Masimo Root Operator'S Manual Download Page 3

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www.masimo.com

Masimo

For Sale in the USA

These operating instructions provide the necessary information for proper operation of all

models of the Root. 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 Root are prerequisites for its proper use. Do not operate Root without completely

reading and understanding these instructions.

Notice:

Purchase or possession of this device does not carry any express or implied license to

use with replacement parts which would, alone or in combination with this device, fall within

the scope of one of the relating patents.

Caution:

Federal (USA) law restricts this device to sale by or on the order of a physician.

Note:

Cleared Use Only: The device and related accessories are cleared by the Food and Drug

Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be

used for any processes, procedures, experiments or any other use for which the device is not

intended or cleared by the applicable regulatory authorities, or in any manner inconsistent

with the directions for use or labeling.

For professional use. See instructions for use for full prescribing information, including

indications, contraindications, warnings, and precautions.

Wireless Radio

FCC ID:VFK-RDS7A
IC:7362A-RDS7A IC Model: RDS-7A

Masimo Corporation

40 Parker

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

ETL Intertek certification.

Conforms to ANSI/AAMI ES 60601-1 and certified to CAN/CSA STD C22.2 No.

60601-1, IEC 60601-2-49, ISO 80601-2-56, and IEC 80601-2-30

Patents:

www.masimo.com/patents.htm

Root, SedLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo and , are

federally registered trademarks of Masimo Corporation.
MOC-9, Iris, Radius-7, and ISA are trademarks of Masimo Corporation. The use of the

trademark Patient SafetyNet is under license from University HealthSystem Consortium. All

other trademarks and registered trademarks are property of their respective owners.

Summary of Contents for Root

Page 1: ...Operator s Manual Root with noninvasive blood pressure and temperature ...

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Page 3: ...iments 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 For professional use See instructions for use for full prescribing information including indications contraindications warnings and precautions Wireless Radio FCC ID VFK RDS7A IC 7362A RDS7A IC Model RDS 7A Masimo Cor...

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Page 5: ... Compliance Warnings and Cautions 16 Chapter 1 Description 19 Features 20 Chapter 2 Setting Up 23 Unpacking and Inspection 23 Guidelines for Setting Up 23 Power On 24 Initial Battery Charging 25 Radical 7 Connection 26 Radius 7 Connection 27 Nurse Call Connection 27 Attach the Probe Well 28 Attach the Temperature Probe 28 Attach NIBP Cuff 28 Chapter 3 Operation 29 About the Status Bar 29 About the...

Page 6: ...etyNet 95 Not Admitted 96 Discharging a Patient 97 Admitting a Patient 98 Not Monitoring Message 100 Monitoring Resumed Message 101 Chapter 7 Radius 7 103 Chapter 8 MOC 9 105 Using MOC 9 Ports 105 Chapter 9 Iris 107 Iris Status Screen 108 Using Iris Connectivity Ports 109 Chapter 10 Messages 111 Chapter 11 Troubleshooting 115 Troubleshooting Radical 7 Radius 7 and MOC 9 Modules 115 Troubleshooting...

Page 7: ...ended Separation Distances 131 Symbols 132 Chapter 13 Service and Maintenance 135 Cleaning 135 Replacing the Fuses 135 Power On Self Test 136 NIBP Module Calibration 136 NIBP Air Leak Test 137 Zero Point Calibration 137 Span Point Calibration 137 Overpressure Test 138 Nurse Call Setting Connections 139 Battery Test 139 Repair Policy 140 Return Procedure 140 Contacting Masimo 140 Limited Warranty 1...

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Page 9: ... 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 a sample 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 instrument or damage to other property CAUTION This is a sample of a caution ...

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Page 11: ... multiple physiological parameters in healthcare environments The Masimo Root Monitoring System when used with the optional ISA module is not intended to be used in road ambulances The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming e g at a central station The optional Masimo Radical 7 Pulse CO Oximeter and Accessories are indicated ...

Page 12: ...ambulances The intended patient population is adult pediatric and infant patients The optional SedLine Sedation Monitor is indicated for use in the operating room OR intensive care unit ICU and clinical research laboratory It is intended to monitor the state of the brain by real time data acquisition and processing of EEG signals The system includes the Patient State Index PSI a proprietary comput...

Page 13: ...ot is not indicated for use outside the healthcare facility CAUTION Root is to be operated by or under the supervision of qualified personnel only The manual accessories directions for use all precautionary information and specifications should be read before use Refer to Operator s Manuals of Patient SafetyNet Radical 7 Radius 7 ISA and SedLine for additional safety information warnings and cauti...

Page 14: ...ace only with fuses of same type current rating and voltage rating WARNING Do not remove the back panel of the device This could cause injury to personnel or device damage WARNING Electrical Shock Hazard To protect against injury follow the directions below Avoid placing the device on surfaces with visible liquid spills Do not soak or immerse the device in liquids Do not attempt to sterilize the d...

Page 15: ...devices that have been designed for Root CAUTION Equipment intended to be connected to signal input signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock Only devices that have been configured to operate with Root may function properly when connected CAUTION Only use the AC power cable provided by Masimo Using a different AC po...

Page 16: ...od pressure measurement error code occurs any blood pressure values reported should be disregarded WARNING Always ensure settings including alarms are appropriate for each patient prior to use WARNING When using multiple devices in the same or similar environment use of the same patient profile including the same alarm presets to avoid confusion that can lead to patient harm CAUTION When setting a...

Page 17: ...ork 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 equipm...

Page 18: ...e within acceptable limits as specified by the applicable safety standards The summation of leakage currents must be checked and in compliance with IEC 60601 1 and UL60601 1 The system leakage current must be checked when connecting external equipment to the system When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs retest befor...

Page 19: ...erference to radio and TV reception If this equipment does cause harmful interference to radio or television which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an ...

