Masimo Rad-5 Operator's Manual
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Masimo Rad-5 Operator's Manual

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Operator's Manual
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Rad-5
/5v
Pulse Oximeter

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Summary of Contents for Masimo Rad-5

  • Page 1 Operator's Manual ® ® Rad-5 Pulse Oximeter...
  • Page 3 General knowledge of pulse oximetry and an understanding of the features and functions of Rad-5/5v are prerequisites for its proper use. Do not operate Rad- 5/5v without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.
  • Page 4 © 2020 Masimo Corporation. www.masimo.com Masimo...

  • Page 5: Table Of Contents

    Basic Operation ---------------------------------------------------------------------------------------- 25 Advanced Operation -----------------------------------------------------------------------------------28 Chapter 5: Alarms and Messages ---------------------------------------------------------------------- 39 Alarm Indication -------------------------------------------------------------------------------------- 39 Alarm Silence ------------------------------------------------------------------------------------------ 40 Messages ------------------------------------------------------------------------------------------------ 41 Chapter 6: Troubleshooting ------------------------------------------------------------------------------ 45 Troubleshooting Chart -------------------------------------------------------------------------------- 45 Chapter 7: Specifications --------------------------------------------------------------------------------- 47 www.masimo.com Masimo...
  • Page 6 Chapter 8: Service and Maintenance ------------------------------------------------------------------ 57 Cleaning ------------------------------------------------------------------------------------------------- 57 Battery Installation and Replacement ------------------------------------------------------------- 57 Performance Verification ----------------------------------------------------------------------------- 58 Repair Policy ------------------------------------------------------------------------------------------- 60 Return Procedure ------------------------------------------------------------------------------------- 60 Restrictions -------------------------------------------------------------------------------------------- 60 Contacting Masimo ------------------------------------------------------------------------------------ 61 Index --------------------------------------------------------------------------------------------------------- 63 www.masimo.com Masimo...

  • Page 7: About This Manual

    ® ® Pulse Oximeter. Important safety information relating to general use of Rad-5/5v appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, 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.

  • Page 9: Product Description, Features And Indications For Use

    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 entry-level 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.

  • Page 10: Indications For Use

    Product Description, Features and Indications for Use Indications for Use Rad-5 The Masimo SET ® Rad-5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate (measured by an SpO sensor). The Masimo SET ®...

  • Page 11: Safety Information, Warnings And Cautions

    Refer servicing to Masimo for repair of this equipment. WARNING: Do not use Rad-5/5v if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm.

  • Page 12: Performance Warnings And Cautions

    WARNING: Rad-5/5v can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds. WARNING: Do not place the Rad-5/5v face against a surface. This will cause the alarm to be muffled. WARNING: Severe anemia may cause erroneous SpO readings.
  • Page 13 WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings. WARNING: Do not use Rad-5/5v on patients that have been injected with dyes or any substance containing dyes, the change in usual blood pigmentation may cause no or incorrect readings.

  • Page 14: Cleaning And Service Warnings And Cautions

    Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO readings. Note: A functional tester cannot be used to assess the accuracy of Rad-5/5v. Note: Additional information specific to the Masimo sensors compatible with Rad-5/5v, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).

  • Page 15: Compliance Warnings And Cautions

    Safety Information, Warnings and Cautions Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: Per RSS-Gen, Section 8.4 This device complies with Industry Canada license- exempt RSS standard(s).

  • Page 17: Chapter 1: Technology Overview

    ® (SET ® Masimo Signal Extraction Technology's signal processing differs from that of 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).
  • Page 18 Rad-5/5v Chapter 1: Technology Overview ® Masimo SET This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
  • Page 19 Rad-5/5v Chapter 1: Technology Overview Functional Oxygen Saturation (SpO2) The Rad-5/5v is calibrated to measure and display functional oxygen saturation (SpO ): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.

  • Page 21: Chapter 2: Description

    Chapter 2: Description This chapter contains the description of the Rad-5/5v physical features. General System Description 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-5v Rad-5...
  • Page 22 Bar is highest when signal quality is best. MAX Sensitivity Indicator On when MAX Sensitivity mode is enabled. See Sensitivity (Rad-5) on page 29. Alarm Silenced Indicator Displays current alarm silence status. See Alarm Silenced Indicator on page 40.
  • Page 23 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. * Available on Rad-5 only. www.masimo.com Masimo...

  • Page 24: Back View

    Rad-5/5v Chapter 2: Description Back View No. Control / Indicator Description Serial Number Label Located inside battery compartment and on back of device. Agency Approvals Agency Approvals Label Label Battery Cover Covers the batteries. Battery Cover Press down and slide the battery cover off the bottom of the Release Rad-5/5v.

  • Page 25: Chapter 3: Basic Setup And Use

    Chapter 3: Basic Setup and Use 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. This chapter contains information about setting up Rad-5/5v before use.
  • Page 26 Confirm that “NO SEn” message now appears on the display with the alarm tone. NOTE: “NO SEn” and “SEn OFF” will only generate an alarm if the Rad-5/5v is actively monitoring a patient when the sensor is disconnected. 11. Rad-5 only: Check the parameter-violation alarm silence operation.

