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

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OPERATOR’S MANUAL

Covers:

Rad-57c: with SpO2 and SpCO

Rad-57m: with SpO2 and SpMet

Rad-57cm: with SpO

SpCO

and SpMet

Signal Extraction

Pulse CO-Oximeter™

Masimo Rainbow® SET

Signal Extraction Pulse CO-Oximeter™

OPERATOR'S MANUAL

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

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

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

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

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

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

reading and understanding these instructions.

NOTICE

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

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

of the relating patents.

CAUTION:

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

PHYSICIAN.

For further information contact:

Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com

EU Authorized Representative for Masimo Corporation:

MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33

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

80fk

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215986, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090,, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www. masimo.com/patents.htm. Other patents pending.

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

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

trademarks of Masimo Corporation.

EC REP

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

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-57™ Handheld Pulse CO-Oximeter™ is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation.

■ Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable

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

■ High intensity extreme lights (such as pulsating strobe lights) directed on the sensor,

may not allow the Pulse CO-Oximeter to obtain vital sign readings.

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

■ A Pulse CO-Oximeter should be considered an early warning device. As a trend

towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition.

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

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

■ The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual,

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

■ Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to replace

the batteries. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

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

of patient entanglement or strangulation.

■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause

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

■ Interfering Substances: SpO

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

■ Severe anemia may cause erroneous SpO2 readings.

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

■ Hemoglobin synthesis disorders may cause erroneous SpHb readings.

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

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

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

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

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

iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

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

from the Pulse CO-Oximeter before bathing the patient.

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

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

to be muffled.

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

Pulse CO-Oximeter, preventing it from working properly.

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

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

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

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

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

procedures remove the Pulse CO-Oximeter from operation until qualified service personnel have corrected the situation.

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

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

accessories.

■ The Pulse CO-Oximeter can be used during defibrillation, but the readings may be

inaccurate for up to 20 seconds.

■ This equipment has been tested and found to comply with the limits for medical

devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

■ Reorient or relocate the receiving device.

■ Increase the separation between the equipment.

■ Consult the manufacturer for help.

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

or any sensors.

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

table of contents

SECTION 1 - OVERVIEW

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

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

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

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

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

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

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

SpO

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

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

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

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

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

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

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

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

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

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

SECTION 2 - SYSTEM DESCRIPTION

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

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

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

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

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

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

SECTION 3 - SETUP

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

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

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

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

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

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

SECTION 4 - OPERATION

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

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

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

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

Successful SpO

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

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

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

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

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

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

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

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

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

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

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

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

table of contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SECTION 5 - ALARMS / MESSAGES

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

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

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

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

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

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

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

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

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

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

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

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

SECTION 8 - SENSOR AND PATIENT CABLES

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

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

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

Masimo Rainbow

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

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

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

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

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

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

SECTION 4 - OPERATION (CONTINUED)

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

table of contents

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

LNOP

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

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

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

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

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

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

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

SECTION 9- SERVICE / MAINTENANCE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SECTION 10- ACCESSORIES

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

SECTION 8 - SENSOR AND PATIENT CABLES (CONTINUED)

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

overview

About this Manual

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

57. Features and specifications apply to all models unless otherwise noted. Important safety information relating to general use of the Rad-57 appears before this introduction. Other important safety information is located throughout the manual where appropriate.

Read the entire safety information section before you operate the monitor.

In addition to the safety section, this manual includes the following sections:

SECTION 1 OVERVIEW gives a general description of Pulse CO-Oximetry.

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

features.

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

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

SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6 TROUBLESHOOTING gives troubleshooting information.

SECTION 7 SPECIFICATIONS gives the detailed specifications of the Rad-57.

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

Masimo Rainbow SET, LNOP

, LNOPv™ and LNCS® sensors, Masimo

Rainbow SET patient cables and Masimo SET patient cables.

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

obtain repair for the Rad-57.

SECTION 10 ACCESSORIES

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

Warnings, Cautions and Notes

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

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

Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device or damage to other property.

Sample of Caution:

CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

A NOTE is provided when extra general information is applicable.

Sample of Note:

NOTE: This is a sample of a Note.

overview

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

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

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

MODEL SUMMARY

All models include SpO

and pulse rate.

MODEL FEATURES

Rad-57c Includes SpCO and PI

Rad-57m Includes SpMet and PI

Rad-57cm Includes SpCO, SpMet and PI

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

FEATURES AND BENEFITS

■ Clinically proven Masimo SET

technology performance

■ Proven for accurate SpO

and pulse rate monitoring in motion and low perfusion

environments

■ SpO

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

■ Low Signal IQ (SIQ™) indicator

■ Lightweight, convenient handheld design

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

■ Visual battery life indicator

■ Audible Alarm for sensor-off and low battery

■ Alarms for high/low SpO

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

■ FastSat

(for SpO2 measurement)

■ Three sensitivity levels - Max, Normal and APOD

(for SpO2 measurement)

■ 72 hours of trending memory

■ Adjustable alarm volume

■ Adjustable averaging 2 to 16 seconds

*See Model Summary for applicable device.

