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Masimo

Contents

About This Manual-------------------------------------------------------------------------------------------7

Product Description, Features and Indications for Use ----------------------------------------------- 9

Product Description ------------------------------------------------------------------------------------- 9

Indications for Use ------------------------------------------------------------------------------------- 10

Contraindications -------------------------------------------------------------------------------------- 11

Safety Information, Warnings and Cautions ---------------------------------------------------------- 13

Safety Warnings and Cautions ----------------------------------------------------------------------- 13

Performance Warnings and Cautions --------------------------------------------------------------- 15

Cleaning and Service Warnings and Cautions --------------------------------------------------- 20

Compliance Warnings and Cautions ---------------------------------------------------------------- 21

Chapter 1: Technology Overview ------------------------------------------------------------------------ 23

Signal Extraction Technology® (SET®) ------------------------------------------------------------ 23

rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 26

rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------ 31

Chapter 2: Description ----------------------------------------------------------------------------------- 35

General System Description ------------------------------------------------------------------------- 35

Features ------------------------------------------------------------------------------------------------- 36

Chapter 3: Setting Up------------------------------------------------------------------------------------ 39

Unpacking and Inspection -------------------------------------------------------------------------- 39

Preparation for Use ----------------------------------------------------------------------------------- 39

Guidelines for Setting Up ---------------------------------------------------------------------------- 39

Powering the Rad-97 ON and OFF ------------------------------------------------------------------ 40

Initial Battery Charging ------------------------------------------------------------------------------- 41

Nurse Call Connection -------------------------------------------------------------------------------- 41

Attach NIBP Cuff --------------------------------------------------------------------------------------- 42

Masimo Kite --------------------------------------------------------------------------------------------- 42

Third-Party Devices ------------------------------------------------------------------------------------ 42

Chapter 4: Operation -------------------------------------------------------------------------------------- 43

Using the Touchscreen and Home Button --------------------------------------------------------- 43

About the Main Screen --------------------------------------------------------------------------------48

About the System Status Light --------------------------------------------------------------------- 56

Summary of Contents for Rad-97

Page 1: ...Operator s Manual Rad 97 Pulse CO Oximeter...

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Page 3: ...l prescribing information including indications contraindications warnings and precautions For professional use See instructions for use for full prescribing information including indications contrain...

Page 4: ...mo owners The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium All other registered trademarks and trademarks are property of their respective owners 201...

Page 5: ...r 1 Technology Overview 23 Signal Extraction Technology SET 23 rainbow Pulse CO Oximetry Technology 26 rainbow Acoustic Monitoring RAM 31 Chapter 2 Description 35 General System Description 35 Feature...

Page 6: ...iatric and Neonatal Profiles 107 Chapter 6 Noninvasive Blood Pressure NIBP 109 Operation NIBP 109 Patient Category 109 Patient Conditions 109 Cuff Selection and Placement 110 Blood Pressure Measuremen...

Page 7: ...ce 154 Connectors 155 Wireless Specifications 155 Guidance and Manufacturer s Declaration Electromagnetic Emissions 158 Guidance and Manufacturer s Declaration Electromagnetic Immunity 158 Recommended...

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Page 9: ...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 state...

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Page 11: ...SpCO methemoglobin SpMet and total hemoglobin SpHb Respiration Rate RR is measured using Acoustic RRa Plethysmographic waveform RRp Oxygen Reserve Index ORi an index to measure changes in oxygen stat...

Page 12: ...terial hemoglobin SpO2 pulse rate PR carboxyhemoglobin saturation SpCO methemoglobin saturation SpMet total hemoglobin concentration SpHb and or respiratory rate RRa The Masimo Rad 97 and Accessories...

Page 13: ...ia recovery and respiratory care The environment is the operating suite intensive care unit and patient room The intended patient population is adult pediatric and infant patients The optional non inv...

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Page 15: ...r 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 pati...

Page 16: ...tient at a time on Rad 97 Note Use and store the Rad 97 in accordance with specifications See the Specifications section in this manual Noninvasive Blood Pressure WARNING Only use Rad 97 in Neonatal m...

