Masimo Rad-5, Rad-5v Operator's Manual

signal extraction pulse oximeters

OPERATOR’S MANUAL

TM

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual i

The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper
operation of all Rad-5 and Rad-5v pulse oximeter models. There may be information provided in this
manual that is not relevant for your pulse oximetry system.

General knowledge of pulse oximetry and an understanding of the features and functions of the
Rad-5 and Rad-5v Pulse Oximeter are prerequisites for proper use.

Do not operate the Rad-5 or Rad-5v Pulse Oximeter without completely reading and understand­ing these instructions.

NOTICE

Purchase or possession of this device does not carry any express or implied license to use with
replacement parts which would, alone or in combination with this device, fall within the scope of one
of the relating patents.

CAUTION:

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

For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com

EU Authorized Representative for Masimo Corporation:

MDSS
Burckhardtstr. 1

30163 Hannover, Germany
Tel.: [phone]
Fax.: [phone]

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

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

© 2006 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Rad-5v, PRONTO,
TrendCom, SatShare, Signal IQ, SIQ, APOD, and FastSat are trademarks of Masimo Corporation.

EC REP

The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the pos­sibility of hazards from errors by following sound engineering design processes, Risk Analysis
and Software Validation.

■

Explosion hazard. Do not use the Pulse Oximeter in the presence of flammable anes­thetics or other flammable substance in combination with air, oxygen-enriched environ­ments, or nitrous oxide.

■

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

■

A Pulse Oximeter should be considered an early warning device. As a trend towards
patient hypoxemia is indicated, blood samples should be analyzed by laboratory
instruments to completely understand the patient’s condition.

■

The Pulse Oximeter is to be operated by qualified personnel only.This manual,
accessory directions for use, all precautionary information, and specifications should
be read before use.

■

Electric shock hazard. Do not open the pulse oximeter cover except to replace the
battery of the unit. Only a qualified operator may perform maintenance procedures
specifically described in this manual. Refer servicing to Masimo for repair of this
equipment.

■

As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.

■

Do not place the pulse oximeter or accessories in any position that might cause it to
fall on the patient. Do not lift the pulse oximeter by the patient cable.

■

Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The
level of increase is approximately equal to the amount of carboxyhemoglobin present.
Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings.

■

Severe anemia may cause erroneous SpO2readings.

■

Do not use the pulse oximeter or oximetry sensors during magnetic resonance imag­ing (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter
may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.

■

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

■

Always remove the sensor from the patient and completely disconnect the patient
from the pulse oximeter before bathing the patient.

■

Do not place the pulse oximeter where the controls can be changed by the patient.

■

Do not place the pulse oximeter face against a surface. This will cause the alarm to
be muffled.

■

Do not place the pulse oximeter on electrical equipment that may affect the pulse
oximeter, preventing it from working properly.

■

Do not expose the pulse oximeter to excessive moisture such as direct exposure to
rain. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.

ii Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual iii

■

Do not place containers containing liquids on or near the pulse oximeter. Liquids
spilled on the pulse oximeter may cause it to perform inaccurately or fail.

■

Failure of Operation - If the pulse oximeter fails any part of the setup procedures remove
the pulse oximeter from operation until qualified service personnel have corrected the situa­tion.

■

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

■

The pulse 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 IEC 60601-1-2, 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.

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

SECTION 1 - OVERVIEW

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

Warnings, cautions and notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

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

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

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

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

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

Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

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

Measured vs. Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Masimo SET Signal Extraction Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Masimo SET Parallel Engines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Masimo SET DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

SECTION 2 - SYSTEM DESCRIPTION

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

Rad-5/5v front panel controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Rad-5/5v rear panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

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

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

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

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

Successful SpO

2

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

Numeric Display - SpO

2

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

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

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

Signal IQ and pulsebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Actions To Be Taken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Battery Level Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

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

Normal patient monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Rad-5v front panel control operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Rad-5 front panel control operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Setup menu (Rad-5 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

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

Setup Menu Level 1 – Alarm Limits and Alarm Volume. . . . . . . . . . . . . . . . . . . .4-11

Setup Menu Level 2 – Averaging and Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

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iv Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual v

table of contents

Setup menu Level 3 - Trend Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Setup Menu Level 4 - LED brightness and Factory Defaults . . . . . . . . . . . . . . . . .4-13

Trend Setup and Use (Rad-5 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

Special menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

Standard and Sleep mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

Sleep mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

SECTION 5 - ALARMS AND MESSAGES

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

Alarm limits (Rad-5 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Alarm Silenced Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

Rad-5/5v specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

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

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

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

Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

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

SECTION 8 - SENSORS & PATIENT CABLES

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

Masimo SpO

2

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

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

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

LNOP® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

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

LNOP® Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

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

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

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

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

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

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

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

SECTION 9 - SERVICE AND MAINTENANCE

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

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

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 1-1

1

overview

About this Manual

This manual explains how to set up and use the Rad-5/5v Handheld Pulse Oximeter.
Important safety information relating to general use of the Rad-5/5v Pulse Oximeter appears
before this introduction. Other important safety information is located throughout the manual
where appropriate.

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

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

SECTION 1 OVERVIEW gives a general description of pulse oximetry.

SECTION 2 SYSTEM DESCRIPTION describes the Rad-5/5v Handheld Pulse

Oximeter system and its functions and features.

SECTION 3 SETUP describes how to setup the Rad-5/5v Handheld Pulse

Oximeter for use.

SECTION 4 OPERATION describes the operation of the Rad-5/5v Pulse

Oximetry system.

SECTION 5 ALARMS AND MESSAGES describes the alarm system

messages.

SECTION 6 TROUBLESHOOTING gives troubleshooting information.

SECTION 7 SPECIFICATIONS gives the detailed specifications of the

Rad-5/5v Handheld Pulse Oximeter.

SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and

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

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain,

service and obtain repair for the Rad-5/5v Handheld Pulse
Oximeter.

SECTION 10 ACCESSORIES.

Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Performance verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Service and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

End-user license agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

SECTION 10 - ACCESSORIES

Rad-5 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

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vi Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 1-3

1

overview

Product Description

The Rad-5 family of Handheld Pulse Oximeters are noninvasive, arterial oxygen saturation
and pulse rate monitors. The Rad-5 family features a multicolored LED display that contin­uously displays numeric values for SpO

2

and pulse rate, as well as LED indicator bars for

Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ

TM

).

The Rad-5 family consists of two models:the full-featured Rad-5 and the Rad-5v entry-level
spot checker. Both units are built on the same motion tolerant pulse oximetry technology,
with the Rad-5 adding parameter alarming, three sensitivity settings and adjustable aver­aging times.

Features that apply to the Rad-5 only will be indicated with “(Rad-5)”.

FEATURES AND BENEFITS

These features are common to the Rad-5 family:

■

Clinically proven Masimo SET®technology performance

■

Applicable for use on neonate, pediatric and adult patients

■

Proven for accurate monitoring in motion and low perfusion environments

■

SpO2, pulse rate, alarm, and perfusion index displays

■

Signal I.Q.®for signal identification and quality indication

■

Lightweight, convenient handheld design

■

Long battery life: over 48 hours on 4 “AA” alkaline batteries

■

Audible Alarm for no sensor, sensor-off, interference detected and low battery

The Rad-5 adds these features:

■

Alarms for High/Low saturation and High/Low pulse rate

■

FastSat

®

■

User defineable alarm limit settings

■

Sleep study mode

■

Three sensitivity levels - Max, Normal and APOD

TM

■

Stores up to 72 hours of trending memory

■

Adjustable alarm volume

■

Adjustable averaging 2 to 16 seconds

Warnings, cautions and notes

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

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

Sample of Warning:

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

Sample of Caution:

CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

A

NOTE

is provided when extra general infor mation is applicable.