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Page 21: ...r for Radical 7 and Radius 7 Battery Module As a bedside monitoring display for parameters on Radical 7 Radius 7 and MOC 9 modules As a bedside monitor for continuous or non continuous NIBP and temperature Note Continuous Mode will take a measurement every one 1 second As a connectivity gateway for standalone devices ...

Page 22: ...rontal display and interface for user interactions 3 Home Button Provides access to the Main Screen 4 Root Charging Indicator Shows an indication of the battery charge for Root 5 AC Power Indicator Shows an indication of AC power connection Root 6 Radical 7 Charging Indicator Shows an indication of battery charge for the Radical 7 in the Docking Station Only the touchscreen version of the Radical ...

Page 23: ...etwork connection to Root using an RJ 45 cable 5 USB Ports 2 Provide USB 2 0 connectivity 6 Power Entry Module Contains the input connector for a hospital grade AC power cord and the fuse holder 7 Equipotential Ground Connector Provides optional functional earthing for Root to eliminate potential differences The use of the Equipotential Ground Connector should be in accordance with IEC 60601 1 8 I...

Page 24: ...atus Lights on page 75 2 Power Button Places Root in Power On Sleep and Power Off modes 3 MOC 9 Ports 3 Provide connectivity for MOC 9 modules 4 NIBP Nib Connection port for NIBP Hose 5 Temperature Probe Port Allows connection of temperature probe to Root 6 Temperature Probe Well Holder Provides dock for temperature probe when not measuring 7 Probe Covers Holder Holds extra probe covers for quick ...

Page 25: ...ed contact Masimo s Technical Service Department See Return Procedure on page 140 Guidelines for Setting Up Root has a built in bracket interface that allows it to be mounted on a pole or roll stand When setting up Root follow these guidelines Place on a stable hard flat and dry surface near the patient Maintain a minimum of three 3 centimeters one 1 inch of free space around Root Ensure that the ...

Page 26: ...Button for two 2 seconds until a single audible tone sounds Once Root turns on if no Radical 7 Radius 7 or MOC 9 module is connected the Root display shows the following message Please Connect a Device The user is now able to connect Radical 7 Radius 7 and MOC 9 module For information about Sleep Mode and Power Off see Sleep and Power Off on page 77 ...

Page 27: ...y is charging by ensuring that the AC Power Indicator 1 is green and the Battery icon on the Status Bar 2 is solid green or has the charging symbol See AC Power Indicator on page 76 and About the Status Bar on page 29 1 2 4 The Root Charging Indicator remains orange while the battery is charging and will illuminate greenwhen Root is fully charged See Root Battery on page 47 and About the Status Ba...

Page 28: ...If the Radical 7 is not yet turned on press the power button on the Radical 7 to power it on When properly connected the Radical 7 Charging Indicator light will illuminate An illuminated Radical 7 Battery icon will also appear in the Status Bar Root display will show active measurements and parameters For Radical 7 charging conditions see Radical 7 and Radius 7 Charging Indicator on page 77 ...

Page 29: ...nual for Radius 7 for more information 5 When properly connected an illuminated Radius 7 Battery icon will appear in the Status Bar and the rainbow Window will appear on the Root display Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System To connect to a Nurse Call System 1 Identify the Nurse Call connection end 1 4 inch round female connector of the cable 2 I...

Page 30: ... probe into the probe well Attach the Temperature Probe 1 Hold the temperature probe cable connector with the spring tab on the right and insert it into the probe port of the temperature module 2 Push the cable connector into place until it clicks 3 Place probe cover onto the temperature probe and dock in the probe well Attach NIBP Cuff 1 Attach a necessary adapter to the end of the cuff hose 2 Co...

Page 31: ...nd MOC 9 modules See Alarm Silence on page 70 2 Audio Pause Displays Audio Pause status and temporarily silences an alarm event See Audio Pause on page 71 3 Standby Mode Allows for patient monitoring to be temporarily suspended Available when using Root with Radius 7 See Standby Mode on page 72 4 Profiles Provides access to the Profiles screen The example shown illustrates that Profiles is current...

Page 32: ...Displays charging status for Radical 7 or Radius 7 and provides access to the Battery Radical screen The example shows that the battery is currently charging See Radical 7 and Radius 7 Charging Indicator on page 77 10 Root Battery Displays charging status for Root and provides access to the Battery Root screen The example shows that the battery is currently charging See Root Charging Indicator on ...

Page 33: ...hy measurements and SedLine module bottom showing brain function measurements Ref Feature Description 1 Status Bar Displays system status as well as icons that provide shortcuts to menu items or actions See About the Status Bar on page 29 2 Windows Provides a dynamic user configurable display area for all the data from connected medical devices 3 Main Menu icon Provides access to the configuration...

Page 34: ...ed medical devices Action Illustration Example Description Press Touch and release Action performed once finger is released Slide Touch move left right up or down and release Moves an object across the display Swipe Touch move left right up or down and release quickly Pinch Touch move and release via two touch points Moving touch points apart zooms in and moving them together zooms out Drag and Dr...

Page 35: ...nner Press center focused tile When closed expands the spinner When open collapses the spinner Swipe up or down When open scrolls through spinner tiles Press unfocused tile When open scrolls tile into center focused position Press anywhere outside spinner When open collapses spinner Slider Slide knob Moves knob Press anywhere along slider path Quickly moves knob to Tap position Slider Spinner Slid...

Page 36: ...asurement menu When parameter or measurement alarm is present silences parameter or measurement alarm Press and hold Enables parameter and measurement drag and drop Well Press parameter or measurement When no parameter or measurement alarm is present opens parameter or measurement menu When parameter or measurement alarm is present silences parameter or measurement alarm Press and hold Enables par...

