Masimo Radical 7 User manual (2019)

Radical-7

Operator's Manual

This Operator’s Manual presents Masimo features and/or products that

are marketed outside of the United States (OUS). It is not intended for

use in the United States.

These operating instructions provide the necessary information for proper

operation of all models of the Radical-7® Pulse CO-Oximeter®. There

may be information provided in this manual that is not relevant for your

system. General knowledge of pulse oximetry and an understanding of

the features and functions of Radical-7 are prerequisites for its proper

use. Do not operate Radical-7 without completely reading and

understanding these instructions.

Notice: Purchase or possession of this device does not carry any express

or implied license to use with replacement parts which would, alone or in

combination with this device, fall within the scope of one of the relating

patents.

Caution: Use of this device must follow the order of a physician.

For professional use. See instructions for Use for full prescribing

information, including indications, contraindications, warnings,

precautions, and adverse events.

Wireless Radio

FCC ID: VKF-RAD7CA or VKF-RAD7A or VKF-RAD7B | IC ID: 7362A-

RAD7CA or 7362A-RAD7A or 7362A-RAD7B

Masimo Corporation

52 Discovery

Irvine, CA 92618, USA

Tel.: [phone]

Fax.: [phone]

www.masimo.com

www.masimo.com 1 Masimo

EU authorized representative for Masimo Corporation:

MDSS GmbH

Schiffgraben 41

D-30175 Hannover, Germany

Authorized Brazil Company Representative:

MEDSTAR IMPORT AND EXPORT EIRELI

R VALENCIO SOARES RODRIGUES, 89- ROOM 1

CEP: 06.730-000

NEIGHBORHOOD: CENTER

MUNICIPALITY: VARGEM GRANDE PAULISTA

UF: SP

Medical electrical equipment

with respect to electric shock, fire and mechanical hazards only

in accordance with

UL 60601-1/CAN/CSA C22.2 No. 601.1

Patents:

Transform, DST, FastSat, FST, Masimo, Pulse CO-Oximeter, PVI, Radical-7,

Root, rainbow, rainbow Acoustic Monitoring, RAM, rainbow Resposable,

RDS, RRa, RRp, SatShare, SedLine, SET, Signal Extraction Technology,

Signal IQ, SpCO, SpHb, and SpMet are federally registered trademarks of

Masimo Corporation.

3D Desat Index Alarm, In Vivo Adjustment, ORI, SpfO2, SpOC and SST are

trademarks of Masimo Corporation. All other trademarks and registered

trademarks are property of their respective owners.

The use of the trademarks PATIENT SAFETYNET and PSN is under license

from University HealthSystem Consortium.

www.masimo.com 2 Masimo

www.masimo.com/patents.htm

, Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation

© 20182019 Masimo Corporation

www.masimo.com 3 Masimo

Contents

About this Manual --------------------------------------------------------- 11

Product Description ------------------------------------------------------- 11

Key Features ------------------------------------------------------------ 12

Indications for Use -------------------------------------------------------- 13

Contraindications ---------------------------------------------------------- 14

Warnings and Cautions ---------------------------------------------------- 15

Safety Warnings and Cautions ------------------------------------------ 15

Performance Warnings and Cautions ----------------------------------- 17

Cleaning and Service Warnings and Cautions -------------------------- 25

Compliance Warnings and Cautions ------------------------------------ 27

Chapter 1: Technology Overview ------------------------------------------ 31

Signal Extraction Technology (SET) ------------------------------------- 31

rainbow Pulse CO-Oximetry Technology® ----------------------------- 34

rainbow Acoustic Monitoring (RAM) Technology ---------------------- 42

Chapter 2: Radical-7 Descriptions ----------------------------------------- 47

General System Description -------------------------------------------- 47

Functionality of the Radical-7------------------------------------------- 47

Handheld ---------------------------------------------------------------- 49

Standalone -------------------------------------------------------------- 53

Monitor Interface With SatShare --------------------------------------- 58

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Radical-7 Contents

Chapter 3: Setup ---------------------------------------------------------- 59

Unpacking and Inspection ---------------------------------------------- 59

Docking Station Power Requirements ---------------------------------- 59

Setting Up the Docking Station ---------------------------------------- 60

Initial Battery Charging ------------------------------------------------- 60

Setting Up for Philips, Agilent, or HP VueLink ------------------------- 61

Setting Up for SpaceLabs Flexport ------------------------------------- 62

Setting Up and Using SatShare ---------------------------------------- 62

Chapter 4: Operation ------------------------------------------------------ 65

Using the Touchscreen and Buttons ----------------------------------- 66

Using Screen Lock ------------------------------------------------------ 67

Using the Home Button ------------------------------------------------ 68

Standby and Power Off ------------------------------------------------- 68

Navigating the Radical-7 ----------------------------------------------- 69

About the Display View ------------------------------------------------ 70

Sensitivity Modes Overview -------------------------------------------- 81

Changing Sensitivity Modes -------------------------------------------- 82

Accessing the Main Menu ---------------------------------------------- 84

Navigating the Main Menu --------------------------------------------- 84

Parameter Settings ----------------------------------------------------- 87

Chapter 5: Profiles -------------------------------------------------------- 145

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Radical-7 Contents

Profiles Overview------------------------------------------------------ 145

Changing Profiles ----------------------------------------------------- 146

Replacing Factory Default Settings for Adult and Neo Profiles ------ 150

Powering Off the Radical-7 ------------------------------------------- 151

Chapter 6: Alarms and Messages --------------------------------------- 153

About Alarms --------------------------------------------------------- 153

Silencing the Alarms -------------------------------------------------- 153

Adaptive Threshold alarm (ATA) Feature ----------------------------- 156

3D Alarms ------------------------------------------------------------- 157

Messages-------------------------------------------------------------- 161

Chapter 7: Troubleshooting --------------------------------------------- 171

Troubleshooting Measurements -------------------------------------- 171

Troubleshooting the Radical-7 ---------------------------------------- 175

Chapter 8: Specifications ------------------------------------------------ 177

Measurement Range -------------------------------------------------- 177

Accuracy (ARMS) ------------------------------------------------------ 178

Resolution ------------------------------------------------------------- 179

Electrical --------------------------------------------------------------- 180

Environmental --------------------------------------------------------- 181

Physical Characteristics ----------------------------------------------- 181

Alarms ----------------------------------------------------------------- 182

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Radical-7 Contents

Display Indicators ------------------------------------------------------ 183

Compliance ------------------------------------------------------------ 183

Output Interface ------------------------------------------------------- 185

Serial Interface Specifications------------------------------------------ 186

Serial Interface Setup -------------------------------------------------- 186

Analog Output and Nurse Call Specifications ------------------------- 188

Symbols ---------------------------------------------------------------- 190

Citations --------------------------------------------------------------- 192

Chapter 9: Service and Maintenance ------------------------------------- 195

Cleaning --------------------------------------------------------------- 195

Battery Operation and Maintenance ---------------------------------- 196

Performance Verification ---------------------------------------------- 200

Repair Policy ----------------------------------------------------------- 203

Return Procedure ------------------------------------------------------ 204

Contacting Masimo ---------------------------------------------------- 204

Appendix ----------------------------------------------------------------- 209

Concepts of Alarm Response Delay ----------------------------------- 209

Guidance and Manufacturer's Declaration- Electromagnetic Emissions

------------------------------------------------------------------------- 210

Manufacturer's Declaration-Electromagnetic Immunity --------------- 212

Recommended Separation Distances---------------------------------- 217

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Radical-7 Contents

Index --------------------------------------------------------------------- 219

www.masimo.com 9 Masimo

About this Manual

This manual explains how to set up and use the Radical-7® Pulse CO-

Oximeter®. Important safety information relating to general use of the

Radical-7 appears in this manual. Read and follow any warnings, cautions,

and notes presented throughout this manual. The following are

explanations of warnings, cautions, and notes.

warning

A

example, injury, serious adverse effect, death) to the patient or user. The

following is an example of a warning:

Warning: This is a sample of a warning statement.

caution

A

or user to avoid injury to the patient, damage to this device, or damage

to other property. The following is an example of a caution:

Caution: This is a sample of a caution statement.

note

A

following is an example of a note:

Note: This is a sample of a note.

is given when actions may result in a serious outcome (for

is given when any special care is to be exercised by the patient

is given when additional general information is applicable. The

Product Description

The Radical-7 is a noninvasive monitor that measures arterial oxygen

saturation (SpO

optional measurements of hemoglobin (SpHb), carboxyhemoglobin

(SpCO®), total oxygen content (SpOC), methemoglobin (SpMet), Pleth

Variability Index (PVI®), Oxygen Reserve Index (ORI™), Acoustic

Respiration Rate (RRa®), and Pleth Respiration Rate (RRp).

), pulse rate (PR), and perfusion index (PI), along with

2

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Radical-7 Product Description

The Radical-7 can be used as either a Handheld or a Standalone monitor.

The Radical-7 features a touchscreen that continuously displays numeric

values for all parameters.

The Radical-7 provides graphical displays for plethysmographic waveform,

respiratory waveform, Signal Identification and Quality Indicator (Signal

IQ®).

The Radical-7 can also be used to interface with a multi-parameter

patient monitor to send Masimo SET® pulse oximetry information to that

monitor for display.

The Radical-7 has an embedded 802.11 wireless radio that can be used

for connectivity.

Key Features

The following features are available for the Radical-7. Some features are

optional:

• Masimo SET® technology is clinically proven to satisfy all

sensitivity and specificity requirements for pulse oximetry.

• Masimo rainbow® technology uses 7+ wavelengths of light to

continuously and noninvasively measure carboxyhemoglobin

(SpCO), methemoglobin (SpMet), and total hemoglobin (SpHb®),

as well as providing a more reliable probe-off detection.

• Total oxygen content (SpOC) provides a calculated measurement

of the amount of oxygen in arterial blood, which may provide

useful information about oxygen both dissolved in plasma and

combined with hemoglobin.