Sample of Note:

NOTE: This is a sample of a Note.

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

overview

1-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

1

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 1-5

1

overview

Pulse Oximetry

GENERAL DESCRIPTION

Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial
oxygen saturation in blood. The measurement is taken by placing a sensor on a patient,
usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects
to the pulse oximetry instrument with a patient cable. The sensor collects signal data from
the patient and sends it to the instrument. The instrument displays the calculated data in
two ways:1) as a percent value for arterial oxygen saturation (SpO

2

), and 2) as a pulse rate

(PR). The following figure shows the general monitoring setup.

PRINCIPLE OF OPERATION

Pulse oximetry is governed by the following principles:

1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood)
differ in their absorption of red and infrared light (spectrophotometry).

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

The Rad-5/5v Handheld Pulse Oximeter uses a two-wavelength pulsatile system to distin­guish between oxygenated and deoxygenated blood. Signal data is obtained by passing
red (rd) (660 nm wavelength) and infrared (ir) (905 nm wavelength) light through a capil­lary bed (for example a fingertip, a hand, a foot) and measuring changes in light absorp­tion during the pulsatile cycle. This information may be useful to clinicians. The radiant
power of the light is rated at 0.79mW (max.). See figure below. The Rad-5/5v utilizes a sen­sor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a
photodiode (photodetector). The photodetector receives the light, converts it into an elec­tronic signal and sends it to the Rad-5/5v for calculation.

Once the Rad-5/5v receives the signal from the sensor, it utilizes Masimo SET signal
extraction technology for calculation of the patient’s functional oxygen saturation and pulse
rate.

1

2

3

1. Instrument

2. Patient Cable

3. Sensor

2

1

1. Light Emitting Diodes (LEDs)

2. Recessed Photo Detector

INDICATIONS FOR USE

The Rad-5 family of Handheld Pulse Oximeters and accessories are indicated for the con­tinuous (Rad-5 only) or spotcheck, noninvasive monitoring of functional oxygen saturation
of arterial hemoglobin (SpO

2

) and pulse rate (measured by an SpO2sensor). The Rad-5
family of Handheld Pulse Oximeters 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.

overview

1-4 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

1

1-7

1

overview

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

MASIMO SET DST

Digitized,
Filtered &

Normalized

R/IR

R/IR

(Conventional

Pulse Oximetry)

Adaptive
Filter with

DST

TM

SST

TM

Proprietary
Algorithm 5

Saturation

Post

Processor

Confidence

Based

Arbitrator

MEAS

CONF

MEAS

CONF

MEAS

CONF

MEAS

CONF

MEAS

CONF

Proprietary

Algorithm 4

MASIMO SET PARALLEL ENGINES

1-6 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

1

overview

FUNCTIONAL VS. FRACTIONAL SATURATION

The Rad-5/5v is calibrated to measure and display functional saturation:the amount of oxy­genated hemoglobin expressed as a percentage of the hemoglobin that can transport oxy­gen. The Rad-5/5v does not measure fractional saturation: oxygenated hemoglobin
expressed as a percentage of all measured hemoglobin, including measured dysfunction­al hemoglobin such as carboxyhemoglobin or methemoglobin. To conver t fractional satu­ration to functional saturation, the fractional saturation measurements must be conver ted
according to:

Functional saturation =

Fractional saturation

x 100

100 - (% carboxyhemoglobin + % methemoglobin)

MEASURED VS. CALCULATED SATURATION

Oxygen saturation measurements obtained from a pulse oximeter are commonly com­pared to saturations calculated from the partial pressure of oxygen (PO

2

) obtained from an
arterial blood gas sample. When comparing the two measurements and interpreting val­ues, caution should be used, as the calculated value obtained from the blood gas sample
may differ from the SpO

2

measurement of the pulse oximeter. Different results are usual­ly obtained from the blood gas sample if the calculated saturation is not appropriately cor­rected for the effects of variables that shift the relationship between PO

2

and saturation,

such as: pH, temperature, the partial pressure of carbon dioxide (PCO

2

), 2,3-DPG, and
fetal hemoglobin. Also, as blood gas samples are usually taken over a period of 20 sec­onds (the time it takes to draw blood) a meaningful comparison can only be achieved if the
core oxygen saturation of the patient is stable and not changing over the period of time that
the blood gas sample is taken.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY

Masimo Signal Extraction Technology’s signal processing differs from conventional pulse
oximeters. Conventional pulse oximeters assume that arterial blood is the only blood mov­ing (pulsating) in the measurement site. During patient motion, however, the non-arterial
blood also moves, 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

TM

(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.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 2-1

2

system description

Introduction

The Rad-5 family of Handheld Pulse Oximeters are full featured pulse oximeters 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-5/5v are powered by 4 “AA”alkaline batteries, which provide over 48 hours of bat­tery life.

■

Rad-5 family offers full Masimo SET technology in a small, handheld device

■

Rad-5 family supports the full line of Masimo sensors and patient cables (see
Section 8,

sensors and patient cables

).

■

Rad-5 family supports standardization of sensors and pulse oximetry technology
throughout the hospital

■

Rad-5v provides essential pulse oximetry features

■

Rad-5 includes all the features of the Rad-5v, plus

■

High/Low saturation alarms

■

High/Low pulse rate alarms

■

User defineable alarm limit settings

■

Sleep study mode

■

Stores up to 72 hours of trending memory

■

Adjustable averaging time

■

Three sensitivity levels - Max, Normal and APOD

■

FastSat

A LNOP DCSC Spot Check Sensor or Masimo Patient Cable and Masimo sensor attach
to the connector on the top of the Rad-5/5v unit. The Rad-5/5v can be used either for spot
checks or continuous (Rad-5) SpO2 monitoring.

system description

2-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 2-3

2

2

system description

CONTROL / INDICATOR DESCRIPTION

1

Patient Cable
Connector

Connects to LNOP DCSC Spot Check sensor or Masimo
Patient Cable

2

FastSat Indicator

Illuminates when the FastSat mode has been enabled.

FastSat enables rapid tracking of arterial oxygen saturation
changes

3

Saturation Display

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

4

Signal IQ /
Pulse Bar

The Signal IQ provides an indication of the quality of the
acquired signal as well as the timing of the pulse. A green
vertical LED bar rises and falls with the pulse, where the
height of the bar indicates the quality of the signal.

5

Pulse Rate Display

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

6

Mode / Enter Button

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

7

Next Button

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

CONTROL / INDICATOR DESCRIPTION

8

Power On / Off

Used to turn the unit on and off.

9

Battery Level
Indicator

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

10

Visual Alarm
Indicator

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

11

Perfusion Index

The Perfusion Index provides an indication of the percentage of
pulsatile signal to non pulsatile signal. The bar is highest when
the quality of the perfused site is best.

12

MAX Sensitivity
Indicator

Illuminates when the MAX Sensitivity mode has been enabled.

