Masimo RAD87B User 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 instrument. 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 instrument does not carry any express or implied license to use this instrument

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

the patents relating to this instrument.

CAUTION:

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

Masimo Corporation

40 Parker

Irvine, CA 92618 USA

Tel.: 949-297-7000

Fax.: 949-297-7001

www.masimo.com

EU Authorized Representative for Masimo Corporation:

EC REP

MDSS GmbH

Schiffgraben 41

D-30175 Hannover, Germany

CONFORMS TO UL STD 60601-1,

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.

Signal Extraction Pulse CO-Oximeter, SET, Rad, RadNet, Radical, , Signal I.Q., Pronto, FastSat, PVI, LNOP,

Rainbow, SpCO, SpMet, SpHb, and LNCS are federally registered trademarks of Masimo Corporation.

Rad-87, Pleth Variability Index, Patient SafetyNet, Rainbow SET,

M-LNCS,

Rad-87 Pulse CO-Oximeter Operator’s Manual

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

SpOC, APOD, Pulse CO-Oximeter, LNOPv,

RI and RRa are 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

CO-Oximeter to obtain readings.

■ Excessive ambient noise may affect the accuracy of the

Sensor.

■ SpO2 monitoring is required when monitoring RRa (Acoustic Respiration).

■ 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 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 instrument. Only a qualiﬁ ed operator may perform maintenance

procedures speciﬁ cally described in this manual. Refer servicing to Masimo for repair of this equipment.

■ Ensure that the HF surgical neutral electrode is properly connected to help prevent unintended

current return paths when using high frequency (HF) surgical equipment.

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

or strangulation.

■ Use cables only from the instrument manufacturer to provide protection against the effects of

discharge from a cardiac defibrillator and burns.

■ 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.

■ SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal

levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO measurement.

■ For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is

approximately equal to the amount of COHb that is present.

NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are

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

■ For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%.

At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.

■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 and SpCO® measurements.

(including pulsating strobe lights) directed on the sensor, may not allow the Pulse

respiration rate reading from the Acoustic Respiration

oximeter should not be used as a replacement or substitute for ECG

oximeter can not measure

Rad-87 Pulse CO-Oximeter Operator’s Manual

Safety Information, Warnings, Cautions and Notes, continued

■ 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 m

■ 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.

■ 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 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

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

perform inaccurately or fail.

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

until qualiﬁ ed service personnel have corrected the situation.

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

■

Do not monitor more than a single patient at a time on the Rad-87.

■ Disposal of product - Comply with local laws in the disposal of the instrument 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 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

Rad-87 Pulse CO-Oximeter Operator’s Manual

instrument to perform inaccurately or fail.

This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA.

This

device (1) This received, including interference that may cause undesired operation.

complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

device

may not cause harmful interference, and (2) this

and SpOC readings.

instrument might read zero for the duration of the

easurements.

instrument may cause it to

instrument from operation

device

must accept any interference

iii

Safety Information, Warnings, Cautions and Notes, continued

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 (instrument with optional radio) wirelessly transmits real-time sensor connectivity status,

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

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

greater than 20 cm from the patient or nearby persons.

■ In accordance with FCC requirements, radio accessories on the Rad-87 (instrument 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 instrument during operation.

■ Ensure the speaker is not covered or the instrument 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 instrument on surfaces with visible liquid spills.

■ Do not soak or immerse the instrument in liquids.

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

device.

■ Use cleaning solutions sparingly.

■ Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration

(FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. The device and related accessories are not intended for use in combination with other medical devices or in high-risk applications.

Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents

Safety Information, Warnings, Cautions and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

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

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

SpO

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

SpMet General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpHb (Total Hemoglobin) General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

CaO2 (Total Arterial Oxygen Content) General Description . . . . . . . . . . . . . . . . . .1-5

SpOC (Pulse CO-Oximetry) General Description. . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Rainbow Acoustic Monitoring 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 SpO

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

Rainbow Acoustic Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

FastSat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Masimo Rainbow SET Parallel Engines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Masimo SET DST® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Measurements . . . . . . . . . 1-7

SECTION 2 - SYSTEM DESCRIPTION

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

Rad-87 Pulse CO-Oximeter - Horizontal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Rad-87 Pulse CO-Oximeter - Vertical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