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

INDICATIONS FOR USE

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

), pulse rate, carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor)* and methemoglobin saturation (measured by a SpCO/SpMet sensor)*. The Rad-57 and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile and home environments.

*See Model Summary for applicable device.

overview

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

overview

Pulse CO-Oximetry

SpO2 GENERAL DESCRIPTION

Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects to the pulse oximetry device with a patient cable. The sensor collects signal data from the patient and sends it to the device. The device displays the calculated data in two ways:

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

)

2) As a pulse rate (PR)

The following figure shows the general monitoring setup.

SpCO GENERAL DESCRIPTION

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

SpMet GENERAL DESCRIPTION

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

1. Device

2. Sensor

3. Patient Cable

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

PRINCIPLE OF OPERATION

Pulse oximetry is governed by the following principles:

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

2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

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

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

* See Model Summary for applicable device.

overview

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

600

650 700 750 800 850 900 950 1000

Wavelength (nm)

Absorption (mm-1)

Carboxyhemoglobin

Oxyhemoglobin

Methemoglobin

Deoxyhemoglobin

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

2. Detector

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

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

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.

MEASURED VS. CALCULATED VALUES

SpO2, SpCO* and SpMet* measurements that can be obtained from the Rad-57 are commonly compared to invasive measurements obtained from blood gas samples. When comparing invasive and noninvasive measurements and interpreting values, caution should be used, as the calculated values obtained from the blood gas sample may differ from the SpO2, SpCO and SpMet measurements of the Pulse CO-Oximeter. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO and SpMet, in addition to the effects of temperature and pH, different results are also expected if concentration of methemoglobin in the blood gas sample are abnormal (less than 90% for arterial oxygen saturation, and greater than 2% for methemoglobin concentration). As blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and methemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO

MEASUREMENTS

Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the non-arterial blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform

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

SpCO AND SpMet MEASUREMENTS DURING PATIENT MOTION

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

* See Model Summary for applicable device.

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

MASIMO RAINBOW SET PARALLEL ENGINES

This figure is for conceptual purposes only.

MASIMO SET DST

overview

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Intermediate Calculations

Confidence

Pre-Processing &

Data Reduction

Digitized, Filtered &

Normalized

LED

Wavelengths

R/IR

(Conventional

Pulse Oximetry)

DST

Adaptive

Filter

SST ™

FST:

Proprietary

Algorithm 3

FST:

Proprietary

Algorithm 4

Rainbow

Specific

Algorithms

Pulse

Rate

Algorithm

Confidence

Based

Arbitrator

Post

Processor

%SpO

%SpCO

%SpMet

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 device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel and the sensor cable connection is located at the top edge of the device.

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

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

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

patient cables).

■ Provides 72 hours of trending memory

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

system description

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

system description

CONTROL / INDICATOR DESCRIPTION

Patient Cable Connector

Connects to a Rainbow Sensor or Rainbow Patient Cable,

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

or LNCS Sensor.

SpCO indicator

Slow flashing indicator: The confidence in the SpCO value

obtained is low.

Fast flashing indicator: Flashes when an SpCO alarm

condition exists.

Saturation (%SpO2) and

Carboxyhemoglobin

(%SpCO) Displays

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

Refer to the Display Button description.

%SpCO Bar

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

Pulse Rate Display

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

Rad-57c

Rad-57c Front Panel Controls

>40

%SpCO

SpCO

Signal Extraction Pulse CO-Oximeter

%SpO

rainbow

%SpCO

1.75

1.5

1.25

.25

<.1

BPM

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

system description

CONTROL / INDICATOR DESCRIPTION

Display Button

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

/pulse rate numeric value.

Mode / 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 during normal patient monitoring.

Power On / Off

Press to turn the device on.

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

Battery Level Indicator

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

Visual Alarm Indicator

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

%SpO2 / %SpCO Indicator

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

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

Low SIQ

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

Alarm Silenced Indicator

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

Alarm Silence Button

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

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.

Speaker

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

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

system description

CONTROL / INDICATOR DESCRIPTION

Patient Cable

Connector

Connects to a Rainbow Sensor or Rainbow Patient Cable,

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

or LNCS Sensor.

SpMet indicator

Slow flashing indicator: The confidence in the SpMet value

obtained is low.

Fast flashing indicator: Flashes when an SpMet alarm

condition exists.

Saturation (%SpO2)

Display

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

. When searching for a saturation

and pulse, it will flash dashed lines.

%SpMet Bar

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

%SpMet / Pulse Rate Display

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

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

Rad-57m

Rad-57m Front Panel Controls

7.5

>20

SpMet

%SpMet

Signal Extraction Pulse CO-Oximeter

%SpO

1.75

1.5

1.25

.25

<.1

%SpMet

BPM

rainbow

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

system description

CONTROL / INDICATOR DESCRIPTION

Display Button

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

Mode / 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 during normal patient monitoring.

Power On / Off

Press to turn the device on.