Page 37: ...nu abandons any changes Menu Navigation When navigating through menus and configuring settings all changes must be confirmed by selecting OK To cancel the changes select Cancel Any screen requiring selection of option s will time out after one 1 minute of inactivity and return to the Main Screen To navigate to the previous screen press the arrow at the top left corner of the touchscreen To return ...

Page 38: ...irections for use or Operator s Manual of Radical 7 Radius 7 and MOC 9 modules Trend View Analog View Ref Feature Description 1 Window The area where all data from a docked Radical 7 Radius 7 or connected MOC 9 module are displayed 2 Drop down Menu This menu allows the user to change between Trend View and Analog View For NIBP and Temperature the drop down menu allows access to additional settings...

Page 39: ...as a graph of its values over time The following diagram and table describe key features of a parameter s Trend Display in Trend View Ref Feature Description 1 Value Range Indicates current viewing of the parameter or measurement Press to access the Trend menu where the minimum and maximum of the range can be modified 2 Trend Graph Displays parameter and measurement over a period of time Zoom in a...

Page 40: ...to the directions for use or operator s manuals for Radical 7 Radius 7 and the appropriate MOC 9 module s The following diagrams and tables describe key features of a parameter s Gauge in Analog View When alarm limits for a specific parameter or measurement are set the corresponding Analog gauge re orients itself General features of the Analog View are Ref Feature Description 1 Needle Indicates cu...

Page 41: ...alarm will be triggered Some ranges display as quarter circles others display as half circles A quarter circle displays when the value has a physiologic normal level at one end of the range A half circle displays when the value has a physiologic normal level in the middle of the display range In the example below the SpO2 gauge is shown as a quarter circle where values lower than 88 will trigger a...

Page 42: ...iew 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 as either a Trend Display or Gauge To expand a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it dims Step 2 Drag the Numeric Value over any Trend Display Step 3 Release the Numeric Value ...

Page 43: ...ration www masimo com 41 Masimo Minimizing a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it shrinks Step 2 Drag the Numeric Value to the Well Step 3 Release the Numeric Value ...

Page 44: ...een press the Main Menu icon The Main Menu options are Device Settings See Device Settings on page 43 About See About on page 52 Trend Settings See Trend Settings on page 52 Profiles See Profiles on page 53 Iris See Iris on page 53 Layout See Layout on page 54 Sounds See Sounds on page 56 NIBP See NIBP on page 61 Temperature See Temperature on page 57 ...

Page 45: ...ons are Localization See Localization on page 44 Wi Fi See Wi Fi on page 45 Ethernet See Ethernet on page 46 Bluetooth See Bluetooth on page 46 Root Battery See Root Battery on page 47 Radical 7 Battery See Radical 7 and Radius 7 Battery on page 47 Brightness See Brightness on page 48 Access Control See Access Control on page 48 Device Output See Device Output on page 50 ...

Page 46: ...ee About the Status Bar on page 29 Option Description Factory Default Setting Configurable Settings Language Selects the language display for Root English Choose from available languages Date Format Sets the display format for current date mm dd yy mm dd yy or dd mm yy Time Sets the display format for current time 12 hour 12 hour or 24 hour Line Frequency Sets to match regional power line frequenc...

Page 47: ...s communication Root s alarm capabilities have been designed to be independent of the Wi Fi communication feature in order to preserve Root s primary alarms Use the Wi Fi screen to enable or disable Wi Fi connectivity When Root is connected to a Wi Fi network the Wi Fi icon on the Status Bar conveys the strength of the connection See About the Status Bar on page 29 Option Description Factory Defau...

Page 48: ...nce Tag Root s detection of Masimo s MyView Presence Tag is an optional feature that allows for the display of predetermined customized settings by a clinician Root utilizes only configured MAC addresses to establish Bluetooth communication to prevent unauthorized connection to other Bluetooth enabled devices Use the Bluetooth screen to enable or disable Bluetooth connectivity When Bluetooth conne...

Page 49: ...level remaining Battery Diagnostics Allows trained personnel to access battery diagnostic information Radical 7 and Radius 7 Battery Use the Battery screen to view the specific percentage of charge on the Radical 7 or Radius 7 s battery For Radical 7 the user can also access the Battery screen by pressing the Battery icon on the Status Bar See About the Status Bar on page 29 Option Description Sta...

Page 50: ... of Root s display brightness based on ambient light Off On or Off Brightness Adjust the brightness level of the Root display by sliding the button 4 is brightest 4 1 2 3 4 Access Control Access Control contains configurable options and settings that require a password To enter Access Control 1 Press the key 2 When the numeric screen displays enter the following numbers 6 2 7 4 Asterisks will be d...

Page 51: ...by Enabled Enable s option for Standby Mode See Standby Mode on page 72 Off On or Off Standby Reminder Tone Interval Allows for time interval of 30 sec 1 min 2 min 3 min 5 min 10 min or 15 min as well as Off 30 sec 30 sec 1 min 2 min 3 min 5 min 10 min 15 min Off Save as Adult Saves current profile parameter as the Adult Profile N A Press Save to load Save as Pediatric Saves current profile parame...

Page 52: ...rity Controls the mechanism of action for triggering to occur Should be changed to accommodate institutional Nurse Call settings Normal Normal or Inverted USB Port 1 Controls the output type for USB Port 1 None None IAP IntelliBridge and ASCII 1 USB Port 2 Controls the output type for USB Port 2 IAP None IAP IntelliBridge and ASCII 1 IntelliBridge Output Controls the data type output for IntelliBr...

Page 53: ...l record system Masimo parameter and waveforms from SET rainbow SET and SedLine channels are supported Note Root supports the transmission of data only Validations of the retrieval and display of data transmitted is the responsibility of the IntelliBridge manufacturer Parameters Supported IntelliBridge connectivity allows for up to six 6 parameters and two 2 waveforms or eight 8 parameters and no ...

