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Root® 

Operator's Manual 

 

 

 

Summary of Contents for Root RDS7A

Page 1: ...Root Operator s Manual ...

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Page 3: ...ssession 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 law restricts this device to sale by or on the order of a physician For professional use See instructions for use for full prescribing information including indications contraind...

Page 4: ...al hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 Patents www masimo com patents htm 2014 Masimo Corporation Root SEDLine Radical 7 rainbow SET Signal Extraction Technology Masimo and are federally registered trademarks of Masimo Corporation MOC 9 Iris and ISA are trademarks of Masimo Corporation The use of the trademark Patient SafetyNet is under license from University HealthS...

Page 5: ...Cleaning and Service Warnings and Cautions 16 Compliance Warnings and Cautions 17 Chapter 1 Description 19 Features 19 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 Nurse Call Connection 26 Chapter 3 Operation 29 About the Status Bar 29 About the Main Screen 31 Using the Touchscreen Interface 33 Menu...

Page 6: ...shooting 77 Troubleshooting Radical 7 Radius 7 and MOC 9 Modules 77 Troubleshooting Root 77 Chapter 10 Specifications 81 Electrical 81 Environmental 81 Display 82 Alarms 83 Nurse Call Specifications 83 Connectors 83 Wireless Specifications 84 EMC Compliance 85 Software Compliance 86 Safety Standards Compliance 86 Guidance and Manufacturer s Declaration Electromagnetic Emissions 87 Guidance and Man...

Page 7: ...ls 94 Chapter 11 Service and Maintenance 97 Cleaning 97 Replacing the Fuses 98 Power On Self Test 98 Nurse Call Setting Connections 98 Battery Test 100 Repair Policy 100 Return Procedure 101 Contacting Masimo 101 Index 105 Outside Back Cover 108 ...

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Page 9: ...d notes A warning is given when actions may result in a serious outcome for example injury serious adverse effect death to the patient or user WARNING This is an example of a warning statement A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient damage to this instrument or damage to other property CAUTION This is an example of a caution...

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Page 11: ... companies to add to the platform measurements Built in network connectivity gateway through Iris for standalone devices such as IV pumps ventilators beds and other patient monitors Docking and charging station for Radical 7 and Radius 7 devices For all prescribing information and instructions for use of the compatible medical devices that are connected to Root see Operator s Manual or Instruction...

Page 12: ...the display of those devices The optional ISA product family consists of three types of sidestream gas analyzers ISA CO2 ISA AX and ISA OR intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases ISA CO2 CO2 ISA AX CO2 N2O Halothane Isoflurane Enflurane Sevoflurane and Desflurane ISA OR CO2 O2 N2O Halothane Isoflurane Enflurane Sev...

Page 13: ...ption Features and Intended Use www masimo com 11 Masimo adult and pediatric patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals and hospital type facilities ...

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Page 15: ...vices with Root WARNING Explosion Hazard Do not use the Root in the presence of flammable anesthetics or other flammable substance in combination with air oxygen enriched environments or nitrous oxide WARNING To reduce the risk of explosion only replace battery with Masimo supplied parts WARNING Fire Hazard To protect against fire hazard replace only with fuses of same type current rating and volt...

Page 16: ... 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 power cable could cause damage to Root Check the power cord and plug to ensure that it is intact and undamaged CAUTION To avoid risk of...

Page 17: ...r a Low Battery alarm may result in the instrument shutting down CAUTION To minimize radio interference other electrical equipment that emits radio frequency transmissions should not be in close proximity to Root CAUTION If the Radical 7 or Radius 7 stops communicating with Root parameters and measurements will not show on the Root however this will not affect Radical 7 s or Radius 7 s ability to ...

Page 18: ... and instrument failure can result CAUTION Do not touch press or rub the display panels with abrasive cleaning compounds instruments brushes rough surface materials or bring them into contact with anything that could scratch the display CAUTION Do not submerge the Root in any cleaning solution or attempt to sterilize by autoclave irradiation steam gas ethylene oxide or any other method This will s...

Page 19: ... cleared by the applicable regulatory authorities or in any manner inconsistent with the instructions for use or labeling Note In accordance with international telecommunication requirements the frequency band of 2 4 GHz and 5 15 to 5 25 Ghz is only for indoor usage to reduce potential for harmful interference to co channel mobile satellite systems Note This device complies with Part 15 of the FCC...

Page 20: ...with a separation distance of at least 20 cm from all persons and must not be co located or operating in conjunction with any other antenna or transmitter Note This equipment has been tested and found to comply with the Class A limits for medical devices according to the EN 60601 1 2 2007 Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful ...