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

Battery Level Indicator

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

Visual Alarm Indicator

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

%SpO2 Indicator

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

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

Low SIQ

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

Alarm Silenced Indicator

Alarm Silence Button

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

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.

Speaker

2-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

system description

Rad-57cm

Rad-57cm Front Panel Controls

CONTROL / INDICATOR

DESCRIPTION

Patient Cable

Connector

Connects to a Rainbow Sensor or Rainbow Patient Cable,

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

or LNCS Sensor.

Low PI Indicator

The Perfusion Index (PI) LED illuminates a constant light when arterial pulsations are very low (weak perfusions).

Saturation

(%SpO2) and

Carboxyhemoglobin

(%SpCO) Displays

The functional arterial hemoglobin oxygen saturation is

displayed in units of SpO2. When searching for a saturation

and pulse, it will flash dashed lines.

See SpCO/SpMet Button description, below.

%SpCO Bar

Illuminates when SpCO capable sensor is attached. Bar will

flash for SpCO alarm conditions. Continuously indicates the concentration of carboxyhemoglobin in increments of: 3, 6, 9, 12, 15, 20, 25, 30, 35, > 40.

Pulse Rate Display and Methemoglobin

(%SpMet) Displays

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

See Display button description.

>40

%SpCO

Signal Extraction Pulse CO-Oximeter

rainbow

Low PI

%SpO

%SpCO

%SpMet

BPM

%SpMet

7.5

>20

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-7

system description

CONTROL / INDICATOR DESCRIPTION

Display Button

Pressing this button will display the numeric SpCO value in place of the SpO2 numeric value and the SpMet value in place of the pulse rate. Pressing this button again will display " PI " in place of SpCO and the PI numeric value in place of the SpMet value. Pressing this button again will return to the SpO2 and pulse rate numeric values.

Mode / 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 during normal patient monitoring.

Power On / Off

Press to turn the device on.

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

Battery Level Indicator

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

Visual Alarm Indicator

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

%SpO2 / %SpCO Indicator

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

%SpMet Bar

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

%SpMet/BPM

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

Low SIQ

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

Alarm Silenced Indicator

Flashes to indicate the alarm is temporarily silenced.

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

Alarm Silence Button

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

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.

Speaker

2-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

system description

Rad-57 Rear Panel (all models)

CONTROL / INDICATOR

DESCRIPTION

Serial Number Label Located on outside of case

Agency Approvals Label Located on outside of case

Battery Cover Located on back of device

Battery Cover Release

Press down and slide the battery cover off the bottom of the oximeter

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 2-9

SYMBOLS

The following symbols are found on the back of the Rad-57 Signal Pulse CO-Oximeter or packaging and are defined below:

SYMBOL DESCRIPTION

Caution, consult accompanying documents

Type BF applied par t complying with IEC 60601-1

WEEE Compliant

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

Rx ONLY

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

Underwriter's Laboratories Inc. approved

5%-95% RH

Storage humidity range: 5% to 95%

-40 C

+70 C

+1060 hPa - +500 hPa

795 mmHg - 375 mmHg

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

Keep dry

Fragile/breakable, handle with care

Year of Manufacture

Manufacturer

system description

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

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 device from the shipping carton and examine for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier

If anything is missing or damaged, contact the Technical Service Department. The contact address and phone numbers are listed in Section 9, Service and Repair.

Preparation for monitoring

The following sections of the manual describe the preparation, set-up and initial installation of the Rad-57 Pulse CO-Oximeter.

POWER REQUIREMENTS

The Rad-57 is powered by 4 “AA” alkaline batteries. Do not use any other type of batteries or power source to run the device. The battery compartment is accessed from the back of the device. 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 device. 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 device 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 less than ten (10) percent battery life remains, the final battery indicator will begin to flash and an audible alarm will sound.

setup

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

Monitor Setup

INITIAL SETUP

1. Inspect the oximeter case for damage.

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

3. Turn the device 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 device 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 DEVICE MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER

LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORESCENT 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 device.

setup

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

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, Alarm Identification,

System Messages and Section 6, Troubleshooting).

Basic Operation

GENERAL SETUP AND USE

1. Inspect the oximeter case for damage.

2. Ensure that the batteries are correctly installed.

3. Connect a Rainbow Sensor or a Red Patient Cable with an LNOP, LNOPv or LNCS

sensor

to the Patient Cable connector of the oximeter. Make sure it is a secure

connection and the cable is not twisted, sliced or frayed. See Section 5, Messages, to view messages that may be displayed pertaining to sensors and cables.

4. Select a sensor that is compatible with the oximeter before connecting it to the patient cable. See Section 8, Sensors and Patient Cables. If using a single patient adhesive or disposable sensor, check that the emitter (red light) and the detector are properly aligned. If using a reusable sensor, make sure it opens and closes smoothly. Remove any substances that may interfere with the transmission of light between the

sensor’s light source and detector.

5. Attach the sensor to the patient. Refer to the Directions for Use of the sensor.

6. Properly align and insert the male-connector end of the sensor into the female-

connector end of device (or patient cable). Make sure it is a secure connection.

