Masimo RAD-57C, RAD-57M, RAD-57CM Operator's Manual

OPERATOR’S
MANUAL

Covers:

Rad-57c:
with SpO2 and SpCO

Rad-57m:
with SpO2 and SpMet

Rad-57cm:
with SpO

2,

SpCO

and SpMet

Signal Extraction

Pulse CO-Oximeter™

Masimo Rainbow® SET

®

Signal Extraction Pulse CO-Oximeter™

OPERATOR'S MANUAL

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

The Rad-57 Signal Extraction Pulse CO-Oximeter Operating Instructions intend to provide the nec-

essary information for proper operation of all Rad-57 Pulse CO-Oximeter models.

General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of

the Rad-57 Signal Extraction Pulse CO-Oximeter models are prerequisites for proper use.

Do not operate any of the Rad-57 Signal Extraction Pulse CO-Oximeter models without completely

reading and understanding these instructions.

NOTICE

Purchase or possession of this device does not carry any express or implied license to use with

replacement parts which would, alone or in combination with this device, fall within the scope of one

of the relating patents.

CAUTION:

FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A

PHYSICIAN.

For further information contact:

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

80fk

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215986,
7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194,
6,684,090,, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311,
6,430,525, 6,388,240, 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, 5,769,785, 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.htm. Other patents pending.

© 2009 Masimo Corporation. Masimo, , SET, LNCS, LNOP, Signal IQ, Discrete Saturation

Transform, DST, FastSat and SpCO are registered trademarks of Masimo Corporation.

Rad-57, Rad-57c, Rad-57m, Rad-57cm, SIQ, LNOPv, SpMet, Pulse CO-Oximeter and APOD are

trademarks of Masimo Corporation.

EC REP

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-57™ Handheld Pulse CO-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 CO-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 CO-Oximeter to obtain vital sign readings.

■ The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.

■ A Pulse CO-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.

■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse

and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.

■ The Pulse CO-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 CO-Oximeter cover except to replace

the batteries. 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 CO-Oximeter or accessories in any position that might cause

it to fall on the patient. Do not lift the Pulse CO-Oximeter by the patient cable.

■ Interfering Substances: SpO

2

is a functional calculation of arterial oxygen saturation.
Carboxyhemoglobin and methemoglobin may erroneously increase SpO2 readings.
The level of increase is approximately equal to the amount of carboxyhemoglobin and/
or methemoglobin present. Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.

■ Severe anemia may cause erroneous SpO2 readings.

■ Elevated levels of Total Bilirubin may lead to inaccurate SpO2 measurements.

■ Hemoglobin synthesis disorders may cause erroneous SpHb readings.

■ Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance

imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse
CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of
the oximetry measurements.

■ If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the

radiation field. If sensor is exposed to the radiation, the reading might be inaccurate
or the device might read zero for the duration of the active radiation period.

ii

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

■ Always remove the sensor from the patient and completely disconnect the patient

from the Pulse CO-Oximeter before bathing the patient.

■ Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.

■ Do not place the Pulse CO-Oximeter face against a surface. This will cause the alarm

to be muffled.

■ Do not place the Pulse CO-Oximeter on electrical equipment that may affect the

Pulse CO-Oximeter, preventing it from working properly.

■ Do not expose the Pulse CO-Oximeter to excessive moisture such as direct exposure

to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately
or fail.

■ Do not place containers containing liquids on or near the Pulse CO-Oximeter. Liquids

spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.

■ Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup

procedures remove the Pulse CO-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 device and/or its

accessories.

■ The Pulse CO-Oximeter 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.

■ Consult the manufacturer for help.

■ A functional tester cannot be utilized to assess the accuracy of the Pulse CO-Oximeter

or any sensors.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

table of contents

iv

SECTION 1 - OVERVIEW

About this manual .......................................................................................................... 1-1

Warnings, Cautions and Notes ...................................................................................... 1-2

Product Description .......................................................................................................1-3

Model Summary ....................................................................................................... 1-3

Features and Benefits .............................................................................................. 1-3

Indications for use .................................................................................................... 1-4

Pulse CO-Oximetry ........................................................................................................ 1-5

SpO

2

General Description........................................................................................ 1-5

SpCO General Description ....................................................................................... 1-5

SpMet General Description ...................................................................................... 1-5

Principle of Operation ............................................................................................... 1-6

Functional vs. Fractional Saturation ......................................................................... 1-6

Measured vs. Calculated Values .............................................................................. 1-7