Page 54: ... Radical 7 Radius 7 and MOC 9 modules will display in a separate list These fields are read only and cannot be configured by the user Trend Settings Use the Trend Settings screen to configure trend viewing on the Main Screen and trend data storage on Root Option Description Factory Default Setting Configurable Settings Default Duration Duration captured by Trend Graph 2 hours 15 30 45 minutes 1 2 ...

Page 55: ...figuration settings on Root The settings of the three default profiles Adult Pediatric and Neonatal configure parameter alarms averaging time and sensitivity modes Custom profiles can also be created to accommodate usage in any hospital care area See the Masimo Instrument Configuration Tool Directions for Use for information on adding Profiles For more information regarding Profiles see the Instru...

Page 56: ...play the parameters and measurements by changing the Layout Style Note This feature only applies to Trend View See Using Trend View on page 37 Option Description Factory Default Setting Configurable Settings Layout Style Controls the sizing of Trend Displays Fixed Fixed or Dynamic The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View ...

Page 57: ...ases to accommodate parameter s expanded or minimized All Trend Displays are always evenly sized For more information about expanding and minimizing parameters see Customizing Windows on page 40 2 Size of each Trend Display is automatically adjusted When the number of Trend Displays reaches maximum viewing capacity additional parameters expanded will result in the replacement of existing Trend Dis...

Page 58: ...left to decrease volume to silence Audio Pause Duration Sets the length of time that the audible alarm remains silenced when Audio Pause is enabled See Audio Pause on page 71 2 minutes 1 2 3 minutes Permanent Permanent with Reminder If Permanent is selected there will be no audible alarms when Audio Pause is enabled but visual alarms will still display If Permanent with Reminder is selected a tone...

Page 59: ...menu allows the user to view and customize settings for the Temperature module by changing any of the following options Alarms See Alarms for Temperature on page 58 Trends See Trends for Temperature on page 59 Additional Settings See Additional Settings for Temperature on page 60 ...

Page 60: ... Off alarm is disabled Low Limit F Low Limit is the lower threshold that triggers an alarm High Off 80 1 109 8 in steps of 0 1 or Off When set to Off alarm is disabled High Limit C The High Limit is upper threshold that triggers an alarm High Off 26 9 43 2 in steps of 0 1 or Off When set to Off alarm is disabled Low Limit C Low Limit is the lower threshold that triggers an alarm High Off 26 8 43 1...

Page 61: ... Temperature Trend Max The upper limit a measurement will be shown 110 0 80 1 110 0 in steps of 0 1 Y Axis Min F The Temperature Trend Min The lower limit a measurement will be shown 80 0 80 0 109 9 in steps of 0 1 Y Axis Max C The Temperature Trend Max The upper limit a measurement will be shown 43 3 26 8 43 3 in steps of 0 1 Y Axis Min C The Temperature Trend Min The lower limit a measurement wi...

Page 62: ...gs User Configurable Settings Unit of Measure The unit of measure for temperature F F C Probe Mode A patient specific probe setting Oral Oral Adult Ax Pediatric Ax Continuous Monitoring Provides continuous temperature readings through a direct measurement Direct measurement is used to continuously read temperatures until it reaches the thermal steady state unchanging Start None Note No menu is giv...

Page 63: ...menu allows the user to view and customize settings for the NIBP module by changing any of the following options Parameter Settings See Parameter Settings for NIBP on page 62 Intervals See Intervals for NIBP on page 67 Calibration See Calibration for NIBP on page 67 ...

Page 64: ... screen touch Parameter Settings and then change individual parameter settings alarms by selecting one the following parameters Systolic Diastolic See Systolic Diastolic SYS DIA on page 63 Pulse Rate See Pulse Rate PR on page 65 Mean Arterial Pressure See Mean Arterial Pressure MAP on page 66 ...

Page 65: ... an alarm High 220 42 259 in steps of 1 or Off When set to Off alarm is disabled Systolic Low Limit Low Limit is the lower threshold that triggers an alarm High 75 41 258 in steps of 1 or Off When set to Off alarm is disabled Diastolic High Limit The High Limit is upper threshold that triggers an alarm High 110 22 199 in steps of 1 or Off When set to Off alarm is disabled Diastolic Low Limit Low L...

Page 66: ...nds and then change any of the following options Options Description Factory Default Settings Configurable Options Y Axis Max The NIBP Trend Max The upper limit a measurement will be shown 260 21 260 in steps of 1 Y Axis Min The NIBP Trend Min The lower limit a measurement will be shown 20 20 259 in steps of 1 ...

Page 67: ...tions Description Alarm Priority Factory Default Settings Configurable Options High Limit The High Limit is upper threshold that triggers an alarm High 120 40 215 in steps of 5 or Off When set to Off alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm High 50 35 210 in steps of 5 or Off When set to Off alarm is disabled ...

Page 68: ...g options Options Description Alarm Priority Factory Default Settings Configurable Options High Limit The High Limit is upper threshold that triggers an alarm High 120 28 219 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 50 27 218 in steps of 1 or Off When set to Off alarm is disabled ...

Page 69: ...rements once every desired interval 15 min 2 min 3 min 4 min 5 min 10 min 15 min 30 min 60 min 90 min Stat Duration Note Option available when Stat mode is selected Stat interval measurement mode will take blood pressure measurements continuously for the desired duration 10 min 5 min 10 min Calibration for NIBP The Calibration option on the NIBP menu allows a qualified service professional to acce...

Page 70: ...in more detail Priority Alarm Sound High 10 pulse burst Medium 3 pulse burst Alarm Source Example Explanation Parameter Level The example shown here is a PR alarm as the reading 142 exceeds the upper alarm limit 140 Note that the borders of both the PR Trend Display as well as the Window are illuminated red and the explanation of the alarm is shown at the top of the Window High PR 140 ...