7. Press the Power button to turn the oximeter on.

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

9. 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).

10. Verify that the display shows the current device settings in the following order:

■ SpO2 Low Alarm Limit

■ SpO2 High Alarm Limit

■ Pulse Rate Low Alarm Limit

■ Pulse Rate High Alarm Limit

■ SpCO Low Alarm Limit*

■ SpCO High Alarm Limit*

■ SpMet Low Alarm Limit*

■ SpMet High Alarm Limit*

■ Sensitivity

■ Averaging Time

■ FastSat: On or Off

*See Model Summary for applicable device.

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

operation

11. On the display, for each corresponding parameter and applicable unit, verify the readings for SpO

, SpCO, SpMet and pulse rate (See Model Summary for

applicable unit).

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

, SpCO, SpMet and

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

and up to 25 sec-

onds for SpCO and SpMet).

12. 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 flashes.

13. 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 monitoring a patient when the sensor was disconnected.

14. Verify parameter 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.

15. To begin patient monitoring:

■ Adjust the alarm limits.

■ Adjust the alarm volume.

■ Adjust the pulse beep volume.

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

Monitoring.

17. Monitor the patient.

18. 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.

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

GENERAL SETUP AND USE (CONTINUED)

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 device settings are set appropriately.

The following table outlines the default values and the values the Rad-57 reverts to after a power cycle:

OPTION FACTORY DEFAULT SETTING

CONFIGURABLE SETTING/

BEHAVIOR AT POWER-UP

SpO2 high alarm limit (Default is OFF)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpO2 low alarm limit (Default is 90%)

Pulse rate high alarm limit (Default is 140 BPM)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

Pulse rate low alarm limit (Default is 50 BPM)

SpCO* high alarm limit (Default is 10%)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpCO* low alarm limit (Default is OFF)

SpMet* high alarm limit (Default is 3%)

Set to Pre-Power Down Setting

See Section 5, Alarm Limits for all settings.

SpMet* low alarm limit (Default is OFF)

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

Sensitivity (Default is Normal)

Set to Pre-Power Down Setting

Normal, MAX or APOD

Display brightness (Default is level 2)

Set to Pre-Power Down Setting

Levels 1 through 4

Pulse tone volume (Default is level 4)

Set to Pre-Power Down Setting

Levels 1 through 7

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 ON)

Set to Pre-Power Down Setting

Off/On

Alarm Silence (Default is All Alarms Active)

Set to All Alarms Active Alarm on/off

*For each corresponding parameter, refer to the applicable device.

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

operation

Successful SpO2 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 detector.

■ 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 Directions for Use for proper sensor application.

MASIMO SENSORS

Before use, carefully read the LNOP, LNOPv, LNCS and Rainbow series sensor Directions for Use.

Use only Masimo oximetry sensors for SpO

measurements.

Tissue damage can be caused by incorrect application or use of an LNOP, LNOPv, LNCS or Rainbow sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.

CAUTIONS

 DO NOT USE DAMAGED LNOP, LNOPv, LNCS OR RAINBOW SENSORS. DO NOT

USE AN LNOP, LNOPv, LNCS OR RAINBOW 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 DIRECTIONS FOR USE). SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO LNOP, LNOPv, LNCS OR RAINBOW SENSORS.

 DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, 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 SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide a good feeling for changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging mode being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the oximeter and reduce the

measured variations of SpO

and PR.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-5

operation

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 instruments or application of the sensor or patient cable. The pulsations from intra-aortic balloon support can be additive to the pulse rate displayed on the Pulse CO-

Oximeter.

NUMERIC DISPLAY - SpCO (for applicable models)

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 measurements may be caused by:

■ Significant levels of methemoglobin.

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Abnormal hemoglobin levels.

■ Abnormally low arterial perfusion.

NUMERIC DISPLAY - SpMet (for applicable models)

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 measurements may be caused by:

 Intravascular dyes such as indocyanine green or methylene blue.

 Abnormal arterial perfusion

NUMERIC DISPLAY - PI (for applicable models)

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 an operating range of < .1 percent to > 5 percent on the Rad-57c and Rad-57m and 0.1 percent to 20.0 percent on the Rad-57cm. A percentage greater than 1.00 percent is desired. Extreme changes in the display number are due to changes in physiology and blood flow.

LOW SIGNAL IQ (LOW SIQ)

The Rad-57 display provides a visual indicator Signal IQ and an alert when the displayed SpO

values are not based on adequate Signal IQ. The Signal IQ indicator is displayed on

the Rad-57 as “Low SIQ”.

4-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

operation

The Low SIQ indicator flashes when the SpO2 measurement 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 an episode 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-57c and Rad-57m. Low Perfusion on the Rad-57cm is shown when the Low PI LED indicator light is illuminated continuously or a PI value of < 0.25 is displayed.

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.

ACTIONS TO BE TAKEN

If the SpO

readings show significant differences, do the following:

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

■ Select a site where the distance between the emitter and detector 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.