Masimo SET Signal Extraction Technology for SpO2 measurements ...................... 1-7

SpCO and SpMet measurements during patient motion ......................................... 1-7

Masimo SET Parallel Engines .................................................................................. 1-8

Masimo SET DST® .................................................................................................. 1-8

SECTION 2 - SYSTEM DESCRIPTION

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

Rad-57c Front Panel Controls .......................................................................................2-2

Rad-57m Front Panel Controls ......................................................................................2-4

Rad-57cm Front Panel Controls ....................................................................................2-6

Rad-57 Rear Panel (all models) ....................................................................................2-8

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

SECTION 3 - SETUP

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

Unpacking and Inspection .............................................................................................3-1

Preparation for Monitoring .............................................................................................3-1

Power Requirements ................................................................................................ 3-1

Monitor Setup ................................................................................................................3-2

Initial Setup............................................................................................................... 3-2

SECTION 4 - OPERATION

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

Basic Operation ............................................................................................................. 4-1

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

Default Settings ........................................................................................................ 4-3

Successful SpO

2

Monitoring .......................................................................................... 4-4

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

Numeric Display - SpO2 ........................................................................................... 4-4

Numeric Display - Pulse Rate ................................................................................. 4-5

Numeric Display - SpCO .......................................................................................... 4-5

Numeric Display - SpMet ......................................................................................... 4-5

Numeric Display - PI ................................................................................................ 4-5

Low Signal IQ (Low SIQ).......................................................................................... 4-5

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

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

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

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

v

table of contents

Battery Level Indicator.............................................................................................. 4-7

Low Battery Audible Alarm ....................................................................................... 4-8

Normal Patient Monitoring .............................................................................................4-9

Setup Menu.................................................................................................................. 4-10

Menu Navigation .................................................................................................... 4-10

Setup Menu Level 1 – Alarm Volume and Alarm Silence ...................................... 4-10

Setup Menu Level 2 – Alarm Limits ....................................................................... 4-10

Setup Menu Level 3 – Sensitivity, Averaging, FastSat and SmartTone ..................4-11

Setup menu Level 4 - Trend Settings ..................................................................... 4-11

Setup Menu Level 5 - LED brightness and Factory Defaults ................................. 4-12

Menu selection ....................................................................................................... 4-12

Power Off ................................................................................................................ 4-12

Special Menu ............................................................................................................... 4-12

Special Menu – Line Frequency Configuration ............................................................ 4-13

Trend Setup and Use ................................................................................................... 4-14

Introduction ............................................................................................................. 4-14

TrendCom Utility Installation ................................................................................... 4-14

TrendCom Utility Operation .................................................................................... 4-14

Erasing Trend Memory ........................................................................................... 4-15

Trend Data Format ................................................................................................. 4-15

Sample Trend Output .............................................................................................. 4-16

SECTION 5 - ALARMS / MESSAGES

Alarm Indication ............................................................................................................. 5-1

Alarm Limits ...................................................................................................................5-1

Alarm Silence ........................................................................................................... 5-3

Alarm Silenced Indicator .......................................................................................... 5-3

Messages ................................................................................................................. 5-4

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

Rad-57 Family Specifications ........................................................................................7-1

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

Accuracy ................................................................................................................... 7-1

Electrical ................................................................................................................... 7-2

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

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

SECTION 8 - SENSOR AND PATIENT CABLES

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

Selecting a Sensor ................................................................................................... 8-1

Sensor Application Instructions ................................................................................ 8-1

Masimo Rainbow

®

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

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

Rainbow Adhesive Sensors ..................................................................................... 8-2

Masimo SpO2 Sensors .................................................................................................. 8-2

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

LNOP® Reusable Sensors ........................................................................................................... 8-3

SECTION 4 - OPERATION (CONTINUED)

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

table of contents

vi

LNOP® Adhesive Sensors ....................................................................................... 8-3

LNOP

®

Specialty Sensors ....................................................................................... 8-3

LNCS® Reusable Sensors ...................................................................................... 8-3

LNCS® Adhesive Sensors ...................................................................................... 8-4

LNOPv™ Adhesive Sensors ............................................................................................ 8-4

Sensor Accuracy ..................................................................................................... 8-4

Cleaning And Reuse Of Masimo Reusable Sensors and Cables ............................ 8-4

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

SECTION 9- SERVICE / MAINTENANCE

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

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

Battery Replacement ................................................................................................ 9-2

Performance Verification ................................................................................................ 9-3

Power-On Self-Test ................................................................................................... 9-3

