Masimo RAD87A User Manual

Rad-87

Pulse CO-Oximeter

OPERATOR’S MANUAL

™

Rad-87

Pulse CO-Oximeter

OPERATOR’S MANUAL

™

The Rad-87 Operating Instructions provide the necessary information for proper operation of all models of the

Rad-87 device. General knowledge of pulse CO-Oximetry and an understanding of the features and functions of the

Rad-87 are a prerequisite for its proper use. Do not operate the Rad-87 without completely reading and understanding

the instructions in this manual.

NOTICE:

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

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

relating to this device.

CAUTION:

Federal law (U.S.) restricts this device to sale by or on the order of a physician.

Masimo Corporation

40 Parker

Irvine, CA 92618

USA

Tel.: [phone]

Fax.: [phone]

www.masimo.com

EU Authorized Representative for Masimo Corporation:

EC REP

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

Tel.: [phone]

Fax.: [phone]

CONFORMS TO UL STD 60601-1, UL STD 763
UL STD 963 AND NSF STD 12;

3149433

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984,

7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194, 6,684,090, 6,654,624,

6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525, 6,388,240, 6,360,114, 6,263,222,

6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952, 5,919,134, 5,769,785, 5,758,644, 5,685,299,

5,632,272, 5,490,505, 5,482,036, international equivalents, or one or more of the patents referenced at www.masimo.

com/patents.htm. Other patents pending.

© 2008 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET,

Radical,

Rainbow and SpCO are federally registered trademarks of Masimo Laboratories.

Rad-87, Pleth Variability Index, PVI, Patient SafetyNet, RadNet, LNOPv and APOD are trademarks of Masimo

Corporation. Rainbow SET, SpMet, SpHb, SpOC, Pulse CO-Oximeter and Signal Extraction Pulse CO-Oximeter

are trademarks of Masimo Laboratories.

Rad-87 Pulse CO-Oximeter Operator’s Manual i

CERTIFIED TO CAN/CSA STD C22.2 NO. 601.1

, Signal IQ, SIQ, FastSat, LNOP and LNCS are federally registered trademarks of Masimo Corporation.

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-87 Pulse CO-Oximeter is designed to minimize the possibility of hazards from errors in the software
program by following sound engineering design processes, Risk Analysis and Software Validation.

■ Explosion hazard. Do not use the Rad-87 in the presence of fl ammable anesthetics or other fl ammable

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

■ High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not allow

the Pulse CO-Oximeter to obtain readings.

■ The Rad-87 is NOT intended for use as an apnea monitor.

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

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

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

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

■ The Rad-87 is to be operated by qualifi ed personnel only. This manual, accessory directions for use,

all precautionary information, and specifi cations should be read before use.

■ Electric shock hazard. Do not open the Rad-87 device. Only a qualifi ed operator may perform

maintenance procedures specifi cally 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 Rad-87 or accessories in any position that might cause it to fall on the patient. Do not

lift the Rad-87 by the power cord or any other cable.

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

may cause erroneous readings.

■ SpO

is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with

2

normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can
not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the
accuracy of the SpO

■ For increased COHb: COHb levels above normal tend to increase the level of SpO

of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of
COHb may occur with a seemingly normal SpO
laboratory analysis (CO-Oximetry) of a blood sample should be performed.

NOTE: High levels of COHb may occur with a seemingly normal SpO

COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.

■ For increased MetHb: the SpO

to 15%. At higher levels of MetHb, the SpO
levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be

measurement.

2

. The level

2

. When elevated levels of COHb are suspected,

2

. When elevated levels of

2

may be decreased by levels of MetHb of up to approximately 10%

2

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

2

performed.

■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO

measurements.

and SpCO

2

■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements.

■ Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO, SpHb and SpOC

measurements.

■ Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC measurements.

Rad-87 Pulse CO-Oximeter Operator’s Manualii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

■ Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet

measurements.

■ Severe anemia may cause erroneous SpO

■

Hemoglobin synthesis disorders may cause erroneous SpHb readings.

readings.

2

■ Do not use the Rad-87 or sensors during magnetic resonance imaging (MRI) scanning. Induced

current could potentially cause burns. The Rad-87 may affect the MRI image and the MRI device may
affect the accuracy of the Pulse CO-Oximetry parameters and measurements.

