OPERATOR'S MANUAL

OPERATOR’S

M ANUAL

Signal Extraction

Pulse CO-Oximeter™

Masimo Rainbow

SET

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

mation 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.: 949-297-7000

Fax.: 949-297-7001

www.masimo.com

EU Authorized Representative for Masimo Corporation:

MDSS GmbH

Schiffgraben 41

D-30175 Hannover, Germany

Covered by one or more of the following U.S patents: 5482036, 5490505, 5632272, 5685299, 5758644,

5769785, 5919134, 6002952, 6011986, 6067462, 6157850, 6229856, 6236872, 6263222, 6360114, 6388240,

6430525, 6463311, 6501975, 6515273, 6606511, 6643530, 6650917, 6654624, 6684090, 6699194, 6745060,

6816741, 6826419, 6850787, 6861639, 6979812, 7186966, 7215984, 7215986, 7221971, 7254433, 7295866,

7328053, 7373194, 7376453, 7377899, 7467002, 7469157, 7471969, 7489958, 7496393, 7499741, 7509154,

7530955, RE38476, RE38492, international equivalents, or one or more of the patents referenced at www.

masimo.com/patents.htm. Other patents pending.

, SET, Rad, LNCS, LNOP, Signal IQ, Discrete Saturation Transform,

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

Rad-57, SIQ, LNOPv, Pulse CO-Oximeter and APOD are trademarks of Masimo Corporation.

EC REP

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

CONTRAINDICATIONS: The Rad-57 is contraindicated for use as an apnea monitor.

Safety Information, Warnings and Cautions

The Rad-57™ 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.

■ The Rad-57 is to be operated by qualified personnel only. This manual, accessories, Directions

for Use, all precautionary information, and specifications should be read before use.

■ Explosion hazard. Do not use the Rad-57 in the presence of flammable anesthetics or other

flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

■ Electric shock hazard. Do not open the Rad-57 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.

■ High intensity extreme lights (such as pulsating strobe lights and direct sunlight) directed on the

sensor, may not allow the Rad-57 to obtain readings.

■ EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause

errors or incorrect measurements on the Rad-57.

■ If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices 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 Rad-57 should not be used as a replacement

or substitute for ECG based arrhythmia analysis.

■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient

entanglement or strangulation.

■ Do not place the Rad-57 or accessories in any position that might cause it to fall on the patient.

■ Do not lift the Rad-57 by the patient cable or sensor.

■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately.

■ Rad-57 should not be used as the sole basis for diagnosis or therapy decisions. It must be used

in conjunction with clinical signs and symptoms.

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

57 before bathing the patient.

■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood

pigmentation may cause erroneous readings.

■ Do not use the Rad-57 or sensors during magnetic resonance imaging (MRI) scanning. Induced

current could potentially cause burns. The Rad-57 may affect the MRI image, and the MRI device

may affect the accuracy of the Pulse CO-Oximetry parameters and measurements.

■ Do not use the Rad-57 during electrocautery.

■ Do not use the Rad-57 or sensor during defibrillation.

■ If using the Rad-57 during full body irradiation, keep the sensor out of the radiation field. If the

sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read

zero for the duration of the active irradiation period.

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

Safety Information, Warnings and Cautions, continued

■ Do not place the Rad-57 where the controls can be changed by the patient.

■ Do not place the Rad-57 on electrical equipment that may affect the instrument, preventing it from

working properly.

■ Do not expose the Rad-57 to excessive moisture such as direct exposure to rain. Excessive moisture

can cause the instrument to perform inaccurately or fail.

■ Do not place containers containing liquids on or near the Rad-57. Liquids spilled on the instrument

may cause it to perform inaccurately or fail.

■ Changes or modifications not expressly approved by the party responsible for compliance could

void the user's authority to operate the equipment

■ SpO

is empirically calibrated to functional arterial oxygen saturation in healthy adult

volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).

The Rad-57 cannot measure elevated levels of COHb or MetHb. Increases in either COHb or

MetHb will affect the accuracy of the SpO

measurement.

■ Inaccurate SpO

readings can be caused by:

z Improper sensor placement

z Elevated levels of COHb and MetHb

z For increased COHb: COHb levels above normal tend to increase the level of SpO2. The

level of increase is approximately equal to the amount of COHb that is present.

z NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated

levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample

should be performed.

■ For increased MetHb: the SpO

may be decreased by levels of MetHb of up to approximately

10% to 15%. At higher levels of MetHb, the SpO

may tend to read in the low to mid 80s.

When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a

blood sample should be performed.

■ Inaccurate SpCO and SpMet readings can be caused by:

z Improper sensor application

z Intravascular dyes such as indocyanine green or methylene blue

z Abnormal hemoglobin levels

z Low arterial perfusion

z Low arterial oxygen saturation levels including altitude induced hypoxemia

z Elevated total bilirubin levels

z Motion artifact

z SpCO readings may not be provided if SpO2 readings are less than 90%

z SpCO readings may not be provided if SpMet readings are greater than 2%

z Intravascular dyes such as indocyanine green or methylene blue

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

iii

Safety Information, Warnings and Cautions, continued

z Externally applied coloring (such as nail polish)

z Elevated levels of bilirubin

z Severe anemia

z Low arterial perfusion

z Motion artifact

■ Do not place the Rad-57 against a surface or cover the speaker. This can cause the system or

battery (non clinical) alarm to be muffled.

■ If the Rad-57 fails any part of the setup procedures remove the instrument from operation

until qualified service personnel have corrected the situation.

■ Use the Rad-57 in accordance with Section 7, Environmental Specications in of this

manual.

■ Do not incinerate batteries.

■ To protect against injury from electric shock, follow the directions below:

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

■ Do not soak or immerse the device in liquids.

■ Use cleanings solutions sparingly.

■ This device complies with part 15 of the FCC Rules. Operation is subject to the following two

conditions: (1) This device may not cause harmful interference, and (2) this device must

accept any interference received, including interference that may cause undesired operation.

■ This equipment has been tested and found to comply with the limits for a Class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable

protection against harmful interference in a residential installation. This equipment generates,

uses and can radiate radio frequency energy and, if not installed and used in accordance with

the instructions, may cause harmful interference to radio communications. However, there is

no guarantee that interference will not occur in a particular installation. If this equipment does

cause harmful interference to radio or television reception, which can be determined by turning

the equipment off and on, the user is encouraged to try to correct the interference by one or

more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

Consult the dealer or an experienced radio/TV technician for help.

■ In accordance with international telecommunication requirements, the frequency band of 5,150

MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to

co-channel mobile satellite systems.

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

Safety Information, Warnings and Cautions, continued

■ 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 and Class B.

■ A functional tester cannot be utilized to assess the accuracy of the Rad-57 or any sensors.

■ Cleared Use Only: The device and related accessories are cleared by the Food and Drug

Administration (FDA) for noninvasive patient monitoring and may not be used for any processes,

procedures, experiments or any other use for which the device is not intended or cleared by the

FDA, or in any manner inconsistent with the instructions for use or labeling. The device and

related accessories are not intended for use in combination with other medical devices or in high-

risk applications.

■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its

accessories.

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

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

Table of Contents

Safety Information, Warnings and Cautions ....................................................................................i

SECTION 1 - OVERVIEW

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

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

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

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

Indications for Use ................................................................................................................1-4

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

SpO

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

SpCO General Description ....................................................................................................1-6

SpMet General Description ...................................................................................................1-6

Pleth Variability Index - (PVI) General Description ...............................................................1-6

Low Perfusion........................................................................................................................1-6

FastSat ..................................................................................................................................1-7

SmartTone ............................................................................................................................ 1-7

Principles of Operation .......................................................................................................... 1-8

Functional vs. Fractional Saturation ...................................................................................... 1-9

Rad-57 vs. Drawn Whole Blood Measurements ...................................................................1-9

Masimo SET Signal Extraction Technology For SpO

Measurements .................................1-9

SpMet, and SpCO Measurements During Patient Motion ....................................................1-9

Masimo Rainbow SET Parallel Engines..............................................................................1-10

Masimo SET DST

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

SECTION 2 - SYSTEM DESCRIPTION

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

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

Rad-57 Rear Panel .................................................................................................................... 2-4

Battery Installation ................................................................................................................. 2-4

Symbols .................................................................................................................................2-5

SECTION 3 - SETUP

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

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

Preparation for Monitoring .......................................................................................................... 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

Monitoring ....................................................................................................... 4-5

Masimo Sensors....................................................................................................................4-5

Numeric Display - SpO

2........................................................................................................4-5

Numeric Display - Pulse Rate ..............................................................................................4-6

Numeric Display - SpCO (upgraded Instrument) ..................................................................4-7

Numeric Display - SpMet (upgraded Instrument) ..................................................................4-7

Numeric Display - PI ...........................................................................................................4-8

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

Table of Contents

Pleth Variability Index - PVI (upgraded Instrument) .............................................................. 4-8

Low Signal IQ (Low SIQ) ......................................................................................................4-8

Low Perfusion........................................................................................................................4-8

Actions to be Taken ..............................................................................................................4-9

Sensitivity ..............................................................................................................................4-9

Battery Level Indicator ........................................................................................................4-10

Low Battery Audible Alarm ..................................................................................................4-10

Normal Patient Monitoring .........................................................................................................4-11

Rad-57 Front Panel Control Operation ...............................................................................4-11

Setup Menu ...............................................................................................................................4-11

Menu Navigation .................................................................................................................4-11

Setup Menu Level 1 – Alarm Volume and Alarm Silence ...................................................4-12

Setup Menu Level 2 – Alarm Limits ....................................................................................4-12

Setup Menu Level 3 – Sensitivity, Averaging, FastSat, SmartTone ....................................4-13

Setup Menu Level 4 - Trend Settings .................................................................................4-14

Setup Menu Level 5 - LED Brightness and Factory Defaults .............................................4-15

Menu Selection....................................................................................................................4-15

Power Off ............................................................................................................................4-15

Special Menu ............................................................................................................................ 4-16

Special Menu – Line Frequency Configuration ...................................................................4-16

Trend Setup and Use ................................................................................................................ 4-17

Introduction ..........................................................................................................................4-17

TrendCom Utility Installation ...............................................................................................4-17

Erasing Trend Memory ........................................................................................................ 4-17

Trend Data Format ..............................................................................................................4-17

SECTION 5 - ALARMS AND 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 Specifications ................................................................................................................. 7-1

Performance .......................................................................................................................... 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 R Series Adhesive Sensors ...................................................................................8-2

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

vii

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

Rainbow Direct Connect Sensors .........................................................................................8-3

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

Rainbow Resposable™ Pulse CO-Oximeter Sensor System ............................................... 8-3

Masimo SpO

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

Red Reusable Sensors ........................................................................................................8-4

LNOP

Reusable Sensors ..........................................................................................................................8-4

LNOP

Adhesive Sensors ....................................................................................................8-4

LNOP

Specialty Sensors ....................................................................................................8-5

M-LNCS

™

/LNCS

Reusable Sensors ................................................................................8-5

M-LNCS

™

/LNCS

Adhesive Sensors ................................................................................. 8-5

M-LNCS

™

/LNCS

Specialty Sensors .................................................................................8-6

LNOPv

Adhesive Sensors .......................................................................................................... 8-6

Sensor Accuracy ...................................................................................................................8-6

Cleaning And Reuse Of Masimo Reusable Sensors and Cables ......................................... 8-6

Reattachment of Single Use Adhesive Sensors ...................................................................8-6

SECTION 9- SERVICE AND MAINTENANCE

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

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

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

Performance Verification ............................................................................................................. 9-2

Power-On Self-Test ...............................................................................................................9-2

Key Press Button Test ........................................................................................................... 9-2

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

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

Service and Repair ..................................................................................................................... 9-3

Repair Policy .........................................................................................................................9-3

Return Procedure ..................................................................................................................9-3

Sales & End-user

License Agreement ........................................................................................ 9-5

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

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

End-User

License ...................................................................................................................... 9-6

Restrictions ................................................................................................................................. 9-6

SECTION 10- ACCESSORIES

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

Table of Contents

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

1-1

Section 1 - Overview

Overview

About this Manual

This manual explains how to set up and use the Rad-57 Instrument Signal Extraction Pulse CO-Oximeter.

