccurate readings and can cause pressure injury.
WARNING: Discontinue and dispose of Armband if it appears to be stained or becomes
excessively moist to minimize risk of skin irritation.
CAUTION: Electrical Shock Hazard: Do not place the Battery Charging Adapter of Radius-7 on
or near the patient. Injury to patient could occur.
Note: Use and store the Radius-7 in accordance with specifications. See the Specifications
section in this manual.
Performance Warnings and Cautions
General
WARNING: Radius-7 should not be used as the sole basis for medical decisions. It must be
used in conjunction with clinical signs and symptoms.
WARNING: The Radius-7 and Accessories are not intended to be used as the sole basis for
making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it
is intended to be used in conjunction with additional methods of assessing clinical signs and
symptoms.
WARNING: If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Radius-7 for proper functioning.
WARNING: Variation in hemoglobin measurements may be profound and may be affected by
sample type, body positioning, as well as other physiological conditions. As with most
hemoglobin data, Radius-7 trend data should be scrutinized in light of a specific patient
condition. Any results exhibiting inconsistency with the patient's clinical status should be
repeated and/or supplemented with additional data.
WARNING: Radius-7 is not an apnea monitor.
WARNING: Radius-7 should not be used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING: Radius-7 may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
WARNING: Do not use during electrocautery. This may affect the accuracy or availability of
the parameters and measurements.
WARNING: When the Radius-7 is connected to Root, all audible alarms will be provided on
the Root.
WARNING: Always pair Radius-7 with Root.
WARNING: Avoid placing Radius-7 against a surface that may cause the alarm to be muffled.
This may result in the inability to detect the audible alarms.
WARNING: Properly apply sensors according to the sensor’s directions for use. Misapplied
sensor or sensors that become partially dislodged may cause no or incorrect readings.
WARNING: Display parameter may not be accurate when a low SIQ message is provided.
Clinicians should consider additional information to supplement values to completely
understand the patient’s condition.
www.masimo.com 12 Masimo
Radius-7 Safety Information, Warnings and Cautions
WARNING: With very low perfusion at the monitored site, the reading may read lower than
core arterial oxygen saturation.
WARNING: If SpO
confirm the patient’s condition.
WARNING: SpO
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
values indicate hypoxemia, a laboratory blood sample should be taken to
2
is empirically calibrated in healthy adult volunteers with normal levels of
2
WARNING: Variation in hemoglobin measurements may be profound and may be affected by
sample type, body positioning, as well as other physiological conditions. As with most
hemoglobin data, Radius-7 trend data should be scrutinized in light of a specific patient
condition. Any results exhibiting inconsistency with the patient's clinical status should be
repeated and/or supplemented with additional data.
WARNING: The Radius-7 should be considered an early warning instrument. Blood samples
should be analyzed by laboratory instruments to completely understand the patient's
condition prior to making clinical decision.
WARNING: SpHb measurements in the ranges of 0 to 8g/dL and 17 to 25 g/dL are provided
for reference information only. The monitor shall display Low SpHb SIQ message along with
the SpHb measurement whenever the measurement is displayed in these ranges.
Furthermore, the display window also changes color providing a visual alarm to alert the user
that the SpHb values are either in the 0 to 8g/dL or 17 to 25 g/dL ranges. Clinicians should
consider additional information to supplement SpHb values, including laboratory diagnostic
tests using blood samples, to completely understand the patient’s condition.
WARNING: Optical, pleth-based measurements (e.g. SpO
can be affected by the following:
, SpHb, SpOC, SpMet, and SpCO)
2
• Improper sensor application or use of use of incorrect sensor.
• Blood pressure cuff applied to the same arm as the sensor site.
• Intravascular dyes such as indocyanine green or methylene blue.
• Venous congestion.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg
position).
• Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
• Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
• Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or
foreign objects in the light path.
• Elevated levels of bilirubin.
• Physiological conditions that can significantly shift the oxygen disassociation
curve.
• A physiological condition that may effect vasomotor tone or changes in vasomotor
tone.
WARNING: Inaccurate SpO
readings may be caused by:
2
• Elevated levels of COHb and/or MetHb.
• Severe anemia.
www.masimo.com 13 Masimo
Radius-7 Safety Information, Warnings and Cautions
• Extremely low arterial perfusion.
• Excessive induced motion.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (Quantitative defects such as Thalassemias).