• Perfusion Index (PI) with trending capability indicates arterial

pulse signal strength and may be used as a diagnostic tool

during low perfusion.

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Radical-7 Indications for Use

• Pleth Variability Index (PVI) may show changes that reflect

physiologic factors such as vascular tone, circulating blood

volume, and intrathoracic pressure excursions. [The utility of PVI

is unknown at this time and requires further clinical studies.

Technical factors that may affect PVI include probe malposition

and patient motion.]

• Oxygen Reserve Index (ORI) is an index to measure changes in

oxygen states under hyperoxic conditions.

• Respiration rate can be determined by the acoustic (RRa) or

plethysmographic waveform (RRp).

• Signal IQ waveform for signal identification and quality indication

during excessive motion and low signal to noise situations.

• FastSat® tracks rapid changes in arterial O

.

2

• Variable pitch provides tonal variance for every 1% change in

saturation.

• SatShare® interface allows transfer of SpO

and pulse rate to an

2

existing multi-parameter monitor and allows for the reading of

SpCO, SpMet, SpHb, and SpOC on adjacent Radical-7® monitor.

• Automatic screen rotation provides upright display for vertical or

horizontal monitor positioning.

• Multi-gesture touchscreen interface.

• Detachable portable Handheld for patient transport.

• Remote alarm interface.

Indications for Use

The Masimo Radical-7 and accessories are indicated for the continuous

noninvasive monitoring of functional oxygen saturation of arterial

www.masimo.com 13 Masimo

Radical-7 Contraindications

hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO),

methemoglobin saturation (SpMet®), total hemoglobin concentration

(SpHb), and/or respiratory rate (RRa).

The Masimo Radical-7 and accessories have been validated and are

indicated for use with adult, pediatric, and neonatal patients during both

no motion and motion conditions, and for patients who are well or poorly

perfused in hospitals, hospital-type facilities, mobile, and home

environments.

In addition, the Masimo Radical-7 and accessories are indicated to

provide the continuous noninvasive monitoring data obtained from the

Masimo rainbow SET® Radical 7 Pulse CO-Oximeter® and accessories of

functional oxygen saturation of arterial hemoglobin (SpO

) and pulse rate

2

(PR) to multi-parameter devices for the display of those devices.

Contraindications

Radical-7 is not intended for use as an apnea monitor.

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Warnings and Cautions

Caution: Radical-7 is to be operated by, or under the supervision of,

qualified personnel only. The manual, accessories, directions for use, all

precautionary information, and specifications should be read before use.

Safety Warnings and Cautions

Warning: Do not use the Radical-7 if it appears or is suspected to be

damaged.

Warning: Do not start or operate Radical-7 unless the setup was verified

to be correct.

Warning: Do not use Radical-7 during magnetic resonance imaging (MRI)

or in an MRI environment.

Warning: Explosion hazard: Do not use the Radical-7 in the presence of

flammable anesthetics or other flammable substance in combination with

air, oxygen-enriched environments, or nitrous oxide.

Warning: Do not place the Radical-7 or accessories in any position that

might cause it to fall on the patient.

Warning: When positioned on a flat surface, the device should be

secured with a mounting system recommended by Masimo.

Warning: To ensure safety, avoid stacking multiple devices or placing

anything on the device during operation.

Warning: To reduce the risk of explosion, only replace battery with

Masimo supplied parts.

Warning: To protect against injury, follow the directions below:

• Avoid placing the device on surfaces with visible liquid spills.

• Do not soak or immerse the device in liquids.

www.masimo.com 15 Masimo

Radical-7 Warnings and Cautions

• Do not attempt to sterilize the device.

• Use cleaning solutions only as instructed in this operator's

manual.

• Do not attempt to clean Radical-7 while monitoring patient.

Warning: To protect from electric shock, always remove the sensor and

completely disconnect Radical-7 before bathing the patient.

Warning: As with all medical equipment, carefully route patient cabling

to reduce the possibility of patient entanglement or strangulation.

Caution: Do not place the Radical-7 where the controls can be changed

by the patient.

Caution: When patients are undergoing photodynamic therapy they may

be sensitive to light sources. Pulse oximetry may be used only under

careful clinical supervision for short time periods to minimize interference

with photodynamic therapy.

Caution: Electric shock hazard: Do not open the Radical-7 cover except to

replace the battery or batteries.

Caution: Electrical shock and flammability hazard: Before cleaning, always

turn off the device and disconnect from any power source.

Caution: To ensure patient electrical isolation, only dock to Masimo

devices that have been designed for Radical-7.

Caution: Use a grounded outlet for proper equipment grounding. A

hospital-grade outlet is required.

Caution: Do not place Radical-7 where the appliance inlet or the AC

power plug cannot be readily disconnected.

Caution: To avoid risk of electrical shock, this equipment must only be

connected to a supply mains with a protective earth connection. Do not

www.masimo.com 16 Masimo

Radical-7 Warnings and Cautions

under any circumstances remove the grounding conductor from the

power plug.

Caution: Only use the AC power cable provided by Masimo. Using a

different AC power cable could cause damage to Radical Docking Station.

Check the power cord and plug to ensure that it is intact and

undamaged.

Caution: To ensure patient electrical isolation, all external device

connections to the Analog Output/Nurse Call connector must be IEC-

60950 compliant.

Caution: To ensure patient electrical isolation, all external device

connections to the RS-232 serial port must be IEC-60950 compliant.

Note: If there is any doubt about the integrity of the protective earth

conductor arrangement, operate the Radical-7 on internal battery power

until the AC power supply protective conductor is fully functional.

Note: Disconnect the device from AC mains by removing the AC power

cord connector from the appliance inlet.

Performance Warnings and Cautions

Warning: Radical-7 is not an apnea monitor.

Warning: Radical-7 should not be used for arrhythmia analysis.

Warning: Radical-7 may be used during defibrillation, but this may affect

the accuracy or availability of the parameters and measurements.

Warning: Radical-7 may be used during defibrillation; however, the

display may require up to 15 seconds to return to normal operation.

Warning: Radical-7 may be used during electrocautery, but this may

affect the accuracy or availability of the parameters and measurements.

www.masimo.com 17 Masimo

Radical-7 Warnings and Cautions

Warning: Do not place containers with liquids on or near Radical-7.

Liquids spilled on Radical-7 may cause it to perform inaccurately or fail.

Warning: Radical-7 is intended only as an adjunct device in patient

assessment. It should not be used as the sole basis for diagnosis or

therapy decisions. It must be used in conjunction with clinical signs and

symptoms.

Warning: A functional tester cannot be used to assess the accuracy of

the Radical-7.

Warning: Interfering Substances: Dyes, or any substance containing dyes,

that change usual blood pigmentation may cause erroneous readings.

Warning: SpO2, SpCO, SpMet, and SpHb are empirically calibrated in

healthy adult volunteers with normal levels of carboxyhemoglobin (COHb)

and methemoglobin (MetHb).

Warning: Inaccurate SpO2 readings may be caused by:

• Improper sensor application.

• Elevated levels of COHb or MetHb: High levels of COHb or

MetHb may occur with a seemingly normal SpO2. When elevated

levels of COHb or MetHb are suspected, laboratory analysis (CO-

Oximetry) of a blood sample should be performed.

• Intravascular dyes, such as indocyanine green or methylene blue.

• Externally applied coloring and texture, such as nail polish, acrylic

nails, glitter, etc.

• Elevated levels of bilirubin

• Severe anemia

• Low arterial perfusion

• Motion artifact

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Radical-7 Warnings and Cautions

Warning: Inaccurate SpHb and SpOC readings may be caused by:

• Improper sensor application

• Intravascular dyes such as indocyanine green or methylene blue

• Externally applied coloring and texture such as nail polish, acrylic

nails, glitter, etc.

• Elevated PaO2 levels

• Elevated levels of bilirubin

• Low arterial perfusion

• Motion artifact

• Low arterial oxygen saturation levels

• Elevated carboxyhemoglobin levels

• Elevated methemoglobin levels

• Hemoglobinopathies and synthesis disorders such as

thalassemias, Hb s, Hb c, sickle cell, etc.

• Vasospastic disease such as Raynaud's

• Elevated altitude

• Peripheral vascular disease

• Liver disease

• EMI radiation interference

Warning: Inaccurate SpCO and SpMet readings can be caused by:

• Improper sensor application

• Intravascular dyes such as indocyanine green or methylene blue

• Abnormal hemoglobin levels

• Low arterial perfusion

www.masimo.com 19 Masimo

Radical-7 Warnings and Cautions

• Low arterial oxygen saturation levels including altitude induced

hypoxemia

• Elevated total bilirubin levels

• Motion artifact

• SpCO readings may not be provided if SpO2 readings are less

than 90%

• SpCO readings may not be provided if SpMet readings are

greater than 2%

Warning: SpCO readings may not be provided if there are low arterial

saturation levels or elevated methemoglobin levels.

Warning: If any measurement seems questionable, first check the

patient’s vital signs by alternate means and then check Radical-7 for

proper functioning.

Warning: Inaccurate respiration rate measurements may be caused by:

• Improper sensor application

• Low arterial perfusion

• Motion artifact

• Low arterial oxygen saturation

• Excessive ambient or environmental noise

Warning: Inaccurate ORI readings may be caused by:

• Improper sensor application

• Intravascular dyes such as indocyanine green or methylene blue

• Externally applied coloring and texture such as nail polish, acrylic

nails, glitter, etc.