Page 17: ...th additional data WARNING Rad 97 is not an apnea monitor WARNING Rad 97 should not be used as a replacement or substitute for ECG based arrhythmia analysis WARNING Rad 97 may be used during defibrill...

Page 18: ...tc 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 o...

Page 19: ...Extremely elevated hemoglobin levels Low arterial perfusion Low arterial oxygen saturation levels including altitude induced hypoxemia Motion induced artifact Physiological conditions that can signif...

Page 20: ...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 s...

Page 21: ...of Wi Fi communication Note Rad 97 s alarm capabilities have been designed to be independent of the Wi Fi communication feature in order to preserve Rad 97 s primary alarms Note Always charge Rad 97 w...

Page 22: ...ition or recycle the Rad 97 as these processes may damage the electrical components potentially leading to patient harm WARNING To avoid electric shock always turn off the Rad 97 and physically discon...

Page 23: ...l 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...

Page 24: ...tion 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...

Page 25: ...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 26: ...rm 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 averagi...

Page 27: ...bject 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 Variab...

Page 28: ...un 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 29: ...ilizes 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 t...

Page 30: ...e 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 expected...

Page 31: ...d part of the above equation is approximately 0 3 ml O2 dL based on PaO2 being approximately 100 mmHg Furthermore for typical carboxyhemoglobin and methemoglobin levels the functional saturation SpO2...

Page 32: ...urement is obtained by placing a sensor on a patient usually on the fingertip for adults and the hand or foot for infants The sensor connects either directly to the Pulse CO Oximetry device or through...

Page 33: ...nts of SpCO SpMet and SpHb during patient motion However because of the changes in the physiological parameters such as blood volume arterial venous coupling etc that occur during patient motion the a...

Page 34: ...primarily related to turbulent respiratory airflow in upper airways Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are...

Page 35: ...continuous The respiratory cycle envelope signal processing principle is similar to methods that sample airway gasses and subsequently determine a respiratory rate Citations 1 A R A Sovij rvi F Dalma...

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Page 37: ...ter contains the description of the Rad 97 physical features General System Description The Rad 97 system includes the following Rad 97 Device AC Power Cord Patient Cable Sensor For a complete list of...

Page 38: ...view and change settings 2 Home Button Provides a multipurpose user interface that allows for navigation to the home screen as well as turning the device on and off 3 Patient Cable Connector Provides...

Page 39: ...tivity 4 Equipotential Ground Connector Provides optional functional earthing for Rad 97 to eliminate potential differences between the earth connections for Rad 97 and another medical device The use...

Page 40: ...be taken not to cover the speaker 2 Swivel Foot Provides stability when placing Rad 97 on a surface in a vertical position 3 Foot Pads Provides physical support to Rad 97 when placed on a surface in...

Page 41: ...tient Cable Sensor 2 Read the Safety Information Warnings and Cautions on page 13 3 Setup the Rad 97 according to the directions provided in this Operator s Manual Guidelines for Setting Up When setti...

Page 42: ...97 will power on To Power OFF Rad 97 When powering off the Rad 97 the device remembers the last settings if the Power on Profile is set to Previous Profile See Access Control on page 94 The device al...

Page 43: ...ch the AC Power Indicator icon to view battery charge details See Rad 97 Battery on page 93 For additional information see Battery Operation and Maintenance on page 172 Nurse Call Connection To connec...

Page 44: ...splays system and parameter status reported by the POC device on a separate monitor Rad 97 must be on the same network as Kite Note If the device is not on the same network it can be added but Kite wi...

Page 45: ...ding these instructions Using the Touchscreen and Home Button 1 Main Screen To access settings and other screens touch a value or icon on the Display View See About the Main Screen on page 48 2 Home P...

Page 46: ...Touch Touch and release Action performed once finger is released Touch and Hold Touch and hold Action performed once hold duration is reached A notification is displayed Swipe Touch and Move Touch mov...

Page 47: ...b left or right Spinner Touch center focused tile When closed expands spinner When open collapses spinner Swipe up or down When open scrolls through spinner tiles Touch unfocused tile When open scroll...

Page 48: ...surement alarm is present opens parameter or measurement menu When parameter or measurement alarm is present silences parameter or measurement alarm Touch and hold Enables parameter and measurement dr...

