Rad-5 and 5v Operators Manual Feb 2016 PDF download

signal extraction pulse oximeter OPERATOR’S

MANUAL

Signal Extraction Pulse Oximeter OPERATOR’S MANUAL

The Rad-5 and Rad-5v Operating Instructions intend to provide the necessary information for proper operation of all Rad-5 and Rad-5v pulse oximeter models. There may be information provided in this manual that is not relevant for your pulse oximetry system. General knowledge of pulse oximetry and an understanding of the features and functions of the Rad-5 and Rad-5v Pulse Oximeter are prerequisites for proper use. Do not operate the Rad-5 or Rad-5v Pulse Oximeter without completely reading and understanding these instructions.

NOTICE Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.

CAUTION: FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. For further information contact: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 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 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 80 fk

Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984 6,850,787, 6,826,419, 6,816,741, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 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. © 2016 Masimo Corporation. All rights reserved. Masimo, SET, , Radical, Rad-5, Signal IQ, APOD, LNOP, LNCS, DCI and FastSat are federally registered trademarks of Masimo Corporation. Rad-5v, TrendCom, SatShare, Discrete Saturation Transform (DST), DCIP, RED, M-LNCS and SIQ are trademarks of Masimo Corporation.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

The Rad-5/5v Handheld Pulse Oximeter’s software program is designed to minimize the possibility of hazards from errors by following sound engineering design processes, Risk Analysis and Software Validation.

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Explosion hazard. Do not use the Pulse Oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

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The Pulse Oximeter is NOT intended for use as an apnea monitor.

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A Pulse Oximeter should be considered an early warning device. As a trend towards patient hypoxemia is indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition.

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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.

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The Pulse Oximeter is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use.

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Electric shock hazard. Do not open the pulse oximeter cover except to replace the batteries. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

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

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Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient. Do not lift the pulse oximeter by the patient cable.

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Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.

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Severe anemia may cause erroneous SpO2 readings.

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Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

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The Rad-5v is not intended for continuous patient monitoring.

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If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation, the reading might be inaccurate or the unit might read zero for the duration of the active radiation period.

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Always remove the sensor from the patient and completely disconnect the patient from the pulse oximeter before bathing the patient.

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Do not place the pulse oximeter where the controls can be changed by the patient.

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Do not place the pulse oximeter face against a surface. This will cause the alarm to be muffled.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES

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Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter, preventing it from working properly.

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Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail.

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Do not place containers containing liquids on or near the pulse oximeter. Liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail.

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Failure of Operation - If the pulse oximeter fails any part of the setup procedures remove the pulse oximeter from operation until qualified service personnel have corrected the situation.

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

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The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.

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This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ■ Reorient or relocate the receiving device. ■ Increase the separation between the equipment. ■ Consult the manufacturer for help.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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table of contents SECTION 1 - OVERVIEW About this Manual��1-1 Warnings, Cautions and Notes��1-2 Product Description��1-3 Features and Benefits ��1-3 Indications for Use��1-4 Pulse Oximetry��1-5 General Description��1-5 Principle of Operation��1-5 Functional vs. Fractional Saturation��1-5 Measured vs. Calculated Saturation ��1-5 Masimo SET Signal Extraction Technology��1-5 Masimo SET Parallel Engines��1-6 Masimo SET DST ��1-6 SECTION 2 - SYSTEM DESCRIPTION Introduction��2-1 Rad-5/5v Front Panel Controls ��2-2 Rad-5/5v Rear Panel��2-4 Symbols��2-5 SECTION 3 - SETUP Introduction��3-1 Unpacking and Inspection��3-1 Preparation for Monitoring��3-1 Power Requirements ��3-1 Monitor Setup ��3-2 Initial Setup��3-2 SECTION 4 - OPERATION Basic Operation��4-1 General Setup and Use��4-1 Default Settings ��4-3 Successful SpO2 Monitoring��4-4 Numeric Display - SpO2��4-4 Masimo Sensors��4-4 Numeric Display - Pulse Rate ��4-5 Signal IQ and Pulse bar��4-5 Low Perfusion��4-6 Actions To Be Taken��4-6 Sensitivity��4-7 Battery Level Indicator��4-7 Low Battery Audible Alarm��4-8 Normal Patient Monitoring��4-9 Rad-5v Front Panel Control Operation��4-9 Rad-5 Front Panel Control Operation��4-9 Setup Menu (Rad-5 only) ��4-10 Menu Navigation ��4-10 Setup Menu Level 1 – Alarm Limits and Alarm Volume. ��4-10 Setup Menu Level 2 – Averaging, Sensitivity, FastSat and SmartTone��4-11 iv