Note:

When using the Maximum Sensitivity setting, the SENSOR

OFF detection performance may be compromised.

13

Alarm Silenced
Indicator

Flashes to indicate the alarm is temporarily silenced (by pushing
the Alarm Silence Button once) or is illuminated solid to indicate
the alarms have been permanently muted (by pushing the Alarm
Silence Button twice) .

14

Alarm Silence
Button

Push once to temporarily silence the alarm for 120 seconds.
Push a second time to permanently mute (suspend) the alarm. A
third push will return the unit to standard alarm monitoring.

15

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.

17

Speaker

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

18

Pulse Tone
Volume

Provides control of the pulse tone volume. Cycles through three
volume levels, and mute. At the loudest level, pressing the Pulse
Tone Volume button will return the volume to mute.

19

Display Brightness

Provides control of the front panel indicator brightness. Cycles
through four brightness levels. At the brightest level, pressing the
Display Brightness button will return the display to the lowest
brightness setting.

1

MAX

2

4

5

8

9

10

11

13

14

15

16

3

7

6

12

17

3

4

5

8

9

1

10

11

13

14

18

19

17

Rad-5

Rad-5v

Rad-5/5v front panel controls

16

Introduction

Before the Rad-5/5v Handheld Pulse Oximeter can be used in a clinical setting, it needs to
be inspected, properly setup and the batteries need to be installed.

Unpacking and inspection

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

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

Service and Repair

.

Preparation for monitoring

The following sections of the manual describe the preparation, set-up and initial installation
of the Rad-5/5v Handheld Pulse Oximeter.

POWER REQUIREMENTS

The Rad-5 and Rad-5v are powered by 4 “AA”alkaline batteries. Do not use any other type
of batteries or power source to run the device. The batter y 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 batter y cover by sliding it back up from the
bottom of the device until the rectangular locking button snaps back into position.

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.

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 DEVICE.

WARNING: REMOVE BATTERIES IF UNIT IS NOT TO BE USED FOR SOME
TIME.

system description

2-4 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 3-1

2

3

setup

CONTROL / INDICATOR DESCRIPTION

1

Serial Number Label Located inside battery compartment and on back of device

2

Agency Approvals Label

3

Battery Cover

4

Battery Cover Release

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

Rad-5/5v rear panel

SYMBOL DESCRIPTION

Caution, consult accompanying documents

BF applied part complying with IEC 60601-1.

WEEE Compliant

Symbols

2

3

1

X X X X X X

FOR PLACEMENT ONLY

2XXX

4

X X X X X X

FOR PLACEMENT ONLY

2XXX

AA

AA

AA

AA

1

X X X X X X

FOR PLACEMENT ONLY

2XXX

1

Masimo Corporation
Irvine, CA 92618
USA

Rad-5
80 FK
UL 60601-1

Rx Only

Masimo Corporation
Irvine, CA 92618
USA

Rad-5v
80 FK
UL 60601-1

Rx Only

Not for Continuous Monitoring

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-1

4

operation

Introduction

To operate the Rad-5 or Rad-5v Pulse Oximeters effectively, the operator must:

■

Know how the oximeter derives its readings (see Section 1,

Pulse 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 an LNOP DCSC Spot Check Sensor or patient cable to the Patient Cable

connector of the oximeter. Make sure it is a firm connection and the cable is not
twisted, sliced or frayed.

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 photode­tector are properly aligned. If using a reusable sensor, make sure it opens and
closes smoothly. Remove any substances that may interfere with the transmission
of light between the sensor’s light source and photodetector.

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

6. Connect the sensor to the patient cable with the logos lining up; make sure it is a

firm connection (does not apply for LNOP DCSC Spot Check Sensor).

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

8. Verify all front-panel indicators momentarily illuminate and a one-second tone is

heard.

9. Verify the display shows mode, SpO

2

Low Alarm Limit, SpO2 High Alarm Limit,
Pulse Rate Low Alarm Limit, Pulse Rate High Alarm Limit, Sensitivity and
Averaging Time.

10. 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

)

11. On the display, verify the readings for SpO

2

and pulse rate.

NOTE: “- - - “ will flash on the numeric display until the SpO2and pulse rate read-
ings have stabilized (approximately 10 seconds).

12. Rad-5 only:
Verify that the patient alarms are functional by setting the high and low SpO

2

and

Monitor setup

INITIAL SETUP

1. Inspect the oximeter case for damage.

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

3. Verify unit powers-up immediately after installing batteries.

4. Turn unit off.

5. Turn the unit on, verify all indicators illuminate and speaker sounds a brief tone.

No other setup is required. Refer to Section 4,

General Setup and Use

for additional steps

to verify proper functioning of the unit.

setup

3-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

3

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-3

4

operation

DEFAULT SETTINGS

The Rad-5/5v oximeters store two types of default values: those that the device automati­cally reverts to after a power cycle, and those that can be changed by the user and will be
remembered after a power cycle.

The following table outlines the default values that the Rad-5 and Rad-5v revert to after a
power cycle:

The following table outlines the default values that the Rad-5 reverts to after a power cycle:

*

Defaults to APOD and Normal only. High Sensitivity will default to normal.

OPTION DEFAULT SETTING

SpO2high alarm limit

Set to Off

SpO2low alarm limit

Set to 90%

Pulse rate high alarm limit Set to 140 BPM

Pulse rate low alarm limit Set to 50 BPM

Averaging Time Set to pre-power down setting

FastSat Set to pre-power down setting

Sensitivity* Set to pre-power down setting

Display brightness Set to pre-power down setting

Pulse tone volume Set to pre-power down setting

Alarm Silence Set to all audible alarms active

Alarm Volume Set to pre-power down setting

Trending on/off

Set to pre-power down setting

(Strongly recommend turning trending off
prior to turning unit off)

Sleep Study Mode Set to pre-power down setting

OPTION DEFAULT SETTING

Display brightness Set to pre-power down setting

Pulse tone volume Set to pre-power down setting

pulse rate alarm limits beyond the patient readings.

■

An alarm tone sounds.

■

The violated alarm limit and reading flash on the display.

11. 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-5/5v was
actively monitoring a patient when the sensor was disconnected.

12. Rad-5 only:
Verify parameter-violation alarm silence operation.

■

Create an alarm condition by lowering the SpO2or pulse rate high alarm lim­its beyond the patient readings.

■

Press the Alarm Silence button.

■

The alarm tone ceases for 120 seconds.

13. To begin patient monitoring:

■

Adjust the alarm limits (Rad-5 only).

■

Adjust the alarm volume (Rad-5 only).

■

Adjust the pulse beep volume.

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

Successful SpO2Monitoring

.

16. Monitor the patient.

17. After monitoring is complete, remove the sensor from the patient and store or dis-

pose of the sensor according to governing rules. See the Directions for Use of the
sensor. If trending is enabled, turn off.

18. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off.

Note: Turn the oximeter off between patients so that it can re-calibrate in order to interpret

new physiological data and to conserve battery life.

operation

4-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-5

4

operation

NUMERIC DISPLAY - PULSE RATE

The Pulse Rate displayed on the Rad-5/5v may differ slightly from the heart rate displayed
on ECG monitors due to differences in averaging times. There may also be a discrepancy
between cardiac electrical activity and peripheral arterial pulsation. Significant differences
may indicate a problem with the signal quality due to physiological changes in the patient
or one of the instruments or application of the sensor or patient cable. The pulsations from
intra-aortic balloon support can be additive to the pulse rate displayed on the pulse oxime­ter .