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

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

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

SECTION 3 - SETUP

Rad-87 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

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

System Interface Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Philips VueLink Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

RadNet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Patient SafetyNet Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents

SECTION 4 - OPERATION

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

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

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

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

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

Successful Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Masimo Pulse CO-Oximetry Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Masimo Acoustic Respiration Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Sensor Time Remaining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Liquid Crystal Display (LCD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Light Emitting Diodes (LED) Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Numeric Display - SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Numeric Display - Pulse Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Numeric display - RRa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Numeric Display - SpCO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Numeric Display - SpHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Numeric Display - SpOC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Numeric Display - PI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Numeric Display - PVI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Signal Indication and Quality Indicator (SIQ) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Low SpCO SIQ and Low SpMet SIQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Low SpHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Signal Indication and Quality Indicator - Acoustic (SIQa) . . . . . . . . . . . . . . . . . 4-13

Acoustic Respiration Sensor Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Rainbow SET, Masimo SET Sensor Placement . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Low Battery Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Normal Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Parameter/Measurement Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Menu Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Setup Menu Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Parameter/Measurement Alarm Limits - Screen 1 . . . . . . . . . . . . . . . . . . . . . . . 4-18

Parameter/Measurement Alarm Limits - Screen 2 . . . . . . . . . . . . . . . . . . . . . . . 4-19

Parameter/Measurement Alarm Limits - Screen 3 . . . . . . . . . . . . . . . . . . . . . . . 4-20

LED Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Setup Menu Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

SpO2 Alarm Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

RRa Alarm Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Clear Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Button Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

FastSat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Trend Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

TrendCom Utility Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

TrendCom Utility Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents

Download Trend Data from Rad-87. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Erasing Trend Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Setup Menu Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

SpO2 Averaging Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

SpHb Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

PVI Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

PI Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

RRa Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

RRa Sensor Status Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Rapid Desat Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Alarm On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Optical Sensor Off Audible Alarm Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Device Profile Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

SmartTone On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Month . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Hour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Minute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Serial Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Interface Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Polarity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Line Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Parameter/Measurement Select - Screen 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

Parameter/Measurement Select - Screen 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

Parameter/Measurement Select - Screen 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

SpHb Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

SpHb Calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

LCD Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

SpHb Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Set Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Home Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Sleep Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Enable/Disable Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

LCD Display Function with Radio Configured and Enabled . . . . . . . . . . . . . . . . 4-42

SECTION 5 - ALARMS AND MESSAGES

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

Alarm Category Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

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

Alarm Limit: User Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Multiple Parameter/Measurement Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

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

Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Alarm Bell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

System Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

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Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

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

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

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

Serial Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

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

SECTION 8 - SENSORS & PATIENT CABLES

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

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

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

Masimo Acoustic Respiration Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

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

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

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

Rainbow R Series Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Rainbow ReSposable™ Pulse CO-Oximeter Sensor System . . . . . . . . . . . . . . . 8-4

Masimo SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

ReSposable™ Pulse CO-Oximeter Sensor System . . . . . . . . . . . . . . . . . . . . . . 8-4

Red Direct Connect Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

LNOP® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

LNOPv™ Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

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

M-LNCS™/LNCS® Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

M-LNCS™/LNCS® Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

M-LNCS™/LNCS® Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Sensor Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Cleaning And Reuse Of Masimo Reusable Sensors and Cables . . . . . . . . . . . . . . . . . . 8-7

Reattachment of a Single Use Acoustic Respiration Sensor . . . . . . . . . . . . . . . . . . . . . 8-7

Reattachment of a Single Use Rainbow SET or Masimo SET Adhesive Sensor . . . . . . 8-7

SECTION 9 - SERVICE & MAINTENANCE

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

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

Battery Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Performance Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

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

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

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

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

End-User License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

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

No Implied License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents

Sensors Licensed for Monitoring Use Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

SECTION 10 - PART NUMBERS

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

Rad-87 Pulse CO-Oximeter Operator’s Manual

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.

SECTION 8 Sensors

Masimo sensors and cables.

SECTION 9 Service & Maintenance describes how to maintain, service and obtain

SECTION 10

Rad-87 Pulse CO-Oximeter Operator’s Manual

repair for the Rad-87 instrument. The Sales and End User License Agreement, including Warranty, is also in this section.

Part Numbers lists the part numbers of the different language Operator's

Manuals that are available for the Rad-87 Pulse CO-Oximeter.

