Operators Manual
88 Pages
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Operators Manual
Rad-G® with temperature
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. Do not operate Rad-G without completely reading and understanding these instructions. If you encounter any serious incident with the product, please notify the competent authority in your country and the manufacturer. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. 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 (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings and precautions. For professional use. 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 Fax.: 949-297-7001 www.masimo.com EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
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MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH Conforms to ANSI/AAMI std. ES 60601-1:2005, Certified to CAN/CSA std. C22.2 No. 60601-1:2008, and applicable Particular, (ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-11:2010) Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents.htm ®, Masimo®, Adaptive Probe Off Detection®, APOD®, FastSat®, PVi®, RRp®, Rad®, Rad-G® SET®, Signal Extraction Technology®, Signal IQ®, and X-Cal® are federally registered trademarks of Masimo Corporation. Rad-G is part of the Rad line of products.
All other trademarks and registered trademarks are property of their respective owners. © 2023 Masimo Corporation
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Contents About This Manual ----------------------------------------------------------------------------------------------------------------5 Product Description, Features and Indications for Use --------------------------------------------------------------7 Product Description ------------------------------------------------------------------------------------------------------------7 Indications for Use --------------------------------------------------------------------------------------------------------------7 Contraindications ---------------------------------------------------------------------------------------------------------------7 Safety Information, Warnings, and Cautions ----------------------------------------------------------------------------9 Safety Warnings and Cautions ----------------------------------------------------------------------------------------------9 Performance Warnings and Cautions ----------------------------------------------------------------------------------- 10 Cleaning and Service Warnings and Cautions------------------------------------------------------------------------ 14 Compliance Warnings and Cautions ------------------------------------------------------------------------------------ 14 Chapter 1: Rad-G Technology Overview -------------------------------------------------------------------------------- 17 Signal Extraction Technology® (SET®) ---------------------------------------------------------------------------------- 17 Temperature Technology --------------------------------------------------------------------------------------------------- 20 Chapter 2: Description --------------------------------------------------------------------------------------------------------- 21 General System Description ----------------------------------------------------------------------------------------------- 21 Features ------------------------------------------------------------------------------------------------------------------------- 21 Chapter 3: Setting Up ---------------------------------------------------------------------------------------------------------- 23 Unpacking and Inspection -------------------------------------------------------------------------------------------------- 23 Preparation for Use----------------------------------------------------------------------------------------------------------- 23 Guidelines for Setting Up --------------------------------------------------------------------------------------------------- 23 Initial Battery Charging ------------------------------------------------------------------------------------------------------ 23 Powering Rad-G ON and OFF -------------------------------------------------------------------------------------------- 25 Set Mode of Operation ------------------------------------------------------------------------------------------------------ 25 Chapter 4: Operation ----------------------------------------------------------------------------------------------------------- 27 Using the Touchscreen and Home Button ----------------------------------------------------------------------------- 27 About the Main Screen ------------------------------------------------------------------------------------------------------ 29 About the Status Bar --------------------------------------------------------------------------------------------------------- 31 Accessing Main Menu Options -------------------------------------------------------------------------------------------- 33 Parameter Settings ----------------------------------------------------------------------------------------------------------- 34 Additional Settings ------------------------------------------------------------------------------------------------------------ 39 Sounds--------------------------------------------------------------------------------------------------------------------------- 40 Device Settings ---------------------------------------------------------------------------------------------------------------- 40 About ----------------------------------------------------------------------------------------------------------------------------- 43 Trends --------------------------------------------------------------------------------------------------------------------------- 44 Chapter 5: Spot-Check Operation------------------------------------------------------------------------------------------ 45 Overview ------------------------------------------------------------------------------------------------------------------------ 45 Spot Checking ----------------------------------------------------------------------------------------------------------------- 45 Chapter 6: Temperature Operation ---------------------------------------------------------------------------------------- 47 Overview ------------------------------------------------------------------------------------------------------------------------ 47 Temperature Measurement ------------------------------------------------------------------------------------------------ 48 www.masimo.com
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Contents