Key Press Button Test .............................................................................................. 9-3

Alarm Limit Test ........................................................................................................ 9-3

LED Brightness ........................................................................................................ 9-3

Service and Repair ........................................................................................................9-4

Repair Policy ............................................................................................................ 9-4

Return Procedure ..................................................................................................... 9-4

Sales & End-user License Agreement .................................................................... 9-5

Warranty .........................................................................................................................9-5

Exclusions ...................................................................................................................... 9-5

End-user License .......................................................................................................... 9-6

Restrictions ................................................................................................................... 9-7

SECTION 10- ACCESSORIES

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

SECTION 8 - SENSOR AND PATIENT CABLES (CONTINUED)

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-1

1

overview

About this Manual

This manual explains how to set up and use the Rad-57c, Rad-57m and Rad-57cm Signal
Extraction Pulse CO-Oximeter. These three products will be generally referred to as the Rad-

57. Features and specifications apply to all models unless otherwise noted. Important safety
information relating to general use of the Rad-57 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 CO-Oximetry.

SECTION 2 SYSTEM DESCRIPTION describes the Rad-57 system, functions and

features.

SECTION 3 SETUP describes how to setup the Rad-57 for use.

SECTION 4 OPERATION describes the operation of the Rad-57.

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 Rad-57.

SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and care for

Masimo Rainbow SET, LNOP

®

, LNOPv™ and LNCS® sensors, Masimo

Rainbow SET patient cables and Masimo SET patient cables.

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain, service and

obtain repair for the Rad-57.

SECTION 10 ACCESSORIES

1-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

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.

overview

1

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-3

1

overview

Product Description

The Rad-57 Handheld Pulse CO-Oximeter with Masimo Rainbow

®

SET® Technology is
a noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-57 features a
multicolored LED display that continuously displays numeric values for SpO

2

and pulse
rate, a Low Signal IQ Indicator (Low SIQ) indicator, alarm status, alarm silence and battery
life.

Certain models include LED indicator bars for Perfusion Index (PI), Carboxyhemoglobin
saturation (%SpCO), Methemoglobin percentage (%SpMet), and SpCO/SpMet sensor
connected.

MODEL SUMMARY

All models include SpO

2

and pulse rate.

MODEL FEATURES

Rad-57c Includes SpCO and PI

Rad-57m Includes SpMet and PI

Rad-57cm Includes SpCO, SpMet and PI

The following list outlines the key features and benefits of the Rad-57 Handheld Pulse
CO-Oximeter.

FEATURES AND BENEFITS

■ Clinically proven Masimo SET

®

technology performance

■ Proven for accurate SpO

2

and pulse rate monitoring in motion and low perfusion

environments

■ SpO

2

, pulse rate, Perfusion Index, % SpCO* and SpMet* displays

■ Low Signal IQ (SIQ™) indicator

■ Lightweight, convenient handheld design

■ Over 8 hours of continuous use on 4 “AA” alkaline batteries

■ Visual battery life indicator

■ Audible Alarm for sensor-off and low battery

■ Alarms for high/low SpO

2

, high/low pulse rate, SpCO* and SpMet*

■ FastSat

®

(for SpO2 measurement)

■ Three sensitivity levels - Max, Normal and APOD

TM

(for SpO2 measurement)

■ 72 hours of trending memory

■ Adjustable alarm volume

■ Adjustable averaging 2 to 16 seconds

*See Model Summary for applicable device.

1-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

INDICATIONS FOR USE

The Rad-57 and accessories are indicated for the continuous, noninvasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO

2

), pulse rate, carboxyhemoglobin
saturation (measured by an SpCO/SpMet sensor)* and methemoglobin saturation
(measured by a SpCO/SpMet sensor)*. The Rad-57 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.

*See Model Summary for applicable device.

overview

1

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-5

1

1

overview

Pulse CO-Oximetry

SpO2 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 connects
to the pulse oximetry device with a patient cable. The sensor collects signal data from the
patient and sends it to the device. The device displays the calculated data in two ways:

1) As a percent value for arterial oxygen saturation (SpO

2

)

2) As a pulse rate (PR)

The following figure shows the general monitoring setup.

SpCO GENERAL DESCRIPTION

Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels
of carbon monoxide concentration (SpCO) in arterial blood. It relies on the same basic
principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The
measurement is obtained by placing a sensor on a patient, usually on the fingertip for
adults and the hand or foot for infants. The sensor connects either directly to the Pulse
CO-Oximetry device or through a patient cable. The sensor collects signal data from the
patient and sends it to the device. The Rad-57c and Rad-57cm display the calculated data
as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound
to hemoglobin.