Page 49: ...r measurement trend menu Trend Zoom Touch Increases time range Touch Decreases time range Touch time label Resets time range to default Alarm Silence icon Touch Silences all alarms Audio Pause icon To...

Page 50: ...ar on page 49 2 Action Menu See About the Action Menu on page 51 3 Waveform View See Waveform Mode on page 79 4 Parameter Display See Understanding Windows on page 53 5 Well See Understanding Windows...

Page 51: ...Profiles screen The example shown illustrates the current Profile is Adult for an adult patient See Chapter 5 Profiles on page 103 4 Device Output Provides access to the Device Output screen See Devic...

Page 52: ...pulse tone volume This icon does not indicate the actual volume level of the alarm and pulse tone See Sounds on page 85 10 Current Time Displays the current time and provides access to the Localizatio...

Page 53: ...be displayed Touch the Battery Charge Status Indicator icon to view battery details See Rad 97 Battery on page 93 About the Action Menu To expand the Action Menu select the arrow in the upper right co...

Page 54: ...e unit ICU APOD Adaptive Probe Off Detection Sensitivity APOD is the recommended sensitivity mode for situations which there is a high probability of the sensor becoming detached It is also the sugges...

Page 55: ...iew and Numeric View When a parameter is minimized it is only displayed in the Well with its Numeric Value and Parameter Label When a parameter is expanded it will be shown in the Parameter display wi...

Page 56: ...he Numeric Value until it shrinks Step 2 Drag the Numeric Value to the Well Step 3 Release the Numeric Value Customizing Trend View There are different ways to view trend information The following is...

Page 57: ...ts Indicate high and low alarm limits for the parameter or measurement if applicable 5 Parameter or Measurement Label Indicates the name of the parameter or measurement Data can be added to or removed...

Page 58: ...Indication None None System is off Green None System is monitoring patient no alarms Yellow Low There is an active low priority alarm Examples of low priority alarms No cable is connected Cable connec...

Page 59: ...Parameter Settings Displayed on devices with NIBP See rainbow Parameter Settings on page 59 Noninvasive Blood Pressure Settings See Noninvasive Blood Pressure NIBP Settings on page 80 Additional Setti...

Page 60: ...89 This icon is neither available nor displayed in the Main Menu when the device is in optional Home mode when available See Home on page 89 Navigating the Main Menu Once the Main Menu screen is displ...

Page 61: ...ny screen requiring selection of option s will time out after one 1 minute of inactivity and return to the Display View To navigate to the previous screen press the arrow in the top left corner of the...

Page 62: ...ccess the desired parameter swipe the on screen icons left or right 2 Touch the icon of the desired parameter Parameter Settings include See SpO2 Settings on page 62 See PR Settings on page 64 See Pi...

Page 63: ...nt causing a sensor initialization to occur Eight hours has elapsed since the In Vivo offset was activated Restore of factory defaults User turns off In Vivo Offset Value When In Vivo Adjustment is ac...

Page 64: ...reshold that triggers an alarm Medium Off 2 to 99 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 88 1 to 98 in steps of 1...

Page 65: ...seconds 2 4 4 6 8 10 12 14 or 16 seconds FastSat See FastSat Overview on page 63 Off Off or On With FastSat the averaging time is dependent on the input signal Defaults to 2 4 seconds when in Sleep S...

Page 66: ...of 0 1 PR Settings From the PR Settings screen change any of the following options PR Alarms on page 64 Trends on page 97 About Parameter Information on page 78 PR Alarms From the PR Alarms screen ch...

Page 67: ...Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm Medium Off 0 04 to 0 09 in steps of 0 01 0 1...

Page 68: ...ngs for PVi on page 67 Trends on page 97 About Parameter Information on page 78 PVi Alarms From the Additional Settings screen change any of the following options Options Description Alarm Priority Fa...

Page 69: ...ion Rate RR Settings RRp is currently not available in the U S A and territories relying on FDA market clearance Rad 97 can determine Respiration Rate RR either by the acoustic signal RRa or the pleth...

Page 70: ...om the RR Settings screen access any of the following screens RRa Alarms on page 68 Additional Settings for RRa on page 69 About Parameter Information on page 78 RRa Alarms From the Alarms screen chan...

