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