Chapter 7: Alarms and Messages ----------------------------------------------------------------------------------------- 49 Alarm Interface---------------------------------------------------------------------------------------------------------------- 49 Messages ---------------------------------------------------------------------------------------------------------------------- 52 Chapter 8: Troubleshooting ------------------------------------------------------------------------------------------------- 53 Troubleshooting Measurements ----------------------------------------------------------------------------------------- 53 Troubleshooting Rad-G----------------------------------------------------------------------------------------------------- 54 Chapter 9: Specifications ---------------------------------------------------------------------------------------------------- 57 Display Range and Display Resolution--------------------------------------------------------------------------------- 57 Accuracy (ARMS)* ----------------------------------------------------------------------------------------------------------- 57 SpO2 Performance Specifications --------------------------------------------------------------------------------------- 58 RRp Performance Specifications ---------------------------------------------------------------------------------------- 60 Electrical ------------------------------------------------------------------------------------------------------------------------ 67 Environmental ----------------------------------------------------------------------------------------------------------------- 67 Physical Characteristics ---------------------------------------------------------------------------------------------------- 67 Historical Data Storage ----------------------------------------------------------------------------------------------------- 68 Historical Data Storage* ---------------------------------------------------------------------------------------------------- 68 Display Indicators ------------------------------------------------------------------------------------------------------------ 68 Compliance -------------------------------------------------------------------------------------------------------------------- 68 Guidance and Manufacturer's Declaration - Electromagnetic Compliance ----------------------------------- 69 Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication Equipment 71 Recommended Separation Distances ---------------------------------------------------------------------------------- 72 Symbols------------------------------------------------------------------------------------------------------------------------- 73 Citations ------------------------------------------------------------------------------------------------------------------------ 74 Chapter 10: Service and Maintenance ----------------------------------------------------------------------------------- 77 Cleaning ------------------------------------------------------------------------------------------------------------------------ 77 Maintenance ------------------------------------------------------------------------------------------------------------------- 77 Performance Verification --------------------------------------------------------------------------------------------------- 77 Repair Policy ------------------------------------------------------------------------------------------------------------------ 78 Return Procedure ------------------------------------------------------------------------------------------------------------ 78 Contacting Masimo ---------------------------------------------------------------------------------------------------------- 79 Appendix: Concepts of Alarm Response Delay ---------------------------------------------------------------------- 81 Concepts of Alarm Response Delay ------------------------------------------------------------------------------------ 81 Index --------------------------------------------------------------------------------------------------------------------------------- 83
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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. 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 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. CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.
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Product Description, Features and Indications for Use Product Description The Rad-G® is intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi) and pleth respiration rate (RRp) and spot-check temperature measurement. The following key features are available for Rad-G®: Masimo SET® technology performance. Noninvasive functional saturation of arterial oxygen hemoglobin (SpO2) and pulse rate (PR), Pleth Variability Index (PVi), and Respiration Rate determined by plethysmographic waveform (RRp). Non-contact surface temperature measurement.
Indications for Use The Rad-G® and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The optional Rad-G® non-contact thermometer feature is intended for the spot-checking of body temperature. The Rad-G® and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. The Rad-G® and Accessories are indicated for the noninvasive spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments. The Rad-G® and Accessories are indicated for the noninvasive spot-checking of Temperature of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.
Contraindications The Rad-G device is not intended for use as an apnea monitor.
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Safety Information, Warnings, and Cautions CAUTION: Rad-G is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all precautionary information, and specifications before use.
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. WARNING: Do not adjust, repair, open, disassemble, or modify the Rad-G. Damage to the device may result in degraded performance and/or patient injury. WARNING: Do not start or operate the Rad-G unless the setup was verified to be correct. Improper setup of this device may result in degraded performance and/or patient injury. WARNING: Do not place the Rad-G or accessories in any position that might cause it to fall on the patient. WARNING: Only use Masimo authorized devices with Rad-G. Using unauthorized devices with Rad-G may result in damage to the device and/or patient injury. WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use; otherwise degraded performance and/or patient injury can result. WARNING: Do not use the Rad-G in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide to avoid risk of explosion. WARNING: Do not use the Rad-G during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Rad-G may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Rad-G during defibrillation. WARNING: To protect against electrical shock injury, follow the directions below: Avoid placing the device on surfaces with visible liquid spills. Do not soak or immerse the device in liquids. Do not attempt to sterilize the device. Use cleaning solutions only as instructed in this Operator's Manual. Do not attempt to clean the Rad-G while monitoring patient. WARNING: To ensure safety, avoid placing anything on the device during operation. WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Rad-G where the controls can be changed by the patient. CAUTION: Do not place Rad-G where the AC power supply cannot be readily disconnected when used on AC power. CAUTION: Only use the AC power adapter provided by Masimo. Using a different AC power adapter could cause damage to the Rad-G. Check the power adapter to ensure that it is intact and undamaged. CAUTION: To ensure patient electrical isolation, all external device connections to the output interface connector must be done using only authorized data cables. www.masimo.com 9 Masimo
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Note: Disconnect the device from AC mains by unplugging the AC power supply from the Rad-G. Note: Use and store the Rad-G in accordance with specifications. See the Specifications section in this manual.