& Patient Cables outlines how to use and care for compatible

1-1

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 instrument 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.

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

Product Description

The Rad-87 Pulse CO-Oximeter Monitor is a noninvasive, arterial oxygen, carboxyhemoglobin, methemoglobin saturation, total hemoglobin concentration, total arterial oxygen content, pulse rate and respiration rate monitor. The Rad-87 features an LED display screen that continuously displays numeric values for SpO2, SpCO*, SpMet*, SpHb*, total arterial oxygen content (SpOC*), perfusion index (PI), pleth variability index* (PVI), pulse rate and respiratory/respiration rate (RRa*). It also provides bar graph displays for quick visual identification of Signal I.Q.® (SIQ™), perfusion index (PI), acoustic Signal Identification Quality (SIQa*) and Respiration Indicator (RI*). 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 specificity pulse CO-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 I.Q. provides signal identification 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, Trend Setup and Use.)

■ Allows user to customize the default settings and set the instrument 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).

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.

■ Rainbow Acoustic Monitoring uses acoustic monitoring technology to measure and display

respiration rate (RRa) while providing the Respiration Indicator (RI) at the sensor site.

■ Pleth Variability Index (PVI)† may show changes that reflect 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 oxygen

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

■ Provides an 802.11a/b/g wireless radio interface with compatible systems (wireless radio model only).

■ Ability to connect to Masimo Patient SafetyNet through a wireless network (wireless radio model only).

* Optional features: SpCO, SpMet, SpHb, SpOC, PVI, RRa, RI, SIQa †

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.

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Overview

Indications for Use

The Masimo Rainbow SET® Rad-87 Pulse CO-Oximeter and accessories are indicated for

the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration and/or respiratory rate (RRa).The Masimo Rainbow SET Rad-87 Pulse CO-Oximeter 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.

Note: Please refer to the sensor Directions for Use (DFU) for specific indications.

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 fingertip 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 figure shows the general monitoring setup.

NORM

APOD

MAX

SENSITIVITY MODE

SIQa

RRa

rbc monitor

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 fingertip 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 reflect 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 fingertip 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

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

instrument. The instrument displays the calculated data as percentage value for the SpMet.

SpHb (Total Hemoglobin) General Description

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 SpO2 monitor with other available parameters/measurements.

CaO2 (Total Arterial Oxygen Content) 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 (CaO2) and is measured in units of ml O2/dl blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen, 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)

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

* Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lippincott

Williams & Wilkins, 1999.

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

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

) as measured by a pulse oximeter is given by:

SpO

= 1.02 x HbO2

SpOC (Pulse CO-Oximetry) General Description

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 O2/g Hb is multiplied by g/dL of Hb, the gram unit in the denominator of ml/g cancels the gram unit in the

numerator of g/dL resulting in ml/dl (ml of oxygen in one dl of blood) as the unit of measure for SpOC.

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

Rainbow Acoustic Monitoring General Description

Rainbow Acoustic Monitoring continuously measures a patient's respiration rate based on airflow sounds generated in the upper airway. The Acoustic Respiration Sensor translates airflow sounds generated in the upper airway to an electrical signal that can be processed to produce a respiration rate, measured as breaths per minute.

Rad-87 Pulse CO-Oximeter Operator’s Manual

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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 figure below).

Absorption Spectra

4.0

3.5

3.0

2.5

2.0

1.5

Absorption (1/mm)

1.0

0.5

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 figure below. Signal data is obtained by passing various visible and infrared lights (LED’s, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25mW. The detector receives the light, converts it into an electronic signal and sends it to the Rad-87 for calculation.

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

2. Detector

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), verified by Masimo sensor skin temperature test procedure.

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

Functional Saturation

The Rad-87 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.

Rad-87 vs. Drawn Whole Blood Measurements

When SpO2, SpCO, SpMet and SpHb measurements obtained from the Rad-87 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2, SpCO, SpMet and SpHb measurements of the Rad-87 Pulse CO-Oximeter. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO, different results are also expected if concentration of methemoglobin in the blood gas sample is elevated. High levels of bilirubin may cause erroneous SpO2, SpMet, SpCO and SpHb 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 fluids 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 SpO2 Measurements

Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the 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 filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST®) reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

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 "---".