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

table of contents SECTION 4 - OPERATION (CONTINUED) Setup menu Level 3 – Trend Settings ��4-11 Setup Menu Level 4 – LED Brightness and Factory Defaults��4-12 Trend Setup and Use (Rad-5 only)��4-13 Introduction��4-13 TrendCom Utility Installation��4-13 TrendCom Utility Operation ��4-13 Erasing Trend Memory��4-14 Trend Data Format��4-14 Sample Trend Output��4-14 Special Menu��4-15 Standard and Sleep mode��4-15 Sleep mode Operation��4-15 SECTION 5 - ALARMS AND MESSAGES Alarm Indication��5-1 Alarm limits (Rad-5 only)��5-1 Alarm Silence��5-2 Alarm Silenced ��5-2 Messages��5-3 SECTION 6 - TROUBLESHOOTING Troubleshooting��6-1 SECTION 7 - SPECIFICATIONS Rad-5/5v Specifications��7-1 Performance��7-1 Accuracy��7-1 Electrical��7-1 Environmental��7-1 Physical Characteristics��7-2 SECTION 8 - SENSORS & PATIENT CABLES Introduction��8-1 Masimo SpO2 Sensors and Cables ��8-1 Selecting a Masimo SET Sensor��8-1 Sensor Application Site ��8-2 Red Direct Connect Reusable Sensors ��8-2 LNOP® Adhesive Sensors ��8-2 LNOP® Specialty Sensors ��8-2 LNCS® Reusable Sensors ��8-3 LNCS® Adhesive Sensors ��8-3 LNCS® Specialty Sensors ��8-3 LNOPvTM Adhesive Sensors ��8-3 LNOP® Reusable Sensors ��8-3 M-LNCS™ Reusable Sensors ��8-4 M-LNCS™ Series Adhesive Sensors ��8-4 Cleaning and Reuse of Masimo Reusable Sensors and Cables��8-4 Reattachment of Single Use Adhesive Sensors ��8-5 Masimo SET Patient Cables��8-5

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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table of contents

SECTION 9 - SERVICE AND MAINTENANCE Introduction��9-1 Cleaning ��9-1 Battery Replacement��9-1 Performance Verification��9-2 Service and Repair��9-4 Repair Policy ��9-4 Return Procedure��9-4 Sales & End-User License Agreement��9-5 Warranty ��9-5 Exclusions��9-5 End-User License ��9-6 Restrictions��9-6 SECTION 10 - ACCESSORIES Rad-5 Accessories ��10-1

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

overview

1

About this Manual This manual explains how to set up and use the Rad-5/5v Handheld Pulse Oximeter. Important safety information relating to general use of the Rad-5/5v Pulse Oximeter appears before this introduction. Other important safety information is located throughout the manual where appropriate. Read the entire safety information section before you operate the monitor. In addition to the safety section, this manual includes the following sections: SECTION 1

OVERVIEW gives a general description of pulse oximetry.

SECTION 2 SYSTEM DESCRIPTION describes the Rad-5/5v Handheld Pulse Oximeter system and its functions and features. SECTION 3 SETUP describes how to setup the Rad-5/5v Handheld Pulse Oximeter for use. SECTION 4

OPERATION describes the operation of the Rad-5/5v Pulse Oximetry system.