Page 71: ...n of the alarm is shown at the top of the Window High Impedance Detected System Level The example shown here is a Low Battery alarm Note that the border of the entire Root display is illuminated red and the explanation of the alarm is shown in the Status Bar Low Battery For more details about specific alarms on Radical 7 Radius 7 and MOC 9 modules see Directions for Use or Operator s Manuals for R...

Page 72: ... parameters and measurements For more information about Silence Duration refer to the instructions for use or Operator s Manuals for Radical 7 Radius 7 and appropriate MOC 9 module s Icon Appearance Description Visual Alarms There are currently no active alarms and no alarms have been silenced No There are currently no active alarms but at least one alarm has been and is still silenced No There is...

Page 73: ...nactive and the icon appears in the following way Audio Pause inactive To activate Audio Pause press the icon It will turn red and the remaining Audio Pause Duration time counts down next to the icon The default duration for Audio Pause is 120 seconds In the example below Audio Pause is activated and there are 15 seconds left until Audio Pause is inactive again To configure Audio Pause see Sounds ...

Page 74: ...turn to the home screen on Root and the Standby icon will appear on the screen in the top left corner 3 Press the Standby icon and a notification message will appear on the screen indicating that monitoring is suspended see image below To exit Standby Mode resume monitoring Tap anywhere on the screen WARNING When Root is in Standby Mode monitoring is suspended and no alarms will be active with the...

Page 75: ...nstrument Configuration Tool which converts the data to a TXT or CSV file Screenshot Capture The user is able to take screenshots of Root displays and download them as png files onto a USB drive To ensure quick downloads the number of screenshots that can be stored in Root is limited to 20 once the limit is reached every new screenshot taken will replace the oldest screenshot taken Note Download t...

Page 76: ...y alarms triggered on Root 2 Plug the USB drive into one of the two USB ports that are located on the back side of Root and the screenshots will automatically begin to download A status message will display briefly at the top of the Root screen to indicate the start of the download Note There must be a folder titled screen_shot in the USB drive with a FAT or FAT32 system file to enable the downloa...

Page 77: ...rity Indication None None Monitoring has not started Green None There is currently no active alarms Flashing Yellow Medium There is an active alarm of medium priority Flashing Red High There is an active alarm of high priority The alarm priority is determined by the Radical 7 Radius 7 and MOC 9 module s that are connected to Root The following are system level alarm messages that accompany System ...

Page 78: ...s connected to an AC power source Off Root is not connected to an AC power source Root Charging Indicator Whenever Root is connected to an AC power source if not fully charged its battery will charge Light Status Battery Indication Green Battery is fully charged Orange Battery is charging Red Battery charging error Off Battery is not being charged Root is not connected to AC power source ...

Page 79: ...ion Green Battery is fully charged Orange Battery is charging Red Battery is unable to charge Off Battery is fully charged not being charged Sleep and Power Off To put Root in the Sleep Mode or Power Off Mode follow these steps State Description Sleep Mode Press and hold the Power Button for two 2 seconds until one 1 audible tone sounds Sleep Mode conserves power while enabling a quicker startup s...

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Page 81: ...e would be if the probe were left in place until steady state is achieved Continuous Mode Continuous mode provides continuous temperature readings through a direct measurement Direct measurement is used to continuously read temperatures until it reaches the thermal steady state unchanging The thermal steady state is achieved through an oral or rectal measurement in approximately 3 minutes and thro...

Page 82: ...itiate spot check Note Ready status will display in the status bar and sound will play 4 Apply a single use disposable probe cover to the temperature probe before measurement WARNING The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings 5 Place the temperature probe on the site to begin spot check WARNING Before use verify the color of the...

Page 83: ...mperature probe in the probe well holder to reset measurement 8 To continuously monitor temperature touch the drop down menu and then select Continuous mode Note Monitor mode can only be enabled if the probe has not been removed from the measurement site during spot check Note Another spot check cannot be performed until the probe is first returned to the probe well holder 9 Dock the temperature p...

Page 84: ... axillary probe in combination with the Root in Adult axillary mode A temperature reading is provided in approximately 12 15 seconds Pediatric axillary Spot Check Mode predictive temperatures are measured using oral axillary probes in combination with the Root in Pediatric axillary mode A temperature reading is provided in approximately 10 13 seconds For oral temperatures place the probe tip under...

Page 85: ...be to the probe well Rectal temperatures are measured using rectal probes which give a Spot Check Mode predictive temperature in approximately 10 13 seconds For rectal temperatures separate the patient s buttocks with one hand Use the other hand to gently insert the probe only 5 8 in 1 5 cm inside the rectum less for infants and children The use of a lubricant is optional Tilt the probe so that th...

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Page 87: ...ory To change patient category see Profiles on page 53 Weight Patient Category Maximum Pressure Greater than 75lbs 34kg Adult 280 mmHg Between 15 4 75lbs 7 34kg Pediatric 280 mmHg Less than 15 4lbs 7kg Neonatal 140 mmHg Cuff Selection and Placement Root uses a quick connect hose with a blood pressure cuff to measure NIBP Based on the Cuff Type that is selected use the following approved blood pres...

Page 88: ...f To place a cuff on the measurement site Wrap the cuff around the 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 patient s clothing The cuff should fit snug to the patient s arm for maximum oscillometric signal quality An appropriate sized cuff should be placed on the non dominate arm where the lower...

Page 89: ...ted The middle of the cuff is at the level of the right atrium of the heart Blood pressure measurements can be affected by the patient s position physiological condition and environmental factors Physiological conditions that can affect blood pressure measurements include but are not limited to cardiac arrhythmias arterial sclerosis poor perfusion diabetes age pregnancy pre eclampsia renal disease...