■ If using Rad-87 during full body radiation, keep the sensor out of the radiation fi eld. If the sensor is

exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration
of the active irradiation period.

■ For home use, ensure that the Rad-87’s alarm can be heard from other rooms in the house especially

when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios
are operating.

■ Always remove the sensor from the patient and completely disconnect the patient from the Rad-87

before bathing the patient.

■ Additional information specific to Masimo sensors including information about parameter/measurement

performance during motion and low perfusion, may be found in the sensor's Directions For Use
(DFU).

■ Do not place the Rad-87 where the controls can be changed by the patient.

■ Do not place the Rad-87's face against a surface. This will cause the alarm to be muffl ed.

■ Do not place the Rad-87 on electrical equipment that may affect the Pulse CO-Oximeter, preventing it

from working properly.

■ Do not expose the Rad-87 to excessive moisture such as direct exposure to rain. Excessive moisture

can cause the device to perform inaccurately or fail.

■ Do not place containers with liquids on or near the Rad-87. Liquids spilled on the device may cause it

to perform inaccurately or fail.

■ If the Rad-87 fails any part of the setup procedures or leakage tests, remove the device from operation

until qualifi ed service personnel have corrected the situation.

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

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

■ The Rad-87 can be used during defi brillation, but the readings may be inaccurate for up to 20

seconds.

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

EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B digital device, Part 15,
FCC Rules/USA. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.

Rad-87 Pulse CO-Oximeter Operator’s Manual iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

■ 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.

■ Connect the equipment into an outlet on a circuit different from that to which the other

device(s) are connected.

■ Consult the manufacturer for help.

■ In order to connect wirelessly to a compatible interface system like Patient SafetyNet, the

Rad-87 should be placed in an environment free from RF shielding, which could hinder
wireless reception.

■ To minimize radio interference, other electrical equipment that emits RF transmissions should

not be in close proximity to the RAD-87.

■ Changes or modifications to the wireless radio feature whether intentional or unintentional are

prohibited without written approval from Masimo Corporation.

■ The Rad-87 (device with optional radio) wirelessly transmits real-time sensor connectivity status,

indicating a connect and/or disconnect state. If the device is in a failure mode then the radio power
is disabled and an error message is indicated on the device display. The device does not have a
powered state where no information is transmitted.

■ In accordance with FCC requirements, the Rad-87 (device with optional radio) must be placed

greater then 20 cm from the patient's head.

■ In accordance with FCC requirements, radio accessories on the Rad-87 (device with optional

radio) cannot be attached directly to the patient using any accessory containing metal
components.

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

5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference
to co-channel mobile satellite systems.

■ The battery should be adequately charged to ensure backup power in case of AC power

disruption.

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

sensors.

■ To ensure safety, avoid stacking multiple devices or placing anything on the device during

operation.

■ Ensure the speaker is not covered or the device is placed face-down on bedding or other

sound absorbing surface.

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

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

■ Do not soak or immerse the device in liquids.

■ Always turn off and disconnect the power cord from the AC power supply before cleaning

the device.

■ Use cleaning solutions sparingly.

Rad-87 Pulse CO-Oximeter Operator’s Manualiv

table of contents

SECTION 1 - OVERVIEW

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

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

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

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

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

Pulse CO-Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpO2 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpCO General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

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

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

Total Arterial Oxygen Content (SpOC) General Description . . . . . . . . . . . . . . . . . 1-5

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

Functional Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Rad-87 vs. Drawn Whole Blood Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

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

SpMet, SpCO, and SpHb and SpOC Measurements During Patient Motion . . . . 1-7

Fastat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

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

Masimo SET DST

SECTION 2 - SYSTEM DESCRIPTION

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

Rad-87 Front Panel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Rad-87 Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

SECTION 3 - SETUP

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

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

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

Rad-87 Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Initial Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Initial Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

SECTION 4 - OPERATION

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

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

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

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

Factory Default and User Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

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

Masimo Pulse CO-Oximetry Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Numeric Display - SpO

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

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

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

Numeric Display - SpHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Rad-87 Pulse CO-Oximeter Operator’s Manual v

2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-5

table of contents

SECTION 4 - OPERATION (CONTINUED)

Numeric Display - SpOC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Numeric Display - PI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Pleth Variability Index (PVI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