• Elevated levels of bilirubin

www.masimo.com 20 Masimo

Radical-7 Warnings and Cautions

• Low arterial perfusion

• Motion artifact

• Patient attached to blood pressure cuff

• Elevated carboxyhemoglobin levels

• Elevated methemoglobin levels

• Vasospastic disease such as Raynaud's

• Peripheral vascular disease

• Hemoglobinopathies and synthesis disorders such as

thalassemias, Hb s, Hb c, sickle cell, etc

• Elevated levels of Dyshemoglobin

• Patient is under Hypocapnic and Hypercapnic Conditions

• EMI radiation interference

• Birthmark(s) or skin discolorations in sensor path

• Moisture on the skin

• Deformed Fingers

• Foreign objects in the light path

• Excessive ambient light or direct sunlight

• Use of incorrect sensor type(size)

• Extreme anemia or extremely low total hemoglobin

concentrations

• Severe vasoconstriction, or hypothermia

• Low ORI SIQ episodes

Warning: ORI is not intended as a replacement for SpO2 monitoring,

PaO2 monitoring, or as a sole indicator of the patient condition.

Caution: ORI measurements are only displayed on Root® when Radical-7

has been configured for ORI and is communicating to Root.

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Radical-7 Warnings and Cautions

Caution: ORI may not indicate additional changes in oxygen states above

200 mmHg of PaO2

Caution: Do not place the Radical-7 on electrical equipment that may

affect the device, preventing it from working properly.

Caution: The device must be configured to match your local power line

frequency to allow for the cancelation of noise introduced by fluorescent

lights and other sources.

Caution: Do not place the Radical-7 against a surface that may cause the

alarm to be muffled.

Caution: Ensure the speaker is not covered.

Caution: To ensure that alarm limits are appropriate for the patient being

monitored, check the limits each time the Radical-7 is used.

Caution: For home use, ensure that the Radical-7 alarm can be heard

from other rooms in the house, especially when noisy appliances such as

vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are

operating.

Caution: When Silence Duration is set to All Mute or All Mute with

Reminder on Radical-7, there will be no audible alarms on Radical-7 or

Patient SafetyNet; however, there will be visual alarms displayed on

Radical-7 and Patient SafetyNet view.

Caution: When All Mute or All Mute with Reminder is selected, there will

be no audible alarms.

Caution: Failure to charge Radical-7 promptly after a Low Battery alarm

may result in the device shutting down.

www.masimo.com 22 Masimo

Radical-7 Warnings and Cautions

Caution: If the Low Perfusion message is frequently displayed, find a

better perfused monitoring site. In the interim, assess the patient and, if

indicated, verify oxygenation status through other means.

Caution: If using pulse oximetry during full body irradiation, keep the

sensor out of the radiation field. If the sensor is exposed to the radiation,

the reading might be inaccurate or the device might read zero for the

duration of the active irradiation period.

Caution: Variation in hemoglobin measurements may be profound and

may be affected by sampling technique as well as the patient's

physiological conditions. Any results exhibiting inconsistency with the

patient’s clinical status should be repeated and/or supplemented with

additional test data. Blood samples should be analyzed by laboratory

instruments prior to clinical decision making to completely understand

the patient’s condition.

Caution: If SpO2 values indicate hypoxemia, a laboratory blood sample

should be taken to confirm the patient’s condition.

Caution: When using In Vivo Adjustment™, confirm offset values(s)

periodically as the difference between the displayed parameter value and

the laboratory reference value may vary over time.

Caution: Do not use In Vivo Adjustment if the monitor displays a Low

SpHb SIQ message.

Note: Use the Radical-7 in accordance with Environmental Specifications

section in this manual.

Note: If the Radical-7 stops communicating with Root, parameters and

measurements will not show on the Root display; however, this will not

affect Radical-7's ability to monitor the patient.

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Radical-7 Warnings and Cautions

Note: It is recommended that Radical-7 battery is fully charged prior to

use.

Note: Always charge Radical-7 when it is not in use to ensure that the

Radical-7 battery remains fully charged.

Note: All batteries lose capacity with age, thus the amount of run time at

Low Battery will vary depending upon the age of the battery.

Note: Do not loop the patient cabling into a tight coil or wrap around

the device, as this can damage the patient cabling.

Note: Additional information specific to the Masimo sensors compatible

with Radical-7, including information about parameter/measurement

performance during motion and low perfusion, may be found in the

sensor's directions for use (DFU).

Note: When using the Maximum Sensitivity setting, performance of the

"Sensor Off" detection may be compromised. If the Radical-7 is in this

setting and the sensor becomes dislodged from the patient, the potential

for false readings may occur due to environmental "noise" such as light,

vibration, and excessive air movement.

Note: The 3D Desat Index™ alarm is intended as an adjunct alarm rather

than in place of the Low SpO2 alarm.

Note: When monitoring acoustic respiration, Masimo recommends

minimally monitoring both oxygenation (SpO2) and respiration (RRa).

Note: High-intensity extreme lights (such as pulsating strobe lights)

directed on the sensor, may not allow the pulse CO-Oximeter® to obtain

vital sign readings.

Warning: Plethysmographic waveforms displayed on multi-parameter

monitors using SatShare should only be used for reference. Only

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Radical-7 Warnings and Cautions

plethysmographic waveforms displayed on the Radical-7 should be used

for monitoring purposes.

Warning: Simultaneous use of SatShare and serial port is not supported.

Caution: To minimize electromagnetic interference, only use a SatShare

cable that has a ferrite bead installed.

Caution: During SatShare operation, alarms may be muted on the

Radical-7. Use the multi-parameter monitor for audible alarms during

SatShare operation.

Caution: Ensure Radical Docking Station is connected to AC power source

when charging Radical-7.

Caution: Do not connect to an electrical outlet controlled by a wall switch

or dimmer.

Note: SatShare signals are ideal simulated waveforms corresponding to

the calculated saturation and pulse rate values and do contain all of the

information contained in physiological waveforms. The multi-parameter

patient monitor decodes these signals into saturation and pulse rate

values.

Cleaning and Service Warnings and Cautions

Warning: Do not adjust, repair, open, disassemble, or modify Radical-7.

Injury to personnel or equipment damage could occur. Return Radical-7

for servicing.

Warning: Electrical Shock Hazard: The battery should be installed and/or

removed from the Radical-7 by qualified personnel only.

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Radical-7 Warnings and Cautions

Warning: Do not use petroleum-based or acetone solutions, or other

harsh solvents, to clean the Radical-7. These substances affect the

device’s materials and device failure can result.

Warning: Do not touch, press, or rub the display panels with abrasive

cleaning compounds, instruments, brushes, rough-surface materials, or

bring them into contact with anything that could scratch the display.

Caution: An operator may only perform maintenance procedures

specifically described in the manual. Refer servicing to qualified service

personnel trained in the repair of this equipment.

Caution: Do not submerge Radical-7 in any cleaning solution or attempt

to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any

other method. This will seriously damage Radical-7.

Note: Changes or modifications not expressly approved by Masimo shall

void the warranty for this equipment.

Note: Excessive cleaning solution can flow into the monitor and cause

damage to internal components.

Warning: Fire Hazard: To protect against fire hazard, replace only with

fuses of same type, current rating, and voltage rating.

Warning: Electrical Shock Hazard: The Docking Station battery should be

installed and/or removed from the Docking Station only by qualified

personnel.

Caution: Electrical Shock Hazard: Carry out periodic tests to verify that

leakage currents of patient-applied circuits and the system are within

acceptable limits as specified by the applicable safety standards. The

summation of leakage currents must be checked and in compliance with

IEC 60601-1 and UL60601-1. The system leakage current must be checked

when connecting external equipment to the system. When an event such

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Radical-7 Warnings and Cautions

as a component drop of approximately 1 meter or greater or a spillage of

blood or other liquids occurs, retest before further use. Injury to

personnel could occur.

Compliance Warnings and Cautions

Warning: Do not incinerate battery.

Caution: Dispose of used batteries according to required country or

regional instructions.

Caution: Disposal of product - Comply with local laws in the disposal of

the device and/or its accessories.

Caution: To minimize radio interference, other electrical equipment that

emits radio frequency transmissions should not be in close proximity to

Radical-7.

Note: Cleared Use Only: The device and related accessories have

obtained CE Mark for noninvasive patient monitoring and may not be

used for any processes, procedures, experiments or any other use for

which the device is not intended or cleared by the applicable regulatory

authorities, or in any manner inconsistent with the instructions for use or

labeling.

Note: This equipment has been tested and found to comply with the

Class B limits for medical devices according to the EN 60601-1-2, Medical

Device Directive 93/42/EEC. These limits are designed to provide

reasonable protection against harmful interference in a typical medical

installation.

Note: This device complies with part 15 of the FCC Rules. Operation is

subject to the following two conditions: (1) This device may not cause

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Radical-7 Warnings and Cautions

harmful interference, and (2) this device must accept any interference

received, including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the

limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

These limits are designed to provide reasonable protection against

harmful interference in a residential installation. This equipment

generates, uses and can radiate radio frequency energy and, if not

installed and used in accordance with the instructions, may cause harmful

interference to radio communications. However, there is no guarantee

that interference will not occur in a particular installation. If this

equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and on,

the user is encouraged to try to correct the interference by one or more

of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from

that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for

help.

Note: This Class B digital apparatus complies with Canadian ICES-003.

Note: In accordance with international telecommunication requirements,

the frequency band of 2.4 GHz and 5.15 to 5.25 Ghz is only for indoor

usage to reduce potential for harmful interference to co-channel mobile

satellite systems.

Note: Users are advised that high-power radars are allocated as primary

users (i.e. priority users) of the bands 5.25-5.35 GHz and 5.65-5.85 GHz

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Radical-7 Warnings and Cautions

and that these radars could cause interference and/or damage to LE-LAN

devices.

Note: In accordance with FCC requirements, radio accessories on Radical-

7 cannot be attached directly to the patient using any accessory

containing metal components.

Note: To satisfy RF exposure requirements, this device and its antenna

must operate with a separation distance of at least 20 cm from all

persons and must not be co-located or operating in conjunction with any

other antenna or transmitter.

Caution: External device connections to the SatShare port must be IEC-

60601-1 compliant.