SECTION 5

ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6

TROUBLESHOOTING gives troubleshooting information.

SECTION 7

SPECIFICATIONS gives the detailed specifications of the Rad-5/5v Handheld Pulse Oximeter.

SECTION 8

SENSORS AND PATIENT CABLES outlines how to use and care for the Masimo SET LNOP and LNCS sensors and Masimo SET patient cables.

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Rad-5/5v Handheld Pulse Oximeter. SECTION 10

ACCESSORIES.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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overview Warnings, Cautions and Notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device or damage to other property. Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note.

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Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

overview

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Product Description The Rad-5 family of Handheld Pulse Oximeters are noninvasive, arterial oxygen saturation and pulse rate monitors. The Rad-5 family features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Perfusion Index (PI) and Signal Identification and Quality Indicator (Signal IQ®). The Rad-5 family consists of two models: the full-featured Rad-5 and the Rad-5v entrylevel spot checker. Both devices are built on the same motion tolerant pulse oximetry technology, with the Rad-5 adding parameter alarming, three sensitivity settings and adjustable averaging times. Features that apply to the Rad-5 only will be indicated with “(Rad-5)”. FEATURES AND BENEFITS These features are common to the Rad-5 family: ■ Clinically proven Masimo SET® technology performance ■

Applicable for use on neonate, pediatric and adult patients

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Proven for accurate monitoring in motion and low perfusion environments

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SpO2, pulse rate, alarm, and perfusion index displays

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Signal I.Q. for signal identification and quality indication

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Lightweight, convenient handheld design

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Long battery life: over 30 hours on 4 “AA” alkaline batteries

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Audible Alarm for no sensor, sensor-off, interference detected and low battery

The Rad-5 adds these features: ■

Alarms for High/Low saturation and High/Low pulse rate FastSat®

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SmartTone

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User definable alarm limit settings

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Sleep study mode

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Three sensitivity levels - Max, Normal and APOD®

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Stores up to 72 hours of trending memory

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Adjustable alarm volume

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Adjustable averaging 2 to 16 seconds

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overview INDICATIONS FOR USE Masimo SET® Rad-5 Pulse Oximeter The Masimo SET® Rad-5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad-5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. INDICATIONS FOR USE Masimo SET® Rad-5v Pulse Oximeter The Masimo SET® Rad-5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad-5v Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. Pulse Oximetry GENERAL DESCRIPTION Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects to the pulse oximetry device with a patient cable. The sensor collects signal data from the patient and sends it to the device. The device displays the calculated data in two ways: 1) as a percent value for arterial oxygen saturation (SpO2), and 2) as a pulse rate (PR). The following figure shows the general monitoring setup. 1. Device 2. Patient Cable 3. Sensor

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3

1

PRINCIPLE OF OPERATION Pulse oximetry is governed by the following principles: 1. 2.

Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

The Rad-5/5v Handheld Pulse Oximeter uses a two-wavelength pulsatile system to distinguish between oxygenated and deoxygenated blood. Signal data is obtained by passing 1-4

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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overview red (rd) (660 nm wavelength) and infrared (ir) (905 nm wavelength) light through a capillary bed (for example a fingertip, a hand, a foot) and measuring changes in light absorption during the pulsatile cycle. This information may be useful to clinicians. The radiant power of the light is rated at 0.79mW (max.). See figure below. The Rad-5/5v utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector). The detector receives the light, converts it into an electronic signal and sends it to the Rad-5/5v for calculation.