Performance Warnings and Cautions WARNING: Rad-G should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: The Rad-G and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. WARNING: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Rad-G for proper functioning. WARNING: Rad-G is not an apnea monitor. WARNING: Rad-G should not be used as a replacement or substitute for ECG-based arrhythmia analysis. WARNING: Always ensure settings including alarm limits and alarm speaker volume are appropriate for each patient and facility's protocol and environment prior to use. Devices in which the alarm speaker is not working or the alarm speaker volume setting is not distinguishable from the facilities ambient noise should not be used. WARNING: When using the Rad-G for spot-check monitoring, no physiological alarms are provided. WARNING: PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi. WARNING: Rad-G may be used during defibrillation. However, this may temporarily affect the accuracy or availability of the parameters. WARNING: Rad-G may be used during electrocautery. However, this may temporarily affect the accuracy or availability of the parameters. WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor or sensors that become partially dislodged may cause no or incorrect readings. WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings. 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. WARNING: Displayed parameter(s) may not be accurate when a low SIQ message is provided. Clinicians should consider additional information to supplement values to completely understand the patient’s condition. WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. WARNING: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: Optical, pleth-based measurements (e.g. SpO2, PVi and RRp) can be affected by the following: www.masimo.com
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Improper sensor application or use of use of incorrect sensor. Blood pressure cuff applied to the same arm as the sensor site. Intravascular dyes such as indocyanine green or methylene blue. Venous congestion. 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. Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or foreign objects in the light path. Elevated levels of bilirubin. Physiological conditions that can significantly shift the oxygen disassociation curve. A physiological condition that may affect vasomotor tone or changes in vasomotor tone. WARNING: No or inaccurate SpO2 readings may be caused by: Improper sensor application. Blood pressure cuff applied to the same arm as the sensor site. Arterial catheter Elevated levels of COHb and/or MetHb. Note: High levels of COHb or MetHb may occur with a seemingly normal SpO2. Intravascular dyes such as indocyanine green or methylene blue. Venous congestion. Excessive venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position). Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc. Moisture, birthmarks, skin discoloration, or foreign objects in the light path. Elevated levels of bilirubin. Severe anemia. Very low arterial perfusion. Hypocapnic or Hypercapnic conditions. Excessive motion. Vasospastic disease such as Raynaud's. Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. Peripheral vascular disease. EMI radiation interference. WARNING: PVi may not accurately reflect fluid responsiveness due to the following conditions: When not on mechanical ventilation. Under mechanical ventilation with a tidal volume less than 8 mL/kg. Venous congestion. Abnormal venous pulsations (e.g. tricuspid valve regurgitation, Trendelenburg position). Conditions which may affect peripheral arterial blood flow (e.g., Hypotension, severe vasoconstriction, severe anemia, or hypothermia.) www.masimo.com
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When applied to a site other than a finger. Low perfusion. Motion. WARNING: Inaccurate RRp readings may be caused by: Low arterial perfusion. Motion induced artifact. Severe anemia. Arrhythmia. CAUTION: The RRp value may be inaccurate under conditions where the pulse rate is less than two times the respiration rate. The following conditions may include, but it’s not limited to: patients with high respiration rate and low heart rate, or patients with specific medical conditions such as sick sinus syndrome, bradycardia due to any primary cardiac conditions as well as secondary condition from beta blockers, digoxin, etc. CAUTION: Respiration rate provides an indicator of central ventilatory drive and not a direct indication that air is moving through the upper airway. 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. CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. CAUTION: High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. CAUTION: To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. CAUTION: When Silence Duration is set to All Mute, there will be no audible alarms on Rad-G; however, there will be visual alarms displayed on Rad-G. CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Rad-G. CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the Rad-G is used. CAUTION: Do not place the Rad-G near electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Rad-G promptly after a Low Battery alarm may result in the device shutting down. CAUTION: Do not connect the AC power supply to an electrical outlet controlled by a wall switch or dimmer.
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CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section. Note: Cables and sensors are provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of patient monitoring time. Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO2 or RRp readings. Note: It is recommended that Rad-G battery is fully charged prior to use. Note: Always charge Rad-G when it is not in use to ensure that the battery remains fully charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery. 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 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. Note: Additional information specific to the Masimo sensors compatible with Rad-G, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).