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

Signal SIQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Sensor Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

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

Low Battery Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

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

Paramater/Measurement Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Menu Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Setup Menu Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Parameter/Measurement Alarm Limits - Screen 1 . . . . . . . . . . . . . . . . . . . . . . . 4-13

Parameter/Measurement Alarm Limits - Screen 2 . . . . . . . . . . . . . . . . . . . . . . . 4-14

Parameter/Measurement Alarm Limits - Screen 3 . . . . . . . . . . . . . . . . . . . . . . . 4-15

LED Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Setup Menu Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Alarm Delay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Clear Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Button Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

FastSat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Trend Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Trend Utility Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Trendcom Utility Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Erasing Trend Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Trend Data Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Sample Trend Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Setup Menu Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Averaging Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Rapid Desat Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Alarm On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Out Put Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Device Profile Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

PVI Bar On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Smart Tone On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Month . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Hour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Minute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

Serial Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Rad-87 Pulse CO-Oximeter Operator’s Manualvi

table of contents

SECTION 4 - OPERATION - (CONTINUED)

Interface Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

System Interfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Philips VueLink Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Radnet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Patient SafetyNet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Polarity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Line Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Parameter/Measurement Select - Screen 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Parameter/Measurement Select - Screen 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Parameter/Measurement Select - Screen 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

LCD Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Set Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Home Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Sleep Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Enable/Disable Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

LCD Display Function with Radio Configured and Enabled . . . . . . . . . . . . . . . . . . .4-35

SECTION 5 - ALARMS AND MESSAGES

Alarm Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

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

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Alarm Limit: User Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Alarm Limit: Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Single Alarm Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Multi-Parameter/Measurement Alarm Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Alarm Priority for Display Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

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

Alarm Bell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

System Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

Rad-87 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

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

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

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

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

Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Serial Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Serial Interface Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Serial Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Nurse Call Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Rad-87 Pulse CO-Oximeter Operator’s Manual vii

table of contents

SECTION 8 - SENSORS & PATIENT CABLES

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

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

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

Masimo Rainbow Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

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

Rainbow Direct Connect Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Masimo SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Red Direct Connect Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

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

LNOP® Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

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

LNOP® Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

LNCS® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

LNCS® Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

®

LNCS

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

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

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

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

SECTION 9 - SERVICE AND MAINTENANCE

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

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

Battery Service and 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 - PART NUMBERS

Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Rad-87 Pulse CO-Oximeter Operator’s Manualviii

overview

About This Manual

This manual explains how to set up and use the Rad-87 Pulse CO-Oximeter containing Masimo
Rainbow SET technology. Important safety information relating to general use of the Rad-87
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 Rad-87 Pulse CO-Oximeter.

SECTION 2 SYSTEM DESCRIPTION describes the Rad-87 Pulse CO-Oximeter

system and its functions and features.

SECTION 3 SETUP describes how to setup the Rad-87 Pulse CO-Oximeter for use.

SECTION 4 OPERATION describes the operation of the Rad-87 Pulse CO-Oximeter

system.

SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6 TROUBLESHOOTING describes troubleshooting information.

SECTION 7 SPECIFICATIONS gives the detailed specifi cations of the Rad-87 Pulse

CO-Oximeter.

1

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

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

SECTION 10 ACCESSORIES lists the available models of the Rad-87 Pulse

Rad-87 Pulse CO-Oximeter Operator’s Manual 1-1

Rainbow SET technology sensors, Masimo Rainbow SET technology
patient cables, Masimo Red sensors and, Masimo Red PC cables.

obtain repair for the Rad-87 Pulse CO-Oximeter.

CO-Oximeter.

1

overview

Warnings, Cautions and Notes

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

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

Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

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

Sample of Caution:

CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.

A NOTE is provided when extra general information is applicable.

Sample of Note:

NOTE: This is a sample of a Note.

1-2 Rad-87 Pulse CO-Oximeter Operator’s Manual

overview

Product Description

The Rad-87 Pulse CO-Oximeter Monitor is a noninvasive, arterial oxygen, carboxyhemoglobin and
methemoglobin saturation, total hemoglobin concentration, total arterial oxygen content and pulse rate
monitor. The Rad-87 features a multicolored LED display that continuously displays numeric values for
SpO2, SpCO®*, SpMet™*, SpHb™*, total arterial oxygen content (SpOC*), perfusion index (PI), pleth
variability index* (PVI) and pulse rate. It also provides bar graph displays for quick visual identifi cation of
Signal Identifi cation Quality (SIQ®), perfusion index and pleth variability index.