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 sensors and

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

Overview

Warnings, Cautions and Notes

Please read and follow any warnings, cautions and notes presented throughout this

manual. An explanation of these labels are as follows:

A WARNING is provided when actions may result in a serious outcome (i.e., injury,

serious adverse affect, death) to the patient or user. Look for text in a gray shaded box.

Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to

the patient, damage to this instrument or damage to other property.

Sample of Caution:

CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

A NOTE is provided when additional general information is applicable.

Sample of Note:

NOTE: This is a sample of a Note.

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

1-3

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

, Perfusion Index (PI) and pulse rate (PR), a Low

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

After upgrading, Carboxyhemoglobin saturation (%SpCO), Methemoglobin percentage (%SpMet), and

Pleth Variability Index (PVI™) can display if the corresponding sensors are attached.

When upgrading the Instrument, follow the upgrade procedures as described in the "Field Upgrader

Tool" Directions for Use, part number 31650.

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

and pulse rate monitoring in motion and low perfusion environments

■ SpO

, pulse rate, Perfusion Index, Pleth Variability Index (PVI)*, carboxyhemoglobin (%

SpCO)* and methemoglobin (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 SpO

, PR, SpCO* and SpMet*, PVI*

■ FastSat

(for SpO

measurement)

■ Three sensitivity levels - Max, Normal and APOD

™

(for SpO

measurement)

■ 72 hours of trending memory

■ Adjustable alarm volume

■ Adjustable averaging 2 to 16 seconds

* available in upgraded Instrument

1-4

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

Overview

Indications for Use

The Masimo SET® Rad-57 Pulse CO-Oximeter and accessories are indicated for the continuous

noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse

rate (measured by an SpO2 sensor) and carboxyhemoglobin and methemoglobin saturation

or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 Pulse

CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients

during both no motion and motion conditions, and for patients who are well or poorly perfused in

hospitals, hospital-type facilities, mobile, and home environments.

* available in upgraded Instrument

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

1-5

Overview

Pulse CO-Oximetry

SpO

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

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 two ways:

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

)

2) As a pulse rate (PR)

The following figure shows the general monitoring setup.

1. Instrument

2. Sensor

3. Patient Cable

1-6

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

Overview

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 instrument or through an instrument patient

cable. The sensor collects signal data from the patient and sends it to the instrument. The Rad-57

displays 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 instrument or through an instrument patient cable.

The sensor collects signal data from the patient and sends it to the instrument. The Rad-57 displays

the calculated data as percentage value for the SpMet.

Pleth Variability Index - (PVI) General Description

The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that

occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over

a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a

percentage (0-100%).

Low Perfusion

It has been suggested that at extremely low perfusion levels, Pulse CO-Oximeters can measure

peripheral saturation, which may differ from central arterial saturation. This “localized hypoxemia” may

result from the metabolic demands of other tissues extracting oxygen proximal to the measurement site

under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that

correlates with the ECG heart rate.)

CAUTION:

IF LOW PERFUSION IS FREQUENTLY INDICATED, FIND A BETTER-PERFUSED MONITORING

SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION

STATUS THROUGH OTHER MEANS.

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

1-7

Overview

FastSat

FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data

is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad-57 is set

to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged

saturation value that is a better representation of the patient’s current oxygenation status. With FastSat,

the averaging time is dependent on the input signal.

SmartTone

The SmartTone feature uses a proprietary algorithm that will provide pulse tones during excessive

motion and low perfusion conditions. The pulse tone is based on an averaged pulse rate measurement

from the proprietary algorithm and may not identify irregular heart beat patterns when there is

excessive artifact present. The Normal Tone feature uses a proprietary algorithm that will provide

pulse tones during non motion and adequate perfusion conditions. In this mode, the pulse tone may

not sound if excessive artifact is present.

1-8

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

Overview

Principles of Operation

Pulse oximetry is governed by the following principles:

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

carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized

hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light

(using spectrophotometry, see gure below).

Carboxyhemoglobin

Oxyhemoglobin

Methemoglobin

Deoxyhemoglobin

Absorption Spectra

Plasma

Absorption (1/mm)

0.5

600 800

1.0

1.5

2.0

2.5

3.0

3.5

4.0

1000 1200 1400 1600

Wavelength (nm)

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, oxidized blood and blood plasma. The

Rad-57 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site

to a photodiode (detector). See gure below. Signal data is obtained by passing various visible and

infrared lights (LED’s, 500 to 1000nm) through a capillary bed (for example, a ngertip, 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 ≤ 25mW.

The detector receives the light, converts it into an electronic signal and sends it to the Rad-57 for

calculation.

GRAPHIC DOCUMENTATION AND APPRO VA L

GR-13315

DRO-10430

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Kevin McHale

GR-13315 Adobe Illustrator 10.0 (.eps)Graphic, LED/Photo Detector Placment

10/5/04

Marketing Communications Date

1. Light Emitting Diodes (LEDs)

(7 + wavelengths)

2. Detector

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 (%SpO

), 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 or 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.

*available in upgraded Instrument

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

1-9

Overview

Functional vs. Fractional Saturation

The Rad-57 is calibrated to measure and display functional saturation (SpO

): 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.

Rad-57 vs. Drawn Whole Blood Measurements

When SpO

, SpCO, and SpMet measurements obtained from the Rad-57 (noninvasive) are compared to

drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution

should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry

measurements may differ from the SpO

, SpCO, and SpMet measurements of the Rad-57 Pulse CO-

Oximeter. In the case of SpO

, different results are usually obtained from the arterial blood gas sample if the

calculated measurement is not appropriately corrected for the effects of variables that shift the relationship

between the partial pressure of oxygen (PO

) and saturation, such as: pH, temperature, the partial pressure

of carbon dioxide (PCO

), 2,3-DPG, and fetal hemoglobin. In the case of SpCO, different results are also

expected if concentration of methemoglobin in the blood gas sample is elevated. High levels of bilirubin may

cause erroneous SpO

, SpMet, and SpCO readings. As blood samples are usually taken over a period of

20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen

saturation, carboxyhemoglobin and methemoglobin concentration of the patient are stable and not changing

over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-

Oximetry measurements of SpO

, SpCO, and SpMet may vary with the rapid administration of uids and

in procedures such as dialysis. Additionally, drawn, whole-blood testing can be affected by sample handling

methods and time elapsed between blood draw and sample testing.

Masimo SET Signal Extraction Technology For SpO

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.

SpMet, and SpCO 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, arterial-venous coupling, etc.

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

excessive motion. When the Rad-57 does not have confidence in the value of a parameter due to

poor signal quality caused by excessive motion or other signal interference, the Low Signal IQ (Low

SIQ) LED will flash.

*available in upgraded Instrument

1-10

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

Overview



Masimo Rainbow SET Parallel Engines

This figure is for conceptual purposes only.

Masimo SET DST

FST

MST

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

2-1

Introduction

The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse oximetry

measurement information, as well as instrument status data, is displayed on the front panel of the

instrument. 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 instrument.

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 instrument.

■ 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 Instrument. The Rad-

57 can be used either as a transport monitor or as a handheld Pulse CO-Oximeter for spot checks.

System Description

Section 2 - System Description

2-2

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

System Description

rainbow

Rad-57

Rad-57 Front Panel Controls

CONTROL / INDICATOR

DESCRIPTION

Patient Cable

Connector

Connects to an appropriate Masimo Sensor or Patient Cable. Refer to

Section 8 for details.

SIQ Bar

The Signal IQ provides an indication of the quality of the acquired

signal as well as the timing of the pulse. A green vertical LED bar

rises and falls with the pulse, where the height of the bar indicates the

quality of the signal.

Display Button

Press to display the parameters/measurements selected in the Setup

Menu screens. Refer to Chapter 4, Setup Menu Level 5 for the options.

Enter Button

Used to enter the setup menus and to select/activate certain entries

within the menu/setup system.

Next Button

Used within the menu/setup system to move through setup options. Not

active when default screen displays.

Power On / Off

Press to turn the Instrument on.

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

Battery Level

Indicator

. Four LED’s indicate the status of the battery. When the final indicator

begins flashing, replace the batteries

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

2-3

System Description

Speaker

Provides audible indication of alarm conditions, pulse tone and feedback

for key-presses. Ensure the speaker is not covered or the Instrument is

placed face-down on bedding or other sound absorbing surface.

Visual Alarm

Indicator

Illuminates when any alrm condition exists. This indicator may not be

turned off or otherwise over-ridden.

Parameter/

Measurement Value

Display and Indicator

Displays parameter/measurement numeric values and indicates

parameter/measurement label.

PI Bar

The Perfusion Index provides an indication of the percentage of pulsatile

signal to non pulsatile signal. The bar is highest when the quality of the

perfused site is best.

Parameter/

Measurement Value

Display and Indicator

Displays parameter/measurement numeric values and indicates

parameter/measurement label.

Low SIQ

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

for details.

Alarm Silenced

Indicator

The indicator can flash or be solidly illuminated. Refer to Alarm Silenced

Indicator in Section 5 for details.

Alarm Silence Button

Push once to temporarily silence the alarm for 120 seconds. Push a

second time to return the Instrument to standard alarm monitoring

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.

2-4

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

System Description

Rad-57 Rear Panel

CONTROL / INDICATOR

DESCRIPTION

GRAPHIC DOCUMENTATION AND APPROVAL

GR-10887

DRO-8890

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Michelle Diaz

GR-10887 Adobe Illustrator 10.0 (.eps)Illustration, callouts for tables, 2/04

2/4/04

Marketing Communications Date

Serial Number Label Located on outside of case

GRAPHIC DOCUMENTATION AND APPROVAL

GR-10887

DRO-8890

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Michelle Diaz

GR-10887 Adobe Illustrator 10.0 (.eps)Illustration, callouts for tables, 2/04

2/4/04

Marketing Communications Date

Agency Approvals Label Located on outside of case

GRAPHIC DOCUMENTATION AND APPROVAL

GR-10887

DRO-8890

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Michelle Diaz

GR-10887 Adobe Illustrator 10.0 (.eps)Illustration, callouts for tables, 2/04

2/4/04

Marketing Communications Date

Battery Cover Located on back of Instrument

GRAPHIC DOCUMENTATION AND APPROVAL

GR-10887

DRO-8890

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Michelle Diaz

GR-10887 Adobe Illustrator 10.0 (.eps)Illustration, callouts for tables, 2/04

2/4/04

Marketing Communications Date

Battery Cover Release

Press down and slide the battery cover off the bottom of

the oximeter

Battery Installation

The Rad-57 is powered by 4 AA alkaline batteries. Do not use any other type of batteries or

power source to run the instrument. The battery compartment is accessed from the back of

the instrument. To install the batteries first remove the battery cover by depressing the small

rectangular button at the bottom of the cover, and sliding the cover down off the bottom of the

instrument. Install the batteries in the directions indicated by the battery icons inside the battery

compartment. Replace the battery cover by sliding it back up from the bottom of the instrument

until the rectangular locking button snaps back into position.

WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY

AFFECT THE ACCURACY OF THE BATTERY LEVEL METER.

WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V COULD

CAUSE DAMAGE TO THE RAD-57.

Battery charge level is indicated by four LED indicators at the bottom of the front panel. All four

indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose

their charge. When the battery life is low, the battery indicator will begin to flash and an audible

alarm will sound.

