Signal Extraction Pulse Oximeter

OPERATOR’S MANUAL

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 The Radical Operating Instructions are intended to provide the necessary information for proper
operation of all models of the Radical pulse oximetry system. There may be information provided
in this manual that is not relevant for your system.
General knowledge of pulse oximetry and an understanding of the features and functions of the
Radical Pulse Oximeter are a prerequisite for proper use.
Do not operate the Radical Pulse Oximeter without completely reading and understanding these
instructions.
NOTICE
Purchase or possession of this device does not carry any express or implied license to use this
device with replacement parts which would, alone or in combination with this device, fall within the
scope of one of the patents relating to this device.
CAUTION:
FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN

Masimo Corporation
2852 Kelvin Avenue
Irvine, CA 92614
USA
Tel.: 949-250-9688
Fax.: 949-250-9686
www.masimo.com

Authorized Representative:
MDSS GmbH
Burckhardstrasse 1
D-30163 Hanover
Germany
Tel.: +49-511-62 62 86 30
Fax.: +49-511-62 62 86 33

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC

SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL 2601-1/CAN/CSA C22.2 No. 601.1

USA Patents 5337744, 5452717, 5482036, 5490505, 5638818, 5645440, 5758644 and 5782757 and international
equivalents. Other patents pending.
Manufactured in USA

© 2001 Masimo Corporation. Masimo, SET and LNOP are federally registered trademarks of Masimo Corporation.
Radical, SatShare, Signal IQ, FastSat and RadicalScreen are trademarks of Masimo Corporation.

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 SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical Signal Extraction Pulse Oximeter is designed to minimize the possibility of hazards from
errors in the software program by following sound engineering design processes, Risk Analysis and
Software Validation.
■ Explosion hazard. Do not use the pulse oximeter in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
■ The pulse oximeter is NOT intended for use as an apnea monitor.
■ A pulse oximeter should be considered an early warning device. As a trend towards patient
hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to
completely understand the patient’s condition.
■ The pulse oximeter is to be operated by qualified personnel only. This manual, accessory
directions for use, all precautionary information, and specifications should be read before use.
■ Electric shock hazard. Do not open the pulse oximeter cover except to replace the battery of the
Handheld unit. Only a qualified operator may perform maintenance procedures specifically
described in this manual. Refer servicing to Masimo for repair of this equipment.
■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
■ Do not place the pulse oximeter or accessories in any position that might cause it to fall on the
patient. Do not lift the pulse oximeter by the power cord or any other cable.
■ Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
■ Severe anemia may cause erroneous SpO2 readings.
■ Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI
image, and the MRI unit may affect the accuracy of the oximetry measurements.
■ For home use, ensure that the pulse oximeter’s 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 being used.
■ Always remove the sensor from the patient and completely disconnect the patient from the
pulse oximeter before bathing the patient.
■ Do not place the pulse oximeter where the controls can be changed by the patient.
■ Do not place the pulse oximeter face against a surface. This will cause the alarm to be muffled.
■ Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter,
preventing it from working properly.
■ Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain.
Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.
■ Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the
pulse oximeter may cause it to perform inaccurately or fail.
■ Failure of Operation - If the pulse oximeter fails any part of the setup procedures or leakage tests,
remove the pulse oximeter from operation until qualified service personnel have corrected the situation.
■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately.

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 SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)
■ The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a
short time.
■ This equipment has been tested and found to comply with the limits for medical devices to the
IEC 601-1-2:1994, Medical Device Directive 93/42/EEC. These limits are designed to provide
reasonable protection against harmful interference in a typical medical 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 other devices in the
vicinity. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, 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 device.
❚ Increase the separation between the equipment.
❚ Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
❚ Consult the manufacturer for help.

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 table of contents

SECTION 1 / OVERVIEW
About this Manual ........................................................................................................................1
Warnings, Cautions and Notes ....................................................................................................2
Product Description ......................................................................................................................3
Features and Benefits................................................................................................3
Indications for Use ....................................................................................................3
Pulse Oximetry..............................................................................................................................4
General Description ..................................................................................................4
Principle of Operation ................................................................................................4
Functional Vs. Fractional Saturation ..........................................................................5
Measured Vs. Calculated Saturation ........................................................................5
Masimo SET Signal Extraction Technology ..............................................................5

SECTION 2 / SYSTEM DESCRIPTION

Introduction ..................................................................................................................................6
Radical Handheld..........................................................................................................................7
Handheld Front Panel................................................................................................7
Pleth + Signal IQ View ....................................................................................7
Numbers View ..................................................................................................7
Handheld Back Panel ..............................................................................................10
Radical Standalone ....................................................................................................................11
Standalone Front Panel ..........................................................................................12
Standalone Back Panel ..........................................................................................13
Symbols ..................................................................................................................14
Radical Monitor Interface ............................................................................................................14

SECTION 3 / SETUP
Introduction ................................................................................................................................15
Unpacking and Inspection ..........................................................................................................15
Preparation for Monitoring ..........................................................................................................15
Radical Power Requirements ..................................................................................15
Initial Battery Charging ............................................................................................16
Initial Installation ......................................................................................................16
Monitor Setup..............................................................................................................................17
SatShare Setup ..........................................................................................................................18
HP VueLink Setup ......................................................................................................................20
Spacelabs Universal Flexport Setup ..........................................................................................20

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 table of contents

SECTION 4 / OPERATION
Introduction ................................................................................................................................21
Basic Operation ..........................................................................................................................21
General Setup and Use ..........................................................................................21
Successful SpO2 Monitoring ......................................................................................................23
Numeric Display-SpO2 ............................................................................................23
Numeric Display-Pulse Rate ..................................................................................23
Signal IQ ..................................................................................................................24
Low Perfusion ..........................................................................................................25
Actions to be Taken..................................................................................................25
Touch Key Control Buttons and Icons ....................................................................26
First Page ................................................................................................................26
Second Page ..........................................................................................................26
Navigating the Main Menu..........................................................................................................27
Main Menu Selection ..............................................................................................27
Menu Categories ....................................................................................................27
Editing a Parameter ................................................................................................28
Menu Tree ................................................................................................................28
Alarms ........................................................................................................................................30
SpO2 High Limits ....................................................................................................30
SpO2 Low Limits......................................................................................................30
Pulse Rate High Limits (BPM) ................................................................................30
Pulse Rate Low Limits (BPM) ................................................................................30
Type of Limits ..........................................................................................................30
Silence ....................................................................................................................31
Level ........................................................................................................................31
Display ........................................................................................................................................32
View ........................................................................................................................32
Pleth + Signal IQ View ..................................................................................32
Pleth Only ......................................................................................................32
Numbers ........................................................................................................32
Contrast....................................................................................................................32
Language ................................................................................................................32
General........................................................................................................................................33
Averaging Time ........................................................................................................33
FastSat ....................................................................................................................33

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 table of contents

Home Use................................................................................................................33
Interface Alarms ......................................................................................................33
SatShare Numbers ..................................................................................................33
Power Save..............................................................................................................33
Clock............................................................................................................................................33
Time ........................................................................................................................33
Time Format ............................................................................................................33
Date ........................................................................................................................33
Date Format ............................................................................................................33
About ..........................................................................................................................................33
Output..........................................................................................................................................34
Serial Mode..............................................................................................................34
ASCII 1 ..........................................................................................................34
ASCII 2 ..........................................................................................................34
HP Vuelink......................................................................................................34
Spacelabs Flexport ........................................................................................34
Analog Output Mode ..............................................................................................34
0%-100%........................................................................................................34
50%-100%......................................................................................................34
0V Output ......................................................................................................34
1V Output ......................................................................................................34
Service ........................................................................................................................................35
Trend Display ..............................................................................................................................36
Navigating Trend Display ........................................................................................38
First Page ......................................................................................................38
Second Page..................................................................................................38
Third Page......................................................................................................38
Trend Setup..............................................................................................................39
%SpO2 High Scale ........................................................................................39
%SpO2 Low Scale ........................................................................................39
PR High Scale (BPM) ....................................................................................39
PR Low Scale (BPM) ....................................................................................39
Default View ..................................................................................................39
Trend Action ..................................................................................................39
Trend Period ............................................................................................................40

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 table of contents

Backlight / Contrast Operation....................................................................................................40

SatShare Operation ....................................................................................................................40
Home Mode Operation ..............................................................................................................42
Password Operation....................................................................................................................42

SECTION 5 / ALARMS AND MESSAGES

Introduction ................................................................................................................................43
Alarm Identification ....................................................................................................................44
Alarm Operation..........................................................................................................................45
Alarm Messages ........................................................................................................................45
System Messages ......................................................................................................................45

SECTION 6 / TROUBLESHOOTING
Troubleshooting ..........................................................................................................................47

SECTION 7 / SPECIFICATIONS
Radical Specifications ................................................................................................................48
Performance ............................................................................................................48
Electrical ..................................................................................................................48
Environmental ..........................................................................................................49
Physical Characteristics ..........................................................................................49
Serial Interface Specifications ....................................................................................................50
Serial Interface Setup ..............................................................................................51
Serial Printer Setup ................................................................................................51
Analog Output/Nurse Call Specifications ..................................................................................52
Analog Output..........................................................................................................53
SpO2 ........................................................................................................................53
Pulse Rate ..............................................................................................................53
Calibration................................................................................................................53
Nurse Call ................................................................................................................53

SECTION 8 / SENSORS AND PATIENT CABLES

Introduction ................................................................................................................................54
Masimo LNOP Sensors ..............................................................................................................54
Selecting a Masimo LNOP Sensor ........................................................................54
Cleaning and Reuse of Masimo LNOP Sensors ....................................................55
Reattachment of Single Use Adhesive Sensors ....................................................55
Masimo SET Patient Cables ......................................................................................................56
Cleaning and Reuse of Masimo SET Patient Cables ............................................56

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 table of contents

SECTION 9 / SERVICE AND MAINTENANCE

Introduction ................................................................................................................................57
Cleaning ................................................................................................................................57
Battery Operation and Maintenance ..........................................................................................58
Replacing the Batteries ..........................................................................................60
Replacing the Fuses................................................................................................61
Performance Verification ............................................................................................................61
Service and Repair ....................................................................................................................65
Repair Policy............................................................................................................65
Return Procedure ....................................................................................................65
Warranty ......................................................................................................................................66
Exclusions ..................................................................................................................................66

SECTION 10 / ACCESSORIES
Accessories ............................................................................................................67

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 ix Radical Signal Extraction Pulse Oximeter Operator’s Manual

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 overview 1

about this manual

This manual explains how to set up and use the Radical Pulse Oximeter. Important safety
information relating to general use of the Radical Pulse Oximeter appears before this
introduction. Other important safety information is located throughout the manual where
appropriate.
Read the entire safety information section before you operate the monitor.
In addition to the safety section, this manual includes the following sections:

SECTION 1 OVERVIEW gives a general description of pulse oximetry.

SECTION 2 SYSTEM DESCRIPTION describes the Radical Pulse Oximeter

system and its functions and features.

SECTION 3 SETUP describes how to setup the Radical Pulse Oximeter for use.

SECTION 4 OPERATION describes the operation of the Radical Pulse

Oximetry system.

SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6 TROUBLESHOOTING gives troubleshooting information.

SECTION 7 SPECIFICATIONS gives the detailed specifications of the

Radical Pulse Oximeter.

SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and

care for the Masimo SET LNOP sensors and Masimo SET
patient cables.

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain,

service and obtain repair for the Radical Pulse Oximeter.

SECTION 10 ACCESSORIES gives you a list of available Radical accessories.

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 1 overview

warnings, cautions and notes

Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:

A WARNING is provided when actions may result in a serious outcome (i.e., injury,
serious adverse affect, death) to the patient or user. Look for text in a gray shaded box.
Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

A CAUTION is given when any special care is to be exercised by the patient or user to
avoid injury to the patient, damage to this device or damage to other property.
Sample of Caution:
CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

A NOTE is provided when extra general information is applicable.

Sample of Note:
NOTE: This is a sample of a Note.

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 overview 1

product description

The Radical Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate
monitor. Radical can be used as either a Handheld or a Standalone monitor. Radical
features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values
for SpO2, pulse rate, plethysmographic waveform and Signal Identification and Quality
TM
Indicator (Signal IQ ). Radical can be used to interface with a multiparameter patient
monitor to provide Masimo SET pulse oximetry information to that monitor for display.

FEATURES AND BENEFITS

■ Clinically proven Masimo SET technology performance
■ Applicable for use on neonate, pediatric and adult patients
■ Proven for accurate monitoring in motion and low perfusion environments
■ Universal application: Handheld, Standalone and Patient Monitor Interface
■ Automatic upright display with RadicalScreen TM

■ Signal IQ for signal identification and quality indication

TM

■ Analog output and nurse call

■ SpO2, pulse rate, alarm, perfusion index, trend, and pleth waveform displays
■ Lightweight design
■ Internal batteries for transport:
Standalone -12 hours (optional)
Handheld - 4 hours
■ Serial output to printers and PCs

INDICATIONS FOR USE

The Radical Pulse Oximeter and accessories are indicated for the continuous, noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate
(measured by an SpO2 sensor).The Radical Pulse Oximeter and accessories are indicated
for use with adult, pediatric and neonatal patients during both motion and no motion
conditions, and for patients who are well or poorly perfused in hospitals, hospital-type
facilities, mobile and home environments. In addition, the Radical Pulse Oximeter is
indicated to provide continuous noninvasive monitoring data, obtained from the Radical
Pulse Oximeter, to validated multiparameter patient monitors* for display on those monitors.

*Contact Masimo for the latest list of SatShare validated multiparameter monitors.