WARNING: Inaccurate SpHb and SpOC readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Low arterial oxygen saturation levels.
• Elevated COHb and/or MetHb levels.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Severe anemia.
WARNING: Inaccurate SpCO readings may be caused by:
• Elevated methemoglobin levels in the range of >15%.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Extremely elevated hemoglobin levels.
• Low arterial perfusion.
• Low arterial oxygen saturation levels including altitude induced hypoxemia.
• Motion induced artifact.
• Severe anemia.
WARNING: SpCO readings may not be provided if there are Low arterial oxygen saturation
levels or elevated methemoglobin levels.
WARNING: Inaccurate SpMet readings may be caused by:
• Elevated carboxyhemoglobin levels in the range of >3%.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin
synthesis disorders (quantitative defects such as Thalassemias).
• Extremely elevated hemoglobin levels.
• Low arterial perfusion.
• Low arterial oxygen saturation levels including altitude induced hypoxemia.
• Motion induced artifact.
• Physiological conditions that can significantly shift the oxygen disassociation
curve.
• Severe anemia.
WARNING: Inaccurate RRa measurements may be caused by:
• Improper sensor application or use of use of incorrect sensor.
www.masimo.com 14 Masimo
Radius-7 Safety Information, Warnings and Cautions
• Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. Cardiac arrhythmias, intra-aortic balloon, etc.).
• Motion artifact.
• Excessive ambient or environmental noise.
CAUTION: Do not place the Radius-7 near electrical equipment that may affect the device,
preventing it from working properly.
CAUTION: Failure to charge Radius-7 promptly after a Low Battery alarm may result in the
device shutting down.
CAUTION: If using Radius-7 during full body irradiation, keep the sensor out of the radiation
field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device
might read zero for the duration of the active irradiation period.
CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to
light sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy.
CAUTION: High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
can interfere with the performance of the sensor.
CAUTION: To prevent interference from ambient light, ensure that the sensor is properly
applied, and cover the sensor site with opaque material, if required. Failure to take this
precaution in high ambient light conditions may result in inaccurate measurements.
CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused
monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status
through other means.
CAUTION: To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to Radius-7.
CAUTION: In order to maintain Bluetooth connectivity with Root, ensure that the Radius-7 is
within approximately 7 m radius and line of sight of Root.
CAUTION: When using Radius-7 in Wi-Fi mode, be aware of the patient's location. Alarms
relayed to Patient SafetyNet will not provide patient location.
CAUTION: When using multiple Radius-7 and Root systems, re-dock the Battery Module to
Root to ensure proper pairing before connecting the Radius-7 to the patient.
CAUTION: If the Radius-7 and Root become unable to communicate, parameters and
measurements will not show on the Root; however, this will not affect Radius-7's ability to
monitor the patient.
CAUTION: In order to establish and maintain Radius-7’s minimum Quality of Service, the
following network specifications should be met before and after installation:
• Wireless Network Connection
During Ping Test, passing result if:
a. At least 98% of packets have latency ≤ 100 milliseconds,
b. No more than 2 % packets loss, and
c. Primary access point signal strength at least -67 dBm.
CAUTION: The wireless quality of services may be influenced by the presence of other devices
that may create radio frequency interference (RFI). Some RFI devices to consider are as
www.masimo.com 15 Masimo
Radius-7 Safety Information, Warnings and Cautions
follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID,
MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices,
consideration should be taken to maximize separation distances and to observe for any
potential signs of interference such as loss of communication or reduced Wi-Fi signal
strength.
CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time Radius-7 is used.
CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing the low SIQ
troubleshooting steps listed in the troubleshooting section.
Note: Cables and sensors are provided with X-Cal™ technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or
Sensor DFU for the specified duration of patient monitoring time.
Note: SpHb readings may be inaccurate for patients with conditions that may cause edema
at the measurement site (eg. kidney disease, pregnancy, etc.).
Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO
SpHb, SpOC, SpCO, and SpMet readings.
,
2
Note: Radius-7 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi
communication.
Note: Radius-7’s alarm capabilities have been designed to be independent of the Wi-Fi
communication feature in order to preserve Radius-7’s primary alarms.
Note: When the Radius-7 is connected directly via Wi-Fi to Patient SafetyNet, the Radius-7
will provide audible alarms.
Note: Before securing Radius-7 onto the patient, make sure the Battery Module is sufficiently
charged.
