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Masimo Rad-G Operator's Manual
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Masimo Rad-G Operator's Manual

Masimo Rad-G Operator's Manual

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Rad-G
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Summary of Contents for Masimo Rad-G

  • Page 1 Operators Manual Rad-G Spot-Check ®...
  • Page 3 These operating instructions provide the necessary information for proper operation of all models of the Rad-G. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of Rad-G are prerequisites for its proper use.

  • Page 5: Table Of Contents

    Performance Warnings and Cautions ----------------------------------------------------------------------------------- 10 Cleaning and Service Warnings and Cautions ------------------------------------------------------------------------ 13 Compliance Warnings and Cautions ------------------------------------------------------------------------------------ 13 Chapter 1: Rad-G Technology Overview -------------------------------------------------------------------------------- 15 Signal Extraction Technology® (SET®) -------------------------------------------------------------------------------- 15 Chapter 2: Description --------------------------------------------------------------------------------------------------------- 19 General System Description ----------------------------------------------------------------------------------------------- 19...
  • Page 6 Recommended Separation Distances ---------------------------------------------------------------------------------- 56 Symbols------------------------------------------------------------------------------------------------------------------------- 56 Citations ------------------------------------------------------------------------------------------------------------------------ 58 Chapter 9: Service and Maintenance ------------------------------------------------------------------------------------- 59 Cleaning ------------------------------------------------------------------------------------------------------------------------ 59 Maintenance ------------------------------------------------------------------------------------------------------------------- 59 Performance Verification --------------------------------------------------------------------------------------------------- 60 Repair Policy ------------------------------------------------------------------------------------------------------------------ 60 Return Procedure ------------------------------------------------------------------------------------------------------------ 61 Contacting Masimo ---------------------------------------------------------------------------------------------------------- 61 Index --------------------------------------------------------------------------------------------------------------------------------- 65 www.masimo.com Masimo...

  • Page 7: About This Manual

    About This Manual This manual explains how to set up and use the Rad-G®. Important safety information relating to general use of Rad-G 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.

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

    Product Description, Features and Indications for Product Description The Rad-G® is intended for the noninvasive spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi ), and pleth ® respiration rate (RRp ®...

  • Page 11: Safety Information, Warnings, And Cautions

    Safety Warnings and Cautions WARNING: Do not use Rad-G 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: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Rad-G, including cables specified. Otherwise, degradation of the performance of this equipment could result.
  • Page 13 Rad-G Safety Information, Warnings, and Cautions • Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position). • Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.). • Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
  • Page 14 CAUTION: If using Rad-G during full body irradiation, 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.

  • Page 15: Cleaning And Service Warnings And Cautions

    Note: When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the Rad-G is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement.
  • Page 16 CAUTION: Device contains an internal battery. Dispose of the battery according to country or regional requirements. CAUTION: Use only the recommended patient cable or direct connect sensor provided by Masimo. See Masimo website for details. (www.masimo.com) Note: Use Rad-G in accordance with the Environmental Specifications section in the Operator's Manual.

  • Page 17: Chapter 1: Rad-G Technology Overview

    ® because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET ® signal processing algorithm, Discrete Saturation Transform...

  • Page 18: Masimo Set® Dst

    SpO pulse rate. Functional Oxygen Saturation (SpO2) The Rad-G 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.

  • Page 19: General Description For Perfusion Index (Pi)

    Rad-G Chapter 1: Rad-G Technology Overview General Description for Perfusion Index (Pi) The Perfusion Index (Pi) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. Pi thus represents a noninvasive measure of peripheral perfusion that can be noninvasively obtained from a pulse oximeter.

  • Page 20: General Description For Respiration Rate (Rrp)

    Rad-G Chapter 1: Rad-G Technology Overview Byon H.J., Lim C.W., Lee J.H., Park Y. H., Kim H.S., Kim C.S., Kim J.T. Br. J. Prediction of fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Anaesth 2013 Apr;110(4):586-91. Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP.