Note: Change or modifications that are not expressly approved by the

manufacturer could void the user’s authority to operate the equipment.

www.masimo.com 29 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

®

), reliably identifies the noise, isolates it and, using adaptive filters,

(FST

cancels it. It then reports the true arterial oxygen saturation for display on

the monitor.

www.masimo.com 31 Masimo

Radical-7 Chapter 1: Technology Overview

Masimo rainbow SET® Parallel Engines

This figure is for conceptual purposes only.

Masimo SET® DST

This figure is for conceptual purposes only.

General Description for Oxygen Saturation (SpO2)

Pulse oximetry is governed by the following principles:

www.masimo.com 32 Masimo

Radical-7 Chapter 1: Technology Overview

1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-

oxygenated blood) differ in their absorption of red and infrared

light (spectrophotometry).

2. The amount of arterial blood in tissue changes with your pulse

(photoplethysmography). Therefore, the amount of light

absorbed by the varying quantities of arterial blood changes as

well.

Successful Monitoring for SpO2, PR, and PI

Stability of the SpO2 readings may be a good indicator of signal validity.

Although stability is a relative term, experience will provide a good

feeling for changes that are artifactual or physiological and the speed,

timing, and behavior of each.

The stability of the readings over time is affected by the averaging mode

being used. The longer the averaging time, the more stable the readings

tend to become. This is due to a dampened response as the signal is

averaged over a longer period of time than during shorter averaging

times. However, longer averaging times delay the response of the

oximeter and reduce the measured variations of SpO

and pulse rate.

2

Functional Oxygen Saturation (SpO2)

The Radical-7 is calibrated to measure and display functional oxygen

saturation (SpO2): the amount of oxyhemoglobin expressed as a

percentage of the hemoglobin that is available to transport oxygen.

Note: Dyshemoglobins are not capable of transporting oxygen, but are

recognized as oxygenated hemoglobins by conventional pulse oximetry.

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Radical-7 Chapter 1: Technology Overview

General Description for Pulse Rate (PR)

Pulse rate (PR) , measured in beats per minute (BPM) is based on the

optical detection of peripheral flow pulse.

General Description for Perfusion Index (PI)

The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the

non-pulsatile or static blood in peripheral tissue. PI thus represents a

noninvasive measure of peripheral perfusion that can be continuously and

noninvasively obtained from a pulse oximeter.

General Description for Pleth Variability Index (PVI)

The pleth variability index (PVI) is a measure of the dynamic changes in

the perfusion index (PI) that occur during the respiratory cycle. The

calculation is accomplished by measuring changes in PI over a time

interval where one or more complete respiratory cycles have occurred.

PVI is displayed as a percentage (0-100%).

The utility of PVI is unknown at this time and requires further clinical

studies. Technical factors that may affect PVI include probe malposition

and patient motion.

rainbow Pulse CO-Oximetry Technology®

rainbow Pulse CO-Oximetry technology is governed by the following

principles:

1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-

oxygenated blood), carboxyhemoglobin (blood with carbon

monoxide content), methemoglobin (blood with oxidized

www.masimo.com 34 Masimo

Radical-7 Chapter 1: Technology Overview

hemoglobin) and blood plasma constituents differ in their

absorption of visible and infrared light (using

spectrophotometry).

2. The amount of arterial blood in tissue changes with pulse

(photoplethysmography). Therefore, the amount of light

absorbed by the varying quantities of arterial blood changes as

well.

The Radical-7 uses a multi-wavelength sensor to distinguish between

oxygenated blood, deoxygenated blood, blood with carbon monoxide,

oxidized blood and blood plasma.

The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs)

that pass light through the site to a diode (detector). Signal data is

obtained by passing various visible and infrared lights (LEDs, 500 to

1400nm) through a capillary bed (for example, a fingertip, a hand, a foot)

and measuring changes in light absorption during the blood pulsatile

cycle. This information may be useful to clinicians. The maximum radiant

power of the strongest light is rated at ≤ 25 mW. The detector receives

the light, converts it into an electronic signal and sends it to the Radical-7

for calculation.

www.masimo.com 35 Masimo

Radical-7 Chapter 1: Technology Overview

Light Emitting Diodes

1.

(LEDs)

(7 + wavelengths)

2. Detector

Once the Radical-7 receives the signal from the sensor, it utilizes

proprietary algorithms to calculate the patient’s functional oxygen

saturation (SpO

[%]), blood levels of carboxyhemoglobin (SpCO [%]),

2

methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb

[g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb measurements

rely on a multi-wavelength calibration equation to quantify the

percentage of carbon monoxide and methemoglobin and the

concentration of total hemoglobin in arterial blood. 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

Radical-7 (noninvasive) are compared to drawn whole blood (invasive)

measurements by blood gas and/or laboratory CO-Oximetry methods,

caution should be taken when evaluating and interpreting the results.

The blood gas and/or laboratory CO-Oximetry measurements may differ

from the SpO

Radical-7. Any comparisons should be simultaneous, meaning the

measurement on the device should be noted at the exact time that blood

is drawn.

www.masimo.com 36 Masimo

, SpCO, SpMet, SpHb, and SpOC measurements of the

2

Radical-7 Chapter 1: Technology Overview

In the case of SpO2, different results are usually obtained from the arterial

blood gas sample if the calculated measurement is not appropriately

corrected for the effects of variables that shift the relationship between

the partial pressure of oxygen (pO

pH,temperature, the partial pressure of carbon dioxide (pCO

) and saturation, such as:

2

), 2,3-DPG,

2

and fetal hemoglobin.

In the case of SpCO, different results are also expected if concentration of

methemoglobin in the blood gas sample is abnormal (greater than 2% for

methemoglobin concentration).

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

, SpMet, SpCO, and

2

SpHb readings. As blood samples are usually taken over a period of 20

seconds (the time it takes to draw the blood) a meaningful comparison

can only be achieved if the oxygen saturation, carboxyhemoglobin, and

methemoglobin concentration of the patient are stable and not changing

over the period of time that the blood gas sample is taken. Subsequently,

blood gas and laboratory CO-Oximetry measurements of SpO

, SpCO,

2

SpMet, SpHb, and SpOC may vary with the rapid administration of fluids

and in procedures such as dialysis. Additionally, drawn whole blood

testing can be affected by sample handling methods and time elapsed

between blood draw and sample testing.

Measurements with Low Signal IQ should not be compared to laboratory

measurements.

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Radical-7 Chapter 1: Technology Overview

General Description for Total Hemoglobin (SpHb)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring

the levels of total hemoglobin (SpHb) in arterial blood. It relies on the

same principles of pulse oximetry to make its SpHb measurement. The

measurement is taken by a sensor capable of measuring SpHb, usually on

the fingertip for adults and pediatric patients.

The sensor connects directly to the Pulse CO-Oximeter or with a patient

cable. The sensor collects signal data from the patient and sends it to the

device. The device displays the calculated data as measurement of total

hemoglobin concentration.

Successful Monitoring for SpHb

A stable SpHb reading is associated with correct sensor placement, small

physiological changes during the measurement and acceptable levels of

arterial perfusion at the measurement site. Physiological changes at the

measurement site are mainly caused by fluctuations in the oxygen

saturation, blood concentration and perfusion. See

Cautions

on page 15 and

Troubleshooting Measurements

Warnings and

on page 171.

General Description for Total Arterial Oxygen Content (CaO2)

Oxygen (O2) is carried in the blood in two forms, either dissolved in

plasma or combined with hemoglobin. The amount of oxygen in the

arterial blood is termed the oxygen content (CaO

units of ml O

/dL blood. One gram of hemoglobin (Hb) can carry 1.34 ml

2

of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3

ml of oxygen*. The oxygen content is determined mathematically as:

www.masimo.com 38 Masimo

) and is measured in

2

Radical-7 Chapter 1: Technology Overview

CaO2 = 1.34 (ml O2/g) x Hb (g/dL) x HbO2 + PaO2 (mmHg) x 0.003 (ml

/dL/mmHg)

O

2

Where HbO

is the fractional arterial oxygen saturation and PaO2 is the

2

partial pressure of arterial oxygen.

For typical PaO

approximately 0.3 ml O

values, the second part of the above equation is

2

/dL based on PaO2 being approximately 100

2

mmHg. Furthermore, for typical carboxyhemoglobin and methemoglobin

levels, the functional saturation (SpO

) as measured by a pulse oximeter

2

is given by:

SpO2 = 1.02 x HbO

When calculating oxygen content (SpOC), the Radical-7 will use SpfO

available instead of SpO

. SpfO2 is the measured fractional arterial

2

2

™ if

2

oxygen saturation.

*Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood

Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999.

General Description for SpOC

The above approximations result in the following reduced equation for

oxygen content via the Pulse CO-Oximeter:

SpOC (ml/dL*) = 1.31 (ml O2/g) x SpHb (g/dL) x SpO2 + 0.3 (ml O2/dL)

*When ml O

/g Hb is multiplied by g/dL of SpHb, the gram unit in the

2

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

Warnings and Cautions

on page 15.

www.masimo.com 39 Masimo

Radical-7 Chapter 1: Technology Overview

General Description for Carboxyhemoglobin (SpCO)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring

the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It

relies on the same basic principles of pulse oximetry (spectrophotometry)

to make its SpCO measurement.

The measurement is obtained by placing a sensor on a patient, usually on

the fingertip for adults and the hand or foot for infants. The sensor

connects either directly to the Pulse CO-Oximetry device or through an

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 concentration (SpMet) in arterial blood. It

relies on the same basic principles of pulse oximetry (spectrophotometry)

to make its SpMet measurement.

www.masimo.com 40 Masimo

Radical-7 Chapter 1: Technology Overview

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.

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.

Warnings and Cautions

See

on page 15.

General Description for Oxygen Reserve Index (ORI)

Pulse CO-Oximetry is a continuous and noninvasive method of measuring

changes in oxygen states in hyperoxic conditions. It relies on the same

principles of pulse oximetry to make its ORi* measurement.