Note: Always charge Radius-7 when it is not in use to ensure that the Radius-7 Battery
Module remains fully charged.
Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will
vary depending upon the age of the Battery Module.
Note: The Radius-7 display enters standby mode after 30s of inactivity. The Radius-7 display
entering standby mode does not affect the monitoring of the patient.
Note: A functional tester cannot be used to assess the accuracy of Radius-7.
Note: When monitoring acoustic respiration, Masimo recommends minimally monitoring
both oxygenation (SpO
) and respiration (RRa).
2
Note: When using Radius-7 in the Maximum Sensitivity setting, performance of the "Sensor
Off" detection may be compromised. If the sensor becomes dislodged from the patient in this
setting, false readings may occur due to environmental "noise" such as light, vibration, and
excessive air movement.
Patient SafetyNet
Note: The wireless communication status between Radius-7 and Patient SafetyNet is
displayed by Patient SafetyNet.
www.masimo.com 16 Masimo
Radius-7 Safety Information, Warnings and Cautions
Cleaning and Service Warnings and Cautions
WARNING: Do not attempt to remanufacture, recondition or recycle the Radius-7 as these
processes may damage the electrical components, potentially leading to patient harm.
WARNING: To avoid electric shock, do not attempt to service the Radius-7 or the Battery
Module. Servicing of the Radius-7 should be done by qualified personnel only.
CAUTION: Only perform maintenance procedures specifically described in the manual.
Otherwise, return the Radius-7 for servicing.
CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds,
instruments, brushes, rough-surface materials, or bring them into contact with anything that
could scratch the display.
CAUTION: To avoid electric shock, always turn off the Radius-7 and physically disconnect it
from Root before cleaning Radius-7.
CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
the Radius-7. These substances affect the device’s materials and device failure can result.
CAUTION: Do not submerge the Radius-7 in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the device.
CAUTION: To prevent damage, do not soak or immerse Radius-7 in any liquid solution.
Compliance Warnings and Cautions
WARNING: Any changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
WARNING: 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.
CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its
accessories.
CAUTION: Dispose of used batteries according to required country or regional requirements.
Note: Use Radius-7 in accordance with the Environmental Specifications section in the
Operator's Manual.
Note: This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user
is encouraged to try to correct the interference by one or more of the following measures:
www.masimo.com 17 Masimo
Radius-7 Safety Information, Warnings and Cautions
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Note: This equipment has been tested and found to comply with the Class B limits for
medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in all
establishments, including domestic establishments.
Note: This Class B digital apparatus complies with Canadian ICES-003.
Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
www.masimo.com 18 Masimo
Chapter 1: Technology Overview
The following chapter contains general descriptions about parameters, measurements, and
the technology used by Masimo products.
Signal Extraction Technology® (SET®)
Masimo Signal Extraction Technology's signal processing differs from that of conventional
pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood
moving (pulsating) in the measurement site. During patient motion, however, the venous
blood also moves, causing conventional pulse oximeters to read low values, because they
cannot distinguish between the arterial and venous blood movement (sometimes referred to
as noise).
Masimo SET pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters
are powerful because they are able to adapt to the varying physiologic signals and/or noise
and separate them by looking at the whole signal and breaking it down to its fundamental
components. The Masimo SET signal processing algorithm, Discrete Saturation Transform®
(DST®), in parallel with Fast Saturation Transform (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.
www.masimo.com 19 Masimo
Radius-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:
• Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated
blood) differ in their absorption of red and infrared light (spectrophotometry).
• The amount of arterial blood in tissue changes with your pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying
quantities of arterial blood changes as well.
Successful Monitoring for SpO2, PR and Pi
Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is
a relative term, experience will provide a good feeling for changes that are artifactual or
physiological and the speed, timing, and behavior of each.
The stability of the readings over time is affected by the averaging time 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 (SpO2)
The Radius-7 is calibrated to measure and display functional oxygen saturation (SpO2): the
amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to
transport oxygen.
Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as
oxygenated hemoglobins by conventional pulse oximetry.
www.masimo.com 20 Masimo
Radius-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%).
PVi may show changes that reflect physiological factors such as vascular tone, circulating
blood volume, and intrathoracic pressure excursions.