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 1 overview

pulse oximetry
GENERAL DESCRIPTION
Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial
oxygen saturation in blood. The measurement is taken by placing a sensor on a patient,
usually on the fingertip for adults, and the hand or foot for neonates. The sensor is
connected to the pulse oximetry instrument with a patient cable.The sensor collects signal
data from the patient and sends it to the instrument. The instrument displays the calculated
data in three ways: 1) as a percent value for arterial oxygen saturation (SpO2), 2) as a pulse
rate (PR) and 3) as a plethysmographic waveform. The following figure shows the general
monitoring setup.

Instrument

Patient Cable

Sensor

PRINCIPLE OF OPERATION
Pulse oximetry is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood)
differ in their absorption of red and infrared light (spectrophotometry).
2. The amount of arterial blood in tissue changes with your pulse (photoplethysography).
Therefore, the amount of light absorbed by the varying quantities of arterial blood
changes as well.
The Radical Pulse Oximeter uses a two-wavelength pulsatile system to distinguish
between oxygenated and deoxygenated blood. Signal data is obtained by passing red (rd)
(660 nm wavelength) and infrared (ir)(905 nm wavelength) light through a capillary bed
(for example a fingertip, a hand, a foot) and measuring changes in light absorption during
the pulsatile cycle. See figure below. The Radical utilizes a sensor with red and infrared
light-emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector).
The photodetector receives the light, converts it into an electronic signal and sends it, via
a patient cable, to the Radical for calculation.

LED's

Recessed
Photo Detector

Once Radical receives the signal from the patient sensor, it utilizes Masimo SET signal
extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate.

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 overview 1

FUNCTIONAL VS. FRACTIONAL SATURATION

The Radical measures and displays functional saturation: the amount of oxygenated
hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The
Radical does not measure fractional saturation: oxygenated hemoglobin expressed as a
percentage of all measured hemoglobin, including measured dysfunctional hemoglobin
such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to
functional saturation, the fractional saturation measurements must be converted
according to:
Fractional saturation
Functional saturation = x 100
100 - (% carboxyhemoglobin + % methemoglobin)

MEASURED VS. CALCULATED SATURATION

Oxygen saturation measurements obtained from a pulse oximeter are commonly
compared to saturations calculated from the partial pressure of oxygen (PO2) obtained
from an arterial blood gas sample. When comparing the two measurements, caution
should be used when interpreting the values, as the calculated value obtained from the
blood gas sample may differ from the SpO2 measurement of the pulse oximeter. Different
results are usually obtained from the blood gas sample if the calculated saturation is not
appropriately corrected for the effects of variables that shift the relationship between PO2
and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2),
2,3-DPG, and fetal hemoglobin. Also, as blood gas samples are usually taken over a period
of 20 seconds (the time it takes to draw blood) a meaningful comparison can only be
achieved if the core oxygen saturation of the patient is stable and not changing over the
period of time that the blood gas sample is taken.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY

Masimo Signal Extraction Technology’s signal processing differs from 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 non-arterial blood
also moves, which causes 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 adaptive digital filtering. Adaptive filters
are powerful because they are able to adapt to the varying physiologic signals and/or noise
and separate them by looking at the whole signal and breaking it down to its fundamental
components. Masimo SET signal processing algorithm, Discrete Saturation TransformTM
(DST), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then
reports the true arterial oxygen saturation for display on the monitor.

Masimo SET DST

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 2 system description

introduction

Radical provides the functionality of three pulse oximeters in one:

■ Radical is a fully featured Handheld pulse oximeter
■ Radical is a fully featured standalone pulse oximeter
■ Radical interfaces to the SpO2 input module of multiparameter patient monitors* to
upgrade conventional pulse oximetry technology to Masimo SET technology.

The Handheld portion of Radical contains the majority

4
90
of the pulse oximeter features. All pulse oximetry
measurement information, as well as device status data
is displayed on the Handheld LCD screen. All user input
is handled through the control buttons on the front panel.
The sensor cable connector is located on the Radical
Handheld oximeter.

The Handheld oximeter snaps into the Radical Docking

Station to provide a fully featured standalone pulse
oximeter. The Docking Station connects to AC power for
standalone operation or charging of the Handheld an
optional Docking Station battery is available. The
standalone Radical features nurse call, analog output and
interfaces to serial printers.

Utilizing a SatShareTM cable, the standalone

Radical also interfaces with the SpO2 input of
a validated multiparameter 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
multiparameter patient monitors*.
CAUTIONS:
■ THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR
IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR PATIENT
WAVEFORM.
■ IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS
RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE
MULTIPARAMETER MONITOR
*Contact Masimo for the latest list of SatShare validated multiparameter monitors.

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 system description 2

radical handheld

The Handheld Radical provides most of the functionality of the pulse oximeter. All user 90

4
input and displays are controlled by this part of the Radical system. The sensor cable
connects into the swivel connector on the Handheld unit.The Handheld is battery powered
and can be used either as a transport monitor or as a Handheld Pulse Oximeter for spot
checks.

HANDHELD FRONT PANEL

The following figure and corresponding text outline all the features of the Handheld Radical:

Pleth + Signal IQ View

1 2 3 4 5 6 7 8 9 10 11

Masimo SET FastSat No Sensor

100
85
%SpO2

140
50
BPM
HPO1 06:10:23pm 03/27/01

23 22 21 20 19 18 17 16 15 14 13 12

Numbers View
23

Masimo SET

160 BPM
100 %SpO2 40
85 11:42:46 03/27/01

5 22

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 2 system description

1 Handheld Press down the Handheld Release Button and pull the Handheld device off
Release the Docking Station.
Button

2 SpO2 The functional arterial hemoglobin oxygen saturation is displayed in units of

Measurement percentage SpO2. The upper and lower SpO2 alarm limits are also displayed
Display next to the SpO2 measurement. When a sensor is not connected to a patient
and during pulse search, the display will show dashed lines. When the
measured value is outside of the alarm limits, the SpO2 Measurement Display
flashes and an alarm will sound. The oxygen saturation is calculated and the
display is updated at a frequency of once per second.

3 Masim Masimo SET The Masimo SET symbol is shown on the Radical display when SET
o SET processing is active.
FastSa
4 FastSat The FastSat symbol is shown on the Radical display whenever the Radical is
t
set to operate in the FastSat mode.

5 Saturation The Saturation Alarm Limits Display shows the upper and lower saturation
Alarm Limits alarm limits. When an alarm limit is reached or exceeded, the SpO2 value and
Display the violated limit flashes.

6 Alarm Status The alarm status indicator (a bell) can be shown with or without a slash. It
Indicator flashes when an alarm condition is present. When the alarm is silenced using
the Alarm Silence Button, an alarm status indicator with a slash and a timer is
shown to indicate that the alarm is temporarily silenced. When the alarm is
silenced through All Mute menu selection, which is permanent until power is
cycled or deselected using menu, an alarm status indicator with a slash is
shown to indicate that alarm has been silenced.

7 System The system messages generated by the instrument are displayed in the
Message Area System Message Area. See Section 5, System Messages.

8 Max Maximum The Maximum Sensitivity icon is shown on the Radical display whenever the
Sensitivity Radical is set to operate in the Maximum sensitivity mode.

9 Battery Status The Battery Status Indicators show the capacity of the Radical Handheld and
Indicators optional Docking Station batteries. The indicator flashes when less than 15
minutes of battery life is left and the battery needs to be recharged. The
Docking Station Battery Status indicator is not shown when the optional
Docking Station battery is not present.

10 Touch Key Press a Touch Key Control Button to select the corresponding touch key icon.
Control Buttons See Section 4, Touch Key Control Buttons and Icons for more details.

11 Loudspeaker The loudspeaker indicates audio alarms. Care should be taken not to cover
the loudspeaker and muffle the audible alarm volume.

12 Patient Cable Connect the patient cable to the Handheld Radical by plugging the cable into
Connector the Patient Cable Connector. Use only Masimo compatible sensors and
cables with this oximeter. See Section 8, Sensors and Patient Cables for more
details.

13 Touch Key The Touch Key Icons indicate the software menu items that can be selected
Icons through the Touch Key Control Buttons. Pressing a Touch Key Control Button
next to an icon selects the option.

14 Signal IQ The Signal IQ shows the acquired signal quality and the timing of the pulse. A
tall vertical line indicates a high quality signal, while a small vertical line
indicates a low quality signal. The Signal IQ waveform display is updated with
a frequency of 31.25 times per second. The Signal IQ may also be shown as
a single, pulsating bar.

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 system description 2

15 Pulse The Pulse Waveform Display shows the acquired plethysmograph waveform.
Waveform The pleth waveform is scaled with signal strength. Signal strength is defined as
Display the relation of arterial pulsatile signal to the non-pulsatile signal component.
The Pulse Waveform Display is updated with a frequency of 31.25 times per
second.

16 Time and Date The Time and Date Indicator displays the current time and date. The date and
Indicator time is displayed in dd/mm/yyyy or mm/dd/yyyy format. Select the date and
time display format in the Clock menu.

17 Backlight/ Press the Backlight Button to change the illumination level of the backlight.
Contrast With the AC line power connected, four levels of illumination are available (in
Button addition to the no illumination level). In the Handheld mode, three levels of
illumination are available (again in addition to the no illumination level). Use
the lowest illumination for most efficient battery usage. The backlight Button is
also used to change the contrast of the LCD display. Press and hold the
Backlight Button for longer than two seconds to change the contrast. Release
the Backlight Button at the desired contrast setting.

18 Alarm Silence Press the Alarm Silence Button to temporarily silence patient alarms. Press the
Button Alarm Silence Button when the SENSOR OFF or NO SENSOR messages are
flashing (i.e. the sensor is removed from the patient) to acknowledge the end of
monitoring. In these states, all further alarms are suspended until the pulse
oximeter starts measuring SpO2 and pulse rate again.
Note: System failure alarms can be silenced by pressing the Power/Standby
or Alarm Silence Button. If the Power/Standby button does not silence the
system fault alarm, press the alarm silence button.

19 Output Mode The Output Mode Indicator displays the output mode selected by the user.
Indicator The Output Mode Indicator also displays the type of SatShareTM cable. The
Output Mode indicator is only displayed when the Radical device actively
outputs data other than ASCII text, or interfaces with a monitor through the
SatShare cable.

20 Power/Standby Press the Power/Standby Button to turn the instrument on. Press, hold the
Button button for more than 2 seconds and then release the button to turn the
instrument off.

21 PI Perfusion Index The Perfusion Index indicates numerically the percentage of pulsatile signal to
non-pulsatile signal.

22 Pulse Rate The Pulse Rate Alarm Limits Display shows the upper and lower pulse rate
Alarm Limits alarm limits. When an alarm limit is reached or exceeded, the pulse rate value
Display and the violated limit flashes.

23 Pulse Rate The Pulse Rate Measurement Display shows the patient’s pulse rate in beats
Measurement per minute. The upper and lower pulse rate alarm limits are also displayed
Display next to the pulse rate measurement. The pulse rate is calculated and the
display is updated at a frequency of once per second.

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 2 system description

HANDHELD BACK PANEL

The Handheld back panel features the interconnection to the Docking Station, an
accessory mount for the pole clamp accessory and access to the Handheld battery pack.

MEDICAL ELECTRICAL EQUIPMENT

UL 2601-1/CAN/CSA C22.2 No. 601.1
11328J-1000

80FK

1251 0000 536

1 2 3

1 Docking The Radical Handheld interfaces with the Docking Station through this
Station connector.
Connector

2 Pole Clamp The optional Pole Clamp accessory attaches to this holder. See the Directions
Accessory for Use of the Pole Clamp accessories for attachment instructions.
Holder

3 Battery Cover The Radical Handheld is powered by a NiMH battery located in this
compartment. For battery care and replacement please see Section 9,
Replacing the Batteries.

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radical standalone

When the Radical Handheld is placed into the Docking Station, the Radical becomes a
full-featured standalone device. The Radical Standalone acts as a battery charger for
the Handheld device and has AC power connection capabilities. The Standalone can also
interface to serial devices, nurse call or analog output devices, and multiparameter patient
monitors through a SatShare cable.
There are several models of Docking Stations available. The following table outline which
features are available for each model of Docking Station.

DOCKING STATION FEATURES RDS-1 RDS-1B RDS-2 RDS-3 RDS-3B

AC Power Input ■ ■ ■ ■ ■
SatShare Interface ■ ■
Serial RS-232 Interface ■ ■ ■ ■
Nurse Call/Analog Output Interface ■ ■ ■ ■
12-hour Extended Battery ■ ■
Automatic Display Rotation Support (Gravity Detector) ■ ■ ■ ■
Docking Station Battery Charging Indicator ■ ■ ■ ■
Handheld Battery Charging Indicator ■ ■ ■ ■ ■
Red Alarm Inidcator ■ ■ ■ ■
AC Power Indicator ■ ■ ■ ■ ■
Docking Indicator ■ ■ ■ ■

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 2 system description

STANDALONE FRONT PANEL

The following figure and corresponding text review the features of the Radical
Standalone device.

1 Masimo SET FastSat Check Sensor

2 100
85
%SpO2
3 140
50
BPM
4 11:42:46 03/27/01

1 Docking The Docking Station Battery Charging Indicator is illuminated when the
Station Battery Docking Station battery is charging. The indicator blinks just prior to charging.
Charging The charging indicator does not illuminate when the battery is fully charged or
Indicator when the battery is not present.