LOW SIGNAL IQ (LOW SIQ) (CONTINUED)

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-7

operation

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 IS IN THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM DEVICE THE PATIENT, THE POTENTIAL FOR FALSE READINGS MAY OCCUR DUE TO ENVIRONMENTAL ‘NOISE’ SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT.

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. Battery capacity is indicated in the following chart.

INDICATION BATTERY CAPACITY

4 LEDs

100% to 75%

3 LEDs

75% to 50%

2 LEDs

50% to 25%

1 LED

25% to 10%

1 FLASHING LED WITH AUDIBLE ALARM

10% to 0%

4-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

LOW BATTERY AUDIBLE ALARM

If a low battery condition occurs during patient monitoring, a low priority alarm will sound, and can be silenced for 120 seconds 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 the device 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.

operation

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-9

operation

Normal Patient Monitoring

During normal operation, the Rad-57 Display shows oxygen saturation (as % SpO

) on the

upper number and Pulse Rate (in beats per minute) on the lower number.

On each model, a 10-LED bar displays the following parameters:

■ Carboxyhemoglobin saturation (%SpCO) and Perfusion Index (PI) on the Rad-57c.

■ Methemoglobin saturation (%SpMet) and Perfusion Index (PI) on the Rad-57m.

■ Carboxyhemoglobin saturation (%SpCO) and Methemoglobin saturation (%SpMet)

on the Rad-57cm. Low Perfusion Index (PI) is displayed with a single LED on this model or the numeric value may be viewed by pressing the Display button.

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

Rad-57c

Rad-57m

Rad-57c and Rad-57m:

Pressing this button will display the numeric SpCO/SpMet value in place of the SpO2/pulse rate numeric value. Pressing this button again will return to the SpO2/pulse rate numeric value.

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. In the event of a multi-parameter alarm condition, the SpO2 / Pulse Rate display will take priority.

Rad-57cm

Rad-57cm:

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

Enters the Rad-57 setup/menu system. See Section 4, Operation.

No function during normal patient monitoring.

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

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.

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

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

4-10 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

operation

Setup Menu

This section gives an overview of the Rad-57 menu selections available. To navigate through the menus, use the Mode/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 Mode/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 is set/selected when either the Mode/Enter or Next keys are pressed.

SETUP MENU LEVEL 1 – ALARM VOLUME AND ALARM SILENCE

Push the Mode/Enter button to enter menu level 1.

BUTTON SETTING

Alarm Volume

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Alarm on/off

SETUP MENU LEVEL 2 – ALARM LIMITS

Push the Mode/Enter button again to enter menu level 2.

BUTTON SETTING

SpO2 Low Alarm Limit

Use Up or Down Arrow Keys to adjust parameter to desired setting.

*See Model Summary for applicable device.

SpO2 High Alarm Limit

Pulse Rate Low Alarm Limit

Pulse Rate High Alarm Limit

SpCO* Low Alarm Limit

SpCO* High Alarm Limit

SpMet* Low Alarm Limit

SpMet* High Alarm Limit

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-11

operation

SETUP MENU LEVEL 3 – AVERAGING AND SENSITIVITY

Push the Mode/Enter button again to enter menu level 3.

BUTTON SETTING

Sensitivity.

HI = Maximum Nor = Normal APO = APOD

Use Up or Down Arrow Keys to adjust parameter to desired setting.

NOTE: These changes affect

SpO

monitoring only.

Use the Up Arrow key to turn on SmartTone.

Averaging. The signal averaging time of this device can be set to:

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

FastSat* On, Off

SmartTone** On, Off

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

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

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

motion and low perfusion conditions. The pulse tone is based off of an averaged pulse rate measurement from the proprietary algorithm and may not identify irregular heart beat patterns when there is excessive artifact present.

SETUP MENU LEVEL 4 - TREND SETTINGS

Push the Mode/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”.

BUTTON SETTING

Trend ON / OFF

Use Up key to turn trend ON. Use Down

key to turn trend OFF

Set Year

Use Up or Down Arrow Keys to adjust

parameter to desired setting.

Set Month

Set Day

Set Hour

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.

4-12 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

operation

SETUP MENU LEVEL 4 - TREND SETTINGS (CONTINUED)

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.

SETUP MENU LEVEL 5 - LED BRIGHTNESS AND FACTORY DEFAULTS

Push the Mode/Enter button again to enter menu level 5.

BUTTON SETTING

LED Display Brightness (4 levels)

NOTE:

All LED indicators are illumi-

nated while adjusting this setting.

Use Up or Down Arrow Keys to adjust parameter to desired setting.

Restore Factory Defaults

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

Saturation/Pulse Rate Mode.

MENU SELECTION

SpO

and pulse rate will be continuously displayed once the sensor is properly placed and

calibration is complete. To display continuous SpCO, SpMet or PI monitoring (see Model

Summary for applicable device), press

. To return to continuous SpO2 monitoring and

pulse rate view, press

again.

display will take priority.