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1. Light Emitting Diodes (LEDs) 2. Detector

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Once the Rad-5/5v receives the signal from the sensor, it utilizes Masimo SET signal extraction technology for calculation of the patient’s functional oxygen saturation and pulse rate. FUNCTIONAL VS. FRACTIONAL SATURATION The Rad-5/5v is calibrated to measure and display functional saturation: the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Rad-5/5v does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin. To convert fractional saturation to functional saturation, the fractional saturation measurements must be converted according to: Functional saturation =

Fractional saturation 100 - (% carboxyhemoglobin + % methemoglobin)

x 100

MEASURED VS. CALCULATED SATURATION Oxygen saturation measurements obtained from a pulse oximeter are commonly compared to saturations calculated from the partial pressure of oxygen (PO2) obtained from an arterial blood gas sample. When comparing the two measurements and interpreting values, caution should be used, as the calculated value obtained from the blood gas sample may differ from the SpO2 measurement of the pulse oximeter. Different results are usually obtained from the blood gas sample if the calculated saturation is not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. Also, as blood gas samples are usually taken over a period of 20 seconds (the time it takes to draw blood) a meaningful comparison can only be achieved if the core oxygen saturation of the patient is stable and not changing over the period of time that the blood gas sample is taken. MASIMO SET SIGNAL EXTRACTION TECHNOLOGY Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the non-arterial blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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overview 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 TransformTM (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. MASIMO SET PARALLEL ENGINES R/IR

(Conventional Pulse Oximetry)

R/IR

Digitized, Filtered & Normalized

Adaptive Filter with DST®

MEAS CONF Post Processor MEAS CONF

MEAS SST

TM

Proprietary Algorithm 4

Proprietary Algorithm 5

CONF

Confidence Based Arbitrator

Saturation

MEAS CONF

MASIMO SET DST

Graphic, Updated Parallel Engines Algorithm, B/W, 10/06 GR-14518 DRO-15482 1-6

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

system description

2

Introduction The Rad-5 family of Handheld Pulse Oximeters are full featured pulse oximeters designed for ease of operation. All pulse oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel and the sensor cable connection is located at the top edge of the device. The Rad-5/5v are powered by 4 “AA” alkaline batteries, which provide over 30 hours of battery life. ■

Rad-5 family offers full Masimo SET technology in a small, handheld device

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Rad-5 family supports the full line of Masimo sensors and patient cables (see Section 8, sensors and patient cables).

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Rad-5 family supports standardization of sensors and pulse oximetry technology throughout the hospital

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Rad-5v provides essential pulse oximetry features

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Rad-5 includes all the features of the Rad-5v, plus ■

High/Low saturation alarms

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High/Low pulse rate alarms

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User definable alarm limit settings

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Sleep study mode

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Stores up to 72 hours of trending memory

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Adjustable averaging time

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Three sensitivity levels - Max, Normal and APOD FastSat®

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SmartTone

A Red Direct Connect Spot Check Sensor or Masimo Patient Cable and Masimo sensor attach to the connector on the top of the Rad-5/5v. The Rad-5/5v can be used either for spot checks or continuous (Rad-5) SpO2 monitoring.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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system description Rad-5/5v front Panel Controls 1

1

2 3 4 5 MAX

6

10

3

11

4

12

5

10 11 13

13

14

7

15

8

16

9 17

Rad-5

18 19

8 9

17

Rad-5v

CONTROL / INDICATOR

DESCRIPTION

1

Patient Cable Connector

2

FastSat Indicator

3

Saturation Display

he functional arterial hemoglobin oxygen saturation is disT played in units of SpO2. When searching for a saturation and pulse, it will flash dashed lines.

4

Signal IQ / Pulse Bar

he Signal IQ provides an indication of the quality of the T acquired signal as well as the timing of the pulse. A green vertical LED bar rises and falls with the pulse, where the height of the bar indicates the quality of the signal.

5

Pulse Rate Display

The pulse rate in beats per minute (bpm). When searching for a saturation and pulse, it will flash dashed lines.

6

Mode / Enter Button

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

7

Next Button

Used within the menu/setup system to move through setup options. Not active during normal patient monitoring.

onnects to Red Direct Connect Series Spot Check sensor C or Masimo Patient Cable Illuminates when the FastSat mode has been enabled.