Page 21: ...ules As a connectivity gateway for standalone devices Features Front View Ref Feature Description 1 Docking Station Provides a docking station for the Radical 7 and Radius 7 Note Battery Charging Adapter required for Radius 7 While docked the Radical 7 can communicate monitored parameters and measurements 2 Root Display and Touchscreen Provides an interface for user interactions 3 Home Button Prov...

Page 22: ... 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 7 is able to communicate monitored parameters and measurements All other versions can only charge in the docking station but not communicate with Root Back View Feature Description 1 Handle Allows the user to transport Root...

Page 23: ...ing 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 Iris Connectivity Ports 4 Pro...

Page 24: ... Right side Left side Feature Description 1 System Status Lights Provides an indication of alarms and system messages See System Status Lights 2 Power Button Places Root in Power On Standby and Power Off modes 3 MOC 9 Ports 3 Provide connectivity for MOC 9 modules ...

Page 25: ... damaged contact Masimo s Technical Service Department See Return Procedure 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 back p...

Page 26: ...and Power Off To Power On press the Power 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 ...

Page 27: ...C power cord into an AC power source 3 Verify that Root s battery 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 and About the Status Bar 1 2 4 The Root Charging Indicator remains orange while the battery is charging and will illuminate greenwhen Root is fully charged See Root ...

Page 28: ...d 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 Charging Indicator Nurse Call Connection Use a Nurse Call connection cable to conn...

Page 29: ...nd female connector of the cable 2 Insert the Nurse Call connection cable securely into the compatible port on Root 3 Depending on the connection type of the Nurse Call System it may be necessary to orient the other end of the Nurse Call connection cable to fit correctly into the system connection 4 For more information see Device Output ...

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Page 31: ...ut to a menu item or an action on Root An example is shown below Ref Feature Description 1 Alarm Silence Displays alarm status and mutes all audible alarms for Root Radical 7 Radius 7 and MOC 9 modules See Alarm Silence 2 Audio Pause Displays Audio Pause status and temporarily silences an alarm event See Audio Pause 3 Profiles Provides access to the Profiles screen The example shown illustrates th...

Page 32: ...icon matches the status colors of connected standalone devices on the Iris screen See Iris 8 Radical 7 Battery Displays charging status for Radical 7 and provides access to the Battery Radical screen The example shows that the battery is currently charging See Radical 7 Charging Indicator 9 Root Battery Displays charging status for Root and provides access to the Battery Root screen The example sh...

Page 33: ...wing rainbow parameters and measurements Phasein module middle showing capnography 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 2 Windows Provides a dynamic user configurable display area for all the data from connected ...

Page 34: ...ot Chapter 3 Operation www masimo com 32 Masimo Ref Feature Description 3 Main Menu icon Provides access to the configuration options for Root and connected medical devices See Accessing Main Menu Options ...

Page 35: ... 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 Drop See Customizing Windows Touch hold drag an object to desired position and drop it by releasing Below ...

Page 36: ... 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 Slide knob Moves knob Press anywhere along slider path Quickly moves knob to Tap position ...

Page 37: ... icon Window 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 parameter and measurement drag and drop Well Press parameter or measurement When no parameter or measurement alarm is present opens parameter or measurement men...

Page 38: ... Zooms out Pan Changes time range Press y axis Opens parameter or measurement trend menu Trend Zoom Press Increases time range Press Decreases time range Press time label Resets time range to default Alarm Silence icon Press Silences all alarms Audio Pause icon Press Enables Audio Pause Other Status Bar icons Press Opens relevant menu Back Arrow Press Exits menu abandons any changes ...

Page 39: ...l 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 to the Main Screen at any time press the Home Button at any time The Home Button is always illuminated when Root is powered on ...

Page 40: ...end View displays each parameter or measurement alongside a graph of its values over time Analog View displays values in relation to alarm ranges Details about the displayed information of parameters and measurements can be found in the instructions for use or Operator s Manual of Radical 7 Radius 7 and MOC 9 modules Trend View Analog View Feature Description 1 Window The area where all data from ...

Page 41: ...abel as well as Alarming Caution and Normal Ranges See Using Analog View 5 Well Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges Using Trend View In Trend View a parameter or measurement is displayed as a graph of its values over time If a Window supports Trend View then Trend View icon displays in the upper right corner Press the icon to view parameter o...

