Masimo Radical-7 User manual

Radical-7
Operator's Manual

www.masimo.com 1 Masimo
This Operator’s Manual presents Masimo features and/or products that
are marketed outside of the United States (OUS). It is not intended for
use in the United States.
These operating instructions provide the necessary information for proper
operation of all models of the Radical-7® Pulse CO-Oximeter®. There
may be information provided in this manual that is not relevant for your
system. General knowledge of pulse oximetry and an understanding of
the features and functions of Radical-7 are prerequisites for its proper
use. Do not operate Radical-7 without completely reading and
understanding these instructions.
Notice: Purchase or possession of this device does not carry any express
or implied license to use with replacement parts which would, alone or in
combination with this device, fall within the scope of one of the relating
patents.
Caution: Use of this device must follow the order of a physician.
For professional use. See instructions for Use for full prescribing
information, including indications, contraindications, warnings,
precautions, and adverse events.
Wireless Radio
FCC ID: VKF-RAD7CA or VKF-RAD7A or VKF-RAD7B | IC ID: 7362A-
RAD7CA or 7362A-RAD7A or 7362A-RAD7B
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com

www.masimo.com 2 Masimo
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Authorized Brazil Company Representative:
MEDSTAR IMPORT AND EXPORT EIRELI
R VALENCIO SOARES RODRIGUES, 89- ROOM 1
CEP: 06.730-000
NEIGHBORHOOD: CENTER
MUNICIPALITY: VARGEM GRANDE PAULISTA
UF: SP
Medical electrical equipment
with respect to electric shock, fire and mechanical hazards only
in accordance with
UL 60601-1/CAN/CSA C22.2 No. 601.1
Patents:
www.masimo.com/patents.htm
, Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation
Transform, DST, FastSat, FST, Masimo, Pulse CO-Oximeter, PVI, Radical-7,
Root, rainbow, rainbow Acoustic Monitoring, RAM, rainbow Resposable,
RDS, RRa, RRp, SatShare, SedLine, SET, Signal Extraction Technology,
Signal IQ, SpCO, SpHb, and SpMet are federally registered trademarks of
Masimo Corporation.
3D Desat Index Alarm, In Vivo Adjustment, ORI, SpfO2, SpOC and SST are
trademarks of Masimo Corporation. All other trademarks and registered
trademarks are property of their respective owners.
The use of the trademarks PATIENT SAFETYNET and PSN is under license
from University HealthSystem Consortium.

www.masimo.com 3 Masimo
© 20182019Masimo Corporation

www.masimo.com 5 Masimo
Contents
About this Manual---------------------------------------------------------11
Product Description -------------------------------------------------------11
Key Features ------------------------------------------------------------12
Indications for Use --------------------------------------------------------13
Contraindications ----------------------------------------------------------14
Warnings and Cautions----------------------------------------------------15
Safety Warnings and Cautions------------------------------------------15
Performance Warnings and Cautions-----------------------------------17
Cleaning and Service Warnings and Cautions --------------------------25
Compliance Warnings and Cautions------------------------------------27
Chapter 1: Technology Overview------------------------------------------31
Signal Extraction Technology (SET) -------------------------------------31
rainbow Pulse CO-Oximetry Technology® -----------------------------34
rainbow Acoustic Monitoring (RAM) Technology ----------------------42
Chapter 2: Radical-7 Descriptions -----------------------------------------47
General System Description --------------------------------------------47
Functionality of the Radical-7-------------------------------------------47
Handheld----------------------------------------------------------------49
Standalone --------------------------------------------------------------53
Monitor Interface With SatShare ---------------------------------------58

