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Rad-5/5v

Chapter 7: Specifications

www.masimo.com

Masimo

Display/Indicators

Display/Indicator Description

Data Display

Rad5/Rad5v

%SpO

, pulse rate, alarm status, alarm silenced status, Signal IQ/pleth

bar, perfusion index bar, battery status

Rad-5 Only

MAX, FastSat

Indicator Type

LED

Compliance

EMC Compliance

IEC 60601-1 2, Class B

Safety Standards Compliance

ANSI/AAMI ES 60601-1:2005+A1:2012

CAN/CSA C22.2 No. 60601-1:2014

IEC 60601-1:2005+A1:2012

EN/ISO 80601-2-61:2011

IEC 60601-1-8:2006+A1:2012 (Rad-5 only)

Equipment Classification per IEC 60601-1

Type of Protection

Internally powered (Battery power)

Summary of Contents for Rad-5

Page 1: ...Operator s Manual Rad 5 5v Pulse Oximeter...

Page 2: ......

Page 3: ...hysician See instructions for use for full prescribing information including indications contraindications warnings and precautions Masimo Corporation 52 Discovery Irvine CA 92618 USA Tel 949 297 7000...

Page 4: ...www masimo com 2 Masimo 2020 Masimo Corporation...

Page 5: ...and Cautions 12 Compliance Warnings and Cautions 13 Chapter 1 Technology Overview 15 Signal Extraction Technology SET 15 Chapter 2 Description 19 General System Description 19 Front View 19 Back View...

Page 6: ...50 Guidance and Manufacturer s Declaration Electromagnetic Emissions 51 Guidance and Manufacturer s Declaration Electromagnetic Immunity 52 Recommended Separation Distances 54 Symbols 55 Citations 56...

Page 7: ...s cautions and notes A warning is given when actions may result in a serious outcome for example injury serious adverse effect death to the patient or user WARNING This is an example of a warning stat...

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Page 9: ...raging times Features that apply to the Rad 5 only will be indicated with Rad 5 Features These features are common to the Rad 5 family Clinically proven Masimo SET technology performance Applicable fo...

Page 10: ...and motion conditions and for patients who are well or poorly perfused in hospitals hospital type facilities mobile and home environments Rad 5v The Masimo SET Rad 5v Pulse Oximeter is indicated for t...

Page 11: ...osition that might cause it to fall on the patient Do not lift the Rad 5 5v by the patient cable WARNING Explosion hazard Do not use the Rad 5 5v in the presence of flammable anesthetics or other flam...

Page 12: ...is to be operated by qualified personnel only This manual accessory directions for use all precautionary information and specifications should be read before use WARNING The Rad 5 is intended for con...

Page 13: ...lied coloring and texture such as nail polish acrylic nails glitter etc Moisture birthmarks skin discoloration nail aberration deformed fingers or foreign objects in the light path Elevated levels of...

Page 14: ...sor Directions for Use for the specified duration of patient monitoring time Note Physiological conditions that result in loss of pulsatile signal may result in no SpO2 readings Note A functional test...

Page 15: ...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 pa...

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Page 17: ...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 filtering Adaptive filter...

Page 18: ...actual or physiological and the speed timing and behavior of each The stability of the readings over time is affected by the averaging mode being used The longer the averaging time the more stable the...

Page 19: ...n also be used to identify the occurrence of a patient s pulse With motion the plethysmographic waveform is often distorted and may be obscured by noise artifact Shown as a vertical line the SpO2 SIQ...

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Page 21: ...The Rad 5 5v includes the following Rad 5 5v Device For a list of compatible sensors and cables visit http www masimo com Front View Rad 5 Rad 5v No Control Indicator Description 1 Patient Cable Conne...

Page 22: ...onitoring 8 Power On Off Used to turn the unit on and off 9 Battery Level Indicator Indicates the status of batteries See Battery Level Indicator on page 26 10 Visual Alarm Indicator Illuminates when...

Page 23: ...olume Cycles through three volume levels and mute At the loudest level pressing the Pulse Tone Volume button will return the volume to mute 19 Display Brightness Provides control of the front panel in...

