Masimo Rad-8 Bedienungsanleitung

Rad-8®

Pulse Oximeter

Signal Extraction Pulse Oximeter

OPERATOR’S MANUAL

Rad-8

Pulse Oximeter

Signal Extraction Pulse Oximeter

OPERATOR’S MANUAL

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual i

The Rad-8 Operating Instructions provide the necessary information for proper operation of the Rad-8 device.

General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-8 are a

prerequisite for its proper use. Do not operate the Rad-8 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.: 949-297-7000

Fax.: 949-297-7001

www.masimo.com

EU Authorized Representative for Masimo Corporation:

EC REP

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

Tel.: +49-511-62 62 86 30

Fax.: +49-511-62 62 86 33

80fk

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC

SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE

WITH UL 60601-1/CAN/CSA C22.2 No. 601.1

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 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, 6,360,114, 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.

SET, Radical, , Rad-8, Signal IQ, SIQ, FastSat, LNOP and LNCS are federally registered trademarks of Masimo

Corporation.

M-LNCS, M-LNC, LNOPv and APOD are trademarks of Masimo Corporation.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-8 Pulse 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-8 in the presence of ﬂammable anesthetics or other ﬂammable

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 Oximeter to obtain readings.

■The Rad-8 is NOT intended for use as an apnea monitor.

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

hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely

understand the patient’s condition.

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

may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or

substitute for ECG based arrhythmia analysis.

■The Rad-8 is to be operated by qualiﬁed personnel only. This manual, accessory directions for use, all

precautionary information, and speciﬁcations should be read before use.

■Electric shock hazard. Do not open the Rad-8 device. Only a qualiﬁed operator may perform

maintenance procedures speciﬁcally described in this manual. Refer servicing to Masimo for repair of

this equipment.

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

entanglement or strangulation.

■Do not place the Rad-8 or accessories in any position that might cause it to fall on the patient. Do not

lift the Rad-8 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.

■SpO2is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with

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 SpO2measurement.

■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.

■Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2measurements. When

elevated levels of MetHb are suspected, laboratory analysis (co-oximetry) of a blood sample should

be performed.

■Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2measurements. When elevated

levels of COHb are suspected, laboratory analysis (co-oximetry) of a blood sample should be

performed.

■Elevated levels of Total Bilirubin may lead to inaccurate SpO2measurements.

■Severe anemia may cause erroneous SpO2readings.

■Do not use the Rad-8 or sensors during magnetic resonance imaging (MRI) scanning. Induced current

could potentially cause burns.The Rad-8 may affect the MRI image and the MRI device may affect the

accuracy of the Pulse Oximetry parameters and measurements.

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

■If using Rad-8 during full body radiation, keep the sensor out of the radiation ﬁeld. 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-8 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-8

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-8 where the controls can be changed by the patient.

■Do not place the Rad-8 face against a surface. This will cause the alarm to be mufﬂed.

■Do not place the Rad-8 on electrical equipment that may affect the Pulse Oximeter, preventing it from

working properly.

■Do not expose the Rad-8 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-8. Liquids spilled on the device may cause it

to perform inaccurately or fail.

■If the Rad-8 fails any part of the setup procedures or leakage tests, remove the device from operation

until qualiﬁed service personnel have corrected the situation.

■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-8 can be used during deﬁbrillation, but the readings may be inaccurate for up to 20

seconds.

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

EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits are designed to provide

reasonable protection against harmful interference in a typical medical installation. This equipment

generates, uses and can radiate radio frequency energy and, if not installed and used in accordance

with the instructions, may cause harmful interference to other devices in the vicinity. However, there

is no guarantee that interference will not occur in a particular installation. If this equipment does

cause harmful interference to other devices, which can be determined by turning the equipment

off and on, the user is encouraged to try to correct the interference by one or more of the following

measures:

■Reorient or relocate the receiving device.

■Increase the separation between the equipment.

■Consult the manufacturer for help.