2 Handheld The Handheld Battery Charging Indicator is illuminated when the Handheld
Battery battery is charging. The indicator blinks just prior to charging. The Charging
Charging Indicator does not illuminate when the battery is fully charged or when the
Indicator battery is not present.

3 Visual Alarm The Visual Alarm Indicator is illuminated when an alarm condition is active and
Indicator the Alarm Status Indicator is shown.

4 AC Power The AC Power Indicator is illuminated when the Radical Docking Station is
Indicator plugged into AC line power.

5 Docking The Docking Indicator is illuminated when the Handheld unit is turned on and
Indicator is properly interfaced to a Docking Station.

NOTE: When the Radical Standalone is turned on, all indicator LEDs initially turn on and off
at start up.

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 system description 2

STANDALONE BACK PANEL

1 2 3

P2 P3

MEDICAL ELECTRICAL EQUIPMENT

UL 2601-1/CAN/CSA C22.2 No. 601.1
80FK

Manufactured by:
Masimo Corporation
Irvine, CA 92614
USA
Made in USA

11329H-0900
U.S.A. Patents 5,482,036; 5,490,505; 5,632,272; 5,685,299;
5,738,644; 5,769,785.

Rx Only

5 4

1 P1 Serial Output Use the Serial Output Connector to connect a serial device, including a serial
Connector printer or PC, to the Radical. The data is provided in standard RS-232C format.
See Section 7, Serial Interface Specifications. All external device connections
to the Serial Output Connector must be IEC-60950 compliant.

2 P2 Analog Output / Use the Analog Output Connector to interface with an analog output device,
Nurse Call such as a chart recorder or nurse call system. All external device connections
Connector to the Analog Output / Nurse Call Connector must be IEC-60950 compliant.

3 P3 SatShare Cable Use the SatShare Cable Connector to connect a SatShare cable to the SpO2
Connector input connector of a multiparameter patient monitor. All external device
connections to the SatShare Cable Connector must be IEC-60101-1-1
compliant. SatShare cables are available to interface with most major
multiparameter 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. Refer to the Masimo web site at www.masimo.com for the
latest SatShare cables and validated instruments.

4 Power Entry The power entry module contains the input connector for AC power, an on/off
Module switch and two fuses. The AC input and the on/off switch provide power to the
system from the AC line. Always connect the pulse oximeter to the mains power
for continuous operation and/or battery recharging.
NOTE: Some power entry modules may not have the on/off switch.
5 Equipotential Use the Equipotential Ground Connector for grounding.
Ground
Connector

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 2 system description

SYMBOLS
The following symbols are found on the back of the Radical Docking Station, they are
defined below:

SYMBOLS
RS-232

SatShare interface

Equipotential Ground Terminal

See Instructions for Use
Fuse Replacement
Analog Out Interface

Nurse Call Interface

NOTE: Some of the interfaces and symbols are not available in all versions of the
Docking Station.

radical monitor interface

In addition to being a full-featured Handheld and Standalone Pulse Oximeter, Radical’s

unique SatShare interface links the Radical to most existing multiparameter patient
monitors through the pulse oximetry patient cable or SpO2 input connector.

■ Upgrades any approved and validated monitor to Masimo SET performance by

using the calculated SpO2 and pulse rate determined by Radical to simulate an
ideal waveform, which is sent to the validated multiparameter patient monitor.
■ Connects into the SpO2 patient cable or SpO2 input connector of the
multiparameter patient monitor.

CAUTION: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT

MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR THE
PATIENT WAVEFORM.

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 set-up 3

introduction

Before the Radical Pulse Oximeter can be used in a clinical setting, it needs to be
inspected, properly setup and the batteries need to be fully charged.

unpacking and inspection

Remove the instrument from the shipping carton and examine for signs of shipping
damage. 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.
If anything is missing or damaged, contact the Technical Service Department. The contact
address and phone numbers are listed in Section 9, Service and Repair.

preparation for monitoring

The following sections of the manual describe the preparation, set-up and initial installation
of the Radical Pulse Oximeter.

RADICAL POWER REQUIREMENTS

Always use a hospital grade, AC power cable to connect the Radical Pulse Oximeter to an
AC power source. Do not connect the Radical Pulse Oximeter Docking Station to an AC outlet
controlled by a switch.
Verify the AC power voltage and frequency before use. Verify that the power source can
provide adequate power rating as indicated on the rear panel of the Radical Docking Station.
The Radical Pulse Oximeter is designed to operate on 100 to 240VAC, 47-63 Hz.The device
is rated at 55 VA max.
Connect a hospital grade power cable to the power entry module of the Radical unit (IEC-320
connector type at the Radical). Connect the power cable to an AC power source.
Turn the AC power switch of the power entry module of the Docking Station to “ | ”*. Ensure
that the unit is adequately powered by verifying that the AC power indicator on the Docking
Station is illuminated.
*NOTE: Some power entry modules may not have the AC power switch.

CAUTION:
■ CONNECT THE OXIMETER ONLY TO A HOSPITAL-GRADE RECEPTACLE.
■ DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM
THE POWER PLUG.
■ DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER CORD
AND PLUG MUST BE INTACT AND UNDAMAGED.

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 3 set-up

■ IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH

CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY
POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY
FUNCTIONAL.
■ TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER
EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.
■ DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH
OR DIMMER.

INITIAL BATTERY CHARGING

Before use, the Radical Handheld battery and the optional Docking Station battery needs
to be fully charged.
To charge the batteries, attach the Handheld unit to the Docking Station, turn the AC power
switch to “ l ”*.Verify that the batteries are charging.The battery charging LED indicators on the
Docking Station flash prior to charging and remain illuminated while the batteries are charging.
Refer to Section 9, Battery Operation and Maintenance, for proper battery charging.
Note: Some power entry modules may not have the AC power switch.

INITIAL INSTALLATION
Place the Docking Station on a stable hard flat surface near the patient. Always place the
Radical unit on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the
Radical Standalone unit. Make sure that Radical loudspeaker is not covered to avoid a
muffled alarm sound.
The Radical Handheld, Docking Station or Standalone should not be operated outside the
following environmental conditions:

OPERATING ENVIRONMENTAL CONDITIONS

TEMPERATURE +5°C to +40°C, +41°F to +104°F

HUMIDITY 5% to 95%, non-condensing

OPERATING ALTITUDE 1060 mbar to 500 mbar pressure

-1000 ft to 18,000 ft (-304 m to 5,486 m)

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 set-up 3

monitor setup

The Radical Pulse Oximeter stores two types of default values: those that Radical
automatically reverts to after a power cycle, and those that can be changed by the user
and will be remembered after a power cycle.
The following table outlines the default values that Radical reverts to after a power cycle.

OPTION DEFAULT SETTING

ALARM SILENCE Alarm silence time is set to 120 seconds

LCD SCREEN ILLUMINATION (AC power) Illumination set to maximum, level 4

LCD SCREEN ILLUMINATION (battery power) Illumination set to off

The following table outlines the type of settings that the user can change and Radical will
remember after a power cycle.

OPTION DEFAULT SETTING

SpO2 HIGH/LOW ALARM LIMIT Set to pre-power down setting

PULSE RATE HIGH/LOW ALARM LIMIT Set to pre-power down setting

DISPLAY VIEW AND CONTRAST Set to pre-power down setting

AVERAGING TIME Set to pre-power down setting

FASTSAT Set to pre-power down setting

HOME USE Set to pre-power down setting

INTERFACE ALARMS Set to pre-power down setting

SATSHARE NUMBERS Set to pre-power down setting

POWER SAVE Set to pre-power down setting

SENSITIVITY Set to pre-power down setting

DATE AND TIME FORMAT Set to pre-power down setting

LANGUAGE Set to pre-power down setting

ANALOG OUTPUT Set to pre-power down setting

SERIAL OUTPUT PORT MODE Set to pre-power down setting

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 3 set-up

ALARM VOLUME Set to pre-power down setting

PULSE BEEP VOLUME Set to pre-power down setting

TREND DISPLAY PARAMETERS Set to pre-power down setting

TREND PERIOD Set to pre-power down setting

satshare setup

The Radical Pulse Oximeter has been proven to be accurate during patient motion and low
perfusion conditions. Saturation and pulse rate values from the Radical may be displayed on
a multiparameter monitor through the SatShare feature.
The SatShare feature provides an ideal, simulated waveform corresponding to the measured
saturation and pulse rate values determined by the Masimo SET technology.This waveform
may be used to display these values on multiparameter monitors through the
multiparameter monitor’s oximetry sensor or input connector.
It is recommended that the Radical is positioned close to the multiparameter monitor with
the Radical screen visibly displaying the plethysmographic waveform and the saturation and
pulse rate measurements.

SatShare Setup:
1. Select the SatShare cable that is appropriate for the multiparameter monitor that is
being connected. Check the Masimo web site at www.masimo.com for the latest list
of available SatShare cables and validated instruments.
2. Connect the labeled end of the cable to the SatShare Cable Connector port on the
back of the Docking Station. Tighten the connector screws for a secure connection.
3. Connect the other end of the SatShare cable either to the sensor connector of the
multiparameter monitor’s SpO2 cable or directly to the SpO2 connector on the monitor.

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 set-up 3

4. Verify that Radical recognizes the correct cable. The name of the SatShare cable will
be displayed on the LCD screen when the SatShare mode is functional.
5. Set the multiparameter monitor’s high and low saturation and pulse rate alarm limits
as appropriate.
6. Set the multiparameter monitor's averaging time to the lowest setting (i.e. fastest
response). Radical's ideal waveform obviates the need for additional averaging by
the monitor. If the multiparameter monitor's averaging time is not changed, the time
to display physiological changes in saturation on the monitor will be increased with
SatShare. However, the delay can be minimized by reducing the multiparameter
monitor's averaging time.
7. While in the SatShare mode, if there are any significant discrepancies between
the readings from the Radical and those on the monitor displaying the values
obtained from SatShare, the values reported by the Radical are to be considered
the correct values.
8. To use the Radical with SatShare while it is not connected to AC power, set the
Power Save parameter in the General menu to "No", refer to Section 4, Operation.
Please note that if the Radical is used in this mode, the length of time the Radical
can operate on battery power will be significantly diminished.
9. Set the SatShare Numbers and the Interface Alarms parameters in the General
menu according to Customer preference.
10. If displaying the simulated waveform is not desirable, it is recommended to turn off
the pleth waveform display of the multiparameter patient monitor.

CAUTIONS:
■ WHILE OPERATING IN SATSHARE MODE, THE AUDIBLE ALARMS MAY BE
DISABLED ON THE RADICAL. USE THE ALARM SETTINGS OF THE
MULTIPARAMETER MONITOR FOR AUDIBLE AND VISUAL ALARM INDICATION.
■ TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY
EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL PULSE
OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY.
■ TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS
MAINTAINED, MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS
PROPERLY SECURED AT THE DOCKING STATION.

WARNING: EXTERNAL DEVICE CONNECTIONS TO THE SATSHARE PORT

MUST BE IEC-60101-1-1 COMPLIANT.

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 3 set-up

hp vuelink setup

1. Select the HP VueLink selection from the Output menu on the Radical. Refer to
Section 4, Output.
2. Connect one end of the VueLink cable to the Serial Output connector on the back of
the Docking Station.
3. Connect the other end of the VueLink cable to the VueLink module and insert the
module into the HP/Agilent monitor rack.
4. The SpO2 and pulse rate values will automatically appear on the HP/Agilent
monitor.
5. In order for the pleth waveform to be displayed on the HP/Agilent monitor and for the
HP/Agilent monitor to indicate the alarm conditions measured by the pulse oximeter, the
user must configure the HP/Agilent monitor. Please see the HP/Agilent Operator’s
manual for complete instructions.
6. The Radical Pulse Oximeter can be set up to audibly indicate all patient alarms
while communicating with the HP VueLink module. Use the Inteface Alarms setting
in the General menu to enable and disable audible alarms on the Radical.

spacelabs universal flexport setup

1. Select the Spacelabs Flexport selection from the Output menu on the Radical.
2. Connect one end of the Spacelabs Flexport cable to the Serial Output connector on
the back of the Docking Station.
3. Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal
Flexport connector.
4. The SpO2 and pulse rate values will automatically appear on the Spacelabs screen.
5. In order for the pleth waveform to be displayed on the Spacelabs screen and for the
Spacelabs monitor to indicate the alarm conditions measured by the pulse oximeter,
the user must configure the Spacelabs monitor. Please see the Spacelabs monitor
Operator’s manual for complete instructions.
6. The Radical Pulse Oximeter can be set up to audibly indicate all patient alarms
while communicating with the Spacelabs Flexport module. Use the Inteface Alarms
setting in the General menu to enable and disable audible alarms on the Radical.

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 operation 4

introduction

To operate the Masimo SET Radical Pulse Oximeter effectively, the device must be set up
properly, and the operator must:
■ Know how the pulse oximeter derives its readings (see Section 1, Pulse Oximetry).
■ Be familiar with its controls, components and operation.
■ Understand its status and alarm messages (see Section 5, Alarm Identification,
System Messages and Section 6, Troubleshooting).

basic operation

GENERAL SETUP AND USE

1. Inspect the oximeter case for damage.

2. Connect the patient cable to the Patient cable connector of the Radical. Make sure
it is a firm connection and the cable is not twisted, sliced or frayed.
3. Ensure that the power cord is plugged into the Power Entry Module of the oximeter
and into the AC power.
4. Ensure that the AC power switch of the Power Entry Module of the Docking Station
is in the “ | “ position.
NOTE: Some power entry modules may not leave the on/off switch.
5. Select a sensor that is compatible with the oximeter before connecting it to the
patient cable. See section 8, Sensors and Patient Cables. If using a single patient
adhesive or disposable sensor, check that the emitter (red light) and the
photodetector (white plastic casing) are properly aligned. If using a reusable
sensor, make sure it opens and closes smoothly. Remove any substances that
may interfere with the transmission of light between the sensor’s light source and
photodetector.
6. Attach the sensor to the patient. Refer to the Directions for Use of the sensor.
7. Connect the sensor to the patient cable with the logos lining up; make sure it is a
firm connection.
8. Press the Power/Standby button to turn the oximeter on.
9. Make sure the display window is free of alarm and system failure messages (see
Section 5, Alarm Identification).
10. On the display, verify
■ The high and low alarm limits for SpO2 and pulse rate.
■ The readings for SpO2 and pulse rate.
NOTE: “—” may appear on the numeric display until the SpO2 and pulse rate
readings have stabilized (approximately 10 seconds).

