Masimo Radical Signal Extraction Operator's Manual

signal extraction pulse oximeter

OPERATOR’S MANUAL

Signal Extraction Pulse Oximeter

OPERATOR’S MANUAL

Radical Signal Extraction Pulse Oximeter Operator’s Manual i

The Radical Operating Instructions 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 its proper use.

Do not operate the Radical Pulse Oximeter without completely reading and understanding the
instructions in this manual.

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
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com

EU Authorized Representative for Masimo Corporation:

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Tel.: [phone]
Fax.: [phone]

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL 60601-1/CAN/CSA C22.2 No. 601.1

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 6,850,787, 6,826,419, 6,816,741,

6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311,

6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952,

5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international

equivalents, or one or more of the patents referenced at www.masimo.com/patents. Products containing Satshare®

feature are also covered by U.S. Patent 6,770,028. Other patents pending.

© 2007 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare,SET, LNOP, LNCS

and LNOPv are federally registered trademarks of Masimo Corporation.

RadNet, RadicalScreen, Signal IQ, FastSat, FastStart and APOD are trademarks of Masimo Corporation.

EC REP

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.

■

High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow
the Pulse Oximeter to obtain vital sign readings.

■

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: SpO2is a functional calculation of arterial oxygen saturation.
Carboxyhemoglobin and Methemoglobin may erroneously increase SpO2readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that
is present. Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings.

■

Severe anemia may cause erroneous SpO2readings.

■

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.

■

If using pulse oximetry during full body irradiation, keep the sensor out of the irradiation field. If
the sensor is exposed to the irradiation, the reading might be inaccurate or the unit might read
zero for the duration of the active irradiation period.

■

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 operating.

■

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.

ii Radical Signal Extraction Pulse Oximeter Operator’s Manual Radical Signal Extraction Pulse Oximeter Operator’s Manual iii

■

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.

■

Disposal of product - Comply with local laws in the disposal of the unit and/or its accessories.

■

The Pulse Oximeter Module can be used during defibrillation, but the readings may be
inaccurate for up to 20 seconds.

■

This equipment has been tested and found to comply with the limits for medical devices to the EN
60601-1-2: 2002, 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.

■

A functional tester cannot be utilized to assess the accuracy of the Pulse Oximeter or any sensors.

SAFETY INFORMATION,WARNINGS, CAUTIONS AND NOTES (CONTINUED)

Radical Signal Extraction Pulse Oximeter Operator’s Manual v

table of contents

First Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Second page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Simplified user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

First page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Second Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Navigating the main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Main menu selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Menu categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Editing a parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Menu tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Config . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Trend display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Navigating the trend display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

First page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Second page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Third page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

Trend setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24

Backlight/contrast operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

Satshare operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26

Home mode operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

Password operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

SECTION 5 - ALARMS/MESSAGES

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Alarm identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

System messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Alarm operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

SECTION 6 - TROUBLESHOOTING

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

SECTION 7 - SPECIFICATIONS

Radical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Serial interface specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3

Serial Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4

Analog output / nurse call specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5

Analog Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

SECTION 1 - OVERVIEW

About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Features and benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Pulse oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Functional saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Measured vs. Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Masimo SET signal extraction technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

SECTION 2 - SYSTEM DESCRIPTION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Handheld Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Handheld back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Radical standalone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6

Standalone Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Standalone Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Radical monitor interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

SECTION 3 - SETUP

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Unpacking and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Preparation for monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Radical power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Initial battery charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Initial installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Custom (user) Defined Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Adult/neo (hospital defined) settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

SatShare Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Philips VueLink setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Spacelabs universal flexport setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

RadNet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

SECTION 4 - OPERATION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

Basic operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

General Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

Successful SpO

2

monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Numeric Display - SpO

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Numeric Display - Pulse Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Signal IQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Actions To Be Taken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Touch key control button and icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Traditional user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

table of contents

iv Radical Signal Extraction Pulse Oximeter Operator’s Manual

SECTION 8 - SENSORS & PATIENT CABLES

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Masimo SpO

2

sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Selecting a Masimo Set Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Sensor Application Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

LNOP

®

Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

LNOP®Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

LNOP®specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

LNOPvTMAdhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

LNCS

TM

Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

LNCSTMAdhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

Cleaning And Reuse Of Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

Reattachment of Single Use adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