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Overview

Rainbow Acoustic Monitoring

Rainbow Acoustic Monitoring is a real time, continuous, non-invasive method for measuring respiration rate based on respiratory sounds. Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1]. These respiratory sounds often have different characteristics depending on the location of recording [2] and they originate in the large airways where air velocity and air turbulence induce vibration in the airway wall. These vibrations are transmitted, for example, through the lung tissue, thoracic wall and trachea to the surface where they may be heard with the aid of a stethoscope, a microphone or more sophisticated devices.

Rainbow Acoustic Monitoring Architecture

The following figure illustrates how a respiratory sound produced by a patient can be turned into a numerical measurement that corresponds to a respiratory parameter.

Patient Sensor

Respiratory Airflow to Sound

Sound to Electrical Signal

Envelope Detection

Acquisiton System

Electrical Signal to Digital Signal

RRa Estimation

Signal Processing

Digital Signal to Respiratory Measurement

Patient

The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways. Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are recorded as respiratory sounds. Although the spectral shape of respiratory sounds varies widely from person to person, it is often reproducible within the same person, likely reflecting the strong influence of individual airway anatomy [2-6].

Sensor

The sensor captures and transmits respiratory sounds (and other biological sounds) much like a microphone does. When subjected to a mechanical strain, (e.g., surface vibrations generated during breathing), the sensor becomes electrically polarized. The degree of polarization is proportional to the applied strain. This is known as the ‘Piezoelectric effect’ in this manual. The output of the sensor is an electric signal that includes a sound signal that is modulated by inspiratory and expiratory phases of the respiratory cycle.

Acquisition System

The acquisition system converts the electrical signal provided by the sensor into a digital signal. This format allows the signal to be processed by a computing device.

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

Signal Processing

The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest. As shown in the figure on the previous page, this can be performed by, for example, determining the digital signal envelope or outline which in turn may be utilized to determine the respiratory rate. In this way, a real-time, continuous breath rate parameter can be obtained and displayed on a monitor which, in many cases, may be realtime and continuous.

The respiratory cycle envelope signal processing principle is similar to methods that sample airway gases and subsequently determine a respiratory rate.

[1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G. Righini, S.A.T. Stoneman. Definition of terms for

applications of respiratory sounds. Eur Respir Rev 2000; 10:77, 597-610.

[2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis lectures on biomedical engineering #8. Morgan

& Claypool Publishers, 2006. [3] Olsen, et al. Mechanisms of lung sound generation. Semin Respir Med 1985; 6: 171-179. [4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds – Advances beyond the stethoscope. Am J Respir Crit

Care Med 1977; 156: 974-987. [5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol

1996; 80: 5-13. [6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath sounds. J Appl Physiol 1981; 50: 307-314.

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 Rad87 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.

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Masimo Rainbow SET Parallel Engines

This ﬁ gure is for conceptual purposes only.

FST

MST

Overview

SpOC

Masimo SET DST®

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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 mea

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 instrument 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 instrument (Horizontal) or on the left of the instrument (Vertical).

surement information, as well as instrument status data, is displayed on

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1234567890123456

APOD

MAX

NORM

APOD

MAX

NORM

System Description

Rad-87 Pulse CO-Oximeter - Horizontal

1 3

NORM

APOD

SENSITIVITY

MODE

SENSITIVITY

MAX

SIQa

1618

RRa

CONTROL / INDICATOR DESCRIPTION

The Device (instrument) Profile LED illuminates when the instrument has been set to user configured "default" settings. Upon power up, the user configured default settings are retained and

Device Profile

LED

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 instrument is returned to the user configured default settings or powered off.

678

DISPLAY

1110

ENTER

Rad-87

rbc monitor

2-2

Sensitivity

Button/Indicator

LCD Display

Signal I.Q. Index

Perfusion Index

Used to set the instrument into Maximum Sensitivity, Normal Sensitivity, or APOD Mode.

The LCD display identifies system settings, monitoring modes, alarm limits, and information from Patient SafetyNet or Philips VueLink (when connected).

The Signal I.Q. 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.

The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal.

Rad-87 Pulse CO-Oximeter Operator’s Manual

System Description

CONTROL / INDICATOR DESCRIPTION

Off: No connection to Masimo Patient SafetyNet or other compatible interface system.