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 4 operation

11. Verify that the patient alarms are functional by setting the high and low SpO2 and
pulse rate alarm limits beyond the patient readings.
■ An alarm tone sounds.
■ The violated alarm limit and reading flash on the display.
■ The red alarm indicator flashes on the Docking Station (standalone operation).
12. Verify the sensor alarms are functional by removing the sensor from the sensor site.
■ SENSOR OFF appears in the message area of the graphic display.
■ The alarm tone sounds.
■ The alarm indicator flashes.
■ Disconnect the sensor from the patient cable or oximeter.
■ Confirm that “NO SENSOR” appears in the message area of the graphic display.
13. Verify alarm silence operation.
■ Create an alarm condition by lowering the SpO2 or pulse rate high alarm
limits beyond the patient readings.
■ Press the Alarm Silence button.
■ The alarm tone ceases for the displayed amount of time.
14. To begin patient monitoring:
■ Adjust the alarm limits.
■ Adjust the alarm volumes.
■ Adjust the pulse beep volume.
15. Verify the sensor is on correctly and that the measured data is appropriate, see
Section 4, Successful SpO2 Monitoring.
16. Monitor the patient.
17. After monitoring is complete, remove the sensor from the patient and store or
dispose of the sensor according to governing rules. See the Directions for Use of
the sensor.
18. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off.

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 operation 4

successful SpO 2 monitoring

The following general points will aid in ensuring oximetry monitoring success.
■ Place the sensor on a site that has sufficient perfusion and provides proper
alignment of the LED’s and photodetector.
■ Place the sensor on a site that has unrestricted blood flow.
■ Do not constrict the monitoring site when securing a sensor with tape.
■ Do not select a site near potential electrical interference (electrosurgical unit, for
example).
■ Read the sensor Directions for Use for proper sensor application.

NUMERIC DISPLAY - SpO2

Stability of the SpO2 readings may be a good indicator of signal validity. Although stability
is a relative term, experience will provide a good feeling for changes that are artifactual or
physiological and the speed, timing, and behavior of each.The stability of the readings over
time is affected by the averaging mode being used.The longer the averaging time, the more
stable the readings tend to become. This is due to a dampened response as the signal is
averaged over a longer period of time than during shorter averaging times. However, longer
averaging times delay the response of the oximeter and reduce the measured variations of
SpO2 and PR.
Inaccurate measurements may be caused by:
■ Significant levels of dysfunctional hemoglobin (e.g., carboxyhemoglobin or
methemoglobin).
■ Intravascular dyes such as indocyanine green or methylene blue.
■ Venous pulsations at the frequency of the patient’s arterial pulse.
■ Very low hemoglobin levels.

NUMERIC DISPLAY - PULSE RATE

The Pulse Rate displayed on the Radical may differ slightly from the heart rate displayed on
ECG monitors due to differences in averaging times. There may also be a discrepancy
between cardiac electrical activity and peripheral arterial pulsation. Significant differences
may indicate a problem with the signal quality due to physiological changes in the patient or
one of the instruments or application of the sensor or patient cable.The pulsations from intra-
aortic balloon support can be additive to the pulse rate displayed on the pulse oximeter .

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 4 operation

SIGNAL IQ
The Radical display provides a visual, indicator of the plethysmogram signal quality and an
alert when the displayed SpO2 values are not based on adequate signal quality. The signal
quality indicator displayed on the Radical is called the Signal IQ.The Signal IQ can be used
to identify the occurrence of a patient's pulse and the associated signal quality of the
measurement.
With motion, the plethysmographic waveform is often distorted and may be obscured by
artifact. The Signal IQ, shown as a vertical line, coincides with the peak of an arterial
pulsation. Even with a plethysmographic waveform obscured by artifact, the Radical locates
the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the
Signal IQ.
The height of the vertical line of the Signal IQ indicates the quality of the measured signal.
A high vertical bar indicates that the SpO2 measurement is based on a good quality signal.
A small vertical bar indicates that the SpO2 measurement is based on data with low signal
quality. When the signal quality is very low the accuracy of the SpO2 measurement may be
compromised, and a “Low Signal IQ” message is displayed in the message area on the
Radical display. When the "Low Signal IQ" message appears proceed with caution and do
the following:

■ Assess the patient.

■ Check the sensor and ensure proper sensor application. The sensor must be well
secured to the site for the Radical to maintain accurate readings. Also, misalignment
of the sensor's emitter and detector can result in smaller signals.
■ Determine if an extreme change in the patient's physiology and blood flow at the
monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion,
sampling of an arterial blood specimen from the hand containing the pulse oximetry
sensor, severe hypotension, peripheral vasoconstriction in response to hypothermia,
medications, or a spell of Raynaud's syndrome.)
■ With neonates or infants, check that the peripheral blood flow to the sensor site is
not interrupted. For example, as may occur while lifting or crossing their legs, during
a diaper change.

After performing the above, if the "Low Signal IQ" message is displayed frequently or
continuously obtaining an arterial blood specimen for CO-oximetry analysis may be
considered to verify the oxygen saturation value.

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 operation 4

LOW PERFUSION
The Radical displays an indicator (i.e., “Low Perfusion” message) when there are very low
amplitude arterial pulsations.
It has been suggested that at extremely low perfusion levels, pulse oximeters can measure
peripheral saturation, which may differ from central arterial saturation1. This “localized
hypoxemia” may result from the metabolic demands of other tissues extracting oxygen
proximal to the monitoring site under conditions of sustained peripheral hypoperfusion.
(This may occur even with a pulse rate that correlates with the ECG heart rate.)

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.

1
Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and
Vasoconstriction. Anesthesiology 1990; 73:532-537

ACTIONS TO BE TAKEN
If the SpO2 readings show significant differences, do the following:
■ Make sure the emitter and photodetector are aligned directly opposite each other.
■ Select a site where the distance between the emitter and photodetector is minimized.
■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-
30% methyl salicylate and 2-10% menthol) for 20-30 seconds. Strong vasodilator
creams, such as nitroglycerin paste, are not recommended.
■ If possible, remove electrical noise sources such as electrosurgical units or other
electrical/electronic equipment. If these solutions are not possible, operate the
oximeter on battery power, or try plugging the oximeter into a different electrical outlet.
■ If artificial nails or excessive fingernail polish are present, select another site or
remove the polish/artificial nails.
■ If possible, ensure that the sensor is placed in a location with low ambient light.
Although the Radical Pulse Oximeter with integrated Masimo SET technology has
significant immunity to ambient light, excessive ambient light may cause readings to
be incorrect.

CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE

PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE
OXIMETER FOR PROPER FUNCTIONING.

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 4 operation

touch key control buttons and icons

touch key The touch key control buttons are the four dark grey control buttons to the right of the
control button Handheld display.To select a touch key icon, press and release the dark gray control button
to the right of the icon.
On the Radical display, four icons are shown on the right side or bottom of the LCD display.

FIRST PAGE

Next Menu Press the Next Menu Page button to access the second page of selections.
Page

Menu Access Press the Menu Access button to enter the main menu.

Increase Press the Increase Loudness button to increase the volume of the pulse beep.
Loudness Seven levels of volume exist.

Decrease Press the Decrease Loudness button to decrease the volume of the pulse beep.
Loudness The lowest volume level will silence the pulse beep.

SECOND PAGE
Next Menu Press the Next Menu Page button to return to the first page of selections.
Page

Trend Display Press the Trend Display button to show the trend data on the display.

Sensitivity Press the Sensitivity button to toggle between the Normal and Maximum
sensitivity modes. Use the Normal sensitivity setting for normal patient
monitoring purposes. Use the Maximum sensitivity setting for improved
sensitivity performance on patients with extremely low perfusion.
Note: When using the Maximum sensitivity setting, the SENSOR OFF detection
performance may be compromised.
The device automatically retains the sensitivity setting after a power cycle.

Rotate Display Press the Rotate Display button to reconfigure the display screen in a vertical or
horizontal format. The display rotates clockwise in 90 degree increments.

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navigating the main menu

When the main menu is accessed, the plethysmograph and Signal IQ waveform displays
are replaced with the main menu items.The touch key icons, displayed along the right edge
of the LCD display, are also replaced by the menu access icons. When the main menu is
accessed the monitor remains functional and the saturation and pulse rate numbers will
continue to be displayed.

MAIN MENU SELECTION

The top menu category uses the following four menu selections and touch key control
buttons and icons.
EXIT Select the Exit icon to exit the main menu.

SELECT Select the Select Category icon to select the highlighted menu item and enter
CATEGORY the next level menu.

PREVIOUS Select the Previous icon to scroll through the menu items without selecting
them. Once a menu item is highlighted, enter the menu by pressing the Select
Category icon.

NEXT Select the Next icon to scroll through the menu items without selecting them.
Once a menu item is highlighted, enter the menu by pressing the Select
Category icon.

MENU CATEGORIES
Once a menu category has been selected, a new set of menu selections and icons
are displayed.
EXIT Select the Exit icon to exit the menu category and return to the previous menu.

EDIT PARAMETER Select the Edit Parameter icon to select the highlighted parameter for editing.

PREVIOUS Select the Previous icon to scroll through the parameters without selecting
them. Once a parameter is highlighted, edit the parameter by pressing the Edit
Parameter icon.

NEXT Select the Next icon to scroll through the parameters without selecting them.
Once a parameter is highlighted, edit the parameter by pressing the Edit
Parameter icon.

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EDITING A PARAMETER
Once a parameter has been selected for editing, a new set of menu selections and icons
are displayed.

EXIT Select the Exit icon to exit the parameter without making the new selections
permanent.

ACCEPT Select the Accept icon to save the changes.

PREVIOUS Select the Previous icon to increase or toggle the parameter settings.

NEXT Select the Next icon to decrease or toggle the parameter settings.

MENU TREE
This section gives an overview of the menu selections that are available. To navigate
through the menus, use the touch key icons and control buttons located on the front panel
of the Handheld, to the right of the LCD display. The following sub-sections describe each
menu item in more detail.

% SpO2 high/low limit

Pulse rate high/low limit (bpm)
ALARMS Type of alarm limits
Silence
Level

View
DISPLAY Contrast
Language

Averaging Time
FastSat
Home Use
GENERAL
Interface Alarms
SatShare Numbers
Power Save

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Time (hour/minute)
Time display format
CLOCK
Date (day/month/year)
Date display format

ABOUT Software Version

Serial Mode
OUTPUT
Analog Output Mode

Handheld Battery Deep Discharge

SERVICE
DS Battery Deep Discharge

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alarms

Check alarm limits each time the pulse oximeter is used to ensure that they are appropriate
for the patient being monitored. An audible alarm and a flashing alarm icon (and indicator
light) will occur when an alarm limit is met or exceeded.

MENU ITEMS DESCRIPTION

SpO2 The SpO2 high alarm limit can be set anywhere between 2% and
HIGH LIMIT 100%, with a 1% step size. In the “----” (off) setting, the alarm can
be turned off completely.

SpO2 The SpO2 low alarm limit can be set anywhere between 1% and
LOW LIMIT 100%, with a 1% step size.
NOTE: The low alarm limit always has to be set below the high alarm setting. When
the high alarm limit is set below the low alarm limit, the low alarm limit will
automatically adjust to the next setting below the newly entered high alarm limit
setting.

PULSE RATE The pulse rate high alarm limit can be set anywhere between
HIGH LIMIT 30 BPM and 240 BPM, with a 5 BPM step size.
(BPM)

PULSE RATE The pulse rate low alarm limit can be set anywhere between
LOW LIMIT 25 BPM and 235 BPM, with a 5 BPM step size.
(BPM)
NOTE: The low alarm limit always has to be set below the high alarm setting. When
the high alarm limit is set below the low alarm limit, the low alarm limit will
automatically adjust to the next setting below the newly entered high alarm limit
setting.

TYPE The Radical stores three types of alarm limits: Adult, Neo or
OF LIMITS Custom limits. Adult and Neo limits are preset and cannot be
changed by the user. The following table outlines the default
values of the preset and custom alarm limits.
SpO2 SpO2 PULSE RATE PULSE RATE
TYPES
(HIGH) (LOW) (HIGH) (LOW)

ADULT LIMITS Off 90% 140 BPM 50 BPM

NEO LIMITS 100% 90% 180 BPM 100 BPM

CUSTOM LIMITS Off* 90%* 140 BPM* 50 BPM*

*NOTE: The custom limits are set to the values listed in the table at the factory. Once the
values are changed, the new values are retained after a power cycle.

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SILENCE This menu allows the user to set the alarm silence period. An
alarm is silenced by pressing the Alarm Silence button on the
front panel.

