Masimo Rad-5 User manual

signal extraction pulse oximeters
OPERATOR’S MANUAL

Signal Extraction Pulse Oximeter
OPERATOR’S MANUAL

i
The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper opera-
tion 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 replace-
ment parts which would, alone or in combination with this device, fall within the scope of one of the relating
patents.
CAUTION:
FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU Authorized Representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Tel.: [phone]
Fax.: [phone]
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL 60601-1/CAN/CSA C22.2 No. 601.1
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.htm. Other patents pending.
© 2009 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Signal IQ, APOD,
LNOP, LNCS, DCI and FastSat are federally registered trademarks of Masimo Corporation.
Rad-5v, TrendCom, SatShare, Discrete Saturation Transform (DST), DCIP, RED, M-LNCS and SIQ are
trademarks of Masimo Corporation.
EC REP
Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual ii
The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the pos-
sibility 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 anes-
thetics or other flammable substance in combination with air, oxygen-enriched environ-
ments, 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.
■Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG based arrhythmia analysis.
■The Pulse Oximeter is to be operated by qualified personnel only. This manual, acces-
sory 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 imag-
ing (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 irradia-
tion 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.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

iii Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual
■ 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 oxi-
meter, 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.
■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 inac-
curate for up to 20 seconds.
■This equipment has been tested and found to comply with the limits for medical devic-
es 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 equip-
ment 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

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual iv
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Measured vs. Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
Masimo SET Signal Extraction Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Masimo SET Parallel Engines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Masimo SET DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
SECTION 2 - SYSTEM DESCRIPTION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Rad-5/5v Front Panel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Rad-5/5v Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
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 SpO2Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Numeric Display - SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Masimo Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Numeric Display - Pulse Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Signal IQ and Pulse bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Actions To Be Taken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Battery Level Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Setup Menu (Rad-5 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Menu Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
Setup Menu Level 1 – Alarm Limits and Alarm Volume. . . . . . . . . . . . . . . . . . . . .4-10
Setup Menu Level 2 – Averaging, Sensitivity, FastSat and SmartTone. . . . . . . . . .4-11
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vRad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual
table of contents
SECTION 4 - OPERATION (CONTINUED)
Setup menu Level 3 – Trend Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
Setup Menu Level 4 – LED Brightness and Factory Defaults. . . . . . . . . . . . . . . . .4-12
Trend Setup and Use (Rad-5 only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
TrendCom Utility Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
TrendCom Utility Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
Erasing Trend Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Trend Data Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Sample Trend Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Special Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Standard and Sleep mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Sleep mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
SECTION 5 - ALARMS AND MESSAGES
Alarm Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm limits (Rad-5 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Alarm Silenced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 SpO2Sensors and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Selecting a Masimo Set Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Sensor Application Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Red Direct Connect Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
LNOP®Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
LNOP®Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
LNCS® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
LNCS®Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
LNCS®Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
LNOPvTM Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
LNOP®Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
M-LNCS™ Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
M-LNCS™ Series Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Cleaning and Reuse of Masimo Reusable Sensors and Cables . . . . . . . . . . . . . . . 8-4
Reattachment of Single Use Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
Masimo SET Patient Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual vi
SECTION 9 - SERVICE AND MAINTENANCE
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Battery Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Performance Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Sales & End-User License Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
End-User License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6
Restrictions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
SECTION 10 - ACCESSORIES
Rad-5 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1
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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.