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

2-5

Symbols

The following symbols may be found on the back of the Rad-57 Signal Pulse CO-Oximeter or

packaging and are defined below:

SYMBOL DESCRIPTION

Caution, consult accompanying documents

GR-10199B

(blue background)

Follow Instructions for Use

Title: Symbol, Type BF Applied Part, 6/04

LAB-4004

Revision B

DRO-9810

6/04

Type BF applied part complying with IEC 60601-1

Title: Label, Printed, WEEE Symbol

LAB-4136

Revision: A

DRO-12000

07/05

NOTE: Label outline is for reference only; do not print.

WEEE Compliant

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

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

Underwriter's Laboratories Inc. approved

GR-17499A

Storage humidity range

GR-17500A

Storage temperature range

Storage altitude range

GR-17476A

Keep dry

GR-17477A

Fragile/breakable, handle with care

Year of Manufacture

Manufacturer

System Description

2-6

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

System Description

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

3-1

Setup

Section 3 - Setup

Introduction

Before the Rad-57 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected,

properly setup and the batteries need to be installed.

Unpacking and Inspection

Remove the instrument from the shipping carton and examine for signs of shipping damage. Check

all materials against the packing list. Save all packing materials, invoice and bill of lading. These may

be required to process a claim with the carrier.

If anything is missing or damaged, contact the Technical Service Department. The contact address

and phone numbers are listed in Section 9, Service and Maintenance.

Preparation for Monitoring

The following sections of the manual describe the preparation, set-up and initial installation of the

Rad-57 Pulse CO-Oximeter.

3-2

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

Setup

Monitor Setup

Initial Setup

1. Inspect the oximeter case for damage.

2. Install 4 (four) new AA alkaline batteries.

3. Turn the Instrument on, the LEDs will scroll in the display window as the sensor calibrates,

verify all indicators illuminate and speaker sounds a brief tone.

4. Configure the Instrument for your regional power line frequency (50 or 60 Hz) if needed.

Default is 60 Hz (standard for the United States). See Section 4, Special Menu, Special menu

- Line Frequency Configuration.

CAUTION: THE INSTRUMENT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE

FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORES-

CENT LIGHTS AND OTHER SOURCES.

No other setup is required. Refer to Section 4, General Setup and Use for additional steps to verify

proper functioning of the Instrument.

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

4-1

Operation

Section 4 - Operation

Introduction

To operate the Rad-57 Pulse CO-Oximeter effectively, the operator must:

■ Know how the oximeter derives its readings (see Section 1, Pulse CO-Oximetry)

■ Be familiar with its controls and operation.

■ Understand its status and alarm messages (see Section 5, Alarms and Messages and Section

6, Troubleshooting).

Basic Operation

General Setup and Use

1. Inspect the Rad-

57 case for damage. If damaged, refer to Section 9, Service and Repair.

2. Install the batteries, refer to Section 2, Battery Installation.

3. Connect a compatible patient cable or a direct connect sensor to the Rad-57. Make sure it is a

firm connection and the cable is not twisted, sliced or frayed.

4. If utilizing a patient cable, select a sensor that is compatible with the Instrument and the patient

before connecting it to the cable. See section 8, Sensors and Patient Cables. If using a single

patient adhesive or disposable sensor, check that the emitter (red light) and the detector are

properly aligned. Remove any substances that may interfere with the transmission of light between

the sensor’s light source and detector.

5 Follow the Indications, Instructions and Cautions in the sensor's Direction for Use when attaching,

reattaching or disconnecting the sensor(s).

6 Press the Power button to turn the Rad-57 on.

7. Verify all front-panel indicators momentarily illuminate and an audible tone is heard

8. Verify the front-panel display is free of alarm and system failure messages (see Section 5,

Alarms and Messages) and the battery indicator shows sufficient charge (see Section 4,

Battery Level Indicator).

9. Verify that the display shows the Instrument's enabled parameter/measurement settings in the

following order:

■ SpO

Low Alarm Limit

■ SpO

High Alarm Limit

■ PR Low Alarm Limit

■ PR High Alarm Limit

■ SpCO

Low Alarm Limit*

■ SpCO

High Alarm Limit*

■ SpMet

Low Alarm Limit*

■ SpMet

High Alarm Limit*

■ PVI Low Alarm Limit*

■ PVI High Alarm Limit*

■ PI Low Alarm Limit*

■ PI High Alarm Limit*

4-2

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

Operation

■ Sensitivity Setting

■ Averaging Time

■ FastSat: Setting

*available in upgraded Instrument

10. On the display, for each corresponding parameter/measurement, verify the readings (depending

on the sensor used), for SpO

, PVI*, SpCO*, SpMet* and PR.

NOTE: “- - - “ will show on the numeric display until the SpO

, SpCO*, PVI, SpMet* and

pulse rate readings have stabilized (less than 20 seconds for SpO

2 and up to 120 seconds for

PVI*,SpCO* and SpMet*).

11. Verify that the patient alarms are functional by setting the high and low SpO

and pulse rate

alarm limits beyond the patient readings.

■ An alarm tone sounds.

■ The violated alarm parameter/measurement flashes.

12. Verify the sensor alarms are functional by removing the sensor from the sensor site.

■ “SEn OFF” message appears on the display.

■ The alarm tone sounds.

■ The Visual Alarm Indicator flashes.

■ Disconnect the sensor from the patient cable or oximeter.

■ Confirm that “NO SEn” message appears on the display.

NOTE: “NO SEn” and “SEn OFF” will only generate an alarm if the Rad-57 was actively monitor-

ing a patient when the sensor was disconnected.

13. Verify parameter/measurement violation alarm silence operation.

■ Create an alarm condition by lowering the SpO

or pulse rate high alarm limits beyond the

patient readings.

■ Press the Alarm Silence button.

■ The alarm tone ceases for 120 seconds.

14. To begin patient monitoring:

■ Adjust the alarm limits.

■ Adjust the alarm volume.

■ Adjust the pulse beep volume.

15. Verify the sensor is applied correctly and that the measured data is appropriate, see Section 4,

Successful SpO

Monitoring.

16. Monitor the patient.

17. After monitoring is complete, remove the sensor from the patient and store or dispose of the

sensor according to governing rules. See the Directions for Use of the sensor.

18. Press and hold the Power On/Off button for 2 seconds to turn the oximeter off.

*available in upgraded Instrument

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

4-3

Operation

Default Settings

The Rad-57 is shipped configured with all values set to factory default. Adjustments made by the user

will be retained after a power cycle for all values except alarm silence.

NOTE: Before use, confirm that the instrument settings are set appropriately.

The following table outlines the default values:

OPTION

FACTORY DEFAULT

SETTING

CONFIGURABLE SETTING/BEHAVIOR AT

POWER-UP

SpCO* low alarm limit (Default is Off)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpCO* high alarm limit (Default is 10%)

SpMet* low alarm limit (Default is Off)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpMet* high alarm limit (Default is 3%)

SpO

low alarm limit (Default is 90%)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpO

high alarm limit (Default is OFF)

Pulse rate low alarm limit (Default is 50 BPM)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

Pulse rate high alarm limit (Default is 140 BPM)

PVI

* low alarm limit

(Default is "---" Off)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

PVI* high alarm limit

(Default is "---" Off)

PI low alarm limit (Default is "---" Off)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

0.04 to 19 then "---"

PI high alarm limit (Default is "---" Off)

Sensitivity (Default is Normal)

Set to Pre-Power Down Setting

Normal, Maximum (HI) or APOD

Averaging Time (Default is 8 seconds)

Set to Pre-Power Down Setting

2, 4, 8, 10, 12, 14, or 16 seconds

FastSat (Default is Off)

Set to Pre-Power Down Setting

Off/On

SmartTone (Default is Off)

Set to Pre-Power Down Setting

Off/On

Display Low SIQ Readings (Default is No)

Set to Pre-Power Down Setting

Yes/No

PVI Averaging (Default is Long)

Set to Pre-Power Down Setting

Long/Short

Display brightness (Default is level 2)

Set to Pre-Power Down Setting

Levels 1 through 4

Pulse tone volume (Default is level 1)

Set to Pre-Power Down Setting

Levels Off through 3

4-4

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

Operation

OPTION

FACTORY DEFAULT

SETTING

CONFIGURABLE SETTING/BEHAVIOR AT

POWER-UP

Alarm Volume (Default is level 1)

Set to Pre-Power Down Setting

Levels 1 through 4

Line Frequency (Default is 60 Hz)

Set to Pre-Power Down Setting

50 Hz/ 60 Hz

Trend Active (Default is Off)

Set to Pre-Power Down Setting

Off/On

Alarm Silence

(Default is All Alarms

Active)

Set to All Alarms Active

Alarm on/off

*available in upgraded Instrument

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

4-5

Operation

Successful SpO

Monitoring

The following general points will aid in ensuring oximetry monitoring success.

■ Place the sensor on a site that is not too thick, has sufficient perfusion and provides proper

alignment of the LED’s and photodetector.

■ Place the sensor on a site that has unrestricted blood flow

■ Do not secure a sensor with tape

■ Do not select a site near potential electrical interference (electrosurgical unit, for example)

■ Read the sensor's Directions for Use for proper sensor application

Masimo Sensors

Before use, carefully read the sensor's Directions for Use.

Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping

the sensor too tightly. Inspect the sensor site as directed in the sensor's Directions for Use to ensure

skin integrity and correct positioning and adhesion of the sensor.

CAUTIONS

DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED

OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN WATER,

SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE

NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR

ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR'S DIRECTIONS

FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE.

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT CABLES IN

WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS

ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE

OR ETHYLENE OXIDE.

DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO

SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE

ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM.

Numeric Display - SpO

Stability of the SpO

readings may be a good indicator of signal validity. Although stability is a

relative term, experience will provide a good feeling for changes that are artifactual or physiological

and the speed, timing, and behavior of each. The stability of the readings over time is affected by

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

to become. This is due to a dampened response as the signal is averaged over a longer period of

time than during shorter averaging times. However, longer averaging times delay the response of the

oximeter and reduce the measured variations of SpO

and PR. Inaccurate measurements may be

caused by

■ Elevated levels of carboxyhemoglobin

■ Elevated levels of methemoglobin

■ Intravascular dyes such as indocyanine green or methylene blue

4-6

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

Operation

■ Externally applied coloring (such as nail polish)

■ Elevated levels of bilirubin

■ Severe anemia

■ Low arterial perfusion

■ Motion artifact

Numeric Display - Pulse Rate

The Pulse Rate displayed on the Rad-57 may differ slightly from the heart rate displayed on ECG

monitors due to differences in averaging times. There may also be a discrepancy between cardiac

electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with

the Signal IQ due to physiological changes in the patient or one of the devices or application of the

sensor or patient cable. The pulsations from intra-aortic balloon support can be additive to the pulse

rate displayed on the Pulse CO-Oximeter. Inaccurate measurements may be caused by

■ Intravascular dyes such as indocyanine green or methylene blue

■ Arrhythmias

■ Intra-aortic balloon support

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

4-7

Operation

Numeric Display - SpCO (upgraded Instrument)

A stable SpCO reading is associated with correct sensor placement, small physiological changes during

the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological

changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood

concentration and perfusion.

Inaccurate SpCO and SpMet readings can be caused by:

■ Improper sensor application

■ Intravascular dyes such as indocyanine green or methylene blue

■ Abnormal hemoglobin levels

■ Low arterial perfusion

■ Low arterial oxygen saturation levels including altitude induced hypoxemia

■ Elevated total bilirubin levels

■ Motion artifact

■ SpCO readings may not be provided if SpO2 readings are less than 90%

■ SpCO readings may not be provided if SpMet readings are greater than 2%

■ Elevated levels of bilirubin

■ Motion artifact

■ Low arterial oxygen saturation levels including altitude induced hypoxemia

Numeric Display - SpMet (upgraded Instrument)

A stable SpMet reading is associated with correct sensor placement, small physiological changes

during the measurement and acceptable levels of arterial perfusion at the measurement site.

Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen

saturation, blood concentration and perfusion.

Inaccurate SpMet readings can be caused by:

■ Improper sensor application

■ Intravascular dyes such as indocyanine green or methylene blue

■ Abnormal hemoglobin levels

■ Low arterial perfusion

■ Low arterial oxygen saturation levels including altitude induced hypoxemia

■ Elevated total bilirubin levels

■ Motion artifact

■ SpCO readings may not be provided if SpO2 readings are less than 90%

■ SpCO readings may not be provided if SpMet readings are greater than 2%

■ Elevated levels of bilirubin

■ Motion artifact

■ Low arterial oxygen saturation levels including altitude induced hypoxemia

4-8

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

Operation

Numeric Display - PI

The Perfusion Index (PI) display provides a relative numeric indication of the pulse strength at the

monitoring site. It is a calculated percentage between the pulsatile signal and nonpulsatile signal of

arterial blood moving through the site. PI may be used to find the best perfused site and to monitor

physiological changes in the patient. It displays a range of < .1% to > 5% on the bar graph display

and a numerical range of 0.03% to 20.0% on the display screen. A percentage greater than 1.00%

is desired. Extreme changes in the display number are due to changes in physiology and blood flow.

Pleth Variability Index - PVI (upgraded Instrument)

The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI)

that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI

over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed

as a percentage (0-100%).

Low Signal IQ (Low SIQ)

The Rad-57 display provides a visual indicator Signal IQ and an alert when the displayed values are not

based on adequate Signal IQ. The Low SIQ indicator flashes when the may be compromised. When

the Low SIQ indicator is flashing, proceed with caution and do the following:

■ Assess the patient.

■ Check the sensor and ensure proper sensor application. The sensor must be well secured to the

site for the Rad-57 to maintain accurate readings. Also, misalignment of the sensor’s emitter and

detector can result in smaller signals.

■ Determine if an extreme change in the patient’s physiology and blood flow at the monitoring site

occurred, (e.g. an inflated blood pressure cuff, a squeezing motion, sampling of an arterial blood

specimen from the hand containing the pulse oximetry sensor, severe hypotension, peripheral

vasoconstriction in response to hypothermia, medications, or a spell of Raynaud’s syndrome.)

■ With neonates or infants, check that the peripheral blood flow to the sensor site has not been

interrupted. For example, as may occur while lifting or crossing their legs during a diaper change.

After performing the above, if the “Low SIQ” indication occurs frequently or continuously, obtaining an

arterial blood specimen for CO-Oximetry analysis may be considered to verify the oxygen saturation

value.

Low Perfusion

Low Perfusion is indicated when the arterial pulsations are very low (weak perfusion). Low Perfusion

is shown when the PI LED indicator bar does not exceed 0.25 on the Rad-57.

CAUTION: IF LOW PERFUSION INDICATION IS FREQUENTLY DISPLAYED, FIND A BETTER

PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY

OXYGENATION STATUS THROUGH OTHER MEANS.

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

4-9

Operation

Actions to be Taken

If the SpO

readings show significant differences, do the following:

■ Make sure the emitter and photodetector are aligned directly opposite each other.

■ Select a site where the distance between the emitter and photodetector is minimized.

■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl

salicylate and 2-10% menthol) and allow to dry for 20-30 seconds. Strong vasodilator creams,

such as nitroglycerin paste, are not recommended.

■ If possible, remove electrical noise sources such as electrosurgical units or other electrical/

electronic equipment.

■ If artificial nails or excessive fingernail polish are present, select another site or remove the

polish/artificial nails.

■ If possible, ensure that the sensor is placed in a location with low ambient light.

CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE PATIENT’S VITAL

SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE CO-OXIMETER FOR PROPER

FUNCTIONING.

Sensitivity

Three sensitivity levels enables a clinician to tailor the response of the Rad-57 to the needs of the

particular patient situation. They are as follows:

■ Normal Sensitivity – This is the recommended mode for typical monitoring purposes. It is

advisable for care areas where patients are observed frequently, such as ICU’s.

■ Adaptive Probe Off Detection (APOD™) – This is the recommended monitoring mode where

there is a high probability of the sensor becoming detached. It is also the suggested mode

for care areas where patients are not visually monitored continuously. This mode delivers

enhanced protection against erroneous pulse rate and arterial oxygen saturation readings

when a sensor becomes inadvertently detached from a patient due to excessive movement.

■ Maximum Sensitivity (MAX) - This mode is recommended for patients with low perfusion or

when the low perfusion message is displayed on the screen in APOD or normal sensitivity

mode. This mode is not recommended for care areas where patients are not monitored

visually, such as general wards. It is designed to interpret and display data at the measuring

site when the signal may be weak due to decreased perfusion. When a sensor becomes

detached from a patient, it will have compromised protection against erroneous pulse rate and

arterial saturation readings

CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, THE PERFORMANCE OF THE

SENSOR OFF DETECTION MAY BE COMPROMISED. IF THE INSTRUMENT IS IN

THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM THE PATIENT, THE

POTENTIAL FOR FALSE READINGS MAY OCCUR DUE TO ENVIRONMENTAL ‘NOISE’

SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT.

4-10

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

Operation

Battery Level Indicator

Four LED indicators provide information on the remaining battery capacity. The operator should

monitor these indicators periodically to determine remaining battery life and if the batteries should

be replaced.

Low Battery Audible Alarm

If a low battery condition occurs during patient monitoring, a medium priority alarm will sound, and

can be acknowledged by pressing the Alarm Silence Button.

If a low battery condition occurs while not monitoring a patient, pressing the Alarm Silence Button will

suspend the the alarm until the power is cycled or patient monitoring begins.

If a low battery condition occurs, immediately discontinue patient monitoring and replace the batteries.

NOTE: Remove batteries when storing Instrument for prolonged periods to maintain battery life.

WARNING: FAILURE TO REPLACE BATTERIES PROMPTLY AFTER A LOW BATTERY

ALARM MAY RESULT IN THE CO-OXIMETER SHUTTING DOWN AND LEAVING THE

PATIENT IN AN UNMONITORED CONDITION.

WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY

AFFECT THE ACCURACY OF THE BATTERY LEVEL METER.

WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V COULD

CAUSE DAMAGE TO THE RAD-57.

WARNING: EFFECTIVE BATTERY LIFE WILL BE REDUCED WHEN OPERATING THE

INSTRUMENT BELOW 5ºF (-15º

C) DUE TO ALKALINE BATTERY TECHNOLOGY.

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

4-11

Operation

Normal Patient Monitoring

The following sections describe the function of the Rad-57 front panel controls during normal patient

monitoring.

Rad-57 Front Panel Control Operation

BUTTON FUNCTION

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Pressing this button will cycle through the numeric values of the enabled parameters/

measurements.

NOTE: If any parameter/measurement breaches its pre-set alarm limit, the Rad-57 will

automatically display the alarming parameter/measurement. Pressing Display during

an alarm condition will enable the display of other parameters for 10 seconds.

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Enters the Rad-57 setup/menu system. Refer to Setup Menus in this Section for

details.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Press to navigate through submenus.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Press once to temporarily silence the alarm for 120 seconds or to acknowledge low

battery or sensor off conditions. Press a second time to return the Instrument to

standard alarm monitoring.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

During normal patient monitoring, the "Up" and "Down" Arrow keys control the

Pulse Tone volume. At the lowest setting, the pulse tone is muted. A low-pitch tone

indicates the highest or lowest setting has been reached.

In the setup/menu system, the "Up" and "Down" Arrow keys select among the options

for each setting.

GR-14720

DRO-16686

Graphic, Rad-57, Data Collection Unit buttons

Power "on/off" button. Press this button to turn the Instrument on.

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

Setup Menu

This section gives an overview of the Rad-57 menu selections available. To navigate through the

menus, use the Enter, Next, Up and Down keys located on the front panel of the Pulse CO-Oximeter,

below the LED display. The following sub sections describe each menu item in more detail. The Pulse

CO-Oximeter has options that allow user configuration to suit specific needs.

Menu Navigation

The Rad-57 set-up and configuration options are accessed through the menu system. The Enter key

is used to enter the menu system and to move through the different menu levels. Within each level of

the system, the Next key is used to move from one option to the next. The Up and Down arrow keys

are used to select values within each option. The parameter/measurement is set/selected when either

the Enter or Next keys are pressed.

4-12

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

Operation

Setup Menu Level 1 – Alarm Volume and Alarm Silence

Push the Enter button to enter menu level 1.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Alarm Volume

Use Up or Down Arrow Keys to adjust

parameter to desired setting.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Alarm on/off

Setup Menu Level 2 – Alarm Limits

Push the Enter button again to enter menu level 2. If the Instrument has not been upgraded, only the

basic parameters will display.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

SpCO* Low Alarm Limit

Use Up or Down Arrow Keys

to adjust parameter to desired

setting.

*available in upgraded

Instrument

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SpCO* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SpMet* Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SpMet* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SpO

Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SpO

High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PR Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PR High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PVI* Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PVI* High Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PI Low Alarm Limit

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PI High Alarm Limit

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

4-13

Operation

Setup Menu Level 3 – Sensitivity, Averaging, FastSat, SmartTone

Push the Enter button again to enter menu level 3.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Sensitivity

†

HI = Maximum

Nor = Normal

APO = APOD

Use Up or Down Arrow

Keys to adjust parameter to

desired setting.

*available in upgraded

Instrument

†

These changes affect SpO

monitoring only.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Averaging

†

. The signal averaging

time of this instrument can be set to:

2*, 4*, 8, 10, 12, 14 or 16 seconds

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

FastSat

† ‡

On, Off

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

SmartTone

†

On, Off

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Display SIQ Readings

Yes, No

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PVI* Averaging

†

Short, Long

‡

Select “Yes” to activate the FastSat algorithm. The FastSat averaging time is dependent on the input

signal. FastSat is automatically enabled in 2 and 4 second averaging.

4-14

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

Operation

Setup Menu Level 4 - Trend Settings

Push the Enter button again to enter menu level 4.

To enable trending of patient data, the trend feature must be enabled (set to ON), and the current date

and time must be set. See Section 4, Trend setup and use.

The current date and time can only be set if the Trend is set to “ON”. The date and time menu

selections are not available if Trend is set to “OFF”.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Trend ON / OFF

Use Up key to turn trend ON. Use Down

key to turn trend OFF

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Set Year

Use Up or Down Arrow Keys to adjust

parameter/measurement to desired

setting.

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Set Month

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Set Day

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Set Hour

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Set Minute

A valid date must be entered. If an invalid date is entered (i.e. February 31), the trend will not turn on

and “tnd off” will be displayed.

NOTE: The date and time must be set before trending will be enabled. The Rad-57 will automatically

‘time out’ of the setup menu after 10 seconds with no key presses. If the Rad-57 should time-out of the

Trend Settings menu, the trend will not be enabled.

NOTE: Enabling trend (setting Trend to “ON”) will erase all trend information in the Rad-57.

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

4-15

Operation

Setup Menu Level 5 - LED Brightness and Factory Defaults

Push the Enter button again to enter menu level 5.

SETTING

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

LED Display Brightness (4 levels)

NOTE:

LED indicators are illumi-

nated while adjusting this setting.

Use Up or Down Arrow Keys

to adjust parameter to desired

setting.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

OFF (automatically powers off the

Rad-57 when button presses and

patient monitoring are absent for

a set time)

15, 10, 5 minutes, No

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

Restore Factory Defaults

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

PI (allows the PI value to be

shown on the Display Screen)

On, Off

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

O2 (select parameter/

measurement display order)

Yes (SpO2/PR, CO*/Met*, OC*,

PVI*, PI) default

No (CO*/Met*, OC*, SpO2/PR,

PVI*, PI)

Pressing

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

a sixth time returns the Rad-57 to patient monitoring display.