Page 42: ...a period of time Zoom in and out of a Trend Line by pinching out and in 3 Numeric Value Indicates current reading of the parameter or measurement 4 Alarm Limits Indicate high and low alarm limits for the parameter or measurement if supported 5 Parameter or Measurement Label Indicates the name of the parameter or measurement ...

Page 43: ...r s manuals for Radical 7 Radius 7 and the appropriate MOC 9 module s If a Window supports Analog View then Analog View icon displays in the upper right corner Press the icon to view parameter and measurement data in Analog View 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 corresp...

Page 44: ...Root Chapter 3 Operation www masimo com 42 Masimo Ref Feature Description 4 Parameter or Measurement Label Indicates the name of the parameter or measurement ...

Page 45: ...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 46: ...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 47: ...ment 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 Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen press the Main Menu icon ...

Page 48: ... www masimo com 46 Masimo The Main Menu options are Device Settings See Device Settings About See About Trend Settings See Trend Settings Profiles See Profiles Iris See Iris Layout See Layout Sounds See Sounds Device Settings ...

Page 49: ...omize settings for Root The Device Settings options are Localization See Localization Wi Fi See Wi Fi Ethernet See Ethernet Bluetooth See Bluetooth Root Battery See Root Battery Radical 7 Battery See Radical 7 Battery Brightness See Brightness Access Control See Access Control Device Output See Device Output ...

Page 50: ...e 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 frequency 60 Hz 50 Hz or 60 Hz Date Sets the current date N A N A Time Sets the current time N A N A Wi Fi The Wi Fi radio allo...

Page 51: ...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 Option Description Factory Default Setting Configurable Settings Wi Fi Enables or disables Wi Fi connectivity Off On or Off Additional fields in the Wi Fi screen disp...

Page 52: ...oximity of Masimo s MyView Presence 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 c...

Page 53: ...ay of battery level remaining Battery Diagnostics Allows trained personnel to access battery diagnostic information Radical 7 Battery Use the Battery screen to view the specific percentage of charge on the Radical 7 s battery The user can also access the Battery screen by pressing the Radical 7 s Battery icon on the Status Bar See About the Status Bar Option Description State of Charge Provides a ...

Page 54: ... Setting Configurable Settings Auto Brightness Allows automatic adjustment 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 ...

Page 55: ...Default Setting Configurable Settings All Mute Enabled Enable parameter Alarm Silence menu option See Sounds Off On or Off Lock Alarm Volume Sets the lowest alarm volume level Off 3 4 or Off Save as Adult Saves current profile parameter as the Adult Profile N A Press Save to load Save as Pediatric Saves current profile parameter as the Pediatric Profile N A Press Save to load Save as Neo Saves cur...

Page 56: ...to occur Should be changed to accommodate institutional Nurse Call settings Normal Normal or Inverted Nurse Call Trigger Controls the source of monitoring which sets off the trigger Alarms Alarms Signal IQ Alarms and Signal IQ Port 0 None None IAP IntelliBridge and ASCII 1 Port 1 IAP None IAP IntelliBridge and ASCII 1 SpecTable Radical Radical Radical Module A Sedline and Sedline Numerics Only Not...

Page 57: ...n number MCU 2 Displays software version number Information about Radical 7 Radius 7 and MOC 7 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 Durati...

Page 58: ...ction controls the management of patient configuration 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 i...

Page 59: ...to display the parameters and measurements by changing the Layout Style Note This feature only applies to Trend View See Using Trend View 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 60: ...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 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 Displays Avail...

Page 61: ... Highest volume Slide towards the 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 2 minutes 1 2 3 minutes Permanent Permanent with Reminder If Permanent is selected there will be no audible alarms but visual alarms will still display If Permanent with Reminder is selected a tone will...

Page 62: ...ty Alarm Sound 1 Five 5 beeps beep beep beep brief pause beep beep 2 Three 3 beeps beep beep beep 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 Hig...

Page 63: ... 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 Instructions for Use or Operator s Manuals for ...

Page 64: ... 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 65: ...Audio Pause is 120 seconds In the example below Audio Pause is activated and there are 117 seconds left until Audio Pause is inactivated again To configure Audio Pause see Sounds Audio Pause active 117 seconds until Audio Pause is inactive Note When Audio Pause is activated powering off and then powering on Root will return Audio Pause to its default inactive state Trend Download Root can store up...

Page 66: ...ity Indication None None Monitoring has not begun Green None There is currently no active alarms Yellow Low There is an active alarm of low priority 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 Status Lights when Radical ...