Masimo SET patient cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

Cleaning And Reuse Of Masimo SET Patient Cables . . . . . . . . . . . . . . . . . . . . . .8-5

SECTION 9 - SERVICE AND MAINTENANCE

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Battery operation and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4

Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Performance verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-9

Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-9

Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-9

Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10

End-user license agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10

SECTION 10 - ACCESSORIES

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

table of contents

vi Radical Signal Extraction Pulse Oximeter Operator’s Manual Radical Signal Extraction Pulse Oximeter Operator’s Manual 1-1

1

overview

About this Manual

This manual explains how to set up and use the Masimo SET Radical Pulse Oximeter,
herein known as the Radical. Important safety information relating to general use of the
Radical 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 system and its

functions and features.

SECTION 3 SETUP describes how to setup the Radical 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 describes 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 Masimo SET 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 lists the available Radical accessories.

Radical Signal Extraction Pulse Oximeter Operator’s Manual 1-3

1

overview

Product description

The Radical Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate
monitor.The Radical can be used as either a Handheld or a Standalone monitor.The
Radical features a backlit Liquid Crystal Display (LCD) that continuously displays
numeric values for SpO

2

, pulse rate, plethysmographic waveform and Signal

Identification and Quality Indicator (Signal IQ

TM

). The 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 as the highest sensitivity and specificity pulse oximeter in the world

■

Signal IQ ®waveform for signal identification and quality indication during excessive
motion and low signal to noise situation

■

FastSat ®tracks rapid changes in arterial O2with high fidelity unlike any other pulse
oximeter

■

FastStartTMallows for rapid measurement from the time the instrument is first turned
on

■

APODTM(Adaptive Probe Off Detection) offers the best probe off detection of
Masimo's three sensitivity modes - APOD, Normal and MAX sensitivity

■

ClearVueTMtechnology delivers the highest resolution display available

■

SmartToneTMbeeps in sync with pulse, and with tonal changes for every 1% drop in
saturation, even under most patient motion conditions

■

SatShare ®interface connection to existing multiparameter monitor

(models RDS-

1/1B only)

■

RS-232, analog output, and nurse call interfaces

(models RDS-1/1B and RDS-3 only)

■

User configurability maximizes operation for all applications

■

Facilitates economical sensor standardization throughout the hospital

■

SpO2, pulse rate, alarm, trending, perfusion index, Signal IQ and plethysmographic
waveform display

■

Automatic screen rotation provides upright display for vertical or horizontal monitor
positioning

(not available on the RDS-2 model)

■

Remote alarming interface

■

Designed for hospital, transport and home use

■

Up to thirty days of trending

INDICATIONS FOR USE

The Radical and accessories are indicated for the continuous, noninvasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO

2

) and pulse rate (measured by

an SpO

2

sensor). The Radical 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 is indicated to provide continuous noninvasive monitoring
data to validated multiparameter patient monitors* for display on those monitors.

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

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:

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.

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

overview

1-2 Radical Signal Extraction Pulse Oximeter Operator’s Manual

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Radical Signal Extraction Pulse Oximeter Operator’s Manual 1-5

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overview

FUNCTIONAL SATURATION

The Radical is calibrated to measure and display functional saturation (SpO

2

): the
amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available
to transport oxygen.

MEASURED VS. CALCULATED SATURATION

Oxygen measurements that can be obtained from the Radical are commonly compared
to invasive measurements obtained from blood gas samples. When comparing invasive
and noninvasive measurements and interpreting values, caution should be used, as the
calculated values obtained from the blood gas sample may differ from the SpO

2

measurements of the pulse oximeter. Different results are usually obtained from the
arterial blood gas sample if the calculated measurement is not appropriately corrected
for the effects of variables that shift the relationship between the partial pressure of
oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon
dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.As blood gas samples are usually taken
over a period of 20 seconds (the time it takes to draw the blood) a meaningful
comparison can only be achieved if the 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 non­arterial 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 parallel engines and
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. The Masimo SET signal processing

algorithm, Discrete Saturation Transform

®

(DST)®, reliably identifies the noise, isolates it
and, using adaptive filters, cancels it. It then repor ts the true arterial oxygen saturation for
display on the monitor.