The measurement is taken by a sensor capable of measuring ORi, usually

on the fingertip for adult or pediatric patients. The sensor connects

directly to the Pulse CO-Oximeter or with a patient cable. The sensor

collects signal data from the patient and sends it to the device. The

device displays the processed data as an indicator of changes in oxygen

states in hyperoxic conditions.

*Available only on Root display

www.masimo.com 41 Masimo

Radical-7 Chapter 1: Technology Overview

Successful Monitoring for ORI

A stable ORi* 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

Cautions

*Available only on Root display

on page 15 and

Troubleshooting Measurements

Warnings and

on page 171.

SpCO, SpMet, and SpHb Measurements During Patient Motion

The Radical-7 displays measurements of SpCO, SpMet, and SpHb during

patient motion. However, because of the changes in the physiological

parameters such as blood volume, arterial-venous coupling, etc. that

occur during patient motion, the accuracy of such measurements may not

be reliable during excessive motion. In this case, the measurement value

for SpCO, SpMet, or SpHb displays as dashes (---) and a message (

,

SpCO SIQ

clinician that the device does not have confidence in the value due to

poor signal quality caused by excessive motion or other signal

interference.

Low SpMet SIQ

, or

Low SpHb SIQ

) displays to alert the

Low

rainbow Acoustic Monitoring (RAM) Technology

rainbow Acoustic Monitoring™ (RAM) continuously measures a patient’s

respiration rate based on airflow sounds generated in the upper airway.

The Acoustic Sensor, which is applied on the patient's neck, translates

airflow sounds generated in the upper airway to an electrical signal that

www.masimo.com 42 Masimo

Radical-7 Chapter 1: Technology Overview

can be processed to produce a respiration rate, measured as breaths per

minute.

Respiratory sounds include sounds related to respiration such as breath

sounds (during inspiration and expiration), adventitious sounds, cough

sounds, snoring sounds, sneezing sounds, and sounds from the

respiratory muscles [1].

These respiratory sounds often have different characteristics depending

on the location of recording [2] and they originate in the large airways

where air velocity and air turbulence induce vibration in the airway wall.

These vibrations are transmitted, for example, through the lung tissue,

thoracic wall and trachea to the surface where they may be heard with

the aid of a stethoscope, a microphone or more sophisticated devices.

rainbow Acoustic Monitoring Architecture

The following figure illustrates how a respiratory sound produced by a

patient can be turned into a numerical measurement that corresponds to

a respiratory parameter.

Patient

Respiratory airflow to

sound

www.masimo.com 43 Masimo

Sensor

Sound to

electrical

signal

Acquisition

System

Electrical signal

to digital signal

Radical-7 Chapter 1: Technology Overview

Signal

Processing

Digital signal to

Envelope

Detection

RRa Estimation

respiratory

measurement

Patient

The generation of respiratory sounds is primarily related to turbulent

respiratory airflow in upper airways. Sound pressure waves within the

airway gas and airway wall motion contribute to the vibrations that reach

the body surface and are recorded as respiratory sounds.

Although the spectral shape of respiratory sounds varies widely from

person to person, it is often reproducible within the same person, likely

reflecting the strong influence of individual airway anatomy [2-6].

Sensor

The sensor captures respiratory sounds (and other biological sounds)

much like a microphone does. When subjected to a mechanical strain,

(e.g., surface vibrations generated during breathing), the sensor becomes

electrically polarized.

The degree of polarization is proportional to the applied strain. The

output of the sensor is an electric signal that includes a sound signal that

is modulated by inspiratory and expiratory phases of the respiratory cycle.

www.masimo.com 44 Masimo

Radical-7 Chapter 1: Technology Overview

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.

Signal Processing

The digital signal produced by the acquisition system is converted into a

measurement that corresponds to the respiratory parameter of interest.

As shown in the previous figure, this can be performed by, for example,

determining the digital signal envelope or outline which in turn may be

utilized to determine the respiratory rate. In this way, a real-time,

continuous breath rate parameter can be obtained and displayed on a

monitor which, in many cases, may be real-time and continuous.

The respiratory cycle envelope signal processing principle is similar to

methods that sample airway gasses and subsequently determine a

respiratory rate.

[1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G.

Righini, S.A.T. Stoneman. Definition of terms for applications of respiratory

sounds. Eur Respir Rev 2000; 10:77, 597-610.

[2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis

lectures on biomedical engineering #8. Morgan & Claypool Publishers,

2006.

[3] Olsen, et al. Mechanisms of lung sound generation. Semin Respir Med

1985; 6: 171-179.

www.masimo.com 45 Masimo

Radical-7 Chapter 1: Technology Overview

[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 46 Masimo

Chapter 2: Radical-7 Descriptions

The following chapter contains the Radical-7 descriptions, including

descriptions of the Handheld monitor , the Standalone monitor, and the

optional SatShare monitor interface.

General System Description

The Radical-7 system includes the following:

1. Device

2. Patient Cable

3. Sensor

For a list of compatible sensors and cables, visit http://www.masimo.com.

Functionality of the Radical-7

The Radical-7 provides the functionality of three devices in one:

Handheld Pulse CO-Oximeter

The Radical-7 is a fully featured Handheld.

www.masimo.com 47 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

The Handheld contains the majority of the device

features. All measurements and device status datum

are displayed on the touchscreen. All user input is

performed through the touchscreen and control

buttons. The sensor cable connector is located on

the Handheld.

Standalone Pulse Oximeter

The Radical-7 is a fully featured Standalone Pulse-Oximeter, and Acoustic

Monitor.

The Handheld snaps into the

Docking Station to provide a fully

featured standalone monitor. The

Docking Station connects to AC

power for standalone operation or

charging of the Handheld. An

optional Docking Station battery is

available. The Standalone features

Nurse Call, analog output, and

serial output.

Monitor Interface

The Radical-7 interfaces to the SpO

patient monitors to upgrade conventional pulse oximetry technology on

input module of multi-parameter

2

the multi-parameter monitor to Masimo SET® technology.

www.masimo.com 48 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Utilizing a SatShare cable, the

standalone Radical-7 also interfaces

with the SpO

input of a validated

2

multi-parameter patient monitor,

instantly upgrading the

conventional pulse oximetry to

Masimo SET® pulse oximetry. The

SatShare cable attaches to the back

of the Radical Docking Station, and

SatShare cables are available to

interface with most multi-parameter

patient monitors.

Handheld

All user input and displays are controlled by this component. The patient

cable connects into the connector on the Handheld device. The Handheld

is battery powered and can be used either as a transport monitor or as a

Handheld Pulse CO-Oximeter for spot checks.

Handheld Front Panel

The following figure numbers and corresponding table describes the

hardware features of the Radical-7.

www.masimo.com 49 Masimo

Radical-7 Chapter 2: Radical-7 Descriptions

Changing the Size

of Parameter Values

Chapter 5: Profiles

button for two (2) seconds. To turn off,

1. Handheld Release button

Press down the Handheld Release

Button to pull the Handheld off the

Docking Station.

2. Touchscreen Display

The Touchscreen Display refers to the

interactive area on the Handheld.

There are different Display Views that

can appear in this area. For more

about using the Touchscreen and

Display Views, see

on page 73.

3. Profile button

The Profile button provides instant

access to the Profile Screen. See

on page 145.

www.masimo.com 50 Masimo

4. Power button

To turn on the Radical-7, press the

Power button. To place Radical-7 in

standby, press and hold the Power

press and hold the button for eight (8)

seconds.

5. Home button

The Home button provides instant

access to the Display View screen.

6. Alarm Silence Button

The Alarm Silence button temporarily

Radical-7 Chapter 2: Radical-7 Descriptions

Silencing the

Alarms

silences alarms. See

on page 153.

7. Speaker

The speaker indicates audio alarms.

Care should be taken not to cover the

speaker and muffle the audible alarm

volume.

8. Patient Cable Connector

Connect a patient cable or a direct

cable sensor into the Radical-7.

Caution: Refer to the Directions for

Use for the sensor before applying it

on patients.

Handheld Back Panel

The Handheld back panel features the connection to the Docking Station,

an accessory mount for the pole clamp accessory, and access to the

Handheld battery pack.

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Radical-7 Chapter 2: Radical-7 Descriptions

Battery Operation

and Maintenance

Item and Description

1. Connector

The Handheld interfaces with the Docking Station through this

connector.

2. Pole Clamp

The optional Pole Clamp accessory attaches to this holder. See the

directions for use of the Pole Clamp accessory for attachment

instructions.

3. Battery Compartment

The Handheld is powered by a lithium ion battery located in this

compartment. For battery care and replacement, see

on page 196.

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Radical-7 Chapter 2: Radical-7 Descriptions

Standalone

When the Handheld is placed into the Docking Station, they become a

full-featured standalone system. In this manual, when the Handheld and

the Docking Station are connected, they are referred to

Standalone

Standalone acts as a battery charger for the Handheld and has AC power

connection capabilities. If the AC power from the wall outlet is

temporarily interrupted, then the battery in the Handheld allows for

continuous operation. The Standalone can also interface with serial

devices, Nurse Call or analog output devices, and multi-parameter patient

monitors through a SatShare cable.

There are several models of compatible Docking Stations available: RDS-1,

RDS-2, and RDS-3. The RDS-1 and RDS-3 are optionally available with

SafetyNet capability. The following table lists which features are available

for each model of Docking Station.

. The

Docking Station Features RDS-1 RDS-2 RDS-

3

AC Power Input

SatShare Interface

Serial RS-232 interface

Nurse Call/Analog Output interface

10-Hour Extended Battery

  











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Radical-7 Chapter 2: Radical-7 Descriptions

Docking Station Features RDS-1 RDS-2 RDS-

3

Automatic Display Rotation Support (Gravity



Detector)

Docking Station Battery Charging indicator

Handheld Battery Charging indicator

Visual Alarm indicator

AC Power indicator

Docking indicator

  



  



Standalone Front Panel

The following figure and corresponding text review the features of the

Radical-7 Standalone. Note that when the Standalone is turned on, all

indicator LEDs initially turn on and off at start up.