Successful SpO2monitoring

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

■

Place the sensor on a site that is not too thick, has sufficient perfusion and provides
proper alignment of the LED’s and photodetector.

■

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

■

Do not constrict the monitoring site when securing a sensor with tape.

■

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

■

Read the sensor Directions for Use for proper sensor application.

NUMERIC DISPLAY - SpO

2

Stability of the SpO2readings 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

2

and PR.

MASIMO SENSORS

Before use, carefully read the LNOP sensor Directions for Use.

Use only Masimo oximetry sensors for SpO

2

measurements.

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

CAUTIONS:

■

DO NOT USE DAMAGED LNOP SENSORS. DO NOT USE AN LNOP SENSOR
WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS. DO NOT
IMMERSE THE SENSOR IN WATER, SOLVENTS, OR CLEANING SOLUTIONS
(THE SENSORS AND CONNECTORS ARE NOT WATERPROOF). DO NOT
STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE.
SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR
REUSABLE MASIMO LNOP SENSORS.

■

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT
CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT
CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY
IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE.

operation

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-7

4

operation

LOW PERFUSION

The Rad-5/5v indicates perfusion on a 10-bar LED indicator. The lower two segments of
the bar will turn red when the amplitude of the arterial pulsations is very low (low perfu­sion).

It has been suggested that at extremely low perfusion levels, pulse oximeters can meas­ure peripheral saturation, which may differ from central arterial saturation

1

. This “localized
hypoxemia” may result from the metabolic demands of other tissues extracting oxygen
proximal to the monitoring site under conditions of sustained peripheral hypoperfusion.
(This may occur even with a pulse rate that correlates with the ECG heart rate.)

CAUTION: IF THE LOW PERFUSION 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.

1

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

ACTIONS TO BE TAKEN

If the SpO

2

readings show significant differences, do the following:

■

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

■

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

■

Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream
(10-30% methyl salicylate and 2-10% menthol) for 20-30 seconds. Strong
vasodilator creams, such as nitroglycerin paste, are not recommended.

■

If possible, remove electrical noise sources such as electrosurgical units or
other electrical/electronic equipment.

■

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

■

If possible, ensure that the sensor is placed in a location with low ambient
light. Although the Rad-5/5v Handheld Pulse Oximeters with integrated
Masimo SET technology have significant immunity to ambient light, excessive
ambient light may cause readings to be incorrect.

CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE
PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE
OXIMETER FOR PROPER FUNCTIONING.

SIGNAL IQ AND PULSEBAR

The Rad-5/5v display provides a visual indicator of the plethysmogram signal quality and
an alert when the displayed SpO

2

values are not based on adequate signal quality. The
signal quality indicator displayed on the Rad-5/5v is called the Signal IQ. The Signal IQ
can be used to identify the occurrence of a patient’s pulse and the associated signal qual­ity of the measurement.

The Signal IQ is shown as a “bouncing bar” indicator, where the peak of the bar coincides
with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured
by artifact, the Rad-5/5v locates the arterial pulsation. The pulse tone (when enabled) coin­cides with the peak of the Signal IQ bar. As saturation increases or decreases, the pulse
tone will ascend or descend accordingly, for each 1%.

The height of the Signal IQ bar indicates the quality of the measured signal. A high verti­cal bar indicates that the SpO

2

measurement is based on a good quality signal. A small

vertical bar indicates that the SpO

2

measurement is based on data with low signal quality.

When the signal quality is very low the accuracy of the SpO

2

measurement may be com­promised. A “Low Signal IQ” is indicated by a bar height of two bars or less and the bars
turn red. When this occurs, 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-5/5v to maintain accurate readings. Also, misalign­ment of the sensor’s emitter and detector can result in smaller signals.

■

Determine if an extreme change in the patient’s physiology and blood flow at the
monitoring site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion,
sampling of an arterial blood specimen from the hand containing the pulse oximetry
sensor, severe hypotension, peripheral vasoconstriction in response to hypother­mia, medications, or a spell of Raynaud’s syndrome.)

■

With neonates or infants, check that the peripheral blood flow to the sensor site is
not interrupted. For example, as may occur while lifting or crossing their legs, dur­ing a diaper change.

After performing the above, if the “Low Signal IQ” indication occurs frequently or continu­ously, obtaining an ar terial blood specimen for CO-oximetry analysis may be considered to
verify the oxygen saturation value.

operation

4-6 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-9

4

operation

Normal patient monitoring

During normal operation, the Rad-5/5v Display shows oxygen saturation (as % Sp02) on
the upper number and Pulse Rate (in beats per minute) on the lower number.

The following sections describe the function of the Rad-5/5v front panel controls during
normal patient monitoring.

RAD-5v FRONT PANEL CONTROL OPERATION

BUTTON FUNCTION

Power on/off. Press to turn Rad-5v on. Press-and-hold for 2 seconds to turn
Rad-5v off.

Front panel indicator brightness. Pressing this button will cycle the brightness
through the full range, then back to the lowest setting to begin the cycle again.

Alarm Silence. Pressing this button will acknowledge and permanently silence a
‘sensor-off’ and ‘no-sensor’ audible alarm (until power is cycled or patient moni­toring begins). It will also suspend a low battery audible alarm if the Rad-5v is
not monitoring a patient.

If a low battery alarm occurs during patient monitoring, pressing the Alarm
Silence button will silence the audible alarm for 120 seconds.

Pulse Tone Volume. Pressing this button will cycle the pulse tone volume through
the full range, then back to the ‘silence’ setting to begin the cycle again.

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.

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

A visual low battery indicator will continue to blink while audible alarms are silenced.

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

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 DEVICE.

WARNING: FAILURE TO REPLACE BATTERIES PROMPLTY AFTER A LOW
BATTERY ALARM MAY RESULT IN THE OXIMETER SHUTTING DOWN LEAV­ING THE PATIENT IN AN UN-MONITORED CONDITION.

INDICATION BATTERY CAPACITY

4 LED’S 100% to 75%

3 LED’S 75% to 50%

2 LED’S 50% to 25%

1 LED 25% to 10%

1 FLASHING LED
WITH AUDIBLE
ALARM

10% to 0%

operation

4-8 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

RAD-5 FRONT PANEL CONTROL OPERATION

Setup menu (Rad-5 only)

This section gives an overview of the Rad-5 menu selections available. These options do
not apply to the Rad-5v. To navigate through the menus, use the

Mode/Enter, Next, Up

and

Down

keys located on the front panel of the oximeter, below the LED display. The follow­ing sub-sections describe each menu item in more detail. The oximeter has options that
allow user configuration to suit specific needs.

MENU NAVIGATION

The Rad-5 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.

BUTTON FUNCTION

Power on/off. Press to turn Rad-5 on. Press-and-hold for 2 seconds to turn
Rad-5 off.

Enters the Rad-5 setup/menu system. See Section 4,

Setup menu

.

No function during normal patient monitoring.

Alarm Silence. Pressing this button one time will temporarily silence a satura­tion or pulse rate high/low limit violation for 120 seconds. A second press will
permanently silence all audible alarms.