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 (SpO

2

)

2. As a pulse rate (PR)

3. As a plethysmographic waveform

The following figure shows the general monitoring setup.

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
distinguishbetween oxygenated and deoxygenated blood. Signal data is obtained by
passing red(rd)(660 nm wavelength) and infrared (ir)(905 nm wavelength) light through
a vascular bed (for example a fingertip, a hand, a foot) and measuring changes in light
absorption during the pulsatile cycle. This information may be useful to clinicians. The
radiant power of the light is rated at 0.79mW (max.). 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 to the Radical for calculation.

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

Recessed
Photo Detector

LED's

overview

1-4 Radical Signal Extraction Pulse Oximeter Operator’s Manual

1

3

2

1

1. Instrument

2. Patient Cable

3. Sensor

Radical Signal Extraction Pulse Oximeter Operator’s Manual 2-1

2

system description

Introduction

Radical provides the functionality of three pulse oximeters in one:

■

The Radical is a fully featured Handheld pulse oximeter

■

The Radical is a fully featured standalone pulse oximeter

■

The Radical interfaces to the SpO2input module of multiparameter patient monitors*
to upgrade conventional pulse oximetry technology to Masimo SET technology.

CAUTIONS:

■

THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR
IS A SIMULATED SIGNAL (NON-NORMALIZED). 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

■

ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.

Refer to Section 3,

SatShare Setup

and Section 4,

SatShare Operation

for additional

details.

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

Utilizing a SatShareTMcable, the standalone
Radical also interfaces with the SpO

2

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*.

4

90

The Handheld portion of the Radical contains the
majority 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.

overview

1-6 Radical Signal Extraction Pulse Oximeter Operator’s Manual

1

Masimo SET DST

Masimo SET Parallel Engines

Digitized,
Filtered &

Normalized

R/IR

R/IR

(Conventional

Pulse Oximetry)

Adaptive
Filter with

DST

TM

SST

TM

Proprietary
Algorithm 5

Saturation

Post

Processor

Confidence

Based

Arbitrator

MEAS

CONF

MEAS

CONF

MEAS

CONF

MEAS

CONF

MEAS

CONF

Proprietary

Algorithm 4

Radical Signal Extraction Pulse Oximeter Operator’s Manual 2-3

2

system description

1

HANDHELD
RELEASE
BUTTON

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

2

SpO

2

MEASUREMENT
DISPLAY

The functional arterial hemoglobin oxygen saturation is displayed
in units of percentage SpO2. The upper and lower SpO2alarm
limits are also displayed next to the SpO2measurement. 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 SpO2Measurement 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

Masimo

SET

MASIMO SET

The Masimo SET symbol is shown on the Radical display when
SET processing is active.

Note: Patient information, not Masimo SET, will be displayed
when using a RadNet compatible unit connected to a RadNet
central station.

4

FastSat

FASTSAT

The FastSat symbol is shown on the Radical display whenever the
Radical is set to operate in the FastSat mode.

5

SATURATION
ALARM LIMITS
DISPLAY

The Saturation Alarm Limits Display shows the upper and lower
saturation alarm limits. When an alarm limit is reached or
exceeded, the SpO2value and the violated limit flashes.

6

ALARM STATUS
INDICATOR

The alarm status indicator (a bell) can be shown with or without a
slash. It 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
MESSAGE
AREA

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

System messages

.

8

Max

APOD

SENSITIVITY

The Max or APOD sensitivity icon is shown on the Radical display
to indicate if the Radical is set to operate in Normal sensitivity,
Maximum sensitivity or Adaptive Probe Off Detection mode.When
in Normal mode, this area will appear blank.

9

BATTERY
STATUS
INDICATORS

The Battery Status Indicators show the capacity of the Radical
Handheld and 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
CONTROL
BUTTONS

Press a Touch Key Control Button to select the corresponding touch key
icon. See Section 4,

Touch Key Control Buttons and Icons

for more

details.

11

SPEAKER

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

12

PATIENT CABLE
CONNECTOR

Connect the patient cable to the Handheld Radical by plugging
the cable into 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
ICONS

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

Radical handheld

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

Numbers View

Masimo SET

11:42:46 03/27/03

10085%SpO

2

160

40

BPM

23

5

22

06:10:23pm 03/27/03

140

50

BPM

100

85

%SpO

2

No Sensor

1110

9

3

2

20

18 17 12

19

1

22423 151316 14

6

HPO1

Masimo SET FastSat

5

7

8

21

system description

2-2 Radical Signal Extraction Pulse Oximeter Operator’s Manual

2

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 may also be shown as a single,
pulsating bar.