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FastSat enables rapid tracking of arterial oxygen saturation changes

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

system description

CONTROL / INDICATOR

DESCRIPTION

8

Power On / Off

Used to turn the unit on and off.

9

Battery Level Indicator

Four LEDs indicate the status of the battery. When the final indicator begins flashing, replace the batteries.

10

Visual Alarm Indicator

Illuminates when any alarm condition exists. This indicator may not be turned-off or otherwise over-ridden.

11

Perfusion Index

The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal. The bar is highest when the quality of the perfused site is best.

12

MAX Sensitivity Indicator

13

Alarm Silenced Indicator

Flashes to indicate the alarm is temporarily silenced (by pushing the Alarm Silence Button once) or is illuminated solid to indicate the alarms have been permanently muted (by pushing the Alarm Silence Button twice) .

14

Alarm Silence Button

Push once to temporarily silence the alarm for 120 seconds. Push a second time to permanently mute (suspend) the alarm. A third push will return the device to standard alarm monitoring.

15 16

Up button Down button

2

Illuminates when the MAX Sensitivity mode has been enabled. Note: When using the Maximum Sensitivity setting, the SENSOR OFF detection performance may be compromised.

During saturation monitoring, use these buttons to adjust the volume of the pulse beep tone. ithin the menu/setup system, these buttons are used to select W values within each menu option. rovides audible indication of alarm conditions, pulse tone and P feedback for key-presses. Ensure the speaker is not covered or the device is placed face-down on bedding or other sound absorbing surface.

17

Speaker

18

Pulse Tone Volume volume levels, and mute. At the loudest level, pressing the Pulse

Provides control of the pulse tone volume. Cycles through three Tone Volume button will return the volume to mute.

19

Display Brightness

Provides control of the front panel indicator brightness. Cycles through four brightness levels. At the brightest level, pressing the Display Brightness button will return the display to the lowest brightness setting.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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system description

2

Rad-5/5v rear panel

1

AA

2

3 1 4

CONTROL / INDICATOR

2-4 4

1

Serial Number Label

2

Agency Approvals Label

3

Battery Cover

4

Battery Cover Release

DEFINITION

Located inside battery compartment and on back of device

Press down and slide the battery cover off the bottom of the oximeter

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

system description

2

SYMBOLS The following symbols are found on the Rad-5/5v or on the packaging and are defined below.

Consult accompanying documents Follow instructions for use (blue background) GR-10199B

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

Rx Only

Federal law restricts this device to sale by or on the order

IC: 7362A-RAD87 of a physician (USA audiences only)

Year of manufacture FCC ID: VKF-RAD87 Storage humidity range Storage temperature range Storage altitude range

ted, WEEE Symbol

Keep dry

line is for reference only; do not print.

EC REP

Fragile/breakable, handle with care EU authorized representative Defibrillation Proof Type BF Caution Underwriter's Laboratory Inc. certification Manufacturer

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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setup

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Introduction Before the Rad-5/5v Handheld Pulse Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be installed. Unpacking and Inspection Remove the device from the shipping carton and examine 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-5/5v Handheld Pulse Oximeter. POWER REQUIREMENTS The Rad-5 and Rad-5v are powered by 4 “AA” alkaline batteries. Do not use any other type of batteries or power source to run the device. The battery compartment is accessed from the back of the device. To install the batteries first remove the battery cover by depressing the small rectangular button at the bottom of the cover, and sliding the cover down off the bottom of the device. Install the batteries in the directions indicated by the battery icons inside the battery compartment. Replace the battery cover by sliding it back up from the bottom of the device until the rectangular locking button snaps back into position. WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER. WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V COULD CAUSE DAMAGE TO THE DEVICE. WARNING: REMOVE BATTERIES IF UNIT IS NOT TO BE USED FOR SOME TIME.

Battery charge level is indicated by four LED indicators at the bottom of the front panel. All four indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their charge. When less than ten (10) percent battery life remains, the final battery indicator will begin to flash and an audible alarm will sound.

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual

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