The Rad-87 is available in four models: vertical Rad-87, horizontal Rad-87, vertical Rad-87 with radio and
horizontal Rad-87 with radio.

FEATURES

These features are common to Rad-87 monitors:

■ Masimo SET is clinically proven to be the highest sensitivity and specifi city pulse oximeter

technology in the world.

■ Rainbow technology continuously and noninvasively measures arterial oxygen saturation (SpO2)

and pulse rate (BPM), as well as providing a reliable probe-off detection.

■ Perfusion Index (PI) with trending capability indicates arterial pulse signal strength during low

perfusion.

■ Accurate on cyanotic infants with congenital heart disease when used with an LNOP® Blue

Sensor.

■ Signal IQ® provides signal identifi cation and quality indication during excessive motion and low

signal to noise situations.

■ FastSat® tracks rapid changes in arterial O2 saturation with high fidelity.

■ Variable pitch provides tonal variance for every 1% change in saturation.

■ Remote alarming interface.

■ Up to 72 hours of trending. (See Section 4, Trends Setup and Use.)

■ Allows user to customize the default settings and set the device to retain these settings through a

power off/on cycle.

■ The LCD Display allows the user to view a scrolling marque of (installed) parameter/measurement

alarm limits, system information, and wireless radio communication (wireless radio model only).

1

OPTIONAL FEATURES

■ Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively

measure carboxyhemoglobin (SpCO), methemoglobin (SpMet) and total hemoglobin
(SpHb), as well as providing a reliable probe-off detection.

■ Pleth Variability Index (PVI) may show changes that refl ect physiologic factors such as

vascular tone, circulating blood volume, and intrathoracic pressure excursions.

■

Total arterial oxygen content (SpOC) provides a calculated measurement of the amount of

1

oxygen in arterial blood which may provide useful information for both oxygen dissolved in
plasma and combined with hemoglobin.

■ Provides a 802.11a/b/g wireless radio which interfaces with compatible systems (wireless radio

model only)

■ Ability to connect to Masimo Patient SafetyNet through a wireless network (wireless radio

model only).

1

The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI

include probe malposition and patient motion.

*Optional features: SpCO, SpMet, SpHb, SpOC, PVI

Rad-87 Pulse CO-Oximeter Operator’s Manual 1-3

1

overview

INDICATIONS FOR USE

The Rad-87 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO
methemoglobin concentration expressed in percentage (SpCO and SpMet) and total hemoglobin

), carboxyhemoglobin and

2

concentration expressed in grams per deciliter (SpHb).The Rad-87 Pulse CO-Oximeter and
accessories are indicated for use with adult, pediatric and neonatal patients during both motion and
no motion conditions, who are well or poorly perfused patients in hospitals, hospital-type facilities,
mobile and home environments.

Pulse CO-Oximetry

SpO2 GENERAL DESCRIPTION

Pulse CO-Oximetry is a continuous and noninvasive 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 fi ngertip for adults and the hand or foot for neonates. The sensor is connected to the
Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the
patient and sends it to the instrument.

The following fi gure shows the general monitoring setup.

1

N
O

R

M
A
P
O

D

M
A
X

97

S

E
N
S
I

T

I

V

I
T

Y
M
O

D
E

76

10.1

r
b

c
m

o
n
i
t

o
r

2

3

1. Instrument

2. Patient Cable

3. Sensor

SpCO GENERAL DESCRIPTION

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of
carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles
of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is
obtained by placing a sensor on a patient, usually on the fi ngertip for adults and the hand or foot
for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through
an instrument patient cable. The sensor collects signal data from the patient and sends it to the
instrument. The instrument displays the calculated data as percentage value for the SpCO, which
refl ect blood levels of carbon monoxide bound to hemoglobin.