Page 71: ...The length 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 dis...

Page 72: ...screen change any of the following options Options Description Alarm Priority Factory Default Settings User Configurable Settings High Limit High Limit is the upper threshold that triggers an alarm H...

Page 73: ...which the system calculates the average of all data points Slow No Averaging Fast Medium Slow Trending Freshness The duration of time that during interference the system displays the last valid readin...

Page 74: ...0 1 mmol L or Off 20 g L to 245 g L in steps of 1 g L or Off When SpHb Precision is set to 1 0 values are rounded down When set to Off alarm is disabled Low Limit Low Limit is the lower threshold that...

Page 75: ...is g L Precision is always 1 whole numbers 0 1 0 1 0 5 or 1 0 Unit of Measure Displays total hemoglobin SpHb as g dL grams per deciliter g L grams per liter or mmol L millimoles per liter Unit of Meas...

Page 76: ...Settings High Limit High Limit is the upper threshold that triggers an alarm Medium 25 2 ml dl to 34 ml dl in steps of 1 ml dl or Off Low Limit Low Limit is the lower threshold that triggers an alarm...

Page 77: ...triggers an alarm Medium Off Off or 0 1 to 2 0 in steps of 0 1 2 5 to 99 in steps of 0 5 Silence Duration Sets the amount of time that the alarm is silenced NA 2 minutes 30 seconds or 1 2 or 5 minute...

Page 78: ...triggers an alarm High 10 2 to 98 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 Medium Off Off or 1 to 97 in steps of 1 When...

Page 79: ...screens ORi Alarms on page 77 Trends on page 97 About Parameter Information on page 78 ORi Alarms From the ORi Alarms screen access the following screens Options Description Alarm Priority Factory De...

Page 80: ...ys information about the parameter Additional Settings Use the Additional Settings screen to configure the following Option Description Factory Default Settings User Configurable Settings Sensitivity...

Page 81: ...examples of some of the waveforms viewable on the Main Screen Signal IQ Indicators Signal IQ SIQ indicators are displayed as vertical bars for each individual pulsation The height of the bar provides...

Page 82: ...e Blood Pressure NIBP Settings Note This feature is optional on Rad 97 devices The NIBP menu allows the user to view and customize settings for the NIBP module by changing any of the following options...

Page 83: ...See Pulse Rate PR on page 83 SYS DIA Settings From the Systolic Diastolic Settings screen access the following screens SYS DIA Alarms on page 81 Trends for NIBP on page 82 About Parameter Information...

Page 84: ...imit is the lower threshold that triggers an alarm Medium 35 Off or 21 198 in steps of 1 When set to Off alarm is disabled Trends for NIBP From the Systolic Diastolic Settings screen touch Trends and...

Page 85: ...18 in steps of 1 When set to Off alarm is disabled Pulse Rate PR From the Pulse Rate Settings screen access the following screens Pulse Rate Alarms on page 83 About Parameter Information on page 78 Pu...

Page 86: ...d pressure measurements once every desired interval 15 minutes 2 3 4 5 10 15 30 60 or 90 minutes Stat Duration Note Option available when Stat mode is selected Stat interval measurement mode will take...

Page 87: ...cription Factory Default Settings User Configurable Settings Alarm Volume Sets the alarm volume level 4 Highest volume 1 to 4 Slide towards the left to decrease volume and to silence Pulse Tone Volume...

Page 88: ...below marked with an are displayed in the Main Menu no other device settings are available See Home on page 89 The Device Settings options are Localization See Localization on page 87 Device Mode See...

Page 89: ...ee About the Status Bar on page 49 Option Description Factory Default Settings User Configurable Settings Language Select the language display for Rad 97 English Choose from available languages Date F...

Page 90: ...again Note Home mode is an optional feature Access to the Device Mode screen is password protected 1 When the screen displays press the key 2 Enter the following 6 2 7 4 To undo an entry press the Bac...

Page 91: ...uring Continuous Monitoring mode When parameters in the Main Menu are selected only parameter information is displayed Settings are not displayed or available See About Parameter Information on page 7...

Page 92: ...in the profile set during Continuous Monitoring mode Home button illumination turns off SpO2 averaging time defaults to 2 4 seconds and cannot be changed See Additional Settings for SpO2 on page 63 Th...