Pressing this button will acknowledge and permanently silence a ‘sensor-off’
and ‘no-sensor’ audible alarm. It will also permanently silence a low battery
audible alarm if the Rad-5 is not monitoring a patient.

If a low battery alarm occurs duing patient monitoring, pressing the Alarm
Silence button will silence the audible alarm for 120 seconds.

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.

operation

4-10 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-11

4

operation

SETUP MENU LEVEL 1 – ALARM LIMITS AND ALARM VOLUME.

SETUP MENU LEVEL 2 – AVERAGING AND SENSITIVITY

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

1

Defaults to APOD and Normal only. High sensitivity will default to normal.

2

FastSat is automatically enabled in 2 and 4 second averaging.

SETTNG

2X

Averaging.The signal averaging time
of this device can be set to:
2*, 4*, 8, 10, 12, 14 or 16 seconds

Use Upor

Down

Arrow Keys to

adjust parameter to desired setting.

Note: The parameter is set/select­ed when the Mode Enter and Next
are pressed.

Sensitivity 1.

Hi = Maximum
Nor = Normal
APO = APOD

FastSat

2

On, Off

SETTNG

Alarm Volume

Use Upor

Down

Arrow Keys to

adjust parameter to desired setting.

Note: The parameter is set/selected
when the Mode Enter and Next are
pressed.

SpO2High Alarm Limit

SpO2Low Alarm Limit

Pulse Rate High Alarm Limit

Pulse Rate Low Alarm Limit

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-13

4

operation

SETUP MENU LEVEL 4 - LED BRIGHTNESS AND FACTORY DEFAULTS

Push the Mode/Enter button again to enter menu level 4.

Pressing a fifth time returns the Rad-5 to patient monitoring in the Saturation/Pulse
Rate Mode. Additionally, the Rad-5 will automatically return to patient monitoring display
from any menu level/setting after 10 seconds with no key presses.

SETTNG

4X

LED Display Brightness (4 levels)

Note: All LED indicators are illumi­nated while adjusting this setting.

Use Upor

Down

Arrow Keys to

adjust parameter to desired setting.

Restore Factory Defaults

Yes/No

Save User Identified Default Settings
(Password: next button, up arrow,

down arrow, next button)

SETUP MENU LEVEL 3 - TREND SETTINGS

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

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”.

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

Note: Press and hold for rapid scrolling:

■

SAT alarm keys up / down will scroll numbers.

■

PR alarm keys up / down will scroll numbers.

Note: The date and time must be set before trending will be enabled. The Rad-5 will
automatically ‘time out’ of the setup menu after 10 seconds with no key presses. If the
Rad-5 should time-out fo 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-

5. Turn trending off prior to turning unit off and storing,

SETTNG

3X

Trend ON / OFF

Use Upkey to turn trend ON.

Use

Down

key to turn trend OFF

Set Year

Use Upor

Down

Arrow Keys to

adjust parameter to desired setting.

Set Month

Set Day

Set Hour

Set Minute

operation

4-12 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 4-15

4

Trend Setup and Use (Rad-5 only)

INTRODUCTION

The Rad-5 can store 72 hours of SpO

2

and Pulse Rate 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 unit is shut off or
when the batteries are replaced.

A special serial cable (see Section 10,

Accessories

) is required to connect the sensor con­nector of the Rad-5 to the PC. 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.

TRENDCOM UTILITY INSTALLATION

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

TRENDCOM UTILITY OPERATION

1. Disconnect patient sensor and/or cable from the Rad-5.

2. Connect the mini-D end of the PRONTO serial cable to the Rad-5 patient cable
connector (see Section 2,

Rad-5 front panel controls

) and connect the DB-9 end to

a COM port on the PC.

3. Turn the Rad-5 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-5 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-5 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-5
from the PRONTO serial cable.

9. Turn the Rad-5 off to exit the trend download mode.

Note: USB to serial port adapters are not suppor ted for trend transfer.

Note: Enabling trend (setting Trend to “ON”) will erase all trend information in the Rad-5.

operation

4-14 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

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-5 off or replacing the batteies will not erase the trend data.

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

TREND DATA FORMAT

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

SAMPLE TREND OUTPUT

07/21/04 09:56:08 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET
07/21/04 09:56:10 SpO2=000 PR=000 PI=00.00 EXC=828:Search,OffPat,SET
07/21/04 09:56:12 SpO2=097 PR=069 PI=04.69 EXC=800:SET
07/21/04 09:56:14 SpO2=096 PR=074 PI=02.28 EXC=C00:LowSigIQ,SET
07/21/04 09:56:16 SpO2=098 PR=078 PI=03.64 EXC=800:SET
07/21/04 09:56:18 SpO2=000 PR=000 PI=00.00 EXC=800:SET
07/21/04 09:56:20 SpO2=000 PR=000 PI=00.00 EXC=820:OffPat,SET
07/21/04 09:56:22 SpO2=096 PR=078 PI=02.68 EXC=800:SET

PARAMETER SPECIFICATION

Date MM\DD\YY

Time HH:MM:SS

SpO2 001 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 is full SET

mode. It requires a SET sensor and needs to acquire some clean
data for this flag to be set

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 5-1

5

alarms and messages

Alarm Indication

An alarm condition is indicated by an audible alarm tone and visual alarm indicator. An Out­of-limit parameter will flash on the Rad-5 only. “SEn OFF” and “nO SEn” will only generate
an alarm condition after a pulse has been found.

Alarm limits (Rad-5 only)

An audible alarm and a flashing alarm status indicator will occur when an alarm limit is met
or exceeded for greater than five seconds. 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 Suspend Mode.

SETTING RANGE

SpO2High Limit

The SpO2high alarm limit can be set anywhere between 2% and
100%, with a 1% step size. In the “----” (off) setting, the SpO2High
Limit alarm is disabled.

SpO2Low Limit

The SpO2 low alarm limit can be set anywhere between 1% and
100%, with a 1% step size.

Note: The low alarm limit must always be set below the high alarm setting.
Attempting to set the high alarm limit below the low alarm limit, the low alarm
limit will automatically adjust the low limit to the next setting below the newly
entered high alarm limit setting.

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 set below the high alarm setting.
Attempting to set the high alarm limit below the low alarm limit, the low alarm
limit will automatically adjust the low limit to the next setting below the newly
entered high alarm limit setting.

WARNING: TO ENSURE THAT ALARM LIMITS ARE APPROPRIATE FOR THE
PATIENT BEING MONITORED, CHECK THE LIMITS EACH TIME THE PULSE
OXIMETER IS USED.

4-16 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

4

Special menu

This section gives an overview of the Rad-5 special menu selections available. To navigate
through the menus, use the

Mode/Enter, Next, Up

and

Down

keys located on the front
panel of the oximeter. The following sub-sections describe each menu item in more detail.
The oximeter has options that allow user configuration to suit specific needs.These selec­tions apply only to the Rad-5

STANDARD AND SLEEP MODE

Turn instrument on, then push and hold the Mode/Enter and Next buttons simultaneously
for 3 seconds to enter the special menu level.