SpMet GENERAL DESCRIPTION

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

TOTAL HEMOGLOBIN (SpHb) GENERAL DESCRIPTION

1-4 Rad-87 Pulse CO-Oximeter Operator’s Manual

overview

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin
(SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make the SpHb measurement.
The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults
and pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The
sensor collects signal data from the patient and sends it to the instrument. The instrument displays the
calculated data as measurement of total hemoglobin concentration. The Rad-87 can be configured to be
a combined SpO

TOTAL ARTERIAL OXYGEN CONTENT (CaO2) GENERAL DESCRIPTION

Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with
hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO
is measured in units of ml O
whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen. The oxygen content is
determined mathematically as:

CaO

= 1.34 (ml O2/g Hb) x Hb (g/dl) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/ 100 mm Hg/dl)

2

Where HbO
arterial oxygen.

For typical PaO
Hg/dl] is approximately 0.3 ml/dl. Furthermore, for typical carboxyhemoglobin and methemoglobin
levels, the functional saturation (SpO

2

Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition.

New York: Lippincott Williams & Wilkins, 1999.

monitor with other available parameters/measurements.

2

2

) and

/dl blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen,

2

is the fractional arterial oxygen saturation and PaO2 is the partial pressure of

2

values, the second part of the above equation [PaO2 (mm Hg) x (0.3 ml O2/ 100 mm

2

) as measured by a pulse oximeter is given by:

2

SpO

= 1.02 x HbO2

2

2

1

SpOC General Description (Pulse CO-Oximetry)

The above approximations result in the following reduced equation for oxygen content via the
Pulse CO-Oximeter:

SpOC (ml/dl*) = 1.31 (ml O

*When ml O
the gram unit in the numerator of g/dl resulting in ml/dl (ml of oxygen in one dl of blood) as the

/g Hb is multiplied by g/dl of Hb, the gram unit in the denominator of ml/g cancels

2

/g Hb) x SpHb (g/dl) x SpO2 + 0.3 ml/dl

2

unit of measure for SpOC.

Rad-87 Pulse CO-Oximeter Operator’s Manual 1-5

1

overview

PRINCIPLE OF OPERATION

Pulse CO-Oximetry is governed by the following principles:

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

Absorption Spectra

4.0

3.5

3.0

2.5

2.0

1.5

Absorption (1/mm)

1.0

0.5

0
600 800

Carboxyhemoglobin

Oxyhemoglobin

Methemoglobin

Deoxyhemoglobin

Plasma

1000 1200 1400 1600

Wavelength (nm)

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

The Rad-87 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood
plasma. The Rad-87 utilizes a sensor with various light-emitting diodes (LEDs) that pass light
through the site to a photodiode (detector). See fi gure below. Signal data is obtained by passing
various visible and infrared lights (LED’s, 500 to 1400nm) through a capillary bed (for example,
a fi ngertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile
cycle. This information may be useful to clinicians. The maximum radiant power of the strongest
light is rated at ≤ 25mW. The detector receives the light, converts it into an electronic signal and
sends it to the Rad-87 for calculation.

1

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

2. Detector

2

Once the Rad-87 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal
extraction technology to calculate the patient’s functional arterial oxygen saturation, blood levels
of carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pulse rate. The SpCO and SpMet
measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon
monoxide and methemoglobin in arterial blood. In an ambient temperature of 35º C the maximum
skin surface temperature has been measured at less than 106º F (41º C), verifi ed by Masimo
sensor skin temperature test procedure.

1-6 Rad-87 Pulse CO-Oximeter Operator’s Manual

overview

FUNCTIONAL SATURATION

The Rad-87 is calibrated to measure and display functional saturation (SpO
expressed as a percentage of the hemoglobin that is available to transport oxygen.

RAD-87 vs. DRAWN WHOLE BLOOD MEASUREMENTS

When SpO
compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry

, SpCO, SpMet and SpHb measurements obtained from the Rad-87 (noninvasive) are

2

methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or
laboratory CO-Oximetry measurements may differ from the SpO
of the Rad-87 Pulse CO-Oximeter. In the case of SpO
arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of

, SpCO, SpMet and SpHb measurements

2

, different results are usually obtained from the

2

variables that shift the relationship between the partial pressure of oxygen (PO
as: pH, temperature, the partial pressure of carbon dioxide (PCO
the case of SpCO, different results are also expected if concentration of methemoglobin in the blood
gas sample is elevated. High levels of bilirubin may cause erroneous SpO
readings. As blood samples are usually taken over a period of 20 seconds (the time it takes to draw
the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin
and methemoglobin concentration of the patient are stable and not changing over the period of time that
the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements of
SpO2, SpCO, SpMet and SpHb may vary with the rapid administration of fl uids and in procedures such
as dialysis. Additionally, drawn, whole-blood testing can be affected by sample handling methods and time
elapsed between blood draw and sample testing.