Radical-7 Contents
www.masimo.com 6 Masimo
Chapter 3: Setup ---------------------------------------------------------- 59
Unpacking and Inspection---------------------------------------------- 59
Docking Station Power Requirements---------------------------------- 59
Setting Up the Docking Station ---------------------------------------- 60
Initial Battery Charging ------------------------------------------------- 60
Setting Up for Philips, Agilent, or HP VueLink ------------------------- 61
Setting Up for SpaceLabs Flexport ------------------------------------- 62
Setting Up and Using SatShare ---------------------------------------- 62
Chapter 4: Operation------------------------------------------------------ 65
Using the Touchscreen and Buttons ----------------------------------- 66
Using Screen Lock ------------------------------------------------------ 67
Using the Home Button ------------------------------------------------ 68
Standby and Power Off------------------------------------------------- 68
Navigating the Radical-7 ----------------------------------------------- 69
About the Display View ------------------------------------------------ 70
Sensitivity Modes Overview -------------------------------------------- 81
Changing Sensitivity Modes -------------------------------------------- 82
Accessing the Main Menu ---------------------------------------------- 84
Navigating the Main Menu--------------------------------------------- 84
Parameter Settings ----------------------------------------------------- 87
Chapter 5: Profiles--------------------------------------------------------145

Radical-7 Contents
www.masimo.com 7 Masimo
Profiles Overview------------------------------------------------------ 145
Changing Profiles ----------------------------------------------------- 146
Replacing Factory Default Settings for Adult and Neo Profiles ------ 150
Powering Off the Radical-7 ------------------------------------------- 151
Chapter 6: Alarms and Messages --------------------------------------- 153
About Alarms --------------------------------------------------------- 153
Silencing the Alarms -------------------------------------------------- 153
Adaptive Threshold alarm (ATA) Feature ----------------------------- 156
3D Alarms------------------------------------------------------------- 157
Messages-------------------------------------------------------------- 161
Chapter 7: Troubleshooting --------------------------------------------- 171
Troubleshooting Measurements -------------------------------------- 171
Troubleshooting the Radical-7---------------------------------------- 175
Chapter 8: Specifications ------------------------------------------------ 177
Measurement Range-------------------------------------------------- 177
Accuracy (ARMS)------------------------------------------------------ 178
Resolution------------------------------------------------------------- 179
Electrical--------------------------------------------------------------- 180
Environmental--------------------------------------------------------- 181
Physical Characteristics ----------------------------------------------- 181
Alarms----------------------------------------------------------------- 182

Radical-7 Contents
www.masimo.com 8 Masimo
Display Indicators------------------------------------------------------183
Compliance ------------------------------------------------------------183
Output Interface -------------------------------------------------------185
Serial Interface Specifications------------------------------------------186
Serial Interface Setup--------------------------------------------------186
Analog Output and Nurse Call Specifications-------------------------188
Symbols----------------------------------------------------------------190
Citations ---------------------------------------------------------------192
Chapter 9: Service and Maintenance-------------------------------------195
Cleaning ---------------------------------------------------------------195
Battery Operation and Maintenance ----------------------------------196
Performance Verification ----------------------------------------------200
Repair Policy -----------------------------------------------------------203
Return Procedure------------------------------------------------------204
Contacting Masimo----------------------------------------------------204
Appendix -----------------------------------------------------------------209
Concepts of Alarm Response Delay -----------------------------------209
Guidance and Manufacturer's Declaration- Electromagnetic Emissions
-------------------------------------------------------------------------210
Manufacturer's Declaration-Electromagnetic Immunity ---------------212
Recommended Separation Distances----------------------------------217

Radical-7 Contents
www.masimo.com 9 Masimo
Index--------------------------------------------------------------------- 219

www.masimo.com 11 Masimo
About this Manual
This manual explains how to set up and use the Radical-7® Pulse CO-
Oximeter®. Important safety information relating to general use of the
Radical-7 appears in this manual. Read and follow any warnings, cautions,
and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A
warning is given when actions may result in a serious outcome (for
example, injury, serious adverse effect, death) to the patient or user. The
following is an example of a warning:
Warning: This is a sample of a warning statement.
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. The following is an example of a caution:
Caution: This is a sample of a caution statement.
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.
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®), Oxygen Reserve Index (ORI™), Acoustic
Respiration Rate (RRa®), and Pleth Respiration Rate (RRp).