  • Page 21: Chapter 2: Description

    Note: Rad-G can be used while the power supply is plugged into an outlet. WARNING: Only use the AC power supply provided by Masimo. Using a different AC power supply could result in degraded performance and/or patient injury, and cause damage to Rad-G. Check the power cord and plug to ensure that it is intact and undamaged.

  • Page 23: Chapter 3: Setting Up

    Unpacking and Inspection To unpack and inspect the Rad-G: Remove the Rad-G from the shipping carton and examine it for signs of shipping damage. Check all materials on the packing list. Save all packing materials, invoice, and bill of lading.

  • Page 24: Powering Rad-G On And Off

    Plug the charger (AC power supply) into a socket (AC power source). See AC Power Indicator. Plug the DC output connector to the bottom of the Rad-G. Verify the plug orientation is correct during connection (see the images below). Powering Rad-G ON and OFF To Power ON Rad-G: Press and release the power button on Rad-G.

  • Page 25: Automatic Power Off

    • If the user continues to press and hold the power button, audible tones sound and the device shuts down after a few seconds. • If the user releases the power button, this cancels the force shut down and Rad-G returns to the Confirm Power Off screen.

  • Page 27: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that Rad-G is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Rad-G without completely reading and understanding these instructions.
  • Page 28 Touch and quickly swipe (left, right, up or Flick down), and release. Below is a list of all the different types of controls available on Rad-G and the various ways to interact with each type of control. Control Applicable Actions...

  • Page 29: About The Main Screen

    Rad-G Chapter 4: Operation Control Applicable Actions Description Icon Menu Touch tile Opens menu specified by tile Swipe left or right (anywhere) Scrolls icons left or right Touch bottom indicator icon Quickly centers tile corresponding to indicator icon Alert Silence...

  • Page 30: Signal Iq Indicators

    Messages on page 39. Sensitivity Modes Overview Three sensitivity levels enable a clinician to tailor the response of Rad-G to the needs of the particular patient situation. See Additional Settings on page 32. The sensitivity levels are as follows: • NORM (Normal Sensitivity) NORM is the recommended sensitivity mode for patients who are experiencing some compromise in blood flow or perfusion.

  • Page 31: Ac Power Indicator

    AC Power Indicator When Rad-G is powered ON, the AC Power Indicator icon will be displayed as follows: Note: To conserve battery use, Rad-G powers OFF automatically after 1 minute without activity. See Automatic Power OFF on page 23.

  • Page 32: Parameter Settings

    Rad-G Chapter 4: Operation Display Main Menu Description Information Icon Option • Set sensitivity mode to Max, Norm, or Additional See Additional Settings on APOD. Settings page 32. • Set Measurement Timeout. • Set pulse tone volume. Sounds See Sounds on page 32.

  • Page 33: Pvi Settings

    When Rad-G is set to FastSat On, the averaging algorithm evaluates all saturation values, providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat set to On, the averaging time is dependent on the input signal.

  • Page 34: Additional Settings

    How long to display the parameter readings 1 minute 1, 2, 3, or 4 minutes Timeout after the sensor is removed from the patient. Sounds Use the Sounds screen to control the volume of sounds on Rad-G. Option Description Factory Default User Configurable Settings...

  • Page 35: Device Settings

    Rad-G Chapter 4: Operation Device Settings The Device Settings menu allows the user to view and customize settings for Rad-G. The Device Settings options are: Localization See Localization on page 33. Brightness See Brightness on page 34. Access Control See Access Control on page 34.

  • Page 36: Access Control

    Rad-G Chapter 4: Operation Brightness Use the Brightness screen to adjust the brightness of Rad-G's display. Option Description Factory Default User Configurable Settings Settings Adjust the brightness level of the display 25% to 100% in steps of Brightness 100% manually.

  • Page 37: About

    Rad-G Chapter 4: Operation About Use the About screen to view the serial number as well as Rad-G software version information. These details may be helpful during troubleshooting or when contacting Masimo for assistance. Option * Description Serial Number Displays the serial number for the device.