*available in upgraded Instrument

Menu Selection

In a fully upgraded Instrument, SpCO and SpMet will be continuously displayed once the sensor is

properly placed and calibration is complete. To display continuous PVI, SpCO, SpMet or PI monitoring

(when available), press

GR-14720

DRO-16686

Graphic, Rad-57, Data Collection Unit buttons

NOTE: If any parameter breaches its pre-set alarm limit, the Rad-57 will automatically display the alarming

parameter. Pressing Display during an alarm condition will enable the display of other parameters for 10 seconds.

Power Off

Off – Press and hold the On/Off button for two seconds.

4-16

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

Operation

Special Menu

This section gives an overview of the Rad-57 special menu selection available. To navigate through

the menu, use the Power, Next, Up and Down keys located on the front panel of the oximeter. The

oximeter has options that allow user configuration to suit specific needs. The following sub-section

describes this menu item in more detail.

Special Menu – Line Frequency Configuration

NOTE: The Instrument must be configured to match your local power line frequency (50 or 60 hz) to

operate properly. The Instrument default is set to 60 hz (standard for the United States).

1. Turn the Rad-57 on and wait for the displays to scroll through the current settings.

2. Simultaneously press and hold the Up

Arrow key and the Enter

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

button.

3. "SEr " will be displayed.

4. Press the Enter

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

button once.

5. Push the Next

GRAPHIC DOCUMENTATION AND APPROVAL

GR-11085

DRO-11386

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Document

Number

TitleProgram

Date

Diana Yuan

GR-11085 Adobe Illustrator 10.0 (.eps)

Illustration, Rainbow, Buttons, 4/05

Illustration, Rainbow, Buttons, 6/05

4/1/05

Marketing Communications Date

button 5 times. “LF” will be diplayed in the top LED display window and

the active line frequency will be displayed in the lower LED display window.

6. Push the Up

arrow to set the line frequency to 60 Hz and the Down arrow to set it

to 50 Hz.

7. Turn the Instrument off.

BUTTON SETTING

Simultaneously

press and hold

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Press

DISPLAY

GR-14946

IC: 7362A-RAD87IC: 7362A-RAD87

FCC ID: VKF-RAD87FCC ID: VKF-RAD87

Use Up or Down Arrow

Keys to adjust parameter to

desired setting.

NOTE: The parameter

is set/selected when the

Instrument is turned off.

GRAPHIC DOCUMENTATION AND APPROVAL

GR-12055

DRO-11793

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Author

Document

Number

TitleProgram

Date

Chris Coleman

GR-12055 Adobe Illustrator 10.0 (.eps)Illustration, Rad-57 Line Frequency Special Menu, 7/05

Illustration, Rad-57 Line Frequency Special Menu, 7/05

7/7/05

Marketing Communications Date

Service menu

Line frequency

Hold

press

Enter Line Frequencey Menu

GRAPHIC DOCUMENTATION AND APPROVAL

GR-12055

DRO-11793

CONFIDENTIAL AND PROPRIETARY

Page 1 of 1

FRM 1379 Rev A

DRO 5201

Approvals

Author

Document

Number

TitleProgram

Date

Chris Coleman

GR-12055 Adobe Illustrator 10.0 (.eps)Illustration, Rad-57 Line Frequency Special Menu, 7/05

Illustration, Rad-57 Line Frequency Special Menu, 7/05

7/7/05

Marketing Communications Date

Service menu

Line frequency

Hold

press

Set Line Frequency

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

4-17

Operation

Trend Setup and Use

Introduction

The Rad-57 can store 72 hours of SpO

Pulse Rate (PR), PVI*, SpCO*, SpMet* and Perfusion

Index trend data, captured at 2 second intervals. This trend data can then be transferred to a PC for

evaluation.

Trend data is stored in non-volatile memory, so it is not erased when the Instrument is shut off or when

the batteries are replaced.

A Data Transfer Download cable is required to connect the sensor connector of the Rad-57 to the PC

and TrendCom software is required to download the trend data on to the PC. Refer to Section 10 -

Accessories and contact Masimo to acquire these optional items. Patient monitoring is not possible

while trend memory is being transferred to a PC.

A trend data download is initiated using the TrendCom utility which downloads the trend data and saves

it to a space-delimited ASCII text (.out) file.

*available in upgraded Instrument

TrendCom Utility Installation

Copy the TrendCom utility from the CD onto a PC running MS-Windows. Refer to Trendcom Directions

for Use for instructions.

Erasing Trend Memory

To erase (clear) the trend memory, turn the trend off and back on again. Enabling trend (setting Trend

to “ON”) will erase all trend data.

NOTE: Turning trend off will not erase trend memory. You may turn trending off and still retrieve the

trend data using TrendCom.

Turning the Rad-57 off or replacing the batteries will not erase the trend data.

Turn trending off before storing the Instrument for any length of time.

Trend Data Format

After a successful download of the trend data, a .out file will be created containing the trend-dump

information in ASCII delimited fomat. The format is defined in the following table.

PARAMETER SPECIFICATION

Date MM\DD\YY

Time HH:MM:SS

Parameter/

Measurement

Numeric value (see the display ranges in the Factory and User

Configurable Default Settings table located at the beginning of this

section)

Non-installed parameters/measurements will display as "---" in Trendcom

4-18

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

Exception

Messages

The exceptions are displayed as a 3 digit, ASCII encoded, hexadecimal value. The binary bits of

the hexadecimal value are encoded as follows:

000 = Normal operation; no exceptions

001 = No Sensor

002 = Defective Sensor

004 = Low Perfusion

008 = Pulse Search

010 = Interference

020 = Sensor Off

040 = Ambient Light

080 = Unrecognized Sensor

100 = reserved

200 = reserved

400 = Low Signal IQ

800 = Masimo SET. This flag means the algorithm is running in full SET mode. It requires a

Masimo sensor and needs to acquire some clean data for this flag to be set.

Operation

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

5-1

Alarms and Messages

Section 5 - Alarms and Messages

Alarm Indication

An alarm condition is indicated by:

■ Audible alarm tone

■ Visual Alarm Indicator

■ Out-of-limit parameter will flash

“SEn OFF” and “nO SEn” will only generate an alarm condition if they occur after a pulse has

been found.

Alarm Limits

CAUTION: TO ENSURE THAT ALARM LIMITS ARE APPROPRIATE FOR THE PATIENT BEING

MONITORED, CHECK THE LIMITS EACH TIME THE PULSE CO-OXIMETER IS USED.

It is recommended that the operator be within a minimum of 10 feet from the Instrument. Directions

for alarm suspension are indicated below. When a sensor is not connected to a patient, or when a

sensor is not connected to its cable, the display will read SEn OFF or NO SEn. An audible alarm

will accompany the display unless the oximeter has been set to Alarm Silence Mode.

SETTING RANGE

SpCO* Low Limit

The SpCO low alarm limit can be set to

“----” (Off) or anywhere between 1% and 97%,

with a 1% step size. In the "----" (Off) setting, the SpCO Low Limit Alarm is disabled.

Factory default setting is “off.”

NOTE: The low alarm limit must always be below the high alarm limit. If the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit.

SpCO* High Limit

The SpCO high alarm limit can be set to

“----” (Off) or anywhere between 2% and 98%,

with a 1% step size. In the "----" (Off) setting, the SpCO High Limit Alarm is disabled.

Factory default setting is 10%.

SpMet* Low Limit

The SpMet low alarm limit can be set to “----” (Off) or anywhere between 0.1% and 99%. The

step size varies. When the range is 0.1 to 1.9% the step size is 0.1. When the range is from 2 to

99, the step size is .5%. In the “----“ (Off) setting, the SpMet Low Limit Alarm is disabled. Factory

default setting is “Off“.

NOTE: The low alarm limit must always be below the high alarm limit. If the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit.

SpMet* High Limit

The SpMet high alarm limit can be set to “----” (Off) or anywhere between 1% and 99.5% The

step size varies. When the range is 1.0 to 1.9% the step size is 0.1. When the range is from 2 to

99.5, the step size is .5% In the “----“ (Off) setting, the SpMet High Alarm Limit Alarm is disabled.

Factory default setting is 3%.

SpO

Low Limit

The SpO

low alarm limit can be set anywhere between 1% and 98%, with a 1% step

size.

NOTE: The low alarm limit must always be below the high alarm limit. If the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit.

5-2

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

SETTING RANGE

SpO

High Limit

The SpO

high alarm limit can be set to “----” (Off)or anywhere between 2% and

99%, with a 1% step size. In the “----” (off) setting, the SpO

High Limit alarm is

disabled.

PR Low Limit

(BPM)

The pulse rate low alarm limit can be set anywhere between 30 BPM and 230 BPM,

with a 5 BPM step size.

NOTE: The low alarm limit must always be below the high alarm limit. If the high

alarm limit is set below the low alarm limit, the low alarm limit will automatically

adjust to the next setting below the newly entered high alarm limit.

PR High Limit

(BPM)

The pulse rate high alarm limit can be set anywhere between 35 BPM and 235

BPM, with a 5 BPM step size.

PVI Low Limit*

The PVI low alarm limit can be set to “----” (Off) or anywhere between 1 and 98%.

Adjust in increments of 1 step size. When PVI is placed in the “----” (Off) setting, the

PVI Low Limit alarm is disabled.

PVI High Limit

The PVI high alarm limit can be set to “----” (Off) or anywhere between 2% and

99%. Adjust in increments of 1% step size. When PVI is placed in the “----” (Off)

setting, the PVI High Limit alarm is disabled.

PI Low Limit*

The PI low alarm limit can be set to “----” (Off) or anywhere between 0.03% and

18%. Adjust in increments of 0.01% step size between 0.03% and 0.1%, 0.1% step

size between 0.1% and 1% and a 1% step size between 1% and 18%. When PI is

placed in the “----” (Off) setting, the PI Low Limit alarm is disabled.

PI High Limit

The PI high alarm limit can be set to “----” (Off) or anywhere between 0.04 % and

19%. Adjust in increments of 0.01% step size between 0.02% and 0.1%, 0.1% step

size between 0.1% and 1% and 1% step size between 1% and 19%. When PI is

placed in the “----” (Off) setting, the PI High Limit alarm is disabled.

*available in upgraded Instrument

NOTE: See Section 4 Operation, Default Settings, for alarm limit behavior after a power cycle or loss

of power. If the user has not adjusted the alarm limits, then they will be set back to the factory defaults.

Alarms and Messages

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

5-3

Alarms and Messages

Alarm Silence

Audible alarms may be suspended, while visual alarms may not. The alarm suspension setting is

controlled by the Alarm Silence Button. Pressing the Alarm Silence Button will suspend the alarm for

120 seconds.

Power On – Alarms are active and Alarm Silenced Indicator is off.

Push Once – Alarm is silenced for 120 seconds and Alarm Silenced Indicator flashes.

Push Twice - Return to Audible Alarm Active.

To continuously silence the alarms, see Section 4 Setup Menu Level 1.

Alarm Silenced Indicator

The Alarm Silenced Indicator provides visual feedback regarding the audible alarm status. The audible

alarms are muted when the indicator is flashing or continuously illuminated.

While monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button

(one time) will silence the alarm tone for 120 seconds and the Alarm Silenced Indicator will flash.

Pressing the Alarm Silence Button a second time (while the Alarm Silenced Indicator is still flashing)

will activate alarms and the alarm silence indicator will be off.