SLEEP MODE OPERATION

The Rad-5 can be placed into the Sleep Mode to allow the unit to capture normal and
abnormal data without the triggering alarms. This mode will blank out the unit display with
the exception of the Battery Level Indicator and the Alarm Silenced Indicator and disable
the alarms even after a power cycle.The keypad will be locked except for the power but­ton. However, any single key press will bring the display back for 10 seconds. Upon power
up, the SLP mode will be displayed along with a 10 second display of parameters. The
Mode Enter and Next key held simultaneously for 3 seconds (select next (STD), Mode
Enter) will put it back into the special menu to exit.

CAUTION: ALARMS ARE DISABLED IN THIS MODE

BUTTONS SETTINGS

+

Simultaneous
for 3 seconds

Standard Mode (STD)

Use Upor

Down

Arrow
Keys to adjust
parameter to
desired setting.

Note: The
parameter is
set/selected
when Mode
Enter or Next
are pressed.

Sleep Mode
(SLP)

LED Display Brightness
(4 levels) Note: Only
availabile Indicators are
illuminated while adjust­ing setting.

5-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 5-3

5

alarms and messages

begins.

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

MESSAGES

The Rad-5/5v will indicate other data or system errors.

Message conditions for the Rad-5 follow:

DISPLAY TYPE SOLUTION

SpO2NUMBER
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.

LEDS FLASH
HORIZONTAL BARS

Pulse Search

Wait for found pulse. (This Search should
occur whenever a sensor is first applied to
a patient).

PULSE BAR TURNS
RED (Bottom two

LEDs only.)

Low Signal IQ

1. Rule out occlusion of blood flow.

2. Verify placement of sensor.

PERFUSION BAR
TURNS RED (Bottom

two LEDs only.)

Low Perfusion

1. Rule out occlusion of blood flow.

2. Attempt to warm patient.

3. Move sensor to better perfused site.

Note: Masimo recommends using an
adhesive sensor whenever low perfusion
is expected or evident.

SINGLE BATTERY
LEVEL INDICATOR
FLASHES (WITH

AUDIBLE ALARM)

Battery level too low Replace batteries immediately.

The following table shows the potential result of failure to respond to the cause of the alarm
condition:

ALARM SILENCE

Audible alarms may be suspended, while visual alarms may not, with the exception of
Sleep Mode, there are three audible alarm suspension settings, all controlled by the Alarm
Suspend Button. Repeated pressing the Alarm Suspend button will cycle though all three
alarm suspend options.

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

Push Once – Alarm is suspended for 120 seconds and Alarm Suspended Indicator flash­es.

Push Twice - Audible alarm is permanently suspended and Alarm Suspended Indicator is
on solid.

Push 3rd time - Return to Audible Alarm Active.

ALARM SILENCED INDICATOR

The Alarm Silenced Indicator provides visual feedback when illuminated, the Rad-5 audi­ble alarms are muted.

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 Alar m Silence Button a second time (while the
Alarm Silenced Indicator is still flashing) will permanently silence the audible alarm, and
the Alarm Silenced Indicator will remain illuminated until the power is cycled or the Alarm
Silence Button is pressed one more time.

While not monitoring a patient, acknowledging an alarm condition by pressing the Alarm
Silence Button (one or more times) will perminantly silence the alarm tone, and the Alarm
Silenced Indicator will remain illuminated until the power is cycled or patient monitoring

alarms and messages

5

PRIORITY

NEED OF

RESPONSE

RESULT OF

FAILURE

DESCRIPTION

High

Immediate

Death or irre­versable injury/
Reversable injury

Having the potential for the event to develop
within a period of time not usually sufficient
for manual corrective action.

Prompt

Death or irre­versable injury

Having the potential for the event to develop
within a period of time usually sufficient for
manual corrective action.

Low

Delayed

Reversable injury/
Minor injury or dis­comfort

Having the potential for the event to develop
within an unspecified time greater than that
given under “Prompt”.

Prompt

Minor injury or dis­comfort

Having the potential for the event to develop
within a period of time usually sufficient for
manual corrective action.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 6-1

6

troubleshooting

Troubleshooting

The following chart describes what to do if the Rad-5/5v system does not operate prop­erly or fails.

PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION

UNIT DOES NOT
POWER ON

Low battery

Check / replace battery

Verify that the trending feature is off, as it
may deplete battery life at a faster rate than
normal.

CONTINUOUS
SPEAKER TONE

Internal Failure

Unit requires service. Press the Alarm
Silence button. If alar m continues to sound,
power down unit and remove batteries.

NO SPEAKER
TONE

Pulse tone set to “mute”

Alarm Suspend Enabled

Press Up Arrow (Rad-5) or Alarm Volume
Adjust (Rad-5v).

Inspect Alarm Suspend Indicator. See
Section 4,

Alarm Suspend

. Press Alarm
Suspend button until Alarm Suspend
Indicator is no longer illuminated or flashing.

BUTTONS DON’T
WORK WHEN
PRESSED

Internal Failure Return for service.

Message conditions for the Rad-5 follow:

DISPLAY TYPE SOLUTION

System Fault

Return for service

There are several error codes, all error
codes require return of the unit to an
authorized service center for repair. See
Section 9,

Service and Repair.

Defective sensor Replace sensor

Unrecognized sensor Connect appropriate cable

Interference detected

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

alarms and messages

5-4 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

5

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 7-1

7

specifications

Rad-5/5v specifications

PERFORMANCE

measurement range

SpO2: 1-100%
Pulse Rate: 25-240 beats per minute (bpm)
Perfusion: 0.02% - 20%

ACCURACY

Saturation 70% to 100%

No Motion

1

Adults, Pediatrics

±

2 digits

Neonate

±

3 digits

Motion

Adults2, Pediatrics

2

±

3 digits

Neonate

±

3 digits

Low Perfusion

4

Adults, Pediatrics

±

2 digits

Neonate

±

3 digits

Pulse Rate Accuracy
Pulse rate: 25-240 bpm

No Motion

1

Adults, Pediatrics, Neonate

±

3 digits

Motion

2

Adults, Pediatrics, Neonate

±

5 digits

Low Perfusion

3

Adults, Pediatrics, Neonate

±

3 digits

Resolution

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

ELECTRICAL

Batteries

Type: 4 “AA” Alkaline

5

Capacity: over 48 hours

4

ENVIRONMENTAL

Operating Temperature: 41°F to 104°F (5°C to 40°C)
Storage Temperature: -40°F to 158°F (-40°C to +70°C)

5

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)

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 8-1

8

sensors & patient cables

Introduction

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

Masimo SpO2sensors

Before use, carefully read the sensor Directions for Use.

Use only Masimo oximetry sensors for SpO

2

measurements. Other oxygen transducers

or sensors may cause improper Rad-5/5v Handheld Pulse Oximeter performance.

Tissue damage can be caused by incorrect application or use of a Masimo 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. DO NOT USE A SENSOR WITH EXPOSED
OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN
WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CON­NECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION,
STEAM, OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE
DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS.

■

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT
CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT
CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRA­DIATION, STEAM, OR ETHYLENE OXIDE.

■

ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MON­ITORS. VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND SENSOR
BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT.

SELECTING A MASIMO SET SENSOR

When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the
available sensor sites, and the duration of monitoring. For more information refer to the
following table or contact your Sales Representative. Use only Masimo SET sensors and
sensor cables. Select an appropriate sensor, apply it as directed, and observe all warn­ings and cautions presented in the directions for use accompanying the sensor.