30, 60, 90,120 SECONDS

The alarm silence duration is set. As an indicator that the alarm
system is silenced, the Alarm Status Indicator is shown as a bell
with a slash through it. A timer is shown next to the bell indicating
the remaining alarm silence duration.
NOTE: The alarm silence period is reset to 120 seconds upon power cycle, except
for when the Radical is set to operate in the Home mode.

ALL MUTE
All patient alarm conditions are silenced. Only system alarms will
be indicated by an audible alarm. As an indicator that the system
is set to All Mute, the Alarm Status Indicator is shown as a
flashing bell with a slash through it.

ALL MUTE WITH AUDIBLE REMINDER

All patient alarm conditions are silenced. Only system alarms will
be indicated by an audible alarm. As a reminder, a single audible
alarm will occur every three minutes. As an indicator that the
system is set to All Mute the Alarm Status Indicator is shown as
a flashing bell with a slash through it.

LEVEL This menu allows the user to set the alarm volume. Four levels
are available: level 1 being the softest and level 4 being the
loudest. The device retains the Alarm Volume setting upon a
power cycle.
NOTE: For home use, set the alarm level to level 4.

WARNING: IF AN ALARM CONDITION OCCURS WHILE THE ALARM SILENCE

PERIOD IS SET TO ALL MUTE, THE ONLY ALARM INDICATIONS WILL BE
VISUAL DISPLAYS AND SYMBOLS RELATED TO THE ALARM CONDITION. NO
ALARM TONE WILL SOUND.

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display

MENU ITEMS DESCRIPTION

VIEW Three views are available: Pleth and Signal IQ, Numbers and
Pleth Only.
PLETH + SIGNAL IQ
Shows the SpO2 and pulse rate numbers on the left or top of the
screen, and the plethysmograph and Signal IQ waveform on the
right or bottom of the screen. The Screen also indicates the
signal strength of the measured signal as a perfusion index (PI).
The PI is calculated as the relation of arterial pulsatile signal to
the non-pulsatile signal component.
PLETH ONLY
Shows the SpO2 and pulse rate numbers on the left or top of the
screen,and the plethysmograph waveform on the right or bottom
of the screen.The Screen also indicates the signal strength of the
measured signal as a perfusion index (PI). The PI is calculated
as the relation of arterial pulsatile signal to the non-pulsatile
signal component.
NUMBERS
Shows the SpO2 and pulse rate numbers and the signal IQ in the
form of a pulse bar on the screen. The Screen also indicates the
signal strength of the measured signal as a perfusion index (PI).
The PI is calculated as the relation of arterial pulsatile signal to
the non-pulsatile signal component.

CONTRAST Allows the user to set the contrast of the LCD display. Contrast
ranges from 1 to 64.
NOTE: The contrast can also be set by pressing and holding the Backlight/
Contrast Button on the front panel.

LANGUAGE Allows the user to select the language displayed on the screen.

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general
MENU ITEMS DESCRIPTION

AVERAGING TIME The signal averaging time of this device can be set to: 2, 4,
8, 10, 12, 14 and 16 seconds*.
*With FastSat the averaging time is dependent on the input signal. For the
2 and 4 second settings the averaging times may range from 2-4 and 4-6
seconds, respectively.

FASTSAT Select “Yes” to activate the FastSat algorithm. In the 2 and

4 seconds averaging mode, the FastSat algorithm is
automatically enabled.
HOME USE Set the Radical to the Home Mode.The Radical will remain
in the Home Mode until the “No” setting is selected. A
password is required to activate or deactive this mode. See
Section 4, Home Use Operation, for a detailed description.
INTERFACE ALARMS During SatShare, HP Vuelink and Spacelabs Flexport
operation, the audible alarms can be enabled or disabled.
SATSHARE NUMBERS During SatShare operation the saturation and pulse rate
measurements can be displayed on the Radical by
selecting a SatShare Numbers setting of “Yes”.
POWER SAVE Select “Yes” to maximize battery-operating time of the
Radical while powered by the Handheld battery or optional
Docking Station battery. Selecting “Yes” will disable
Docking Station functions such as SatShare, Serial and
Analog output. Selecting “No” will activate these Docking
Station functions while operating on battery power. (While
operating in the Power Save mode, a power cycle of the
Radical may be required to activate the Docking Station
again after it has been disabled.)

clock
MENU ITEMS DESCRIPTION

TIME Set the time - hour and minutes - in 12 or 24 hour format.

TIME FORMAT Set the format of the time display as it will be shown on the front
panel. Available options are 12 hour (default) and 24 hour display.
DATE Set the date (day, month and year).
DATE FORMAT Set the format of the date display as it will be shown on the front
panel. Available options are mm/dd/yyyy (default) and
dd/mm/yyyy.

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about

This displays the copyright and software versions of the Handheld and
Docking Station.

output
Note: The output menu selections are only available when the Radical Handheld is
interfaced to the Docking Station.

MENU ITEMS DESCRIPTION

SERIAL MODE The following serial output modes are supported. All serial
output is RS-232 based. See the interface specifications in
Section 7, Specifications.
ASCII 1
ASCII text data is sent to the serial interface at one-second
intervals. The ASCII text includes: date and time stamp, SpO2
pulse rate, PI, and alarm and exception values. All text is single
line followed by a line feed character and a carriage return.
ASCII 2
ASCII text data is sent to the serial interface following a query
from the connecting computer.
HP VUELINK
SpO2, pulse rate and plethysmographic waveform data are sent
in HP VueLink format to the serial port.
SPACELABS FLEXPORT
SpO2, pulse rate and plethysmographic waveform data are sent
in Spacelabs Flexport format to the serial port.
ANALOG 0%-100%
OUTPUT Scales the saturation measurement with 0% being equal to 0
MODE Volt and 100% equal to 1 Volt.
50%-100%
Scales the saturation measurement with 50% being equal to 0
Volt and 100% equal to 1 Volt.
0V Output
A 0 Volt calibration signal is mapped onto the SpO2 and pulse
rate analog output. Use this signal for calibration of recording
devices. (0 Volts represents a saturation of 0% and a pulse rate
of 0 bpm).

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1V Output
A 1 Volt calibration signal is mapped onto the SpO2 and pulse rate
analog output. Use this signal for calibration of recording devices.
(1 Volt represents a saturation of 100% and a pulse rate of 250 bpm).

CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY

EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE RADICAL
PULSE OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY.

service
NOTE: The Service menu selections are only available when the Radical Handheld is
interfaced to the Docking Station.

Only qualified Biomedical or Clinical Engineering department personnel should access the
service menu. See Section 4, Password Operation, on how to enter the password.

MENU ITEM DESCRIPTION

HANDHELD To deep discharge the Handheld battery select this menu item.
BATTERY See Section 9, Battery Operation and Maintenance, for more information.
DISCHARGE:

DS To deep discharge the optional Docking Station battery select this menu
BATTERY item. See Section 9, Battery Operation and Maintenance, for
DISCHARGE: more information.

The discharge cycle will take approximately 16 hours to complete for the Handheld battery.
The Docking Station battery will take approximately 30 hours to complete. A message will
appear in the service screen when the discharge cycle is complete. The batteries will be
fully charged after completion of the cycle.
NOTE: In order for the discharge cycle to be properly completed, AC power must be
supplied to the instrument throughout the cycle.

WARNING: WHEN DEEP-DISCHARGING THE HANDHELD OR DOCKING

STATION BATTERY, MAKE SURE THAT THE DEVICE HAS BEEN REMOVED
FROM SERVICE UNTIL FULL BATTERY CAPABILITY CAN BE RESTORED.

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trend display

Once the Trend Display touch key icon is selected the trend data is displayed on the main
screen. The Radical stores one data set of SpO2, pulse rate and system messages in a
dedicated memory area. Depending on the Trend Period, a setting for how often the data
is stored in the trend memory, the Radical can store between 72 hours and 30 days worth
of trend data. The Radical also employs a sophisticated data compression scheme. The
actual amount of trend data that is stored is dependent on the type of data that is collected.
The Radical only stores data in the trend memory while the device is turned on, and the
trend data remains in memory until the memory fills up, or is cleared by the user.

CAUTION: CHANGING THE DATE AND TIME OF THE SYSTEM CLOCK, OR

CHANGING THE TREND PERIOD, WILL ALSO CLEAR THE DATA IN THE TREND
MEMORY.

The following table outlines the trend capacity for sample Trend Period settings:

TREND PERIOD TREND MEMORY CAPACITY

2 SECONDS MINIMUM OF 72 HOURS (3 DAYS)
10 SECONDS TYPICALLY 720 HOURS (30 DAYS)

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Masimo SET 91 10 Min Trend 03/27/01 11:42:46

% SpO2 90 97 99 BPM 60 70 80
100
100
85
%SpO2
60
140 160
50
BPM
30

1 The top line on the trend display shows the time scale of the trend graph, followed
by the starting date, starting time and end time of the data set that is displayed on
the screen.
2 The second line of the display shows the minimum, average, and maximum SpO2
and pulse rate measurements contained in the displayed data set (excluding zero
measurements).
3 The vertical scale of the SpO2 and pulse rate graphs can be set in the Trend
Setup menu.
4 A dark line on the trend graph indicates the averaged data, while grayed-out data
points show minimum and maximum values.

5 A grayed-out box or line located on the bottom axis of the saturation graph indicates
a period of time for which the Low Signal IQ indicator was active, indicating the
signal quality was very low and the accuracy of the measurement may have been
compromised.
6 The second trend graph shows the pulse rate measurements displayed versus time.

7 The first trend graph shows the SpO2 measurements displayed versus time.

By default, the trend display automatically refreshes, at a rate of once every 10 seconds, to
show the latest measured SpO2 and pulse rate data. This feature is only available while the
trend view is 2 hours or less, and the latest measured data is shown. If the user scrolls
through the data set to display previously recorded trend data, or if the trend scale is greater
than 2 hours, the trend display will time out after 1 minute of inactivity (i.e. the user does not
press any of the touch key control buttons) and the normal Radical display will be shown.

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NAVIGATING THE TREND DISPLAY

In the Trend Display view there are a total of 10 touch key icon selections on
3 pages of menu selections.

FIRST PAGE
Next Menu Press the Next Menu Page button to access the next page of menu selections.
Page

Exit Press the Exit button to return to the normal display screen.

Scroll Left Press the Scroll Left button to scroll through the data set. The display scrolls by ½
the selected time scale. For example if a 2 hr display view is selected, then pressing
the Scroll Left button will scroll the displayed data by 1 hr to the left.

Scroll Right Press the Scroll Right button to scroll through the data set.The display scrolls by ½
the selected time scale. For example if a 2 hr display view is selected, then pressing
the Scroll Right button will scroll the displayed data by 1 hr to the right.

SECOND PAGE
Next Menu Press the Next Menu Page button to access the next page of menu selections.
Page

Zoom Press the Zoom button to change the time scale of the trend view. The available
time scales are 24 hrs, 12 hrs, 8 hrs, 4 hrs, 2 hrs, 1 hr, 30 minutes, 10 minutes, 1
minute and 20 seconds. The Zoom button uses the last recorded data point as the
zoom reference point. In other words, the last recorded data point is always shown
as the right-most data point on the display.

Zoom from Press the Zoom from Left button to zoom into the data set while keeping the data
Left point that is shown on the right side of the trend graph as the zoom reference point.

Zoom from Press the Zoom from Right button to zoom into the data set while keeping the data
Right point that is shown on the left side of the trend graph as the zoom reference point.

THIRD PAGE
Next Menu Press the Next Menu Page button to return to the first page of menu selections.
Page

Trend Setup Press the Trend Setup button to enter the Trend Setup Menu.

Histogram Press the Histogram button to display the selected data set (the data set shown in
the trend view) in histogram format.

Clear Trend Press the clear Trend Data button to clear the data stored in the trend memory.
Data

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TREND SETUP
This menu allows the user to set the default trend settings and to clear the trend data, or
download the trend data to the serial port. The default settings are used to scale the trend
graphs when the trend data button, located on the main display, is accessed.

MENU ITEMS DESCRIPTION

%SpO2 HIGH Sets the high scale of the SpO2 trend graph.
SCALE:

%SpO2 LOW Sets the lower scale of the SpO2 trend graph.
SCALE:

PR HIGH SCALE Sets the high scale of the pulse rate trend graph.
(BPM):

PR LOW SCALE Sets the lower scale of the pulse rate trend graph.
(BPM):

DEFAULT VIEW: Selects the default time scale of the trend view. This setting only
selects the time scale of the trend view when the trend data is
initially displayed, (i.e. when the trend data is initially accessed).
The selections are 24 hrs, 12 hrs, 8 hrs, 4 hrs, 2 hrs, 1 hr, 30
minutes, 10 minutes, 1 minute and 20 seconds.

TREND ACTION Serial Dump

To send all the data that is stored in trend memory to the serial port
select the Serial Dump option. Use this option to communicate the
stored data set to trend graphing software applications.
Analog Dump
To send all the data that is stored in the trend memory to the
analog output select the Analog Dump option. Use this option to
print the trend information on an analog chart recorder.
Print
To print the trend data that is shown in the Trend View select the
Print option. The trend data is first printed in histogram format,
followed by a table of data that shows the time and date stamp of
a trend record, and the SpO2 and pulse rate measurement. Each
trend record is printed on a single line, followed by a carriage
return and line feed character.