MASIMO SET SIGNAL EXTRACTION TECHNOLOGY FOR SpO

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 venous 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 fi ltering. Adaptive fi lters are powerful because they are able to adapt to the varying
physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its
fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform

®

(DST

) reliably identifi es the noise, isolates it and, using adaptive fi lters, cancels it. It then reports the true

arterial oxygen saturation for display on the monitor.

SpMet, SpCO, AND SpHb MEASUREMENTS DURING PATIENT MOTION

The Rad-87 displays measurements of SpCO, SpMet and SpHb during patient motion. However,
because of the changes in the physiological parameters such as blood volume, arterial-venous
coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable
during excessive motion. When the Rad-87 does not have confidence in the value of a parameter due
to poor signal quality caused by excessive motion or other signal interference, the measurement for
the parameter will alternate with "---".

FASTSAT

FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data
is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad-87 is set
to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged
saturation value that is a better representation of the patient’s current oxygenation status. With FastSat,
the averaging time is dependent on the input signal.

): the amount of oxyhemoglobin

2

) and saturation, such

), 2,3-DPG, and fetal hemoglobin. In

2

2

, SpMet, SpCO and SpHb

2

MEASUREMENTS

2

®

1

Rad-87 Pulse CO-Oximeter Operator’s Manual 1-7

1

MASIMO RAINBOW SET PARALLEL ENGINES

This fi gure is for conceptual purposes only.

12

FST

MST

SpOC

MASIMO SET DST

1-8 Rad-87 Pulse CO-Oximeter Operator’s Manual

system description

Introduction

The Rad-87 Pulse CO-Oximeters are full featured devices designed for ease of operation. All pulse
CO-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. The sensor cable
connections are located on the left side of the front panel for the Rad-87 horizontal device and the
bottom of the front panel for the Rad-87 vertical device.

■ Rad-87 offers full Masimo SET technology in a small compact device

■ Rad-87 supports the full line of Masimo sensors and patient cables (see Section 8, Sensors

and Patient Cables)

■ Rad-87 supports standardization of sensors, and pulse CO-Oximetry technology throughout

the hospital

■ The LCD Display identifies system settings, monitoring modes, alarm limits and information

from Patient SafetyNet or Philips VueLink (when connected). The LCD is located on top of the
device (Horizontal) or on the left of the device (Ver tical).

2

Rad-87 Pulse CO-Oximeter Operator’s Manual 2-1

2

1234567890123456

APOD

MAX

NORM

APOD

MAX

NORM

system description

RAD-87 PULSE CO-OXIMETER - HORIZONTAL

1 23 5678 91011

APOD

APOD

APOD

APOD

CONTROL / INDICATOR DESCRIPTION

Device Profile

1

LED

4

DISPLAY

NORM

NORM

NORM

NORM

SENSITIVITY

SENSITIVITY

MODE

MODE

SENSITIVITY

SENSITIVITY

MAX

MAX

MAX

MAX

10.1

DISPLAY

ENTER

ENTER

rbc monitor

rbc monitor

Rad-87

Rad-87

121314151617181920

The Device Profile LED illuminates when the device has been

set to user configured "default" settings. Upon power up, the

user configured default settings are retained and the Device

Profile LED remain lit.

When user configured default settings are active, any changes

to the default settings cause the Device Profile LED to turn

off until the device is returned to the user configured default

settings or powered off.

Sensitivity

2

Button/Indicator

Used to set the device into Maximum Sensitivity, Normal

Sensitivity, or APOD Mode.

The LCD display identifies system settings, monitoring modes, alarm

3

LCD Display

limits, and information from Patient SafetyNet or Philips VueLink (when

connected.)

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

4

Signal IQ Index

5

Perfusion Index

2-2 Rad-87 Pulse CO-Oximeter Operator’s Manual

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.

The Perfusion Index provides an indication of the percentage of

pulsatile signal to non pulsatile signal.