High ambient light sources such as surgical lights (especially those with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
can interfere with the performance of an SpO

2

sensor.To prevent interference from ambi-

ent 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.

PHYSICAL CHARACTERISTICS

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

Weight: 13oz. (0.32 kg)

Rad-5 Modes

Rad-5 Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds

6

Rad-5 Sensitivity: Normal, Maximum and APOD
Rad-5v Averaging mode: 8 seconds
Rad-5v Sensitivity: Normal

Alarms

Sensor condition, system failure and low battery alarms
Rad-5 only: Audible and visual alarms for high low saturation and pulse rate

(SpO2range 1-100%, pulse rate range 25-240 bpm)

High Priority: 799 Hz tone, 5 pulse burst, pulse spacing: 0.250s,

0.250s, 0.500s, 0.250s, repeat time:10s
Low Priority: 432 Hz tone, 3 pulses, repeat time: 5s
Alarm Volume: High Priority: 75 dB (max), Low Priority: 75 dB (max)

Display/Indicators

Data display: %SpO2, pulse rate, alarm status, alarm silenced status,

Signal IQ / pleth bar, perfusion index bar, battery status
Rad-5 only: MAX, FastSat
Type: LED

Compliance

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

Type of Protection: Internally powered (on battery power)
Degree of Protection-Patient Cable: Type BF-Applied Part
Rad-5 Mode of Operation: Continuous
Rad-5v Mode of Operation: Not Continuous (Spot Check)

1 Masimo SET technology with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult

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

2

against a laboratory co-oximeter and ECG monitor. This varia-

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

2 Masimo SET technology with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers

in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion
between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

3 Masimo 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.

4 This represents approximate run time at lowest indicator brightness and pulse tone turned off using new, fully charged batteries.

Ensure trending is off to maximize battery life.

5 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.

6 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.

specifications

7-2 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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8

sensors & patient cables

LNOP®SPECIALTY SENSORS

(LNOP sensors must be used in conjunction with PC cables)

LNCSTMREUSABLE SENSORS

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

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

LNCSTMADHESIVE SENSORS

(LNCS sensors must be used in conjunction with 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

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

Weight Saturation Accuracy Pulse Rate Accuracy

Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOP Hi Fi
Inf/Ped

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

10-30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

LNOP Hi Fi
Neo/Adult

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

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

SENSOR APPLICATION SITE

Unless indicated otherwise in the directions for use, reposition reusable sensors at least
every 4 hours and adhesive sensors at least every 8 hours.

LNOP

®

REUSABLE SENSORS

(LNOP sensors must be used in conjunction with PC cables)

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 PC cables)

Weight Saturation Accuracy Pulse Rate Accuracy

Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

LNOP Adt > 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 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

Weight Saturation Accuracy Pulse Rate Accuracy

Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

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

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

LNOP Y-I

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

> 3 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 DCSC > 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

sensors & patient cables

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 8-5

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sensors & patient cables

Masimo SET patient cables

Reusable patient cables of various lengths are available. Only use appropriate Masimo
oximetry patient cables for SpO2measurements. Other patient cables may cause improp-

er Rad-5/5v handheld pulse oximeter performance.

CLEANING AND REUSE OF MASIMO SET PATIENT CABLES

Patient cables can be cleaned per the following procedure:

■

Remove the cable from the sensor.

■

Disconnect the cable from the monitor.

■

Wipe clean with a 70% isopropyl alcohol pad.

■

Allow the cable to dry before returning it to operation.

CAUTIONS:

■

CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF
PATIENT ENTANGLEMENT OR STRANGULATION.

■

DO NOT SOAK OR IMMERSE PATIENT CABLES IN ANY LIQUID SOLUTION. DO
NOT STERILIZE PATIENT CABLES BY IRRADIATION, STEAM, OR ETHYLENE
OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE
FOR REUSABLE MASIMO PATIENT CABLES.

■

DO NOT REPROCESS ANY MASIMO SET PATIENT CABLES.

LNOPvTMADHESIVE SENSORS

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

CLEANING AND REUSE OF MASIMO SENSORS

Reusable sensors can be cleaned per the following procedure:

■

Remove the sensor from the patient.

■

Disconnect the sensor from the monitor.

■

Wipe the entire sensor clean with a 70% isopropyl alcohol pad.

■

Allow the sensor to air dry before returning it to operation.

REATTACHMENT OF SINGLE USE ADHESIVE SENSORS

■

Single use sensors may be reapplied to the same patient if the emitter and detector
windows are clear and the adhesive still adheres to the skin.

■

The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol
wipe and allowing the sensor to thoroughly air dry prior to replacement on the patient.

NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly
positioned. Reposition the sensor or choose a different monitoring site.

CAUTIONS:

■

DO NOT REPROCESS ANY SINGLE USE SENSORS.

■

DO NOT SOAK OR IMMERSE THE SENSOR IN ANY LIQUID SOLUTION. DO NOT STER­ILIZE ANY MASIMO SENSOR BY IRRADIATION, STEAM, OR ETHYLENE OXIDE.

WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO SINGLE
USE SENSORS ON THE SAME PATIENT.

Weight Saturation Accuracy Pulse Rate Accuracy

Low Perfusion Accuracy

SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate

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

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

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

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

LNOPv Pd-L 10-50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm

sensors & patient cables

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9

service / maintenance

Introduction

This chapter covers how to test the operation of the Rad-5/5v how to properly clean the
Rad-5/5v pulse oximeter, how to replace the batteries and how to obtain service.

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

Cleaning

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

To clean the outer surface of the oximeter, use a soft cloth dampened with a mild soap and
water. Do not allow liquids to enter the interior of the instrument.

CAUTIONS:

■

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

■

DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID.

■

USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN
FLOW INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS.

■

DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE
CLEANING COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE
MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD
SCRATCH THE PANEL.

■

DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER
HARSH SOLVENTS, TO CLEAN THE OXIMETER. THESE SUBSTANCES
ATTACK THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT.

Refer to Section 8,

Cleaning and Reuse of Masimo LNOP Sensors

for cleaning instructions

of the sensor.

BATTERY REPLACEMENT

The Rad-5 and Rad-5v are powered by 4 “AA”alkaline batteries. Do not use any other type
of batteries or power source to run the device. The batter y 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

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

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 9-3

9

service / maintenance

4. Repeat steps 1 to 3 with the Low Saturation Alarm parameter.

5. Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter.

6. Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter.

7. Reset the alarm limits again to the original settings.

LED Brightness:

1. Rad-5: 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. Rad-5v: push the Display Brightness key several times to cycle through all four
brightness levels

3. Exit the Menu system by pressing the Mode/Enter key or waiting for the normal
time-out.

Testing Rad-5 with Masimo SET Tester (Optional):

1. Turn the Oximeter off and then on again.

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

3. Verify that within 20 seconds a Signal IQ/pulsebar is displayed.

4. Verify that the SpO

2

measurement is between 79% and 84%.

5. Verify that the pulse rate measurement is between 55 bpm and 65 bpm.

6. Set the SpO

2

low alarm limit to 90 (see Section 4,

Setup Menu Level 1 - Alarm

Limits and Alarm Volume

).

7. Verify that an audible alarm occurs and the SpO

2

measurement and the Alarm indi-

cator are both flashing.

8. Press the Alarm Silence button once and verify that the alarm is silenced and the
Alarm Silence Indicator is flashing.