POWER OFF

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

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 4-13

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 device must be configured to match your local power line frequency (50 or 60 hz)

to operate properly. The 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 Mode/Enter

button.

3. "SEr " will be displayed.

4. Press the Mode/Enter

button once.

5. Push the Next

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 device off.

BUTTON SETTING

Simultaneously press and hold

Press

Use Up or Down Arrow Keys to adjust parameter to desired setting.

NOTE: The parameter is set/selected when the device is turned off.

Enter Line Frequencey Menu

Set Line Frequency

4-14 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

operation

Trend Setup and Use

INTRODUCTION

The Rad-57 can store 72 hours of SpO

Pulse Rate, 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 device is shut off or when the batteries are replaced.

A Pronto serial 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.

*See Model Summary for applicable device.

TRENDCOM UTILITY INSTALLATION

Copy the TrendCom utility from the CD onto a PC running MS-Windows.

TRENDCOM UTILITY OPERATION

1. Disconnect patient cable from the Rad-57.

2. Connect the mini-D end of the Rad-57 PRONTO serial cable to the Rad-57 patient cable connector (See Section 2, Rad-57 front panel controls) and connect the DB-9 end to a COM port on the PC.

3. Turn the Rad-57 on

4. Start the TrendCom Utility

5. Select the appropriate COM port number, if necessary.

6. Push the RETRIEVE TREND button on the TrendCom utility. Select the desired location and assign a filename for the trend file. Press Save.

7. The Rad-57 will display “dat out” while trend data is being transferred. A progress bar will advance to indicate the status of the download. Larger trend files will take longer to download. Transfer time is approximately 20 seconds per hour of trend data.

NOTE: During download of trend information, all normal Rad-57 functions are

unavailable and the keypad is locked, except for the power button.

8. When trend data transfer is complete, close TrendCom and disconnect the Rad-57 from the Rad-57 PRONTO serial cable.

9. Turn the Rad-57 off to exit the trend download mode.

NOTE: USB to serial port adapters are not supported for trend transfer.

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

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 device for any length of time.

TREND DATA FORMAT

After a successful download of the trend data, a .out file will be created containing the trenddump information in ASCII delimited format. The format is defined in the following table.

PARAMETER SPECIFICATION

Date

MM\DD\YY

Time

HH:MM:SS

SpO2*

001 to 100, or "---" meaning parameter not available

SpCO*

00.00 to 100, or "---" meaning parameter not available

SpMet*

00.00 to 100, or "---" meaning parameter not available

Pulse Rate

001 to 240, or "---" meaning parameter not available

Perfusion Index

00.00 to 20.00

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.

*See Model Summary for applicable device.

operation

4-16 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

SAMPLE TREND OUTPUT

02/08/06 16:40:50 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000001 No Cable 02/08/06 16:40:52 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000001 No Cable 02/08/06 16:40:54 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:40:56 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:40:58 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:00 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:02 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:04 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:06 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:08 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:10 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:12 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:14 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:41:16 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00000080 No Sensor 02/08/06 16:54:18 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00200000 Sensor Off Patient 02/08/06 16:54:20 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00200000 Sensor Off Patient 02/08/06 16:54:22 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00200000 Sensor Off Patient 02/08/06 16:54:24 SpO2=000 PR=000 PI=00.00 SpCO=00.00 Met=00.00 EXC=00200000 Sensor Off Patient

operation

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

alarms / 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 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 COOXIMETER IS USED.

An audible alarm and a flashing alarm status indicator will occur when an alarm limit is exceeded for greater than five seconds. It is best that the operator be within a minimum of 10 feet from the unit. 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

SpO2 High Limit

The SpO2 high alarm limit can be set anywhere between 2% and 100%, with a 1% step size. In the “----” (off) setting, the SpO2 High Limit alarm is disabled.

SpO2 Low Limit

The SpO

low alarm limit can be set anywhere between 1% and 100%, 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.

Pulse Rate High Limit (BPM)

The pulse rate high alarm limit can be set anywhere between 30 BPM and 240 BPM, with a 5 BPM step size.

Pulse Rate Low Limit (BPM)

The pulse rate low alarm limit can be set anywhere between 25 BPM and 235 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.

SpCO* High Limit

The SpCO high alarm limit can be set anywhere between 5% and 40%, with a 5% step size. In the "----" (off) setting, the SpCO High Limit Alarm is disabled. Factory default setting is 10%.

SpCO* Low Limit

The SpCO low alarm limit can be set anywhere between 5% and 35%, with a 5% 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.

*See Model Summary for applicable device.

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

alarms / messages

ALARM LIMITS (CONTINUED)

SETTING RANGE

SpMet* High Limit

The SpMet high alarm limit can be set anywhere between .5% and 30% with a .5% step size. In the “----“ (off) setting, the SpMet High Alarm Limit Alarm is disabled. Factory default setting is 3%.

SpMet* Low Limit

The SpMet low alarm limit can be set anywhere between .5% and 29.5% with a .5% step size. 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.

*See Model Summary for applicable device.