Integrated Temperature WARNING: If any measurement seems questionable, repeat the measurement after allowing some additional time for the patient temperature to stabilize or check the patient’s vital signs by alternate means and then check Rad-G for proper functioning. WARNING: No or inaccurate temperature readings may result due to the following: Directed to measurement site other than the forehead. Obstructed access to skins surface (e.g. perspiration, excess oil, hair, tattoos, piercing, paint, heavy make-up). Directed to measurement site with non-uniform blood flow (e.g. scar tissue, compromised tissue due to skin disorder, drug therapies that affect normal body temperature). Obstructed temperature sensor opening. Use on patients with severe or therapeutic hypothermia due to exposure to external heat/cold sources and/or certain therapies Measurement performed in presence of interfering infrared light sources (e.g., direct sunlight or heating lamps).
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Cleaning and Service Warnings and Cautions WARNING: Do not attempt to remanufacture, recondition or recycle the Rad-G as these processes may damage the electrical components, potentially leading to patient harm. WARNING: To avoid electric shock, do not attempt to replace or remove the Battery from the Rad-G. Service of Rad-G should be done by qualified personnel only. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Rad-G for servicing. CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display. CAUTION: To avoid permanent damage to the Rad-G, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the RadG. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge the Rad-G in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: To prevent damage, do not soak or immerse Rad-G in any liquid solution.
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). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Per RSS-Gen, Radio apparatus shall comply with the requirements to include required notices or statements to the user of equipment with each unit of equipment model offered for sale. CAUTION: Comply with local laws in the disposal of the device and/or its accessories. 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. Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, www.masimo.com
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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 antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2015. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: This Class B digital apparatus complies with Canadian ICES-003.
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Chapter 1: Rad-G Technology Overview The following chapter contains general descriptions about functional oxygen saturation (SpO2) and Signal IQ used by Masimo products.
Signal Extraction Technology® (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). Masimo SET® pulse oximetry utilizes parallel engines and adaptive 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 Transform® (DST®), in parallel with Fast Saturation Transform (FST®), 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 rainbow SET® Parallel Engines This figure is for conceptual purposes only.
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Chapter 1: Rad-G Technology Overview
Masimo SET® DST This figure is for conceptual purposes only.
General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: 1.
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
2.
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.
Successful Monitoring for SpO2, PR and Pi Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term, experience will provide a good feeling for changes that are artifactual or physiological and the speed, timing, and behavior of each. The stability of the readings over time is affected by the averaging time being used. The longer the averaging time, the more stable the readings tend to become. This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times. However, longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 and pulse rate.
Functional Oxygen Saturation (SpO2) The Rad-G is calibrated to measure and display functional oxygen saturation (SpO2): 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.
General Description for Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse. www.masimo.com
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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 continuously and noninvasively obtained from a pulse oximeter.
General Description for Pleth Variability Index (PVi) The Pleth Variability Index (PVi) is a measure of the dynamic changes in the Perfusion Index (Pi) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in Pi over a time interval where one or more complete respiratory cycles have occurred. PVi is displayed as a percentage (0-100%). PVi may show changes that reflect physiological factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. The utility of PVi has been evaluated in clinical studies [1-11]. Technical and clinical factors that may affect PVi include probe malposition, probe site, patient motion, skin incision, spontaneous breathing activity, lung compliance, open pericardium, use of vasopressors or vasodilators, low perfusion index, subject age, arrhythmias, left or right heart failure, and tidal volume [12-14].
Citations for Pleth Variability Index (PVi) 1.
Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot J.J. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008 Aug;101(2):200-6.
2.
Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct;111(4):910-4.
3.
Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4.
Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. Anesth Analg. The Ability of Pleth Variability Index to Predict the Hemodynamic Effects of Positive EndExpiratory Pressure in Mechanically Ventilated Patients under General Anesthesia. 2010 Mar 1;110(3):792-8.
5.
Tsuchiya M., Yamada T., Asada A. Pleth Variability Index Predicts Hypotension During Anesthesia Induction. Acta Anesthesiol Scand. 2010 May;54(5):596-602.
6.
Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9.
7.
Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors in Hans Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
8.
Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. Anesth. 2012 Oct;26(5):696-701.
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9.
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.
10.
Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 Oct;28(5):634-9.
11.
Yu Y., Dong J., Xu Z., Shen H., Zheng J. Pleth Variability Index-Directed Fluid Management in Abdominal Surgery under Combined General and Epidural Anesthesia. J Clin Monit Comput. 2014 Feb 21.