9. Wait 120 seconds and verify that the alarm silence times out and the audible alarm
is activated again and the Alarm Silence Indicator is off.

10. Press the up arrow button several times and verify that the loudness of the pulse
beep tone increases.

11. Press the down arrow button and verify that the loudness of the pulse beep tone
decreases until the pulse beep tone is turned off.

Testing Rad-5v with Masimo SET Tester (Optional):

1. Turn the Oximeter off and then on again.

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

3. Verify that within 20 seconds a Signal IQ/pulsebar is displayed.

by sliding it back up from the bottom of the device until the rectangular locking button snaps
back into position.

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.

Performance verification

To test the performance of the Rad-5/5v pulse oximeter following repairs or during routine
maintenance, follow the procedure outlined in this section. If the Rad-5/5v fails any of the
described tests, discontinue its use and correct the problem before returning the unit back
to the user.

Before performing the following tests verify or install new batteries into the Rad-5/5v
Handheld. Also disconnect any patient cables or pulse oximetry probes or serial cables
from the instrument.

Power-On Self-Test:

1. Turn the monitor on by depressing the Power Button. For about 5 seconds all avail­able LEDs are illuminated and a brief beep tone sounds.

2. The oximeter begins normal operation.

Key Press Button Test:

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

Alarm Limit Test (Rad-5 only):

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

2

or pulse rate measurement display.

3. Return the High Saturation Alarm parameter to its original setting.

WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BAT-

TERIES 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 DEVICE.

service / maintenance

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 9-5

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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 unit 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-5/5v unit for service, please follow the Return Procedure.

RETURN PROCEDURE

Please clean contaminated/dirty equipment before returning and make sure it is fully dry
before packing the equipment. Package the equipment securely – in the original shipping
container if possible – and enclose the following infor mation and items:

■

Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA num­ber.

■

A letter describing in detail any difficulties experienced with the pulse oximeter.
Please include the RMA number in the letter.

■

Warranty information – a copy of the invoice or other applicable documentation
must be included.

■

Purchase order number to cover repair if the oximeter is not under warranty, or for
tracking purposes if it is.

■

Ship-to and bill-to information.

■

Person (name, telephone/Telex/fax number, and country) to contact for any
questions about the repairs.

■

A certificate stating the oximeter has been decontaminated for bloodborne
pathogens.

Return Rad-5/5v pulse oximeter to the following shipping address:

Masimo Corporation
40 Parker
Irvine, California 92618
949-297-7000
FAX [phone]

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.

4. Verify that the SpO2measurement is between 79% and 84%.

5. Verify that the pulse rate measurement is between 55 bpm and 65 bpm.

6. Press the Pulse Tone Volume button several times and verify that the loudness of

the pulse beep tone increases, then is turned off, then repeats the cycle

7. Disconnect the Masimo Set Tester from the Rad-5v.

8. Verify that an audible alarm occurs, that the front panel displays “nO SEn” and the
Alarm indicator is flashing.

8. Press the Alarm Silence button once and verify that the alarm is silenced and the
Alarm Silence Indicator is off.

service / maintenance

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9

service / maintenance

in, any MASIMO software and/or firmware and the documentation, and all copies
thereof, remain at all times vested in MASIMO Corporation, licensor to MASIMO, and
they do not pass to Purchaser.

3. Assignment: 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; any
attempt without such consent, to assign any rights, duties or obligations arising here­under shall be void.

4. Copy Restrictions: The software/firmware 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. You may be held legally responsible for any copyright infringe­ment that is cause or incurred by your failure to abide by the terms of this license.
Nothing in this license provides any rights beyond those provided by 17 U.S.C. §117.

5. Use Restriction: As the Purchaser, you may physically transfer the products from one
location to another provided that the software/firmware is not copied. You may not
electronically transfer the software/firmware from the products to any other device.
You may not disclose, publish, translate, release or distribute copies of the
software/firmware or accompanying written materials to others. You may not modify,
adapt, translate, reverse engineer, decompile, disassemble, or create derivative
works based on the software/firmware. You may not modify, adapt, translate, or cre­ate derivative works based on the written materials without the prior written consent
of MASIMO.

6. Transfer Restrictions: The software/firmware is licensed to the Purchaser, and may
not be transferred to anyone, except other end-users, without the prior written con­sent of MASIMO. In no event may you transfer, assign, rent, lease, sell, or otherwise
dispose of the software/firmware or the products on a temporary basis.

7. Beneficiary: Masimo Corporation is a Beneficiary of this Agreement and has the right
to enforce its provisions.

8. U.S. Government Rights: If you are acquiring software (including the related docu­mentation) on behalf of any part of the United State 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.

Warranty

Masimo warrants to the initial purchaser that each new pulse oximeter will be free from
defects in workmanship or materials for a period of one (1) year from the date of purchase.
Masimo’s sole obligation under this warranty is to repair or replace any product that
Masimo deems to be covered under warranty with a repaired or a replacement pulse
oximeter.

Batteries are not warrantied.

To request a replacement under warranty, 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

This warranty does not extend to any product that has been subject to misuse, neglect or
accident; that has been damaged by causes external to the product; that has been used in
violation of the operating instructions supplied with the product. The warranty does not
extend to any product that has been connected to an unlicensed instrument system,
modified accessories or any unit that has been disassembled or reassembled by anyone
but an authorized Masimo agent.

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

End-user license agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE “PURCHASER,”
AND Masimo Corporation (“MASIMO”). 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.

1. Grant of License: In consideration of payment of the license fee, which is part of the
price paid for this product, MASIMO grants to Purchaser a nonexclusive, nontrans­ferable license, without right to sublicense, to use the copy of the incorporated soft­ware/firmware and documentation in connection with Purchaser's use of the
Masimo Products for their labeled purpose. MASIMO reserves all rights not
expressly granted to Purchaser.

2. Ownership of Software/Firmware: Title to, ownership of, and all rights and interests

service / maintenance

9-6 Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 10-1

10

accessories

Rad-5 Accessories

PART NUMBER DESCRIPTION

1908

TrendCom Software for trend download. Requires MS-Windows, PRONTO
trend download serial cable, TrendCom software and PC with available
COM port.

1909

PRONTO trend download serial cable. Requires TrendCom software and
PC with available COM port.

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

13158 Nylon protective carrying case

1795 Masimo SET Tester (with modular plug and cable)

13096 Rad-5 Users Manual, English

13261 Rad-5 Users Manual, French

13262 Rad-5/5v Users Manual, German

13263 Rad-5/5v Users Manual, Italian

13264 Rad-5/5v Users Manual, Spanish

13265 Rad-5/5v Users Manual, Swedish

13266 Rad-5/5v Users Manual, Dutch

13267 Rad-5/5v Users Manual, Danish

13268 Rad-5/5v Users Manual, Portuguese

13427 Rad-5/5v Users Manual, Japanese

1593 Masimo SET tester (with Mini-D connector)

13017/3349E-0106

www.masimo.com

Instruments and sensors containing Masimo SET technology are identified with the
Masimo SET logo. Look for the Masimo SET designation on both the
sensors and monitors to ensure accurate pulse oximetry when needed most.

© 2006 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Rad-5v, PRONTO, TrendCom, SatShare,
Signal IQ, SIQ, APOD, and FastSat are trademarks of Masimo Corporation.