Wireless

Indicator

Alarm Limits

Button

Display Button

DISPLAY

Flashing Green: Rad-87 attempts to connect to Patient SafetyNet or other compatible interface system.

Solid Green: Rad-87 is connected to the Patient SafetyNet or other compatible interface system.

Used to enter the alarm menu to adjust Hi/Low SpO2, SpCO, SpMet, SpHb, PI, PVI, RRa and pulse rate alarm limits.

The LED indicator (located above the Alarm Limits Button) will

illuminate when one or more of the factory default alarm settings is

changed to alert the user to verify alarm settings.

Allows movement through the 3 different display screens to view sets of parameters and measurements.

Also used to exit setup menu screens and return the display to screen 1.

Press and hold the button down for 5 seconds to scroll through instrument settings on the LCD Display.

Alarm Bell

The Alarm Bell flashes red to indicate a high priority alarm.

Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the “SEN OFF” message is flashing (i.e. the sensor is

Alarm Silence

Button

removed from the patient) to acknowledge the end of monitoring. In this state, all further alarms are silenced until the Pulse CO-Oximeter starts measuring patient parameters/measurements again.

NOTE: The alarm silence time can be set for 120, 90, 60 and

30 seconds.

Solid Green: Collecting data, no alarms.

Solid Yellow:

1. low priority alarms.

2. Not monitoring and no alarms.

System Status

Light

3. Sleep Mode.

4. Interface Alarms "Alarm Tones Off".

5. RRa mode only, no alarms.

Flashing Yellow:

1. Low parameter/measurement confidence.

2. Medium priority alarms.

Flashing Red: High priority alarms.

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System Description

CONTROL / INDICATOR DESCRIPTION

Enter Button

Brightness

Button

Up Button

Down Button

Respiration

Indicator

Rainbow Acoustic

Monitoring Signal Quality

Battery Charge Level Indicator

SIQa

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

Controls the level of the brightness for the LED display by providing 4 levels of brightness. Each press of the button increases the brightness one level. Once level 4 is accessed, an additional press of the button returns the brightness to level 1. Press the Enter Button to save the desired choice.

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 or the numeric value for the parameter/measurement alarm feature.

Pressing and holding down these buttons allow for the rapid scrolling of alarm limits.

The Respiration Indicator (RI) displays the level of sound that is detected by the Acoustic Respiration Sensor. A tall vertical line indicates a high sound level, while a short vertical line indicates a low sound level. During SpO2 only or combined SpO2 and Rainbow Acoustic Monitoring, the bar will be green. During Rainbow Acoustic Monitoring only, the bar will be orange.

The Rainbow Acoustic Monitoring Signal Quality (SIQa) displays the confidence in the RRa value displayed on the monitor. A tall vertical line indicates high confidence, while a short vertical line indicates low confidence. During SpO2 only or combined SpO2 and Rainbow Acoustic Monitoring, the bar will be green. During Rainbow Acoustic Monitoring only, the bar will be orange.

Provides a visual representation of the battery charge status.

When plugged into an AC outlet, only the first bar is illuminated. When unplugged, bars illuminate to indicate battery charge. As the battery discharges power, bar illumination decreases from right to left.

A low battery status is indicated by a low audible beep and the first battery bar to the left flashing green.

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AC Power Indicator

Power Button

Pulse CO-Oximeter Patient Cable Connector

Speaker

The AC Power Indicator is illuminated when the Rad-87 is connected to AC power and during battery charging.

Used to turn the instrument on and off. Press the button once to power on the device. Press the button for 2 seconds to power off the device.

Connects to a Masimo Pulse CO-Oximeter sensor or Masimo Pulse CO-Oximeter Patient Cable with a sensor.

Provides audible indication of alarm conditions, pulse tone and feedback for key-presses.

Rad-87 Pulse CO-Oximeter Operator’s Manual

MAX

NORM

System Description

Rad-87 Pulse CO-Oximeter - Vertical

888

8 8 8

888

SIQa

NORM

MAX

97 76

RRa

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Rad-87 Rear Panel

System Description

Nurse Call Connector

Serial Output Connector

Equipotential Ground Connector

Use the 1/4” round Connector to interface with a nurse call system. This is a stereo output and should be utilized with a stereo cable. All external device connections to the Nurse Call Connector must be IEC60950 compliant.