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Radical-7 Chapter 2: Radical-7 Descriptions

Item and Description

1. Docking Station Battery Charging Indicator

The Docking Station Battery Charging indicator is illuminated

when the Docking Station battery is charging. The indicator

blinks just prior to charging. The Charging Indicator does not

illuminate when the battery is fully charged or when the

battery is not present.

2. Handheld Battery Charging indicator

The Handheld Battery Charging indicator is illuminated when

the Handheld battery is charging. The indicator blinks just

prior to charging. The Charging Indicator does not illuminate

when the battery is fully charged or when the battery is not

present.

3. Visual Alarm Indicator

The Visual Alarm indicator is illuminated when an alarm

condition is active and the Alarm Status Indicator is shown.

4. AC Power Indicator

The AC Power indicator is illuminated when the Radical-7

Docking Station is plugged into AC line power.

5. Docking Indicator

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Radical-7 Chapter 2: Radical-7 Descriptions

Item and Description

The Docking indicator is illuminated when the Handheld

device is turned on and is properly interfaced to a Docking

Station.

Standalone Back Panel

The following figure and corresponding text review the features of the

Radical-7 Standalone.

Item and Description

1. Serial Output connector

Use the Serial Output connector with a ferrite bead installed to connect

a serial device, including a serial printer, a monitoring system or PC to

the Radical-7. The data is provided in standard RS-232C format. All

external device connections to the Serial Output connector must be IEC-

60950 compliant.

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Radical-7 Chapter 2: Radical-7 Descriptions

Serial Interface Specifications

www.masimo.com

Item and Description

2. Analog Output/Nurse Call connector

Use the Analog Output connector with a ferrite bead installed to

interface with an analog output device, such as a chart recorder or

Nurse Call system. All external device connections to the Analog

Output/Nurse Call connector must be IEC-60950 compliant.

See

on page 186.

3. SatShare Cable connector

Use the SatShare Cable connector to connect a SatShare cable to the

SpO

input connector of a multi-parameter patient monitor. All external

2

device connections to the SatShare Cable Connector must be IEC-

60601-1-1 compliant. SatShare cables are available to interface with

most major multi-parameter patient monitors. Check the label on the

SatShare cable and the SatShare Directions for Use to ensure that the

correct cable is used for each type of patient monitor.

Visit

for the latest SatShare cables and validated

devices.

4. Power Entry module

The Power Entry module contains the input connector for AC power

and two fuses. The AC input provides power to the system from the AC

line. Always connect the Radical-7 to the mains power for continuous

operation and/ or battery recharging. Note: Use the power cord as the

means to disconnect the device from the mains power supply.

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Radical-7 Chapter 2: Radical-7 Descriptions

Item and Description

5. Equipotential Ground connector

Use the Equipotential Ground connector for grounding.

Monitor Interface With SatShare

The Radical-7 has a unique SatShare interface that links to most existing

multi-parameter patient monitors through a SatShare cable.

• Upgrades any approved and validated monitor to Masimo SET®

performance by using the calculated SpO

and pulse rate

2

determined by Radical-7 to simulate an ideal plethysmograph

waveform, which is sent to the validated multi-parameter patient

monitor.

• Connects into the SpO

patient cable or SpO2 input connector of

2

the multi-parameter patient monitor.

See

Setting Up and Using SatShare

on page 62.

www.masimo.com 58 Masimo

Chapter 3: Setup

The following chapter contains information about setting up the Radical-7

before use.

Unpacking and Inspection

To unpack and inspect the device

1. Remove the device from the shipping carton and examine it for

signs of shipping damage.

2. Check all materials against the packing list. Save all packing

materials, invoice and bill of lading. These may be required to

process a claim with the carrier.

3. If anything is missing or damaged, contact the Technical Service

Department. See

Return Procedure

Docking Station Power Requirements

on page 204.

• Always use a hospital-grade, AC power cable to connect the

Docking Station to an AC power source.

• Do not connect the Docking Station to an AC outlet that is

controlled by a switch because the power to the Docking Station

may be inadvertently switched off.

• Verify the AC power voltage and line frequency before use.

• Verify that the power source can provide an adequate power

rating as indicated on the rear panel of the Docking Station.

• The Radical-7 is designed to operate on 100 to 240VAC, 47-63

Hz.

• The Radical-7 is rated at 55 VA max.

www.masimo.com 59 Masimo

Radical-7 Chapter 3: Setup

• Connect a hospital-grade power cable (IEC-320 connector type

at the device) to the Power Entry module on the Docking

Station.

• Connect the power cable to an AC power source.

• Ensure that the device is adequately powered by verifying that

the AC power indicator on the Docking Station is illuminated.

Warnings and Cautions

See

on page 15.

Setting Up the Docking Station

Place the Docking Station on a stable hard flat surface near the patient.

Always place the Radical-7 on a dry surface. Maintain a minimum of 3 cm

(1 inch) free space around the Radical-7. Make sure that the Radical-7

speaker is not covered to avoid a muffled alarm sound.

The Radical-7 Handheld, Docking Station or Standalone should not be

operated outside the environmental conditions listed in the specifications

section

Environmental

on page 181.

Initial Battery Charging

Before use, the Radical-7 Handheld battery and the Docking Station

battery must be charged completely.

To charge the Handheld and Docking Station for the first time

1. Attach the Handheld to the Docking Station.

2. Plug in the AC power cord to power entry module. Make sure it

is securely plugged in.

3. Plug the AC power cord into an AC power source.

4. Verify that the batteries are charging.

www.masimo.com 60 Masimo

Radical-7 Chapter 3: Setup

• The Battery Charging indicators on the Docking Station flash

prior to charging and remain illuminated while the batteries

are charging.

See

Standalone Front Panel

Maintenance

on page 196.

on page 54 and

Battery Operation and

Setting Up for Philips, Agilent, or HP VueLink

To set up for use with VueLink compatible monitors (Philips, Agilent, or HP)

1. On the Radical-7, on the

device output

screen, for the

option, select Hp VueLink.

2. Connect one end of the VueLink cable to the Serial Output

connector on the Docking Station.

3. Connect the other end of the VueLink cable to the VueLink

module and insert the module into the VueLink compatible

monitor rack.

The SpO

and pulse rate values appear on the VueLink

2

compatible monitor.

4. In order for the plethysmographic waveform to be displayed on

the VueLink compatible monitor, and for the VueLink monitor to

convey alarm conditions measured by the Radical-7, the VueLink

compatible monitor must be properly configured.

5. See instructions for use provided with the VueLink compatible

monitor and the VueLink module. See

Serial Interface Specifications

and

Compliance

on page 186.

on page 183

serial

www.masimo.com 61 Masimo

Radical-7 Chapter 3: Setup

Setting Up for SpaceLabs Flexport

To set up for use with SpaceLabs Flexport

1. On the Radical-7, on the

device output

screen, for the

serial

option, select SpaceLabs Flexport.

2. Connect one end of the Spacelabs Flexport cable to the Serial

Output connector on the Docking Station.

3. Connect the other end of the Spacelabs Flexport cable to the

Spacelabs Universal Flexport connector.

The SpO

and pulse rate values appear on the Spacelabs screen.

2

4. In order for the plethysmographic waveform to be displayed on

the Spacelabs screen, and for the Spacelabs monitor to convey

alarm conditions measured by the Radical-7, the Spacelabs

monitor must be properly configured.

5. See instructions for use provided with the Spacelabs monitor.

Compliance

See

Specifications

on page 183 and

on page 186.

Serial Interface

Setting Up and Using SatShare

Parameter values from the Radical-7 can be displayed on a multi-

parameter monitor through the SatShare feature. The SatShare feature

provides an ideal, simulated plethysmographic waveform that

corresponds to the parameter values determined the by Radical-7. This

waveform may be used to display these values on multi-parameter

monitors through the multi-parameter oximetry sensor or input

connector.

It is recommended that the Radical-7 be positioned near the multi-

parameter monitor, with the Radical-7 screen displaying the

www.masimo.com 62 Masimo

Radical-7 Chapter 3: Setup

plethysmographic waveform and the parameter values. Refer to the

instructions for use provided with the multi-parameter monitor. See

Compliance

To set up for use with SatShare interface

1. Select the SatShare cable that is appropriate for the multi-

2. Connect the labeled end of the SatShare cable to the SatShare

3. Connect the other end of the SatShare cable to one of the

on page 183.

parameter monitor. For the latest list of available SatShare cables

and validated devices, see

Cable connector on the Docking Station. See

Panel

on page 56. For a secure connection, tighten the cable

connector screws.

following:

• Sensor connector of the multi-parameter monitor cable

• Directly to the multi-parameter monitor

www.masimo.com

.

Standalone Back

4. Verify that the multi-parameter monitor recognizes the SatShare

cable.

5. As appropriate, configure alarm limits on the multi-parameter

monitor.

6. Set the averaging time for the multi-parameter monitor to its

lowest setting (or fastest response). The ideal waveform for the

Radical-7 requires additional averaging by the monitor. If the

averaging time of the multi-parameter monitor is not changed,

the time to display physiological changes in saturation on the

monitor is increased with SatShare. However, the delay can be

minimized by reducing the averaging time on the multi-

parameter monitor.

www.masimo.com 63 Masimo

Radical-7 Chapter 3: Setup

7. While in the SatShare mode, if there are any significant

discrepancies between the readings from Radical-7 and those on

the monitor displaying the values obtained from SatShare, the

values reported by the Radical-7 are to be considered the correct

values.

8. It is possible to use the Radical-7 with SatShare while the

Radical-7 is not connected to AC power. However, in this

configuration, battery run time is reduced. See

Operation and Maintenance

on page 196.

Battery

9. On the Radical-7, turn on the

Device Output

10. If displaying the simulated waveform is not desirable, it is

recommended to turn off the plethysmographic waveform

display of the multi-parameter patient monitor. See

on page 126.