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

■ Ensure the speaker is not covered or the device is not 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-8 Signal Extraction Pulse Oximeter Operator’s Manual

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

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

SpO2General Description................................................................................................ 1-4

Principle of Operation....................................................................................................... 1-4

Functional Saturation........................................................................................................ 1-5

Rad-8 vs. Drawn Whole Blood Measurements................................................................. 1-5

Signal Extraction Technology (SET) for SpO2Measurements ........................................ 1-6

FastSat.............................................................................................................................. 1-6

Masimo SET Parallel Engines .......................................................................................... 1-6

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

SECTION 2 - SYSTEM DESCRIPTION

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

Rad-8 Front Panel (Horizonatal Model)....................................................................................... 2-2

Rad-8 - Front Panel (Vertical Model)............................................................................................ 2-2

Rad-8 Front Panel Controls/Indicators ......................................................................................... 2-3

Rad-8 Rear Panel......................................................................................................................... 2-4

Symbols........................................................................................................................................ 2-5

SECTION 3 - SETUP

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

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

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

Power Requirements ........................................................................................................ 3-1

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

Factory Default and User Configurable Settings .............................................................. 4-3

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

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

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

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

Numeric Display - PI......................................................................................................... 4-5

Low Perfusion ................................................................................................................... 4-5

Actions to be Taken .......................................................................................................... 4-6

Signal IQ - (SIQ)............................................................................................................... 4-6

Sensor Placement ............................................................................................................ 4-7

Sensitivity.......................................................................................................................... 4-7

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

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

Setup Menu ...................................................................................................................... 4-9

Menu Navigation............................................................................................................... 4-9

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

table of contents

SECTION 4 - OPERATION (CONTINUED)

Setup Menu Level 1 ......................................................................................................... 4-9

Alarm Limits...................................................................................................................... 4-9

LED Brightness............................................................................................................... 4-10

Setup Menu Level 2 ....................................................................................................... 4-10

Alarm Volume ................................................................................................................. 4-10

Alarm Silence ................................................................................................................. 4-11

Alarm Delay .................................................................................................................... 4-11

Clear Trend ..................................................................................................................... 4-12

Button Volume................................................................................................................. 4-12

Sensitivity........................................................................................................................ 4-13

FastSat............................................................................................................................ 4-13

Setup Menu Level 3 (Enter Button + Down Button Menu Settings) ............................. 4-14

Averaging Time............................................................................................................... 4-14

Rapid Desat Limit ........................................................................................................... 4-15

Alarm On/Off................................................................................................................... 4-15

Default Settings .............................................................................................................. 4-16

SmartTone On/Off........................................................................................................... 4-16

Year................................................................................................................................. 4-17

Month.............................................................................................................................. 4-17

Day ................................................................................................................................. 4-18

Hour ............................................................................................................................... 4-18

Minute ............................................................................................................................ 4-19

Software Version ............................................................................................................ 4-19

Serial Output ................................................................................................................. 4-20

Interface Alarms ............................................................................................................ 4-20

Nurse Call....................................................................................................................... 4-21

Polarity............................................................................................................................ 4-21

Setup Menu Level 4 (Enter Button + Up Button Menu Settings) .................................. 4-22

Set Mode ........................................................................................................................ 4-22

System Interfaces....................................................................................................................... 4-22

Philips VueLink Setup ..................................................................................................... 4-22

Patient Safety Net/RadNet Setup ................................................................................... 4-22

Trend Setup and Use.................................................................................................................. 4-23

Introduction..................................................................................................................... 4-23

Trend Utility Installation................................................................................................... 4-23

TrendCom Utility Operation............................................................................................. 4-23

Erasing Trend Memory.................................................................................................... 4-23

Trend Data Format.......................................................................................................... 4-24

Sample Trend Output...................................................................................................... 4-24

Home Mode Operation................................................................................................... 4-25

Sleep Mode Operation ................................................................................................... 4-25

SECTION 5 - ALARMS AND MESSAGES

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

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

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

Alarm Silence ..................................................................................................................... 5-3

Alarm Bell ........................................................................................................................... 5-3

Alarm On/Off ...................................................................................................................... 5-3

Messages ..................................................................................................................................... 5-4

Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual

SECTION 6 - TROUBLESHOOTING

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

SECTION 7 - SPECIFICATIONS

Rad-8 Specifications .................................................................................................................... 7-1