SpMet GENERAL DESCRIPTION

Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels
of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic
principles of pulse oximetry (spectrophotometry) to make its SpMet measurement. The
measurement is obtained by placing a sensor on a patient, usually on the fingertip for
adults and the hand or foot for infants. The sensor connects either directly to the Pulse
CO-Oximetry or through a patient cable. The sensor collects signal data from the patient
and sends it to the device. The Rad-57m and Rad-57cm display the calculated data as
percentage value for the SpMet.

1

3

2

1. Device

2. Sensor

3. Patient Cable

1-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

PRINCIPLE OF OPERATION

Pulse oximetry is governed by the following principles:

1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood),
carboxyhemoglobin (blood with carbon monoxide content) and methemoglobin
(blood with oxidized hemoglobin content) species differ in their absorption of visible
and infrared light (using spectrophotometry, see figure below).

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 Rad-57 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood
with oxidized hemoglobin. The Rad-57 utilizes a sensor with various light-emitting diodes
(LEDs) that pass light through the site to a photodiode (detector). See figure below. Signal
data is obtained by passing various visible and infrared lights (LED’s, 500 to 1000nm)
through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in
light absorption during the blood pulsatile cycle. This information may be useful to clinicians.
The maximum radiant power of the strongest light is rated at 22mW. The detector receives
the light, converts it into an electronic signal and sends it to the Rad-57 for calculation.

Once the Rad-57 receives the signal from the sensor, it utilizes Masimo Rainbow SET
signal extraction technology to calculate the patient’s functional oxygen saturation, blood
levels of carboxyhemoglobin (SpCO*), methemoglobin (SpMet*) and pulse rate. The SpCO
and SpMet measurements rely on a multiwavelength calibration equation to quantify the
percentage of carbon monoxide and methemoglobin in arterial blood. The maximum of
the skin surface temperature is measured at an ambient temperature of less than 106º F
(41º C). This is verified by Masimo sensor skin temperature test procedures.

* See Model Summary for applicable device.

overview

Rad-57cm Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

600

650 700 750 800 850 900 950 1000

0

2

4

6

8

Wavelength (nm)

Absorption (mm-1)

Carboxyhemoglobin

Oxyhemoglobin

Methemoglobin

Deoxyhemoglobin

1

2

1. Light Emitting Diodes (LEDs)
(7 + wavelengths)

2. Detector

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 1-7

1

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

overview

FUNCTIONAL VS. FRACTIONAL SATURATION

The Rad-57 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. Note that carboxyhemoglobin is not capable of transporting oxygen, but
is recognized as oxygenated hemoglobin by conventional pulse oximetry.

MEASURED VS. CALCULATED VALUES

SpO2, SpCO* and SpMet* measurements that can be obtained from the Rad-57 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 SpO2, SpCO and SpMet measurements of the Pulse CO-Oximeter. In the case
of SpO2, different results are usually obtained from the arterial blood gas sample if the
calculated measurement is not appropriately corrected for the effects of variables that
shift the relationship between the partial pressure of oxygen (PO2) and saturation, such
as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal
hemoglobin. In the case of SpCO and SpMet, in addition to the effects of temperature and
pH, different results are also expected if concentration of methemoglobin in the blood gas
sample are abnormal (less than 90% for arterial oxygen saturation, and greater than 2%
for methemoglobin concentration). 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 oxygen saturation, carboxyhemoglobin and methemoglobin concentration of
the patient are stable and not changing over the period of time that the blood gas sample
is taken.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO

2

MEASUREMENTS

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, causing conventional pulse oximeters to read low values,
because they cannot distinguish between the arterial and venous blood movement
(sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and
adaptive 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 reports the true arterial oxygen saturation for
display on the monitor.

SpCO AND SpMet MEASUREMENTS DURING PATIENT MOTION

The Rad-57 displays measurements of SpCO* and SpMet* during patient motion. However,
because of the changes in the physiological parameters such as blood volume, arterial­venous coupling, etc. that occur during patient motion, the accuracy of such measurements
may not be readable during excessive motion.

* See Model Summary for applicable device.

1-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

1

MASIMO RAINBOW SET PARALLEL ENGINES

This figure is for conceptual purposes only.