The utility of PVi has been evaluated in clinical studies [1-11]. Technical and clinical factors
that may affect PVi include probe malposition, probe site, patient motion, skin incision,
spontaneous breathing activity, lung compliance, open pericardium, use of vasopressors or
vasodilators, low perfusion index, subject age, arrhythmias, left or right heart failure, and tidal
volume [12-14].
Citations for Pleth Variability Index (PVi)
1. Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot J.J.
Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter
Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the
Operating Theatre. Br J Anaesth. 2008 Aug;101(2):200-6.
2. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse
Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid
Management. Anesth Analg. 2010 Oct;111(4):910-4.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C.
Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to
Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major
Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. Anesth Analg. The
Ability of Pleth Variability Index to Predict the Hemodynamic Effects of Positive
End-Expiratory Pressure in Mechanically Ventilated Patients under General
Anesthesia. 2010 Mar 1;110(3):792-8.
5. Tsuchiya M., Yamada T., Asada A. Pleth Variability Index Predicts Hypotension
During Anesthesia Induction. Acta Anesthesiol Scand. 2010 May;54(5):596-602.
6. Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene
B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid
Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9.
www.masimo.com 21 Masimo
Radius-7 Chapter 1: Technology Overview
7. Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to
Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors in
Hans Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
8. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J.
Prediction of Volume Responsiveness using Pleth Variability Index in Patients
Undergoing Cardiac Surgery after Cardiopulmonary Bypass. Anesth. 2012
Oct;26(5):696-701.
9. Byon H.J., Lim C.W., Lee J.H., Park Y. H., Kim H.S., Kim C.S., Kim J.T. Br. J.
Prediction of fluid Responsiveness in Mechanically Ventilated Children Undergoing
Neurosurgery. Anaesth 2013 Apr;110(4):586-91.
10. Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP.
Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated
Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot
Study. J Crit Care. 2013 Oct;28(5):634-9.
11. Yu Y., Dong J., Xu Z., Shen H., Zheng J. Pleth Variability Index-Directed Fluid
Management in Abdominal Surgery under Combined General and Epidural
Anesthesia. J Clin Monit Comput. 2014 Feb 21.
12. Desgranges F.P., Desebbe O., Ghazouani A., Gilbert K., Keller G., Chiari P., Robin
J.,Bastien O., Lehot J.J., Cannesson M. Br. J. Anaesth 2011 Sep;107(3):329-35.
13. Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J
Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97.
14. Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y.
Impact of Skin Incision on the Pleth Variability Index. J Clin Monit Comput 2011
Aug;25(4):215-21.
Signal IQ
The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO2
value. The SpO
SIQ can also be used to identify the occurrence of a patient’s pulse.
2
With motion, the plethysmographic waveform is often distorted and may be obscured by
noise artifact. Shown as a vertical line, the SpO
pulsation. Even with a plethysmographic waveform obscured by artifact, the Signal IQ
SIQ coincides with the peak of an arterial
2
identifies the timing that the algorithms have determined for the arterial pulsation. The
pulse tone (when enabled) coincides with the vertical line of the SpO
SIQ.
2
The height of the vertical line of the SpO2 SIQ provides an assessment of the confidence in
the measurement displayed. A high vertical bar indicates higher confidence in the
measurement. A small vertical bar indicates lower confidence in the displayed measurement.
When the Signal IQ is very low, this suggests that the accuracy of the displayed measurement
may be compromised. See About the Main Screen on page 42.
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).
www.masimo.com 22 Masimo
Radius-7 Chapter 1: Technology Overview
2. The amount of arterial blood in tissue changes with pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying
quantities of arterial blood changes as well.
The Radius-7 uses a multi-wavelength sensor to distinguish between oxygenated blood,
deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma.
The Radius-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 Radius-7 for calculation.
1. Light Emitting Diodes (LEDs)
(7 + wavelengths)
2. Detector
www.masimo.com 23 Masimo
Radius-7 Chapter 1: Technology Overview
Once Radius-7 receives the signal from the sensor, it utilizes proprietary algorithms to
calculate the patient’s functional oxygen saturation (SpO
carboxyhemoglobin saturation (SpCO [%]), methemoglobin saturation (SpMet [%]), total
[%]), blood levels of
2
hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb
measurements rely on a multi-wavelength calibration equation to quantify the percentage of
carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial
blood. Maximum skin-sensor interface temperature was tested to be less than 41º C (106º F)
in a minimum ambient temperature of 35º C (95º F). The tests were conducted with sensors
operating at reasonable worst case power.