Page 90: ... which is usually referred to as the mean arterial pressure MAP As cuff deflation continues the diastolic pressure can be determined based upon the rapidly diminishing amplitude of the pressure fluctuations Spot Check Measurement To spot check measure NIBP 1 Ensure that the correct patient profile is selected before measurement WARNING Only use Root in Neonatal mode with a neonatal blood pressure ...

Page 91: ...atient See Cuff Selection and Placement on page 85 4 Touch the Start button to begin measurement 5 Wait for measurement to complete or touch the Stop button to stop measurement Note Measuring status displayed in the status bar 6 Wait for measurement values to appear to ensure that spot check is complete ...

Page 92: ...terval To measure blood pressure in Automatic interval mode 1 Ensure that the correct patient profile is selected before measurement WARNING Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates 2 To change the patient profile touch the Main Menu icon then select Profiles Touch the Profile Name to select the desired patient profile ...

Page 93: ... Set Mode to Automatic and then select the desired Interval The measurement mode can also be changed using the action menu WARNING Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference 5 To begin measurement touch the Start Auto button and then press the arrow at the top left corner of the touchscreen to return to the Main View 6 Wait for measureme...

Page 94: ...blood pressure measurements continuously for the desired duration To measure blood pressure in Stat interval mode 1 Ensure that the correct patient profile is selected before measurement WARNING Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates 2 To change the patient profile touch the Main Menu icon then select Profiles Touch the Profile Name...

Page 95: ...t Mode to Stat and then select the desired Stat Duration The measurement site can also be changed using the action menu WARNING 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 at the top left corner of the touchscreen to return to the Main View 6 Wait for measurement ...

Page 96: ...Root Chapter 5 NIBP Measurement www masimo com 94 Masimo Note Once measurement is completed and values appear the next measurement will begin and repeat until duration time has elapsed ...

Page 97: ...he Admit Discharge icon is located at the bottom left of the screen and allows for clinicians to admit or discharge patient s on Masimo Patient SafetyNet directly from Root Note In order to use this feature Masimo Patient SafetyNet software version 5 0 1 0 or higher is required ...

Page 98: ...mitted see Fig 1 message will appear on the Root screen when the sensor is placed onto a patient and a patient has not yet been admitted on the Root Press the Admit button on the screen to admit the patient or press skip and the patient data will not be transmitted to the Masimo Patient Safety Net Fig 1 ...

Page 99: ...charging a Patient To discharge 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 2 3 A confirmation message will appear See Fig 3 Press Discharge on the screen Fig 2 Fig 3 ...

Page 100: ...creen 2 Select the patient name by pressing the search button on the screen see Fig 4 3 Select the search icon and select the patient s name from the list see Fig 5 or filter by typing patient s last name and select the patient from the list Fig 4 Fig 5 In the assignment section of the admit patient menu see Fig 6 select the primary pager then press Admit on the screen as shown in the image below ...

Page 101: ...Root Chapter 6 Admit and Discharge to Patient SafetyNet www masimo com 99 Masimo Fig 6 ...

Page 102: ...he sensor is off the patient for an extended period of time a Not Monitoring message will appear on the screen see Fig 7 Acknowledge the message by pressing Cancel or Discharge Press Discharge to discharge the patient that is currently admitted on the Root or press Cancel to keep the same patient admitted Fig 7 ...

Page 103: ...n the sensor is taken off and placed back onto a patient a Monitoring Resumed message will appear on the Root screen see Fig 8 If this is a new patient press Discharge on the screen to discharge the previous patient If the same patient is being monitored press Confirm to continue monitoring the same patient Fig 8 ...

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Page 105: ...leth Variability Index PVI along with Acoustic Respiration Rate RRa It uses a Bluetooth connection to transfer parameter data to Root When Radius 7 is connected to Root via Bluetooth the device automatically creates a Window that displays all the data from Radius 7 Root also acts as a charging station for Radius 7 Radius 7 is docked onto Root via a Battery Charging Adapter See Radius 7 Operator s ...

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Page 107: ...ndow that displays all the data from that module The example below shows the SedLine and Capnography Windows which display data from the SedLine brain function monitoring and ISA capnography MOC 9 modules that are connected to Root Using MOC 9 Ports Use a MOC 9 cable to connect other MOC 9 modules to Root To use an MOC 9 Port 1 Identify the MOC 9 end of the cable 2 Orient the cable to fit correctl...

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Page 109: ...c health records Below is an example of one way Root can be used in a network setting using Patient SafetyNet Root receives and may display information from Radical 7 MOC 9 modules as well as standalone devices Ref Description 1 Standalone devices connected via Iris e g monitor pump ventilator 2 Root 3 MOC 9 modules 4 Patient SafetyNet or Masimo Connectivity Gateway 5 Notification devices 6 Electr...

Page 110: ...essfully connected to a Patient SafetyNet or Connectivity Gateway Gray No standalone device is connected to the Iris Connectivity Port Additionally the Ports are also mapped to the Iris icon on the Status Bar When a standalone device is connected to Root via one of the Ports the corresponding part of the icon will be lit green or yellow In the example below a standalone device is connected to Iris...

Page 111: ...nect standalone devices to Root Port 1 Port 2 Port 3 Port 4 To connect a standalone device via an Iris Connectivity Port 1 Connect the RS 232 end of the Iris Adapter to the standalone device 2 Connect the RJ 45 end of the Iris Adapter to any of the four 4 compatible Iris Connectivity Ports on Root using a RJ 45 cable ...

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Page 113: ...ot responsive Check probe tip condition Re insert probe into probe well or check for alignment problem If problem persists replace the probe If problem still persists contact Customer Service Retake Measurement An error has occurred in the process of taking a patient temperature measurement Try another measurement cycle If problem persists replace probe Check Ambient Temperature Ambient temperatur...