MASIMO SET DST

®

overview

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Pre-Processing &

Data Reduction

Digitized, Filtered &

Normalized

LED

Wavelengths

R/IR

(Conventional

Pulse Oximetry)

DST

Adaptive

Filter

SST ™

®

FST:

Proprietary

Algorithm 3

FST:

Proprietary

Algorithm 4

Rainbow

Specific

Algorithms

Pulse

Rate

Algorithm

Confidence

Based

Arbitrator

Post

Processor

%SpO

2

%SpCO

%SpMet

PI

PR

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-1

2

Introduction

The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse
oximetry measurement information, as well as device status data, is displayed on the front
panel of the device. All user input is handled by control buttons on the front panel and the
sensor cable connection is located at the top edge of the device.

The Rad-57 is powered by 4 “AA” alkaline batteries, which provides a minimum of 8 hours
of battery life.

■ Rad-57 offers full Masimo Rainbow SET Technology in a small, hand held device.

■ Rad-57 supports the full line of Masimo sensors (see Section 8, sensors and

patient cables).

■ Provides 72 hours of trending memory

A Direct Connect Rainbow reusable sensor or patient cable or a Direct Connect Red
reusable sensor or patient cable attaches to the patient cable connector on the top of the
Rad-57. The Rad-57 can be used either as a transport monitor or as a handheld Pulse
CO-Oximeter for spot checks.

2

system description

2-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

2

system description

CONTROL / INDICATOR DESCRIPTION

1

Patient Cable Connector

Connects to a Rainbow Sensor or Rainbow Patient Cable,

Red Sensor or a Red Patient Cable with an LNOP, LNOPv

or LNCS Sensor.

2

SpCO indicator

Slow flashing indicator: The confidence in the SpCO value

obtained is low.

Fast flashing indicator: Flashes when an SpCO alarm

condition exists.

3

Saturation (%SpO2) and

Carboxyhemoglobin

(%SpCO) Displays

The functional arterial hemoglobin oxygen saturation is
displayed in units of SpO2. When searching for a saturation
and pulse, it will flash dashed lines.

Refer to the Display Button description.

4

%SpCO Bar

Illuminates when SpCO capable sensor is attached. Bar will
flash for SpCO alarm conditions. Continuously indicates the
concentration of carboxyhemoglobin in increments of: 3, 6, 9,
12, 15, 20, 25, 30, 35, > 40.

5

Pulse Rate Display

The pulse rate in beats per minute (bpm). When searching for
a saturation and pulse, it will flash dashed lines.

Rad-57c

Rad-57c Front Panel Controls

2

3

4

5

1

11

12

14

16

17

18

6

8

9

13

15

7

10

<3

6

9

12

15

20

25

30

35

>40

%SpCO

SpCO

Signal Extraction Pulse CO-Oximeter

%SpO

2

rainbow

%SpCO

1

2

3

1.75

>5

1.5

1.25

.5

.25

<.1

BPM

PI

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-3

2

system description

CONTROL / INDICATOR DESCRIPTION

6

Display Button

Pressing this button will display the numeric SpCO value
in place of the SpO2 numeric value and CO in the place of
pulse rate. Pressing this button again will return to the SpO

2

/pulse rate numeric value.

7

Mode / Enter Button

Used to enter the setup menus and to select/activate certain
entries within the menu/setup system.

8

Next Button

Used within the menu/setup system to move through setup
options. Not active during normal patient monitoring.

9

Power On / Off

Press to turn the device on.

Press-and-hold for 2 seconds to turn the device off.

10

Battery Level Indicator

Four LED’s indicate the status of the battery. When the final
indicator begins flashing, replace the batteries.

11

Visual Alarm Indicator

Illuminates when any alarm condition exists. This indicator
may not be turned-off or otherwise over-ridden.

12

%SpO2 / %SpCO
Indicator

Indicator above label will illuminate to provide an additional
visual indication of the value currently being displayed.

13

PI

Perfusion Index, or PI, is a relative assessment of the
perfusion at the monitoring site. PI is displayed on a 10
segment LED bar, ranging from < .1% (very weak perfusion)
to >5% (strong perfusion). The highest LED will remain lit
continuously to allow a PI level to be viewed. The Perfusion
Index is the ratio of the AC (pulsatile) to DC (non-pulsatile)
components of the IR (Infrared) signal where the AC and DC
components correspond to the pulsatile and non-pulsatile
amounts of blood, respectively.

14

Low SIQ

Flashes to indicate low SpO2 Signal IQ. Refer to Section
4, Low Signal IQ.

