Operators Manual
120 Pages
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Page 1
Operator's Manual
Radius-7®
Wearable Pulse CO-Oximeter®
For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Radius-7. 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 Radius-7 are prerequisites for its proper use. Do not operate Radius-7 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. 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. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) 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. 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. Wireless Radio: Contains: FCC ID: VKF-MWM1 or VKF-MWM2 | Model: Radius-7 | IC: 7362A- MWM1 or 7362A-MWM2 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 ANSI/AAMI ES 60601-1:2005/A1, CAN/CSA C22.2 No. 60601-1:2014, and applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-8:2006/AMD1:2012) Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents.htm
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®, Masimo®, Pulse CO-Oximeter®, Radius-7®, Root®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, PVi®, RAM®, rainbow®, rainbow Acoustic Monitoring®, rainbow Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet®, and X-Cal® are federally registered trademarks of Masimo Corporation. SpOC™ is a trademark of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademark Patient SafetyNet™ is under license from University HealthSystem Consortium. © 2020 Masimo Corporation
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Contents About this Manual -------------------------------------------------------------------------------------------7 Product Description, Features and Indications for Use----------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use-------------------------------------------------------------------------------------- 9 Contraindications -------------------------------------------------------------------------------------- 10 Safety Information, Warnings and Cautions ---------------------------------------------------------- 11 Safety Warnings and Cautions ----------------------------------------------------------------------- 11 Performance Warnings and Cautions --------------------------------------------------------------- 12 Cleaning and Service Warnings and Cautions ---------------------------------------------------- 17 Compliance Warnings and Cautions ---------------------------------------------------------------- 17 Chapter 1: Technology Overview ------------------------------------------------------------------------ 19 Signal Extraction Technology® (SET®) ------------------------------------------------------------ 19 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 22 rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------ 26 Chapter 2: System Components------------------------------------------------------------------------- 29 General System Description -------------------------------------------------------------------------- 29 Radius-7 Instrument Module ------------------------------------------------------------------------- 29 Radius-7 Battery Module ----------------------------------------------------------------------------- 30 Radius-7 Armband ------------------------------------------------------------------------------------- 31 Radius-7 Battery Charging Adapter ----------------------------------------------------------------- 32 Chapter 3: Setting Up------------------------------------------------------------------------------------ 33 Unpacking and Inspection -------------------------------------------------------------------------- 33 Preparation for Use ----------------------------------------------------------------------------------- 33 Charging the Radius-7 Battery Module ------------------------------------------------------------ 33 Connecting Radius-7 to Root via Bluetooth ------------------------------------------------------- 34 Connecting Radius-7 to Patient SafetyNet ------------------------------------------------------- 35 Securing Radius-7 to Patient ------------------------------------------------------------------------ 35 Removing Radius-7 from Patient -------------------------------------------------------------------- 37 Chapter 4: Operation ------------------------------------------------------------------------------------- 39 Using the Touchpad ---------------------------------------------------------------------------------- 39 About the Main Screen ------------------------------------------------------------------------------- 40 www.masimo.com
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Contents
Navigating Radius-7 Main Menu -------------------------------------------------------------------- 40 Navigating Radius-7 Settings on Root ------------------------------------------------------------- 41 Parameter Settings ------------------------------------------------------------------------------------ 44 Trends--------------------------------------------------------------------------------------------------- 60 Chapter 5: Alarms and Messages ----------------------------------------------------------------------- 63 About Alarms ------------------------------------------------------------------------------------------- 63 3D Alarms ----------------------------------------------------------------------------------------------- 64 Messages ------------------------------------------------------------------------------------------------ 66 Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 71 Troubleshooting Measurements--------------------------------------------------------------------- 71 Troubleshooting Radius-7 ---------------------------------------------------------------------------- 73 Radius-7 Error Codes ---------------------------------------------------------------------------------- 74 Chapter 7: Specifications --------------------------------------------------------------------------------- 75 Measurement Range ---------------------------------------------------------------------------------- 75 Accuracy (ARMS*) ------------------------------------------------------------------------------------- 75 Resolution ----------------------------------------------------------------------------------------------- 77 ARMS Performance Specifications ------------------------------------------------------------------ 77 RRp Performance Specifications -------------------------------------------------------------------- 82 Electrical------------------------------------------------------------------------------------------------ 90 Environmental------------------------------------------------------------------------------------------ 91 Physical Characteristics ------------------------------------------------------------------------------ 91 Alarms --------------------------------------------------------------------------------------------------- 92 Display Indicators-------------------------------------------------------------------------------------- 92 EMC Compliance --------------------------------------------------------------------------------------- 92 Safety Standards Compliance ----------------------------------------------------------------------- 93 Wireless Specifications ------------------------------------------------------------------------------- 94 Guidance and Manufacturer's Declaration- Electromagnetic Emissions --------------------- 97 Guidance and Manufacturer's Declaration- Electromagnetic Immunity --------------------- 97 Recommended Separation Distances -------------------------------------------------------------- 99 Symbols------------------------------------------------------------------------------------------------ 100 Citations ----------------------------------------------------------------------------------------------- 102 Chapter 8: Service and Maintenance ---------------------------------------------------------------- 105 Cleaning ----------------------------------------------------------------------------------------------- 105 www.masimo.com
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Battery Operation and Maintenance ------------------------------------------------------------- 105 Safety Checks ----------------------------------------------------------------------------------------- 105 Repair Policy ------------------------------------------------------------------------------------------ 107 Return Procedure------------------------------------------------------------------------------------- 107 Contacting Masimo ---------------------------------------------------------------------------------- 107 Appendix: Concepts of Alarm Response Delay------------------------------------------------------- 111 Concepts of Alarm Response Delay ---------------------------------------------------------------- 111 Index ------------------------------------------------------------------------------------------------------- 113
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About this Manual This manual explains how to set up and use the Radius-7® Wearable Pulse CO-Oximeter®. Important safety information relating to general use of the Radius-7 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 Radius-7® Wearable Pulse CO-Oximeter® is a noninvasive device that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi®) along with optional measurements of hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), total oxygen content (SpOC™), methemoglobin (SpMet®), Acoustic Respiration Rate (RRa®), and Pleth Respiration Rate (RRp®). The following key features are available for the Radius-7: •
Patient wearable device for continuous monitoring when the patient is ambulatory.
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Bluetooth radio for transfer of parameter data to the Root patient monitoring and connectivity platform.
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Optional Wi-Fi for direct communication throughout the hospital to the Patient SafetyNet™ remote monitoring system.
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Masimo SET® and rainbow® SET technology performance.
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SpO2 and pulse rate monitoring in motion and low perfusion environments.
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Continuous and noninvasive monitoring of carboxyhemoglobin (SpCO), methemoglobin (SpMet), and total hemoglobin (SpHb).
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Respiration rate can be determined by the acoustic (RRa) or plethysmographic waveform (RRp).
Indications for Use The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions www.masimo.com
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Product Description, Features and Indications for Use
in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from the pleth (RRp) for adult and pediatrics during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
Contraindications There are no contraindications.
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Safety Information, Warnings and Cautions CAUTION: Radius-7 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 should be read before use. Refer to the Operator’s Manual for Root for additional safety information, warnings, and cautions.
Safety Warnings and Cautions WARNING: Do not use Radius-7 if it appears or is suspected to be damaged. WARNING: Always use Radius-7 in conjunction with Root. Do not use parts from other systems. Injury to personnel or equipment damage could occur. WARNING: Do not adjust, repair, open, disassemble, or modify the Radius-7. Damage to the device may result in degraded performance and/or patient injury. WARNING: Do not start or operate the Radius-7 unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury. WARNING: Only use Masimo authorized devices with Radius-7. Using unauthorized devices with Radius-7 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 Radius-7 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 Radius-7 during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Radius-7 may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Radius-7 during defibrillation. WARNING: Electrical Shock Hazard: To protect against injury, follow the directions below: •
Avoid placing the device on surfaces with visible liquid spills.
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Do not soak or immerse the device in liquids.
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Do not attempt to sterilize the device.
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Use cleaning solutions only as instructed in this Operator's Manual.
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Do not attempt to clean the Radius-7 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. WARNING: The Armband site must be checked frequently or per clinical protocol to ensure adequate securement, circulation and skin integrity.
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WARNING: Armbands applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure injury. WARNING: Discontinue and dispose of Armband if it appears to be stained or becomes excessively moist to minimize risk of skin irritation. CAUTION: Electrical Shock Hazard: Do not place the Battery Charging Adapter of Radius-7 on or near the patient. Injury to patient could occur. Note: Use and store the Radius-7 in accordance with specifications. See the Specifications section in this manual.
Performance Warnings and Cautions General WARNING: Radius-7 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Always ensure settings including alarms are appropriate for each patient and facility's protocols prior to use. WARNING: The Radius-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; 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 Radius-7 for proper functioning. WARNING: Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. WARNING: Radius-7 is not an apnea monitor. WARNING: Radius-7 should not be used as a replacement or substitute for ECG-based arrhythmia analysis. WARNING: Radius-7 may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Do not use during electrocautery. This may affect the accuracy or availability of the parameters and measurements. WARNING: When the Radius-7 is connected to Root, all audible alarms will be provided on the Root. WARNING: Always pair Radius-7 with Root. WARNING: Avoid placing Radius-7 against a surface that may cause the alarm to be muffled. This may result in the inability to detect the audible alarms. WARNING: Properly apply sensors according to the sensor’s directions for use. Misapplied sensor or sensors that become partially dislodged may cause no or incorrect readings. www.masimo.com
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WARNING: Display parameter 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: With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation. 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: SpHb measurements in the ranges of 0 to 8g/dL and 17 to 25 g/dL are provided for reference information only. The monitor shall display Low SpHb SIQ message along with the SpHb measurement whenever the measurement is displayed in these ranges. Furthermore, the display window also changes color providing a visual alarm to alert the user that the SpHb values are either in the 0 to 8g/dL or 17 to 25 g/dL ranges. Clinicians should consider additional information to supplement SpHb values, including laboratory diagnostic tests using blood samples, to completely understand the patient’s condition. WARNING: Optical, pleth-based measurements (e.g. SpO2, SpHb, SpOC, SpMet, SpCO, and RRp) can be affected by the following: •
Improper sensor application or use of use of incorrect sensor.
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Blood pressure cuff applied to the same arm as the sensor site.
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Intravascular dyes such as indocyanine green or methylene blue.
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Venous congestion.
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Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).
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Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
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Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
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Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or foreign objects in the light path.
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Elevated levels of bilirubin.
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Physiological conditions that can significantly shift the oxygen disassociation curve.
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A physiological condition that may effect vasomotor tone or changes in vasomotor tone.
WARNING: Inaccurate SpO2 readings may be caused by: •
Elevated levels of COHb and/or MetHb.
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Severe anemia.
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Extremely low arterial perfusion.
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Excessive induced motion.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (Quantitative defects such as Thalassemias).
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Safety Information, Warnings and Cautions
WARNING: Inaccurate SpHb and SpOC readings may be caused by: •
Low arterial perfusion.
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Motion induced artifact.
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Low arterial oxygen saturation levels.
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Elevated COHb and/or MetHb levels.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
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Severe anemia.
WARNING: Inaccurate SpCO readings may be caused by: •
Elevated methemoglobin levels in the range of >15%.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
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Extremely elevated hemoglobin levels.
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Low arterial perfusion.
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Low arterial oxygen saturation levels including altitude induced hypoxemia.
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Motion induced artifact.
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Severe anemia.
WARNING: SpCO readings may not be provided if there are Low arterial oxygen saturation levels or elevated methemoglobin levels. WARNING: Inaccurate SpMet readings may be caused by: •
Elevated carboxyhemoglobin levels in the range of >3%.
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Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias).
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Extremely elevated hemoglobin levels.
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Low arterial perfusion.
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Low arterial oxygen saturation levels including altitude induced hypoxemia.
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Motion induced artifact.
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Physiological conditions that can significantly shift the oxygen disassociation curve.
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Severe anemia.
WARNING: Inaccurate RRa measurements may be caused by: •
Improper sensor application or use of incorrect sensor.
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Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
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Motion artifact.
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Excessive ambient or environmental noise.
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WARNING: Inaccurate RRp measurements may be caused by: •
Low arterial perfusion.
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Motion induced artifact.
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Severe anemia.
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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: Do not place the Radius-7 near electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Radius-7 promptly after a Low Battery alarm may result in the device shutting down. CAUTION: If using Radius-7 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: 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 Radius-7. CAUTION: In order to maintain Bluetooth connectivity with Root, ensure that the Radius-7 is within approximately 7 m radius and line of sight of Root. CAUTION: When using Radius-7 in Wi-Fi mode, be aware of the patient's location. Alarms relayed to Patient SafetyNet will not provide patient location. CAUTION: When using multiple Radius-7 and Root systems, re-dock the Battery Module to Root to ensure proper pairing before connecting the Radius-7 to the patient. CAUTION: If the Radius-7 and Root become unable to communicate, parameters and measurements will not show on the Root; however, this will not affect Radius-7's ability to monitor the patient.
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Safety Information, Warnings and Cautions
CAUTION: In order to establish and maintain Radius-7’s minimum Quality of Service, the following network specifications should be met before and after installation: •
Wireless Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 100 milliseconds, b. No more than 2 % packets loss, and c. Primary access point signal strength at least -67 dBm.
CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time Radius-7 is used. 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: SpHb readings may be inaccurate for patients with conditions that may cause edema at the measurement site (eg. kidney disease, pregnancy, etc.). Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO2, SpHb, SpOC, SpCO, SpMet, and RRp readings. Note: Radius-7 is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Radius-7’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Radius-7’s primary alarms. Note: When the Radius-7 is connected directly via Wi-Fi to Patient SafetyNet, the Radius-7 will provide audible alarms. Note: Before securing Radius-7 onto the patient, make sure the Battery Module is sufficiently charged. Note: Always charge Radius-7 when it is not in use to ensure that the Radius-7 Battery Module 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 Module. Note: The Radius-7 display enters standby mode after 30s of inactivity. The Radius-7 display entering standby mode does not affect the monitoring of the patient. Note: A functional tester cannot be used to assess the accuracy of Radius-7. Note: When monitoring acoustic respiration, Masimo recommends minimally monitoring both oxygenation (SpO2) and respiration (RRa). www.masimo.com
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Note: When using Radius-7 in the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the sensor becomes dislodged from the patient in this setting, false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement.
Patient SafetyNet Note: The wireless communication status between Radius-7 and Patient SafetyNet is displayed by Patient SafetyNet.
Cleaning and Service Warnings and Cautions WARNING: Do not attempt to remanufacture, recondition or recycle the Radius-7 as these processes may damage the electrical components, potentially leading to patient harm. WARNING: To avoid electric shock, do not attempt to service the Radius-7 or the Battery Module. Servicing of the Radius-7 should be done by qualified personnel only. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Radius-7 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 electric shock, always turn off the Radius-7 and physically disconnect it from Root before cleaning Radius-7. CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Radius-7. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge the Radius-7 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 Radius-7 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: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. CAUTION: Dispose of used batteries according to required country or regional requirements. Note: Use Radius-7 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 www.masimo.com
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Safety Information, Warnings and Cautions
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, 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.
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Increase the separation between the equipment and receiver.
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Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
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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: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: This Class B digital apparatus complies with Canadian ICES-003. Note: 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.
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Chapter 1: Technology Overview The following chapter contains general descriptions about parameters, measurements, and the technology 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: 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: •
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
•
The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
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 Radius-7 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.
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Chapter 1: Technology Overview
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.
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.
2. 3.
4.
5. 6.
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