12.
Desgranges F.P., Desebbe O., Ghazouani A., Gilbert K., Keller G., Chiari P., Robin J.,Bastien O., Lehot J.J., Cannesson M. Br. J. Anaesth 2011 Sep;107(3):329-35.
13.
Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97.
14.
Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y. Impact of Skin Incision on the Pleth Variability Index. J Clin Monit Comput 2011 Aug;25(4):215-21.
General Description for Respiration Rate (RRp) Respiration rate can be determined by the plethysmographic waveform (RRp). This method measures respirations per minute (rpm) based on cyclic variation in photoplethysmogram (i.e. pleth or PPG) to establish a respiration rate measurement.
Signal IQ The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO2 value. The SpO2 SIQ can 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 coincides with the peak of an arterial pulsation. Even with a plethysmographic waveform obscured by artifact, the Signal IQ identifies the timing that the algorithms have determined for the arterial pulsation. The pulse tone (when enabled) coincides with the vertical line of the SpO2 SIQ. The height of the vertical line of the SpO2 SIQ provides an assessment of the confidence in the measurement displayed. A high vertical bar indicates higher confidence in the measurement. A small vertical bar indicates lower confidence in the displayed measurement. When the Signal IQ is very low, this suggests that the accuracy of the displayed measurement may be compromised.
Temperature Technology Rad-G uses an infrared optical sensor to detect infrared blackbody radiation that is naturally emitted based upon the human body temperature through the skin surface. The infrared radiation detected is processed using a Masimo proprietary algorithm to determine the skin surface temperature that is adjusted to display the approximation of the patient’s body or core temperature as measured by a sublingual thermometer.
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Chapter 2: Description General System Description The Rad-G system includes the following: Rad-G Device Masimo patient cable and/or sensor AC/DC Power Supply * Only use with Masimo supplied AC/DC Power Supply (PN 38602); (Input Rating 100-240V~, 50-60Hz, 0.6A; Output 5V, 1.2A, 6W).
Features Front View 1. Patient Cable Connector: Allows connection to a direct-connect sensor, patient cable or data cable. 2. Power Button: Powers Rad-G On and Off. See Powering Rad-G ON and OFF on page 24. 3. Display and Touchscreen: User interface to view parameters and change settings. See Using the Touchscreen and Home Button on page 27. 4. Temperature Window: Displays temperature and provides the icon that provides the ability to perform the temperature measurement. See Temperature Window on page 47. 5. Backward Navigation Button: Navigate back from a selection or exit a menu item. 6. Home Button: Multipurpose user interface that allows for navigation to the home screen. 7. Main Menu Button: Access to main menu settings. See Accessing Main Menu Options on page 32. 8. Speaker: The speaker supports audible indicators or instructions. 9. DC Input Connector: Connection to an AC power supply for battery charging. 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.
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Rad-G with temperature
Chapter 2: Description
Back View 1. Infrared Optical Sensor The sensor that is directed to the patient forehead to provide body temperature measurements. See Temperature Measurement on page 48.
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Chapter 3: Setting Up Unpacking and Inspection To unpack and inspect the Rad-G: 1.
Remove the Rad-G from the shipping carton and examine it for signs of shipping damage.
2.
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.
3.
If anything is missing or damaged, contact the Masimo Technical Service Department. See Return Procedure on page 78.
Preparation for Use Prior to setting up the Rad-G, perform the following steps: 1.
Confirm that you have all system components: Rad-G Device Masimo patient cable and/or sensor AC/DC Power Supply
2. 3.
Read the Safety Information, Warnings, and Cautions on page 9. Setup the Rad-G according to the directions provided in this Operator's Manual.
Guidelines for Setting Up When setting up Rad-G, follow these guidelines: 1.
Charge Rad-G's battery fully before use. See Initial Battery Charging on page 23.
2.
Rad-G should not be operated outside the environmental conditions listed in the specifications section even during charging. See Environmental on page 67.
Initial Battery Charging Before use, the Rad-G battery should be fully charged. Note: The Rad-G must be ON during recharging if the battery is completely depleted.
To charge Rad-G: 1.
Before charging, make sure the plug configuration is appropriate. a) If an incorrect plug insert is included in the AC power supply, then remove it by using a thumb or finger to slide the spring loaded locking key downward (see image 1). b) Attach the correct plug insert by tipping of the blade assembly into the power supply at a 30-60 degree angle (see image 2). Note: The top edge of the blade assembly is flat and the bottom edge is U shaped. The power supply has the corresponding shapes.
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