  • Page 27: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that Rad-5/5v is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Rad-5/5v without completely reading and understanding these instructions.
  • Page 28 During normal operation, the Rad-5/5v Display shows oxygen saturation (as % SpO ) on the upper number and Pulse Rate (in beats per minute) on the lower number. The following sections describe the function of the Rad-5/5v front panel controls during normal patient monitoring. Rad-5 Front Panel Control Operation...
  • Page 29 If a low battery alarm occurs during patient monitoring, press this button to silence the audible alarm for 120 seconds. Pressing this button also permanently silences ‘sensor-off’ or ‘no-sensor’ audible alarms as well as a low battery audible alarm (if the Rad-5 is not monitoring a patient). Pulse Tone Volume Press this button repeatedly to cycle through the pulse tone volume range, and back to the ‘silence’...

  • Page 30: Advanced Operation

    Option Default Setting Brightness display Set to pre-power down setting Pulse tone volume Set to pre-power down setting The following table outlines the default values that the Rad-5 reverts to after a power cycle: Option Default Setting* high alarm limit...
  • Page 31 Sleep Study Mode Set to pre-power down setting * To manual revert Rad-5 to the default values, see Menu Level 4 - LED Brightness and Factory Defaults on page 36. ** Defaults to APOD and Normal only. High Sensitivity will default to normal.
  • Page 32 On Rad-5, an audible alarm and a flashing alarm status indicator will occur when an alarm limit is met or exceeded for greater than five seconds. Directions for alarm suspension are indicated below.
  • Page 33 The Data Transfer Download Cable (PN 2063) is required to connect the sensor connector of the Rad-5 to the PC. Patient monitoring is not possible while trend memory is being transferred to a PC. A trend data download is initiated using the TrendCom utility, which downloads the trend data and saves it to a space- delimited ASCII text (.out) file.
  • Page 34 Note: Turning trend off will not erase trend memory. You may turn trending off and still retrieve the trend data using TrendCom.  Turning the Rad-5 off or replacing the batteries will not erase the trend data.  Turn trending off before storing the device for any length of time.
  • Page 35 07/21/04 09:56:22 SpO2=096 PR=078 PI=02.68 EXC=800:SET Menu Navigation The Rad-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 system, the Next key is used to move from one option to the next.
  • Page 36 Rad-5/5v Chapter 4: Operation Menu Level 2 - Averaging, Sensitivity, FastSat, and SmartTone Push the Mode/Enter button again to enter menu level 2. Button Setting Averaging Use Up or Down Arrow Keys to adjust parameter to desired setting. The signal averaging...
  • Page 37 Note: The date and time must be set before trending will be enabled. The Rad-5 will automatically ‘time out’ of the setup menu after 10 seconds with no key presses. If the Rad-5 should time-out to the Trend Settings menu, the trend will not be enabled.
  • Page 38 10-seconds. Upon power up, SLP mode is displayed along with a 10- second display of parameters. Pressing and holding both the Mode Enter and Next keys for 3 seconds (select next (STD), Mode Enter) will put Rad-5 back into the special menu to exit. CAUTION: Alarms are disabled in this mode.
  • Page 39 Rad-5/5v Chapter 4: Operation Buttons Settings Standard Mode Use Up or Down Arrow Keys to adjust parameter to desired setting. LED Display Brightness (4 levels) Note: The parameter is set/selected when the Note: Only available Mode/Enter and Next indicators Sleep Mode buttons are pressed.

  • Page 41: Chapter 5: Alarms And Messages

    “SEn OFF” and “nO SEn” will only generate an alarm condition after a pulse has been found.  Rad-5 only: Audible and visual alarms for high low saturation and pulse rate (SpO range 1-100%, pulse rate range 25-240 bpm). The following table shows the potential result of failure to respond to the cause of the alarm...

  • Page 42: Alarm Silence

    Alarm Silenced Indicator The Alarm Silenced Indicator provides visual feedback when illuminated, the audible alarms on Rad-5/5v are muted. See Front View on page 19. While monitoring a patient, acknowledging an alarm condition by pressing the Alarm Silence Button (one time) will silence the alarm tone for 120 seconds and the Alarm Silenced Indicator will flash.

  • Page 43: Messages

    Rad-5/5v Chapter 5: Alarms and Messages Messages The Rad-5/5v will indicate data or system errors. Rad-5 Messages The following messages display on Rad-5: Display Type Solution  Assess /address patient condition. number Saturation flashes limit alarm  Re-set alarm limits if indicated.
  • Page 44 Rad-5/5v Chapter 5: Alarms and Messages Display Type Solution Defective Replace sensor BAD SEN sensor Unrecognized Connect appropriate cable sensor blinking Interference Ensure that the sensor is properly applied, and INT DET detected cover the sensor site with opaque material, if Blinking required.
  • Page 45 Rad-5/5v Chapter 5: Alarms and Messages Display Type Solution Message Unrecognized or defective sensor Replace sensor Sensor life expired Replace sensor as soon as possible blinking No adhesive sensor connected Connect adhesive sensor NO ADH Incompatible adhesive sensor Replace adhesive sensor...