15

PULSE
WAVEFORM
DISPLAY

The Pulse Waveform Display shows the acquired
plethysmograph waveform.The pleth waveform is scaled with
signal strength. Signal strength is defined as the relation of
arterial pulsatile signal to the non-pulsatile signal
component.

16

TIME AND DATE
INDICATOR

The Time and Date Indicator displays the current time and
date. The time is displayed in 12 or 24 hour format. The date
is displayed in dd/mm/yy or mm/dd/yy format.Select the date
and time display formats in the Clock menu.

17

BACKLIGHT/
CONTRAST
BUTTON

Press the Backlight Button to change the illumination level of
the backlight. With the AC line power connected, four levels
of illumination are available (in 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 six seconds to change the contrast. Release the
Backlight Button at the desired contrast setting.

18

ALARM
SILENCE
BUTTON

Press the Alarm Silence Button to temporarily silence patient
and low battery alarms. Press the 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 SpO2and 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
INDICATOR

The Output Mode Indicator displays the output mode
selected by the user (Philips Vuelink or Spacelabs Flexport).
The Output Mode Indicator also displays the type of
SatShare® 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. The Output Mode Indicator will take
place of the Time and Date indicator when utilized.

Philips Vuelink

20

POWER/STAND
BY BUTTON

Press the Power/Standby Button to turn the instrument on.
Press, hold the 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 (pulse strength)

22

PULSE RATE
ALARM LIMITS
DISPLAY

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

23

PULSE RATE

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

system description

2-4 Radical Signal Extraction Pulse Oximeter Operator’s Manual

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Radical Signal Extraction Pulse Oximeter Operator’s Manual 2-5

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.

1

DOCKING
STATION
CONNECTOR

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

2

POLE CLAMP
ACCESSORY
HOLDER

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

3

BATTERY PACK

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

.

1251 0000 536

MEDICAL ELECTRICAL EQUIPMENT

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

80FK

11328/2269M-0805

Covered by one or more of the following U.S. Patents: RE38,492,

RE38,476, 6,850,787, 6,826,419, 6,816,741, 6,699,194,

6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530,

6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525,

6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830,

6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134,

5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272,

5,490,505, 5,482,036, international equivalents, or one or more

of the patents referenced at www.masimo.com/patents.

Products containing Satshare® feature are also covered by

U.S. Patent 6,770,028. Other patents pending.

1

2 3

Radical Signal Extraction Pulse Oximeter Operator’s Manual 2-7

2

system description

STANDALONE FRONT PANEL

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

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

1

DOCKING
STATION
BATTERY
CHARGING
INDICATOR

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

2

HANDHELD
BATTERY
CHARGING
INDICATOR

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

3

VISUAL
ALARM
INDICATOR

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

4

AC POWER
INDICATOR

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

5

DOCKING
INDICATOR

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

Check Sensor

Masimo SET FastSat

11:42:46 03/27/03

100

85

%SpO

2

140

50

BPM

1

2

3

4

5

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.

The RDS-1 and RDS-3 are optionally available with RadNet capability. (Refer to Section 3

RadNet Setup for details).

DOCKING STATION FEATURES RDS-1 RDS-1B RDS-2 RDS-3 RDS-3B RDS-4

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 Indicator

■ ■ ■ ■ ■

AC Power Indicator

■ ■ ■ ■ ■ ■

Docking Indicator

■ ■ ■ ■ ■

Handheld Battery Deep
Discharge Support

■ ■ ■ ■ ■

Docking Station Battery Deep
Discharge Support

■ ■ ■ ■ ■

system description

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Radical Signal Extraction Pulse Oximeter Operator’s Manual 2-9

2

system description

SYMBOLS

The following symbols are found on the Radical unit, Docking Station or packaging and
are defined below:

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

Docking Station.

STANDALONE BACK PANEL

1

SERIAL OUTPUT
CONNECTOR

Use the Serial Output Connector with a ferrite bead installed to
connect a serial device, including a serial printer, RadNet Interface
Module or PC, to the Radical. The data is provided in standard RS­232C format. See Section 7,

Serial Interface Specifications

. All
external device connections to the Serial Output Connector must be
IEC-60950 compliant.