Page 67: ...o 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 68: ...letely shuts down Root and results in a longer startup sequence Chapter 4 Radius 7 The Radius 7 is a patient wearable device for continuous monitoring when the patient is ambulatory It measures arterial oxygen saturation SpO2 pulse rate PR perfusion index PI and Pleth Variability Index PVI along with Acoustic Respiration Rate RRa It uses a Bluetooth or Wi Fi connection to transfer parameter data t...

Page 69: ...in the tissue rSO2 including cerebral tissue It can be used in any hospital and hospital type facility where rSO2 measurements might improve patient outcomes The Masimo O3 Regional Oximeter and Sensors are indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood rSO2 in the tissue below the sensor in hospital and hospital type facilities See the O3 Oper...

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Page 71: ...ys 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 Phasein 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 correctly into an MO...

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Page 73: ...ronic 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 4 Standalone devices connected via Iris e g monitor pump ventilator 5 Root 6 Radical 7 7 MOC 9 modules 8 Patient SafetyNet or Masimo Connectivity Gateway 9 Electronic ...

Page 74: ...afetyNet or Connectivity Gateway Yellow Standalone device is successfully connected to Root however Root is not successfully 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 corr...

Page 75: ...ropriate version of Masimo Patient SafetyNet Using Iris Connectivity Ports Use Iris Adapters and RJ 45 cables to connect 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...

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Page 77: ...nnected A MOC 9 module is disconnected from Root Reconnect module or acknowledge message by pressing the Alarm Silence icon Radical 7 Disconnected Radical 7 is disconnected from Root Reconnect Radical 7 or acknowledge message by pressing the Alarm Silence icon Radius 7 Disconnected Radius 7 is disconnected from Root Reconnect Radius 7 or acknowledge message by pressing the Alarm Silence icon For a...

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Page 79: ...operly Replace the fuse See Replacing the Fuses Root turns on but Main Screen is dim or blank The brightness setting is not correct Adjust the brightness setting See Brightness If the condition persists Root requires service Contact Masimo Technical Support See Return Procedure Touch functionality is not responsive Internal Failure Root requires service Contact Masimo Technical Support See Return ...

Page 80: ...ure To silence an alarm press the Power Button for eight 8 seconds If alarm continues to sound Power Off Root Root requires service See Return Procedure 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 Standby Mode press Power Button for two 2 seconds To Power Off when turned on or in Standby Mode press the Power But...

Page 81: ...Chapter 9 Troubleshooting www masimo com 79 Masimo Symptom Possible Cause Correction Nurse Call does not communicate Connection error Unplug and replug Nurse Call connector See Nurse Call Setting Connections ...

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Page 83: ...Root AC Power requirements 100 240 VAC 47 63 Hz 65 W Max Fuses 2 2 Amp Fast Acting 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 battery Environmental Root Operating Temperature 32 F to 122 F 0 C to 50 C Transport Storage Temperature...

Page 84: ...densing Operating Altitude 500 mbar to 1060 mbar 1000 ft to 18 000 ft 304 m to 5 486 m 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 Characteristic Description Type Multi Touch P Cap ...

Page 85: ...ellow Nurse Call Specifications The Nurse Call relays have the following electrical specifications per switch Parameter Specification Max Voltage 36 VDC or 24 VAC peak Connectors Connector Type Number of Ports Ethernet 10 100 MBps 1 Nurse Call 1 4 inch round female 1 MOC 9 Masimo Connector 3 USB USB 2 0 2 Iris RS 232 RJ 45 4 ...

Page 86: ...put Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types OFDM BPSK CCK Modulation Signals Analog and Digital Available Data Rates 802 11a 6 9 12 18 24 36 48 54 Mbps 802 11b 1 2 5 5 11 Mbps 802 11g 6 9 12 18 24 36 48 54 Mbps Communication Bluetooth Type Bluetooth Frequency 2402 2480 MHz Max Peak Output Power Bluetooth 1 3 dBm Classification of Output Power Rating Conducted...

Page 87: ...d Authentication Encryption 64 128 bit WEP Dynamic WEP WPA TKIP WPA2 AES Authentication Open System Shared Key Pre Shared Key PSK 802 1X LEAP PEAP TTLS TLS EAP FAST Radio Compliance USA FCC ID VKF RDS7A Model RDS7A Canada IC 7362A RDS7 IC Model RDS7A RSS 210 Europe EN 300 328 EN 301 489 17 R TTE Directive EMC Compliance EMC Compliance EN 60601 1 2 Class A device ...