If the alarms have been silenced, per Setup Menu Level 1, then the Alarm Silence indicator will be

continuously illuminated. The Alarm Silence indicator will remain illuminated until after a power cycle

or until the alarms are enabled (see Section 4, Setup Menu).

While not monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button

(one or more times) will permanently silence the alarm tone, and the Alarm Silenced Indicator will

remain illuminated until the power is cycled or patient monitoring begins.

Should the alarm condition be created by low batteries, replace the batteries before monitoring begins

or continues.

5-4

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

Alarms and Messages

Messages

The Rad-57 will indicate other data or system errors.

Message conditions for the Rad-57 follow:

DISPLAY REASON SOLUTION

NUMERIC VALUE

FLASHES

Parameter alarm

Assess /address patient condition.

Re-set alarm limits if indicated.

SEN

No Sensor Connected Connect sensor to cable.

SEN

OFF

Sensor off patient

1. Reattach sensor to patient.

2. Verify proper sensor placement.

SEN

SpO

sensor attached

If SpCO and/or SpMet parameters are

desired, attach a Rainbow sensor to the

Instrument.

LEDS FLASH

HORIZONTAL BARS

Pulse Search

Wait for pulse detection. (This search should

occur whenever a sensor is first applied to a

patient). If necessary, shield the sensor from

excessive ambient or strobing light.

CIRCULATING LEDS Sensor is calibrating

LOW SIQ INDICATOR

FLASHES

Low Signal IQ

1. Rule out occlusion of blood flow.

2. Verify placement of sensor.

PERFUSION INDEX (PI)

BAR* TURNS RED

(Bottom two LEDs only.)

Low Signal Strength

1. Rule out occlusion of blood flow.

2. Attempt to warm patient.

3. Move sensor to better perfused site.

NOTE: Masimo recommends using an

adhesive sensor whenever low perfusion is

expected or evident.

SINGLE BATTERY LEVEL

INDICATOR FLASHES

(WITH AUDIBLE ALARM)

Battery level too low Replace batteries immediately.

CBL

No Cable Connected Connect appropriate cable to Instrument.

*available in upgraded Instrument

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

5-5

Alarms and Messages

*available in upgraded Instrument

DISPLAY REASON SOLUTION

Err

System Fault

Return for service.

There are several error codes. All error

codes require return of the Instrument to an

authorized service center for repair. See

Section 9, Service and Repair for return

procedure.

RPL

Cbl

Defective cable Replace cable

RPL

SeN

Sensor life expired Replace sensor

RPL

ADH

Defective adhesive

sensor (resposable)

Replace adhesive sensor (resposable)

RPL

Reu

Defective reusable

sensor (resposable)

Replace reusable sensor (resposable)

INT

DET

(Blinking)

Interference detected

Ensure that the sensor is properly applied,

and cover the sensor site with opaque

material, if required.

INC

SeN

Incompatible sensor

Unrecognized sensor

Insert Masimo sensor

INC

Cbl

Incompatible cable

Unrecognized cable

Insert Masimo cable

INC

adH

Incompatible

adhesive sensor is

attached (resposable)

Attach compatible adhesive sensor

(resposable)

adH

No adhesive sensor is

attached (resposable)

Attach adhesive sensor (resposable)

SEN

000

No sensor uses

remaining

Insert new Masimo sensor

CBL

000

No cable uses

remaining

Insert new Masimo cable

5-6

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

Alarms and Messages

DISPLAY REASON SOLUTION

Temporary blinking message:

rPL

CbL

Cable life expired Replace cable as soon as possible

Temporary blinking message:

rPL

SEn

Sensor life expired Replace sensor as soon as possible

Temporary blinking message:

rPL

AdH

Adhesive sensor life

expired

Replace adhesive sensor as soon as possible

CHc

SEN

Check sensor

connection

Reattach sensor

*available in upgraded Instrument

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

6-1

Troubleshooting

Section 6 - Troubleshooting

Troubleshooting

The following chart describes what to do if the Rad-57 system does not operate properly or fails.

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

INSTRUMENT DOES

NOT POWER ON

Depleted battery Check and/or replace the batteries.

CONTINUOUS

SPEAKER TONE

Internal Failure

Instrument requires service. Press the Alarm Silence

button to silence the alarm. If alarm continues to

sound, power down Instrument and remove Handheld

battery if necessary.

BUTTONS DON’T

WORK WHEN

PRESSED

Internal failure Instrument requires service.

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

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

NUMERIC VALUE

FLASHES

Saturation alarm limit

exceeded.

Assess/address patient condition

Re-set alarm limits if indicated.

SENSOR OFF

MESSAGE

Sensor not connected to

patient properly.

Sensor is damaged.

Properly reapply the sensor on the patient and

reconnect the sensor to the Instrument or patient

cable.

If the sensor is damaged, replace the sensor.

NO SENSOR

MESSAGE

Sensor is disconnected

from patient cable.

Sensor connected upside

down into patient cable.

Check to see if the sensor LED is flashing. Disconnect

and reconnect the sensor. If the LED fails to operate,

replace the sensor.

LOW PERFUSION

Improper sensor type.

Poorly perfused site.

Sensor is too tight.

A disorder such

as hypothermia,

vasoconstriction,

hypovolemia, peripheral

vascular disease or

anemia.

Sensor is damaged.

Verify proper sensor and sensor size for the patient.

Check and see if blood flow to the site is restricted.

Be sure that the sensor is not on too tight.

Set Instrument to MAX sensitivity.

Warm the patient or sensor site.

Move sensor to better perfused site.

LOW SIGNAL

QUALITY

Improper sensor type or

application.

Excessive motion relative

to perfusion.

Sensor is damaged or not

functioning

Check and see if blood flow to the site is restricted.

Check the placement of the sensor.

Re-apply sensor or move to a different site.

6-2

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

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

SpO

VALUES DO

NOT CORRELATE

WITH CLINICAL

ASSESSMENT OR

ABGS.

Low perfusion or sensor

displacement.

Check for error messages. See section 5=Messages

for recommended corrections.

Check placement of sensor or if it is too tight.

Reapply sensor or select a new site.

Set to MAX sensitivity and confirm that the sensor is

securely on the patient.

Refer to sensor Directions For Use.

UNEXPECTEDLY

HIGH SpO

, SpCO*

OR SpMet READING

Low SIQ or Perfusion

Index (PI) values

Reposition sensor to site with strong SIQ and PI.

Average readings taken from three different sites to

improve accuracy. Submit blood sample for laboratory

CO-Oximetry test for comparison.

Inappropriate sensor size

or sensor measurement

location.

Verify proper sensor for patient size.

Verify proper sensor site.

UNEXPECTEDLY

HIGH SpCO

READING

Possible elevated

methemoglobin level

†

Submit blood sample for laboratory CO-Oximetry test.

DIFFICULTY OR

NO SpO

/SPCO*/

SPMET* READING

Low battery/ not plugged

into AC power supply.

Insert handheld into docking station, verify docking

station power cord plugged in and docking station

power indicator light is illuminated.

Interference from line-

frequency induced noise.

Verify/set 50/60hz menu setting. Refer to Section 3,

Initial Setup for details.

Inappropriate sensor or

sensor size.

Verify proper sensor and sensor size for the patient.

Excessive ambient or

strobing light.

Shield the sensor from excessive or strobing light.

Also, see Section 4, Successful Monitoring for additional information.

CIRCLING 000'S

(ZERO'S)

Instrument is searching

for pulse.

If Instrument fails to display within 30 seconds,

disconnect and reconnect. If pulse search continues,

move sensor to better perfused site.

DIFFICULTY OR

NO SpCO/SpMet

READING

Excessive motion Minimize or eliminate motion at the monitoring site.

Inappropriate sensor or

sensor size.

Verify use of an SpCO/SpMet capable sensor. Verify

proper sensor size for the patient.

*available in upgraded Instrument

†

As with all CO-Oximeters, elevated methemoglobin levels may cause falsely elevated carboxyhe-

moglobin values.

Troubleshooting

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

7-1

Specifications

Section 7 - Specifications

Rad-57 Specifications

PERFORMANCE

Measurement Range

SpO

: 0 -100%

SpMet*: 0 - 99.9%

SpCO*: 0 - 99%

Pulse Rate: 25 - 240 (bpm)

Perfusion Index: 0.02% - 20%

Pleth Variability Index (PVI*): 0 - 100%

Accuracy:

Arterial Oxygen Saturation Accuracy

Saturation 60% to 80%

No Motion

Adults, Infants, Pediatrics ±3%

Saturation 70% to 100%

No Motion

Adults, Infants, Pediatrics ± 2%

Neonates

†

± 3%

Motion

Adults, Infants, Pediatrics, Neonates

± 3%

Low Perfusion

Adults, Infants, Pediatrics, Neonates ± 2%

Pulse Rate Accuracy

Pulse Rate: 25 - 240 (bpm)

No Motion

Adults, Infants, Pediatrics, Neonates

± 3 bpm

Motion

Adults, Infants, Pediatrics, Neonates

± 5 bpm

Low Perfusion

Adults, Infants, Pediatrics, Neonates

± 3 bpm

Carboxyhemoglobin saturation accuracy (%SpCO*)

Adults, Infants, Pediatrics

1% - 40% ± 3%

Methemoglobin saturation accuracy (%SpMet*)

Adults, Infants, Pediatrics, Neonates 1% - 15% ± 1%

Resolution

Arterial Oxygen Saturation (%SpO

) 1%

Carboxyhemoglobin Saturation (%SpCO*) 1%

Methemoglobin Saturation (%SpMet*) 0 .1%

Pulse Rate (bpm) 1 bpm

7-2

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

Specifications

Interfering Substances

Carboxyhemoglobin and methemoglobin will erroneously alter oxygen saturation 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 arterial pigmentation may cause erroneous readings.

ELECTRICAL

Batteries

Type: 4 AA alkaline

Capacity: up to 10 hours

Isolation: No external power or ground connection, internally powered only, DC current.

ENVIRONMENTAL

Operating Temperature: 0°F to 129°F (-18°C to 54°C)

Transportation/Storage Temperature: -40°F to 158°F (-40°C to +70°C)

Operating Humidity: 5% to 95%, non-condensing

Operating Altitude:

500 mbar to 1060 mbar pressure,

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

PHYSICAL CHARACTERISTICS

Dimensions: 6.2” x 3.0” x 1.4” (15.8 cm x 7.6cm x 3.6 cm)

Weight: 13oz. (0.37 kg)

SpO

Modes

Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds

Sensitivity: Normal, Maximum and APOD

Alarms

Audible and visual alarms for high low saturation and pulse rate (SpO

range 1% - 99%, SpCO range 1% - 98%,

SpMet range 1% - 99.5%, PI range 0.03% - 19%, PVI range 1% - 99%, pulse rate range 30 - 235BPM)

High Priority:

800 Hz tone, 5 pulse burst, pulse spacing:

78ms, 78ms, 320ms, 78ms, repeat time:10s

Medium Priority: 500Hz tone, 3 pulse, repeat time: 5s

Volume:

67 dB (max.)

Display/Indicators*

Data display: %SpO

, %SpCO, ml/dl, pulse rate, %SpMet, PI, PI bar, Pleth Variability Index, alarm status, alarm

silenced status, Low Signal IQ, battery status. SIQ bar

Type: LED

Display update rate 1 second

Response time <20 seconds

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

7-3

Specifications

Compliance

EMC Compliance: EN60601-1-2, Class B

Equipment Classification: IEC 60601-1

Type of Protection: Internally powered (on battery power)

Degree of Protection-Patient Cable: Type BF-Applied Part

Mode of Operation: Continuous

1 SpO

SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO

0% - 40% SpCO and 0% -

15% SpMet against a laboratory CO-Oximeter. SpO

and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135

days old and weighting between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70 - 100% SaO2 and 0.5 - 2.5%

HbMet with a resultant accuracy of 2.9% SpO

and 0.9% SpMet. Contact Masimo for testing specifications.