Pulse CO-Oximetry vs. Drawn Whole Blood Measurements
When SpO2, SpCO, SpMet, and SpHb measurements obtained from the Radius-7
(noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas
and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and
interpreting the results.
The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO
SpMet, SpHb, and SpOC measurements of the Radius-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 SpO
the calculated measurement is not appropriately corrected for the effects of variables that
, different results are usually obtained from the arterial blood gas sample if
2
shift the relationship between the partial pressure of oxygen (pO2) and saturation, such as:
pH, temperature, the partial pressure of carbon dioxide (pCO
hemoglobin.
), 2,3-DPG, and fetal
2
In the case of SpCO, different results are also expected if the level of methemoglobin (MetHb)
in the blood gas sample is abnormal (greater than 2% for MetHb).
In the case of SpHb, variation in hemoglobin measurements may be profound and may be
affected by sampling technique as well as the patient's physiological conditions. Any results
exhibiting inconsistency with the patient's clinical status should be repeated and/or
supplemented with additional test data. As with most hemoglobin tests, a laboratory blood
sample should be analyzed prior to clinical decision making.
High levels of bilirubin may cause erroneous SpO
samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a
, SpMet, SpCO, and SpHb readings. As blood
2
meaningful comparison can only be achieved if the oxygen saturation (SaO2), levels of
carboxyhemoglobin (COHb), and MetHb of the patient are stable and not changing over the
period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory
CO-Oximetry measurements of SpO
administration of fluids and in procedures such as dialysis. Additionally, drawn whole blood
, SpCO, SpMet, SpHb, and SpOC may vary with the rapid
2
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.
, SpCO,
2
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.
www.masimo.com 24 Masimo
Radius-7 Chapter 1: Technology Overview
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 71.
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 O
*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.
/g) x SpHb (g/dL) x SpO2 + 0.3 (ml O2/dL)
2
General Description for Carboxyhemoglobin (SpCO)
Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of
carboxyhemoglobin saturation (SpCO) in arterial blood. It relies on the same basic principles
of pulse oximetry (spectrophotometry) to make its SpCO measurement.
The measurement is obtained by placing a sensor on a patient, usually on the fingertip for
adults and the hand or foot for infants. The sensor connects either directly to the Pulse
CO-Oximetry device or through a device patient cable.
The sensor collects signal data from the patient and sends it to the device. The device
displays the calculated data as percentage value for the SpCO, which reflect blood levels of
carbon monoxide bound to hemoglobin.
Successful Monitoring for SpCO
A stable SpCO reading is associated with correct sensor placement, small physiological
changes during the measurement and acceptable levels of arterial perfusion in the patient's
fingertip (measurement site). Physiological changes at the measurement site are mainly
caused by fluctuations in the oxygen saturation, blood concentration and perfusion.
General Description for Methemoglobin (SpMet)
Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of
methemoglobin saturation (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 device or through a patient cable.
www.masimo.com 25 Masimo
Radius-7 Chapter 1: Technology Overview
The sensor collects signal data from the patient and sends it to the device. The device
displays the calculated data as percentage value for the SpMet.
Successful Monitoring for SpMet
A stable SpMet reading is associated with correct sensor placement, small physiological
changes during the measurement and acceptable levels of arterial perfusion in the patient’s
fingertip (measurement site).
Physiological changes at the measurement site are mainly caused by fluctuations in the
oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings and
Cautions on page 11.
SpCO, SpMet, and SpHb Measurements During Patient Motion
The Radius-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 device does not have
confidence in the value due to poor signal quality caused by excessive motion or other signal
interference.
rainbow Acoustic Monitoring™ (RAM™)
rainbow Acoustic Monitoring (RAM) continuously measures a patient’s respiration rate based
on airflow sounds generated in the upper airway. The Acoustic Sensor, which is applied on the
patient's neck, translates airflow sounds generated in the upper airway to an electrical signal
that 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.
www.masimo.com 26 Masimo
Radius-7 Chapter 1: Technology Overview
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
Signal
Processing
Digital signal to respiratory
measurement
Sensor
Sound to
electrical signal
Envelope
Detection
Acquisition System
Electrical signal to
digital signal
RRa Estimation
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.
www.masimo.com 27 Masimo
Radius-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.
Citations
[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.
www.masimo.com 28 Masimo
Loading...