Page 24: ...ndicator Description 1 Serial Number Label Located inside battery compartment and on back of device 2 Agency Approvals Label Agency Approvals Label 3 Battery Cover Covers the batteries 4 Battery Cover...

Page 25: ...talled 4 Press and hold the Power On Off Button for 2 seconds to turn the oximeter off See Front View on page 19 5 Press the Power On Off Button to turn the device on again Verify all LEDs light up an...

Page 26: ...ving the sensor from the patient SEn OFF message appears on the display The alarm tone sounds The Visual Alarm Indicator flashes 10 Disconnect the sensor from the patient cable or device Confirm that...

Page 27: ...On Off Button 2 The Rad 5 5v will power down and turn off LED Indicators For LED indicator descriptions and locations see Front View on page 19 To modify the brightness of the LEDs see Menu Level 4 L...

Page 28: ...00 to 75 3 LEDs 75 to 50 2 LEDs 50 to 25 1 LED 25 to 10 1 Flashing LED with Audible Alarm 10 to 0 Normal Patient Monitoring During normal operation the Rad 5 5v Display shows oxygen saturation as SpO2...

Page 29: ...the lowest setting the pulse tone is muted A low pitch tone indicates the highest or lowest setting has been reached In the setup menu system the Up and Down Arrow keys select among the options for ea...

Page 30: ...tlines the default values that the Rad 5 5v revert to after a power cycle Option Default Setting Brightness display Set to pre power down setting Pulse tone volume Set to pre power down setting The fo...

Page 31: ...Averaging Sensitivity FastSat and SmartTone on page 34 They are as follows Normal Sensitivity Nor This is the recommended mode for patients that are experiencing some compromise in blood flow or perf...

Page 32: ...will accompany the display unless the oximeter has been set to Alarm Suspend Mode To modify the alarm limits see Menu Level 2 Averaging Sensitivity FastSat and SmartTone on page 34 Setting Range SpO2...

Page 33: ...Rad 5 patient cable connector see Front View on page 19 and connect the DB 9 end to a COM port on the PC 3 Turn the Rad 5 on 4 Start the TrendCom Utility 5 Select the appropriate COM port number if ne...

Page 34: ...meter Specification Date MM DD YY Time HH MM SS SpO2 001 to 100 or meaning parameter not available Pulse rate 001 to 240 or meaning parameter not available Perfusion Index 00 00 to 20 00 Exception Mes...

Page 35: ...d 5 settings and configuration options are accessed through the menu system The Mode Enter key is used to enter the menu system and to move through the different menu levels Within each level of the s...

Page 36: ...t buttons are pressed Use the Up Arrow key to turn on SmartTone Sensitivity 2 Hi Maximum Nor Normal APO APOD FastSat 1 On Off SmartTone 3 On Off 1 FastSat is automatically enabled in 2 and 4 second av...

Page 37: ...own Arrow Keys to adjust parameter to desired setting Set month Set Day Set Hour Set Minute A valid date must be entered If an invalid date is entered i e February 31 the trend will not turn on and tn...

Page 38: ...and Down keys located on the front panel of the oximeter The following sub sections describe each menu item in more detail The oximeter has options that allow user configuration to suit specific needs...

Page 39: ...andard Mode Use Up or Down Arrow Keys to adjust parameter to desired setting Note The parameter is set selected when the Mode Enter and Next buttons are pressed Sleep Mode SLP LED Display Brightness 4...

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Page 41: ...ufficient for manual corrective action Prompt Death or irreversible injury Having the potential for the event to develop within a period of time usually sufficient for manual corrective action Low Del...

Page 42: ...ded except for the Sleep Mode Power On Alarms are active and Alarm Suspended Indicator is off Push Once Alarm is suspended for 120 seconds and Alarm Suspended Indicator flashes Push Twice Audible alar...

Page 43: ...bars Pulse Search Wait for found pulse This search should occur whenever a sensor is first applied to a patient Pulse bar turns red bottom two LEDs only Low Perfusion Rule out occlusion of blood flow...

Page 44: ...roperly applied and cover the sensor site with opaque material if required Rad 5v Messages The following messages display on Rad 5v Display Message Type Solution NO CBL No cable connected Connect cabl...