2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark

skin pigmentation in induced hypoxia studies in the range of 70-100% SpO

against a laboratory CO-Oximeter and ECG monitor. This variation equals

plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin

pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive

motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO

against a laboratory CO-Oximeter and

ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

4 The Rad-57 has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2* simulator and Masimo's simulator with signal

strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70-100%. This variation equals plus or minus one

standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

5 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This

variation equals plus or minus one standard deviation which encompasses 68% of the population

6 This represents approximate run time at lowest indicator brightness, using new, fully charged batteries.

7 If alkaline batteries are to be stored for extended periods of time, it is recommended that they be stored between -0°C to +30°C, and at a relative

humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished,

and lifetime of the batteries may be shortened.

8 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from 2-4 and 4-6

seconds, respectively.

7-4

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

Specifications

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

8-1

Sensors and Patient Cables

Introduction

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

Before use of any sensor, carefully read the sensor’s Directions for Use.

Use only Masimo oximetry sensors and cables for SpO

, SpCO, SpMet measurements. Other

oxygen transducers or sensors may cause improper Rad-57 Pulse CO-Oximeter performance.

Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the

sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin

integrity and correct positioning and adhesion of the sensor.

CAUTIONS:

■ DO NOT USE DAMAGED SENSORS OR PATIENT CABLES. DO NOT USE A SENSOR OR

PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS.

■ DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER, SOLVENTS, OR

CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT WATERPROOF).

■ DO NOT STERILIZE SENSORS OR PATIENT CABLES BY IRRADIATION, STEAM,

AUTOCLAVE OR ETHYLENE OXIDE (UNLESS OTHERWISE INDICATED ON THE SENSOR

DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR

USE FOR REUSABLE MASIMO SENSORS.

■ DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY SENSORS AS

THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY

LEADING TO PATIENT HARM.

■ ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS.

VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND SENSOR BEFORE USE,

OTHERWISE PATIENT INJURY CAN RESULT.

Selecting a Sensor

When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the

available sensor sites, and the duration of monitoring. For more information refer to the

following table or contact your Sales Representative. Use only Masimo sensors and sensor cables.

Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented

in the Directions for Use accompanying the sensor.

High ambient and strobing light sources such as surgical lights (especially those with a xenon light

source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere

with the performance of the sensor. To prevent interference from ambient or strobing light, ensure that

the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to

take this precaution in high ambient light conditions may result in inaccurate measurements.

Sensor Application Instructions

Unless indicated otherwise in the directions for use, reposition reusable sensors at least every 4 hours

and for adhesive sensors inspect the site at least every 8 hours or sooner. If indicated by circulatory

condition or skin integrity, reapply to a different monitoring site.

Section 8 - Sensor and Patient Cables

8-2

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

Masimo Rainbow

Sensors

Masimo Rainbow sensors must be used with the Rad-57 to enable measurement of Carboxyhemoglobin

(SpCO), and/or Methemoglobin (SpMet). Rainbow sensors will only function with Instruments

containing Masimo Rainbow SET Technology or licensed to use Rainbow compatible sensors.

Rainbow sensors connect to the instrument directly or with a patient cable.

Rainbow R Series Adhesive Sensors

SpO

, SpMet, and pulse rate accuracy for the Rainbow sensors is specified in the following table.

Rainbow adhesive sensors must be used in conjunction with Rainbow RC cables.

Sensor

Application

Site

Weight

Range

Saturation Accuracy Pulse Rate Accuracy

Low Perfusion

Accuracy

SpMet

Accuracy

No Motion Motion No Motion Motion Saturation

Pulse

Rate

No Motion

R1 25

Finger or toe > 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

R1 25L

Finger or toe > 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

R1 20

Finger or toe

10 - 50

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

R1 20-L

Thumb or

great toe

3 - 10 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

Finger or toe

10 - 30

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ±1%

Rainbow Adhesive Sensors

SpO

, SpCO, SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following

table.

Rainbow adhesive sensors must be used in conjunction with Rainbow RC cables.

Sensor

Weight Saturation Accuracy

Pulse Rate

Accuracy

Low Perfusion

Accuracy

SpCO

Accuracy

SpMet

Accuracy

Range No Motion Motion

Motion

Motion Saturation

Pulse

Rate

Motion

R25 > 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3.5% ± 1%

R25-L > 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3.5% ± 1%

R20 3 - 10 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3.5% ± 1%

R20-L

3 - 10 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3.5% ± 1%

10 - 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3.5% ± 1%

Sensors and Patient Cables

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

8-3

Rainbow Direct Connect Sensors

SpO

and SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following table.

Rainbow Direct Connect sensors connect to the instrument directly.

SENSOR

Weight

Range

Saturation Accuracy Pulse Rate Accuracy

Low Perfusion

Accuracy

SpMet

Accuracy

No Motion Motion No Motion Motion Saturation Pulse Rate No Motion

DC-3

DC-12

> 30 kg

60 - 80 ± 3%

70 -100 ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

DCP-3

DCP-12

10 - 50 kg

60 - 80 ± 3%

70 -100 ± 2%

± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 1%

Rainbow Reusable Sensors

SpO

, SpCO, SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following

table.

Rainbow reusable sensors must be used in conjunction with Rainbow RC cables.

Sensor

Weight

Range

Saturation Accuracy Pulse Rate Accuracy

Low Perfusion

Accuracy

SpCO

Accuracy

SpMet

Accuracy

No Motion Motion No Motion Motion Saturation

Pulse

Rate

No Motion No Motion

DCI > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3% ± 1%

DCIP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3% ± 1%

Rainbow Resposable™ Pulse CO-Oximeter Sensor System

SpO

, SpMet, and pulse rate accuracy for the Rainbow Resposable two piece sensor system is

specified in the following table.

Sensor

Application Site Weight Range

Saturation

Accuracy

Pulse Rate

Accuracy

Low Perfusion Accuracy SpMet Accuracy

Saturation Pulse Rate

R2-25a

R2-25r

Middle or ring

finger

> 30 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3 bpm ± 2% ± 3 bpm ± 1%

R2-20a

R2-20r

Middle or ring

finger

10 - 50 kg

60 - 80% ± 3%

70 - 100% ± 2%

± 3 bpm ± 2% ± 3 bpm ± 1%

Sensors and Patient Cables

8-4

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

Masimo SpO

Sensors

The Rad-57 may also use standard Masimo LNOP, LNOPv and LNCS SpO

sensors, when used with

Red PC and LNCS Cables respectively. This will allow the Rad-57 to work as a Masimo SET pulse

oximeter without the carboxyhemoglobin or methemoglobin measurement.

Select the appropriate patient cable to attach the LNOP, LNOPv or LNCS sensor to the instrument.

Red Reusable Sensors

SpO

and pulse rate accuracy for the Red sensors is specified in the following table.

Sensor

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

Range No Motion Motion No Motion Motion Saturation Pulse Rate

Red DCI > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

Red DCIP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP

Reusable Sensors

LNOP sensors must be used in conjunction with Red PC cables.

Sensor

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOP DCI > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP DCIP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP YI > 1 kg ± 2% ± 3% ± 3 bpm ± 5 bpm N/A N/A

LNOP TC-I > 30 kg ± 3.5% N/A ± 3 bpm N/A ± 3.5% ± 3 bpm

LNOP DC-195 > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP TF-I > 30 kg ± 2% N/A ± 3 bpm N/A ± 2% ± 3 bpm

NOTE: The LNOP TF-I and TC-I sensors were not validated under motion conditions.

LNOP

Adhesive Sensors

LNOP sensors must be used in conjunction with Red PC cables.

Sensor

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOP Adt > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP Adtx > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP Pdt 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP Pdtx 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP Neo-L

< 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

> 40 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP NeoPt-L < 1 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

LNOP Inf-L 3 - 20 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

Sensors and Patient Cables

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

8-5

LNOP

Specialty Sensors

LNOP sensors must be used in conjunction with Red PC cables.

Sensor

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOP Blue 2.5 - 30 kg

60 - 80% ± 4% N/A ± 3 bpm N/A ± 3% ± 3 bpm

70 - 100% ± 3.3% N/A ± 3 bpm N/A ± 3% ± 3 bpm

80 - 100% ± 3% N/A ± 3 bpm N/A ± 3% ± 3 bpm

LNOP Trauma

> 30 kg

± 2% ± 3% ± 3 bpm ± 5 bpm

N/A N/A

LNOP

Newborn Neo

< 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

LNOP

Newborn Inf

3 - 20 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS

™

/LNCS

Reusable Sensors

M-LNCS sensors must be used in conjuction with Rainbow patient cable series. LNCS reusable sensors

must be used in conjunction with Red LNC cables.

M-LNCS/LNCS

DCI

> 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS

DCIP

10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS

TC-I

> 30 kg ± 3.5% N/A ± 3 bpm N/A ± 3.5% ± 3 bpm

M-LNCS/LNCS

TF-I

> 30 kg ± 2% N/A ± 3 bpm N/A ± 2% ± 3 bpm

M-LNCS/LNCS YI > 1 kg ± 2% ± 3% ± 3 bpm ± 5 bpm N/A N/A

NOTE: The M-LNCS and LNCS TF-I and TC-I sensors were not validated under motion conditions.

M-LNCS

™

/LNCS

Adhesive Sensors

M-LNCS sensors must be used in conjuction with Rainbow patient cable series.

LNCS sensors must be used in conjunction with Red LNC cables.

SENSOR

Weight

Range

Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

Motion

Motion No Motion Motion Saturation Pulse Rate

M-LNCS/LNCSAdtx

M-LNCS/LNCSAdtx-3

> 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS Pdtx

M-LNCS/LNCS Pdtx-3

10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS Inf-L

M-LNCS/LNCS Inf

M-LNCS/LNCS Inf-3

3 - 20 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS Neo-L

M-LNCS/LNCS Neo

M-LNCS/LNCS Neo-3

< 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

> 40 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS NeoPt

M-LNCS/LNCSNeoPt-L

M-LNCS/LNCS NeoPt-3

< 1 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

M-LNCS/LNCS

NeoPt-500

< 1 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

Sensors and Patient Cables

8-6

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

M-LNCS

™

/LNCS

Specialty Sensors

M-LNCS sensors must be used in conjuction with Rainbow patient cable series.

LNCS sensors must be used in conjunction with Red LNC cables.

SENSOR

Weight

Range

Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

No Motion Motion No Motion Motion Saturation Pulse Rate

M-LNCS/LNCS

Newborn

Infant/Pediatric

< 3 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

M-LNCS/LNCS

Newborn

Neonatal

< 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

M-LNCS/LNCS

Trauma

> 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOPv

Adhesive Sensors

(LNOPv sensors must be used in conjunction with Red PC cables)

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOPv Ad > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

Sensor Accuracy

Refer to Section 7, Specifications for SpO

, SpCO, SpMet and pulse rate accuracy, unless otherwise

specified in the tables above. Accuracy specified when used with Masimo Rainbow SET technology

pulse CO-Oximetry monitors or with licensed Masimo SET pulse oximetry modules during no motion.

Numbers represent ± 1 standard deviation. Plus or minus one standard deviation represents 68%

of the population. SpO

accuracy from 70% to 100%. Pulse Rate accuracy from 25 to 240bpm.

Carboxyhemoglobin accuracy (SpCO) from 1 to 40%. Methemoglobin accuracy (SpMet) from 1 to

15%.

Cleaning And Reuse Of Masimo Reusable Sensors and Cables

Reusable sensors and patient cables can be cleaned per the following procedure:

■ Remove the sensor from the patient.

■ Disconnect the sensor from the patient cable.

■ Disconnect the patient cable from the monitor.

■ Wipe the entire sensor and/or patient cable clean with a 70% isopropyl alcohol pad.