Page 93: ...ce in vertical position Landscape with device in horizontal position Portrait Inverted Portrait Landscape or Inverted Landscape Ethernet Use the Ethernet screen to enable or disable Ethernet connectiv...

Page 94: ...ngth of the connection The user can also access the Wi Fi screen by pressing the Wi Fi icon on the Status Bar See About the Status Bar on page 49 Option Description Factory Default Settings User Confi...

Page 95: ...annot be configured by the user Your Masimo sales representative can provide necessary information regarding an initial Bluetooth connection Note Presence Monitoring must be disabled in order for Rad...

Page 96: ...Description Factory Default Settings User Configurable Settings Auto Brightness Allows automatic adjustment of display brightness based on the ambient light level Off On or Off Brightness Adjust the...

Page 97: ...larm volume level Off 3 4 or Off Screen Lock Allows the user to lock the touchscreen to prevent accidental changes Off On or Off USB Port Baudrate Sets the USB port communication speed 921600 9600 192...

Page 98: ...ontrols the mechanism of action for triggering to occur Should be changed to accommodate institutional Nurse Call settings Normal Normal or Inverted USB Port Controls the communication protocol used t...

Page 99: ...he technology level software These fields are read only and cannot be configured by the user Trends Trend settings allow the user to configure the Y axis maximum and Y axis minimum for each parameter...

Page 100: ...in increments of 0 1 SpHb mmol L Y axis Min 3 1 mmol L 0 0 to 15 4 mmol L in increments of 0 1 Y axis Max 12 4 mmol L 0 1 to 15 5 mmol L in increments of 0 1 SpHb g L Y axis Min 50 g L 0 to 249 g L in...

Page 101: ...FDA market clearance Note When the device is in optional Home mode if available Trend settings are not available The device operates using the Trend settings set during Continuous Monitoring mode See...

Page 102: ...SB drive in the next step there must be a folder titled screen_shot in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots 2 Plug the USB drive into the USB port lo...

Page 103: ...t SafetyNet Depending on patient status different icons display on the Main Screen Icon Name Description Admit Select to admit a patient Discharge Indicates a patient is currently admitted Select to d...

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Page 105: ...EDIATRIC and the color of the Profile button turns Green Neonatal Displays in the Status bar as NEO and the color of the Profile button turns Pink If the Profile setting is changed to NEO Rad 97 will...

Page 106: ...asimo com 104 Masimo Select Profiles from the Main Menu as shown below Once the Profiles screen displays you can switch to a different profile or choose a different patient category Adult Pediatric Ne...

Page 107: ...Blue Pediatric Green Neonatal Purple If the profile is displayed with an asterisk Home button illumination is turned Off To choose a different category for the selected patient profile From the Profi...

Page 108: ...reen to select patient type Option Description Factory Default Setting Configurable Settings Profile Name Identifies the profile currently active on Rad 97 Adult Adult Pediatric Neonatal Custom Patien...

Page 109: ...in place of the factory default settings the Profile button still changes to the same Blue Green or Pink color respectively See Profiles Overview on page 103 The user can also load preferred profile s...

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Page 111: ...n the rapidly diminishing amplitude of the pressure fluctuations Patient Category The below table provides a method for selecting the appropriate Noninvasive Blood Pressure NIBP patient category To ch...

Page 112: ...s elapse before the first reading is taken Cuff Selection and Placement Rad 97 uses a quick connect hose with a blood pressure cuff to measure NIBP Based on the cuff type selected use the following ap...

Page 113: ...easurement site Wrap the cuff around the non dominant arm making sure that the Artery Marker is aligned over the brachial artery as shown in the image below If possible do not wrap the cuff over the p...

Page 114: ...ressure of NIBP Ensure that the proper patient profile and associated patient category are appropriate for the intended patient 2 To change the patient profile touch the Main Menu icon then select Pro...

Page 115: ...ff to measure blood pressure on neonates 2 To change the patient profile touch the Main Menu icon then select Profiles Touch the Profile Name and select the desired patient profile 3 Properly place th...

Page 116: ...w 7 Wait for measurement to complete or touch the Stop button to stop the measurement Note Once finished measuring values will appear and the next measurement will begin after the specified interval S...