Page 114: ...onnected or is not responsive Reconnect Temperature Probe and try another measurement cycle Check Cuff Weak Signal Weak or no signal measured during blood pressure measurement Check that the hose is connected Check that 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 Chec...

Page 115: ... Calibration Required Blood pressure measurement transducer may be out of range or there has been a calibration data failure Perform calibration procedures per User Manual If problem still persists contact Customer Service For additional messages see Instructions for Use or Operator s Manuals for Radical 7 Radius 7 and MOC 9 modules ...

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Page 117: ...ain Screen is dim or blank The brightness setting is not correct Adjust the brightness setting See Brightness on page 48 If the condition persists Root requires service Contact Masimo Technical Support See Return Procedure on page 140 Touch functionality is not responsive Internal failure Root requires service Contact Masimo Technical Support See Return Procedure on page 140 Not displaying data fr...

Page 118: ...ure on page 140 Power Button does not respond when pressed Power Button may need to be pressed for a longer time To Power On when turned off or in Sleep Mode press Power Button for two 2 seconds To Power Off when turned on or in Sleep Mode press the Power Button for eight 8 seconds Internal failure Root requires service See Return Procedure on page 140 Home Button does not work when pressed Intern...

Page 119: ...perature Between 80 F and 110 F 26 7 C and 43 3 C All patient populations 0 2 F 0 11 C Temperature Measurement Site Mode Number of Subjects Clinical Bias C Limits of Agreement Clinical Repeatability Oral 106 0 01 0 63 0 14 Rectal 105 0 12 0 59 0 29 Pediatric Axillary 117 0 03 0 56 0 14 Adult Axillary 105 0 13 0 43 0 14 Test Report 2010036 Test Report of Clinical Investigation to demonstrate that t...

Page 120: ... Systolic 40 260 mmHg Diastolic 20 200 mmHg MAP 26 220 mmHg Pediatric Systolic 40 230 mmHg Diastolic 20 160 mmHg MAP 26 183 mmHg Neonatal Systolic 40 130 mmHg Diastolic 20 100 mmHg MAP 26 110 mmHg Temperature Measurement Display Range Temperature 80 110 F 26 7 43 3 C Pulse Rate Measurement Display Range Pulse Rate PR 30 220 bpm ...

Page 121: ...en 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 Root AC Power requirements 100 240 VAC 47 63 Hz 180 VA Max Fuses 2 2 Amp Metric 5x20mm 250V 1500A Breaking Capacity Battery Type 10 8V Lithium Ion Nominal Capacity 4 hours Maximum Charging Time 4 hours This represents approximate run time at the lowest brightness using a fully charged ba...

Page 122: ... C to 50 C Operating Humidity 15 to 95 non condensing Storage Humidity 15 to 95 non condensing Operating Air Pressure 500 mbar to 1060 mbar 1000 ft to 18 000 ft 304 m to 5 486 m Touchscreen Display Characteristic Description Type Backlit Active Matrix TFT LCD Resolution 1280 x 800 pixels Size 10 1 in 25 65 cm Diagonal Color 24 bit RGB Touchscreen Type Multi Touch P Cap ...

Page 123: ...burst pulse spacing 0 250s 0 250s 0 500s 0 250s repeat time 10s Medium Priority Flashing Yellow 3 pulse burst pulse spacing 0 375s 0 375s repeat time 7s Low Priority Yellow 1 pulse burst repeat time 5s Nurse Call Specifications The Nurse Call relays have the following electrical specifications per switch Parameter Specification Max Voltage 36 VDC or 24 VAC peak ...

Page 124: ...232 RJ 45 4 NIBP Male Quick Connect 1 Temperature MOLEX 52271 0690 1 Wireless Specifications Communication Wi Fi Type WLAN Radio IEEE 802 11 a b g Frequency 802 11a 5180 5240 MHz 5745 5825 MHz 802 11b g 2412 2462 MHz Max Peak Output Power WLAN 17 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types OFDM BPSK CCK Modulation Signals Analog and D...

Page 125: ...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 Analog and Digital Available Data Rates Bluetooth 1 Mbps Security and Authentication Encryption 64 128 bit WEP Dynamic WEP WPA TKIP WPA2 AES Authentication Open System Shared Key Pre Shared Key PSK 802 1X...

Page 126: ...anada IC 7362A RDS7A IC Model RDS 7A RSS 210 Europe EN 300 328 EN 301 893 EN 301 489 1 EN 301 489 17 R TTE Directive Compliance Electrical Safety ANSI AAMI ES 60601 1 2005 CAN CSA C22 2 No 60601 1 2008 EN 60601 1 1990 AI 1993 A2 1995 IEC 60601 1 2005 IEC 60601 2 49 2011 IEC 80601 2 30 2009 ISO 80601 2 56 2012 ...

Page 127: ...0 2002 ISO 81060 2 2009 EN 1060 1 1996 A2 2009 EN 1060 3 1997 A2 2009 EN 1060 4 2004 EMC Compliance EN 60601 1 2 Class A Radio Compliance USA FCC ID VKF RDS7A Model RDS 7A Canada IC 7362A RDS7A IC Model RDS 7A RSS 210 Europe EN 300 328 EN 301 893 EN 301 489 1 EN 301 489 17 R TTE Directive ...

Page 128: ...ernally powered on battery power Degree of Protection of Electrical Shock Defibrillation proof BF Applied Parts with the exception to the applied parts that are provided with the BF Applied Part marking Protection against harm from liquid ingress IPX1 Protection against liquid drops falling vertically Mode of Operation Continuous Operation ...

Page 129: ...ould assure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 ME Equipment uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A For hospital environment only Not intended for use i...

Page 130: ...be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical hospital environment Voltage dips short interruptions and voltage variations on power supply...