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TREND PERIOD
The Trend period setting determines how often a set of SpO2 and pulse rate data points is
stored in trend memory. A setting of 2, for example, sets the Radical to store one set of
SpO2 and pulse rate measurements every 2 seconds, resulting in a minimum trend
capacity of 72 hours. A setting of 10, for example sets the Radical to store one set of data
points every 10 seconds, resulting in a typical trend storage capacity of 30 days.
NOTE: Since the Radical employs a sophisticated data compression scheme the actual
trend capacity is dependent on the type of data that is collected.

backlight/contrast operation

The backlit LCD screen of the Radical Handheld can be set to four levels of illumination, in
addition to no illumination, when Radical operates as a standalone pulse oximeter. The
Radical temporarily indicates the illumination level on the display following a change in
illumination level. To select the level of illumination simply press the Backlight/Contrast
button located on the front panel of the Handheld.
When the Radical Handheld unit is released from the Docking Station the illumination of
the LCD screen automatically reverts to the lowest level (backlight off) to conserve battery
power. To select a different level of illumination, press the Backlight/Contrast button again.
In the Handheld mode, three levels of illumination are available.
When the Handheld unit is re-attached to the Docking Station, as well as when the Radical
is powered on in the Standalone configuration, the backlight is automatically set to the
maximum illumination when the unit is AC line powered.
To change the contrast of the LCD screen, select the Contrast parameter of the Display
menu. While changing the contrast setting, the screen will refresh to reflect the current
setting.
The contrast of the LCD screen can also be changed by depressing and holding the
Backlight/Contrast button located on the front panel of the Handheld. While holding the
Backlight/Contrast button, the screen will refresh to reflect the current setting. Release the
button at the desired setting.

satshare operation

When the SatShare cable is connected to the Radical and to a multiparameter patient
monitor, the Radical automatically starts to operate in the SatShare mode.
In the SatShare mode, Radical operates as follows:
■ All visual alarms remain active.
■ All audible alarms may be disabled by software configuration of the Radical.
■ The SpO2 and pulse rate numbers may or may not be displayed on the Radical
display depending on the SatShare Numbers setting of the General menu.
■ All other items are displayed, including the alarm limits, the plethysmogram and
Signal IQ waveform.

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 operation 4

■ The user can access the menu system.

■ If the SatShare cable is connected to the Radical only, and not to a patient monitor,
the SatShare cable type is flashing on the LCD screen.
■ Once Radical detects the presence of a patient monitor, the SatShare cable type
remains constantly displayed on the LCD screen.
■ Patient Alarms of the multiparameter patient monitor will be triggered by the alarm
setting of the patient monitor and not the Radical. To synchronize the alarm events
set the alarm limits of the Radical to those of the patient monitor, or vice versa.
■ Once Radical detects that the SatShare cable is disconnected from the patient
monitor, or if the patient monitor is turned off, Radical automatically returns to normal,
standalone operation.
■ In the SatShare mode, the pulse beep tone of the Radical is disabled.
■ The Radical may automatically set the averaging time during SatShare operation.
For averaging times of 10 seconds and higher, the Radical will automatically set the
averaging time to 8 seconds during SatShare operation. Averaging times of 2, 4 or
8 seconds remain unchanged during SatShare operation. When the Radical returns
to non-SatShare operation, the Radical will maintain the averaging time setting
used in the SatShare mode.

CAUTIONS:
■ SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS
CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE
VALUES AND DO NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN
PHYSIOLOGICAL WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR
DECODES THESE SIGNALS INTO SATURATION AND PULSE RATE VALUES.
■ DURING SATSHARE OPERATION, THE AUDIBLE PATIENT ALARMS MAY BE
AUTOMATICALLY DISABLED AND SILENCED. USE THE MULTIPARAMETER
PATIENT MONITOR ALARMS TO INDICATE ALARM CONDITIONS.
■ DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM
DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC
PURPOSES. INSTEAD, USE THE PLETH WAVEFORM DISPLAYED ON THE
RADICAL SCREEN.
To return from SatShare operation to normal standalone operation, simply disconnect the
SatShare cable from the patient monitor or disconnect the SatShare cable from the
SatShare connector on the back of the Radical.

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 4 operation

home mode operation

The Radical can be placed into the Home Mode to protect unqualified users from changing
the Radical alarm settings and operation. Entering a password does not automatically reset
the Radical to the Normal operating mode. In the Home Mode, a password is required to
access the menu system and the touch key control buttons and icons.
NOTE: When the Radical is set to operate in the Home mode the default values that the
Radical reverts to after a power cycle are set according to Section 3, Monitor Setup, with
the exception of the Alarm Silence setting, which is set to the pre-power down setting.

password operation

The Radical password is 2-3-1. To enter the password use the touch-key control buttons to
the right or bottom of the LCD display and press the buttons in the sequence shown in the
following figure:
✘ ✘ ✘
3 Then press ➙ 3 3
First press ➙ 2 2 2

1 1 Finally press ➙ 1

To return to normal operating mode set the General/Home Use parameters to “No”.

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introduction

The following sections outline system alarms, messages displayed on the LCD screen.
Please become thoroughly familiar with this information before operating the pulse
oximeter.

alarm identification

The Radical Pulse Oximeter visually and audibly indicates alarm conditions that the
system detects. The integrated loudspeaker indicates alarm conditions audibly. The
LCD screen and the LED lights on the Docking Station indicate the visual alarms.
Audible alarms may be silenced, without affecting the operation of visual alarms.
Two levels of alarm priority are implemented: high and low priority.
The following table outlines the alarm priority specifications.

ALARM DESCRIPTION
HIGH PRIORITY Audible and visual alarms for high and low saturation (SpO2
range 1-100%) and pulse rate (pulse rate range 25-240 bpm).
Audible and visual alarms for system failures.
Sensor Failure and Disconnect.

LOW PRIORITY Audible and visual alarms for low battery.

NOTE: High priority alarms indicate that immediate operator response is required.
Low priority alarms indicate that operator awareness is required.

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alarm operation

For averaging modes of less than 14 seconds, the Radical indicates saturation and pulse
rate alarms within 3 seconds of when the alarm condition is met. For averaging modes of
14 and 16 seconds, the Radical indicates saturation and pulse rate alarms within 10
seconds of when the alarm condition is met. Saturation changes of greater than 5% are
indicated immediately, irrespective of averaging time. The Radical visually indicates an
alarm by flashing the measured value and the alarm limits. Alarms are audibly indicated
according to system configuration.

alarm messages

Alarm messages indicate a problem or condition, which may affect accurate monitoring
values. Do not ignore these messages. Correct any fault before continuing.
Press the Alarm Silence key to temporarily silence the audible alarm. Alarm messages and
violating values flash on the display, and the Docking Station front panel alarm indicator
flashes red if the Handheld unit is in the Docking Station. If the measurement returns to
within limits, the alarm turns off.
A list of alarm conditions that cause audible and visual alarm indications and the displayed
alarm messages are shown in the following table. The reason of why these alarms might
occur is also shown.

MESSAGE DESCRIPTION
SENSOR OFF The sensor is not properly attached to the patient.

NO SENSOR The sensor is not properly attached to the monitor.

SpO2 HIGH The high SpO2 rate limit has been exceeded.

SpO2 LOW The low SpO2 rate limit has been exceeded..

PR HIGH The high pulse rate limit has been exceeded.

PR LOW The low pulse rate limit has been exceeded.

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 alarms/messages 5

system messages

The following chart alphabetically lists all system messages displayed on the LCD
screen. The cause of the message, and the action(s) to be taken are also shown.
The operator should become thoroughly familiar with this information before using the
oximeter for patient monitoring.

MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION

AMBIENT LIGHT Too much light on Remove or reduce lighting.

patient (sensor). Cover sensor from light.
Inadequate tissue Reposition sensor.
covering sensor detector.

DEFECTIVE Oximeter cannot identify Broken sensor cable wire or

SENSOR the connected sensor inoperative LEDs or faulty detector;
the sensor has failed. Replace sensor. Refer to the instructions for
the sensor being used.

INTERFERENCE Outside signal or energy Remove outside interference.

preventing reading.

INVALID SENSOR Oximeter cannot identify Broken sensor cable wire or inoperative
the connected sensor LEDs or faulty detector; the sensor has
failed. Replace sensor. Refer to the
instructions for the sensor being used.

LOW BATTERY Battery charge is low. Charge battery by placing the Radical
Handheld into the Docking Station and
powering the unit with AC line power.
Replace battery if necessary.

LOW PERFUSION Signal too small. Move sensor to better perfused site. Refer
to Section 4, Low Perfusion.

LOW SIGNAL IQ Low signal quality. Ensure proper sensor application. Move
sensor to a better perfused site. Refer to
Section 4, Signal IQ.

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 5 alarms/messages

NO SENSOR Sensor not fully inserted May be an incorrect sensor, or a defective

into the connector. sensor or cable. Insert sensor into connector.
Disconnect and reconnect sensor. Refer to
the instructions for the sensor being used.
Sensor inserted upside Disconnect and reconnect the sensor
down. with the logos matching.

PULSE SEARCH Unit is searching for If values are not displayed within
patient’s pulse. 30 seconds, disconnect and reconnect
sensor. If pulse search continues, remove
sensor and replace on a better perfused site.

SENSOR OFF Sensor off patient. Disconnect and reconnect sensor.

Reattach sensor.

SERVICE * Internal Failure. Unit requires service.

REQUIRED

* The SERVICE REQUIRED message fills the entire display.

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 troubleshooting 6

troubleshooting

The following chart describes what to do if the Radical system does not operate properly
or fails.

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

UNIT DOES NOT One or both of the fuses Replace the fuses.
POWER ON. have blown.

UNIT POWERS ON The viewing contrast Use the Backlight/Contrast button to adjust
BUT THE GRAPHIC is not correct. the viewing angle. If the condition
DISPLAY IS BLANK. persists, the unit requires service.

CONTINUOUS Internal failure. Unit requires service. Press the Alarm

SPEAKER TONE. Silence button to silence the alarm. If
alarm continues to sound, power down
unit and remove Handheld battery if
necessary.

BUTTONS DON’T Internal failure. Unit requires service.

WORK WHEN
PRESSED

The following chart describes what to do when encountering common problems:

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

HANDHELD BATTERY AC power cable may be Restore power to the device.

DOES NOT CHARGE. disconnected.
AC power switch is turned
off.

PRINT FUNCTION Wrong serial cable is used. Make sure a null modem cable is
DOES NOT WORK. used.

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 7 specifications

radical specifications
PERFORMANCE
measurement range
SpO2: 1-100%
Pulse Rate: 25-240 beats per minute (bpm)
Perfusion: 0.02% - 20%

accuracy
Saturation 70% to 100%
No Motion1
Adults, Pediatrics ±2 digits
Neonate ±3 digits
Motion
Adults2 , Pediatrics2 ±3 digits
Neonate3 ±3 digits
Low Perfusion4
Adults, Pediatrics ±2 digits
Neonate ±3 digits
Pulse Rate Accuracy
pulse rate: 25-240 bpm
No Motion1
Adults, Pediatrics, Neonate ±3 digits
Motion2,3
Adults, Pediatrics, Neonate ±5 digits
Low Perfusion4
Adults, Pediatrics, Neonate ±3 digits

resolution
Saturation (%SpO2) 1%
Pulse Rate (bpm) 1 bpm

ELECTRICAL
standalone
AC Power requirements: 100-240 VAC, 47-63 Hz
Power consumption: 55 VA
Fuses: 1 Amp, Fast Acting, Metric, (5x20mm), 250V

batteries
Handheld:
Type: NiMH
Capacity: 4 hours5
Charging time: 3 hours
Docking Station (RDS-1B, RDS-3B):
Type: NiMH
Capacity: 12 hours5
Charging time: 6 hours

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 specifications 7

ENVIRONMENTAL
Operating Temperature: 41°F to 104°F (5°C to 40°C)
Storage Temperature: -40°F to 158°F (-40°C to +70°C)6
Operating Humidity: 5% to 95%, non-condensing
Operating Altitude: 1060 mbar to 500 mbar pressure,
-1000 ft to 18,000 ft (-304 m to 5,486 m)

PHYSICAL CHARACTERISTICS
dimensions
Handheld: 8.9” x 3.3” x 2.1” (22.6 cm x 8.4cm x 5.3 cm)
Standalone: 3.5” x 10.5” x 7.7” (8.9 cm x 26.7cm x 19.6cm)

weight
Handheld: 1.3 lbs. (0.59 kg)
Docking Station (RDS-1, RDS-2, RDS-3): 2.5 lbs. (1.14 kg)
Docking Station (RD-1B, RDS-3B): 4.11 lbs (1.86 kg)
Standalone (RDS-1, RDS-2, RDS-3): 3.8 lbs. (1.73 kg)
Standalone (RDS-1B, RDS-3B): 5.4 lbs. (2.45 kg)

trending
72 hours of trending at 2 second resolution, up to 30 days of trending at 10 second resolution , output
to serial printer or other serial devices

modes
Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds7
Sensitivity: Normal and Maximum8

alarms
Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1-100%, pulse rate
range 25-240 bpm)
Sensor condition, system failure and low battery alarms
High Priority: 571 Hz tone, 5 pulse burst, pulse spacing: 0.250s,
0.250s, 0.500s, 0.250s, repeat time:10s
Low Priority: 500Hz tone, 1 pulse, repeat time: 5s
Alarm Muted reminder: 500Hz tone, 2 pulse burst, pulse spacing 0.375s, repeat time: 3min.

display/Indicators
Data display: %SpO2, pulse rate, pleth waveform, alarm
status, trends, status messages, Signal IQ and perfusion index
Type: Backlit LCD
Pixels: 480 x 160 dots
Dot Pitch: 0.25 mm

output interface
SatShare (RDS-1, RDS-1B),
Serial RS-232, Analog Output, Nurse Call (RDS-1, RDS-1B, RDS-3, RDS-3B)
HP Vuelink, Spacelabs Universal Flexport (RDS-1, RDS-1B, RDS-3, RDS-3B)