  • Page 39: Chapter 5: Performing A Spot-Check

    Use for the specific sensor for proper site selection and application. After the sensor is placed, the Rad-G looks for a pulse. Once a pulse is detected, the waveform displays and the measurement begins as the Rad-G obtains values.

  • Page 41: Chapter 6: Messages

    Chapter 6: Messages The following chapter contains information about messages that appear on Rad-G. For more information, see Chapter 7: Troubleshooting on page 41. Rad-G Messages The following section lists common messages, their potential causes, and next steps. Message Potential Causes Next Steps Device is searching for pulse.

  • Page 43: Chapter 7: Troubleshooting

    Chapter 7: Troubleshooting The following chapter contains troubleshooting information for the Rad-G. Troubleshooting Measurements The following section lists possible measurement symptoms, the potential cause, and next steps. For additional information, see Safety Information, Warnings, and Cautions on page 9. Symptom...

  • Page 44: Troubleshooting Rad-G

    Rad-G Chapter 7: Troubleshooting Troubleshooting Rad-G The following section lists possible Rad-G symptoms, potential causes, and next steps. For more information, see Messages on page 39. Symptom Potential Causes Next Steps Device does not turn on or • Depleted Battery.

  • Page 45: Chapter 8: Specifications

    Chapter 8: Specifications The following chapter contains specifications for the Rad-G. Display Range and Display Resolution Measurement Display Range Resolution (Functional Oxygen Saturation) 0% to 100% PR (Pulse Rate) 25 bpm to 240 bpm 1 bpm Pi (Perfusion Index) 0.00 to 20 0.01...

  • Page 46: Spo2 Performance Specifications

    Note: A functional tester cannot be used to assess the accuracy of Rad-G. Note: A functional tester can only provide an indication of the contribution to the total error from the monitor which is different from the independently demonstrated accuracy of the calibration curve for the monitor and sensor combination.

  • Page 47: Rrp Performance Specifications

    Rad-G Chapter 8: Specifications RRp Performance Specifications The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in healthy adult subjects with upper 95% and lower 95% limits of agreement. Figure 1: Subject by Subject Bland-Altman plot of RRp with respect to RRref_c The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in hospitalized adult subjects with upper 95% and lower 95% limits of agreement.

  • Page 48: Medical Conditions

    Rad-G Chapter 8: Specifications The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in hospitalized pediatric subjects with upper 95% and lower 95% limits of agreement. Figure 3: Bland-Altman plot of RRp with respect to RRref_c...
  • Page 49 Rad-G Chapter 8: Specifications Medical Conditions from Clinical Study of Hospitalized Adult Patients Nonunion of left long finger metacarpal Endocrine/Metabolic fracture Diabetes Osteoarthritis Hyperlipidemia Right fourth metatarsal fracture Right lower leg and foot compartment Hypomagnesemia syndrome Hypothyroidism Scar contracture left hand...
  • Page 50 Rad-G Chapter 8: Specifications Medical Conditions from Clinical Study of Hospitalized Adult Patients Chronic Thrombocytopenia Glaucoma Opthalmology Hereditary Spherocytosis Leukocytosis Glaucoma Sickle Cell Disease Other Hepatobiliary Lethargy Cholecystitis Subdural Hematoma Pain Cholecystitis with Choledocholithiasis Cholelithiasis Acute post-operative pain Chronic Cholecystitis...
  • Page 51 Rad-G Chapter 8: Specifications Pediatric Medical Conditions Medical Conditions from Clinical Study of Hospitalized Pediatric Patients Congenital Musculoskeletal and Connective Tissue (Cont.) Arthrogryposis Multiplex Congenita Radius and ulna distal fracture, left sequela Congenital/Neurological Right fourth metatarsal fracture Cerebral Palsy Right Leg Pain...