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.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 5-3

alarms / 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 / messages

MESSAGES

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

Message conditions for the Rad-57 follow:

DISPLAY TYPE SOLUTION

SpO2 NUMBER FLASHES

Saturation limit alarm

Assess /address patient condition.

Re-set alarm limits if indicated.

PULSE RATE NUMBER FLASHES

Pulse Rate limit alarm

Assess /address patient condition.

Re-set alarm limits if indicated.

No Sensor Connected Connect sensor to cable.

Sensor off patient

1. Reattach sensor to patient.

2. Verify proper sensor placement.

SpO2 sensor attached

If SpCO and/or SpMet parameters are desired, attach a Rainbow sensor to the device.

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 SpO

Signal IQ

1. Rule out occlusion of blood flow.

2. Verify placement of sensor.

PERFUSION INDEX (PI) BAR* TURNS RED

(Bottom two LEDs only.)

OR LOW PI LED IS FLASHING

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.

% SpCO* BAR GRAPH

Alarm Condition

Continuously indicates the concentration of Carboxyhemoglobin in the following increments: 3, 6, 9, 12, 15, 20, 25, 30, 35 and >40. When an SpCO alarm is violated, the bargraph will flash the color of the SpCO level being violated along with an audible alarm.

NOTE: For a more accurate reading press the SpCO button.

*See Model Summary for applicable device.

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

MESSAGES CONTINUED

DISPLAY TYPE SOLUTION

% SpMet* BAR GRAPH

Alarm Condition

Continuously indicates the concentration of Methemoglobin in the following increments: .5, 1, 2, 3, 4, 5, 7.5, 10, 15 and >20%. When an SpMet alarm is violated, the bargraph will flash at the SpMet level being violated along with an audible alarm.

SINGLE BATTERY LEVEL INDICATOR FLASHES (WITH AUDI-

BLE ALARM)

Battery level too low Replace batteries immediately.

No Cable Connected Connect appropriate cable to device.

System Fault

Return for service.

There are several error codes. All error codes require returning the device to an authorized service center for repair. See Section 9, Service and Repair for return procedure.

Defective cable Replace cable

Incompatible cable Connect appropriate cable

Defective sensor Replace sensor

Unrecognized sensor

Connect appropriate sensor

Interference detected

Ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required.

*See Model Summary for applicable device.

alarms / messages

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

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

DEVICE DOES NOT POWER ON

Low battery Check and/or replace the batteries.

BATTERY RUN-TIME IS SIGNIFICANTLY REDUCED

Effective battery life will be reduced when operating the device below 5 degrees Fahrenheit due to alkaline battery technology.

Remove the batteries and allow them to warm up to room temperature, re-install them and check the battery indicator level. If the battery capacity remains low, replace batteries.

CONTINUOUS SPEAKER TONE

Internal Failure

Device requires service. Press the Alarm Silence button to silence the alarm. If alarm continues to sound, power down device and remove Handheld battery if necessary.

BUTTONS DON’T WORK WHEN PRESSED

Internal failure Device requires service.

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

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

SpO2 NUMBER 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 device 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 the device to MAX sensitivity.

Warm the patient or sensor site.

Move sensor to better perfused site.

6-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

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.

SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGS.

Low perfusion or sensor displacement.

Check for error messages. See section 5 System 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 SpO2, 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 COOximetry test.

DIFFICULTY OR NO SpO2/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 linefrequency 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.

PULSE SEARCH MESSAGE

The device is searching for pulse.

If device 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.

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

carboxyhemoglobin values.

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

specifications

Rad-57 Family Specifications

PERFORMANCE

Measurement range

Oxygen Saturation (%SpO2): 1-100%

Carboxyhemoglobin Saturation (%SpCO*) 0 - 99%

Methemoglobin Saturation (%SpMet*) 0 - 99.9%

Pulse Rate (bpm): 25-240 beats per minute

Perfusion Index: 0.02 - 20%

ACCURACY

Saturation

70% to 100%

No Motion

Adults, Pediatrics ±2 digits

Neonate ±3 digits

Motion

Adults, Pediatrics ±3 digits

Neonate ±3 digits

Low Perfusion

Adults, Pediatrics ±2 digits

Neonate ±3 digits

Carboxyhemoglobin Saturation Accuracy (%SpCO*)

1% - 40% ±3 digits

Methemoglobin Saturation Accuracy (%SpMet*)

1% - 15% ±1 digit

Pulse Rate (bpm) during no motion conditions

Adults, Pediatrics, Neonate 25 to 240 ±3 digits

Pulse Rate (bpm) during motion conditions

Adults, Pediatrics, Neonate 25 to 240 ±5 digits

Resolution

Oxygen Saturation (%SpO2)1%

Carboxyhemoglobin saturation (%SpCO*), digital display 1%

Carboxyhemoglobin saturation(%SpCO*), continuous bar display

3, 6, 9, 12, 15, 20, 25, 30, 35, > 40%

Methemoglobin saturation (%SpMet*), digital display .1%

Methemoglobin saturation(%SpMet*), continuous bar display .5, 1-5, 7.5, 10, 15 >20%

Pulse Rate (bpm)

1 bpm

*See Model Summary for applicable device.