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 7 specifications

compliance
EMC Compliance: EN60601-1-2, Class B
Equipment Classification: IEC 60601-1-1 / UL 2601-1

Type of Protection: Class 1 (on AC power), Internally powered (on battery power)
Degree of Protection-Patient Cable: Type BF-Applied Part
Degree of Protection-SatShare Cable: Type CF-Applied Part
Enclosed Degree of Ingress Protection from Solids/Liquids: IPX1
Mode of Operation: Continuous
1 The Masimo SET Radical Pulse Oximeter with LNOP Adt sensors has been validated for no motion accuracy in human blood studies
on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor.
This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
2 The Masimo SET Radical Pulse Oximeter with LNOP Adt sensors has been validated for motion accuracy in human blood studies on
healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2
cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2
against a laboratory co-oximeter and ECG monitor.This variation equals plus or minus one standard deviation. Plus or minus one standard
deviation encompasses 68% of the population.
3 The Masimo SET Radical Pulse Oximeter with LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in
human blood studies on neonates while moving the neonate’s foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-
oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Pulse or minus one standard deviation
encompasses 68% of the population.
4 The Masimo SET Radical Pulse Oximeter with SatShare has been validated for low perfusion accuracy in bench top testing against a
Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for
saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
5 This represents approximate run time with no backlight and Power Save mode, using a new, fully charged battery.
6 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a
relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity
may be diminished, and lifetime of the batteries may be shortened.
7 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from
2-4 and 4-6 seconds, respectively.
8 Maximum sensitivity mode fixes perfusion limit to 0.02%.

serial interface specifications

The digital interface for serial communication is based on the standard RS-232 protocol.
The Radical Pulse Oximeter by default always outputs ASCII1 text data through the serial
port, unless the user selects a different output mode in the Output menu. To interface with
the Radical and receive serial text data, simply connect a serial interface cable to the
serial output connector located on the back of the Radical Docking Station.
NOTE: The Radical serial interface is only available when the Radical Handheld is properly attached to the Radical
Docking Station.
NOTE: The serial interface is not available in all versions of the docking station.

Once serial communication is established, packets of data are communicated at 1 second

intervals.The data packets contain: the date, time, SpO2, pulse rate, perfusion index and
alarm and exception values. (in ASCII format).

WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE ANALOG OUTPUT/

NURSE CALL CONNECTOR MUST BE IEC-60950 COMPLIANT.

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 specifications 7

SERIAL INTERFACE SETUP:

To interface with the Radical serial port, set the following communication parameters on the
interfacing serial device:

PARAMETER SETTING

BAUD RATE 9600 Baud bi-directional

NUMBER OF BITS PER CHARACTER 8

PARITY None

BITS 1 start, 1 stop

HANDSHAKING None

CONNECTOR TYPE Female DB-9

The pin-outs for the RS-232 connector are shown in the following table:

PIN SIGNAL NAME

1 No Connection

2 Receive data – RS-232 ±9 V (±5 Vmin)

3 Transmit data – RS-232 ±9 V (±5 Vmin)

4 No Connection

5 Signal Ground Reference for COM signals

6 No Connection

7 No Connection

8 No Connection

9 No Connection

SERIAL PRINTER SETUP

To print the SpO2 and pulse rate data in ASCII1 format on a serial printer, simply connect
the laser printer to the serial port. Once serial communication is established, the Radical
automatically will start printing the ASCII1 text data.

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 7 specifications

analog output / nurse call specifications

The Analog Out and Nurse Call are features accessible on the same female high density
DB-15 connector.
NOTE: The Radical analog output / nurse call interface is only available when the Radical
Handheld is properly attached to the Radical Docking Station.
NOTE: The analog output/nurse call interface is no available in all version of the Docking
Station.

WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE RS-232 SERIAL

PORT MUST BE IEC-60950 COMPLIANT.

The following table shows the pinout of the analog output and nurse call.

PIN SIGNAL NAME

1 +5V (60mA max.)

2 Ground

3 Ground

4 Ground

5 Ground

6 Nurse Call (Normally Open)

7 Nurse Call (Normally Closed)

8 Ground

9 Analog Out - %SpO2

10 Ground

11 Ground

12 Nurse Call – Common

13 Ground

14 Ground

15 Analog Out – Pulse Rate

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 specifications 7

ANALOG OUTPUT
Radical can interface with various analog recording devices and/or strip chart recorders
through its Analog Output connector located on the back of the Docking Station. SpO2 and
pulse rate parameters are output simultaneously and continuously. The
output signals vary from approximately 0 to 1 volt in a linear fashion.
NOTE: The actual SpO2 and Pulse Rate voltages will vary from approximately 40mV to
980mV in 3.9mV steps.

SpO2
0 volts represents either 0% SpO2 or 50% SpO2. In either case, 1 volt is used to represent
100% SpO2. The range mapping for %SpO2 can be selected by accessing the menu
system under Output-Analog Output Mode.

PULSE RATE
For Pulse Rate, 0 volts represents 0 BPM, while 1volt is used to represent 250 BPM.

CALIBRATION
For measurement device calibration purposes, the analog output signals can be set to either
0 volts or 1 volt in the menu system under Output/Analog Output Mode.These settings affect
both channels. Calibrate your analog recording system to those levels before use.

NURSE CALL
The nurse call feature is available when Radical is operating in its standalone configuration.
The nurse call feature on the Radical Pulse Oximeter is based on the relay closing or
opening depending on alarm events. For maximum flexibility, either normally open (pin 6)
or normally closed (pin 7) signals are available. Only qualified personnel should connect
one of these two signals and common (pin 12) to a hospital’s nurse call system. During an
alarm condition, the normally open pin will be connected to the common pin and the
normally closed will be disconnected.
The nurse call relays have the following electrical specifications per switch:

PARAMETER SPECIFICATION

Max Voltage 100VDC or ACpeak

Max Current 100mA

WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE

ALARMS ARE SILENCED.

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 8 sensor/patient cables

introduction

This section covers the use and cleaning of Masimo LNOP sensors and Masimo SET
patient cables.

®
masimo LNOP sensors

Before use, carefully read the LNOP sensor Directions for Use.
Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers or
sensors may cause improper Radical Pulse Oximeter performance.
Tissue damage can be caused by incorrect application or use of an LNOP sensor, for example
by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions
for Use to ensure skin integrity and correct positioning and adhesion of the sensor.
CAUTIONS:
■ DO NOT USE DAMAGED LNOP SENSORS. DO NOT USE AN LNOP SENSOR
WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS. DO NOT
IMMERSE THE SENSOR IN WATER, SOLVENTS, OR CLEANING SOLUTIONS
(THE SENSORS AND CONNECTORS ARE NOT WATERPROOF). DO NOT
STERILIZE BY IRRADIATION, STEAM, OR ETHYLENE OXIDE. SEE THE
CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE
MASIMO LNOP SENSORS.
■ DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT
CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT
CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY
IRRADIATION, STEAM, OR ETHYLENE OXIDE.

SELECTING A MASIMO LNOP SENSOR

When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the
available sensor sites, and the duration of monitoring. For more information refer to the
following table or contact your Sales Representative. Use only Masimo SET sensors and
sensor cables. Select an appropriate sensor, apply it as directed, and observe all warnings
and cautions presented in the directions for use accompanying the sensor.
High ambient light sources such as surgical lights (especially those with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can
interfere with the performance of an SpO2 sensor. To prevent interference from ambient
light, ensure that the sensor is properly applied, and cover the sensor site with opaque
material, if required. Failure to take this precaution in high ambient light conditions may
result in inaccurate measurements.

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 sensor/patient cables 8

SENSOR USAGE PATIENT WEIGHT

LNOP ADT Single Use Adults > 30 kg

LNOP PDT Single Use Pediatrics and Slender Adults >10 kg and < 50 kg

LNOP NEO Single Use Neonate < 10 kg

LNOP NEO PT Single Use Neonate < 1 kg, or with poor skin integrity

LNOP DCI Reusable Adults and Pediatrics > 30 kg

LNOP DCIP Reusable Pediatrics >10 kg and <50 kg

LNOP DCSC Reusable Adult and Pediatrics >30 kg, for spot check applications

CLEANING AND REUSE OF MASIMO LNOP SENSORS

Reusable sensors can be cleaned per the following procedure:
■ Remove the sensor from the patient.
■ Disconnect the sensor from the monitor.
■ Wipe the entire sensor clean with a 70% isopropyl alcohol pad.
■ Allow the sensor to air dry before returning it to operation.

REATTACHMENT OF SINGLE USE ADHESIVE SENSORS

■ LNOP single use sensors may be reapplied to the same patient if the emitter and
detector windows are clear and the adhesive still adheres to the skin.
■ The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol
wipe and allowing the sensor to thoroughly air dry prior to replacement on the
patient.
NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly
positioned. Reposition the sensor or choose a different monitoring site.

WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO LNOP

SINGLE USE SENSORS ON THE SAME PATIENT.

CAUTIONS:

■ DO NOT REPROCESS ANY LNOP SINGLE USE SENSORS.

■ DO NOT SOAK OR IMMERSE THE SENSOR IN ANY LIQUID SOLUTION.

DO NOT STERILIZE ANY MASIMO SENSOR BY IRRADIATION, STEAM,
OR ETHYLENE OXIDE.

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 8 sensors/patient cables

masimo SET patient cables

Reusable patient cables of various lengths are available. All cables that display the
Masimo SET logo are designed to work with any Masimo LNOP sensor and with any pulse
oximeter or multiparameter instrument displaying the Masimo SET logo.
Only use Masimo oximetry patient cables for SpO2 measurements. Other patient cables
may cause improper Radical pulse oximeter performance.

CLEANING AND REUSE OF MASIMO SET PATIENT CABLES

Patient cables can be cleaned per the following procedure:
■ Remove the cable from the sensor.
■ Disconnect the cable from the monitor.
■ Wipe clean with a 70% isopropyl alcohol pad.
■ Allow the cable to dry before returning it to operation.

CAUTIONS:
■ CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF
PATIENT ENTANGLEMENT OR STRANGULATION.
■ DO NOT SOAK OR IMMERSE PATIENT CABLES IN ANY LIQUID SOLUTION. DO
NOT STERILIZE PATIENT CABLES BY IRRADIATION, STEAM, OR ETHYLENE
OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE
FOR REUSABLE MASIMO PATIENT CABLES.
■ DO NOT REPROCESS ANY MASIMO SET PATIENT CABLES.

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 service/maintenance 9

introduction

This chapter covers how to test the operation of the Radical and the SatShare interface,
how to properly clean the Radical pulse oximeter, how to recharge and replace the
batteries, how to replace the fuses, and how to obtain service.
Under normal operation, no internal adjustment or recalibration is required. Safety tests
and internal adjustments should be done by qualified personnel only. Safety checks should
be performed at regular intervals or in accordance with local and governmental regulations.

WARNING: ELECTRICAL SHOCK AND FLAMMABILITY HAZARD - BEFORE

CLEANING THE OXIMETER, ALWAYS TURN IT OFF AND DISCONNECT THE
POWER CORD FROM THE AC POWER SUPPLY.

cleaning

To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and
gently wipe the panel.
To clean the outer surface of the oximeter, use a soft cloth dampened with a mild soap and
water. Do not allow liquids to enter the interior of the instrument.

CAUTIONS:
■ DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THIS
OXIMETER.
■ DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID.
■ USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW
INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS.
■ DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE
CLEANING COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE
MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD
SCRATCH THE PANEL.
■ DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER
HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES ATTACK
THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT.

Refer to Section 8, Cleaning and Reuse of Masimo LNOP Sensors for cleaning instructions
of the sensor.

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 9 service/maintenance

battery operation and maintenance

The Radical Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride battery. The Radical
Docking Station may include the optional 6.5 Amp-Hour Nickel Metal Hydride battery.
Before using the Radical as a Handheld or transport monitor, the Handheld battery and the
optional Docking Station battery need to be fully charged.
To charge the battery(s), attach the Handheld unit to the Docking Station. Ensure that AC
power is attached to the Docking Station.Turn the AC power switch to the “ l ” position.Verify
that the battery(s) are charging; the battery charging LED indicators on the Docking Station
flash prior to charging and remain illuminated while the battery(s) are charging. A
continuously flashing battery charging LED indicates that the internal battery temperature
exceeds recommended operating conditions for proper battery charging. Proper battery
charging will proceed when the temperature returns to recommended operating conditions.
The Handheld battery requires approximately 2 to 3 hours for charging. The optional
Docking Station battery requires approximately 6 hours for charging.
When the battery charging LED indicators turn off, additional trickle charging may occur to
complete charging. Although battery charging can occur while the Handheld is docked and
powered on, most efficient charge times are achieved with the Handheld unit turned off.

CAUTIONS:
■ ALL BATTERIES LOSE CAPACITY WITH AGE, THUS THE AMOUNT OF RUN
TIME LEFT AT LOW BATTERY WILL VARY DEPENDING UPON THE AGE OF
THE BATTERY.
■ AT LOW BATTERY CONNECT THE RADICAL TO AC POWER TO PREVENT
LOSS OF POWER.
During battery operation of the Radical, please note that the following operating conditions
affect the estimated run-time of the included batteries:
■ Illumination of the backlit LCD screen. To conserve battery power, keep the backlit
LCD screen at minimum illumination.
■ Volume of the alarm tones. To conserve battery power, keep the frequency of the
audible alarms to a minimum and at minimum volume.
■ The SatShare feature.To conserve battery power, always keep the unit on AC line power.
Memory effects of the batteries may shorten run-time of the batteries. As a precaution
against memory effects, it is advisable to completely discharge and fully recharge the
batteries at least once every six (6) months. To properly discharge the batteries, use the
Battery Discharge function, as described in Section 4, Service.