15

Alarm Silenced Indicator

Flashes to indicate the alarm is temporarily silenced. A solid
illuminated light indicates that the alarms are permanently
silenced until the power is cycled or the alarms are enabled
per Setup Menu 1 in Section 4.

16

Alarm Silence Button

Push once to temporarily silence the alarm for 120 seconds.
Push a second time to return the device to standard alarm
monitoring.

17

Up button

Down button

During saturation monitoring, use these buttons to adjust the
volume of the pulse beep tone.

Within the menu/setup system, these buttons are used to
select values within each menu option.

18

Speaker

Provides audible indication of alarm conditions, pulse tone
and feedback for key-presses. Ensure the speaker is not
covered or the device is placed face-down on bedding or
other sound absorbing surface.

2-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

2

system description

CONTROL / INDICATOR DESCRIPTION

1

Patient Cable

Connector

Connects to a Rainbow Sensor or Rainbow Patient Cable,

Red Sensor or a Red Patient Cable with an LNOP, LNOPv

or LNCS Sensor.

2

SpMet indicator

Slow flashing indicator: The confidence in the SpMet value

obtained is low.

Fast flashing indicator: Flashes when an SpMet alarm

condition exists.

3

Saturation (%SpO2)

Display

The functional arterial hemoglobin oxygen saturation is
displayed in units of SpO

2

. When searching for a saturation

and pulse, it will flash dashed lines.

4

%SpMet Bar

Illuminates when SpMet capable sensor is attached. Bar will
flash for SpMet alarm conditions. Continuously indicates the
concentration of Methemoglobin in increments: .5, 1-5, 7.5,
10, 15 >20%.

5

%SpMet / Pulse Rate
Display

Indicator above label will illuminate to provide an additional
visual indication of the SpMet value currently being
displayed.

The pulse rate in beats per minute (bpm). When searching
for a saturation and pulse, it will flash dashed lines.

Rad-57m

Rad-57m Front Panel Controls

2

3

4

5

1

11

12

14

16

17

18

6

8

9

13

15

7

10

.5

1

2

3

4

5

7.5

10

15

>20

SpMet

%SpMet

Signal Extraction Pulse CO-Oximeter

%SpO

2

1

2

3

1.75

>5

1.5

1.25

.5

.25

<.1

%SpMet

BPM

PI

rainbow

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-5

2

system description

CONTROL / INDICATOR DESCRIPTION

6

Display Button

Pressing this button will display the numeric SpMet value
in place of the pulse rate numeric value until the SpMet
button is pressed again.

7

Mode / Enter Button

Used to enter the setup menus and to select/activate
certain entries within the menu/setup system.

8

Next Button

Used within the menu/setup system to move through setup
options. Not active during normal patient monitoring.

9

Power On / Off

Press to turn the device on.

Press-and-hold for 2 seconds to turn the device off.

10

Battery Level Indicator

Four LED’s indicate the status of the battery. When the
final indicator begins flashing, replace the batteries.

11

Visual Alarm Indicator

Illuminates when any alarm condition exists. This indicator
may not be turned-off or otherwise over-ridden.

12

%SpO2 Indicator

Indicator above label will illuminate to provide an additional
visual indication of the value currently being displayed.

13

PI

Perfusion Index, or PI, is a relative assessment of the
perfusion at the monitoring site. PI is displayed on a
10 segment LED bar, ranging from < .1% (very weak
perfusion) to >5% (strong perfusion). The highest LED will
remain lit continuously to allow a PI level to be viewed. The
Perfusion Index is the ratio of the AC (pulsatile) to DC (non­pulsatile) components of the IR (Infrared) signal where the
AC and DC components correspond to the pulsatile and
non-pulsatile amounts of blood, respectively.

14

Low SIQ

Flashes to indicate low SpO2 Signal IQ. Refer to Section
4, Low Signal IQ.

15

Alarm Silenced Indicator

Flashes to indicate the alarm is temporarily silenced.
A solid illuminated light indicates that the alarms are
permanently silenced until the power is cycled or the
alarms are enabled per Setup Menu 1 in Section 4.

16

Alarm Silence Button

Push once to temporarily silence the alarm for 120
seconds. Push a second time to return the device to
standard alarm monitoring.

17

Up button

Down button

During saturation monitoring, use these buttons to adjust
the volume of the pulse beep tone.

Within the menu/setup system, these buttons are used to
select values within each menu option.

18

Speaker

Provides audible indication of alarm conditions, pulse tone
and feedback for key-presses. Ensure the speaker is not
covered or the device is placed face-down on bedding or
other sound absorbing surface.