Page 45: ...lace sensor as soon as possible NO ADH No adhesive sensor connected Connect adhesive sensor INC ADH Incompatible adhesive sensor Replace adhesive sensor RPL ADH Defective or unrecognized adhesive sens...

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Page 47: ...ife at a faster rate than normal Continuous Speaker Tone Internal Failure Device requires service Press the Alarm Silence button If alarm continues to sound power down the device and remove batteries...

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Page 49: ...ion Index 0 02 to 20 Accuracy ARMS Oxygen Saturation SpO2 No Motion 1 SpO2 from 70 to 100 Adults Pediatrics Infants 2 Neonates 3 Motion SpO2 from 70 to 100 Adults 2 Pediatrics 2 Infants 2 2 Neonates 3...

Page 50: ...when compared to the reference device under a controlled study Resolution Parameter Resolution SpO2 1 PR 1 bpm Electrical Battery Type 4 AA Alkaline 5 Capacity 30 hours 6 Environmental Environmental...

Page 51: ...oz Modes Modes Rad 5 Averaging Mode 2 4 8 10 12 or 16 seconds 7 Sensitivity Normal Maximum and APOD Rad 5v Averaging Mode 8 seconds Sensitivity Normal Alarms Alarm Details High Priority 799 Hz tone 5...

Page 52: ...bar perfusion index bar battery status Rad 5 Only MAX FastSat Indicator Type LED Compliance EMC Compliance IEC 60601 1 2 Class B Safety Standards Compliance ANSI AAMI ES 60601 1 2005 A1 2012 CAN CSA C...

Page 53: ...Guidance and Manufacturer s Declarations Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below The customer or the user of the ME Equipment...

Page 54: ...should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital envir...

Page 55: ...601 Test Level Compliance Level Recommended Separation Distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000 4 3 3 V m 150 kHz to 80MHz 3 V m 80 M...

Page 56: ...operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ME Equipment b Over the frequency range 150 kHz to 80 MHz field strengths shou...

Page 57: ...symbols are found on the Rad 5 5v or packaging and are defined below Symbols Definition Symbols Definition Follow Instructions for Use Consult instructions for use Mark of Conformity to European Medic...

Page 58: ...ive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO Oximeter and ECG monitor 3 Masimo SET technology has been valid...

Page 59: ...5 sodium hypochlorite solution Up to 55 alcohol 0 5 quaternary ammonium chloride solution such as Ecolab Asepti Wipe II Germicidal Wipes or PDI Super Sani Cloth Germicidal Wipes Accelerated Hydrogen...

Page 60: ...ll available LEDs are illuminated and a brief beep tone sounds 2 The oximeter begins normal operation Key Press Button Test With the monitor turned on with the exception of the Power Button press each...

Page 61: ...Verify that an audible alarm occurs and the SpO2 measurement and the Alarm indicator are both flashing 8 Press the Alarm Silence button once and verify that the alarm is silenced and the Alarm Silenc...

Page 62: ...e invoice or other applicable documentation Purchase order number to cover repair if the Rad 5 5v is not under warranty or for tracking purposes if it is Ship to and bill to information Contact person...

Page 63: ...ication reproduction release performance display or disclosure of the Software including the related documentation by the U S Government or any of its agencies shall be governed solely by the terms of...

Page 64: ...nditions or warranties regarding the Product No other warranty applies express or implied including without limitation any implied warranty of merchantability fitness for a particular purpose satisfac...

Page 65: ...hooting 47 Chapter 7 Specifications 49 Chapter 8 Service and Maintenance 44 61 Citations 58 Cleaning 61 Cleaning and Service Warnings and Cautions 12 Compliance 52 Compliance Warnings and Cautions 13...

Page 66: ...ng 25 28 O Operation 33 P Performance Verification 62 Performance Warnings and Cautions 10 Perfusion Index 27 Physical Characteristics 51 Power Rad 5 5v On and Off 27 Power On Self Test 62 Product Des...

Page 67: ...9 Special Menu 39 Standard and Sleep Mode 39 Successful Monitoring for SpO2 and PR 17 25 Symbols 57 T Testing Rad 5 5v with Masimo SET Tester 63 Trend Data Format 34 Trend Settings 33 37 TrendCom Util...

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