Page 117: ...Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference 5 To begin measurement touch the Start Stat button and then press the arrow in the top left corn...

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Page 119: ...patient Discharge Indicates a patient is currently admitted Select to discharge admitted patient Note In order to use this feature Masimo Patient SafetyNet software V5 0 6 5 or higher is required Not...

Page 120: ...t 1 Press the Admit icon on the bottom left of the screen to open the Patient screen 2 Select the patient name by pressing the Search button see Fig 1 3 Select the patient s name from the list see Fig...

Page 121: ...ar on the screen Acknowledge the message by pressing Cancel or Discharge Press Discharge to discharge the patient that is currently admitted on Rad 97 or press Cancel to keep the same patient admitted...

Page 122: ...Discharging a Patient 1 Press the Discharge icon on the bottom left of the screen to open the Patient screen 2 Select the Discharge button on the bottom of the screen see Fig 4 3 A confirmation messag...

Page 123: ...ow that displays all the data from that device on the Main Screen Connect Device to Rad 97 To connect a third party device to Rad 97 using Bluetooth perform the following 1 Ensure Bluetooth is enabled...

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Page 125: ...ity Alarm Sound High 10 pulse burst Medium 3 pulse burst Alarm Source Example Explanation Parameter Level The example shown here is a PR alarm PR Low as the reading exceeds the lower alarm limit Note...

Page 126: ...be used to temporarily suspend audible alarms for a pre configured amount of time Silence Duration Silence Duration configurations vary across different parameters and measurements For more informati...

Page 127: ...Bar or the Alarm Silence button If the alarm is for a specific parameter touch the alarming parameter Parameters are highlighted when in an alarm state Audible alarms that are temporarily suspended b...

Page 128: ...e Alarms menu for each parameter Audio Pause Audio Pause temporarily suspends all audible alarms on Rad 97 When it is active visual alarms are not impacted and will still display The Audio Pause icon...

Page 129: ...t is always active SpO2 values that fall below the standard low alarm limit but remain above the ATA low alarm threshold activates visual alarms and a temporary audible notification If the ATA low ala...

Page 130: ...rations beyond a defined level from the patient s baseline saturation over a specific period of time Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed user s...

Page 131: ...97 measures perfusion at the monitored SpO2 site by comparing the pulsatile signal to the non pulsatile signal and expressing that ratio as a percentage Pi has been clinically proven to be useful as...

Page 132: ...al alarms 50 10 to 99 in steps of 1 Timeout The length of time over which 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...

Page 133: ...Defective sensor Replace sensor Pulse CO Ox Sensor Near Expiration or RAM Sensor Near Expiration Reusable sensor has less than 10 patient monitoring time remaining Replace with new reusable sensor Pu...

Page 134: ...se provided with the sensor Disconnect and reconnect the sensor into the Patient Cable connector Check to see if the sensor LED is flashing Disconnect and reconnect the sensor If the LED fails to oper...

Page 135: ...e sensor Pulse CO Ox No Adhesive Sensor Connected or RAM No Adhesive Sensor Connected When a single patient use sensor is used the adhesive portion of the sensor is not connected Ensure the adhesive p...

Page 136: ...es low signal confidence in the SpCO measurement displayed Ensure proper sensor application Check sensor to see if it is working properly If not replace the sensor See Successful Monitoring for SpCO o...

Page 137: ...t the correct size cuff is being applied Check that the cuff is in the correct position Check that there is no excessive clothing between arm and cuff Retake another measurement Check that the cuff is...

Page 138: ...ment transducer may be out of range or there has been a calibration data failure Perform calibration procedures See Chapter 12 Service and Maintenance on page 167 If problem still persists contact Mas...

Page 139: ...w SIQ message displayed Low signal quality Sensor is damaged or not functioning Improper sensor type or application Excessive motion Low perfusion Verify Sensor type and size and re apply sensor See D...

Page 140: ...Replace sensor Verify the device and sensor are configured with the parameter Verify proper sensor and sensor size for the patient Shield the sensor from excessive or strobing light Minimize or elimin...