Interface Specifications

Satshare Numbers

on page 186.

option. See

Serial

www.masimo.com 64 Masimo

Chapter 4: Operation

The following chapter contains information about using the Radical-7.

www.masimo.com 65 Masimo

Radical-7 Chapter 4: Operation

About the Display

View

Chapter 5: Profiles

Silencing the Alarms

Using the Touchscreen and Buttons

1. Display View

To access other screens,

touch a value on the Display

View. See

on page 70.

2. Profiles button

To the access the

Profiles

screen, press Profiles. See

on page

145.

3. Alarm Silence button

To temporarily silence audible

alarms, press Alarm Silence.

See

on

page 153.

4. Home button

To return to the

Display View

press Home.

5. Power button

To turn on the Radical-7,

press the Power button. To

turn off, press and hold the

button for more than 2

seconds

www.masimo.com 66 Masimo

,

Radical-7 Chapter 4: Operation

Using Screen Lock

When turned on, the

interaction with

Screen Lock

Display View

feature may prevent unintentional

.

Using the Screen Lock feature

1. When turned on, any interaction with the

the Screen Lock feature.

2. To bypass

Screen Lock

when it appears, press and hold the Lock

icon until it unlocks.

3. To turn on or turn off

117.

Screen Lock

Display View

, see

Access Control

triggers

on page

www.masimo.com 67 Masimo

Radical-7 Chapter 4: Operation

Using the Home Button

One option to return to

Display View

is by using the Home button.

To return to Display View using the Home button

• From any screen, press Home.

Standby and Power Off

To put Radical-7 in Standby Mode or to Power Off, follow these steps:

State Description

Press and hold the Power Button for two (2) seconds until a

Standby

Mode

single audible tone sounds.

Standby Mode conserves power while enabling a quicker

startup sequence.

Press and hold the Power Button for eight (8) seconds, until

two (2) audible tones sound. The Home Button will flash on

Power Off

and off, and the Power Button will flash orange.

Power Off completely shuts down Root and results in a

longer startup sequence.

www.masimo.com 68 Masimo

Radical-7 Chapter 4: Operation

Navigating the Radical-7

Navigate the Radical-7 screens via the

Display View

or the

Main Menu

.

Display View

The following is the primary interactive screen that the user views.

To access the Main Menu screen

• Touch the gear icon at the lower right corner of the display.

Main Menu

The following is the

Main Menu

screen where users can access additional

screens and information. Users can swipe the screen left or right to pan

the Menu Icons. Users can touch the arrow icon to return to the

. See

View

Accessing the Main Menu

on page 84.

Display

Display Timeout

When no user interaction occurs within one minute, the display times out

and returns to the

Display View

.

www.masimo.com 69 Masimo

Radical-7 Chapter 4: Operation

About the Display View

The

Display View

consists of different areas:

Status Bar. See

Parameter Display. See

page 73.

About the Status Bar

on page 72.

Changing the Size of Parameter Values

on

www.masimo.com 70 Masimo

Radical-7 Chapter 4: Operation

Trend Field. See

Waveform and Trend Views

Small Parameter View. See

on page 76.

Accessing the Main Menu

on page 84.

www.masimo.com 71 Masimo

Radical-7 Chapter 4: Operation

About the Status Bar

The Status Bar is visible on the top portion of the

Display View

.

Status Bar

Access additional screens, more information, or toggle features by

touching directly on any of the following indicators in the Status Bar.

• Sensitivity Modes. See

• Profiles. See

•

Messages

•

WiFi

on page 124.

Profiles Overview

on page 161.

Sensitivity Modes Overview

on page 145.

on page 81.

Battery

•

•

Sounds

• Time settings. See

on page 125.

on page 113.

Localization

on page 121.

www.masimo.com 72 Masimo

Radical-7 Chapter 4: Operation

Changing the Size of Parameter Values

To change the size of parameter values on the Display View

1. On the

parameters, as shown above.

2. When the parameter value dims, shakes, and grows in size, drag

and drop that parameter above the

3. The parameter value appears on the screen in a larger font. The

device automatically configures the screen for optimal display of

the parameter values.

4. To remove parameter values from the larger font display, press

and hold the larger parameter value. Then drag and drop the

parameter value back to the

Small Parameter v

iew, touch and hold any one of the

Trend Field

Small Parameter

.

view.

Trend Field

The

Trend Field

Trends

on page 127.

To access trend, waveform, or customize the views on the Display View screen

www.masimo.com 73 Masimo

allows users to access various customizable views. See

Radical-7 Chapter 4: Operation

1. Touch the Trend Field, as shown below.

2. The following screen appears.

3. Swipe up or swipe down the available options.

4. Touch on the desired option.

www.masimo.com 74 Masimo

Radical-7 Chapter 4: Operation

5. The

Trend Field

displays trend data specific to the option that

was selected.

Pulse Bar

The

Pulse Bar

the Signal IQ (SIQ) displayed on each individual pulsation. The height of

the bars provides an assessment of the confidence in the measurement

displayed. See

is a visual indicator that conveys the detection of pulse and

Signal IQ Indicators

on page 77.

www.masimo.com 75 Masimo

Radical-7 Chapter 4: Operation

Waveform and Trend Views

The following section contain information about trends and waveforms

available from the

Trend Field

on the

Display View

screen. The following

are examples of some of the views that are available.

Pleth + Sig IQ + Acoustic View

Shows the parameter values on the top of the screen. The waveform is

located below the parameter values. The

Small Parameter

along the bottom of the screen. This view contains the Pleth waveform,

signal quality indications, and acoustic waveform.

view is located

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Radical-7 Chapter 4: Operation

Signal IQ Indicators

The Signal IQ (SIQ), displayed on each individual pulsation, is conveyed

by vertical bars, as shown below. The height of the bar provides an

assessment of the confidence in the measurement displayed.

Acoustic Waveform View

Shows the parameter values on the top of the screen. The RRa waveform

is located below the parameter values. The

Small Parameter

located along the bottom of the screen. Acoustic Respiratory Rate (RRa)

must be available for this feature to be shown. This view contains

acoustic respiratory rate waveform only.

view is

www.masimo.com 77 Masimo

Radical-7 Chapter 4: Operation

Pleth + Sig IQ + Acoustic View

Shows the parameter values on the top of the screen. The waveform is

located below the parameter values. The

along the bottom of the screen. This view contains the Pleth waveform,

signal quality indications, and acoustic waveform.

Small Parameter

view is located

Parameter Quick Trend View

This view displays the quick trend of the selected parameter over an

adjustable period of time. The default is 1 hour. Enlarge the quick trend

to the full trend view by touching the expand icon of the waveform

display.

www.masimo.com 78 Masimo

Radical-7 Chapter 4: Operation

With a pinch gesture, using two fingers, the user can zoom in and out of

the quick trend data within the

Trend Field

.

About Events Feature

The Events feature provides graphical display of parameter or

measurement alarms and non-clinical exception messages. This feature is

only viewable in the Full Trend screen; however, it is available at all times

for all parameters and measurements. For more information about these

alarms and exceptions, see Chapter 6: Alarms and Messages.

Events appear as color-coded circles along the trend of a parameter or

measurement.

Color of

Event

Circle

Red

Visibility Description

Parameter or

measurement

alarm.

Example

Messages

•

SpO2 low

•

SpCO high

•

PR low

www.masimo.com 79 Masimo

Radical-7 Chapter 4: Operation

Yellow

Specific to parameters

and measurements

shown in Full Trend

screen.

Whenever in Full Trend

screen.

Change in In

Vivo offset.

Non-clinical

exception.

SpO2 In Vivo

•

offset

changed: -1.9

Replace

•

sensor

•

Low battery

•

No cable

connected

In the example below showing two (2) Events, the yellow circle represents

a system exception and the red circle represents a parameter alarm

related to the patient’s SpO

level.

2

If there are two (2) parameters and/or measurements displayed in the Full

Trend screen, then only Events related to those parameters and/or

measurements will be visible.

Using the same example, tapping on the red circle reveals a message box

displaying the alarm (

Start SpO2 Low

), the reading (

SpO2 87

), as well as

www.masimo.com 80 Masimo

Radical-7 Chapter 4: Operation

its timestamp (

11:34:56 AM

), which correlates with the position of the

vertical blue line.

To view time and reading information about a specific parameter or

measurement, tap anywhere along the trend.

Using the same example, tapping on the trend somewhere towards the

right reveals a message box displaying the parameter reading (

and its timestamp (

12:11:32 PM

).

SpO2 96

)

Sensitivity Modes Overview

Three sensitivity levels enable a clinician to tailor the response of the

Radical-7 to the needs of the particular patient situation. Access the

www.masimo.com 81 Masimo

Radical-7 Chapter 4: Operation

menu by touching on the indicator in the upper left corner of the

. The sensitivity levels are as follows:

View

• NORM (Normal Sensitivity)

NORM is the recommended sensitivity mode for patients who

are experiencing some compromise in blood flow or perfusion. It

is advisable for care areas where patients are observed

frequently, such as an intensive care unit (ICU).

• APOD® (Adaptive Probe Off Detection® Sensitivity)

APOD is the recommended sensitivity mode where there is a

high probability of the sensor becoming detached. It is also the

suggested mode for care areas where patients are not visually

monitored continuously. This mode delivers enhanced protection

against erroneous pulse rate and arterial oxygen saturation

readings when a sensor becomes inadvertently detached from a

patient due to excessive movement.

• MAX (Maximum Sensitivity)

MAX is recommended sensitivity mode for patients with low

perfusion or when a

low perfusion

message displays in APOD or

NORM mode. MAX mode is not recommended for care areas

where patients are not monitored visually, such as general wards.

It is designed to interpret and display data at the measuring site

when the signal may be weak due to decreased perfusion. When

a sensor becomes detached from a patient, it will have

compromised protection against erroneous pulse rate and

arterial saturation readings.