Page 131: ...aration distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may...

Page 132: ...ith accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above the ME Equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessar...

Page 133: ...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 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 7 3 7 7 37 100 11 7 11 7 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in met...

Page 134: ...ltitude Limitation Date of Manufacture Storage Humidity Limitation Non ionizing Electromagnetic Radiation Keep Dry IPX1 Protection Against Liquid Drops Falling Vertically Fragile Breakable Handle with Care Federal USA Law Restricts this Device to Sale by Or on the Order of a Physician Fuse Replacement See Replacing the Fuses ETL Intertek Certification Equipotential Ground Terminal Federal Communic...

Page 135: ...tion Proof Type BF Caution Type BF Applied Part Product contains no natural rubber latex Product contains no PVC polyvinyl chloride material Artery symbol and arrow should be placed over brachial or femoral artery Index Line Cuff index line must fall within range markings for an accurate measurement Arm Circumference Instructions Directions for Use Manuals are available in electronic format http w...

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Page 137: ...d Replace fuse s with UL Listed fuses rated 250V 2 amp metric 5x20 mm and with a breaking capacity of minimum 1500A WARNING To ensure safety only replace with appropriately rated fuses The fuses can be removed by hand or with a 5 millimeter or 3 16 inch screwdriver To replace the fuse s 1 Power Off Root completely Do not put in Sleep Mode See Sleep and Power Off on page 77 2 Remove the AC power co...

Page 138: ...d all test equipment must be in excellent working order to properly perform this test It is important to verify the calibration before changing it Historical data has shown that the transducers rarely need to be re calibrated although we still suggest that the calibration be verified annually Procedure 1 Enter NIBP menu select Calibration 2 Connect a manometer volume and the hand bulb to the Modul...

Page 139: ...ovided as a reference and intended for qualified service professionals only Calibration Steps 1 Enter NIBP menu select Calibration and select Zero Point Calibration 2 Connect a manometer volume and the hand bulb to the Module using T adapters and connection tubing 3 Apply 0 zero mmHg to the module 4 Touch the Calibrate to start the zero point calibration 5 Results are displayed for Zero Point Cali...

Page 140: ...ediatrics 300 10mmHg Neonates 150 5mmHg Test Method The steps outlined below are for manually performing an overpressure test Some or all of these steps may be incorporated into a service tool provided by the medical device manufacturer 1 Connect a manometer volume and hand bulb to Module using T adapters 2 Touch the Test button on the display 3 Increase the pressure to approximately 250mmHg using...

Page 141: ...ital s Nurse Call system Cable Description Nurse Call Event Menu Setting 2 contacts normally opened Nurse Call Polarity Normal 2 contacts normally closed Nurse Call Polarity Inverse 1 and 2 contacts normally opened 2 and 3 contacts normally closed Nurse Call Polarity Normal 1 and 2 contacts normally closed 2 and 3 contacts normally opened Nurse Call Polarity Inverse 1 and 2 contacts normally close...

Page 142: ...hnical Support Ask for an RMA number Package the equipment securely in the original shipping container if possible and enclose or include the following information and items A letter describing in detail any difficulties experienced with the Root Include the RMA number in the letter Warranty information a copy of the invoice or other applicable documentation must be included Purchase order number ...

Page 143: ...t must be replaced under warranty it will be replaced and the cost of shipment covered All other shipping costs must be paid by purchaser Exclusions The warranty does not apply to any non Masimo branded product or any software even if packaged with the Product or any Product that was a not new or in its original packaging when supplied to purchaser b modified without Masimo s written permission c ...

Page 144: ...ense arising from the use or loss of use of any Products or Software In no event shall Masimo s liability arising from any Product or Software under contract warranty tort strict liability or otherwise exceed the amount paid by purchaser for the Product or Software The above limitations do not preclude any liability that cannot legally be disclaimed by contract Sales End User License Agreement Thi...

Page 145: ...rchaser transfer assign rent lease sell or otherwise dispose of the Product or the Software on a temporary basis Purchaser shall not assign or transfer this License in whole or in part by operation of law or otherwise without Masimo s prior written consent except that the Software and all of Purchaser s rights hereunder shall transfer automatically to any party that legally acquires title to the P...

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Page 147: ...on for NIBP 61 67 Capturing Screenshots 74 Chapter 1 Description 19 Chapter 10 Messages 111 Chapter 11 Troubleshooting 115 Chapter 12 Specifications 117 Chapter 13 Service and Maintenance 67 135 Chapter 2 Setting Up 23 Chapter 3 Operation 29 Chapter 4 Temperature Measurement 79 Chapter 5 NIBP Measurement 85 Chapter 6 Admit and Discharge to Patient SafetyNet 95 Chapter 7 Radius 7 103 Chapter 8 MOC ...

Page 148: ...62 66 Measurement Accuracy 117 Menu Navigation 35 Monitoring Resumed Message 101 N NIBP 42 61 NIBP Air Leak Test 137 NIBP Module Calibration 136 NIBP Pressurization Ranges 119 Not Admitted 96 Not Monitoring Message 100 Nurse Call Connection 27 Nurse Call Setting Connections 116 139 Nurse Call Specifications 121 O Operation NIBP 88 Operation Temperature 79 Overpressure Test 138 P Parameter Settings...

Page 149: ...ration 137 Spot Check Measurement 88 Standby Mode 29 49 72 Stat Interval Measurement 92 Symbols 132 System Status Lights 22 75 Systolic Diastolic SYS DIA 62 63 T Taking Temperature Measurement 79 Temperature 42 57 Temperature Probes 82 Touchscreen Display 120 Trend Download 73 Trend Settings 42 52 Trends for NIBP 64 Trends for Temperature 57 59 Troubleshooting Radical 7 Radius 7 and MOC 9 Modules ...

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