Radical-7 Product Description
www.masimo.com 12 Masimo
The Radical-7 can be used as either a Handheld or a Standalone monitor.
The Radical-7 features a touchscreen that continuously displays numeric
values for all parameters.
The Radical-7 provides graphical displays for plethysmographic waveform,
respiratory waveform, Signal Identification and Quality Indicator (Signal
IQ®).
The Radical-7 can also be used to interface with a multi-parameter
patient monitor to send Masimo SET® pulse oximetry information to that
monitor for display.
The Radical-7 has an embedded 802.11 wireless radio that can be used
for connectivity.
Key Features
The following features are available for the Radical-7. Some features are
optional:
•Masimo SET® technology is clinically proven to satisfy all
sensitivity and specificity requirements for pulse oximetry.
•Masimo rainbow® technology uses 7+ wavelengths of light to
continuously and noninvasively measure carboxyhemoglobin
(SpCO), methemoglobin (SpMet), and total hemoglobin (SpHb®),
as well as providing a more reliable probe-off detection.
•Total oxygen content (SpOC) provides a calculated measurement
of the amount of oxygen in arterial blood, which may provide
useful information about oxygen both dissolved in plasma and
combined with hemoglobin.
•Perfusion Index (PI) with trending capability indicates arterial
pulse signal strength and may be used as a diagnostic tool
during low perfusion.

Radical-7 Indications for Use
www.masimo.com 13 Masimo
•Pleth Variability Index (PVI) may show changes that reflect
physiologic factors such as vascular tone, circulating blood
volume, and intrathoracic pressure excursions. [The utility of PVI
is unknown at this time and requires further clinical studies.
Technical factors that may affect PVI include probe malposition
and patient motion.]
•Oxygen Reserve Index (ORI) is an index to measure changes in
oxygen states under hyperoxic conditions.
•Respiration rate can be determined by the acoustic (RRa) or
plethysmographic waveform (RRp).
•Signal IQ waveform for signal identification and quality indication
during excessive motion and low signal to noise situations.
•FastSat® tracks rapid changes in arterial O2.
•Variable pitch provides tonal variance for every 1% change in
saturation.
•SatShare® interface allows transfer of SpO2and 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

Radical-7 Contraindications
www.masimo.com 14 Masimo
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
Radical-7 is not intended for use as an apnea monitor.

www.masimo.com 15 Masimo
Warnings and Cautions
Caution: Radical-7 is to be operated by, or under the supervision of,
qualified personnel only. The manual, accessories, directions for use, all
precautionary information, and specifications should be read before use.
Safety Warnings and Cautions
Warning: Do not use the Radical-7 if it appears or is suspected to be
damaged.
Warning: Do not start or operate Radical-7 unless the setup was verified
to be correct.
Warning: Do not use Radical-7 during magnetic resonance imaging (MRI)
or in an MRI environment.
Warning: Explosion hazard: Do not use the Radical-7 in the presence of
flammable anesthetics or other flammable substance in combination with
air, oxygen-enriched environments, or nitrous oxide.
Warning: Do not place the Radical-7 or accessories in any position that
might cause it to fall on the patient.
Warning: When positioned on a flat surface, the device should be
secured with a mounting system recommended by Masimo.
Warning: To ensure safety, avoid stacking multiple devices or placing
anything on the device during operation.
Warning: To reduce the risk of explosion, only replace battery with
Masimo supplied parts.
Warning: To protect against injury, follow the directions below:
•Avoid placing the device on surfaces with visible liquid spills.
•Do not soak or immerse the device in liquids.