  • Page 52: Electrical

    Hemangioma - Lower lip Electrical AC Power Requirements AC Power requirements 100-240VAC, 50/60Hz, 0.6A Power consumption < 6W Note: Only use with Masimo AC/DC Power Supply (PN 38602); Input Rating 100-240V~, 50-60Hz, 0.6A; Output 5V, 1.2A, 6W. Battery Type Lithium ion Capacity...

  • Page 53: Environmental

    Service Life 10 Years Historical Data Storage* Historical Data Storage* Data Storage 96 hours *Stored data may be viewed and transferred using Masimo Trace and a data download cable to a computer. Display Indicators Item Description Display Update Rate 1 second...

  • Page 54: Compliance

    Rad-G Chapter 8: Specifications Item Description Pixels 320 dots x 240 dots Compliance EMC Compliance IEC 60601-1-2:2014 EN/ISO 80601-2-61:2017, Clause 202.6.2.3, 20 V/m Safety Standards Compliance ANSI/AAMI ES 60601-1 + Am 1 CAN/CSA C22.2 No. 60601-1 IEC 60601-1 + Am 1...

  • Page 55: Guidance And Manufacturer's Declarations - Electromagnetic Emissions

    Rad-G Chapter 8: Specifications Guidance and Manufacturer's Declarations - Electromagnetic Emissions 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 should assure that it is used in such an environment.
  • Page 56 Rad-G Chapter 8: Specifications Guidance and Manufacturer's Declarations - Electromagnetic Immunity Voltage dips, 0% UT, 0.5 0% UT, 0.5 cycle, Mains power quality should be that of a typical short cycle, at 0°, at 0°, 45°, 90°, commercial or hospital environment.

  • Page 57: Test Specifications For Enclosure Port Immunity To Rf Wireless Communication Equipment

    Rad-G Chapter 8: Specifications Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication Equipment Test Band Service (a) Modulation Maximum Distance Immunity Frequency Power Test Level (MHz) (MHz) (V/m) Pulse 380- modulation TETRA 400 18 Hz FM (c) 430-...

  • Page 58: Recommended Separation Distances

    Rad-G Chapter 8: Specifications Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent...
  • Page 59 Not made with natural rubber Manufacturer latex Date of manufacture Catalog number (model number) YYYY-MM-DD Storage temperature range Masimo reference number Keep dry Serial number Storage humidity limitation Fragile, handle with care Do not use if package is Atmospheric pressure limitation...

  • Page 60: Citations

    100% SpO against a laboratory CO-Oximeter and ECG monitor. [3] The Rad-G has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2TM* simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70%-100%.

  • Page 61: Chapter 9: Service And Maintenance

    CAUTION: To prevent damage, do not soak or immerse the device in any liquid solution. CAUTION: Do not sterilize by irradiation, steam, and autoclave or ethylene oxide. NOTE: Rad-G is a reusable device and may be used on multiple patients, as per the instructions in this manual.

  • Page 62: Performance Verification

    To test the performance of the Rad-G following repairs or during routine maintenance, follow the procedure outlined in this chapter. If the Rad-G fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user.

  • Page 63: Return Procedure

    Product; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operator’s www.masimo.com...

  • Page 64: Limitation Of Warranty

    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 Rad-G Chapter 9: Service and Maintenance 227.7202 FAR 12.212, as applicable. Any use, modification, 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 this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement.

  • Page 67: Index

    Index Compliance Warnings and Cautions • 13 Contacting Masimo • 39, 42, 61 Contraindications • 7 About • 30, 35 Device Settings • 30, 33 About the Main Screen • 25, 27 Display Indicators • 51 About the Status Bar • 27, 28, 33 Display Range and Display Resolution •...
  • Page 68 Using the Touchscreen and Home Button • 19, 25 Physical Characteristics • 51 Using the Touchscreen Interface • 25 Pi Settings • 30, 31 Powering Rad-G ON and OFF • 19, 22 Power-On Self-Test • 60 Preparation for Use • 21 Product Description • 7 Product Description, Features and Indications for Use •...
  • Page 70 305707/LAB-12534A-0125...