Page 141: ...Assessment or Arterial Blood Gas Measurements Low perfusion Sensor displacement Check for error messages See Chapter 9 Alarms and Messages on page 123 Check placement of sensor or if it is too tight...

Page 142: ...nnection Contact Masimo Service See Contacting Masimo on page 173 System failure technical alarm active Internal failure Turn Rad 97 Off and On Contact Masimo service See Contacting Masimo on page 173...

Page 143: ...rly grounded Relocate the device from other devices that may cause electromagnetic interference Contact Masimo service See Contacting Masimo on page 173 Battery run time significantly reduced Battery...

Page 144: ...port not configured correctly Nurse call system not available Internal failure Check Nurse call connector is fully connected to the device Check Nurse call port configuration See Device Output on page...

Page 145: ...Wi Fi is not turned on and or not correctly configured Location does not have wireless availability Connected network is not available Internal failure Check external device compatibility Check that...

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Page 147: ...0 99 PVi Pleth Variability Index 0 to 100 RRa Respiration Rate 0 rpm to 70 rpm 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 Met...

Page 148: ...Adults Pediatrics Infants 2 Neonates 3 Motion 3 SpO2 from 70 to 100 All patient populations 3 Low perfusion 4 SpO2 from 70 to 100 All patient populations 2 Pulse Rate PR Range 25 to 240 bpm No motion...

Page 149: ...ccuracy is a statistical calculation of the difference between device measurements and reference measurements Approximately two thirds of the device measurements fell within ARMS of the reference meas...

Page 150: ...e compatible sensor Measurement ARMS Values for Disposable RD SET Series Sensors SpO2 Accuracy Range ARMS 70 80 1 4 80 90 1 6 90 100 1 1 70 100 1 4 The table below provides the upper 95 and lower 95 l...

Page 151: ...lot represents the correlation of the SpO2 SaO2 2 versus SpO2 SaO2 under no motion with an upper 95 and lower 95 limits of agreement Figure 1 Disposable RD SET Series Sensors ARMS 70 100 Resolution Pa...

Page 152: ...n the U S A and territories relying on FDA market clearance Noninvasive Blood Pressure NIBP Specifications Measurement Range Measurement Patient Population Display Range Systolic Adult 40 260 mmHg Ped...

Page 153: ...n 75 lbs 34 kg Adult 160 mmHg 280 mmHg Between 15 4 75 lbs 7 34 kg Pediatric 140 mmHg 280 mmHg Less than 15 4 lbs 7 kg Neonatal 90 mmHg 140 mmHg Electrical AC Power Requirements AC Power requirements...

Page 154: ...erating Humidity Non NIBP 10 to 95 non condensing NIBP 15 to 95 non condensing Storage Transport Humidity Non NIBP 10 to 90 non condensing NIBP 15 to 90 non condensing Operating Atmospheric Pressure 5...

Page 155: ...y Flashing yellow 550 Hz tone 3 pulse burst pulse spacing 0 375s 0 375s repeat time 7s Low Priority Solid yellow No audible alarms Alarm Characteristic Description Alarm Volume High Priority 75 dB min...

Page 156: ...ompliance ANSI AAMI ES 60601 1 2005 CAN CSA C22 2 No 60601 1 IEC 62366 IEC 60601 1 6 IEC 60601 1 2005 IEC 60601 1 8 IEC 60601 1 11 IEC 60601 2 49 IEC 80601 2 30 NIBP EN ISO 80601 2 61 2011 Equipment C...

Page 157: ...ode of Operation Continuous operation Connectors Connector Type Ethernet 10 100 Mbps Nurse Call 1 4 inch round female USB USB 2 0 NIBP Nib Male Quick Connect Wireless Specifications Communication Wi F...

Page 158: ...ooth Frequency 2402 2480 MHz Max Peak Output Power Bluetooth 1 3 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types DH5 Modulation Signals Anal...

Page 159: ...Specifications www masimo com 157 Masimo Radio Compliance USA FCC ID VKF MWM1 Model RAD 97 Canada IC 7362A MWM1 IC Model MWM1 RSS 210 Europe EN 300 328 EN 301 893 EN 301 489 1 EN 301 489 17 R TTE Dire...

Page 160: ...Suitable for use in all establishments including domestic environments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Ha...