2

ANALOG OUTPUT
/ NURSE CALL
CONNECTOR

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

3

SATSHARE
CABLE
CONNECTOR

Use the SatShare Cable Connector to connect a SatShare cable to
the SpO2input connector of a multiparameter patient monitor. All
external device connections to the SatShare Cable Connector must
be IEC-60601-1 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
MODULE

The power entry module contains the input connector for AC power
and two fuses. The AC input provides power to the system from the
AC line. Always connect the pulse oximeter to the mains power for
continuous operation and/or battery recharging.

NOTE: Use the power cord as the means to disconnect the device
from the mains power supply.

5

EQUIPOTENTIAL
GROUND
CONNECTOR

Use the Equipotential Ground Connector for grounding.

1

2

3

5 4

P2 P3

Manufactured by:
Masimo Corporation
Irvine, CA 92618 USA
Made in USA

Rx Only

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476,
6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624,
6,650,917, 6,643,530, 6,606,511, 6,584,336, 6,501,975, 6,463,311, 6,430,525,
6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462,
6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299,
5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the
patents referenced at www.masimo.com/patents. Products containing Satshare®

P1P1

MEDICAL ELECTRICAL EQUIPMENT

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

80FK

system description

2-8 Radical Signal Extraction Pulse Oximeter Operator’s Manual

2

SYMBOLS DEFINITION

RS-232

SatShare interface

Equipotential Ground Terminal

See Instructions for Use

Fuse Replacement

Analog Out Interface

Nurse Call Interface

WEEE Compliant

Mark of Conformity to European Medical Device
Directive 93/42/EEC

Rx ONLY

Federal law restricts this device to sale by or on the
order of a physician (USA audiences only)

Underwriter's Laboratories Inc. approved

NON

STERILE

5%-95% RH

Storage humidity range: 5% to 95%

-40 C

+70 C

+1060 hPa - +500 hPa

795 mmHg - 375 mmHg

Storage temperature range: +70C to -40C
Storage altitude range: +1600hPa to +500hPa

Keep dry

Fragile/breakable, handle with care

Year of Manufacture

IPX1

Protection against liquid drops falling vertically.

Defibrillation Proof Type BF

Radical Signal Extraction Pulse Oximeter Operator’s Manual 3-1

3

setup

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 it 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. Ensure that the unit is adequately powered by verifying that the AC power
indicator on the Docking Station is illuminated.

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.

■

USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM
THE MAINS POWER SUPPLY.

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 SpO2input connector.

■

Upgrades any approved and validated monitor to Masimo SET performance by using
the calculated SpO

2

and pulse rate determined by Radical to simulate an ideal

waveform, which is sent to the validated multiparameter patient monitor.

■

Connects into the SpO2patient cable or SpO2input connector of the multiparameter
patient monitor.

Refer to Section 3,

SatShare Setup

and Section 4,

SatShare Operation

for additional

details.

CAUTION: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT
MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR THE
PATIENT WAVEFORM.

CAUTION: ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.

system description

2-10 Radical Signal Extraction Pulse Oximeter Operator’s Manual

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Radical Signal Extraction Pulse Oximeter Operator’s Manual 3-3

3

setup

Monitor setup

The Radical maintains three types of default values which will automatically reverts to
after a power cycle:

■

Factory – these options are restored to factory values

■

Custom – these settings can be changed by the user and retained through the power
cycle.

■

Adult / Neo – these settings can be selected to revert to factory or hospital-defined
values (for Adult or Neonatal) after a power cycle.

The following outlines the default values the Radical reverts to after a power cycle.

FACTORY DEFAULT SETTINGS

CUSTOM (USER) DEFINED SETTINGS

This mode is indicated by “Mode Custom” on the Alar ms menu.

The following table outlines the settings that may be changed by the user and the Radical
will remember after a power cycle.

OPTION DEFAULT 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

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

OPTION DEFAULT SETTING

LCD SCREEN ILLUMINATION

AC Power
Battery Power

Set to maximum, level 4
Set to off

SENSITIVITY Set to normal mode

■

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 and plug in the AC
power cord. 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.

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)

setup

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