Masimo Radius-7 User manual

Operator's Manual
Radius-7®Wearable Pulse
CO-Oximeter®

www.masimo.com 1 Masimo
For Sale in the USA
These operating instructions provide the necessary information for proper operation of all
models of the 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.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
E357969
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
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
related Collateral (ANSI/AAMI/IEC 60601-1-8:2006) Standards for which the
product has been found to comply by UL.
Patents: www.masimo.com/patents.htm
®, Masimo®, Pulse CO-Oximeter®, Radius-7®, Root®, Adaptive Probe Off Detection®,
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 2 Masimo
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 3 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

Radius-7 Contents
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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

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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 7 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.

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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 (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index
(PVi®) along with optional measurements of hemoglobin (SpHb®), carboxyhemoglobin
(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.
•SpO2 and pulse rate monitoring in motion and low perfusion environments.
•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.

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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.

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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.

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WARNING: With very low perfusion at the monitored site, the reading may read lower than
core arterial oxygen saturation.
WARNING: If SpO2values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
WARNING: SpO2is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: 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. SpO2, SpHb, SpOC, SpMet, and SpCO)
can be affected by the following:
•Improper sensor application or use of use of incorrect sensor.
•Blood pressure cuff applied to the same arm as the sensor site.
•Intravascular dyes such as indocyanine green or methylene blue.
•Venous congestion.
•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 SpO2readings may be caused by:
•Elevated levels of COHb and/or MetHb.
•Severe anemia.

Radius-7 Safety Information, Warnings and Cautions
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•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.

Radius-7 Safety Information, Warnings and Cautions
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•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

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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 SpO2,
SpHb, SpOC, SpCO, and SpMet readings.
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 (SpO2) and respiration (RRa).
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.

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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:

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•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.