■ Allow to air dry thoroughly before returning it to operation.

CAUTION: CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF PATIENT

ENTANGLEMENT OR STRANGULATION.

Reattachment of Single Use Adhesive Sensors

■ Single use sensors may be reapplied to the same patient if the emitter and detector windows

are clear and the adhesive still adheres to the skin.

NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly

positioned. Reposition the sensor or choose a different monitoring site.

CAUTION: DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY SENSORS

AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY

LEADING TO PATIENT HARM.

Sensors and Patient Cables

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

9-1

Service and Maintenance

Introduction

This chapter covers how to test the operation of the Rad-57, how to properly clean the Rad-57 Pulse

CO-Oximeter, how to replace the batteries and how to obtain service.

Under normal operation, no internal adjustment or recalibration is required.

WARNING: BEFORE CLEANING THE OXIMETER, ALWAYS TURN IT OFF AND

REMOVE THE BATTERIES.

Cleaning

To clean the display panel, use a cotton swab moistened with 70% isopropyl alcohol and gently wipe

the panel.

To clean the outer surface of the oximeter, use a soft cloth dampened with a mild soap and water. Do

not allow liquids to enter the interior of the Instrument.

CAUTIONS:

■ DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THIS OXIMETER.

■ DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID.

■ USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW INTO THE

MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS.

■ DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE CLEANING

COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE MATERIALS, OR BRING

THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL.

■ DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER HARSH

SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES ATTACK THE

INSTRUMENT’S MATERIALS AND INSTRUMENT FAILURE CAN RESULT.

Refer to Section 8, Cleaning and Reuse of Masimo Reusable Sensors and Patient Cables for cleaning

instructions of the sensor and patient cables.

Section 9- Service and Maintenance

9-2

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

Service and Maintenance

Battery Replacement

The Rad-57 is powered by 4 AA alkaline batteries. Do not use any other type of batteries or power

source to run the instrument. The battery compartment is accessed from the back of the intrument. To

replace the batteries first remove the battery cover by depressing the small rectangular button at the

bottom of the cover, and sliding the cover down off the bottom of the instrument. Remove the batteries

and install new batteries in the directions indicated by the battery icons inside the battery compartment.

Replace the battery cover by sliding it back up from the bottom of the instrument until the rectangular

locking button snaps back into position.

WARNING: FAILURE TO REPLACE BATTERIES PROMPTLY AFTER A LOW

BATTERY ALARM MAY RESULT IN THE CO-OXIMETER SHUTTING DOWN AND

LEAVING THE PATIENT IN AN UNMONITORED CONDITION.

WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE

BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER.

WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V

COULD CAUSE DAMAGE TO THE RAD-57.

WARNING: EFFECTIVE BATTERY LIFE WILL BE REDUCED WHEN OPERATING

THE INSTRUMENT BELOW 5ºF (-15º

C) DUE TO ALKALINE BATTERY

TECHNOLOGY.

Battery charge level is indicated by four LED indicators at the bottom of the front panel. All four

indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their

charge. When less than ten (10) percent battery life remains, the final battery indicator will begin to

flash and an audible alarm will sound.

Be sure to follow local regulations in regards to battery disposal.

Performance Verification

To test the performance of the Rad-57 Pulse CO-Oximeter following repairs or during routine

maintenance, follow the procedure outlined in this section. If the Rad-57 fails any of the described

tests, discontinue its use and correct the problem before returning the Instrument back to the user.

Before performing the following tests verify or install new batteries into the Rad-57 Handheld. Also

disconnect any patient cables, pulse oximetry probes or serial cables from the Instrument.

Power-On Self-Test

1. Turn the monitor on by depressing the Power Button. For about 5 seconds all available LEDs

are illuminated and a brief beep tone sounds.

2. The oximeter begins normal operation.

Key Press Button Test

1. With the exception of the Power Button, press each button and verify that the oximeter

acknowledges each key-press with an audible beep tone or by indicating a change on the

display.

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

9-3

Alarm Limit Test

1. With the monitor turned on, select the Menu Access key and enter the Alarm menu.

Change the High Saturation Alarm parameter to a value two points below the currently

selected value, and accept the change.

2. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display, next to the

SpO

or pulse rate measurement display.

3. Return the High Saturation Alarm parameter to its original setting.

4. Repeat steps 1 to 3 with the Low Saturation Alarm parameter.

5. Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter.

6. Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter.

7. Perform the above steps for the SpCO and SpMet alarm limits.

8. Reset the alarm limits again to the original settings.

LED Brightness

1. With the monitor turned on, select menu level 3 (see Section 4, Setup Menu Level 3 - LED

Brightness and Factory Defaults) and use the Up and Down Arrow keys to cycle through all 4

brightness levels.

2. Exit the Menu system by pressing the Enter key or waiting for the normal time-out.

Service and Repair

Repair Policy

Masimo or an authorized Service Department must perform warranty repair and service. Do not use

malfunctioning equipment. Have the Instrument repaired.

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

described in Section 9, Cleaning. Make sure it is fully dry before packing the equipment.

To return the Rad-57 Instrument for service, please follow the Return Procedure.

WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT

FOR BATTERY REPLACEMENT. AN OPERATOR MAY ONLY PERFORM

MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL.

REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE

REPAIR OF THIS EQUIPMENT.

Return Procedure

Please clean contaminated/dirty equipment before returning and make sure it is fully dry before

packing the equipment. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA

number. Package the equipment securely – in the original shipping container if possible – and enclose

or include the following information and items:

■ A letter describing in detail any difficulties experienced with the Pulse CO-Oximeter. Please

include the RMA number in the letter.

Service and Maintenance

9-4

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

Service and Maintenance

■ Warranty information – a copy of the invoice or other applicable documentation must be

included.

■ Purchase order number to cover repair if the oximeter is not under warranty, or for tracking

purposes if it is.

■ Ship-to and bill-to information.

■ Person (name, telephone/Telex/fax number, and country) to contact for any questions about

the repairs.

■ A certificate stating the oximeter has been decontaminated for bloodborne pathogens.

Return Rad-57 Pulse CO-Oximeter to the following shipping address:

FOR USA, CANADA & ASIA

PACIFIC (EXCEPT JAPAN):

Masimo Corporation

40 Parker

Irvine, California 92618

Tel: 949-297-7000

FAX: 949-297-7001

FOR JAPAN:

Masimo Japan Corporation

Kojimachi Office

World Time Bldg. 4F

10-7, Ichiban-cho, Chiyoda-ku,

Tokyo 102-0082 JAPAN

Tel: 03 3237 3057, FAX: 03 3238 1110

FOR EUROPE:

Masimo International Sàrl

Puits-Godet 10

2000 Neuchatel - Switzerland

Tel: +41 32 720 1111

Fax.: +41 32 724 1448

ALL OTHER LOCATIONS:

Contact your local Masimo Representative

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

9-5

Service and Maintenance

Sales & End-user

License Agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, (“PURCHASER”) AND MASIMO CORPORATION

(“MASIMO”) FOR THE PURCHASE OF THIS PRODUCT ("PRODUCT”) AND A LICENSE IN THE INCLUDED OR

EMBEDDED SOFTWARE ("SOFTWARE"). EXCEPT AS OTHERWISE EXPRESSLY AGREED IN A SEPARATE

CONTRACT FOR THE ACQUISITION OF THIS PRODUCT. THE FOLLOWING TERMS ARE THE ENTIRE

AGREEMENT BETWEEN PARTIES REGARDING YOUR PURCHASE OF THIS PRODUCT. IF YOU DO NOT

AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PRODUCT, INCLUDING

ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO MASIMO FOR A

FULL REFUND.

Warranty

Masimo warrants to the initial purchaser for a period of one (1) year from the date of purchase that: (i) each

new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the

Product and Software will perform substantially as labeled in the directions for use. Masimo’s sole obligation under

this warranty is to repair or replace any Product or Software that is covered under warranty.

Batteries are not warrantied.

To request a replacement under warranty, Purchaser must contact Masimo for a returned goods authorization. If

Masimo determines that a product must be replaced or repaired under warranty, it will be replaced or repaired and

the cost of shipment covered. All other shipping costs shall be the responsibility of the Purchaser.

Exclusions

The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed

because of: a) modification of the Product or Software without Masimo’s written authorization; b) supplies, devices or

electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product

by anyone other than an authorized Masimo agent; d) use of the Product with sensors or other accessories other

than those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in environments

for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather,

war, or any act of God. This warranty does not extend to any Product that has been reprocessed, reconditioned or

recycled.

This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any

temporary Products modules or any Products for which Seller does not otherwise receive a usage or purchase fee;

all such Products are provided AS-IS without warranty.

THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED

BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO THE PRODUCT AND SOFTWARE. THIS

WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES, INCLUDING WITHOUT

LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR

PURPOSE. MASIMO SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL

LOSS, DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE

OF ANY PRODUCTS OR SOFTWARE. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM ANY

PRODUCT AND SOFTWARE (UNDER CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHER

CLAIM) EXCEED THE AMOUNT PAID BY PURCHASER FOR THE PRODUCTS GIVING RISE TO SUCH

CLAIM. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT

CANNOT LEGALLY BE DISCLAIMED BY CONTRACT.

9-6

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

Service and Maintenance

End-User

License

1. Grant of License: In consideration of payment of the Software license fee, which is part of the

price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except

as set forth below) license ("License"), without right to sublicense, to use the copy of the Software

in connection with Purchaser's use of the Product for its labeled purpose as set forth in these

directions for use. Masimo reserves all rights not expressly granted to Purchaser.

2. Ownership of Software: Software is licensed not sold. All rights and interests in the Software and all

copies thereof, remain at all times vested in Masimo and do not pass to Purchaser. Any references in

this Agreement to the purchase of sale of the Software shall be deemed the purchase of the sale of

a Software License as set forth herein.

Restrictions

1. Copyright Restrictions: The software and the accompanying written materials are copyrighted.

Unauthorized copying of the software, including software that has been modified, merged, or included

with other software, or other written materials is expressly forbidden. Purchaser may be held legally

responsible for any copyright infringement that is cause or incurred by Purchaser's failure to abide by

the terms of this Agreement. Nothing in this license provides any rights beyond those provided by 17

U.S.C. §117.

2. Use Restriction: Purchaser may physically transfer the products from one location to another provided

that the Software is not copied. Purchaser may not electronically transfer the software from the

Product to any other device. Purchaser may not disclose, publish, translate, release or distribute

copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative

works based on the Software or the written materials.

3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise

dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or

transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior

written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer

automatically to any party that legally acquires title to the Product with which this Software is

included. Any attempt to assign any rights, duties or obligations arising hereunder other than as

set forth in this paragraph shall be void.

4. U.S. Government Rights: If Purchaser is acquiring software (including the related documentation)

on behalf of any part of the United States Government, the following provisions apply: the software

is deemed to be “commercial software” and “commercial computer software documentation,”

respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification,

reproduction, release, performance, display or disclosure of the software (including the related

documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms

of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this

Agreement.

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

10-1

Accessories

Section 10- Accessories

Accessories

PART NUMBER DESCRIPTION

1842 Rubber protective boot, Grey

1980 Rubber protective boot, Yellow

1981 Rubber protective boot, Red

1982 Rubber protective boot, Orange

2097 Rubber protective boot, Royal Blue

2098 Rubber protective boot, Light Blue

2099 Rubber protective boot, Pink

2208 Protective carrying case, black

2209 Protective carrying case, red

13158 Nylon protective carrying case

1908 CD, TrendCom Software

2063 Data Transfer Download Cable

38217/9204A-0216

www.masimo.com

Instruments and sensors containing Masimo Rainbow SET technology are

identified with the Masimo Rainbow SET logo.