Use the Serial Output Connector to connect a serial device, including a serial printer, RadNet Interface Module, or PC, to the Rad-87. See Section 7, Output Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant.

Use the Equipotential Ground Connector for grounding.

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AC Power Receptacle

For continuous operation and/or battery recharging, plug the AC power cord into an AC power receptacle.

Rad-87 Pulse CO-Oximeter Operator’s Manual

System Description

Symbols

The following symbols may be found on the Rad-87 or packaging and are defined below:

RS-232

Equipotential Ground Terminal

Consult accompanying documents

Nurse Call Interface

WEEE compliant

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

Rx Only

5%-95% RH

+70 C

-40 C

+1060 hPa - +500 hPa 95 mmHg - 375 mmHg

EC REP

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

Year of manufacture

Storage humidity range: 10% to 95%

Storage temperature range: -40˚C to +70˚C Storage altitude range: 500 mbar to 1060 mbar

Keep dry

Fragile/breakable, handle with care

Indicates wireless Radio signal (wireless radio model only)

EU authorized representative

Deﬁ brillation Proof Type BF

Caution

Manufacturer

Electrical Testing Laboratory cer tification

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LCD Display

The LCD Display shows radio communication information when radio communication is active (wireless radio model only). It also shows system information. All Rad-87 models are equipped with an LCD display which is located on the top panel of a horizontal model, or on the left side panel of a vertical model.

The LCD Display illuminates upon start up and displays the installed parameter/measurement's low and high alarm limits. Once the Rad-87 completes system initiation, the display light turns off. As the front panel buttons are pressed, each menu selection is shown on the LCD Display.

When Rad-87 actively communicates with another system using the radio feature, the LCD Display shows the following:

■ Patient SafetyNet: The LCD Display shows the information sent from the Patient

SafetyNet to the Rad-87.

■ Philips VueLink: The LCD Display shows "VueLink Conn" and "Alarm Tones On" or

"Alarm Tones Off".

NOTE: When the Rad-87 is interfaced to the Philips VueLink and the LCD Display shows

"Alarm Tones On", audible alarms are active at the instrument. When the LCD Display

shows "Alarm Tones Off", audible alarms are inactive at the instrument.

If the Display Button is pressed down for 5 seconds, the LCD Display shows the following settings three times and then returns to the default screen. The display cycle can be interrupted by pressing any button except for the Sensitivity or the Alarm Silence Buttons.

■ System Settings

■ Monitoring Mode: Normal, Sleep or Home

■ Installed parameter/measurement's low and high alarm limits

■ Sensor Time (if applicable)

■ Audible Alarm

■ Alarm Volume

■ Alarm Silence

■ Alarm Delay

■ Rapid Desat

■ Sensitivity

■ Averaging Time

System Description

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Setup

Rad-87 Setup

Introduction

Before the Rad-87 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged.

Unpacking and Inspection

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

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

Preparation for Monitoring

The following sections of the manual describe the preparation, set-up and initial installation of the Rad-87 Pulse CO-Oximeter.

Rad-87 Power Requirements

Always use a hospital grade, AC power cable to connect the Rad-87 to an AC power source.

Verify the AC power voltage and frequency before use. Verify the power source can provide adequate power rating as indicated on the rear panel of the Rad-87. The Rad-87 is designed to operate on 100 to 240VAC, 47-63 Hz. The instrument is rated at 20 VA max.

Connect a hospital grade power cable to the power entry module of the Rad-87 device(IEC-320 connector type at the device). Connect the power cable to an AC power source. Ensure the instrument is adequately powered by verifying that the AC power indicator on the Rad-87 is illuminated.

CAUTION:

• Connect the Rad-87 only to a hospital-grade receptacle (for hospital use).

• Do not under any circumstances remove the grounding conductor from the power

plug.

• Do not use extension cords or adapters of any type. The power cord and plug must

be intact and undamaged.

• Use the power cord as the means to disconnect the instrument from the main power

supply.

• If there is any doubt about the integrity of the protective earth conductor

arrangement, operate the Rad-87 on internal battery power until the AC power supply protective conductor is fully functional.

• To ensure patient electrical isolation, connect only to other equipment with

electrically isolated circuits.

• Do not connect to an electrical outlet controlled by a wall switch or dimmer.

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