7-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

specifications

Interfering Substances

Carboxyhemoglobin and methemoglobin may erroneously increase 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: over 8 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, pulse rate, carboxyhemoglobin and methemoglobin (SpO

range 1-100%, pulse rate range 25-240 bpm, SpCO 5%-40%, SpMet 0.5% - 30%)

Sensor condition, system failure and low battery alarms

High Priority:

571 Hz tone, 5 pulse burst, pulse spacing:

0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s

Low Priority: 500Hz tone, 1 pulse, repeat time: 5s

Volume:

75 dB (max.)

Display/Indicators*

Data display: %SpO2, %SpCO, SpCO bar, pulse rate, %SpMet, SpMet bar, PI, PI bar, alarm status,

alarm silenced status, Low Signal IQ, battery status.

Type: LED

Display update rate 1 second

Response time <20 seconds

*See Model Summary for applicable device.

ACCURACY (CONTINUED)

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

Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow sensors has 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% SpO2 against a laboratory CO-Oximeter and ECG monitor. 1% was added to account for the properties of fetal hemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow sensors has 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% SpO2 against a laboratory CO-Oximeter and ECG monitor. 1% was added to account for the properties of fetal hemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the

population.

Masimo Rainbow SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

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

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.

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.

SpCO accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation

in the range of 0% - 40% SpCO against a laboratory CO-Oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpCO accuracy has not been validated under motion conditions.

SpMet accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation

in the range of 0% - 15% SpMet against a laboratory CO-Oximeter. The variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpMet accuracy has not been validated under motion conditions.

Masimo Rainbow SET technology with LNOP, LNOPv, LNCS and Rainbow sensors has 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.

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

sensors & 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 COMPATIBILITY 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.

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 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 device directly or with a patient cable.

RAINBOW REUSABLE SENSORS

SpO

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

following table.

Sensor

Weight

Saturation

Accuracy

Pulse Rate

Accuracy

Low Perfusion

Accuracy

SpCO

Accuracy

SpMet

Accuracy

Range

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 ADHESIVE SENSORS

(Rainbow adhesive sensors must be used in conjunction with Rainbow patient cables)

SpO2, SpCO, SpMet and pulse rate accuracy for the Rainbow sensors is specified in the following table.

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%

Masimo SpO2 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 device.

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

sensors & patient cables

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 8-3

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 < 10 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

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

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 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

LNCS® REUSABLE SENSORS

(LNCS sensors must be used in conjunction with Red LNC cables)

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNCS DC-I > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNCS DC-IP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

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

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

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

sensors & patient cables

Masimo SpO2 Sensors continued

8-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

LNCS® ADHESIVE SENSORS

(LNCS sensors must be used in conjunction with Red LNC cables)

Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

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

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

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

LNCS Neo-L

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

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

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

LNOPvTM 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 Ne < 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm

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

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 & patient cables

Masimo SpO2 Sensors continued

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 9-1

service / maintenance

Introduction

This chapter covers how to test the operation of the Rad-57, how to properly clean the Rad57 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 device.

CAUTIONS:

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

OXIMETER.

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

■ USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW

INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS.

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

CLEANING COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL.

■ DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER

HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES ATTACK THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT.

Refer to Section 8, Cleaning and Reuse of Masimo Reusable Sensors and Cables for cleaning instructions of the sensor and patient cables.

9-2 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

service / 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 device. The battery compartment is accessed from the back of the device. 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 device. 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 device 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 DEVICE BELOW 5ºF (-15º

C) DUE TO ALKALINE BATTERY TECHNOLOGY

Be sure to follow local regulations in regards to battery disposal.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 9-3

service / maintenance

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 device 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 device.

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.

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 Mode/Enter key or waiting for the normal time-out.

9-4 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

service / maintenance

Service and Repair

REPAIR POLICY

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

■ 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 and Asia Pacific: For Europe: For Other Locations:

Masimo Corporation 40 Parker Irvine, California 92618 Tel.: 949-297-7000 Fax.: 949-297-7001

Masimo Europe Limited 304 RN6, Le Bois des Cotes 2 69760 Limonest, France Tel: +33 (0) 472 17 93 70 FAXL +33 (0) 478 35 78 08

Contact your local Representative

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual 9-5

service / maintenance

Sales & End-user

License Agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE (“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 PACKAGE, 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.

9-6 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Exclusions continued

THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO MASIMO’S PRODUCTS. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MASIMO SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE OF ANY PRODUCTS 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.

End-user

License

1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for this 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 incorporated software/firmware and documentation 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 they 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.

service / maintenance

Restrictions

1. Copy 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 products 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 you are 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

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

PRONTO Cable, Rad-57, 20-pin

www.masimo.com

31740/4517C-0709

Devices and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo.

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

Specifications and Main Features

Frequently Asked Questions

User Manual