Display

Changing Sensitivity Modes

There are two ways to change the sensitivity modes.

www.masimo.com 82 Masimo

Radical-7 Chapter 4: Operation

1. Press the indication on the top left of the

2. Alternatively, from the

the

Profiles

screen, select the desired mode by scrolling up or

Main Menu

, touch the

down. Then select OK.

Display View

Profiles

.

icon. From

Note that the device will revert to APOD mode after a power

cycle.

Changing Profiles

See

on page 146.

www.masimo.com 83 Masimo

Radical-7 Chapter 4: Operation

Accessing the Main Menu

To access

bottom right corner of the

Main Menu

from the

Small Parameter View

Navigating the Main Menu

Display View

, touch the gear icon on the

.

• From the

Main Menu

screen, touch the icons for any of the

following screens:

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Radical-7 Chapter 4: Operation

Device Settings

Parameter Settings

Changing Profiles

3D Alarms

Trends

Trend Field

Sounds

Device Settings

See

on page 116.

Parameter Settings

See

Profiles

See

3D Alarms

See

on page 157.

Trends

on page 87.

on page 146.

www.masimo.com 85 Masimo

See

page 73.

Sound

See

on page 127 and

on page 113.

on

Radical-7 Chapter 4: Operation

About

About

See

on page 141.

www.masimo.com 86 Masimo

Radical-7 Chapter 4: Operation

Parameter Settings

The following is an example of the

Parameter Settings

screen. Only

parameters that have been loaded onto the system will be visible.

To access any of the available parameter setting screens

1. From the

Parameter Settings

screen, to access the desired

parameter, flick the on-screen icons left or right.

2. Touch the icon of the desired parameter. For details, see any of

the following sections.

SpO2 Settings

SpHb Settings

on page 91.

on page 94.

PVI Settings

PR Settings

on page 106.

on page 98.

www.masimo.com 87 Masimo

Radical-7 Chapter 4: Operation

Perfusion Index (PI) Settings

SpCO Settings

SpMet Settings

SpOC Settings

Respiration Rate (RR)

on page 108.

on page 109.

on page 111.

on page 101

on page 99.

About Parameter Information

Additional information about each parameter is available.

To access additional information about parameters

1. From the parameter settings screen, touch the About icon. The

following is an example for SpHb.

www.masimo.com 88 Masimo

Radical-7 Chapter 4: Operation

2. An

About

screen appears for the selected parameter.

In Vivo Adjustment Overview

The In Vivo Adjustment feature lets clinicians manually adjust one or

more clinical parameters to match that of a corresponding laboratory

reference for continuous trending. To remind clinicians that the feature is

active, an offset value displays alongside the adjusted parameter value.

The In Vivo Adjustment feature for a parameter can be turned on by

accessing the In Vivo screen in the settings menu of that parameter. After

enabling the feature, set an offset value. Once the feature is enabled, a

positive or a negative offset value appears, as shown in the following

illustration.

The In Vivo offset is set to zero for any of the following:

• Cable or sensor is disconnected from device.

• Sensor goes off patient causing a sensor initialization to occur.

• Eight hours has elapsed since the In Vivo value was activated.

• Restore of factory defaults.

• The user turns off In Vivo.

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Radical-7 Chapter 4: Operation

Offset Value

When In Vivo Adjustment is activated for a specific parameter, the offset

value appears beneath that specific parameter. A positive value means

that the displayed parameter value has been increased (according to a

laboratory reference value as entered by a clinician) and a negative value

means the displayed parameter value has been decreased (according to a

laboratory reference value as entered by a clinician).

In the example below, the displayed SpO

value of 95 takes into account

2

an offset of -1.0, and the displayed SpHb value of 13.8 takes into account

an offset of +0.4.

The In Vivo Adjustment feature can be set to

Off

default setting is

. If set to On, the parameter value is adjusted and an

On

or

Off

. the factory

offset value appears. The offset value is set by the user.

The feature applies to any of the following parameters:

In Vivo for SpO2

In Vivo for SpHb

on page 94.

on page 98.

In Vivo for SpCO

In Vivo for SpMet

on page 108.

on page 110.

www.masimo.com 90 Masimo

Radical-7 Chapter 4: Operation

Low Limit is the lower threshold

SpO2 Settings

Access any of the following options:

Alarms for SpO2

on page 91.

Additional Settings for SpO2

About Parameter Information

Alarms for SpO2

From the

Options Description

High Limit

Alarms

screen, change any of the following options:

The High Limit is upper

threshold that triggers an

alarm.

on page 92.

on page 88.

Factory

Default

Settings

Off

Configurable

Options

2% to 99% in

steps of 1%,

or Off

When set to

Off, alarm is

disabled

Low Limit

www.masimo.com 91 Masimo

that triggers an alarm.

88%

1% to 98% in

steps of 1%

Radical-7 Chapter 4: Operation

Adaptive Threshold alarm

(ATA) Feature

Options Description

Sets the Rapid Desat limit

threshold to the selected

amount below the Low Alarm

Rapid

Desat

Limit. When SpO

below rapid desat limit the

audio and visual alarm are

immediately triggered without

respect to the alarm delay.

Alarm

Delay

When an alarm condition is

met, this feature delays the

audible part of an alarm.

ATA establishes patient-specific

Adaptive

Threshold

Alarm

(ATA)

limit thresholds based upon the

baseline value of the

parameter.

See

value falls

2

on page 156.

Factory

Default

Settings

-10%

5

seconds

Configurable

Options

Off, -5%, or -

10%

0, 5, 10, or 15

seconds

Off Off or On

Additional Settings for SpO2

From the

www.masimo.com 92 Masimo

Additional Settings

screen, change any of the following options:

Radical-7 Chapter 4: Operation

User Configurable

FastSat Overview

Options Description Factory

Default

Settings

Settings

Averaging

Time

The length of time over

which the system

calculates the average of

8 seconds 2-4, 4-6, 8, 10,

12, 14, or 16

seconds

all data points.

FastSat

See

on

Off On or Off

page 93.

FastSat Overview

FastSat enables rapid tracking of arterial oxygen saturation changes.

Arterial oxygen saturation data is averaged using pulse oximeter

averaging algorithms to smooth the trend.

On

When the Radical-7 is set to FastSat

evaluates all the saturation values providing an averaged saturation value

that is a better representation of the patient’s current oxygenation status.

With FastSat, the averaging time is dependent on the input signal.

, the averaging algorithm

www.masimo.com 93 Masimo

Radical-7 Chapter 4: Operation

In Vivo

Adjustment Overview

In Vivo

Adjustment Overview

Adjust difference of ±

In Vivo for SpO2

From the

In Vivo

screen, change any of the following options:

Options Description Factory

Default

Settings

Enabled See

Off On or Off

on page 89.

Offset

Amount

See

0 when

turned on

on page 89.

SpHb Settings

From the

SpHb Alarms

Additional Settings for SpHb

SpHb Settings

on page 94.

screen, access any of the following screens:

on page 96.

User Configurable

Settings

6%, in steps of 0.1%

About Parameter Information

SpHb Alarms

From the

www.masimo.com 94 Masimo

Alarms

on page 88.

screen, change any of the following options:

Radical-7 Chapter 4: Operation

Options Description Factory

Default

Settings

High

Limit

The High Limit is

upper threshold that

triggers an alarm.

17.0 g/dL

(170 g/L)

(11.0

mmol/L)

User Configurable

Settings

2.0 g/dL to 24.5 g/dL in

steps of 0.1 g/dL, or Off

(2 g/L to 249 g/L in

steps of 1 g/L, or Off)

(2.0 mmol/L to 15.0

mmol/L in steps of 0.1

mmol/L, or Off)

When SpHb Precision is

set to 1.0, the values are

rounded down.

When set to Off, alarm is

disabled.

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Radical-7 Chapter 4: Operation

Options Description Factory

Default

Settings

Low

Limit

The Low Limit is

lower threshold that

7.0 g/dL

(70 g/L)

triggers an alarm.

(4.0

mmol/L)

User Configurable

Settings

Off, or 1.0 g/dL to 23.5

g/dL in steps of 0.1 g/dL

(Off, or 1 g/L to 248 g/L

in steps of 1 g/L)

(Off, or 1.0 mmol/L to

14.5 mmol/L, in steps of

0.1 mmol/L)

When SpHb Precision is

set to 1.0, values are

rounded down.

When set to Off, alarm is

disabled.

Additional Settings for SpHb

From the

www.masimo.com 96 Masimo

Additional Settings

screen, change any of the following options:

Radical-7 Chapter 4: Operation

Options Description Factory

Default

Settings

Averaging

Time

The length of time over which

the system calculates the

Medium Short,

average of all data points.

Calibration Provides an arterial or venous

Venous Arterial or

value that displays on the main

screen.

Precision Allows the user to set the

0.1 0.1, 0.5, or 1.0

decimal for SpHb.

Unit of

Measure*

Displays total hemoglobin

(SpHb) as g/dL (grams per

g/dL g/dL, g/L, or

deciliter), g/L (grams per liter),

or mmol/L (milimoles per liter).

Unit of Measure can not be

changed during active

monitoring.

User

Configurable

Settings

Medium, or

Long

Venous

(whole

numbers)

mmol/L,

*Changing Unit of Measure will delete all prior trend data for all

parameters.

www.masimo.com 97 Masimo

Radical-7 Chapter 4: Operation

In Vivo

Adjustment

Overview

In Vivo

Adjustment

Overview

In Vivo for SpHb

From the

In Vivo

screen, change any of the following options:

Options Description Factory

Default

Settings

In Vivo

See

Off On or Off

Calibration

on page 89.

In Vivo

See

0

Calibration

Offset

on page 89.

PR Settings

From the

PR Setting

s screen, change any of the following options:

User Configurable

Settings

± 3 g/dL in steps

of ± 0.1 g/dL

PR Alarms

About Parameter Information

PR Alarms

From the

www.masimo.com 98 Masimo

on page 98.

PR Alarms

screen, change any of the following options:

on page 88.