Radical-7 Warnings and Cautions
www.masimo.com 16 Masimo
•Do not attempt to sterilize the device.
•Use cleaning solutions only as instructed in this operator's
manual.
•Do not attempt to clean Radical-7 while monitoring patient.
Warning: To protect from electric shock, always remove the sensor and
completely disconnect Radical-7 before bathing the patient.
Warning: As with all medical equipment, carefully route patient cabling
to reduce the possibility of patient entanglement or strangulation.
Caution: Do not place the Radical-7 where the controls can be changed
by the patient.
Caution: When patients are undergoing photodynamic therapy they may
be sensitive to light sources. Pulse oximetry may be used only under
careful clinical supervision for short time periods to minimize interference
with photodynamic therapy.
Caution: Electric shock hazard: Do not open the Radical-7 cover except to
replace the battery or batteries.
Caution: Electrical shock and flammability hazard: Before cleaning, always
turn off the device and disconnect from any power source.
Caution: To ensure patient electrical isolation, only dock to Masimo
devices that have been designed for Radical-7.
Caution: Use a grounded outlet for proper equipment grounding. A
hospital-grade outlet is required.
Caution: Do not place Radical-7 where the appliance inlet or the AC
power plug cannot be readily disconnected.
Caution: To avoid risk of electrical shock, this equipment must only be
connected to a supply mains with a protective earth connection. Do not

Radical-7 Warnings and Cautions
www.masimo.com 17 Masimo
under any circumstances remove the grounding conductor from the
power plug.
Caution: Only use the AC power cable provided by Masimo. Using a
different AC power cable could cause damage to Radical Docking Station.
Check the power cord and plug to ensure that it is intact and
undamaged.
Caution: To ensure patient electrical isolation, all external device
connections to the Analog Output/Nurse Call connector must be IEC-
60950 compliant.
Caution: To ensure patient electrical isolation, all external device
connections to the RS-232 serial port must be IEC-60950 compliant.
Note: If there is any doubt about the integrity of the protective earth
conductor arrangement, operate the Radical-7 on internal battery power
until the AC power supply protective conductor is fully functional.
Note: Disconnect the device from AC mains by removing the AC power
cord connector from the appliance inlet.
Performance Warnings and Cautions
Warning: Radical-7 is not an apnea monitor.
Warning: Radical-7 should not be used for arrhythmia analysis.
Warning: Radical-7 may be used during defibrillation, but this may affect
the accuracy or availability of the parameters and measurements.
Warning: Radical-7 may be used during defibrillation; however, the
display may require up to 15 seconds to return to normal operation.
Warning: Radical-7 may be used during electrocautery, but this may
affect the accuracy or availability of the parameters and measurements.

Radical-7 Warnings and Cautions
www.masimo.com 18 Masimo
Warning: Do not place containers with liquids on or near Radical-7.
Liquids spilled on Radical-7 may cause it to perform inaccurately or fail.
Warning: Radical-7 is intended only as an adjunct device in patient
assessment. It should not be used as the sole basis for diagnosis or
therapy decisions. It must be used in conjunction with clinical signs and
symptoms.
Warning: A functional tester cannot be used to assess the accuracy of
the Radical-7.
Warning: Interfering Substances: Dyes, or any substance containing dyes,
that change usual blood pigmentation may cause erroneous readings.
Warning: SpO2, SpCO, SpMet, and SpHb are empirically calibrated in
healthy adult volunteers with normal levels of carboxyhemoglobin (COHb)
and methemoglobin (MetHb).
Warning: Inaccurate SpO2 readings may be caused by:
•Improper sensor application.
•Elevated levels of COHb or MetHb: High levels of COHb or
MetHb may occur with a seemingly normal SpO2. When elevated
levels of COHb or MetHb are suspected, laboratory analysis (CO-
Oximetry) of a blood sample should be performed.
•Intravascular dyes, such as indocyanine green or methylene blue.
•Externally applied coloring and texture, such as nail polish, acrylic
nails, glitter, etc.
•Elevated levels of bilirubin
•Severe anemia
•Low arterial perfusion
•Motion artifact