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 service/maintenance 9

CAUTION:
■ IF THE RADICAL HAS NOT BEEN CHARGED FOR 1 MONTH OR MORE, THEN
RECHARGE THE BATTERY PRIOR TO USE.
The following tables outline the estimated run times of the battery powered Radical Pulse
Oximeter.The time estimates are based on a Radical with fully charged batteries.The time
estimates are also based on a Radical with and without backlight lit, and the power save
feature enabled and disabled.
The Radical Pulse Oximeter is always configured to include the Handheld battery. It may
optionally be configured to include the Docking Station battery. Please determine the
configuration of your system before referencing the following tables.
Configuration #1:
Radical configured to only include the Handheld battery (standard configuration); the
Docking Station battery is excluded.
NOTE: For this configuration, it is advisable to operate only the Radical Handheld unit when
running on battery power. Although it is possible to operate the entire Standalone unit (the
Handheld attached to the Docking Station, with the Handheld battery powering the Docking
Station as well) on battery power, the capacity of the Handheld battery pack is insufficient
to support this mode for long periods of time. The Power Save setting in the General menu
determines whether the Docking Station is powered or not during battery operation. See
Section 4, General, for a detailed description on proper use of the Power Save setting.

RADICAL CONFIGURATION OPERATION MODE RUN-TIME

HANDHELD ONLY Power Save “yes” 3 to 4 hrs

Backlight turned “off”

STANDALONE Power Save “no” 1 hr

Backlight turned “on”

Configuration #2:
Radical configured to include the Handheld and the Docking Station battery:

RADICAL CONFIGURATION OPERATION MODE RUN-TIME

STANDALONE Power Save “yes” 12 hrs

Backlight turned “off”

STANDALONE Power Save “no” 6 to 7 hrs

Backlight turned “on”

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 9 service/maintenance

WARNING: THE DOCKING STATION BATTERY SHOULD BE INSTALLED AND/OR

REMOVED FROM DOCKING STATION BY QUALIFIED PERSONNEL ONLY.

REPLACING THE BATTERIES

■ Before installing or removing the battery, make sure the AC power cord is removed
and power to the pulse oximeter is turned off.

To replace the Handheld battery, follow these instructions:

■ Turn the Radical Handheld off and remove the patient cable connection. Detach the
Radical Handheld from the Docking Station (if docked).
■ Loosen the closure screw on the battery compartment door and lift off the battery
compartment door cover.
■ Pull out the battery.
■ Take a new battery, and place it in the compartment.
■ Replace the battery door and tighten the closure screw.
■ Place Handheld into Docking Station, turn on line power and charge battery
according to Section 9, Battery Operation and Maintenance.

CAUTION: FOLLOW LOCAL GOVERNING GUIDELINES FOR PROPER DISPOSAL OF

INTERNAL BATTERIES. DO NOT INCINERATE.

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REPLACING THE FUSES

Should a power problem blow one or both of the fuses in the power entry module on the
rear panel, the fuse(s) will need to be replaced.
To replace the fuses, you will need a flat-blade screwdriver (5mm; 3/16”).
To replace the fuses:
■ Disconnect unit from AC power.
■ Use the small flat-blade screwdriver and gently pry loose the fuse holder in the
right portion of the power entry module.
■ Note how the fuses are placed in the fuse holder for installation of the new fuses.
■ To remove the fuses from the fuse holder, use the edge of the screwdriver blade to
pry against the bottom of the metal portion of the fuse where it is secured to the
glass portion of the fuse.
■ Place two fuses (1 Amp, Metric, fast acting, 5x20mm, 250V) in the fuse holder,
properly orienting the fuses.
■ Slide the fuse holder back into the power entry module and press firmly to make
sure it is firmly inserted.
■ The Unit is ready to be reconnected to AC power.
NOTE: If the fuses blow shortly after replacement, the unit requires service.

WARNING: FIRE HAZARD:TO PROTECT AGAINST FIRE HAZARD, REPLACE ONLY

WITH FUSES OF THE SAME TYPE, CURRENT RATING, AND VOLTAGE RATING.

performance verification

To test the performance of the Radical pulse oximeter following repairs or during routine
maintenance, follow the procedure outlined in this section. If the Radical fails any of the
described tests, discontinue its use and correct the problem before returning the unit back
to the user.
Before performing the following tests place the Radical Handheld into the Docking Station,
connect the Radical to AC power and fully charge the Radical Handheld battery (the AC
mains switch must be on). Also disconnect any patient cables or pulse oximetry probes, as
well as SatShare, serial or analog output cables from the instrument. Set the Radical to
normal operating mode by selecting the Home Use parameter in the General Menu to “No”.

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 9 service/maintenance

Power-On Self-Test:
1. Connect the monitor to AC power and verify that the AC Power Indicator is lit. If it is
not lit verify that the AC mains switch is on.
2. Turn the monitor on by depressing the Power/Standby Button. Within 5 seconds all
available LEDs are illuminated, a 1-second beep tone sounds, and the Masimo
SET logo is displayed.
3. The green Docking Indicator LED is illuminated and the Radical begins normal
operation.

Key Press Button Test:

1. With the exception of the Power/Standby Button, press each soft key button and
verify that the Radical acknowledges each key-press with an audible beep tone or
by indicating a change on the display.

Alarm Limit Test:

1. With the monitor turned on, select the Menu Access key and enter the Alarm
menu. Change the High Saturation Alarm parameter to a value two points below
the currently selected value, and accept the change.
2. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display,
next to the SpO2 or pulse rate measurement display.
3. Return the High Saturation Alarm parameter to its original setting.
4. Repeat steps 1 to 3 with the Low Saturation Alarm parameter.
5. Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter.
6. Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter.
7. Reset the alarm limits again to the original settings.

Display Contrast Test:

1. With the monitor turned on, select the Menu Access key and enter the Display
menu. Change the Contrast parameter by scrolling through the contrast settings.
2. Return the Contrast setting to the original value, or a value that allows maximum
viewing contrast.
3. Exit the Menu system and press and hold down the Backlight/Contrast button for
several seconds. The display will scroll again through all the contrast settings.
4. Release the Backlight/Contrast button again when the display shows maximum
viewing contrast.

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 service/maintenance 9

Testing with Masimo SET Tester (Optional):

1. Turn the Radical off and then on again.
2. Set the alarm limits to:

% SpO2 Pulse Rate

High 100 140
Low 90 50

3. Connect the Masimo SET Tester to the Patient Cable Connecter.

4. Verify that within 20 seconds a plethysmographic and a Signal IQ waveform displays.
(may require the Radical to be set to the Pleth and Signal IQ display setting).
5. Verify that the SpO2 measurement is between 79% and 84%.
6. Verify that the pulse rate measurement is between 55 bpm and 65 bpm.
7. Verify that an audible alarm occurs and that the SpO2 measurement and the low
SpO2 alarm are flashing
8. Press the Alarm Silence button once and verify that the alarm is silenced.
9. Wait 120 seconds and verify that the alarm silence times out and the audible alarm
is activated again.
10. Press the Increase Loudness button several times and verify that the loudness of
the pulse beep tone increases.
11. Press the Decrease Loudness button and verify that the loudness of the pulse
beep tone decreases. Press the Decrease Loudness button and verify that the
loudness of the pulse beep tone can be turned off.

Nurse Call Test:

1. Disconnect the patient cable or the Masimo SET Tester from the Radical and turn
the instrument on. Ensure that there are no audible alarms and that the audible
alarms are not silenced.
2. Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call -
Common) of the analog output connector on the Radical. Connect the positive lead
of the multi-meter to pin 6 (Nurse Call - Normally Open) of the analog output
connector and measure that the resistance is greater than 1 MΩ (open circuit).
3. Trigger an alarm on the monitor (e.g. by disconnecting a sensor after it was
measuring data) and verify that the resistance is less than 35 ohms.

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 9 service/maintenance

Analog Output Test

1. Disconnect all patient cables and sensors from the Radical. Turn the Radical off
and then on again.
2. Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog
output connector on the Radical. Connect the positive lead of the voltmeter to pin 9
(Analog Out - % SpO2) of the analog output connector.
3. Enter the menu system and set the "Output", "Analog Output Mode" to "0V Signal".
Verify that the voltmeter measures a voltage of approximately 40mV.
4. Enter the menu system and set the "Output", "Analog Output Mode" to "1V Signal".
Verify that the voltmeter measures a voltage of approximately 980mV.
5. Repeat Steps 2 and 3, with the positive lead of the voltmeter connected to pin 15
(Analog Out - Pulse Rate).
6. Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are
between 0V and 1V while measuring a saturation and pulse rate..

Battery Test
1. Fully charge the Radical pulse oximeter by placing the Handheld into the Docking
Station and connecting the AC power (the AC mains switch must be on).
2. Verify that the green Handheld Battery Indicator LED is lit up.
3. When the Radical is fully charged the green Handheld Battery Indicator turns off.
4. Turn the Radical on and verify that the Battery indicator shows a full charge.

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 service/maintenance 9

service and repair

REPAIR POLICY
Masimo or an authorized Service Department must perform warranty repair and service.
Do not use malfunctioning equipment. Have the unit repaired.

WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR

BATTERY REPLACEMENT. AN OPERATOR MAY ONLY PERFORM
MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL.
REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE
REPAIR OF THIS EQUIPMENT.

Please clean contaminated/dirty equipment before returning, following the cleaning

procedure described in Section 9, Cleaning. Make sure it is fully dry before packing the
equipment.
To return the Radical unit for service, please follow the Return Procedure.

RETURN PROCEDURE
Please clean contaminated/dirty equipment before returning and make sure it is fully dry
before packing the equipment. Package the equipment securely – in the original shipping
container if possible – and enclose the following information and items:
■ Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA
number.
■ A letter describing in detail any difficulties experienced with the pulse oximeter.
Please include the RMA number in the letter.
■ Warranty information – a copy of the invoice or other applicable documentation
must be included.
■ Purchase order number to cover repair if the oximeter is not under warranty, or for
tracking purposes if it is.
■ Ship-to and bill-to information.
■ Person (name, telephone/Telex/fax number, and country) to contact for any
questions about the repairs.
■ A certificate stating the oximeter has been decontaminated for bloodborne
pathogens.

Return Radical pulse oximeter to the following shipping address:

Masimo Corporation
2852 Kelvin Ave
Irvine, California 92614
949-250-9688
FAX 949-250-9686

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warranty

Masimo warrants to the initial purchaser that each new pulse oximeter will be free from
defects in workmanship or materials for a period of three (3) years from the date of
purchase. Masimo’s sole obligation under this warranty is to repair or replace any product
that Masimo deems to be covered under warranty with a repaired or a replacement pulse
oximeter.
To request a replacement under warranty, contact the licensed manufacturer or Masimo for
a returned goods authorization. If the licensed manufacturer or Masimo determines that a
product must be replaced under warranty, it will be replaced and the cost of shipment
covered. All other shipping costs shall be the responsibility of the purchaser.

exclusions

This warranty does not extend to any product that has been subject to misuse, neglect or
accident; that has been damaged by causes external to the Product; that has been used
in violation of the operating instructions supplied with the product. The warranty does not
extend to any product that has been connected to an unlicensed instrument system,
modified accessories or any unit that has been disassembled or reassembled by anyone
but an authorized Masimo agent.
THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY
THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS
TO MASIMO’S PRODUCTS. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL
OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
MASIMO SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR
CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY
ARISING FROM THE USE OR LOSS OF USE OF ANY PRODUCTS.

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 accessories 10

accessories

The following accessories and re-order parts are available with the Radical Signal
Extraction pulse oximeter:

ACCESSORIES PART NUMBER

RADICAL HANDHELD 1309

RADICAL DOCKING STATION RDS-1 1310

RADICAL DOCKING STATION RDS-1B 1311

RADICAL DOCKING STATION RDS-2 1392

RADICAL HANDHELD LOCK 1395

REPLACEMENT BATTERY RADICAL - HANDHELD 1315

POLE CLAMP 1317

OPERATOR’S MANUAL - ENGLISH 11601

OPERATOR’S MANUAL - GERMAN 11714

OPERATOR’S MANUAL - FRENCH 11715

OPERATOR’S MANUAL - ITALIAN 11716

OPERATOR’S MANUAL - PORTUGUESE 11717

OPERATOR’S MANUAL - SPANISH 11718

OPERATOR’S MANUAL - DUTCH 11901

OPERATOR’S MANUAL - DANISH 11902

OPERATOR’S MANUAL - SWEDISH 11903

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 10 accessories

ACCESSORIES PART NUMBER

SATSHARE CABLE-DO01 1324

SATSHARE CABLE-DO02 1326

SATSHARE CABLE-DO03 1528

SATSHARE CABLE-DO04 1533

SATSHARE CABLE-DS01 1325

SATSHARE CABLE-DS02 1539

SATSHARE CABLE-HP01 1320

SATSHARE CABLE-MQ01 1321

SATSHARE CABLE-NK01 1367

SATSHARE CABLE-OH01 1366

SATSHARE CABLE-SL01 1323

SATSHARE CABLE-SL02 1362

SATSHARE CABLE-SM01 1322

Please visit our website, www.masimo.com, for updated information about accessories.

11601E-0801

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