Page 161: ...tions and voltage variations on power supply input lines 100 dip in mains voltage for 0 5 cycle 60 dip in mains voltage for 5 cycle 30 dip in mains voltage for 25 cycle 100 dip in mains voltage for 0...

Page 162: ...e applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed tra...

Page 163: ...ed 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 0 18 Sqrt P 800 MHz to 2 5GHz d 0 35 Sqrt P 0...

Page 164: ...d electronic equipment WEEE Non Sterile Defibrillation proof Type BF applied part NIBP Protection from ingress of particulates than 12 5 mm and against vertically falling water drops Recyclable Author...

Page 165: ...manufacture YYYY MM DD Masimo reference number Storage temperature range Serial number Keep dry Fragile handle with care Storage humidity limitation Do not use if package is damaged Atmospheric pressu...

Page 166: ...rainbow SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced...

Page 167: ...for the Masimo Acoustic Respiration Sensor and Instrument has been validated for the range of 4 to 70 respirations per minute in bench top testing Clinical validation for up to 30 respirations per mi...

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Page 169: ...visible residue Note Pay particular attention to cracks crevices and hard to reach areas of the device Repeat the above cleaning step using a fresh wipe Allow the Rad 97 to dry thoroughly before using...

Page 170: ...tervals or in accordance with local and governmental regulations To test the performance of the Rad 97 following repairs or during routine maintenance follow the procedure outlined in this chapter If...

Page 171: ...ent Cable connector on the Rad 97 to connect the Masimo SET Tester to the Rad 97 3 See the directions for use that were provided with the Masimo SET Tester Nurse Call Test To conduct a Nurse Call test...

Page 172: ...lb to the Module using T adapters and connection tubing 4 Touch the Test button on the display to start the calibration 5 Apply various pressures between 0 mmHg and 280 mmHg to the Module with the han...

Page 173: ...ntended for qualified service professionals only Calibration Steps 1 Enter NIBP menu and select Calibration 2 Enter password 4258 and select Span Point Calibration 3 Connect a manometer volume and the...

Page 174: ...ria above return the module for service to an authorized service center Maintenance Battery Operation and Maintenance The Rad 97 includes a lithium ion rechargeable battery Before using the Rad 97 wit...

Page 175: ...ner if possible and enclose or include the following information and items A letter describing in detail any difficulties experienced with the Rad 97 Include the RMA number in the letter Warranty info...

Page 176: ...sories not intended by Masimo to be used with the Product f not used or maintained as provided in the operator s manual or as otherwise provided in its labeling g reprocessed reconditioned or recycled...

Page 177: ...sfer the Software from the Product to any other device Purchaser may not disclose publish translate release distribute copies of modify adapt translate reverse engineer decompile disassemble or create...

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Page 179: ...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 180: ...e 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 communi...

Page 181: ...65 66 Additional Settings for PVi 66 67 Additional Settings for RRa 67 68 69 Additional Settings for RRp 67 70 71 Additional Settings for SpHb 71 73 Additional Settings for SpO2 62 63 90 Admitting a...

Page 182: ...5 D Desat Index 128 129 Device Mode 86 88 Device Output 41 49 87 96 142 169 Device Settings 57 86 134 Discharging a Patient 120 Display Indicators 153 Display Range 145 Downloading Screenshots 100 E E...

Page 183: ...ET Parallel Engines 23 Masimo SET DST 24 Measurement Range 150 Messages 130 Monitoring Resumed Message 119 N Navigating the Main Menu 58 NIBP Air Leak Test 170 NIBP Module Calibration 170 Noninvasive...

Page 184: ...124 rainbow Pulse CO Oximetry Technology 26 Recommended Separation Distances 161 Regulatory Notice 9 Repair Policy 173 Replacing Factory Default Settings for Adult Pediatric and Neonatal Profiles 95 1...

Page 185: ...SpMet 30 134 Successful Monitoring for SpO2 PR and Pi 24 Symbols 162 SYS DIA Alarms 81 SYS DIA Settings 81 T Testing with the optional Masimo SET Tester 169 Third Party Devices 42 Touchscreen Function...

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Masimo Rad-97, Operator'S Manual

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Summary of Contents for Rad-97

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