Page 88: ...andards Compliance Protection from Ingress of Liquids IPX1 per IEC 60529 Electrical and Mechanical Safety UL 60601 1 2003 CAN CSA 22 2 No 601 1 2005 IEC 60601 1 UL 60601 1 1988 A1 1991 A2 1995 EN 60601 1 1990 AI 1993 A2 1995 ISO 9919 2005 IEC 60601 2 49 2001 Type of Protection Class I on AC power Internally powered on battery power ...

Page 89: ...uld 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 in...

Page 90: ...st Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should 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 ...

Page 91: ...s power quality should be that of a typical commercial or hospital environment Root provides a battery for continued operation during power mains interruption for a maximum of 4 hours Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment Conducted RF IEC 61000 4 6 3 ...

Page 92: ...o the frequency of the transmitter Recommended separation 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 survey should be less than the complianc...

Page 93: ...AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with 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 ope...

Page 94: ...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 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 mete...

Page 95: ...Root Chapter 10 Specifications www masimo com 93 Masimo ...

Page 96: ...ufacturer Storage Temperature Limitation Storage Altitude 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 section of the Operator...

Page 97: ...s Unit has been Registered as a Radio Device USB port Mark of Conformity to European Medical Device Directive 93 42 EEC AC Current Authorized representative in the European community Nurse Call Interface Wireless Features Can be Used in Member States with the restriction of indoor use in France Defibrillation Proof Type BF ...

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Page 99: ...the Root should be cleaned when the device is visibly dirty before and after each procedure and or according to hospital practice To surface clean wipe down the outer surface of Root using any of the following solvents Cidex Plus 3 4 glutaraldehyde 10 bleach solution 70 isopropyl alcohol solution Do not allow liquids to enter the interior of Root Using the recommended cleaning solutions on the tou...

Page 100: ...lling up The fuse should easily be removed Do not force 5 Place a new fuse in the fuse holder 6 If replacing both fuses repeat steps 4 and 5 for the second fuse 7 Slide the fuse holder back into the Power Entry Module and press firmly to make sure it is secure Root is ready to be reconnected to AC power If the fuses fail shortly after replacement Root requires service See Repair Policy Power On Se...

Page 101: ...ll 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 closed 2 and 3 conta...

Page 102: ...4 Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge Repair Policy Masimo or an authorized Service Department must perform warranty repair and service Do not use malfunctioning equipment Have the device repaired Clean contaminated and or dirty equipment before returning following the cleaning procedure described in Cleaning Make sure the equipment i...

Page 103: ...ficulties 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 to cover repair if the Root is not under warranty or for tracking purposes if it is Ship to and bill to information Person name telephone Telex fax number and country to contact for any questions about the repai...

Page 104: ...by Masimo e use of the Product and Software in ways or in environments for which they are not labeled and f neglect misuse improper operation accident fire water vandalism weather war or any act of God This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product This warranty does not extend to any Product that has been reproc...

Page 105: ... Masimo for the purchase of this Product Product and a license in the included or embedded Software Software except as otherwise expressly agreed in a separate contract for the acquisition of this Product the following terms are the entire agreement between the parties regarding your purchase of this Product If you do not agree to the terms of this agreement promptly return the entire Product incl...

Page 106: ...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...

Page 107: ...ance 83 Chapter 2 Setting Up 21 Chapter 3 Operation 25 Chapter 4 Radius 7 58 Chapter 5 MOC 9 59 Chapter 5 O3 Regional Oximetry 58 Chapter 7 Iris 61 Chapter 8 Messages 65 Chapter 9 Troubleshooting 67 Cleaning 83 Connectors 71 Contacting Masimo 86 Customizing Windows 37 D Device Output 46 Device Settings 39 Display 70 E Electrical 69 EMC Compliance 73 Environmental 69 Ethernet 42 Exclusions 87 F Fea...

Page 108: ...cription Features and Intended Use 9 Profiles 48 R Radical 7 Battery 44 Radical 7 Connection 24 Recommended Separation Distances 78 Repair Policy 85 Replacing the Fuses 83 Restrictions 88 Return Procedure 86 Root Battery 43 Root Charging Indicator 57 S Safety Information Warnings and Cautions 11 Safety Standards Compliance 74 Sales End User License Agreement 87 Side Views 19 Software Compliance 73...

Page 109: ...derstanding Windows 32 Unpacking and Inspection 21 Using Analog View 34 Using Iris Connectivity Ports 63 Using MOC 9 Ports 59 Using the Touchscreen Interface 28 Using Trend View 33 W Warranty with Battery 87 Wi Fi 41 Wireless Specifications 71 ...

Page 110: ...Root Outside Back Cover www masimo com 108 Masimo Outside Back Cover ...

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