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

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

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

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

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

Serial Interface Specifications...................................................................................................... 7-3

Serial Interface Setup ...................................................................................................... 7-3

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

Nurse Call Specifications ............................................................................................................. 7-4

Nurse Call......................................................................................................................... 7-4

SECTION 8 - SENSORS & PATIENT CABLES

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

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

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

Masimo SpO2Sensors................................................................................................................. 8-2

Red Direct Connect Sensors ........................................................................................... 8-2

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

LNOPv™Adhesive Sensors ............................................................................................ 8-3

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

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

LNCS®Adhesive Sensors ............................................................................................... 8-4

M-LNCS™DCI®& DCIP Sensors................................................................................... 8-4

Sensor Accuracy.............................................................................................................. 8-5

Cleaning And Reuse Of Masimo Reusable Sensors and Cables.................................... 8-5

Reattachment of Single Use Adhesive Sensors .............................................................. 8-5

SECTION 9 - SERVICE AND MAINTENANCE

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

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

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

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

SECTION 10 - ACCESSORIES

Accessories ................................................................................................................................ 10-1

table of contents

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

overview

About This Manual

This manual explains how to set up and use the Rad-8 Pulse Oximeter. Important safety

information relating to general use of the Rad-8 Pulse Oximeter appears before this introduction.

Other important safety information is located throughout the manual where appropriate.

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

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

SECTION 1 OVERVIEW gives a general description of pulse oximetry.

SECTION 2 SYSTEM DESCRIPTION describes the Rad-8 Pulse Oximeter

system and its functions and features.

SECTION 3 SETUP describes how to setup the Rad-8 Pulse Oximeter for use.

SECTION 4 OPERATION describes the operation of the Rad-8 Pulse

Oximetry system.

SECTION 5 ALARMS AND MESSAGES describes the alarm system

messages.

SECTION 6 TROUBLESHOOTING describes troubleshooting information.

SECTION 7 SPECIFICATIONS gives the detailed specifications of the

Rad-8 Pulse Oximeter.

SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and

care for the Masimo SET LNOP and LNCS sensors and Masimo

SET patient cables.

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain,

service and obtain repair for the Rad-8 Pulse Oximeter.

SECTION 10 ACCESSORIES list the available Rad-8 accessories.

Andere Handbücher für Rad-8

Inhaltsverzeichnis

Andere Masimo Medizinische Geräte Handbücher

Masimo

Masimo Pronto Pulse CO-Oximeter Bedienungsanleitung

Masimo

Masimo SafetyNet Alert Bedienungsanleitung

Masimo

Masimo RD SET GE Series Handbuch

Masimo

Masimo Rad-G Bedienungsanleitung

Masimo

Masimo Radical 7 Bedienungsanleitung

Masimo

Masimo Radius PPG Bedienungsanleitung

Masimo

Masimo O3 Regional Oximeter Bedienungsanleitung

Masimo

Masimo Pronto Pulse CO-Oximeter Bedienungsanleitung

Masimo

Masimo iSpO2 Bedienungsanleitung

Masimo

Masimo Radius PCG Bedienungsanleitung

Masimo

Masimo Radius-7 Bedienungsanleitung

Masimo

Masimo Radical-7 Bedienungsanleitung

Masimo

Masimo M-LNCS Series Bedienungsanleitung

Masimo

Masimo Red DCI Bedienungsanleitung

Masimo

Masimo SafetyNet Handbuch

Masimo

Masimo Adhesive Pads Handbuch

Masimo

Masimo Rad-97 Bedienungsanleitung

Masimo

Masimo Rad-87 Bedienungsanleitung

Masimo

Masimo RD rainbow SET MD20 Series Handbuch

Masimo

Masimo NomoLine Luer Series Bedienungsanleitung

Masimo

Masimo sedline Bedienungsanleitung

Masimo

Masimo Rad-8 Bedienungsanleitung

Masimo

Masimo LNCS DBI Series Handbuch

Masimo

Masimo NomoLine-O Sampling Lines Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

Medipost-Nutristoma

Medipost-Nutristoma MD300K2 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

FujiFilm

FujiFilm Sonart Betriebsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung