Operator's Manual
Radius-7
®
Wearable Pulse
CO-Oximeter
Page 1: ...Operator s Manual Radius 7 Wearable Pulse CO Oximeter...
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Page 3: ...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 profe...
Page 4: ...C and X Cal are trademarks 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...
Page 5: ...tion 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 30 Radius 7 Ba...
Page 6: ...fications 75 Measurement Range 75 Accuracy ARMS 75 ARMS Performance Specifications 77 Resolution 80 Electrical 81 Environmental 81 Physical Characteristics 82 Alarms 82 Display Indicators 83 EMC Compl...
Page 7: ...s 7 Contents www masimo com 5 Masimo Safety Checks 96 Repair Policy 97 Return Procedure 97 Contacting Masimo 98 Appendix Concepts of Alarm Response Delay 101 Concepts of Alarm Response Delay 101 Index...
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Page 9: ...f 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 war...
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Page 11: ...et remote monitoring system Masimo SET and rainbow SET technology performance SpO2 and pulse rate monitoring in motion and low perfusion environments Continuous and noninvasive monitoring of carboxyhe...
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Page 13: ...ned 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...
Page 14: ...oglobin measurements may be profound and may be affected by sample type body positioning as well as other physiological conditions As with most hemoglobin data Radius 7 trend data should be scrutinize...
Page 15: ...urement 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 8...
Page 16: ...synthesis disorders quantitative defects such as Thalassemias Extremely elevated hemoglobin levels Low arterial perfusion Low arterial oxygen saturation levels including altitude induced hypoxemia Mot...
Page 17: ...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 pat...
Page 18: ...ings 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...
Page 19: ...e 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 1...
Page 20: ...he 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 a...
Page 21: ...use 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 ar...
Page 22: ...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...
Page 23: ...ubject 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 Varia...
Page 24: ...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 Signal IQ The Signal...
Page 25: ...utilizes a sensor with various light emitting diodes LEDs that pass light through the site to a diode detector Signal data is obtained by passing various visible and infrared lights LEDs 500 to 1400nm...
Page 26: ...n the partial pressure of oxygen pO2 and saturation such as pH temperature the partial pressure of carbon dioxide pCO2 2 3 DPG and fetal hemoglobin In the case of SpCO different results are also expec...
Page 27: ...nciples of pulse oximetry spectrophotometry to make its SpCO measurement The measurement is obtained by placing a sensor on a patient usually on the fingertip for adults and the hand or foot for infan...
Page 28: ...s as dashes and a message Low SpCO SIQ Low SpMet SIQ or Low SpHb SIQ displays to alert the clinician that the device does not have confidence in the value due to poor signal quality caused by excessiv...
Page 29: ...reach the body surface and are recorded as respiratory sounds Although the spectral shape of respiratory sounds varies widely from person to person it is often reproducible within the same person lik...
Page 30: ...s that sample airway gasses and subsequently determine a respiratory rate Citations 1 A R A Sovij rvi F Dalmasso J Vanderschool L P Malmberg G Righini S A T Stoneman Definition of terms for applicatio...
Page 31: ...s of the following components Instrument Module Battery Module Armband Battery Charging Adapter The Battery Charging Adapter docks onto the Root to function as both a charger and holder for the Radius...
Page 32: ...can be connected to Radius 7 via this connector CAUTION Refer to the Directions for Use for the sensor before applying it on patients 2 Contact Pins The pins provide a data and power connection to th...
Page 33: ...arms in the event the communication to secondary display is lost 2 Release Buttons These buttons are used to release the Battery Module from the Instrument Module and Battery Charging Adapter 3 Displa...
Page 34: ...The Armband is used to secure Radius 7 to the patient The Armband comes in three different sizes small 11 9 medium 16 4 and large 25 4 The Instrument Module and Armband are keyed so that they can only...
Page 35: ...n the Root docking station during initial setup the adapter should not be removed during patient monitoring The following table describes the features of the Battery Charging Adapter Ref Feature Descr...
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Page 37: ...or damaged contact the Technical Service Department See Chapter 8 Service and Maintenance on page 95 Preparation for Use Prior to setting up the Radius 7 for monitoring perform the following steps 1 C...
Page 38: ...attery information See Battery Operation and Maintenance on page 95 Connecting Radius 7 to Root via Bluetooth In order connect the Radius 7 to Root via Bluetooth connection perform the following steps...
Page 39: ...is not connected to a wireless network A blue icon indicates Radius 7 is connected to a wireless network but not communicating with Patient SafetyNet A green icon indicates Radius 7 is connected to a...
Page 40: ...Radius 7 Chapter 3 Setting Up www masimo com 38 Masimo To secure the Radius 7 to a patient follow the instructions below with the help of the visual aid...
Page 41: ...Note The Radius 7 should be oriented so that the Acoustic Sensor connector is the closest connector to the patient s neck 6 Loop the Armband strap around the patient s arm and thread the strap through...
Page 42: ...ff of the Instrument Module 5 Undo the key of the armband plastic and slide the Instrument Module away from the Armband Note Do not to dispose of the Radius 7 instrument module when changing the repla...
Page 43: ...and stay for a prescribed amount of time Release finger once action had been performed Enter and Exit the Main Screen Silence acknowledge alarms Swipe Touch move left right up or down and release View...
Page 44: ...aneously 3 Waveform Field Displays SIQ and the pleth waveform with the respiration waveform blue in the background Navigating Radius 7 Main Menu From the Main Screen touch and hold the Touchpad on the...
Page 45: ...ttings including alarms and trends See Configuring Parameters on page 44 Additional settings including Averaging time and FastSat See Additional Settings on page 45 The Radius 7 settings may be config...
Page 46: ...neous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement MAX Maximum Sensitivity MAX is the recommended sensitivit...
Page 47: ...page 64 Additional Settings See Additional Settings on page 45 Additional Settings Use the Additional Settings screen to configure the following Option Description Default Setting Configurable Settin...
Page 48: ...ls see any of the following sections See SpO2 Settings on page 46 See PR Settings on page 48 See Pi Settings on page 49 See PVi Settings on page 51 See Respiration Rate RR Settings on page 53 See SpHb...
Page 49: ...h limit threshold value that triggers an alarm NA Off Off or 1 to 10 in steps of 1 Low Caution Range Provides an early indicator for a parameter approaching the low limit threshold value that triggers...
Page 50: ...dependent on the input signal FastSat Overview FastSat enables rapid tracking of arterial oxygen saturation changes Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithm...
Page 51: ...Provides an early indicator for a parameter approaching the high limit threshold value that triggers an alarm NA 20 Off or 5 to 25 in steps of 5 Low Caution Range Provides an early indicator for a pa...
Page 52: ...larm Medium 0 30 Step size Off or 0 03 to 0 09 in steps of 0 01 0 10 to 0 90 in steps of 0 10 1 to 18 in steps of 1 High Caution Range Provides an early indicator for a parameter approaching the high...
Page 53: ...Factory Default Settings User Configurable Settings Averaging Time The length of time over which the system calculates the average of all data points Long Short or Long PVi Settings From the PVi Setti...
Page 54: ...Limit is the lower threshold that triggers an alarm Medium 5 Off or 1 to 98 in steps of 1 When set to Off alarms are disabled High Caution Range Provides an early indicator for a parameter approachin...
Page 55: ...al RRa For more information see RRa Settings on page 53 From the RR Settings screen change any of the following options RRa Alarms on page 54 Additional Settings for RRa on page 55 About Parameter Inf...
Page 56: ...gh 6 breaths per minute Off or 5 to 68 breaths per minute in steps of 1 breath per minute High Caution Range Provides an early indicator for a parameter approaching the high limit threshold value that...
Page 57: ...of time over which the system calculates the average of all data points Slow Trending No Averaging Fast Medium or Slow Freshness The duration of time that during interference the system displays the...
Page 58: ...he nearest whole number When set to Off alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm High 7 0 g dL 4 0 mmol L 70 g L 1 0 g dL to 23 5 g dL in steps of 0 1 g dL o...
Page 59: ...ettings for SpHb Option Description Factory Default Settings User Configurable Options Averaging Time The length of time over which the system calculates the average of all data points Medium Short Me...
Page 60: ...um 25 2 to 34 in steps of 1 or Off When set to Off alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm High 10 Off or 1 to 33 in steps of 1 When set to Off alarm is dis...
Page 61: ...et to Off alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm Medium Off Off or 0 1 to 2 in steps of 0 1 2 5 to 99 in steps 0 5 When set to Off alarm is disabled High C...
Page 62: ...Off alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm Medium Off Off or 1 to 97 in steps of 1 When set to Off alarm is disabled High Caution Range Provides an early...
Page 63: ...epending on the selected parameter Trend Settings Use the Trend Settings screen under each Parameter Setting screen to configure Trend Views on Root Option Description Factory Default Setting User Con...
Page 64: ...9 in steps of 1 Y axis Max 35 1 to 70 in steps of 1 SpCO Y axis Min 0 0 to 99 in steps of 1 Y axis Max 40 1 to 100 in steps of 1 SpMet Y axis Min 0 0 0 0 to 99 5 in increments of 0 5 Y axis Max 15 0 1...
Page 65: ...le alarms will sound on Root but not Radius 7 In this case audible alarms can be temporarily silenced on Root Visual alarms will display on both Radius 7 and Root until the alarm condition has been ad...
Page 66: ...linicians to saturation levels that exceed user selected thresholds These thresholds are typically established to detect significant changes from patients baseline saturation levels However in select...
Page 67: ...lsatile signal and expressing that ratio as a percentage Pi has been clinically proven to be useful as a predictor of the level of illness in neonates and adults It has also been shown that Pi may cha...
Page 68: ...the percent change in Pi is monitored None None or 1 5 30 minutes 1 4 8 12 24 36 48 hours Messages The following section lists common messages their potential causes and next steps Alarm Message Descr...
Page 69: ...meter upgrades Pulse CO Ox Sensor Near Expiration or RAM Sensor Near Expiration Sensor has less than 10 patient monitoring time remaining Replace sensor Pulse CO Ox No Adhesive Sensor Connected or RAM...
Page 70: ...n the patient and reconnect the sensor to the Instrument Module If the sensor is damaged replace the sensor Pulse CO Ox Pulse Search Device is searching for pulse If device fails to display within 30...
Page 71: ...IQ Indicates low signal confidence in the value displayed due to poor signal strength Ensure proper sensor application Move sensor to a better perfused site See Signal IQ on page 22 Low SpCO SIQ Indic...
Page 72: ...line power Replace Battery Module if necessary Device disconnected Device has lost Bluetooth connectivity with Root Check if Bluetooth is enabled on Root See the Operator s Manual for Root Check conn...
Page 73: ...or eliminate motion at the monitoring site Set to Maximum Sensitivity See Sensitivity Modes Overview on page 44 Difficulty obtaining a reading Interference from line frequency induced noise Misaligned...
Page 74: ...for comparison Check patient conditions indicated to affect SpCO accuracy SpHb reading is dim and Low SpHb SIQ message displays The SpHb reading is outside of the accuracy range See Chapter 7 Specifi...
Page 75: ...e the Operator s Manual for Root 2 Check if Bluetooth is enabled on Radius 7 by accessing the About panel on the Main Menu See Connecting Radius 7 to Root via Bluetooth on page 36 3 Verify the Mac add...
Page 76: ...tchdog fault 3 Instrument Module IB RAM fault 4 Instrument Module IB ROM fault 5 Instrument Module IB Processor fault 6 Instrument Module IB Temperature out of range 7 Voltage out of range 8 MX Techno...
Page 77: ...lity Index 0 to 100 RRa Respiration Rate 0 bpm to 70 bpm SpHb Hemoglobin 0 0 g dL to 25 0 g dL 0 g L to 250 g L 0 0 mmol L to 15 5 mmol L SpCO Carboxyhemoglobin 0 to 99 SpMet Methemoglobin 0 0 to 99 9...
Page 78: ...oxyhemoglobin Level SpCO 1 Range of 1 to 40 Adults Pediatrics 3 Methemoglobin Level SpMet 1 Range 1 to 15 Adults Pediatrics 1 Total Hemoglobin SpHb 6 Range of 8 g dL to 17 g dL Adults Pediatrics 1 g d...
Page 79: ...clinical studies under no motion conditions This SpO2 data is representative of data obtained from Masimo rainbow SET Technology and compatible Masimo sensors The below Bland Altman plots represent th...
Page 80: ...ter 7 Specifications www masimo com 78 Masimo Measurement Arms Values for rainbow Reuse DCI Sensors SpO2 Accuracy Range Arms 70 80 1 88 80 90 1 72 90 100 1 21 70 100 1 63 Figure 2 rainbow Reuse Sensor...
Page 81: ...Chapter 7 Specifications www masimo com 79 Masimo Measurement Arms Values for rainbow Adhesive R1 Series Sensors SpO2 Accuracy Range Arms 60 70 3 42 70 80 2 49 60 80 2 99 Figure 3 rainbow R1 Series Ar...
Page 82: ...Masimo Measurement Arms Values for rainbow Adhesive R1 Series Sensors SpO2 Accuracy Range Arms 70 80 2 47 80 90 1 80 90 100 1 57 70 100 1 98 Figure 4 rainbow R1 Series Arms 70 100 Resolution Parameter...
Page 83: ...itoring Display off Bluetooth on Wi Fi off Charging Time 6 hours Note For information on Root Battery see Specifications in the Operator s Manual for Root Environmental Radius 7 Environmental Conditio...
Page 84: ...0 21 lbs 93g Instrument Module 0 15 lbs 67g Alarms Alarm Priority Alarm Status Color Audio Alarm Description High Priority Flashing red 571 Hz tone 10 pulse burst pulse spacing 0 25s 0 25s 0 50s 0 25s...
Page 85: ...ED Pixels 160 X 128 Dot Pitch 0 073 W mm X 0 219 H mm EMC Compliance EMC Compliance IEC 60601 1 2 2007 Class B Safety Standards Compliance Safety Standards Compliance ANSI AAMI ES 60601 1 2005 CAN CSA...
Page 86: ...s from splashing water Mode of Operation Continuous Environment Not suitable for use in the presence of flammable anesthetics Wireless Specifications Communication Wi Fi Type WLAN Radio IEEE 802 11 a...
Page 87: ...d Output Power Type Fixed at the Factory Modulation Types DH5 Modulation Signals Analog and Digital Available Data Rates Bluetooth 1 Mbps Security and Authentication Encryption 64 128 bit WEP Dynamic...
Page 88: ...red operation of the device Guidance and Manufacturer s Declaration Electromagnetic Emissions Guidance and Manufacturer s Declarations Electromagnetic Emissions The ME Equipment is intended for use in...
Page 89: ...rs are covered with synthetic material the relative humidity should be at least 30 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels...
Page 90: ...jects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast ca...
Page 91: ...ted maximum output power of transmitter W Separation Distance According to Frequency of Transmitter m 150 K Hz to 80 MHz d 1 17 Sqrt P 80 MHz to 800 MHz d 1 17 Sqrt P 800 MHz to 2 5GHz d 2 33 Sqrt P 0...
Page 92: ...r spray from any direction Defibrillation proof Type BF applied part Separate collection for electrical and electronic equipment WEEE Authorized representative in the European community Recyclable Cau...
Page 93: ...ber Storage temperature range Masimo reference number Keep dry Serial number Storage humidity limitation Fragile handle with care Atmospheric pressure limitation Do not use if package is damaged Nurse...
Page 94: ...5 to 2 5 HbMet with a resultant accuracy of 2 9 SpO2 and 0 9 SpMet Contact Masimo for testing specifications 2 The Masimo rainbow SET technology with Masimo sensors has been validated for no motion ac...
Page 95: ...deviation which encompasses 68 of the population 6 SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the ra...
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Page 97: ...ex Plus 3 4 glutaraldehyde 10 bleach solution 70 isopropyl alcohol solution Using the recommended cleaning solutions on the display panel will not affect the performance of the Radius 7 WARNING Do not...
Page 98: ...ors or patient cables Disconnect the Battery Module from the Instrument Module See Chapter 3 Setting Up on page 35 Ensure that the Battery Module is charged Speaker Display and Touchpad Function Test...
Page 99: ...is fully dry before packing To return the device for service refer to Return Procedure on page 97 Return Procedure Clean contaminated dirty equipment before returning following instructions in Cleani...
Page 100: ...in its original packaging when supplied to purchaser b modified without Masimo s written permission c supplies devices or systems external to the Product d disassembled reassembled or repaired by any...
Page 101: ...Restrictions Purchaser may physically transfer the Product from one location to another provided that the Software is not copied Purchaser may not electronically transfer the Software from the Produc...
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Page 103: ...tion Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists While Alarm Signal Generation Delay is the time from the onset of an a...
Page 104: ...ve to show the delay due to processing and averaging The Alarm Signal Generation Delay is graphically represented as t3 t2 in the figure above to show the delay due to alarm system strategy and commun...
Page 105: ...s 77 B Battery Operation and Maintenance 36 95 97 Battery Test 97 C Chapter 1 Technology Overview 19 Chapter 2 System Components 29 37 Chapter 3 Setting Up 35 96 Chapter 4 Operation 41 Chapter 5 Alarm...
Page 106: ...nufacturer s Declaration Electromagnetic Immunity 87 I Indications for Use 9 L Limitation of Warranty 98 Limited Warranty 98 M Masimo rainbow SET Parallel Engines 19 Masimo SET DST 20 Measurement Rang...
Page 107: ...uring Radius 7 to Patient 37 Sensitivity Modes Overview 43 44 45 71 Sensor 27 Signal Extraction Technology SET 19 Signal IQ 22 69 Signal Processing 28 SpCO Alarms 60 SpCO Settings 46 60 SpCO SpMet and...
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