  • Page 47: Chapter 6: Troubleshooting

    Chapter 6: Troubleshooting Troubleshooting Chart The following chart describes what to do if the Rad-5/5v system does not operate properly or fails. Problem Possible Cause Recommendation  Check / replace battery. Device Does not Low battery Power On  Verify that the trending feature is off, as it may deplete battery life at a faster rate than normal.

  • Page 49: Chapter 7: Specifications

    Chapter 7: Specifications The following chapter contains specifications for the Rad-5/5v. Display Range Measurement Display Range (Functional Oxygen Saturation) 1% to 100% PR (Pulse Rate) 25 bpm to 240 bpm Pi (Perfusion Index) 0.02% to 20% Accuracy (ARMS*) Oxygen Saturation (SpO...

  • Page 50: Resolution

    Rad-5/5v Chapter 7: Specifications * The ARMS Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of the measured values fell within +/- the ARMS value when compared to the reference device under a controlled study.

  • Page 51: Physical Characteristics

    Rad-5/5v Chapter 7: Specifications Physical Characteristics Physical Characteristics Dimensions 15.8 cm x 7.6 cm x 3.6 cm (6.2” x 3.0” x 1.4”) Weight 0.32 kg. (13 oz.) Modes Modes Rad-5 Averaging Mode 2, 4, 8, 10, 12, or 16 seconds [7]...

  • Page 52: Display/Indicators

    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) www.masimo.com Masimo...

  • Page 53: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Rad-5/5v Chapter 7: Specifications Equipment Classification per IEC 60601-1 Degree of Protection of Type BF-Applied Part Electrical Shock Protection against IP22, Protection from ingress of particulates > than 12.5 mm and harm from liquid protection against vertically falling water drops when enclosure ingress is tilted at 15 degrees.

  • Page 54: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    Rad-5/5v Chapter 7: Specifications IEC 61000-3- Guidance and Manufacturer's Declaration - Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
  • Page 55 Rad-5/5v Chapter 7: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Power frequency 3 A/m 3 A/m Power frequency magnetic fields (50/ 60 Hz) should be at levels characteristic of magnetic field typical location in a typical hospital environment. IEC 61000-4-3...

  • Page 56: Recommended Separation Distances

    Rad-5/5v Chapter 7: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 57: Symbols

    Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Symbols The following symbols are found on the Rad-5/5v, or packaging and are defined below. Symbols Definition...

  • Page 58: Citations

    Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100% SpO against a laboratory CO-Oximeter and ECG monitor. [3] Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%.

  • Page 59: Chapter 8: Service And Maintenance

    CAUTION: Do not allow liquids to enter the interior of the device. Dry the device thoroughly prior to using on a patient. The surfaces of the Rad-5/5v may be cleaned with the following solvents or cleaning agents:  70% Isopropyl Alcohol (IPA) ...

  • Page 60: Performance Verification

    To test the performance of the Rad-5/5v following repairs or during routine maintenance, follow the procedures outlined in this section. If the Rad-5/5v fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user.
  • Page 61 Rad-5 Turn the Oximeter off and then on again. Connect the Masimo SET Tester to the Patient Cable Connector. Verify that within 20 seconds a Signal IQ/pulse bar is displayed. Verify that the SpO2 measurement is between 79% and 84%.

  • Page 62: Repair Policy

     A certificate stating the Rad-5/5v has been decontaminated for bloodborne pathogens Return the Rad-5/5v to the shipping address listed in Contacting Masimo on page 61 below. Restrictions Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden.

  • Page 63: Contacting Masimo

    (6) months from the original date the Product was obtained by the end-user purchaser. Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty.
  • Page 64 Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software.

  • Page 65: Index

    Contacting Masimo • 23, 64, 65 Advanced Operation • 30 Contraindications • 8 Alarm Indication • 41 Alarm Limit Test (Rad-5) • 62 Alarm Limits • 32, 36 Default Settings • 30 Alarm Silence • 20, 42, 47 Display Range • 49 Alarm Silenced Indicator •...
  • Page 66 Perfusion Index • 27 Initial Setup • 23 Physical Characteristics • 51 Installation • 33 Power Rad-5/5v On and Off • 27 Power-On Self-Test • 62 Product Description • 7 Key Press Button Test • 62 Product Description, Features and Indications for Use •...
  • Page 67 Standard and Sleep Mode • 39 Successful Monitoring for SpO2 and PR • 17, 25 Symbols • 57 Testing Rad-5/5v with Masimo SET Tester • 63 Trend Data Format • 34 Trend Settings • 33, 37 TrendCom Utility • 33 Troubleshooting Chart •...
  • Page 70 33606/LAB-5724H-0920...

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